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Title:
FLUID FILLED INSOLE
Document Type and Number:
WIPO Patent Application WO/1999/049747
Kind Code:
A1
Abstract:
A fluid filled insole comprises a fluid tight bladder having upper and lower layers and a generally foot-shaped, planar configuration, with proximal forefoot, midfoot and hindfoot regions; a heavy, viscous, sterile liquid substantially filling the bladder; at least two but no more than six transversely spaced forefoot flow deflectors joining the upper and lower layers in the proximal forefoot region of the bladder; at least one but no more than five transversely spaced hindfoot flow deflectors joining the upper and lower layers in the hindfoot region of the bladder; flow passages matched to the anatomical structure of the foot between the forefoot and hindfoot flow deflectors and the medial and lateral and peripheral margins of the bladder; a flow controller matched to the border between the lateral and medial longitudinal arch, whereby liquid flows from the hindfoot region to the forefoot region and vice versa. The flow through the insole passages and channels matches the anatomical structure of the foot; disperses the user's weight evenly over the area of the foot, thereby reducing peak pressures on the plantar surfaces of the user's foot; provides directional stability when using the insole for walking, running or standing; improves the venous pump function with resulting medical benefits; and ensures an accumulation of liquid under the medial arch of the user's foot to form a liquid pillow that matches the anatomical structure of the medial longitudinal arch.

Inventors:
SCHOESLER HENNING RAUN (DK)
Application Number:
PCT/DK1999/000116
Publication Date:
October 07, 1999
Filing Date:
March 08, 1999
Export Citation:
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Assignee:
SCHOESLER HENNING RAUN (DK)
International Classes:
A43B17/02; A43B17/03; (IPC1-7): A43B13/40
Foreign References:
DE19522100A11996-11-28
US4567677A1986-02-04
US5806208A1998-09-15
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Claims:
What is Claimed Is : (FINAL CI CLAIMS 19.7.1996, USA, Application No.: 08/687, 787)
1. An improved insoie adapted to be worn beneath the wearer's foot, the foot having a first metatarsal, second metatarsal and lateral metatarsal bones, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally footshaped configuration with a metatarsal region, a heel region and an arch region there between, wherein the improvement comprises : at least two but no more than six transversely spaced flow deflectors in the metatarsal region of said bladder ; at least three, but no more than seven longitudinal flow passages between each of said flow deflectors and between said flow deflectors and the lateral and medial margins of the metatarsal region of said bladder. said metatarsal flow passages being spaced transversely across the metatarsal region of said bladder, one said metatarsal flow passage matched to underlie the first metatarsal bones of the wearer's foot, a second of said metatarsal flow passages matched to underlie the second metatarsal bones of the wearer's foot, and the remaining longitudinal flow passages matched to underlie the remaining lateral metatarsal bones of the wearer's foot, each said metatarsal flow passage extending in a straight, longitudinal, unobstructed path within the metatarsal region, and at least one of said metatarsal flow passages extending in a straight, longitudinal, unobstructed path between the metatarsal region and the arch region of said bladder, whereby said fluid is deflected by said flow deflectors to flow longitudinally through each said metatarsal flow passage in a straight, unobstructed path within said metatarsal region and from said metatarsal region to said arch region and vice versa.
2. An improved insole as in claim 1, wherein flow restricting means are placed in the proximal end of the metatarsal region, one said restrictor adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin, said pair of restrictors defining a longitudinal flow channel there between, said channel having a transverse width that is less than 50 per cent of the maximum straight transverse width of the metatarsal region of said bladder.
3. An improved insole as in claim 1, wherein said flow deflectors and resulting longitudinal flow passages are arranged in a shape that laterally, medially, transversely. and longitudinally matches the anatomical structure of one or more of the metatarsal bones, said shape being arranged in an arc, a semicircle, an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction.
4. An improved insole as in claim 1, wherein said improvement further comprises at least one but no more than five transversely spaced heel flow deflectors in the heel region of said bladder, and at least two but no more than six longitudinal heel flow passages in the heel region of said bladder, each said heel flow passage having a transverse dimension that is no more than ten percent greater than or less than any other heel flow passage, each said heel flow passage extending in a straight, unobstructed path within the heel region of said bladder, and at least one of said heel flow passages extending in a straight, longitudinal, unobstructed path from the heel region to the arch region of said bladder, whereby said fluid is deflected by said heel flow deflectors to flow longitudinally through each said heel flow passage in a straight unobstructed path within said heel region and from said heel region to said arch region and vice versa.
5. An improved insole as in claim 4, wherein said improvement further comprises a pair of heel flow restrictors in the distal end of the heel region of said bladder, one said heel flow deflectors adjacent the medial peripheral margin of said bladder and the other adjacent the peripheral lateral margin. said pair of heel restrictors defining at least one longitudinal heel flow channel there between, said heel channel having a transverse width of between 10 and 30 percent of the maximum straight transverse width of the heel region of said bladder.
6. An improved insole as in claim 1, the wearer's foot having a lateral midfoot, a medial arch and a border there between, said insole further comprising an elongated flow restricting means in the arch region of said bladder, the elongation of said flow restricting means matching the border between the medial longitudinal arch and lateral midfoot of the wearer's foot, said arch flow restricting means for restricting flow from said heel region to said. metatarsal region and vice versa, and defining a semienclosed region in which accumulation of liquid occurs when flowing into the arch region and vice versa, said accumulation forming a liquid pillow underlying and matching the high medial longitudinal arch area of the wearer's foot.
7. An improved insole as in claim 1, wherein said bladder comprises an upper layer and a lower layer joined at their peripheral margins, said bladder further comprising a layer of sweat absorbing material laminated to and substantially covering the outer surface of said upper layer, said material enabling perspiration.
8. An improved insole as in claim 1, wherein said fluid comprises 85 to 98 percent by weight of large molecular, hygroscopic, polyvalent alcohol and 2 to 15 percent by weight distilled water, and/or wherein flow of said fluid is restricted by the viscosity and density of said fluid being at least 1.10 times the density and viscosity of water.
9. An improved insole as in claim 1, wherein each said metatarsal flow passage has a transverse dimension that is no more than ten percent greater than or less than any other metatarsal flow passage.
10. An improved insole as in claim 1 wherein said bladder comprises an upper layer and a lower layer of thermoplastic film, each said bladder layer being of about 600 to about 800 micrometer thickness, said bladder layers being welded to each other at their peripheral margins.
11. An improved insole as in claim 1, wherein said insole is incorporated into footwear.
12. An improved insole as in claim 1, further comprising barrier means in said bladder placed at the border between the arch and heel regions for preventing flow of said fluid from said arch region into said heel region; and a solid or semisolid shock absorbing material in said heel region of said bladder.
13. An improved insole as in claim 1, further comprising a transverse metatarsal wall at the proximal end of said metatarsal region, said metatarsal wall extending from lateral peripheral margin to the medial peripheral margin of said bladder, said transverse wall having at least one opening therein, said opening defining a longitudinal flow channel between said metatarsal and said arch regions of said bladder, and a transverse heel wall at the distal end of said heel region, said heel wall at the distal end of said heel region, said heel wall extending from lateral peripheral margin to the medial peripheral margin of said bladder, said heel wall having at least one opening therein, said opening defining a longitudinal flow channel between said heel and said arch regions of said bladder.
14. An improved insole as in claim 1, the wearer's foot having a lateral midfoot and a medial longitudinal arch, said insole further comprising a pair of flow restrictors in the arch region of said bladder. one said restrictor underlying the medial longitudinal arch and the other restrictor underlying the lateral midfoot, said arch flow restrictors defining at least one longitudinal arch flow channel there between for flow of said fluid from said metatarsal region to said heel region and vice versa, said one restrictor underlying the medial arch having an opening therein to accept said fluid within said one restrictor defining a semi enclosed region in which accumulation of liquid occurs when flowing through said opening and vice versa, said accumulation forming a liquid pillow underlying and matching the medial longitudinal arch area of the wearer's foot.
15. An insole, comprising a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, sweat absorbing, flexible material; said upper and lower layers being sealing joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, footshaped configuration having a metatarsal region, a heel region and an arch region there between; at least two but no more than six transversely spaced metatarsal flow deflectors between said upper material layer and said lower material layer in said metatarsal region; longitudinal metatarsal flow passages between said metatarsal flow deflectors and between said metatarsal flow deflectors and the medial and lateral margins of said bladder, each said metatarsal flow passage having a transverse dimension of between 0.95 and 1.05 times Wm, where Wm equals Wm = (Dm ~ Sm)/ (Nm + 1) where Dm is the maximum straight transverse width of said metatarsal region, Sm is the sum of the transverse dimensions of said metatarsal flow deflectors, and Nm is the number of metatarsal flow deflectors; said metatarsal flow passages extending in a straight, unobstructed, longitudinal path within the metatarsal region, and at least one of said metatarsal flow passages extending in a straight, unobstructed, longitudinal path between said metatarsal region and said arch region; at least one but no more than five evenly and transversely spaced heel flow deflectors between said upper material layer and said lower material layer in said heel region; longitudinal heel flow passages between each said heel flow deflector and between said heel flow deflectors and the medial and lateral margins of said bladder, each said heel flow channel having a transverse dimension of between 0.95 and 1.05 times Wh, where Wh equals Wh = (D,Sh)/ (N. +1) where Dh is the maximum straight transverse width of said heel region, Sh is the sum of the transverse dimensions of said heel flow deflectors, and Nh is the number of heel flow deflectors; said heel flow passages extending in a straight, unobstructed, longitudinal path within the heel region, and at least one of said heel flow passages extending in a straight, unobstructed, longitudinal path between said heel region and said arch region; and communicating with the heel and arch regions of said bladder ; and a sterile fluid within said bladder, said fluid having a density and viscosity of at least 1.10 times that of water and comprising about 85 to 98 percent large molecular, polyvalent hygroscopic alcohol and about 2 to 15 percent distilled water, said fluid flowable from said heel region to said metatarsal region and vice versa and flowable through said metatarsal flow passages and said heel flow passages.
16. An insole as in claim 15. wherein the insole is adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral midfoot, a medial longitudinal arch and a longitudinal border there between, said insole further comprising an elongated flow restricting means in the arch region of said bladder, the elongation of said flow restricting means matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal midfoot of the wearer's foot. said arch flow restricting means for restricting flow from said heel region to said metatarsal region and vice versa, and defining a semienclosed region in which accumulation of liquid occurs when flowing into the medial longitudinal arch region and vice versa, said accumulation forming a liquid pillow underlying and matching the medial longitudinal arch area of the wearer's foot.
17. An insole as in claim 15, further comprising a layer of sweat absorbing material laminated to and substantially covering said outer surface of said upper layer of flexible material.
18. An improved insole as in claim 15, wherein said insole is adapted to be worn beneath the anatomical structure of the wearer's foot, the foot having first metatarsal, second metatarsal and lateral metatarsal bones, and wherein one of said metatarsal flow passages is matched to underlie the first metatarsal bones of the wearer's foot, a second of said metatarsal flow passages is matched to underlie the second metatarsal bones of the wearer's foot, and the remaining flow passages are matched to underlie the remaining lateral metatarsal bones of the wearer's foot.
19. An insole, comprising a substantially fluid tight bladder, said bladder comprising an upper layer and a lower layer sealing joined at their peripheral margins, said bladder having a generally foot shaped planar configuration with a metatarsal region, a heel region and an arch region there between ; a sterile, nontoxic liquid substantially filling the metatarsal and arch regions of said bladder, said liquid comprising about 85 to 98 percent large molecular hygroscopic, polyvalent alcohol and about 2 to 10 percent distilled water; at least two evenly and transversely spaced metatarsal weld points joining said upper and lower bladder layers in said metatarsal region of said bladder ; longitudinal, metatarsal flow passages in said metatarsal region between said metatarsal weld points, between said metatarsal weld points and the medial margin of said metatarsal region of said bladder and between said metatarsal weld points and the lateral margin of said metatarsal region of said bladder, each metatarsal flow passage having a transverse dimension that is no more than 10 per cent greater or smaller than any other metatarsal flow passage, said metatarsal flow passages being substantially parallel and evenly spaced transversely across the metatarsal region of said bladder, said sterile liquid being flowable in an unobstructed longitudinal direction through each of said metatarsal flow passages in the metatarsal region and between the metatarsal and arch regions of said bladder ; barrier means in said bladder for preventing flow of said fluid from said metatarsal and arch regions into said heel region : a solid or semisolid shock absorbing material sandwiched between said upper and lower bladder layers in said heel region.
20. An improved insole adapted to be worn beneath the wearer's foot, the foot having a first metatarsal, second metatarsal, lateral metatarsal bones, a lateral midfoot, a medial arch and a border there between, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally footshaped configuration with a metatarsal region, a heel region and an arch region there between, wherein the improvement comprises: at least three but no more than seven metatarsal flow passages between said flow deflectors and between the lateral and medial peripheral margins of the metatarsal region of said bladder, said metatarsal flow passages being spaced transversely across the metatarsal region of said bladder, one said metatarsal flow passage matched to underlie the first metatarsal bones of the wearer's foot, a second of said metatarsal flow passages to underlie the second metatarsal bones of the wearer's foot, and the remaining flow passages to underlie the lateral metatarsal bones of the wearer's foot, each said metatarsal flow passage extending in a straight, longitudinal, unobstructed path within the metatarsal region, and at least one of said metatarsal flow passages extending in a straight, longitudinal, unobstructed, substantially parallel path between the metatarsal region and the arch region of said bladder, whereby said fluid is deflected by said flow deflectors to flow longitudinally through each said metatarsal flow passage in a straight, unobstructed, substantially parallel path within said metatarsal region and from said metatarsal region to said arch region and vice versa; a pair of flow restrictors in the proximal end of the metatarsal region, one said restrictor adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin, said pair of restrictors defining at least one longitudinal flow channel there between, said channel having a transverse width that is less than 50 per cent of the maximum straight transverse width of the metatarsal region of said bladder ; at least one but no more than five transversely spaced heel flow deflectors in the heel region of said bladder, and at least two but no more than six longitudinal heel flow passages in the heel region of said bladder, each said heel flow passage having a transverse dimension that is no more than ten percent greater than or less than other heel flow passage, each said heel flow passage extending in a straight, unobstructed, substantially parallel path within the heel region of said bladder, and at least one of said heel flow passages extending in a straight. longitudinal unobstructed path from the heel region to the arch region of said bladder, whereby said fluid is deflected by said heel flow deflectors to flow longitudinally through each said heel flow passage in a straight unobstructed path within said heel region and from said heel region to said arch region and vice versa ; a pair of heel flow restrictors in the distal end of the heel region of said bladder, one of said heel flow restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the peripheral lateral margin, said pair of heel restrictors defining a longitudinal heel flow channel there between, said heel channel having a transverse width of between 10 and 30 per cent of the maximum straight transverse width of the heel region of said bladder ; and an elongated flow restricting means in the arch region of said bladder, the elongation of said flow restricting means matching the border between the medial longitudinal arch and the lateral midfoot of the wearer s foot. said arch flow restricting means for restricting flow from said heel region to said metatarsal region and vice versa, and defining a semienelosed region in which accumulation of liquid occurs when flowing into said medial arch region and vice versa, said accumulation forming a liquid pillow underlying and matching the medial longitudinal arch area of the wearer's foot.
Description:
FLUID FILLED INSOLE Cross Reference : This application is a continuation-in-part of copending application serial no.

08/047, 685 filed on April 15,1993, now abandoned.

Background of the Invention : The present invention is directed to therapeutic fluid filled insoles, and more particularly to insole bladders having fluid flow directing and restricting members within the bladder with the purpose of achieving improved medical benefits and directional stability to the users.

Fluid filled insoles have long been known in the art, see for example, U. S. Patent No.

4,567,677 to James Zona, U. S. Patent No. 4,115,934 to Hall, U. S. Patent No. 4,123,855 to Thedford, U. S. Patent No. 2,080,469 to Gilbert and U. S. Design Patent No. D246, 486 to John W. Nickel. Prior art insoles commonly comprise a bladder having an upper layer and a lower layer. The two layers are welded together at their marginal periphery. The bladder has a planar, foot-shaped configuration, which includes a forefoot region, a hindfoot region, and a midfoot region there between. The bladder is filled with a fluid, such as water or air. The broader technical functions of fluid filled insoles are well documented, whereas the medical benefits are only partly documented. It is not generally known that fluid filled insoles may be designed to accomplish specific medical benefits. The known technical functions include cushioning of the feet by a massaging action on the plantar surface of the feet due to movement of the fluid within the bladder, thus achieving comfort to the user.

The fluid filled insoles of the prior art have not been entirely satisfactory, however, in the area of providing demonstrative medical benefits, neither as a device for eliminating or relieving fatigue in the lower extremities by providing stress distribution and activation of the venous pump function nor for achieving directional stability to the user when wearing the insole. Existing prior art insoles have little or no means for controlling both the transverse and longitudinal flow and the rate of fluid flow within the insole nor for matching the flow of fluid to the anatomical structure of the foot. As a user walks, the user's weight is initially applied to heel, and then is transferred to the ball of the foot. This causes the fluid within the bladder to move, respectively, from the hindfoot region to the forefoot region and then back towards the hindfoot again. Without means for directing fluid flow anatomically within the bladder, the fluid will flow uncontrollably and thus causing directional instability to the user when wearing the insole. Without means for controlling and restricting the rate of fluid flow vis-a-vis viscosity and density of the fluid, the user's feet will simply jump through the fluid, and thus the fluid insole has no cushioning or massaging effect.

Some prior art devices, such as the insole of the Zona patent, have attempted to regulate flow from the hindfoot region to forefoot region and vice versa by placing flow restricting means in the midfoot area of the bladder. These flow restricting devices are only partly effective, however, since they neither match the anatomical structure of the foot nor regulate or direct the flow within the forefoot or hindfoot regions of the bladder to achieve directional stability and local stress distribution. In addition, the midfoot flow restricting means are not matched to the longitudinal medial anatomical structure of the arch. Matching the anatomical structure of the foot to the location, direction, quantity and duration of fluid flow are important to achieve therapeutic benefits, stress distribution and directional stability.

Some prior art insoles, as shown for example in the Hall or Nickel patents have attempted to regulate fluid flow within the forefoot and hindfoot regions. But, these efforts have not been satisfactory because the fluid flow is not matched to the anatomical structure of said regions, but rather directed to the outer, medial and lateral, margins of the insole, away from the areas of the foot where fluid massaging action and pressure distribution is required when considering the physiology and anatomy of the foot.

The Thedford patent has also attempted to regulate fluid flow within the forefoot and hindfoot regions. These teachings have not been satisfaetory-because the fluid flow is neither adapted to the anatomical structure of the foot nor arranged in a fashion that achieves directional stability to the user during the flow of fluid within the insole. Further, the Thedford patent teaches prohibition or blocking of longitudinal flow within the bladder, redirecting the flow in a transverse direction.

The Gilbert patent has attempted to regulate fluid flow by randomly dispersing flow restrictors across the entire surface of the insole, which, again, does neither match the anatomical structure of the foot nor achieve directional stability. The Gilbert patent does not specify any particular arrangement of flow restrictors or fluid flow, but teaches that the "spots""may be disposed at any desirable location with any desirable frequency"which makes flow control indefinite. Further, the Gilbert patent permits air to shift in any direction and partly arranges flow restricting means to block longitudinal flow.

Many prior art insoles are filled with ordinary water or other fluids that not only quickly evaporate and thus significantly reduces the industrial applicability (life time) of the insole, but also develops bacteria and/or other microorganisms, causing the fluid to become toxic and thus environmentally unsafe. In addition, existing prior art insoles do not consider the fluid itself as a flow restricting means and thus significantly limits the therapeutic value of the insole by allowing the fluid to flow at a rate that cannot satisfactorily provide pressure distribution.

Finally, none of the prior art insoles considers local pressure distribution within the midfoot, forefoot and hindfoot regions of the bladder by directing, controlling and restricting the flow of fluid within the midfoot, forefoot and hindfoot regions. This lacking consideration significantly limits the medical and therapeutic applications of the prior art insoles. It would be desirable to have a fluid filled insole that (i) controls and directs the fluid to match the anatomical structure of the foot and achieve directional stability to the user wearing the insole, (ii) maximizes even pressure distribution to minimize peak pressures on the foot, both across the entire area of the foot and within each of the hindfoot, midfoot and forefoot regions, (iii) ensures minimum evaporation of the fluid to maximize the life time of the insole, (iv) provides a fluid that is environmentally safe, and (v) devises a fluid that functions as a flow restricting means vis-a-vis the density and viscosity of said fluid, and which otherwise overcomes the limitations inherent in the prior art.

OBJECTS OF THE INVENTION: It is an object of the invention to provide an insole that has a superior therapeutic fatigue-relieving effect by providing maximum pressure distribution in each of the hindfoot, midfoot and forefoot areas of the plantar surface of the user's foot, thereby improving the venous pump function and increasing blood circulation.

It is a further object of the invention to provide a fluid filled insole wherein the fluid flow matches the anatomical structure of normal feet; the fluid being directed and controlled in transverse and longitudinal flow passages that are adapted to the anatomical structure of normal feet, thereby achieving directional stability for the user when wearing the insole.

It is another object of the invention to provide a liquid filled insole that maximizes even distribution of the user's weight both over the total area of the foot and within each of the hindfoot, midfoot and forefoot regions, reducing peak pressures on the plantar surfaces of the user's feet.

It is a fourth object of the invention to provide an insole filled with a sterile, non- toxic, non-greasy fluid that not only has low evaporation and diffusion rates but also remains non-toxic during the entire life time of the insole.

It is a fifth object of the invention to provide a liquid filled insole that is durable and not prone to lose fluid by leakage, evaporation or diffusion, thus prolonging the life time of the insole.

It is a sixth object of the invention to provide a fluid filled insole that maximizes even pressure distribution within each of the forefoot, midfoot and hindfoot regions by (i) restricting the flow of liquid between the three regions and by (ii) directing po controlling the liquid within each of the regions (local pressure stress distribution).

It is a seventh object of the invention to provide a fluid filled insole that provides shock absorption in the heel area and maximizes even pressure distribution within each of the forefoot and midfoot regions.

It is an eighth object of the invention to provide a fluid filled insole that accumulates as much liquid as possible within each of the hindfoot and forefoot areas.

SUMMARY OF THE INVENTION: The insole of the invention comprises a fluid tight bladder having an upper layer of flexible material and a lower layer of flexible material sealingly joined together at their peripheral margins. The bladder has a generally foot shaped planar configuration, with a proximal forefoot region, a hindfoot region, and a midfoot region there between. The bladder is filled with a large molecular, non-evaporable, highly viscous, sterile liquid, preferably a mixture of hygroscopic, polyvalent alcohol and distilled water. Within the proximal forefoot region of the bladder is positioned between two and five flow deflectors, equally spaced transversely one from the other, and spaced from the medial and lateral margins of the bladder. The flow deflectors comprise weld points joining the upper and lower bladder layers. Substantially equally sized longitudinal flow channels are formed between the flow deflectors and between the flow deflectors and medial and lateral margins of the bladder.

In the proximal part of the forefoot area is positioned a flow controller that restricts the flow of fluid between the proximal part of the forefoot region to the midfoot region and vice versa.

Between two and five, preferably two, flow deflectors are located in the hindfoot region of the bladder. At least one longitudinal hindfoot flow channel is formed between the heel flow deflectors, and at least two longitudinal channels are formed between the hindfoot flow deflectors and the medial and lateral margins of the bladder. Thereby, fluid flowing within the hindfoot and forefoot regions and from these regions into the midfoot region and vice versa will be channeled through the longitudinal flow channels in the forefoot and hindfoot regions in a controlled fashion, resulting in enhanced medical and therapeutic benefits as explained below.

The bladder is filled with a large molecular, non-evaporable, highly viscous, sterile liquid, preferably a mixture of hygroscopic, polyvalent alcohol and distilled water. The fluid has a viscosity and density of at least 1. 10 times that of ordinary water. I refer to this as a "heavy liquid."For the above reasons, the density of the fluid, measured by g/m3, is higher than the density of water (density= weight), because a higher weight of the fluid (compared to water) restricts the flow of fluid. For the same reasons, the thickness (viscosity) is also higher than water, because a higher thickness of the fluid (compared to water) restricts the flow of fluid. This mixture is sterile, non-toxic and resistant to contamination by bacteria or other microorganisms, thereby ensuring an environmentally safe fluid within the insole.

Further, the mixture of hygroscopic, polyvalent alcohol and distilled water is not susceptible to evaporation or diffusion through the bladder layers. It is also autoclavable. In the event of a bladder puncture, the liquid may be easily removed from clothing and footwear, as the mixture is relatively non-greasy.

The insole of the invention has been tested and found to provide several desirable medical and therapeutic benefits. The insole relieves fatigue during prolonged standing or walking by distributing the user's weight evenly and symmetrically over the area of the foot, thereby reducing peak pressures exerted on the plantar surface of the user's foot and the deformation of soft tissue. The reduction in pressure thereby further relieves stress on the bones of the foot that can cause foot pain, hard skin and in extreme situations, ulceration.

Second, the controlled flow of fluid through the bladder across the plantar surface of the user's feet provides a therapeutic movement of the small intrinsic muscles of the feet.

The movement of the muscles animates the venous pump function increasing blood circulation, which in turn improves transport of oxygen and nutrients to the cells in the foot and removal of waste products excreted from the cells. Improved blood circulation reduces the amounts of lactic acid, thereby reducing the occurrence of myasthenia ("tired muscles").

Third, the specific locations of the flow deflectors enable a fluid flow that is matched to the anatomical structure of the foot and thus aid in physiologically correct walking and running. This in turn provides not only directional stability when the fluid moves within the insole, but also corrects the foot abnormalities over supination and over pronation found in asymmetric feet.

Other attributes and benefits of the present invention will become apparent from the following detailed specification when read in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS : Fig. 1 is a plan view of a first embodiment of the fluid filled insole of the invention.

Fig. 1-B is a plan view of the human foot illustrating the medial and lateral portions thereof.

Fig. 1-C is a dorsal view of the bones of the human foot.

Fig. 2 is a cross-sectional view of the first embodiment of the invention taken along line 2-2 of Fig. 1.

Fig. 3 is a cross sectional view of the first embodiment of the invention taken along line 3-3 of Fig. 1.

Fig. 4 is a plan view of a second embodiment of the invention.

Fig. 5 is a plan view of a third embodiment of the invention.

Fig. 6 is a plan view of the fourth embodiment of the invention.

Fig. 7 is a plan view of a fifth embodiment of the invention.

Fig. 8 is a plan view of a sixth embodiment of the invention.

Fig. 9 is a plan view of a seventh embodiment of the invention.

Fig. 10 is a cross-sectional view of the seventh embodiment of the invention taken along line 10-10 of Fig. 9.

Fig. 11 is a plan view of an eighth embodiment of the invention.

Fig. 12 is a plan view of a ninth embodiment of the invention.

Fig. 13 is a plan view of a tenth embodiment of the invention.

Fig. 14 is a plan view of an eleventh embodiment of the invention.

DETAILED DESCRIPTION : Turning now to the drawings, Figs. 1-B and 1-C illustrate the structure of the human foot. The foot comprises a (i) hindfoot region containing the talus 1 and os calcis 2 bones; (ii) a midfoot region containing the cuneiform 3, cuboid 4 and navicular 5 bones; and the forefoot region comprising the metatarsals 6, the proximal phalanges 7, and the middle 8 and distal 9 phalanges. The forefoot region can be divided into two sub-regions, the distal sub- region comprising the middle and distal phalanges, and the proximal forefoot region which comprises the metatarsals and proximal phalange. The ap tnp) ude a longitudinal arch, having a medial and a lateral side. The medial longitudinal arch is defined by the navicular and medial cuneiform bones of the midfoot and the about the proximal half of the first, second and third metatarsals.

In Figs. 1 through 3, a first embodiment of the fluid filled insole of the invention is shown. The insole comprises a bladder 10 having an upper layer 12 and a lower layer 14.

The insole preferably further includes a layer of sweat absorbing material 16 substantially covering and laminated to the outer surface of upper layer 14. The bladder layers 12 and 14 are sealing joined at their peripheral margins 18. For reference, the medial peripheral margin is numbered 20 and the lateral peripheral margin is numbered 22. The bladder comprises three main regions, namely a forefoot region 25, a hindfoot region 26 and a midfoot region 28 therebetween. The forefoot region is divided into a distal subregion 30 and a proximal forefoot region 24.

The interior cavity 32 of the bladder 10 is filled with a sterile, non-toxic, non- evaporable fluid with a density and viscosity of at least 1.10 times that of water. The fluid is preferably a"heavy liquid"mixture of large molecular, hygroscopic polyvalent alcohol and distilled water, as is more fully described below. The fluid may flow between and throughout the proximal forefoot, midfoot and hindfoot regions. The distal forefoot sub- region preferably does not contain fluid. Within the proximal forefoot region 24 of bladder 22 there are at least two but no more than six transversely spaced flow deflectors 34.

Preferably, there are three forefoot flow deflectors 34, but, one could employ between two and six forefoot flow deflectors. The shape of the flow deflectors is preferably circular or oval, but other shapes may alternatively be used. The distance between each of the flow deflectors and between the flow deflectors and the medial and lateral peripheral margins of the bladder forms longitudinal, substantially parallel, forefoot flow passages. Each flow passage has a substantially equal transverse dimension, W",. By"substantially equal transverse dimension,"I mean between 0.95 and 1.05 times Wm, where Wm is calculated as follows: Wm = (Dn~Sm)/ (Nm + 1) Dm is the maximum straight transverse width of the forefoot region, Sm is the sum of the transverse dimensions of the forefoot flow deflectors, and Nm is the number of forefoot flow deflectors.

The forefoot flow deflectors are arranged in a shape that laterally, medially, transversely and longitudinally matches the anatomical structure of the proximal forefoot region, the shape being for example, but not limited to, an arc, a semicircle, or a trapezoid, the convex side of the shape facing in a distal direction. The spacing between the flow deflectors depends on (i) the shoe or foot size, (ii) the diameter of the flow deflectors, and (iii) the number of flow deflectors. With two forefoot flow deflectors, the spacing from centerline to centerline between flow deflectors would be 33 % or one third of the transverse straight distance between the lateral and medial peripheral margins of the bladder measured at the location of the flow deflectors. If n flow deflectors are placed in the proximal forefoot region, then n + 1 longitudinal flow passages are formed.

The flow deflectors 34 are formed by weld points joining the upper blade layer 12 to the lower bladder layer 14. Formation of flow deflectors by welding points joining the bladder layers improves the structural integrity of the bladder, improving durability. Between flow deflectors 34 are flow passages 36 through which fluid flows during use of the insole.

Additional flow passages 38 are also formed in the proximal forefoot region between flow deflectors 34 and the medial peripheral margin 20, and between flow deflectors 34 and the lateral peripheral margin 22. The forefoot flow passages 36 and 38 extend in a straight, unobstructed, longitudinal direction. By"longitudinal"it is meant that the flow direction varies by no more than 10 degrees (plus or minus) from the straight longitudinal axis of the insole. Flow deflectors 34 are shown as being circular, but other shapes, such as oval or ellipse, may be alternatively used.

In the hindfoot region 26 of bladder 10 there are at least one but no more than five flow deflectors 40. Because the hindfoot region is a smaller area than the forefoot region, two flow deflectors are preferably used. Alternatively, one, three, four or five could be used. The hindfoot flow deflectors 40 are formed in the same manner as the forefoot flow deflectors, by a weld point joining the upper and lower bladder layers 12 and 14. At least one generally longitudinal flow passage 42 is formed between hindfoot flow deflectors 40, if two or more hindfoot deflectors are used. Additional hindfoot flow passages 44 are formed between hindfoot deflectors 40 and the medial and lateral peripheral margins of the bladder.

Bridging the proximal forefoot region and the midfoot region 28 of bladder 10 are flow controllers 46, which are generally matched to the wearer's arch. The arch flow controllers may be configured in several different ways, but must match the contour or anatomical structure of the longitudinal arches of a normal foot, as described above in reference to Figs. 1-B and 1-C. The lateral edge of the longitudinal medial arch is generally an elongated semicircle line at the longitudinal border of the lateral and medial arch of a normal foot, such as shown in Fig. 1-B. The longitudinal medial arch extends from the proximal part of the midfoot area to about the mid-point of the metatarsals, as shown in Fig.

1-B, defining an arch area 29. Flow controller 48 is shaped and located to match at least a portion of the border between the medial and lateral longitudinal arch. A somewhat restricted, central flow channel 52 is formed between controllers 48 and 50. Side flow channels 54 are formed between the flow controllers 46 and the peripheral margins 18 of bladder 10.

The second through sixth embodiments of the fluid filled insole of the invention, Figs.

4 through 8, are identical in all respects except that alternative flow controllers in the arch area 29 of the bladder are employed. The second embodiment of the invention, illustrated in Fig. 4, shows a flow controller comprising three weld points 56 joining the upper and lower bladder layers. Arch flow channels 58 are formed between the weld points.

Fig. 5 shows the third embodiment of the insole of the invention. The flow controllers in the arch region comprises a multiplicity of weld points 60 arranged in a diagonal arc. Plural flow channels 62 are formed between the weld points.

Fig. 6 illustrates a fourth embodiment of the fluid filled insole of the invention. The fourth embodiment is characterized by a multiplicity of weld points 64 arranged in a semicircular elongated line that matches the anatomical structure of the medial longitudinal arch, such as depicted in Fig. 1-B, and that is located at the border between the lateral and medial longitudinal arches. Arch flow channels 68 are formed between the weld points.

Figs. 7 and 8 illustrate, respectively, fifth and sixth embodiments of the fluid filled insole of the invention. The fifth embodiment has a longitudinal arch flow controller comprising a single elongated semicircle shaped weld 70, between the upper and lower bladder layers, forming adjacent flow channel 72. The sixth embodiment has a longitudinal arch flow controller comprising two elongated semicircle shaped welds 74 forming an interior flow channel 76.

Fig. 9 and 10 illustrate a seventh embodiment of the invention. The seventh embodiment is similar to the fifth embodiment, Fig. 7, except for the construction of the hindfoot region, which comprises a shock absorbing foam material or a non-flowable, semi- solid gel, as opposed to a flowable liquid filled bladder. More specifically, the seventh embodiment comprises a bladder 10 having an upper layer 12 and a lower layer 14. A layer of sweat absorbing material 16 is laminated to the outer surface of the upper layer 14. The bladder 10 has a liquid filled proximal forefoot region 24 and midfoot region 28. The proximal forefoot region 24 includes transversely spaced flow deflectors 34 and longitudinal flow channels 36 and 38 as described above. The arch region 29 includes a flow controller 70 and flow passage 72. The insole further comprises a hindfoot region 26 and a distal forefoot region 30, but these latter two regions are not filled with flowable liquid. Rather distal forefoot region 30 is unfilled and hindfoot region 26 is filled with either a static, non- flowable, semi-solid gel or a shock absorbing foam cushion 78. A barrier wall 80 separates the liquid filled regions 24 and 28 from the hindfoot region 26 and prevents liquid from flowing from the proximal forefoot and midfoot regions into the heel region.

The eighth to the eleventh embodiments of the fluid filled insole of the invention, Figs. 11-14, show new flow restricting features in the arch region 29, in the distal part of the hindfoot region and in the proximal part of the proximal forefoot region. The four embodiments all have arch flow controllers similar to flow controller 46 and a shape similar to elongated semicircle line in Fig. 1-B. The numeration of said flow controllers is 72 in Figs. 11-14. Figure 11 shows the eighth embodiment of the invention. It is similar to Figure 1 with a single longitudinal arch flow controller comprising a single elongated semicircular shaped weld 72 and, forming adjacent flow channel 70. The weld 72 is placed at the border between the longitudinal lateral and medial arches, such as depicted in Fig. 1-B, and being similar to weld line 48 in Fig. 1. In the distal part of the hindfoot region are placed hindfoot flow restrictors 90 adjacent to the lateral and medial peripheral margins, this pair of hindfoot flow restrictors defining a longitudinal channel 91 therebetween, the channel 91 having a transverse width of between 10 and 30 percent of the maximum straight transverse width of the hindfoot region of the bladder.

Figure 12 shows the ninth embodiment of the invention. It is similar to Figure 11 except for the additional placement of a pair of flow restrictors 92 in the proximal end of the proximal forefoot region. One restrictor 92 is adjacent the medial peripheral margin, and the other is adjacent the lateral peripheral margin. The pair of restrictors 92 define a longitudinal flow channel 93 therebetween, the channel 93 having a transverse width that is less than 50% of the maximum straight transverse width of the proximal forefoot region of the bladder.

Figures 13 and 14 illustrate, respectively, tenth and eleventh embodiments of the fluid filled insole of the invention. The tenth embodiment, Fig. 13, shows a communicating compartmentalized structure of the insole. Substantially transverse walls 43 and 45 are formed at the intersections of (i) the proximal part of the proximal forefoot region and the distal part of the arch region, and (ii) the proximal part of the arch region and the distal part of the hindfoot region. The transverse wall 43 is located at the intersection between the proximal part of the forefoot region and the distal part of the longitudinal arch region have at least one opening, preferably one at the midpoint, forming a substantially straight longitudinal channel 47 through which the fluid can flow from the proximal forefoot region and into the midfoot region and vice versa. The size of the opening is between 10% and 25% of the straight distance between the lateral and medial peripheral margins measured at the location of said transverse wall. The opening is not limited to one but could be several openings. The opening is preferably placed at the midpoint on said transverse wall 43, but could be placed anywhere along said transverse wall.

The transverse wall 45 located at the border between the proximal part of the midfoot region area and the distal part of the hindfoot region has at least one opening, preferably one at the midpoint, forming a substantially straight longitudinal channel 49 through which the fluid can flow from the hindfoot region and into the midfoot region and vice versa. The size of the opening is between 10% and 25% of the straight distance between the lateral and medial peripheral margins measured at the location of the transverse wall. The opening 49 is not limited to one but could be several openings. The opening is preferably placed at the midpoint of the transverse wall, but could be placed anywhere along the transverse wall.

Fig. 13 has an arch flow controller identical to the one in Fig. 1, Fig. 11 and Fig.

12, comprising a single elongated semicircle shaped weld 72, between the upper and lower bladder layers, forming adjacent flow channel 70. In the area or volume defined by the longitudinal arch flow controller 72 and the medial peripheral margin of the bladder a liquid pillow is formed that matches the anatomical structure of the medial longitudinal arch region of a normal foot. The flow controller must have a shape as an elongated semicircle and be placed at the border between the lateral and medial arch of a normal foot. The width range is two to ten millimeters, depending on the foot or shoe size. In this way, liquid will flow from the proximal forefoot region and into the medial arch region, thus forming a liquid pillow under the area of the medial arch.

Fig. 14 shows an eleventh embodiment of the invention. The eleventh embodiment is generally a communicating, semi-compartmentalized structure in which the liquid is controlled by two elongated flow restrictors 51 and 53 extending from the proximal forefoot region to the hindfoot region. Thus, the entire longitudinal arch region is divided into two elongated flow restrictors 51 and 53 of substantially equal area. The two flow restrictors 51 and 53 are semicircular lines that form medial and lateral longitudinal arch areas 55 and 57.

A substantially straight longitudinal channel 59 is formed in the arch region between the two flow restrictors 51 and 53 in which liquid flows from the proximal forefoot region through the longitudinal arch channel and into the hindfoot region. The lateral elongated flow restrictor 53 generally extends through the intersection between the longitudinal arch and proximal forefoot region and further to the lateral peripheral margin also at said intersection.

The medial elongated flow restrictor 51 generally extends through the intersection between the longitudinal arch and proximal forefoot region and further to the medial peripheral margin also at said intersection.

In the lateral proximal corner of the proximal forefoot region, flow of liquid is blocked by the elongated lateral flow restrictor 53 and thus cannot flow into the lateral longitudinal arch region 57, but only through the longitudinal channel 59 between the two elongated flow restrictors. In the medial proximal corner of the proximal forefoot region, an opening 61 is made with the purpose of allowing liquid from the proximal forefoot region to flow into the medial longitudinal arch region 55. Thereby, liquid may accumulate within the area of the medial longitudinal arch. Thus, liquid may flow from the proximal forefoot region through both the longitudinal channel 59 between the two elongated flow restrictors and through the opening 61 at the medial border between the arch and proximal forefoot region. Medial longitudinal arch region 55 has an elongated, semicircular weld line 72 that is identical to weld line 72 in the medial midfoot area of Fig. 11.

The bladder is preferably fabricated from polyurethane sheet although other thermoplastic materials, such as EVA, PVC or vinyl may also be used. The thickness of each bladder layer should be from about 600 to 800 micrometers, 600 micrometers being preferred. The sweat absorbing material is preferably about 250 micrometers in thickness.

The bladder may be formed by conventional radio frequency or dielectric welding techniques.

Other welding techniques, such as thermal welding may be used alternatively. The bladder is filled with the liquid mixture leaving an opening in the peripheral weld, through which liquid may be introduced, then sealing the opening. The insole of the invention may be made and sold as an insole for removable placement in shoes by the user. Also, the insole may be built into footwear as a permanent feature.

The fluid used to fill the cavity 32 of the bladder 10 is a mixture of distilled water and a sterile, non-toxic, non-evaporable, large molecular, hygroscopic liquid to prevent evaporation or diffusion through the bladder. Polyvalent alcohols with large molecules and with non-toxic properties are preferred. One suitable formulation comprises approximately 85-98%, hygroscopic polyvalent alcohol and approximately 2-15% distilled water. By using this mixture in lieu of plain water, improved benefits are achieved: The mixture of the invention as compared to water does not evaporate or diffuse through the bladder layers, thereby significantly improving life time and durability of the insole. The liquid can withstand autoclaving as may be required by health care institutions. The insoles can be used in temperature ranges from minus 20 degrees Celsius to plus 120 degrees Celsius, because both the liquid mixture and bladder materials can withstand these temperature extremes. The liquid is fully sterile and non-toxic, and thus environmentally safe.

The sterility and/or non toxicness of the fluid is extremely important for several reasons. Children, people and animals could bite the insole, possibly drinking or swallowing the liquid. Water becomes septic after a few months of storage in some insoles, because bacteria will grow and flourish in the water.

Compared to water, the mixture of polyvalent alcohol and distilled water has a significantly higher density and viscosity. The fluid of the invention has a preferred density and viscosity range of at least 1.10 times that of water. The actual filling of fluid with a particular density that is at least 1.10 times that of water depends on the flow restricting means within the bladder. Generally, the more the flow of liquid within the bladder is restricted by flow restricting means in the forefoot, midfoot and hindfoot regions, the lower the requirement for the density and viscosity of the liquid. Inversely, the fewer flow restricting means within the bladder, the higher the density and viscosity required. The density and viscosity of the fluid causes an improvement in the effects on the user's foot when wearing the insoles, because the density and viscosity generally controls the rate of flow of the viscous liquid within the insole. In this way, the density and viscosity determine not only the degree of pressure distribution with following reduction of peak pressures on the plantar surface of the foot, but also directional stability.

The liquid used is a thick or heavy liquid that is resistant to flow, but not so thick that flow is unduly restricted. It is intended that when body weight is applied to one area of the bladder, the fluid will slowly and gradually flow out of the area over a few milli-seconds of time, thus the fluid is functioning as a flow restricting means and thereby enable an improved weight pressure distribution as compared to the fluid being ordinary water. The fluid will not"jump"out of an area upon application of load. I refer to this as a"heavy liquid."For the above reasons, the density of said fluid, measured by g/m3, is higher than the density of water (density = weight), because a higher weight of the fluid (compared to water) restricts the rate of flow of fluid. For same reasons, the thickness (viscosity) is also higher than water, because a higher thickness of the fluid (compared to water) restricts the flow of fluid.

The liquid is relatively non-greasy. Thus, if the insoles are punctured or for any reason the liquid runs out into the user's socks or shoes, the shoes and socks may be readily cleaned.

Testing has shown that there are four basic beneficial effects from wearing the insoles of the invention, namely: (1) reducing stress on the foot; (2) improves the venous pump function by causing a movement of all the small intrinsic foot muscles; (3) symmetric walking, and (4) directional stability. Each of these therapeutic benefits will be explained in turn.

In the body, blood is pumped from the heart through the arteries out to the energy consuming muscles, where the blood carries the various energy substances such as carbohydrates and oxygen. Within the muscles, the energy is subsequently provided by an oxidation process in which carbohydrates interact with oxygen creating carbon dioxide, water and energy. If a person is working extremely hard--resulting in substantial use of muscles --the oxygen supplied to the muscles (through the blood supply) is insufficient to supply the muscles with sufficient energy. Energy may also be produced in the muscles by splitting of glycogen into lactic acid and energy. Glycogen is a substance in the muscles. The oxygen- poor blood and cell waste products that have resulted from the energy production will then be transported through the veins back to the heart and the purifying organs of the body. The veins function with the muscles to form a venous pump system that eases the transport of the blood back to the heart. The venous pump functions in cooperation with the muscle activity since the moving muscles cause the veins to stretch and contract. Since the veins internally are equipped with valves (flaps) that prevent the blood from flowing away from the heart, the muscle activity on the veins causes the veins to function as a pump system that significantly increases blood transportation back to the heart.

When an individual is standing or walking for more than four hours per day, the foot muscles may receive insufficient movement and exercise. Individual movement of the many small muscles in the foot is hindered. If the foot muscles have insufficient strength, they do not have the sustaining strength to maintain the weight of the body, and the heel bone and metatarsal bones may sink downwardly. The following chain reaction occurs: 1. When the feet collapse ("sink down"), the foot muscles are compressed, which reduces blood flow. Simultaneously, low muscle activity from the compression of the foot muscles causes a reduction of the venous pump function.

2. The foot muscles do not receive sufficient oxygen and carbohydrate quantities for maintaining adequate energy production and oxidation.

3. Because of the constant pressure and lack of supply of oxygen and carbohydrates, the foot muscles start to produce energy by splitting of glycogen to lactic acid and energy.

4. Because blood circulation is hindered, the process will accumulate lactic acid in the foot muscles.

5. Lactic acid causes tiredness, heavy legs, and later pain, depending on the length of time walking or standing.

6. The tiredness feeling tends to cause people to place themselves in inappropriate or awkward positions in an effort to remedy the feeling, again affecting other muscles, leading to pain in legs, back, head, etc.

With the insole of the invention, the movement of the liquid within the bladder will result in the user's body weight being more evenly distributed over the area of the foot; thus relieving peak pressures on the foot muscles. Further, the simultaneous movement of fluid within the bladder causes the small intrinsic foot muscles to move, which, combined with the stress distribution or stress effect, improves the venous pump function and thus avoiding the above chain reaction. Tests reveal that the insole of the invention reduces stress, measured by the average pressure in kilograms per square centimeter against the plantar surface of the user's foot. The improved spreading of the user's weight is particularly applicable during standing or walking. It is important to avoid high pressure on heel and metatarsal bones, since such pressure can cause foot pain, hard skin, and, in extreme situations, ulceration.

These abnormalities are well known in diabetic feet.

The weight of the user pressurizes the liquid within the bladder. The pressurized liquid will constantly move the non-loaded parts of the bladder upwards. Movement or weight shift by the user will cause fluid movement, whereby a constant movement of the small internal foot muscles occurs. Considerably improved venous pump function is thereby established in the foot itself. A constant massage of the foot sole occurs for each time weight distribution is changed by the movement of the fluid within the three regions. When the feet, and thus the weight, is placed on the ground, a weight pressure redistribution action takes place between the feet and the insoles, stimulating the blood veins. The effect is a considerably improved venous pump function. Increased blood circulation is obviously very important for any person participating in a standing, walking or running activity. The function of the blood is to transport oxygen and nutrients to the cells, and return waste products to be excreted from the user's kidneys, through the urine. Improved blood circulation will decrease the amount of lactic acid, an element known as causing myasthenia ("tired muscles"). Blood circulation is thus very important to individuals applying their muscles extensively, since muscle exertion constrains the blood corpuscles, thus hampering the transport of nutrients and waste products. Another effect of insufficient blood supply is a reduction of the contraction ability of the muscles. The fluid filled insole of the invention enhances the location, amount and duration of beneficial stress distribution as compared to the prior art vis-a-vis the flow of fluid that is specifically matched to the anatomical structure of the foot (Figs. 1-B and 1-C). A positive effect is a reduction and in many instances elimination of the painful effect of soreness in feet, legs, neck, head, and back caused by standing or walking for many hours a day.

The features that distinguish, the current invention from the prior art is further the specific location of the flow deflectors and restrictors in the forefoot, midfoot and hindfoot regions, enabling a flow of fluid matched to the structure of the bones of the feet. The flow deflectors and restrictors and their following flow passages ensure directional stability during locomotion by enabling a controlled circulation of liquid that is matched to the anatomical structure of the normal foot. This is important since uncontrolled liquid circulation would result in unstable walking, unstable weight distribution, and potentially the development of foot abnormalities. Directional stability, as achieved by the designed liquid circulation of the invention and as distinguishable over the prior art, ensures a symmetric locomotion pattern for the wearer, because the weight is resting on the foot's natural points and the weight is more evenly distributed on the foot. The function is similar to waterbeds. Obviously, the weight is the heaviest where one first places his foot on the ground, which is, logically, individual from person to person. The insole can help the problems involved in over- supination and over-pronation, i. e., where the user's feet are turning abnormally either to the medial, inner side or the lateral, outer side of the foot ("asymmetric feet"). The combination of dispersing of weight pressure and directionally stabilizing fluid circulation also supports a functionally correct take-off ; a factor crucial for walking or running in a physiologically correct manner.

FLUID FILLED INSOLE CROSS REFERENCE This application is a continuation-in-part of copending application serial no. 08/687,787 filed July 19,1996, which is a continuation-in-part of application serial no. 08/047,685 filed on April 15,1993, now abandoned.

BACKGROUND OF THE INVENTION The present invention is directed to therapeutic fluid filled insoles, and more particularly to insole bladders having fluid flow directing and controlling members within the bladder with the purpose of achieving improved medical benefits and directional stability to the users.

Fluid filled insoles have long been known in the art, see for example, U. S. Patent No.

4, 567, 677 to James Zona. U. S. Patent No. 4,115,934 to Hall, U. S. Patent No. 4,123,855 to Thedford, U. S. Patent No. 2, 080, 469 to Gilbert and U. S. Design Patent No. D246, 486 to John W.

Nickel. Prior art insoles commonly comprise a bladder having an upper layer and a lower layer.

The two layers are welded together at their marginal periphery. The bladder has a planar, foot- shaped configuration, which includes a forefoot region, a hindfoot region, and a midfoot region there between. The bladder is filled with a fluid, such as water or air. The broader technical functions of fluid filled insoles are well documented, whereas the medical benefits are only partly documented. It is not generally known that fluid filled insoles may be designed to accomplish specific medical benefits. Two significant limitations in the prior art are: (1) the flow of liquid/fluid is not matched to the anatomical structure of the foot, and (2) flow of fluid does not provide directional stability. The known technical functions include cushioning of the feet by a massaging action on the plantar surface of the feet due to movement of the fluid within the bladder, thus achieving comfort to the user.

The fluid filled insoles of the prior art have not been entirely satisfactory, however, in the area of providing demonstrative medical benefits. neither as a device for relieving fatigue in the lower extremities by providing pressure or stress distribution and activation of the venous pump function nor for achieving directional stability to the user when wearing the insole. Existing prior-art insoles have little or no means for : (1) controlling both the transverse and longitudinal flow, (2) controlling the rate of fluid flow within the insole, or (3) matching the flow of fluid to the anatomical structure of the foot. As a user walks, the user's weight is initially applied to heel, and then is transferred to the ball of the foot. This causes the fluid within the bladder to move, respectively, from the hindfoot region to the forefoot region and then back towards the hindfoot again. Further. without means for directing fluid flow anatomically within the bladder, the fluid will flow uncontrollably and thus causing directional instability to the user when wearing the insole. Without means for controlling and restricting the rate of fluid flow vis-a-vis the viscosity and density of the fluid. the foot will simply"jump through"the fluid in the insole when the wearer's weight is applied, and thus the fluid insole has little pressure distribution or massaging effect.

Some prior art devices. such as the insole of the Zona patent, have attempted to regulate flow from the hindfoot region to forefoot region and vice versa by placing flow restricting means in the midfoot area of the bladder.'These flow restricting devices are only partly effective, however, since they neither match the anatomical structure of the foot nor control the flow within the forefoot or hindfoot regions of the bladder to achieve directional stability and local pressure distribution. In addition. the midfoot flow restricting means are not matched to the anatomical structure of the longitudinal medial arch. Matching the anatomical structure of the foot to the location, direction, quantity and duration of fluid flow fully determine therapeutic benefits, pressure distribution and directional stability.

Some prior art insoles, as shown for example in the Hall or Nickel patents have attempted to regulate fluid flow within the forefoot and hindfoot regions. But, these efforts have not been satisfactory because the fluid flow is not matched to the anatomical structure of said local regions, but rather directed to the outer, medial and lateral. margins of the insole, away from the areas of the foot where fluid massaging action and pressure distribution are required when considering the physiology and anatomy of the foot.

The Thedford patent has also attempted to regulate fluid flow within the forefoot and hindfoot regions. These teachings have not been anatomically satisfactory because the fluid flow is neither adapted to the anatomical structure of the foot nor arranged in a fashion that achieves directional stability to the user during the flow of fluid within the insole. Further, the Thedford patent teaches prohibition or blocking of longitudinal flow within the bladder redirecting the flow in a transverse direction.

The Gilbert patent has attempted to regulate fluid flow by randomly dispersing flow restrictors across the entire surface of the insole. which, again, does neither match the anatomical structure of the foot nor achieve directional stability. The Gilbert patent does not specify any particular arrangement of flow restrictors or fluid flow, but teaches that the"spots""may be disposed at any desirable location with any desirable frequency"which makes flow control indefinite. Further, the Gilbert patent permits air to shift in any direction and partly arranges flow restricting means to block longitudinal flow.

Many prior art insoles are filled with ordinary water or other fluids that not only quickly evaporate and thus significantly reduce the industrial applicability (life time) of the insole, but also develops bacteria and/or other microorganisms, causing the fluid to become toxic and thus environmentally unsafe. In addition, existing prior art insoles do not consider the fluid itself as a flow restricting means and thus significantly limits the therapeutic value of the insole by allowing the fluid to flow at a rate that cannot satisfactorily provide pressure distribution. The rate of fluid flow significantly influences pressure distribution.

Finally, none of the prior art insoles considers local pressure distribution within each of the midfoot, forefoot and hindfoot regions of the bladder by directing and anatomically controlling the flow of fluid within each of the midfoot, forefoot and hindfoot regions. This lacking consideration significantly limits the medical and therapeutic applications of the prior art insoles. It would be desirable to have a fluid filled insole that (i) controls and directs the fluid to match the anatomical structure of the foot and achieves directional stability to the user wearing the insole, (ii) maximizes pressure distribution to minimize peak pressures on the foot, both across the entire area of the foot and within each of the hindfoot, midfoot and forefoot regions, (iii) ensures minimum evaporation of the fluid to maximize the life time of the insole, (iv) provides a fluid that is environmentally safe. and (v) devises a fluid that functions as a flow restricting means vis-a-vis the density and viscosity of the fluid to enable maximum pressure distribution, and which otherwise overcomes the limitations inherent in the prior art.

OBJECTS OF THE INVENTION It is an object of the invention to provide an insole that has a superior therapeutic fatigue- relieving effect by providing maximum pressure distribution in each of the hindfoot, midfoot and forefoot areas of the plantar surface of the user's foot, while improving the muscular venous pump function by means of the flow of fluid interacting with foot movements.

It is a further object of the invention to provide a fluid filled insole wherein the fluid flow matches the anatomical structure of functionally normal feet; the fluid being directed and controlled in transverse and longitudinal flow passages that are adapted to the anatomical structure of functionally normal feet, thereby achieving directional stability for the user when wearing the insole.

It is another object of the invention to provide a liquid filled insole that increases the weight bearing surface area of the user's foot by improving the distribution of the user's weight both over the total area of the foot and within each of the hindfoot, midfoot and forefoot regions, thereby reducing peak pressures on the plantar surface of the user's foot.

It is a fourth object of the invention to provide an insole filled with a sterile, non-toxic, non-greasy fluid that not only has low evaporation rates but also remains environmentally safe during the entire life time of the insole.

It is a fifth object of the invention to provide a liquid filled insole that is durable and not prone to lose fluid by leakage, evaporation or diffusion, thus prolonging the life time of the insole.

It is a sixth object of the invention to provide a fluid filled insole that increases the weight bearing surface within each of the forefoot, midfoot and hindfoot regions by (i) restricting the flow of liquid between the three regions and by (ii) directing and controlling the liquid within each of the regions (local pressure distribution).

It is a seventh object of the invention to provide a fluid filled insole that provides shock absorption in the heel area and maximizes pressure distribution within each of the forefoot and midfoot regions.

It is an eighth object of the invention to provide a fluid filled insole that accumulates anatomically optional quantities of liquid within each of the hindfoot and forefoot areas to enable optimal pressure distribution.

SUMMARY OF THE INVENTION The insole of the invention comprises a fluid tight bladder having an upper layer of flexible material and a lower layer of flexible material sealingly joined together at their peripheral margins. The bladder has a generally foot shaped planar configuration, with a proximal forefoot region. a hindfoot region, and a midfoot region there between. The bladder is filled with a large molecular. non-evaporable. highly viscous, sterile liquid, preferably a mixture of hygroscopic, polyvalent alcohol and distilled water. Within the proximal forefoot region of the bladder is positioned, at least one. but optimally between two and five flow deflectors, with adjacent flow deflectors substantially equally spaced transversely from the imaginary longitudinal centerlines of each other, and spaced from the medial and lateral margins of the bladder. The flow deflectors comprise weld points joining the upper and lower bladder layers.

Substantially equally sized longitudinal flow channels are formed between the flow deflectors and between the flow deflectors and medial and lateral margins of the bladder.

Bridging the proximal forefoot region and the midfoot region of the bladder is a flow controller, which is generally anatomically matched to the structure of the longitudinal arches of a functionally normal foot. The arch flow controller comprises an elongated, semicircular shaped weld, between the upper and lower bladder layers. The longitudinal arch flow controller and the medial peripheral margin of the bladder define a semi-enclosed volume. In use, a liquid pad or pillow is formed that substantially underlies the anatomical structure of the medial longitudinal arch region of a functionally normal foot.

In accordance with the present invention, there are alternate configurations in the hindfoot region of the insole. In a first embodiment. between one and five hindfoot flow defectors are located in the hindfoot region. At least two longitudinal channels are formed between the hindfoot flow deflector (s) and the medial and lateral margins of the bladder. If two or more are so used, at least one longitudinal hindfoot flow channel is formed between the hindfoot deflectors. Thereby, fluid flowing within the hindfoot and forefoot regions and from these regions into the midfoot region and vice versa will be channeled through the longitudinal flow channels in the forefoot and hindfoot regions in a controlled fashion, resulting in enhanced medical and therapeutic benefits as explained below.

A second and most preferred embodiment of the invention is characterized by a pair of flow restrictors at the distal end of the hindfoot region, one on the lateral margin of the bladder and the other on the medial margin. The pair of hindfoot restrictors form a longitudinal flow channel there between. The proximal hindfoot region is free of flow deflectors or the like.

A third embodiment of the invention is characterized by a shock absorbing pad provided in at least a portion of the hindfoot region. A barrier is placed between the midfoot and hindfoot regions to prevent the shock absorbing pad from being saturated with liquid. The pad preferably underlies the heel bone.

The bladder is filled with a large molecular, non-evaporable, highly viscous, sterile liquid, preferably a mixture of hygroscopic, polyvalent alcohol and distilled water. The fluid has a viscosity and density of at least 1.10 times that of ordinary water. I refer to this as a"heavy liquid."For the above reasons, the density of the fluid, measured by g/m3, is higher than the density of water (density=weight), because a higher weight of the fluid (compared to water) restricts the rate of fluid flow. For the same reasons, the thickness (viscosity) is also higher than that of water, because a higher thickness of the fluid (compared to water) restricts the rate of fluid flow. This mixture is sterile. non-toxic and resistant to contamination by bacteria or other microorganisms, thereby ensuring an environmentally safe fluid within the insole. Further, the mixture of hygroscopic, polyvalent alcohol and distilled water is not susceptible to evaporation or diffusion through the bladder layers. It is also autoclavable. In the event of a bladder puncture, the liquid may be easily removed from clothing and footwear. as the mixture is also relatively non-greasy.

The insole of the invention has been tested and found to provide several desirable medical benefits. The insole relieves fatigue during prolonged standing or walking by distributing the user's weight anatomically over the area of the foot. The weight bearing surface area of the wearer's feet is increased, thereby reducing peak pressures exerted on the plantar surface of the user's foot and resulting deformation of soft tissue. The reduction in pressure thereby further relieves stress on the bones of the foot that can cause foot pain, hard skin and in extreme situations, ulceration.

Second, the anatomically controlled flow of fluid through the bladder across the plantar surface of the user's feet provides a therapeutic movement of the small intrinsic muscles of the feet. The movement of the muscles animates the venous pump function increasing blood circulation, which in turn improves transport of oxygen and nutrients to the cells in the foot and removal of waste products excreted from the cells.

Third, the specific locations of the flow deflectors enable a fluid flow that is matched to the anatomical structure of the foot and thus aid in anatomically correct locomotion. This in turn provides not only directional stability when the fluid moves within the insole, but also alleviates the foot abnormalities over supination and over pronation found in asymmetric feet.

Other attributes and benefits of the present invention will become apparent from the following detailed specification when read in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. I is a plan view of a first embodiment of the fluid filled insole of the invention.

Fig. 1-B is a plan view of the human foot illustrating the medial and lateral portions thereof, and showing a typical weight distribution pattern of a normal foot.

Fig. 1-C is a dorsal view of the bones of the human foot.

Fig. 2 is a cross-sectional view of the first embodiment of the invention taken along line 2-2 of Fig. 1.

Fig. 3 is a cross sectional view of the first embodiment of the invention taken along line 3-3 of Fig. 1.

Fig. 4 is a plan view of a second embodiment of the invention.

Fig. 5 is a plan view of a third embodiment of the invention.

Fig. 6 is a cross-sectional view of the third embodiment of the invention taken along line 6-6 of Fig. 9.

DETAILED DESCRIPTION Turning now to the drawings. Figs. I-B and 1-C illustrate the structure of the human foot.

The foot comprises a (i) hindfoot region containing the talus I and os calcis 2 bones ; (ii) a midfoot region containing the cuneiform 3, cuboid 4 and navicular 5 bones; and the forefoot region comprising the metatarsals 6. the proximal phalanges 7, and the middle 8 and distal 9 phalanges. The forefoot region can be divided into two sub-regions, the distal sub-region comprising the middle and distal phalanges. and the proximal forefoot region which comprises the metatarsals and proximal phalanges. The foot also includes a longitudinal arch, having a medial and a lateral side. The medial longitudinal arch is defined by the navicular and medial cuneiform bones of the midfoot and the about the proximal half of the first, second and third metatarsals. The typical weight bearing area of a normal foot appears from Fig. 1-B. The weight is not equally distributed over the plantar area of the foot. In a functionally normal foot, the medial midfoot typically bears only limited weight.

In Figs. I through 3, a first embodiment of the fluid filled insole of the invention is shown. The insole comprises a bladder 10 having an upper layer 12 and a lower layer 14. The insole preferably further includes a layer of textile or a sweat absorbing material 16 substantially covering and laminated to the outer surface of upper layer 12. Optionally a textile layer could be added to the bottom surface of the insole. The bladder layers 12 and 14 are sealing joined at their peripheral margins 18. For reference, the medial peripheral margin is numbered 20 and the lateral peripheral margin is numbered 22. The bladder comprises three main regions, namely a forefoot region 25, a hindfoot region 26 and a midfoot region 28 there between. The forefoot region is divided into a distal subregion 30 and a proximal forefoot region 24.

The interior cavity 32 of the bladder 10 is filled with a sterile, non-toxic, non-evaporable fluid with a density and viscosity of at least 1. i0 times that of water. The fluid is preferably a "heavy liquid"mixture of large molecular, hygroscopic polyvalent alcohol and distilled water, as is more fully described below. In the first embodiment the fluid may flow between and throughout the proximal forefoot, midfoot and hindfoot regions. The distal forefoot sub-region 30 preferably does not contain fluid. Within the proximal forefoot region 24 of bladder 22 there are at least one, but preferably between two and six transversely spaced flow deflectors 34. In the illustrated embodiment there are three forefoot flow deflectors 34, but, one could employ between one and six forefoot flow deflectors. The shape of the flow deflectors is preferably circular or oval, but other shapes may alternatively be used. The space between each of the flow deflectors and between the flow deflectors and the medial and lateral peripheral margins of the bladder forms substantially longitudinal forefoot flow passages. This means that the distance between the imaginary longitudinal centerlines of adjacent deflectors is substantially equally dimensioned or sized. Each flow passage between adjacent deflectors has a substantially equal transverse dimension, Wm. By"substantially equal transverse dimension,"I mean between 0.95 and 1.05 times Wm, where Wm is calculated as follows: Wm = (Dm~Sm)/ (Nnl + 1 ! Dm is the maximum straight transverse width of the forefoot region, Sm is the sum of the transverse dimensions of the forefoot flow deflectors, and Nm is the number of forefoot flow deflectors.

The forefoot flow deflectors are arranged in a shape to form flow passages that laterally, medially, transversely and longitudinally matches the anatomical structure of the proximal forefoot region, the shape being for example, but not limited to, an arc, a semicircle, or a trapezoid, the convex side of the shape facing in a distal direction. The spacing between the flow deflectors depends on (i) the shoe or foot size, (ii) the diameter of the flow deflectors, and (iii) the number of flow deflectors. With two forefoot flow deflectors, the spacing from imaginary longitudinal centerline to centerline between flow deflectors would be 33% or one third of the transverse straight distance between the lateral and medial peripheral margins of the bladder measured at the location of the flow deflectors. If n flow deflectors are placed in the proximal forefoot region, then n + 1 longitudinal flow passages are formed.

The flow deflectors 34 are formed by weld points joining the upper bladder layer 12 to the lower bladder layer 14. Formation of flow deflectors by welding points joining the bladder layers improves the structural integrity of the bladder, improving durability. Between flow deflectors 34 are flow passages 36 through which fluid flows during use of the insole. Additional flow passages 38 are also formed in the proximal forefoot region between flow deflectors 34 and the medial peripheral margin 20, and between flow deflectors 34 and the lateral peripheral margin 22. The forefoot flow passages 36 and 38 extend in a straight, longitudinal direction. By "longitudinal"it is meant that the flow direction varies by no more than 10 degrees (plus or minus) from the imaginary straight longitudinal axis of the insole. At least one passage flows in an unobstructed path to the mid foot region of the bladder. Flow deflectors 34 are shown as being circular, but other shapes, such as oval or ellipse, may be alternatively used.

Bridging the proximal forefoot region and the midfoot region 28 of bladder 10 is a flow controller 48, which is generally matched to the wearer's arch. The arch flow controller may be configured in several different ways, but must match the contour or anatomical structure of the longitudinal arches of a normal foot, as described above in reference to Figs. 1-B and 1-C. The lateral edge of the longitudinal medial arch is generally an elongated, semicircular line substantially at the longitudinal border of the lateral and medial arch of a normal foot, such as shown in Fig. 1-B. The longitudinal medial arch extends from the proximal part of the midfoot area to about the mid-point of the metatarsals. as shown in Fig. 1-B. Flow controller 48 is shaped and located to match at least a portion of the border between the medial and lateral longitudinal arch. A midfoot flow channel 70 is formed on the lateral side of controller 48. A semi-enclosed area or volume 29 is defined by the longitudinal arch flow controller 48 and the medial peripheral margin of the bladder that substantially matches the anatomical structure of the medial longitudinal arch region of a normal foot. In this way, liquid will flow from the proximal forefoot region and into the medial arch region, thus forming a liquid pad or pillow substantially under the area of the medial arch.

In accordance with the present invention there are three alternate configurations for the hindfoot region of the insole of the invention. In the first embodiment, Figs. 1-3, the hindfoot region 26 of bladder 10 includes at least one but no more than five flow deflectors 40. Because the hindfoot region is a smaller area than the forefoot region, two flow deflectors are preferably used. Alternatively, one. three, four or five could be used in this first embodiment. The hindfoot flow deflectors 40 are formed in the same manner as the forefoot flow deflectors, by a weld point joining the upper and lower bladder layers 12 and 14. At least one generally longitudinal flow passage 42 is formed between hindfoot flow deflectors 40, if two or more hindfoot deflectors are used. Additional hindfoot flow passages 44 are formed between hindfoot deflectors 40 and the medial and lateral peripheral margins of the bladder.

The second and most preferred embodiment of the fluid filled insole of the invention is illustrated in Fig. 4. The second embodiment is similar to the first embodiment, except as to the construction of the hindfoot region. There are no flow deflectors in the hindfoot region, however, there are flow restricting features in the distal part of the hindfoot region that regulate the flow of fluid into and out of the hindfoot region. Specifically, a pair of flow restrictors 90 are located adjacent to the lateral and medial peripheral margins, respectively, in the distal end of the hindfoot region, roughly at the border between the hindfoot and midfoot regions. This pair of hindfoot flow restrictors defines a longitudinal channel 91 there between, the channel 91 having a transverse width of between 10 and 30 percent of the maximum straight transverse width of the hindfoot region of the bladder. The second embodiment preferably includes a longitudinal arch flow controller similar to flow controller 48. The weld 48 is placed substantially at the border between the longitudinal lateral and medial arches, such as depicted in Fig. 1-B, and is similar to weld line 48 of the first embodiment Fig. 5 and 6 illustrate a third embodiment of the invention. The third embodiment is similar to the other embodiments, except for the construction of the hindfoot region. In this embodiment, at least a portion of the hindfoot region comprises a shock absorbing foam material or a non-flowable, semi-solid gel. as opposed to a flowable liquid filled bladder. More specifically, the third embodiment comprises a bladder 10 having an upper layer 12 and a lower layer 14. Preferably, a layer of textile or a sweat absorbing material 16 is laminated to the outer surface of the upper layer 14. The bladder 10 has a liquid filled proximal forefoot region 24 and midfoot region 28. The proximal forefoot region 24 includes transversely spaced flow deflectors 34 and longitudinal flow channels 36 and 38 as described above. The arch region includes a flow controller 48 and lateral flow passage 70. The insole further comprises a hindfoot region 26 and a distal forefoot region 30, but these latter two regions are not filled with flowable liquid. Rather distal forefoot region 30 is unfilled and hindfoot region 26 is at least partially filled with either a static, non-flowable, semi-solid gel or a shock absorbing foam cushion 78. A barrier wall 80 separates the flowable liquid filled regions 24 and 28 from the hindfoot region 26 and prevents liquid from flowing from the proximal forefoot and midfoot regions into the hindfoot region.

The shock absorbing pad need not cover the entire area of the hindfoot region. It is necessary only to cover the area beneath the heel bone.

The bladder is preferably fabricated from polyurethane film although other thermoplastic materials, such as EVA, PVC or vinyl may also be used. The thickness of each bladder layer should be from about 300 to 800 micrometers, 400 micrometers being preferred. The sweat absorbing material is preferably about 250 micrometers in thickness. Other textile materials may be used for comfort or breathability regardless of sweat absorbing properties. The bladder may be formed by conventional radio frequency or dielectric welding techniques. Other welding techniques, such as thermal welding may be used alternatively. The bladder is filled with the liquid mixture leaving an opening in the peripheral weld, through which liquid may be introduced, then sealing the opening. The insole of the invention may be made and sold as an insole for removable placement in shoes by the user. Also, the insole may be built into footwear as a permanent feature.

The fluid used to fill the cavity 32 of the bladder 10 is preferably a mixture of distilled water and a sterile, non-toxic, non-evaporable, large molecular, hygroscopic liquid to prevent evaporation or diffusion through the bladder. Polyvalent alcohols with large molecules and with non-toxic properties are preferred. One suitable formulation comprises approximately 85-98%, hygroscopic polyvalent alcohol and approximately 2-15% distilled water. By using this mixture in lieu of plain water, improved benefits are achieved: The mixture of the invention as compared to water does not evaporate or diffuse through the bladder layers, thereby significantly improving life time and durability of the insole. The liquid can withstand autoclaving as may be required by health care institutions. The insoles can be used in temperature ranges from minus 20 degrees Celsius to plus 120 degrees Celsius, because both the liquid mixture and bladder materials can withstand these temperature extremes. The liquid is fully sterile and non-toxic, and thus environmentally safe.

The sterility and/or non toxicness of the fluid is extremely important for several reasons.

Children, people and animals could bite the insole, possibly drinking or swallowing the liquid.

Water becomes septic after a few months of storage within insoles, because bacteria will grow and flourish in the water.

Compared to water, the mixture of polyvalent alcohol and distilled water has a significantly higher density and viscosity. The fluid of the invention has a preferred density and viscosity range of at least 1.10 times that of water. The actual filling of fluid with a particular density that is at least 1.10 times that of water depends on the flow controlling means within the bladder. Generally, the more the flow of liquid within the bladder is restricted by flow controlling means in the forefoot, midfoot and hindfoot regions, the lower the requirement for the density and viscosity of the liquid. Inversely, the fewer flow controlling means within the bladder, the higher the density and viscosity required. The density and viscosity of the fluid causes an improvement in the effects on the user's foot when wearing the insoles, because the density and viscosity generally controls the rate of flow of the viscous liquid within the insole. In this way, the density and viscosity strongly influence not only the degree of pressure distribution with following reduction of peak pressures on the plantar surface of the foot, but also directional stability.

The liquid used is a thick or heavy liquid that is resistant to flow, but not so thick that flow is unduly restricted. It is intended that when body weight is applied to one area of the bladder, the fluid will slowly and gradually flow out of the area after application of load over a few milli-seconds of time, thus the fluid is functioning as a flow restricting means and thereby enable an improved weight pressure distribution as compared to the fluid being ordinary water.

Preferably, the fluid does not leave a region before the weight load is applied to that region.

Referring to Fig. 4 as an example, when a user places his/her heel to the hindfoot region the fluid will not immediately leave the region. i. e., the fluid will not"jump"out of that area upon application of load. Rather, the fluid will not flow out of the hindfoot region before application of weight load has occured. I refer to this as a"heavy liquid."For the above reasons, the density of said fluid, measured by g/m3, is higher than the density of water (density = weight), because a higher weight of the fluid (compared to water) restricts the rate of flow of fluid. For same reasons, the thickness (viscosity) is also higher than water, because a higher thickness of the fluid (compared to water) restricts the flow of fluid, and thus enable application of weight load before the fluid leaves a region.

The liquid is relatively non-greasy. Thus, if the insoles are punctured or for any reason the liquid runs out into the user's socks or shoes, the shoes and socks may be readily cleaned.

Testing has shown that there are four basic beneficial effects from wearing the insoles of the invention, namely: (1) reducing pressure on the foot; (2) improves the venous pump function by causing a movement of all the small intrinsic foot muscles; (3) symmetric walking, and (4) directional stability. Each of these therapeutic benefits will be explained in turn.

In the body, blood is pumped from the heart through the arteries out to the energy consuming muscles, where the blood carries the various energy substances such as carbohydrates and oxygen. Within the muscles, the energy is subsequently provided by an oxidation process in which carbohydrates interact with oxygen creating carbon dioxide, water and energy. If a person is working extremely hard--resulting in substantial use of muscles--the oxygen supplied to the muscles (through the blood supply) is insufficient to supply the muscles with sufficient energy.

Energy may also be produced in the muscles by splitting of glycogen into lactic acid and energy.

Glycogen is a substance in the muscles. The oxygen-poor blood and cell waste products that have resulted from the energy production will then be transported through the veins back to the heart and the purifying organs of the body. The veins function with the muscles to form a venous pump system that eases the transport of the blood back to the heart. The venous pump functions in cooperation with the muscle activity since the moving muscles cause the veins to stretch and contract. Since the veins internally are equipped with valves (flaps) that prevent the blood from flowing away from the heart, the muscle activity on the veins causes the veins to function as a pump system that significantly increases blood transportation back to the heart.

When an individual is standing or walking for more than four hours per day, the foot muscles may receive insufficient movement and exercise. Individual movement of the many small muscles in the foot is hindered. If the foot muscles have insufficient strength, they do not have the sustaining strength to maintain the weight of the body, and the heel bone and metatarsal bones may sink downwardly. The following chain reaction occurs: 1. When the feet collapse ("sink down"), the foot muscles are compressed, which reduces blood flow. Simultaneously, low muscle activity from the compression of the foot muscles causes a reduction of the venous pump function.

2. The foot muscles do not receive sufficient oxygen and carbohydrate quantities for maintaining adequate energy production and oxidation.

3. Because of the constant pressure and lack of supply of oxygen and carbohydrates, the foot muscles start to produce energy by splitting of glycogen to lactic acid and energy.

4. Because blood circulation is hindered, the process will accumulate lactic acid in the foot muscles.

5. Lactic acid causes fatigue. heavy legs, and later pain, depending on the length of time walking or standing.

6. The fatigue feeling tends to cause people to place themselves in inappropriate or awkward positions in an effort to remedy the feeling, again affecting other muscles, leading to pain in legs, back, head, etc.

With the insole of the invention. the movement of the liquid within the bladder will result in the user's body weight being more widely distributed over the area of the foot, thereby increasing the weight bearing surface area of the foot, and relieving peak pressures on the foot muscles. Again, the weight is not equally distributed on/over the plantar surface area of a normal foot, see Fig. 1-B. Further, the simultaneous movement of fluid within the bladder causes the small intrinsic foot muscles to move, which, combined with the pressure distribution effect, improves the venous pump function and thus avoiding the above chain reaction. Tests reveal that the insole of the invention reduces peak pressures, measured by the average pressure in kilograms per square centimeter against the plantar surface of the user's foot. The improved distribution of the user's weight is particularly applicable during standing or walking. It is important to avoid high pressure on heel and metatarsal bones, since such pressure can cause foot pain, hard skin, and, in extreme situations, ulceration. These abnormalities are well known in diabetic feet.

The weight of the user pressurizes the liquid within the bladder. The pressurized liquid will constantly move the non-loaded parts of the bladder upwards. Movement or weight shift by the user will cause fluid movement, whereby a constant movement of the small internal foot muscles occurs. A considerably improved venous pump function is thereby established in the foot itself. A constant massage of the foot sole occurs for each time weight distribution is changed by the movement of the fluid within the three regions. When the feet, and thus the weight, is placed on the insoles, a weight pressure redistribution action takes place between the feet and the insoles, stimulating the blood veins. The effect is a considerably improved venous pump function, which is obviously very important for any person participating in a standing, walking or running activity. The function of the blood is to transport oxygen and nutrients to the cells, and return waste products to be excreted from the user's kidneys, through the urine.

Improved blood circulation will decrease the amount of lactic acid, an element known as causing fatigue or myasthenia. Blood circulation is thus very important to individuals applying their muscles extensively, since muscle exertion constrains the blood corpuscles, thus hampering the transport of nutrients and waste products. Another effect of insufficient blood supply is a reduction of the contraction ability of the muscles. The fluid filled insole of the invention enhances the location, degree and duration of beneficial pressure distribution as compared to the prior art vis-a-vis the flow of fluid that is specifically matched to the anatomical structure of the foot (Figs. 1-B and 1-C). A positive effect is a reduction and in many instances elimination of the painful effect of soreness in feet, legs. and back caused by prolonged standing or walking.

The features that distinguish the current invention from the prior art is further the specific location of the flow deflectors and restrictors in the forefoot, midfoot and hindfoot regions, enabling a flow of fluid matched to the anatomical structure of the feet. The flow deflectors and restrictors and their following flow passages ensure directional stability during locomotion by enabling a controlled circulation of liquid that is matched to the anatomical structure of the normal foot. This is important since uncontrolled liquid circulation would result in unstable walking, unstable weight distribution, discomfort, and potentially the development of foot abnormalities. Directional stability. as achieved by the designed liquid circulation of the invention and as distinguishable over the prior art, ensures an anatomical locomotion pattern for the wearer, because the weight is anatomically distributed on the foot. The insole can alleviate the problems involved in over-supination and over-pronation, i. e., where the user's feet are turning abnormally either to the medial, inner side or the lateral, outer side of the foot ("asymmetric feet"). The combination of distribution of weight pressure and directionally stabilizing fluid circulation also supports a functionally correct take-off ; a factor crucial for walking or running in a physiologically correct manner.

While the preferred embodiment of the present invention has been shown and described, it is to be understood that various modifications and changes could be made thereto without departing from the scope of the appended claims.

What is claims is: 1. An improved insole adapted to be worn beneath a wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region there between, wherein the improvement comprises: at least one but no more than six transversely spaced flow deflectors in the proximal forefoot region of said bladder, said deflectors being spaced apart relative to one another; at least two, but no more than seven forefoot flow passages between each of said flow deflectors and between said flow deflectors and the lateral and medial margins of the proximal forefoot region of said bladder, said forefoot flow passages having substantially equal transverse dimension, and at least one of said forefoot flow passages extending between the proximal forefoot region and the midfoot region of said bladder; and said fluid comprising a heavy, viscous liquid.

. 2. An improved insole as in claim 1, further comprising a pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel there between.

3. An improved insole as in claim 1, the wearer's foot having a lateral longitudinal arch and a medial longitudinal arch and a border there between, said insole further comprising an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the border between lateral and the medial longitudinal arch of the wearer's foot, said flow controller controlling liquid flow from said hindfoot region to said proximal forefoot region and vice versa, and defining a semi- enclosed volume in which accumulation of liquid occurs when liquid flows into the longitudinal arch region.

4. An improved insole as in claim 1, wherein said bladder comprises an upper layer and a lower layer joined at their peripheral margins, said bladder further comprising a textile layer attached to and substantially covering at least one of said layers.

5. An improved insole as in claim 1, further comprising a barrier in said bladder at the border between the midfoot and hindfoot regions for preventing flow of said fluid from said midfoot region into said hindfoot region; and a solid or semi-solid shock absorbing material in said bladder covering at least a portion of said hindfoot region.

6. An improved insole as in claim 1 wherein said insole is incorporated into footwear.

7. An insole. comprising a lower layer of substantially impermeable, flexible material ; an upper layer of substantially impermeable, flexible material; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, foot-shaped configuration having distal forefoot region, a proximal forefoot region, a hindfoot region and a midfoot region there between, and a liquid barrier between said distal forefoot region and said proximal forefoot region; at least one but no more than six transversely spaced forefoot flow deflectors between said upper material layer and said lower material layer in said proximal forefoot region; forefoot flow passages between said forefoot flow deflectors and between said forefoot flow deflectors and the medial and laterai margins of said bladder, each said forefoot flow passages having a substantially equal transverse dimension; at least one of said forefoot flow passages extending between said proximal forefoot region and said midfoot region; a pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel there between; and a liquid within said bladder, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa, and said distal forefoot region being substantially liquid free.

8. An insole as in claim 7, wherein said insole is adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border there between, said insole further comprising an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for directing flow from said hindfoot region to said forefoot region and vice versa.

9. An insole as in claim 7, wherein said liquid is a sterile, heavy liquid.

10. An insole, comprising a substantially fluid tight bladder, said bladder comprising an upper layer and a lower layer sealing joined at their peripheral margins, said bladder having a generally foot shaped planar configuration with a forefoot region, a hindfoot region and an midfoot region there between; a sterile, non-toxic liquid substantially filling the forefoot and midfoot regions of said bladder, said liquid comprising about 85 to 98 percent large molecular, hygroscopic, polyvalent alcohol and about 2 to 10 percent distilled water; one or more transversely spaced forefoot weld points joining said upper and lower bladder layers in said forefoot region of said bladder; longitudinal, forefoot flow passages in said forefoot region between said forefoot weld points, between said forefoot weld points and the medial margin of said forefoot region of said bladder and between said forefoot weld points and the lateral margin of said forefoot region of said bladder, each forefoot flow passage having a substantially equal transverse dimension, said forefoot flow passages being substantially parallel and evenly spaced transversely across the forefoot region of said bladder, said sterile liquid being flowable in a longitudinal direction through at least one of said forefoot flow between the forefoot and midfoot regions of said bladder; barrier means in said bladder for preventing flow of said fluid from said forefoot and midfoot regions into said hindfoot region ; and a solid or semi-solid shock absorbing material sandwiched between said upper and lower bladder layers in at least a portion of said hindfoot region.

FLUID FILLED INSOLE ABSTRACT OF THE DISCLOSURE A fluid filled insole comprises a fluid tight bladder having upper ad lower layers and a generally foot-shaped, planar configuration, with proximal forefoot, midfoot and hindfoot regions; a heavy, viscous, sterile liquid substantially filling the bladder; at least one, preferably between two and six transversely spaced forefoot flow deflectors joining the upper and lower layers in the proximal forefoot region of the bladder; flow passages matched to the anatomical structure of the foot between the forefoot flow deflectors and the medial and lateral and peripheral margins of the bladder; and a flow controller matched to the border between the lateral and medial longitudinal arch. The hindfoot region of the bladder may comprise, alternatively (1) at least one hindfoot flow deflector, (2) flow restrictors in the distal hindfoot defining a central longitudinal flow channel between the liindfoot and midfoot regions, or (3) a barrier between the midfoot and hindfoot regions, and the hindfoot region comprising at least in part of a shock absorbing material. The flow of fluid within the insole is thereby matched to the anatomical structure of functionally normal feet.

(Applicants Reference : C: \Probody\Patent\Pct-patent\March 1999\US 99CIP# I R (draft 7 mar 99 PGJ email 7-3-99-hrs corr). doc) (ITEM 3) FLUID FILLED INSOLE CROSS REFERENCE This application is a continuation-in-part, divisional of copending application serial no.

08/687,787 filed July 19,1996, which is a continuation-in-part of application serial no.

08/047,685 filed on April 15,1993, now abandoned.

BACKGROUND OF THE INVENTION The present invention is directed to therapeutic fluid filled insoles, and more particularly to insole bladders having fluid flow directing and controlling members within the bladder with the purpose of achieving improved medical benefits and directional stability to the users.

Fluid filled insoles have long been known in the art, see for example, U. S. Patent No.

4,567,677 to James Zona, U. S. Patent No. 4,115,934 to Hall, U. S. Patent No. 4. 1'3 855 to Thedford, U. S. Patent No. 2,080,469 to Gilbert and U. S. Design Patent No. D246, 4861e) John W.

Nickel. Prior art insoles commonly comprise a bladder having an upper layer and a lower layer.

The two layers are welded together at their marginal periphery. The bladder has a planar, foot- shaped configuration, which includes a forefoot region, a hindfoot region, and a midot region there between. The bladder is filled with a fluid, such as water or air. The broader technical functions of fluid filled insoles are well documented, whereas the medical benefits are only marginally documented. It is not generally known that fluid filled insoles may be designed to accomplish specific medical benefits. Two significant limitations in the prior art arc : (1) the flow of liquid/fluid is not matched to the anatomical structure of the foot, and (2) the flow of fluid does not provide directional stability. The known technical functions include cushioning of the feet by a massaging action on the plantar surface of the feet due to movement ut the fluid within the bladder, thus achieving comfort to the user.

The fluid filled insoles of the prior art have not been entirely satisfactory, however, in the area of providing demonstrative medical benefits, neither as a device for relieving fatigue in the lower extremities by providing pressure distribution and activation of the venous pump function nor for achieving directional stability to the user when wearing the insole. Existing prior art insoles have little or no means for: (1) controlling both the transverse and longitudinal flow. (2) the rate of fluid flow within the insole, or (3) for matching the flow of fluid to the anatomical structure of the foot. As a user walks, the user's weight is initially applied to heel, old then is transferred to the ball of the foot. This causes the fluid within the bladder to move, respectively, from the hindfoot region to the forefoot region and then back towards the hindfoot again.

Further, without means for directing fluid flow anatomically within the bladder, the fluid will flow uncontrollably and thus causing directional instability to the user when wearing the insole.

Without means for controlling and restricting the rate of fluid flow vis-a-vis the viscosity and density of the fluid, the feet will simply"jump through"the fluid in the insole when weight load is applied, and thus the fluid insole has little pressure distribution or massaging effect.

Some prior art devices, such as the insole of the Zona patent, have attempted to regulate flow from the hindfoot region to forefoot region and vice versa by placing flow-restricting means in the midfoot area of the bladder. These flow restricting devices are only parti effective, however, since they neither match the anatomical structure of the foot nor control the ilow within the forefoot or hindfoot regions of the bladder to achieve directional stability and local pressure distribution within each of the hindfoot, midfoot and forefoot regions. In addition, the midfoot flow restricting means are not matched to the anatomical structure of the longitudinal medial arch. Matching the anatomical structure of the foot to the location, direction, quantity and duration of fluid flow fully determine therapeutic benefits, pressure distribution and directional stability.

Some prior art insoles, as shown for example in the Hall or Nickel patents have attempted to regulate fluid flow within the forefoot and hindfoot regions. But, these efforts ha,, c not been anatomically satisfactory because the fluid flow is not matched to the anatomical structure of said regions, but rather directed to the outer, medial and lateral, margins of the insole, awa ! ^ from the areas of the foot where fluid massaging action and pressure distribution is required when considering the physiology and anatomy of the foot.

The Thedford patent has also attempted to regulate fluid flow within the forefoot and hindfoot regions. These teachings have not been anatomically satisfactory because the fluid flow is neither adapted to the anatomical structure of the foot nor arranged in a fashion that achieves directional stability to the user during the flow of fluid within the insole. further, the Thedford patent teaches prohibition or blocking of longitudinal flow within the bladder, redirecting the flow in a transverse direction that is not anatomical.

The Gilbert patent has attempted to regulate fluid flow by randomly dispersing flow restrictors across the entire surface of the insole, which, again, does neither match the anatomical structure of the foot nor achieve directional stability. The Gilbert patent does not specify any particular arrangement of flow restrictors or fluid flow, but teaches that the"spots'"may be disposed at any desirable location with any desirable frequency"which makes flow control indefinite. Further. the Gilbert patent permits air to shift in any direction and part) \ arranges flow-restricting means to block longitudinal flow, which, again, is not anatomical.

Many prior art insoles are filled with ordinary water or other fluids that not only quickly evaporate and thus significantly reduce the industrial applicability (lifetime) of the insole, but also develops bacteria and/or other microorganisms, causing the fluid to become toxic and thus environmentally unsafe. In addition, existing prior art insoles do not consider the fluid itself as a flow controlling means and thus significantly limits the therapeutic value of the insole by allowing the fluid to flow at a rate that cannot satisfactorily provide pressure distribution. The rate of fluid flow significantly influences pressure distribution.

Finally, none of the prior art insoles considers local pressure distribution within each of the midfoot, forefoot and hindfoot regions of the bladder by directing and anatomically controlling the flow of fluid within each of the midfoot, forefoot and hindfoot regions. This lacking consideration significantly limits the medical and therapeutic applications of the prior art insoles. It would be desirable to have a fluid filled insole that (i) controls and directs the fluid to match the anatomical structure of the foot and achieve directional stability to the user \\ earing the insole, (ii) maximizes pressure distribution to minimize peak pressures on the foot, both across the entire area of the foot and within each of the hindfoot, midfoot and forefoot regions, (iii) ensures minimum evaporation of the fluid to maximize the life time of the insole, (iv) provides a fluid that is environmentally safe, and (v) devises a fluid that functions as a flow restricting means vis-a-vis the density and viscosity of the fluid to enable maximum pressure distribution, and which otherwise overcomes the limitations inherent in the prior art.

OBJECTS OF THE INVENTION It is an object of the invention to provide an insole that has a superior therapeutic fatigue- relieving effect by providing maximum pressure distribution in each of the hindfoot. midfoot and forefoot areas of the plantar surface of the user's foot, while improving the muscular venous pump function by means of the flow of fluid interacting with foot movements.

It is a further object of the invention to provide a fluid filled insole wherein the fluid flow matches the anatomical structure of functionally normal feet; the fluid being directed and controlled in transverse and longitudinal flow passages that are adapted to the anatomical structure of functionally normal feet, thereby achieving directional stability for the user when wearing the insole.

It is another object of the invention to provide a liquid filled insole that increases the weight bearing surface area of the user's foot by improving the distribution of the user's weight both over the total area of the foot and within each of the hindfoot, midfoot and forefoot regions, thereby reducing peak pressures on the plantar surface of the user's foot.

It is a fourth object of the invention to provide an insole filled with a sterile. non-toxic, non-greasy fluid that not only has low evaporation rates but also remains environmentally safe during the entire lifetime of the insole.

It is a fifth object of the invention to provide a liquid filled insole that is durable and not prone to lose fluid by leakage, evaporation or diffusion, thus prolonging the lifetime of the insole.

It is a sixth object of the invention to provide a fluid filled insole that increases the weight bearing surface within each of the forefoot, midfoot and hindfoot regions by (i) restricting the flow of liquid between the three regions and by (ii) anatomically directing and controlling the liquid within each of the regions (local pressure distribution).

It is an eighth object of the invention to provide a fluid filled insole that accumulates anatomically optimal quantities of liquid within each of the hindfoot and forefoot areas to enable optimal pressure distribution.

SUMMARY OF THE INVENTION The insole of the invention comprises a fluid tight bladder having an upper layer of flexible material and a lower layer of flexible material sealingly joined together at their peripheral margins. The bladder has a generally foot shaped planar configuration. with a proximal forefoot region, a hindfoot region, and a midfoot region there between. The bladder is filled with a large molecular, non-evaporable, highly viscous, sterile liquid. preferable a mixture of hygroscopic, polyvalent alcohol and distilled water. Within the proximal forefooi region of the bladder is positioned, optimally between one and five flow deflectors, the imaginary longitudinal centerlines of which are substantially equally spaced transversely one from the other, and spaced from the medial and lateral margins of the bladder. The flow deflectors comprise weld points joining the upper and lower bladder layers. Substantially equally dimensioned longitudinal flow channels are formed between the flow deflectors and between the flow deflectors and medial and lateral margins of the bladder. However, it should be understood that flow deflectors while desirable are not strictly needed.

The hindtoot region of the bladder optionally comprises between one and fi e hindfoot flow defectors. At least two longitudinal channels are formed between the hin (tfoot flow deflector (s) and the medial and lateral margins of the bladder. If two or more are so used. at least one longitudinal hindfoot flow channel is formed between the hindfoot deflectors. Thereby, fluid flowing within the hindfoot and forefoot regions and from these regions into the midfoot region and vice versa ill be channeled through the longitudinal flow channels in the forefoot and hindfoot regions in a controlled fashion, resulting in enhanced medical and therapeutic benefits as explained below. It should be recognized, however, that the hindfoot flow deflectors are optional, and are not strictly required. This must be viewed in combination with the means for controlling fluid flow into and out of the hindfoot region.

In accordance with the present invention there are two alternative structures bridging the proximal forefoot region and the distal hindfoot region. A first embodiment is characterized by two transverse walls, preferably ovally formed, one in the proximal end of the proximal forefoot region, and the other in the distal end of the hindfoot region. Each wall has at least one opening, preferably one at the midpoint, forming a substantially straight longitudinal channel through which the fluid can flow from the proximal forefoot region and into the midfoot region. from the midfoot region to the hindfoot region and vice versa.

A second embodiment is characterized by two elongated flow controllers extending from the proximal forefoot region to the distal hindfoot region. One controller substantiall\ underlies the wearer's medial arch and the other substantially underlies the wearer's lateral arch. A substantially straight longitudinal channel is formed in between the two flow controllers. through which liquid flows from the proximal forefoot region through the longitudinal arch channel and into the hindfoot region. The lateral flow controller forms a volume under the lateral ; rch that is not filled with liquid. The medial flow controller, however, has an opening that allows liquid from the proximal forefoot region to flow into the medial longitudinal arch area. Thereby, liquid may accumulate within the area of the medial longitudinal arch. Thus, liquid may flo\\ from the proximal forefoot region through both the longitudinal channel between the two elongated f) ow restrictors and through the opening between the arch and proximal forefoot region In use. a liquid pad or pillow is formed that substantially underlies the anatomical structure of the medial longitudinal arch region of a normal foot. In the second embodiment, flow deflectors may optionally be provided in the forefoot or heel regions, but are not strictly required.

The bladder is filled with a large molecular, non-evaporable, highly viscuus. sterile liquid, preferably a mixture of hygroscopic, polyvalent alcohol and distilled water. The fluid has a viscosity and density of at least 1.10 times that of ordinary water. I refer to this ah a"heavy liquid."For the above reasons, the density of the fluid, measured by g/m3. is higher than the density of water (density=weight), because a higher weight of the fluid (compared to water) restricts the rate of fluid flow. For the same reasons, the thickness (viscosity) is also higher than water, because a higher thickness of the fluid (compared to water) restricts the rate of fluid flow.

This mixture is sterile, non-toxic and resistant to contamination by bacteria or other microorganisms. thereby ensuring an environmentally safe fluid within the insole. 1 further. the mixture of hygroscopic, polyvalent alcohol and distilled water is not susceptible to evaporation or diffusion through the bladder layers. It is also autoclavable. In the event of a bladder puncture, the liquid may be easily removed from clothing and footwear, as the mixture is also relatively non-greasy.

The insole of the invention has been tested and found to provide several desirable medical benefits. The insole relieves fatigue during prolonged standing or walking by distributing the user's weight anatomically over the area of the foot. The weight bearing surface urea of the wearer's feet is increased, thereby reducing peak pressures exerted on the plantar surface of the user's foot and resulting deformation of soft tissue. The reduction in pressure thereby further relieves stress on the bones of the foot that can cause foot pain, hard skin and in extreme situations, ulceration.

Second, when interacting with the feet during locomotion, the anatomically controlled flow of fluid through the bladder across the plantar surface of the user's feet provides a therapeutic movement of the small intrinsic muscles of the feet. The movement of the muscles animates the venous pump function increasing blood circulation, which in turn improves transport of oxygen and nutrients to the cells in the foot and removal of waste products excreted from the cells.

Third, the specific locations of the flow deflectors and restrictors/controller enable a fluid flow that is matched to the anatomical structure of the foot and thus aid in anatomically correct locomotion. This in turn provides not only directional stability during locomotion when the fluid moves within the insole, but also alleviates the foot abnormalities over supination and over pronation found in asymmetric feet.

Other attributes and benefits of the present invention will become apparent from the following detailed specification when read in conjunction with the accompanying draw ings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a plan view of the human foot illustrating the medial and later.)) portions thereof, and shows a typical weight pressure distribution pattern of a normal foot.

Fig. 2 is a dorsal view of the bones of the human foot.

Fig. 3 is a plan view of a first embodiment of the invention.

Fig. 4 is a plan view of a second embodiment of the invention.

Fig. 5 is a cross-section taken along line 5-5 of Fig. 4.

DETAILED DESCRIPTION Turning now to the drawings, Figs. 1 and 2 illustrate the anatomical structure of the human foot. The foot comprises a (i) hindfoot region containing the talus 1 and os calcis 2 bones; (ii) a midfoot region containing the cuneiform 3, cuboid 4 and navicular 5 bones ; and the forefoot region comprising the metatarsals 6, the proximal phalanges 7, and the middle 8 and distal 9 phalanges. The forefoot region can be divided into two sub-regions. the distal sub-region comprising the middle and distal phalanges, and the proximal forefoot region, which comprises the metatarsals and proximal phalanges. The foot also includes a longitudinal arch-having a medial and a lateral side. The medial longitudinal arch is defined by the navicular and medial cuneiform bones of the midfoot and the about the proximal half of the first, second and third metatarsals. The typical weight bearing area of a normal foot appears from Fig. 1. The weight is not equally distributed over the plantar area of the foot. In a functionally normal foot. the medial midfoot typically bears little weight.

In Fig. 3. a first embodiment of the fluid filled insole of the invention is shown. The insole comprises a bladder 10 having an upper layer 12 and a lower layer 14. t he insole preferably further includes a layer of textile or a sweat absorbing material 16 substantially covering and laminated to the outer surface of upper layer 12. Optionally a textile layer could be added to the bottom surface of the insole. The bladder layers 12 and 14 are sealing joined at their peripheral margins 18. For reference, the medial peripheral margin is numbered () and the lateral peripheral margin is numbered 22. The bladder comprises three main regions namely a forefoot region 25. a hindfoot region 26 and a midfoot region 28 there between. The forefoot region is divided into a distal subregion 30 and a proximal forefoot region 24.

The interior cavity 32 of the bladder 10 is filled with a sterile, non-toxic, non-evaporable fluid with a density and viscosity of at least 1.10 times that of water. The fluid is preferably a "heavy liquid"mixture of large molecular, hygroscopic polyvalent alcohol and distilled water as is more fully described below. In the first embodiment the fluid may flow between and throughout the proximal forefoot, midfoot and hindfoot regions. The distal forefoot sub-region 30 preferably does not contain fluid. Within the proximal forefoot region 24 of bladder 22 there are at least one, but preferably between two and six transversely spaced flow deflectors 34. The deflectors are evenly spaced; that is, the transverse dimension from the imaginary longitudinal centerline of each deflector to the next adjacent imaginary longitudinal centerline is of substantially equal dimension. In the illustrated embodiment there are three forefoot flow deflectors 34, but. one could employ between one and six forefoot flow deflectors. The shape of the flow deflectors is preferably circular or oval, but other shapes may alternatively be used. The space between each of the imaginary longitudinal centerlines of adjacent flow deflectors and between the flow deflectors and the medial and lateral peripheral margins of the bladder forms substantially longitudinal forefoot flow passages. Each flow passage between adjacent deflectors has a substantially equal transverse dimension, Wm. By"substantially equal transverse dimension,"I mean between 0.95 and 1.05 times Wm, where Wm is calculated as follow s : W'n = (Dm-Sm)/ (Nm + 1) Dm is the maximum straight transverse width of the forefoot region. Sm is the sum of the transverse dimensions of the forefoot flow deflectors, and Nm is the number of forefoot flow deflectors.

The forefoot flow deflectors are arranged in a shape that laterally, medially, transversely and longitudinal) y matches the anatomical structure of the proximal forefoot region. the shape being for example. but not limited to, an arc, a semicircle, or a trapezoid, the convex side of the shape facing in a distal direction. The spacing between the imaginary longitudinal centerlines of the flow deflectors depends on (i) the shoe or foot size, (ii) the diameter of the flow deflectors, and (iii) the number of flow deflectors. With two forefoot flow deflectors, the spacing from imaginary longitudinal centerline to centerline between flow deflectors would be 3\% or one third of the transverse straight distance between the lateral and medial peripheral margins of the bladder measured at the location of the flow deflectors. If n flow deflectors are placed in the proximal forefoot region, then n + 1 longitudinal flow passages are formed.

The flow deflectors 34 are formed by weld points joining the upper bladder layer 12 to the lower bladder layer 14. Formation of flow deflectors by welding points joining the bladder layers improves the structural integrity of the bladder, improving durability. Between flow deflectors 34 are flow passages 36 through which fluid flows during use of the insole.

Additional flow passages 38 are also formed in the proximal forefoot region between flow deflectors 34 and the medial peripheral margin 20, and between flow deflectors 34 and the lateral peripheral margin 22. The forefoot flow passages 36 and 38 extend in a straight, longitudinal direction. By"longitudinal"it is meant that the flow direction varies by no more than 0 degrees (plus or minus) from the straight longitudinal axis of the insole. At least one passage lows in an unobstructed path to the mid foot region of the bladder. Flow deflectors 34 are show n as being circular, but other shapes, such as oval or ellipse, may be alternatively used.

Bridging the proximal forefoot region and the midfoot region 28 of bladder 11) is a flow controller 72, which is generally matched to the wearer's arch such as depicted in Fig. 1. The arch flow controller may be configured in several different ways, but must match the contour or anatomical structure of the longitudinal arches of a normal foot, as described above in reference to Figs. 1 and 2. The lateral edge of the longitudinal medial arch is generally an elongated, semicircular line substantially at the longitudinal border of the lateral and medial arch of a normal foot, such as shown in Fig. 1. The longitudinal medial arch extends from the proximal part of the midfoot area to about the mid-point of the metatarsals, as shown in Fig 1. Flow controller 72 is shaped and located to match at least a portion of the border between the medial and lateral longitudinal arch. A midfoot flow channel 70 is formed on the lateral side of controller 72. A semi-enclosed area or volume 29 is defined by the longitudinal arch flow controller 72 and the medial peripheral margin of the bladder that substantially matches the anatomical structure of the medial longitudinal arch region of a normal foot. In this \\ay, liquid will flow from the proximal forefoot region and into the medial arch region, thus forming a liquid pad or pillow substantially under the area of the medial arch.

The hindfoot region 26 of the insole 10 of the invention optionally includes cue to five flow deflectors 40. However, such hindfoot flow deflectors are not strictly required. One could practice the invention as defined by the appended claims with no hindfoot flow deflectors. This must be viewed in combination with the overall structure of fluid flow within the Insole. but specifically how fluid flow into and out of the hindfoot region is controlled. Because the hindfoot region is a smaller area than the forefoot region, two flow deflectors arc shown.

Alternatively, zero. one, three, four or five could be used. The hindfoot flow deflectors 40 are formed in the same manner as the forefoot flow deflectors, by a weld point joining the upper and lower bladder layers 12 and 14. At least one generally longitudinal flow passage 42 is formed between hindfoot flow deflectors 40, if two or more hindfoot deflectors are used. additional hindfoot flow passages 44 are formed between hindfoot deflectors 40 and the medial and lateral peripheral margins of the bladder. The transverse spacing and dimensions of the hindfoot flow passages is not critical and may vary as desired.

The first embodiment, Fig. 3, comprises a communicating compartmentalized structure of the insole. Substantially transverse walls 43 and 45 are formed at the intersections of (i) the proximal part of the proximal forefoot region and the distal part of the arch region, und (ii) the proximal part of the arch region and the distal part of the hindfoot region. The transverse wall 43 in the proximal end of the forefoot region has at least one opening, preferably me at the midpoint, forming a longitudinal channel 47 through which the fluid can flow from the proximal forefoot region and into the midfoot region and vice versa. The size of the opening is between 10% and 25% of the straight distance between the lateral and medial periphery margins measured at the location of said transverse wall. The opening is not limited to one but could be several openings. The opening is preferably placed at the midpoint on said transverse wall 43, but could be placed anywhere along said transverse wall.

Similarly. the transverse wall 45 located in the distal end of the hindfoot region has at least one opening, preferably one at the midpoint, forming a longitudinal channel 49 through which the fluid can flow from the hindfoot region and into the midfoot region and R ice versa.

The size of the opening is between 10% and 25% of the straight distance between the lateral and medial peripheral margins measured at the location of the transverse wall. The opening 49 is not limited to one but could be several openings. The opening is preferably placed at the midpoint of the transverse wall. but could be placed anywhere along the transverse wall. The shupe of said transverse walls are preferably, but not limited to, oval or ellipse, but other shapes mua\ be used alternatively.

The aforesaid transverse walls and openings may be alternatively viewed and described as a pair of flow restrictors placed against the lateral and medial margins of the bladder. The fl (w passage is formed by leaving an opening between the respective restrictors.

Fig. 4 shows a second embodiment of the invention. The second embodiment is similar to the first embodiment with a more structured longitudinal central passageway. It is generally a communicating. semi-compartmentalized structure in which the liquid is controlled by two elongated flow restrictors 51 and 53 extending from the proximal forefoot region to the hindfoot region. Flow restrictor 51 defines a medial longitudinal arch area 55. Flow restrictor 53 defines a lateral longitudinal arch area 57. A substantially straight longitudinal channel 59 is formed between the two flow restrictors 51 and 53, through which liquid flows from the proximal forefoot region into the hindfoot region and vice versa. The lateral elongated flow restrictor 53 has one end beginning at the lateral margin of the bladder in the proximal end of the proximal forefoot region. extends substantially along the border between the lateral and medial longitudinal arches. and ends at the lateral peripheral margin of the bladder in the distal end of the hindfoot region. The lateral longitudinal arch area of the bladder is not filled with liquid. The medial elongated flow restrictor 51 has one end beginning at the medial margin of the bladder in the proximal end of the proximal forefoot region, extends substantially along the border between the lateral and medial longitudinal arches, and ends at the medial peripheral margin of the bladder in the distal end of the hindfoot region. The medial longitudinal arch area is filled with liquid.

In the lateral proximal corner of the proximal forefoot region, flow of liquid is blocked by the elongated lateral flow restrictor 53 and thus cannot flow into the lateral longitudinal arch area 57, but only through the longitudinal channel 59 between the two elongated flow restrictors. An opening 61 is made in the medial proximal corner of the forefoot region with the purpose of allowing liquid from the proximal forefoot region to flow into the medial longitudinal arch region 55. The opening is preferably in the portion of restrictor wall 51 that is in the proximal end of the proximal forefoot region. Thereby, liquid may accumulate within the medial longitudinal arch area. Liquid may also flow from the proximal forefoot region through the longitudinal channel 59 between the two elongated flow restrictors.

As compared to the first embodiment, the transverse legs of restrictors 5L53 of the second embodiment are substantially equivalent to the transverse walls 43,45 o) the first embodiment. The longitudinal legs of the medial and lateral restrictors 51,53 connect the openings in the transverse legs to form channel 59. The longitudinal leg of medial restrictor 51 assists in confining fluid within the medial arch area, in much the same manner as tht C-shaped controller in the first embodiment, to form a liquid pad or pillow supporting the wearer's medial longitudinal arch.

In the second embodiment, optional forefoot flow deflectors 34 and hind foot flow deflectors 40 may be provided, but are not strictly necessary.

The bladder is preferably fabricated from polyurethane film although other thermoplastic materials, such as EVA, PVC or vinyl may also be used. The thickness of each bladder layer should be from about 300 to 800 micrometers, 400 micrometers being preferred. ! he sweat absorbing material is preferably about 250 micrometers in thickness. Other textile materials may be used for comfort or breathability regardless of sweat absorbing properties. The bladder may be formed by conventional radio frequency or dielectric welding techniques. Other welding techniques, such as thermal welding may be used alternatively. The bladder is filled with the liquid mixture leaving an opening in the peripheral weld, through which liquid may be introduced, then sealing the opening. The insole of the invention may be made and sold as an insole for removable placement in shoes by the user. Also, the insole may be built int) íootwear as a permanent feature.

The fluid used to fill the cavity 32 of the bladder 10 is preferably a mixture oi distilled water and a sterile. non-toxic, non-evaporable, large molecular, hygroscopic liquid to prevent evaporation or diffusion through the bladder. Polyvalent alcohols with large molecules and with non-toxic properties are preferred. One suitable formulation comprises approximately 85-98%, hygroscopic polyvalent alcohol and approximately 2-15% distilled water. By using this mixture in lieu of plain water, improved benefits are achieved: The mixture of the invention as compared to water does not evaporate or diffuse through the bladder layers, thereby significantly improving life time and durability of the insole. The liquid can withstand autoclaving as may be required by health care institutions. The insoles can be used in temperature ranges from minus'() degrees Celsius to plus 120 degrees Celsius, because both the liquid mixture and bladder materials can withstand these temperature extremes. The liquid is fully sterile and non-toxic. and thus environmentally safe.

The sterility and/or non-toxicness of the fluid is extremely important for several reasons.

Children, people and animals could bite the insole, possibly drinking or swallowing the liquid.

Water becomes septic after a few months of storage within insoles, because bacteria will grow and flourish in the water.

Compared to water, the mixture of polyvalent alcohol and distilled water has a significantly higher density and viscosity. The fluid of the invention has a preferred density and viscosity range of at least 1.10 times that of water. The actual filling of fluid with ; particular density that is at least 1.10 times that of water depends on the flow controlling means within the bladder. Generally, the more the flow of liquid within the bladder is restricted by flow controlling means in the forefoot, midfoot and hindfoot regions, the lower the requirement for the density and viscosity of the liquid. Inversely, the fewer flow controlling means \within the bladder, the higher the density and viscosity required. The density and viscosity ot the fluid causes an improvement in the effects on the user's foot when wearing the insoles, because the density and viscosity generally controls the rate of flow of the viscous liquid within the insole. In this way, the density and viscosity strongly influence not only the degree of pressure distribution with following reduction of peak pressures on the plantar surface of the foot. but also directional stability.

The liquid used is a thick or heavy liquid that is resistant to flow. but not so thick that flow is unduly restricted. It is intended that when body weight is applied to one area of the bladder, the fluid will slowly and gradually flow out of the area after application of lad over a few milli-seconds of time, thus the fluid is functioning as a flow restricting means and thereby enable an improved weight pressure distribution as compared to the fluid being ordinary water.

Preferably, the fluid does not leave a region before the weight load is applied to that region.

Referring to Fig. 4 as an example, when a user places his/her heel to the hindfoot region the fluid will not immediately leave the region, i. e., the fluid will not"jump"out of that area upon application of load. Rather, the fluid will not flow out of the hindfoot region before after application of weight load has occurred. I refer to this as a"heavy liquid."For the above reasons, the density of said fluid, measured by g/m3, is higher than the density of water (density = weight), because a higher weight of the fluid (compared to water) restricts the rate of flow of fluid. For same reasons, the thickness (viscosity) is also higher than water, because a higher thickness of the fluid (compared to water) restricts the flow of fluid, and thus enable application of load before the fluid leaves a region.

The liquid is relatively non-greasy. Thus, if the insoles are punctured or for. my reason the liquid runs out into the user's socks or shoes, the shoes and socks may be readily cleaned.

Testing has shown that there are four basic beneficial effects from wearing the insoles of the invention, namely: (1) reducing pressure on the foot; (2) improves the venous pump function by causing a movement of all the small intrinsic foot muscles ; (3) symmetric walking, and (4) directional stability. Each of these therapeutic benefits will be explained in turn.

In the body, blood is pumped from the heart through the arteries out to the energy consuming muscles, where the blood carries the various energy substances such as carbohydrates and oxygen. Within the muscles, the energy is subsequently provided by an oxidation process in which carbohydrates interact with oxygen creating carbon dioxide, water and energy. I f a person is working extremely hard--resulting in substantial use of muscles--the oxygen supplied to the muscles (through the blood supply) is insufficient to supply the muscles with sufficient energy.

Energy may also be produced in the muscles by splitting of glycogen into lactic acid and energy.

Glycogen is a substance in the muscles. The oxygen-poor blood and cell waste products that have resulted from the energy production will then be transported through the veins back to the heart and the purifying organs of the body. The veins function with the muscles to form a venous pump system that eases the transport of the blood back to the heart. The venous pump functions in cooperation with the muscle activity since the moving muscles cause the veins to stretch and contract. Since the veins internally are equipped with valves (flaps) that prevent the hlood from flowing away from the heart, the muscle activity on the veins causes the veins to function as a pump system that significantly increases blood transportation back to the heart.

When an individual is standing or walking for more than four hours per da\. the foot muscles may receive insufficient movement and exercise. Individual movement ol the many small muscles in the foot is hindered. If the foot muscles have insufficient strength, they do not have the sustaining strength to maintain the weight of the body, and the heel bone and metatarsal bones may sink downwardly. The following chain reaction occurs: 1. When the feet collapse ("sink down"), the foot muscles are compressed. which reduces blood flow. Simultaneously, low muscle activity from the compression of the foot muscles causes a reduction of the venous pump function.

2. The foot muscles do not receive sufficient oxygen and carbohydrate quantities for maintaining adequate energy production and oxidation.

3. Because of the constant pressure and lack of supply of oxygen and carbohydrates, the foot muscles start to produce energy by splitting of glycogen to lactic acid and energy.

4. Because blood circulation is hindered, the process will accumulate lactic acid in the foot muscles.

5. Lactic acid causes fatigue, heavy legs, and later pain, depending on the length of time walking or standing.

6. The fatigue feeling tends to cause people to place themselves in inappropriate or awkward positions in an effort to remedy the feeling. again affecting other muscles, leading to pain in legs, back, head, etc.

With the insole of the invention, the movement of the liquid within the bladder will result in the user's body weight being more widely distributed over the area of the fovl. thereby increasing the weight bearing surface area of the foot, and relieving peak pressures on the foot muscles. The weight is not equally distributed over the plantar surface area of the foot. see Fig.

1. Further, the simultaneous movement of fluid within the bladder causes the small intrinsic foot muscles to move. which, combined with the pressure distribution effect, improves the venous pump function and thus avoiding the above chain reaction. Tests reveal that the insole of the invention reduces peak pressures, measured by the average pressure in kilograms per square centimeter against the plantar surface of the user's foot. The improved distribution ou'té user's weight is particularly applicable during standing or walking. It is important to ; void high pressure on heel and metatarsal bones, since such pressure can cause foot pain, hard s) \in. and. in extreme situations. ulceration. These abnormalities are well known in diabetic feet.

The weight of the user pressurizes the liquid within the bladder. The pressurized liquid will constantly move the non-loaded parts of the bladder upwards. Movement or weight shift by the user will cause fluid movement, whereby a constant movement of the small internal foot muscles occurs. A considerably improved venous pump function is thereby established in the foot itself. A constant massage of the foot sole occurs for each time weight distribution is changed by the movement of the fluid within the three regions. When the feet, and thus the weight, is placed on the insoles, a weight pressure redistribution action takes place between the feet and the insoles. stimulating the blood veins. The effect is a considerably impro\ cd venous pump function, which is obviously very important for any person participating in ; standing, walking or running activity. The function of the blood is to transport oxygen and nutrients to the cells, and return waste products to be excreted from the user's kidneys. through the urine.

Improved blood circulation will decrease the amount of lactic acid, an element known as causing fatigue or myasthenia. Blood circulation is thus very important to individuals applying their muscles extensively, since muscle exertion constrains the blood corpuscles. thus hampering the transport of nutrients and waste products. Another effect of insufficient blood supply is a reduction of the contraction ability of the muscles. The fluid filled insole of the invention enhances the location, degree and duration of beneficial pressure distribution as compared to the prior art vis-a-vis the flow of fluid that is specifically matched to the anatomical structure of the foot (Figs. 1 and 2). A positive effect is a reduction and in many instances elimination of the painful effect of soreness in feet, legs, and back caused by prolonged standing or walking.

The features that distinguish the current invention from the prior art is further the specific location of the flow deflectors and restrictors in the forefoot, midfoot and hindfoot regions, enabling a flow of fluid matched to the anatomical structure of the feet. The flow deflectors and restrictors and their following flow passages ensure directional stability during locomotion by enabling a controlled circulation of liquid that is matched to the anatomical structure of the normal foot. This is important since uncontrolled liquid circulation would result in unstable walking, unstable weight distribution, discomfort, and potentially the development of foot abnormalities. Directional stability, as achieved by the designed liquid circulation of the invention and as distinguishable over the prior art, ensures an anatomical locomotion pattern for the wearer, because the weight is anatomically distributed on the surface area of the foot. The insole can alleviate the problems involved in over-supination and over-pronation, i. e.. where the user's feet are turning abnormally either to the medial, inner side or the lateral, outer side of the foot ("asymmetric feet"). The combination of distribution of weight pressure and directionally stabilizing fluid circulation also supports a functionally correct take-off : a factor crucial for walking or running in a physiologically correct manner.

While the preferred embodiment of the present invention has been shown and described, it is to be understood that various modifications and changes could be made thereto without departing from the scope of the appended claims.

What is claimed is: 1. An improved insole adapted to be worn beneath a wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region there between. wherein the improvement comprises: at least one but no more than six transversely spaced flow deflectors in the proximal forefoot region of said bladder, said deflectors being spaced apart relative to one another at least two. but no more than seven forefoot flow passages between each of said flow deflectors and between said flow deflectors and the lateral and medial margins of the proximal forefoot region of said bladder, said forefoot flow passages having substantially equal transverse dimension; a transverse wall in the proximal end of the proximal forefoot region. said transverse wall having at least one opening therein to allow fluid to flow from the proximal forefoot region to the midfoot region of said bladder; and said fluid comprising a heavy, viscous liquid.

2. An improved insole as in claim 1, further comprising a transverse wall in the distal end of the hindfoot region of said bladder, said transverse wall defining at least one opening therein to allow fluid to flow from the hindfoot region to the midfoot region and vice versa.

3. An improved insole as in claim 2, further comprising a longitudinal channel between said opening in said proximal forefoot wall and said opening in said hindfoot wall, whereby said channel conveys fluid from said forefoot region to said hindfoot region, and vice versa 4. An improved insole as in claim 3, wherein said forefoot wall, longitudinal channel and hindfoot wall define a medial area and a lateral area substantially underlying, respectively. the wearer's medial and lateral longitudinal arches, said lateral volume being empty of liquid. and further comprising a opening into said medial area within said bladder whereby fluid may flow into said medial area.

5. An improved insole as in claim 1, further comprising at least one flow deflector in the hindfoot region of said bladder, and at least two hindfoot flow passages between said at least one flow hindfoot flow deflector and said lateral and medial margins of said bladder, each (% i said hind foot flow passages having substantially equal transverse dimension.

6. An insole as in claim 1, wherein said insole is adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border there between, said insole further comprising an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot.

7. An improved insole as in claim 1, wherein said insole is incorporated into footwear.

8. An insole, comprising a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, flexible material; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, foot-shaped configuration having distal forefoot region, a proximal forefoot region, a hindfoot region and a midfoot region there between; at least one but no more than six transversely spaced forefoot flow deflectors between said upper material layer and said lower material layer in said proximal forefoot : forefoot flow passages between said forefoot flow deflectors and between said forefoot flow deflectors and the medial and lateral margins of said bladder, each said forefoot f) w passages having a substantially equal transverse dimension; a transverse forefoot wall at the proximal end of said forefoot region, said forefoot wall extending from the lateral peripheral margin to the medial peripheral margin of said bidder, said transverse forefoot wall having at least one opening therein, said opening defining a longitudinal flow channel between said forefoot and said midfoot regions of said bladder : a transverse hindfoot wall at the distal end of said hindfoot region, said hindfoot wall extending from lateral peripheral margin to the medial peripheral margin of said bladder. said hindfoot wall having at least one opening therein, said opening defining a longitudinal ilow channel between said hindfoot and said midfoot regions of said bladder a liquid within said bladder, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa, and said distal forefoot region being substantially liquid free.

9. An insole as in claim 8, wherein said insole is adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border there between, said insole further comprising an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for directing flow from said hindfoot region to said forefoot region and vice versa.

10. An insole as in claim 8, wherein said liquid is a sterile, heavy liquid.

11. An improved insole adapted to be worn beneath a wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region there between, wherein the improvement comprises: at least one but no more than six transversely spaced flow deflectors in the proximal forefoot region of said bladder, said deflectors being spaced apart relative to one another : at least two. but no more than seven forefoot flow passages between each of said flow deflectors and between said flow deflectors and the lateral and medial margins of the proximal forefoot region of said bladder, said forefoot flow passages having substantially equal transverse dimension; a medial flow restrictor in said bladder defining an area underlying the wearer's medial longitudinal arch and extending from the medial peripheral margin in the proximal end of the proximal forefoot region of said bladder, substantially along the border between the wearer's medial and lateral longitudinal arch, to the medial peripheral margin in the distal end ou'té hindfoot region of said bladder, said flow restrictor having an opening therein to allow lluid to accumulate within said medial flow restrictor underlying the wearer's medial longitudinal arch ; a lateral tlow restrictor in said bladder underlying the wearer's lateral longitudinal arch, and extending from the lateral peripheral margin in the proximal end of the proximal forefoot region of said bladder, substantially along the border between the wearer's lateral and medial longitudinal arch. to the lateral peripheral margin in the distal end of the hindfoot region of said bladder, said lateral flow restrictor being substantially free of liquid; a longitudinal flow channel between said medial and lateral flow restrictors, said longitudinal flow channel conveying fluid from the proximal forefoot region to the hind foot region and vice versa ; and said fluid comprising a heavy, viscous liquid.

12. An insole, comprising: a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, flexible material; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder. said bladder having a generally planar, foot-shaped configuration having distal forefoot region, a proximal forefoot region, a hindfoot region and a midfoot region there between; a pair of flow restrictors at the proximal end of the proximal forefoot region of said bladder, one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel there between; a pair of flow restrictors in the distal end of the hindfoot region of said bladder. one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal llow channel there between.

(Applicants reference : C: \Probody\Patent\Pct-patent\March 1999\99CIP#2 R2 PGJ email 8-3-9'). DOC) FLUID FILLED INSOLE (ITEM 3) ABSTRACT OF THE DISCLOSURE A fluid filled insole wherein the flow of fluid is matched to the anatomical structure of functionally normal feet comprises a fluid tight bladder having upper and lower layers and a generally foot-shaped, planar configuration, with proximal forefoot, midfoot and hindfoot regions; a heavy. viscous, sterile liquid substantially filling the bladder; at least one, preferably between two and six transversely spaced forefoot flow deflectors joining the upper and lower layers in the proximal forefoot region of the bladder; flow passages matched to the anatomical structure of the foot between the forefoot flow deflectors and the medial and lateral and peripheral margins of the bladder; and two transverse walls, one in the proximal end of said proximal forefoot region and the other in the distal end of the hindfoot region, each transverse wall having an opening forming a longitudinal passageway. Alternatively, the walls muy be viewed as two pairs of flow restrictors; one pair of restrictors in the proximal end of the proximal forefoot region and the other pair in the distal end of the hindfoot region, each pair of restrictors defining a longitudinal flow channel there between. Also included is an elongated flow restrictor in the arch region. A second embodiment has two elongated flow controllers extending from the proximal forefoot region to the distal hindfoot region, the controllers substantially underlying the medial and lateral longitudinal arches.

(ITEM 4) FLUID FILLED INSOLE WITH METATARSAL PAD CROSS REFERENCE This application is a continuation-in-part of copending application serial no. uS/687 787 filed July 19,1996. which is a continuation-in-part of application serial no. 08/047,685 filed on April 15,1993, now abandoned.

BACKGROUND OF THE INVENTION The present invention is directed to therapeutic fluid filled insoles, and more particularly to insole bladders having a pad or cushion in the forefoot region of the insole and having fluid controlling means in the midfoot and hindfoot regions. The purpose of the combination is to achieve improved medical benefits and directional stability to the users.

Fluid filled insoles have long been known in the art, see for example, U. S. Patent No.

4,567,677 to James Zona, U. S. Patent No. 4,115,934 to Hall, U. S. Patent No. 4. 12"). 855 to Thedford, U. S. Patent No. 2,080,469 to Gilbert and U. S. Design Patent No. D246, 486 to John W.

Nickel. Prior art insoles commonly comprise a bladder having an upper layer and a lower layer.

The two layers are welded together at their marginal periphery. The bladder has a planar, foot- shaped configuration, which includes a forefoot region, a hindfoot region, and a midfoot region there between. The bladder is filled with a fluid, such as water or air. The broader technical functions of fluid filled insoles are well documented, whereas the medical benefits are only marginally documented. It is not generally known that fluid filled insoles may be designed to accomplish specific medical benefits. Two significant limitations in the prior art arc : (1) the flow of liquid/fluid is not matched to the anatomical structure of the foot. and (2) flow of fluid does not provide directional stability. The known technical functions include cushioning of the feet by a massaging action on the plantar surface of the feet due to movement of the il muid within the bladder, thus achieving comfort to the user.

The fluid tilled insoles of the prior art have not been entirely satisfactory, however, in the area of providing demonstrative medical benefits, neither as a device for relieving fatigue in the lower extremities by providing pressure or stress distribution and activation of the venous pump function nor for achieving directional stability to the user when wearing the insole Existing prior art insoles have little or no means for: (1) controlling both the transverse and longitudinal flow of fluid, (2) controlling the rate of fluid flow within the insole, or (3) matching the flow of fluid to the anatomical structure of the foot. As a user walks, the user's weight is initia l Iy applied to heel, and then is transferred to the ball of the foot. This causes the fluid within the bladder to move, respectively. from the hindfoot region to the forefoot region and then back towards the hindfoot again. Further, without means for directing fluid flow anatomically within the bladder, the fluid will flow uncontrollably and thus causing directional instability to the user when wearing the insole. Without means for controlling and restricting the rate of fluid flo\\ vis-a-vis viscosity and density of the fluid, the foot will simply"jump through"the fluid in the insole when the wearer's weight is applied, and thus the fluid insole has little pressure distribution or massaging effect.

Some prior art devices, such as the insole of the Zona patent, have attempted to regulate flow from the hindfoot region to forefoot region and vice versa by placing flow restricting means in the midfoot area of the bladder. These flow restricting devices are only marginally effective, however, since they neither match the anatomical structure of the foot nor control the flow within the forefoot or hindfoot regions of the bladder to achieve directional stability and local pressure distribution. In addition, the midfoot flow restricting means are not matched to the anatomical structure of the longitudinal medial arch. Matching the anatomical structure of the foot to the location, direction, quantity and duration of fluid flow fully determine therapeutic benefits, pressure distribution and directional stability.

Some prior art insoles, as shown for example in the Hall or Nickel patents have attempted to regulate fluid flow within the forefoot and hindfoot regions. But, these efforts ha\ e not been satisfactory because the fluid flow is not matched to the anatomical structure of said local regions, but rather directed to the outer, medial and lateral, margins of the insole, awl from the areas of the foot where fluid massaging action and pressure distribution is required when considering the physiology and anatomy of the foot.

The Thedford patent has also attempted to regulate fluid flow within the forefoot and hindfoot regions. These teachings have not been anatomically satisfactory because the fluid flow is neither adapted to the anatomical structure of the foot nor arranged in a fashion that achieves directional stability to the user during the flow of fluid within the insole. further, the Thedford patent teaches prohibition or blocking of longitudinal flow within the bladder, redirecting the flow in a transverse direction.

The Gilbert patent has attempted to regulate fluid flow by randomly dispersing flow restrictors across the entire surface of the insole, which, again, does neither match the. Illatomical structure of the foot nor achieve directional stability. The Gilbert patent does not specify any particular arrangement of flow restrictors or fluid flow, but teaches that the"spots"may be disposed at any desirable location with any desirable frequency"which makes flow control indefinite. Further. the Gilbert patent permits air to shift in any direction and partis arranges flow restricting means to block longitudinal flow.

Many prior art insoles are filled with ordinary water or other fluids that not olll quickly evaporate and thus significantly reduce the industrial applicability (life time) of the msole. but also develops bacteria and/or other microorganisms, causing the fluid to become toxic and thus environmentally unsafe. In addition, existing prior art insoles do not consider the fluid itself as a flow restricting means and thus significantly limits the therapeutic value of the insole hx allowing the fluid to flow at a rate that cannot satisfactorily provide pressure distribution. The r ; lte of fluid flow significantly influences pressure distribution.

None of the prior art insoles considers local pressure distribution within e. lch of the midfoot, forefoot and hindfoot regions of the bladder by directing and anatomically controlling the flow of fluid within each of the midfoot, forefoot and hindfoot regions.

Finally, none of the prior art insoles considers combining (i) fluid flow in the hindfoot and midfoot regions with (ii) pads or cushions in the forefoot region with the purpose of diffusing forefoot discomfort and relieving pain at localized areas. These lacking considerations significantly limit the medical and therapeutic applications of the prior art insoles. 1 would be desirable to have a fluid filled insole that (i) controls and directs the fluid to match the anatomical structure of the foot and achieves directional stability to the user wearing the insole, (ii) maximizes pressure distribution to minimize peak pressures on the foot, both across the entire area of the foot and within each of the hindfoot, midfoot and forefoot regions, (ici) ensures minimum evaporation of the fluid to maximize the life time of the insole. (iv) provides a fluid that is environmentally safe, (v) devises a fluid that functions as a flow restricting means vis-a- vis the density and viscosity of the fluid to enable maximum pressure distribution, (vi ; combines (i) to (v) with pads or cushions in the forefoot region to achieve support and relieve pain at localized areas, and which otherwise overcomes the limitations inherent in the prior art.

OBJECTS OF THE INVENTION It is an object of the invention to provide an insole that has a superior therapeutic fatigue- relieving effect bon providing maximum pressure distribution in each of the hindfoot, midfoot and forefoot areas of the plantar surface of the user's foot, while improving the muscular venous pump function by means of the flow of fluid interacting with foot movements.

It is a further object of the invention to provide a fluid filled insole wherein the fluid flow matches the anatomical structure of functionally normal feet; the fluid being directed and controlled in transverse and longitudinal flow passages that are adapted to the anatomical structure of functionally normal feet, thereby achieving directional stability for the user when wearing the insole.

It is another object of the invention to provide a liquid filled insole that increases the weight bearing surface area of the user's foot by improving the distribution of the user's weight both over the total area of the foot and within each of the hindfoot, midfoot and forefoot regions, thereby reducing peak pressures on the plantar surface of the user's foot.

It is a fourth object of the invention to provide an insole filled with a sterile. non-toxic, non-greasy fluid that not only has low evaporation rates but also remains environmentally safe during the entire life time of the insole.

It is a fifth object of the invention to provide a liquid filled insole that is durable and not prone to lose fluid by leakage, evaporation or diffusion, thus prolonging the life time of the insole.

It is a sixth object of the invention to provide a fluid filled insole that increases the weight bearing surface within each of the forefoot, midfoot and hindfoot regions by (i) res) ricting the flow of liquid between the three regions and by (ii) directing and controlling the liquid within each of the regions (local pressure distribution).

It is a seventh object of the invention to provide a fluid filled insole that enables pain and discomfort relief within localized areas of the forefoot region by providing pads or cushions in said region.

SUMMARY OF THE INVENTION The insole of the invention comprises a fluid tight bladder having an upper layer of flexible material and a lower layer of flexible material sealingly joined together at their peripheral margins. The bladder has a generally foot shaped planar configuration. with a proximal forefoot region, a hindfoot region, and a midfoot region there between. The bladder is filled with a large molecular, non-evaporable, highly viscous, sterile liquid. preferable a mixture of hygroscopic. polyvalent alcohol and distilled water. Within the proximal forefoot region of the bladder is positioned, at least one metatarsal pad preferably proximal to one or more of the wearer's metatarsal heads. A barrier is placed around the pad to prevent the pad (s) from being saturated with liquid. Preferably, at least a portion of the pad underlies the wearer's first metatarsal head. The metatarsal pad (s) comprise a cushioning foam material or a non-flowable, semi-solid fluid or gel, as opposed to a flowable liquid bladder.

More specifically, a first embodiment comprises a single, relatively large pad that substantially underlies the area proximal to all five metatarsal heads of a normal foot. t he shape of the metatarsal pad is preferably oval or elliptical, but alternative shapes may be used A second embodiment of the invention is characterized by plural (two to six) metatarsal pad flow deflectors preferably placed substantially proximal to one or more of the metatarsal heads in the proximal forefoot region. Preferably, at least one of the pads underlies the first metatarsal head. A metatarsal pad flow deflector placed just proximal to one of the metatarsal heads elevates the heads and will result mechanically in decreased extension of the metatarsophalangeal joints.

It is desirable, but not necessary, that the metatarsal pads are substantially equally spaced transversely one from the other, and spaced from the medial and lateral margins of the bladder.

Substantially equally sized longitudinal flow channels may thus be formed between the flow deflectors and between the flow deflectors and medial and lateral margins of the bladder.

Bridging the proximal forefoot region and the midfoot region of the bladder is a flow controller, which is generally anatomically matched to the structure of the longitudinal arches of a normal foot. The arch flow controller comprises an elongated, semicircular shaped weld, between the upper and lower bladder layers. The longitudinal arch flow control) o and the medial peripheral margin of the bladder define a semi-enclosed volume. In use, a liquid pad or pillow is formed that substantially underlies the anatomical structure of the medial longitudinal arch region of a normal foot.

The insole of the invention preferably further comprises a pair of flow restrictors at the distal end of the hindfoot region, one on the lateral margin of the bladder and the other on the medial margin. The pair of hindfoot restrictors form a longitudinal flow channel there between.

The proximal hindfoot region is preferably free of flow deflectors or the like.

A third embodiment is similar to the first, but is provided with between one and five hindfoot flow deflectors. Substantially equal sized, longitudinal hindfoot flow passages are created between the hindfoot deflectors, as disclosed in my US Patent No. 5,878. 10 issued March 9,1999, which is hereby incorporated by reference.

A fourth embodiment is similar to the second, but is provided with a pair of flow restrictors against the lateral and medial margins in the proximal end of the proximal forefoot region of the bladder. A longitudinal flow channel is created between the restrictors, as disclosed in my US Patent No. 5,878,510.

The majority of the bladder is filled with a large molecular, non-evaporahle. highly viscous, sterile liquid, preferably a mixture of hygroscopic, polyvalent alcohol and distilled water. The distal forefoot region and the metatarsal pads are preferably free of liquid. She liquid has a viscosity and density of at least 1.10 times that of ordinary water. I refer to this as a"heavy liquid."For the above reasons, the density of the fluid, measured by g/m3. is higher than the density of water (density=weight), because a higher weight of the fluid (compared to water) restricts the rate of fluid flow. For the same reasons, the thickness (viscosity) is also higher than that of water, because a higher thickness of the fluid (compared to water) restricts the i-. tte of fluid flow. This mixture is sterile, non-toxic and resistant to contamination by bacteria or other microorganisms. thereby ensuring an environmentally safe fluid within the insole. l v her. the mixture of hygroscopic, polyvalent alcohol and distilled water is not susceptible to evaporation or diffusion through the bladder layers. It is also autoclavable. In the event of a bladder puncture, the liquid may be easily removed from clothing and footwear, as the mixture is also relatively non-greasy.

The insole of the invention provides several desirable medical benefits.) he insole relieves fatigue during prolonged standing or walking by distributing the user's weight anatomically over the area of the foot. The weight bearing surface area of the wearer's feet is increased, thereby reducing peak pressures exerted on the plantar surface of the users foot and resulting deformation of soft tissue. The reduction in pressure thereby further relieves stress on the bones of the foot that can cause foot pain, hard skin and in extreme situations, ulceration.

Second, the anatomically controlled flow of fluid through the bladder across the plantar surface of the user's feet provides a therapeutic movement of the small intrinsic muscles of the feet. The movement of the muscles animates the venous pump function increasing blood circulation, which in turn improves transport of oxygen and nutrients to the cells in the foot and removal of waste products excreted from the cells.

Third, the fluid flow and the specific location of the metatarsal pads is matched to the anatomical structure of the foot and thus aid in anatomically correct locomotion. This in turn provides not only directional stability when the fluid moves within the insole. but als (, alleviates the foot abnormalities over supination and over pronation found in asymmetric feet.

Fourth, the metatarsal pads enable specific discomfort and pain relief at localised areas in the forefoot region by their location just proximal to and around the painful areas.

Other attributes and benefits of the present invention will become apparen from the following detailed specification when read in conjunction with the accompanying drap ings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a plan view of the human foot illustrating the medial and lateral portions thereof, and the weight bearing area of a typical, functionally normal foot.

Fig. 2 is a dorsal view of the bones of the human foot.

Fig. 3 is a plan view of a first embodiment of the invention.

Fig. 4 is a plan view of a second embodiment of the invention.

Fig. 5 is a cross-sectional view of the first embodiment of the invention taken along line 5-5 of Fig. 3.

Fig. 6 is a plan view of a third embodiment of the invention.

Fig. 7 is a plan view of a fourth embodiment of the invention.

DETAILED DESCRIPTION Turning now to the drawings, Figs. 1 and 2 illustrate the structure of the human toot. The foot comprises a (i) hindfoot region containing the talus 1 and os calcis 2 bones; (ii) a midfoot region containing the cuneiform 3, cuboid 4 and navicular 5 bones ; and the forel) ot region comprising the metatarsals 6, the proximal phalanges 7, and the middle 8 and distal 9 phalanges.

The forefoot region can be divided into two sub-regions, the distal sub-region comprising the middle and distal phalanges, and the proximal forefoot region which comprises the metatarsals and proximal phalanges. The foot also includes a longitudinal arch, having a medial and a lateral side. The medial longitudinal arch is defined by the navicular and medial cuneiform bones of the midfoot and the about the proximal half of the first, second and third metatarsals. The typical weight bearing area of a functionally normal foot appears from Fig. 1. The weight is not equally distributed over the plantar area of the foot.

In Figs. 3 and 5, a first embodiment of the fluid filled insole of the invention is shown.

The insole comprises a bladder 10 having an upper layer 12 and a lower layer 14. ! he insole preferably further includes a layer of textile or a sweat absorbing material 16 substantially covering and laminated to the outer surface of upper layer 12. Optionally a textile layer could be added to the bottom surface of the insole. The bladder layers 12 and 14 are sealing joined at their peripheral margins 18. For reference, the medial peripheral margin is numbered 9 () and the lateral peripheral margin is numbered 22. The bladder comprises three main regions, namely a forefoot region 25. a hindfoot region 26 and a midfoot region 28 there between. The forefoot region is divided into a distal subregion 30 and a proximal forefoot region 24.

The interior cavity 32 of the bladder 10 is filled with a sterile, non-toxic, non-cvaporable fluid with a density and viscosity of at least 1.10 times that of water. The fluid is preferably a "heavy liquid"mixture of large molecular, hygroscopic polyvalent alcohol and distilled water, as is more fully described below. The fluid may flow between and throughout the proximal forefoot, midfoot and hindfoot regions. The distal forefoot sub-region 30 preferably does not contain fluid.

Within the proximal forefoot region 24 of bladder 22 there is a metatarsal pad 80 substantially proximal to the wearer's metatarsal headss. A barrier 82 is placed around the pad to prevent the pad from being saturated with liquid. Preferably, at least a portion of the pad underlies the wearer's first metatarsal head. The pad 80 need not cover the entire urea of the forefoot region. The metatarsal pad comprises a cushioning foam material or a non-flowable, semi-solid fluid or gel, as opposed to a flowable liquid bladder. More specifically. a first embodiment comprises a single, relatively large pad that substantially underlies the five metatarsal heads in the forefoot region. The shape of the metatarsal pad is preferably oval or elliptical, but alternative shapes may be used.

Fig. 4 shows a second embodiment of the invention is characterized by plural (two to six) metatarsal pad flow-deflectors180 preferably placed substantially proximal to one or more of the five metatarsal heads in the proximal forefoot region. Preferably, at least one of the pads 180 underlies the first metatarsal head. A metatarsal pad flow deflector placed just proximal to one of the metatarsal heads elevates the heads and will result mechanically in decreased extension of the metatarsophalangeal joints. The metatarsal pads 180 are substantially equally spaced transversely from the imaginary longitudinal centerline of each other, and spaced from) he medial and lateral margins of the bladder. In both the first and second embodiments, substantially equally dimensioned longitudinal flow channels are formed between the flow deflectors and between the flow deflectors and medial and lateral margins of the bladder.

The metatarsal pads 180 are arranged in a shape that laterally, medially, transversely and longitudinally matches the anatomical structure of the proximal forefoot region, the shape being for example, but not limited to, an arc, a semicircle, or a trapezoid, the convex side o ! the shape facing in a distal direction. The arrangement and spacing between pads may desirabls be made in the same manner as the forefoot flow deflectors disclosed in my US Patent No. 5, 87x.) 10.

The metatarsal pads 80,180 are formed by welding the upper bladder layer 12 1"the lower bladder layer 14 circumferentially around the pads 80,180 to form a barrier 82,182. Metatarsal pads 80,180 are shown as being oval or circular, but other shapes may be alternatively used.

Bridging the proximal forefoot region and the midfoot region 28 of bladder l ts is a flow controller 48, which is generally matched to the wearer's arch. The arch flow controlier may be configured in several different ways, but must match the contour or anatomical structure of the longitudinal arches of a normal foot, as described above in reference to Figs. 1 and 2. the lateral edge of the longitudinal medial arch is generally an elongated, semicircular line substantially at the longitudinal border of the lateral and medial arch of a normal foot, such as shown in Fig. 1.

The longitudinal medial arch extends from the proximal part of the midfoot area to about the mid-point of the metatarsals, as shown in Fig. 1. Flow controller 48 is shaped and located to match at least a portion of the border between the medial and lateral longitudinal arch. A midfoot flow channel 70 is formed on the lateral side of controller 48. A semi-encloSed area or volume 29 is defined by the longitudinal arch flow controller 48 and the medial peripheral margin of the bladder that substantially matches at least a portion of the anatomical structure of the medial longitudinal arch region of a normal foot. In this way, liquid will flou from the proximal forefoot region and into the medial arch region, thus substantially forming a liquid pad or pillow under at least a portion of the area of the medial arch.

In the hindfoot region, there are flow restricting features in the distal part of the hindfoot region that regulate the flow of fluid into and out of the hindfoot region. Specifically. a pair of flow restrictors 90 are located adjacent to the lateral and medial peripheral margins, respectively, in the distal end of the hindfoot region, roughly at the border between the hindfoot and midfoot regions. This pair of hindfoot flow restrictors defines a longitudinal channel 91 there between, the channel 91 having a transverse width of between 10 and 30 percent of the maximum straight transverse width of the hindfoot region of the bladder.

Fig. 6 illustrates a third embodiment of the invention, which is similar to the first embodiment. The third embodiment is provided with between one and five, preferably two, hindfoot flow deflectors 40. Substantially equal sized, longitudinal hindfoot flow passages 42, 44 are formed between the hindfoot deflectors and between the lateral and medial margins of the bladder as disclosed in my US Patent No. 5,878,510. However, it should be appreciated the such hindfoot flow deflectors are optional and are not strictly required.

Fig. 7 illustrates a fourth embodiment, which is similar to the second embodiment. The fourth embodiment is provided with a pair of flow restrictors 43 against the lateral md medial margins in the proximal end of the proximal forefoot region of the bladder. A longitudinal flow channel 47 is created between the restrictors, as disclosed in my US Patent No. 5,878, 510.

The bladder is preferably fabricated from polyurethane film although other thermoplastic materials, such as EVA, PVC or vinyl may also be used. The thickness of each bladder layer should be from about 300 to 800 micrometers, 400 micrometers being preferred. I'he sweat absorbing material is preferably about 250 micrometers in thickness. Other textile materials may be used for comfort or breathability regardless of sweat absorbing properties. The bladder may be formed by conventional radio frequency or dielectric welding techniques. Other welding techniques, such as thermal welding may be used alternatively. The bladder is filled with the liquid mixture leaving an opening in the peripheral weld, through which liquid may be introduced, then sealing the opening. The insole of the invention may be made and sold as an insole for removable placement in shoes by the user. Also, the insole may be built into footwear as a permanent feature.

The fluid used to fill the cavity 32 of the bladder 10 is preferably a mixture of distilled water and a sterile. non-toxic, non-evaporable, large molecular, hygroscopic liquid to prevent evaporation or diffusion through the bladder. Polyvalent alcohols with large molecules and with non-toxic properties are preferred. One suitable formulation comprises approximately 85-98%, hygroscopic polyvalent alcohol and approximately 2-15% distilled water. By using this mixture in lieu of plain water, improved benefits are achieved: The mixture of the invention as compared to water does not evaporate or diffuse through the bladder layers, thereby significantly improving life time and durability of the insole. The liquid can withstand autoclaving as may be required by health care institutions. The insoles can be used in temperature ranges from minus degrees Celsius to plus 120 degrees Celsius, because both the liquid mixture and bladder materials can withstand these temperature extremes. The liquid is fully sterile and non-toxic and thus environmentally safe.

The sterility and/or non toxicness of the fluid is extremely important for several reasons.

Children, people and animals could bite the insole, possibly drinking or swallowing the liquid.

Water becomes septic after a few months of storage within insoles, because bacteria will grow and flourish in the water.

Compared to water, the mixture of polyvalent alcohol and distilled water has a significantly higher density and viscosity. The fluid of the invention has a preferred density and viscosity range ot at least 1.10 times that of water. The actual filling of fluid with Li particular density that is at least 1.10 times that of water depends on the flow controlling means within the bladder. Generally, the more the flow of liquid within the bladder is restricted by flow controlling means in the forefoot, midfoot and hindfoot regions, the lower the requirement for the density and viscosity of the liquid. Inversely, the fewer flow controlling means within the bladder, the higher the density and viscosity required. The density and viscosity ol'the fluid causes an improvement in the effects on the user's foot when wearing the insoles, because the density and viscosity generally controls the rate of flow of the viscous liquid within the insole. In this way, the density and viscosity strongly influence not only the degree of pressure distribution with following reduction of peak pressures on the plantar surface of the foot, but also directional stability.

The liquid used is a thick or heavy liquid that is resistant to flow. but not so thick that flow is unduly restricted. It is intended that when body weight is applied to one area of the bladder, the fluid will slowly and gradually flow out of the area after application of load over a few milli-seconds of time, thus the fluid is functioning as a flow restricting means and thereby enable an improved weight pressure distribution as compared to the fluid being ordinary water.

Preferably, the fluid does not leave a region before the weight load is applied to that region.

Referring to Fig. 3 as an example, when a user places his/her heel to the hindfoot region the fluid will not immediately leave the region, i. e., the fluid will not"jump"out of that area upon application of load. Rather, the fluid will not flow out of the hindfoot region before application of weight load has occurred. I refer to this as a"heavy liquid."For the above reasons, the density of said fluid, measured by g/m3, is higher than the density of water (density weight), because a higher weight of the fluid (compared to water) restricts the rate of flow of fluid. For same reasons, the thickness (viscosity) is also higher than water, because a higher thickness of the fluid (compared to water) restricts the flow of fluid, and thus enable application of weight load before the fluid leaves a region.

The liquid is relatively non-greasy. Thus, if the insoles are punctured or for any reason the liquid runs out into the user's socks or shoes, the shoes and socks may be readily cleaned.

Testing has shown that there are five basic beneficial effects from wearing the insoles of the invention, namely : (1) reducing pressure on the foot; (2) improves the venous pump function by causing a movement of all the small intrinsic foot muscles; (3) symmetric walking, (4) directional stability, and (5) pain relief at localized areas in the forefoot region b\ means of placing pads or cushions just proximal to and around the painful area. Each of these therapeutic benefits will be explained in turn.

In the body. blood is pumped from the heart through the arteries out to the energy consuming muscles. where the blood carries the various energy substances such as carbohydrates and oxygen. Within the muscles, the energy is subsequently provided by an oxidation process in which carbohydrates interact with oxygen creating carbon dioxide, water and energy. I i a person is working extremely hard--resulting in substantial use of muscles--the oxygen supplied to the muscles (through the blood supply) is insufficient to supply the muscles with sufficient energy.

Energy may also be produced in the muscles by splitting of glycogen into lactic acid and energy.

Glycogen is a substance in the muscles. The oxygen-poor blood and ce) ! waste products that have resulted from the energy production will then be transported through the veins hack to the heart and the purifying organs of the body. The veins function with the muscles to form a venous pump system that eases the transport of the blood back to the heart. The venous pump functions in cooperation with the muscle activity since the moving muscles cause the veins to stretch and contract. Since the veins internally are equipped with valves (flaps) that prevent the blood from flowing away from the heart, the muscle activity on the veins causes the veins to function as a pump system that significantly increases blood transportation back to the heart.

When an individual is standing or walking for more than four hours per day. the foot muscles may receive insufficient movement and exercise. Individual movement oi the many small muscles in the foot is hindered. If the foot muscles have insufficient strength, they do not have the sustaining strength to maintain the weight of the body, and the heel bone and metatarsal bones may sink downwardly. The following chain reaction occurs: 1. When the feet collapse ("sink down"), the foot muscles are compressed. which reduces blood flow. Simultaneously, low muscle activity from the compression of the foot muscles causes a reduction of the venous pump function.

2. The foot muscles do not receive sufficient oxygen and carbohydrate quantities for maintaining adequate energy production and oxidation.

3. Because of the constant pressure and lack of supply of oxygen and carbohydrates, the foot muscles start to produce energy by splitting of glycogen to lactic acid and energy.

4. Because blood circulation is hindered, the process will accumulate lactic acid in the foot muscles.

5. Lactic acid causes fatigue, heavy legs, and later pain, depending on the length of time walking or standing.

6. The fatigue feeling tends to cause people to place themselves in inappropriate or awkward positions in an effort to remedy the feeling, again affecting other muscles. leading to pain in legs, back, head, etc.

With the insole of the invention, the movement of the liquid within the bladder will result in the user's body weight being more widely distributed over the area of the foot. thereby increasing the weight bearing surface area of the foot, and relieving peak pressures on the foot muscles. Again. the weight is not equally distributed on/over the plantar surface area of a normal foot, see Fig. 1. Further, the simultaneous movement of fluid within the bladder causes the small intrinsic foot muscles to move, which, combined with the pressure distribution effect improves the venous pump function and thus avoiding the above chain reaction. Tests reveal that the insole of the invention reduces peak pressures, measured by the average pressure in kilograms per square centimeter against the plantar surface of the user's foot. The improved distribution of the user's weight is particularly applicable during standing or walking. It is important to avoid high pressure on heel and metatarsal bones, since such pressure can cause foot pain. hard skin, and, in extreme situations, ulceration. These abnormalities are well known in diabetic teet.

The weight of the user pressurizes the liquid within the bladder. The pressurized liquid will constantly move the non-loaded parts of the bladder upwards. Movement or weight shift by the user will cause fluid movement, whereby a constant movement of the small internal foot muscles occurs. A considerably improved venous pump function is thereby established in the foot itself. A constant massage of the foot sole occurs for each time weight distribution is changed by the movement of the fluid within the three regions. When the feet, and thus the weight, is placed on the insoles, a weight pressure redistribution action takes place between the feet and the insoles, stimulating the blood veins. The effect is a considerably impro\ ed venous pump function, which is obviously very important for any person participating in Li standing, walking or running activity. The function of the blood is to transport oxygen and nutrients to the cells, and return waste products to be excreted from the user's kidneys. through the urine.

Improved blood circulation will decrease the amount of lactic acid, an element known as causing fatigue or myasthenia. Blood circulation is thus very important to individuals applying their muscles extensively. since muscle exertion constrains the blood corpuscles. thus hampering the transport of nutrients and waste products. Another effect of insufficient blood supply is a reduction of the contraction ability of the muscles. The fluid filled insole of the invention enhances the location, degree and duration of beneficial pressure distribution as compared to the prior art vis-a-vis the flow of fluid that is specifically matched to the anatomical structure of the foot (Figs. 1-B and 1-C). A positive effect is a reduction and in many instances elimination of the painful effect of soreness in feet, legs, and back caused by prolonged standing or waking. The features structure of the feet. The flow deflectors and restrictors and their following flow passages ensure directional stability during locomotion by enabling a controlled circulation of liquid that is matched to the anatomical structure of the normal foot. This is important since uncontrolled liquid circulation would result in unstable walking, unstable weight distribution, discomfort, and potentially the development of foot abnormalities. Directional stability. as achieved by the designed liquid circulation of the invention and as distinguishable over the prior art. ensures an anatomical locomotion pattern for the wearer, because the weight is anatomically distributed on the foot. The insole can alleviate the problems involved in over-supination and over-pronation, i. e., where the user's feet are turning abnormally either to the medial, inner side or the lateral, outer side of the foot ("asymmetric feet"). The combination of distribution of weight pressure and directionally stabilizing fluid circulation also supports a functionally correct take-off a factor crucial for walking or running in a physiologically correct manner.

Finally, with the forefoot pads or cushions of the invention, the insole combines the above distinguishable advantages of anatomical fluid flow with pain relief within localized areas of the forefoot region. Most forefoot problems can be treated with some kind of simple orthotic support, such as cushions, pads or air cell neoprene devices. For localized areas, treatment can be performed with a pad placed just proximal to and around the painful area. For example, a pad placed just proximal to one of the metatarsal heads elevates the heads and \\ill result mechanically in decreased extension of the corresponding metatarsophalangeal joints.

While the preferred embodiment of the present invention has been shown and described, it is to be understood that various modifications and changes could be made thereto without departing from the scope of the appended claims.

What is claims is: 1. An improved insole adapted to be worn beneath a wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal ! forefoot region, a hindfoot region and a midfoot region there between. wherein the improvement comprises: at least one metatarsal pad of solid or semi-solid material in at least a portion oi the proximal forefoot region of said bladder; forefoot flow passages between said metatarsal pad and the lateral and medial margins of the proximal forefoot region of said bladder, said forefoot flow passages having substantially equal transverse dimension ; a pair of flow restrictors at the distal end of the hindfoot region of said bladder. one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal llow channel there between ; and said fluid comprising a heavy, viscous liquid.

2. An improved insole as in claim 1, wherein there are at least two but no more than six transversely spaced metatarsal pads in said proximal forefoot region, and further comprising at least one flow passage between said metatarsal pads.

3. An improved insole as in claim 1, the wearer's foot having a lateral longitudinal arch and a medial longitudinal arch and a border there between, said insole further comprising an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the border between lateral and the medial longitudinal arch of the wearer's foot, said flow controller controlling liquid flow from said hindfoot region to said proximal forefoot region and vice versa, and substantially defining a semi-enclosed volume in which accumulation of liquid occurs when liquid flows into the medial longitudinal arch region.

4. An improved insole as in claim 1, wherein said bladder comprises an upper liver and a lower layer joined at their peripheral margins, said bladder further comprising a textile layer attached to and substantially covering at least one of said layers.

5. An improved insole as in claim 1, wherein said insole is incorporated into footwear.

6. An insole, comprising a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, flexible material; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a general)) planar, foot-shaped configuration having distal forefoot region, a proximal forefoot region, a hindfoot region and a midfoot region there between; a metatarsal pad between said upper material layer and said lower material layer in said proximal forefoot region; forefoot flow passages between said metatarsal pad and the medial and lateral margins of said bladder; an elongated flow controller bridging the forefoot and midfoot regions of said bladder. the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot ; a pair of flow restrictors at the distal end of the hindfoot region of said bladder. one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal low channel there between ; and a liquid within said bladder, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa, and said distal forefoot region being substantiallv liquid free.

7. An insole as in claim 6, said metatarsal pad comprising a solid or semi-solid material.

8. An insole as in claim 6, wherein said liquid is a sterile, heavy liquid.

9. An insole, comprising a substantially fluid tight bladder, said bladder comprising an upper layer and a lower layer sealing joined at their peripheral margins, said bladder having a generally fout shaped planar configuration with a proximal forefoot region, a hindfoot region and an midioot region there between ; a heavy liquid substantially filling said bladder ; at least to transversely spaced metatarsal pads between said upper and loeel bladder layers in said proximal forefoot region of said bladder, said pads comprising a solid or semi-solid material; and longitudinal, forefoot flow passages in said proximal forefoot region between said pads, between said pads and the medial margin of said proximal forefoot region of said bladder and between said pads and the lateral margin of said forefoot region of said bladder, said liquid being flowable in a longitudinal direction through at least one of said forefoot flow between the forefoot and midfoot regions of said bladder.

10. An insole as in claim 9, further comprising a pair of flow restrictors in the distal end of the hindfoot region of said bladder, one of said restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow chunnel there between.

(Applicants Reference: C: \Probody\Patent\Pct-patent\March 1999\99CIP#3 Revision 2 march 8 email P () J. DOC) FLUID FILLED INSOLE WITH A METATARSAL PAD (ITEM 4) ABSTRACT OF THE DISCLOSURE A fluid filled insole comprises a fluid tight bladder having upper and lower layers and a generally foot-shaped, planar configuration, with proximal forefoot, midfoot and hindi' (sot regions; a heavy. viscous, sterile liquid substantially filling the bladder; at least one metatarsal pad in the proximal forefoot region of the bladder; flow passages between the metatarsal pad and the medial and lateral and peripheral margins of the bladder; a flow controller bridging the proximal forefoot and midfoot regions of the bladder and matched to the border between the lateral and medial longitudinal arch; and flow restrictors in the distal hindfoot defining a central longitudinal flow channel between the hindfoot and midfoot regions. The metatarsal pads and fluid flow are matched to the anatomical structure of the foot. Modifications and Additions to US Claims Originally Filed Julv 19, 1996. CIP-Application 08/687. 787.

Explanation : Brackets [] = Leave out (deleted Underlinings : Modifications to original Application Filed July 19,1996.

US CLAIM 1 : 1. An improved insole adapted to be worn beneath the wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot [metatarsal] region, a hindfoot [heel] region and a midfoot [arch] region therebetween, wherein the improvement comprises: .. at least two but no more than six transversely spaced flow deflectors in the proximal forefoot [metatarsal] region of said bladder. said deflectors being equally spaced apart relative to one another at least three, but no more than seven forefoot [longitudinal] flow passages between each of said flow deflectors and between said flow deflectors and the lateral and medial margins of the proximal forefoot [metatarsal] region of said bladder, said forefoot flow passages [havel having substantial equal transverse dimension, and at least one of said forefoot [metatarsal] flow passages extending between the proximal forefoot [metatarsal] region and the midfoot [arch] region of said bladder ; at least one but no more than five transversely spaced flow deflectors in the hindfoot region of said bladder at least one but not more than six flow Passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the lateral and medial margins of said bladder, said hindfoot flow passages having substantially equal transverse dimension, and at least one of said hindfoot flow passages extending from the hindfoot region into the midfoot region of said bladder A pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent of the media ! oeriphera) margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel therebetween ; and said fluid comprising heavy, viscous liquid US CLAIM 2 : 2. (amended). An improved insole as in claim 1, further comprising a pair of flow restrictors fatl in the proximal end of said proximal forefoot region. one said restrictor adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin, said pair of restrictors defining a longitudinal flow channel therebetween, said channel having a transverse width that is less than 50 per cent of the maximum straight transverse width of the proximal forefoot [metatarsal] region of said bladder US CLAIM 3: 3. (amended) An improved insole as in claim 1, wherein said flow deflectors and resulting [longitudinal] flow passages are substantially arranged in a shape that laterally, medially, transversely and longitudinally matches the anatomical structure of one or more of the metatarsal bones, [said shape being arranged in an arc, a semicircle, an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction.] CLAIM 3-A: (Addition) 3-A. An improved insole as in claim 1, wherein said forefoot flow deflectors and resulting flow passages are arranged in a shape that substantially matches the anterior metatarsal arch formed across the heads of the five metatarsal bones, the convex side of said shape facing in a distal direction.

CLAIM 3-B: (Addition) 3-B. An improved insole as in claim 1, wherein said flow deflectors and resulting ftonaitudina ! 1 f) ow passages are substantially arranged in a shape that laterally. medially. transversely and tongitudinattv matches the anatomical structure of one or more of the metatarsal heads, fsaid shape being arranged in an arc, a semicircle, an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction. 1 CLAIM 3-C: (Addition) 3-C. An improved insole as in claim 3, wherein said shape is arranged in an arc. a semicircle an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction.

CLAIM 3-D: (Addition) 3-D.: An improved insole as in claim 1, further comprising a metatarsal pad in at least a portion of said proximal forefoot region, said metatarsal pad being located substantially proximal to one or more of the metatarsal heads CLAIM 3-E: (Addition) 3-E. : An improved insole as in claim 1, further comprising one metatarsal pad in forefoot region, located substantially proximal to the first metatarsal head of the wearer's foot, a second metatarsal pad in said forefoot region located substantial proximal to the second metatarsal head of the wearer's foot, and further metatarsal pads, as a whole or individually, are located substantial proximal to the remaining metatarsal heads of the wearer's foot US CLAIM 4: 4. (amended) An improved insole as in claim 1, wherein said improvement further comprises [at teast one but] no more than five transversely spaced heel flow deflectors in the hindfoot [heel] region of said bladder, and at least [two] one but no more than six [longitudinal] hindfoot heel flow passages in the hindfoot [heel] region of said bladder, each said heel flow passage having a transverse dimension that varies [is] no more than ten percent from [greater than or less than] any other hindfoot heels flow passage, path and at least one of said heel flow passages extending between [in a straight, longitudinal, unobstructed path from] between the hindfoot [heel] region to the midfoot [arch] region of said bladder, CLAIM 4-A: (Addition) 4-A.: An improved insole as in claim 1, wherein said hindfoot flow deflectors and resulting [longitudinal] flow passages are substantially arranged in a shape that laterally, medially, transversely and longitudinally matches the anatomical structure of one or more of the hindfoot bones, [said shape being arranged in an arc, a semicircle, an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction.] CLAIM 4-B: (Addition) 4-B. An improved insole as in claim 1, wherein said hindfoot flow deflectors and resulting flow passages are substantially arranged in a shape that laterallv, mediallv, transversely and longitudinally matches the anatomical structure of the heel bone.

CLAIM 4-C: (Addition) 4-C. An insole as in claim 4-A. wherein said shape is arranged in an arc. a semicircle, an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction. w US CLAIM 5: 5.: [ (Amended) An improved insole as in claim 1 [4], wherein said longitudinal flow channel between said hindfoot and midfoot region a transverse width of between 10 and 30 percent of the maximum straight transverse width of the hindfoot [heel] region of said bladder.] US Claim 5 Changed on 30.7.1998: 5. : (twice amended) An improved insole as in claim 1, wherein said longitudinal flow channel at the distal end of the hindfoot region has a transverse width of between 10 and 30 per cent of the maximum straight transverse width of the hindfoot region of said bladder 4 US CLAIM : 6.: (amended) An improved insole as in claim 1, the wearer's foot having [a] lateral and [midfoot, a] longitudinal medial arches and a border therebetween, said insole further comprising an elongated <BR> <BR> flow controller, at least partiaNv [######### #####] in the midfoot [arch] region of said bladder the<BR> elongation of said flow controller substantiallv [restricting means] matching the border between the lateral and the medial longitudinal arch [and lateral midfoot] of the wearer's foot, said flow controller controlling liquid flow from said hindfoot [heeí] region to said proximal forefoot region and vice versa, and defining a semi-enclosed volume [region] in which accumulation of liquid occurs when liquid flows [ftowng] into the longitudinal arch region, [and vice versa,] said accumulation forming a liquid pillow underlying the medial l aS arch area of the wearer's foot CLAIM 6-A: Claim 1 (Addition) 6-A.: An improved insole as in claim 1, the wearer's foot having lateral and longitudinal medial arches and a border therebetween, said insole further comprising an elongated flow controller, at least partially in the midfoot region of said bladder, the elongation of said flow controller substantially matching the border between the lateral and the medial longitudinal arch of the wearer's foot, said flow controller controlling liquid flow from said hindfoot region to said proximal forefoot region and vice versa, and at least one midfoot flow passage between said flow controller and the lateral and medial margins of the midfoot region of said bladder, and at least one of said midfoot flow passages extending between the proximal forefoot and the midfoot region of said bladder l US CLAIM 7: 7. (amended) An improved insole as in claim 1, wherein said bladder comprises an upper layer and a lower layer joined at their peripheral margins, said bladder further comprising a layer of sweat absorbing material laminated to and substantially covering the outer surface of said upper layer, said material for absorbing [enabling] perspiration CLAIM 7-A : (Addition) 7-A. An improved insole as in claim 1, wherein said bladder comprises an upper layer and a lower layer joined at their peripheral margins, said bladder further comprising a layer of textile material laminated to and substantially covering the outer surface of said upper layer.

US CLAIM 8: 8.: (amended) An improved insole as in claim 1, wherein said fluid comprises 85 to 98 percent by weight of large molecular, hygroscopic, polyvalent alcohol and 2 to 15 percent by weight distilled water, [and/or wherein flow of said fluid is restricted by the viscosity and density of said fluid being at least 1.10 times the density and viscosity of water.] CLAIM 8-A : (Addition) 8-A. An improved insole as in claim 1, wherein flow of said fluid is restricted by the fluid being highly viscous, said fluid having a viscosity of at least 1.10 times that of water.

CLAIM 8-B (Addition) 8-B. An improved insole as in claim 1, wherein flow of said fluid is restricted by the density of said fluid being at least 1.10 times that of water.

US CLAIM 9: 9.: (amended) An improved insole as in claim 1, wherein each said forefoot flow passage l metatafsal #4eow] a transverse dimension that varies [is] no more than ten percent from [greater or tesc thap] any other [metatarsal] forefoot passage.

CLAIM 9-A : (Addition) 9-A. An improved insole as in claim 1, wherein one of said forefoot flow passages is matched to substantially underlie the first metatarsal bone of the wearer's foot, a second of said metatarsal flow passages matched to substantially underlie the second metatarsal bone of the wearer's foot, and the remaining longitudinal flow passages, as a whole or individually, are matched to substantially underlie the remaining metatarsal bones of the wearer's foot.

CLAIM 9-B: (Addition) 9-B. An improved insole as in claim 1, wherein one of said forefoot flow deflectors is located substantially proximal to the first metatarsal head of the wearer's foot, a second of said forefoot flow deflectors located substantially proximal to the second metatarsal head of the wearer's foot, and the remaining of said flow deflectors, as a whole or individual, are located substantially proximal to the remaining metatarsal heads of the wearer's foot w US CLAIM 10 10. An improved insole as in claim 1 wherein said bladder comprises an upper layer and a lower layer of thermoplastic film, each said bladder layer being of about 200 to about 800 micrometer thickness, said bladder layers being welded to each other at their peripheral margins.

US CLAIM 11 11. : An improved insole as in claim 1, wherein said insole is incorporated into footwear. w US CLAIM 12: 12.: (amended) An improved insole as in claim 1, further comprising barrier means in said bladder placed at the border between the midfoot [arch] and hindfoot [heel] regions for preventing flow of said fluid from said midfoot [arch] region into said hindfoot [heel] region; and a solid or semi-solid shock absorbing material in at least a portion of said hindfoot [heel] region of said bladder.

CLAIM 12-A: (Addition) 12-A. (new) An improved insole as in claim 1, further comprising a solid or semi-solid shock absorbing material in said hindfoot region of said bladder, said material matched to substantially underlie, at least partially, the heel bone of the wearer's foot.

US CLAIM 13 : 13.: (amended) An improved insole as in claim 1, further comprising a transverse metatarsal wall at the proximal end of said forefoot [metatarsal] region, said metatarsal wall extending from the lateral peripheral margin to the medial peripheral margin of said bladder, said transverse wall having at least one opening therein, said opening defining a longitudinal flow channel between said forefoot [metatarsal] and said midfoot [arch] regions of said bladder, and a transverse heel wall at the distal end of said hindfoot [heel] region, said heel wall at the distal end of said hindfoot [heel] region, said heel wall extending from lateral peripheral margin to the medial peripheral margin of said bladder, said heel wall having at least one opening therein, said opening defining a longitudinal flow channel between said hindfoot [heel] and said midfoot [arch] regions of said bladder.

US CLAIM 14: 14. (amended) An improved insole as in claim 1, the wearer's foot having a lateral longitudinal arch [midfoot] and a medial longitudinal arch, said insole further comprising a pair of flow restrictors in the midfoot [arch] region of said bladder, one said restrictor substantially underlying the medial longitudinal arch and the other restrictor substantially underlying the lateral longitudinal arch [midfoot], said midfoot [arch] flow restrictors defining at least one substantial longitudinal midfoot [arch] flow channel there between for flow of said fluid from said forefoot [metatarsal] region to said hindfoot [heel] region and vice versa, said one restrictor underlying the medial midfoot [arch] having an opening therein to accept said fluid within said one restrictor defining a semi-enclosed region in which accumulation of liquid occurs when flowing through said opening and vice versa, said accumulation forming a liquid pillow underlying and matching the medial longitudinal arch area of the wearer's foot.

US CLAIM 15: 15. (twice amended) An insole adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border therebetween, comprising a lower layer of substantially impermeable, flexible material ; an upper layer of substantially impermeable, flexible material ; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, foot-shaped configuration having a distal forefoot region, a proximal forefoot region and a midfoot region therebetween, and a liquid barrier between said distal forefoot region and said proximal forefoot region; at least two but no more than six transversely spaced forefoot flow deflectors between said upper material layer and said lower material layer in said proximal forefoot region ; forefoot flow passages between said forefoot flow deflectors and between said forefoot [metatarsal] flow deflectors and the medial and lateral margins of said bladder, each said forefoot flow passages having a substantially equal transverse dimension; at least one of said forefoot flow passages extending between said proximal forefoot region and said midfoot region; at least one but no more than five transversely spaced hindfoot flow deflectors between said upper material layer and said lower material layer in said hindfoot region; hindfoot flow passages between each of said hindfoot flow deflectors and between said hindfoot flow deflectors and the medial and lateral margins of said bladder, each said hindfoot flow passage having a substantially equal transverse dimension; at least one of said hindfoot [heel] flow passages extending between said hindfoot and midfoot regions; [and] a sterile, heavy, viscous liquid within said bladder, said liquid comprising about 85 to 98 percent large molecular, polyvalent hygroscopic alcohol and about 2 to 15 percent distilled water, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa and flowable through said forefoot flow passages and said hindfoot flow passages, and said distal forefoot region being substantially liquid free : and an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for restricting flow from said hindfoot region to said forefoot region and vice versa, and defining a semi- enclosed volume in which accumulation of liquid occurs when fluid flows into the medial longitudinal arch area, said accumulation forming a liquid pillow substantially matching the medial lonqitudinal arch area of the wearer's foot.

CLAIM 15-A: (Addition) 15-A. An insole adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border therebetween, comprising a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, flexible material ; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, foot-shaped configuration having a distal forefoot region, a proximal forefoot region and a midfoot region therebetween, and a liquid barrier between said distal forefoot region and said proximal forefoot region; at least one but no more than six transversely spaced forefoot flow deflectors between said upper material layer and said lower material layer in said proximal forefoot region; forefoot flow passages between said forefoot flow deflectors and between said forefoot [metatarsal] flow deflectors and the medial and lateral margins of said bladder, each said forefoot flow passages having a substantially equal transverse dimension; at least one of said forefoot flow passages extending between said proximal forefoot region and said midfoot region; no more than five transversely spaced hindfoot flow deflectors between said upper material layer and said lower material layer in said hindfoot region; hindfoot flow passages between said hindfoot flow deflectors and the medial and lateral margins of said bladder, each said hindfoot flow passage having a substantially equal transverse dimension; . at least one of said hindfoot [heel] flow passages extending between said hindfoot and midfoot regions; [and] a sterile, heavy, viscous liquid within said bladder, said liquid comprising about 85 to 98 percent large molecular, polyvalent hygroscopic alcohol and about 2 to 15 percent distilled water, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa and flowable through said forefoot flow passages and said hindfoot flow passages, and said distal forefoot region being substantially liquid free ; and an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for restricting flow from said hindfoot region to said forefoot region and vice versa, and defining a semi- enclosed volume in which accumulation of liquid occurs when fluid flows into the medial longitudinal arch area, said accumulation forming a liquid pillow substantially matching the medial longitudinal arch area of the wearer's foot.

US CLAIM 16: 16. An insole as in claim 15, wherein the insole is adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral midfoot, a medial longitudinal midfoot [arch] and a longitudinal border there between, said insole further comprising an elongated flow controller in the arch region of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for controlling flow from said [heel] hindfoot region to said [metatarsal] forefoot region and vice versa, and defining a semi-enciosed region in which accumulation of liquid occurs when flowing into the medial longitudinal midfoot [arch] region and vice versa, said accumulation forming a liquid pillow substantially underlying and matching the medial longitudinal arch area of the wearer's foot.

US CLAIM 17 : 17. An insole as in claim 15, further comprising a layer of sweat absorbing material laminated to and substantially covering said outer surface of said upper layer of flexible material.

CLAIM 17-A: (Addition) 17-A. An insole as in claim 15, further comprising a layer of textile material laminated to and substantially covering said outer surface of said upper layer of flexible material 4 US CLAIM 18: 18. (Amended) An improved insole as in claim 15, wherein said insole is adapted to be worn beneath the plantar surface [anatomical structure] of the wearer's foot, the foot having a first metatarsal, a second metatarsal and lateral metatarsal bones, and wherein one of said forefoot [metatarsal] flow passages is matched to substantially underlie the first metatarsal bone [s] of the wearer's foot, a second of said [metatarsal] flow passages is matched to substantially underlie the second metatarsal bone [s] of the wearer's foot, and each [the] remaining flow passage [s are] matched to substantially underlie a respective one of the remaining lateral metatarsal bones of the wearer's foot.

US CLAIM 18-A: (Addition) 18-A. An improved insole as in claim 15, wherein one of said forefoot flow passages is matched to substantially underlie the first metatarsal bone of the wearer's foot, a second of said metatarsal flow passages matched to substantially underlie the second metatarsal bone of the wearer's foot, and the remaining longitudinal flow passages, as a whole or individually, are matched to substantially underlie the remaining metatarsal bones of the wearer's foot.

US CLAIM 18-B: (Addition) 18-B. An improved insole as in claim 15, wherein one of said forefoot flow deflectors is located substantially proximal to the first metatarsal head of the wearer's foot, a second of said metatarsal flow deflectors located substantially proximal to the second metatarsal head of the wearer's foot, and the remaining of said flow deflectors, as a whole or individual, are located substantially proximal to the remaining metatarsal heads of the wearer's foot US CLAIM 19: (Not Yet Allowed) 19. (amended) An insole, comprising a substantially fluid tight bladder, said bladder comprising an upper layer and a lower layer sealing joined at their peripheral margins, said bladder having a generally foot shaped planar configuration with a forefoot [metatarsal] region, a hindfoot [heel] region and an midfoot [arch] region therebetween; a heavy viscous liquid [steriie, non-toxic liquid] substantially filling the metatarsal and midfoot [arch] regions of said bladder, [said liquid comprising about 85 to 98 percent large molecular, hygroscopic, polyvalent alcohol and about 2 to 10 percent distilled water ;] at least two but no more than six?? [evenly and] transversely spaced flow deflectors in the proximal forefoot region [metatarsal weld points joining said upper and lower bladder layers in said metatarsal region] of said bladder ; [longitudinal,] forefoot [metatarsal] flow passages in said forefoot [metatarsal] region between said flow deflectors [metatarsal weld points], between said flow deflectors [metatarsal weld points] and the medial margin of said forefoot [metatarsal] region of said bladder and between said flow deflectors [metatarsal weld points] and the lateral margin of said forefoot [metatarsal] region of said bladder, each forefoot [metatarsal] flow passage having a transverse dimension that varies [is] no more than 10 per cent from [greater or smatter than] any other forefoot lmetatarsal] flow passage, said forefoot [metatarsal] flow passages being substantially parallel and evenly spaced transversely across the metatarsal region of said bladder, said [sterile] liquid being flowable [in an unobstructed longitudinal dírection] through each of said forefoot [metatarsal] flow passages in the forefoot [metatarsal] region and between the forefoot [metatarsal] and midfoot [arch] regions of said bladder ; # barrier means in said bladder for preventing flow of said fluid from said forefoot [metatarsal] and midfoot [arch] regions into said hindfoot [heel] region; a solid or semi-solid shock absorbing material sandwiched between said upper and lower bladder layers in at least a portion of said hindfoot [heel] region.

US CLAIM 20: 20. (amended 26.3.98): An improved insole adapted to be worn beneath the wearer's foot, the foot having a first metatarsal, a second metatarsal [,] and lateral metatarsal bones, a lateral longitudinal arch. [midfoot,] a medial longitudinal arch and a border therebetween, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot [metatarsal] region, a hindfoot [heel] region and a midfoot [an arch] region therebetween, wherein the improvement comprises: at least two but no more than six transversely spaced forefoot flow deflectors in the proximal forefoot region of said bladder at least three but no more than seven forefoot [metatarsal] flow passages between said flow deflectors and between the lateral and medial peripheral margins of the proximal forefoot [metatarsal] region of said bladder, said forefoot [metatarsal] flow passages being spaced transversely across the forefoot [metatarsal] region of said bladder, one said forefoot [metatarsal] flow passage matched to underlie the first metatarsal bone [s] of the wearer's foot, a second of said forefoot [metatarsal] flow passages to underlie the second metatarsal bone [s] of the wearer's foot, and the remaining flow passages matched to [underlie] the lateral metatarsal bones of the wearer's foot, feach said forefoot [##########] ######, and] at least one of said forefoot [metatarsal] flow passages extending [in a<BR> ########, ############, ############ #########################] between the proximal forefoot [metatarsal] region and the midfoot [arch] region of said bladder, [whereby satd ftu) d) s deflected by ;! E ! f : gg ! a pair of flow restrictors in the proximal end of the proximal forefoot metatarsal] region ; one said restrictor adjacent the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin, said pair of restrictors defining at least one longitudinal flow channel there between, said channel having a transverse width that is less than 50 per cent of the maximum straight transverse width of the forefoot [metatarsal] region of said bladder ; at least one but no more than five transversely spaced hindfoot [heei] flow deflectors in the hindfoot [heel] region of said bladder ;. at least two but no more than six [longitudinal] hindfoot [heel] flow passages in the hindfoot [heell region of said bladder, each said hindfoot [heel] flow passage having a transverse dimension that varies [is] no more than ten percent from any other hindfoot [heel] flow passage, at least one of said hindfoot [heel] flow passages extending from the hindfoot [heel] region to the midfoot [arch] region of said bladder, a pair of hindfoot [heel] flow restrictors in the distal end of the hindfoot [heel] region of said bladder, one of said hindfoot [heel] flow restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the peripheral lateral margin, said pair of hindfoot [heel] restrictors defining a substantially longitudinal hindfoot [heel] flow channel there between, said hindfoot [heel] channel having a transverse width of between 10 and 30 per cent of the maximum straight transverse width of the hindfoot [heel] region of said bladder ; and an elongated flow controller [restricting means] at least partially in both the proximal forefot region and the midfoot [arch] region of said bladder, the elongation of said flow controller [restricting means] matching the border between the medial longitudinal longitudinal arch [midfoot] and the lateral midfoot of the wearer's foot, said controller [arch flow restricting means] for restricting flow from said hindfoot [heel] region to said forefoot [metatarsal] region and vice versa, and defining a semi-enclosed volume [region] in which accumulation of liquid occurs when fluid flows [flowing] into said medial arch region [and vice versa], said accumulation forming a liquid pillow substantially [underlying and] matching the medial longitudinal arch area of the wearer's foot.

CLAIM 21: (Addition) 21. An improved insole or bladder as in any of the preceding claims, wherein said insole or bladder is incorporated into footwear CLAIM 22: (Addition) 22.: An improved insole adapted to be worn beneath the wearer's foot, the foot having a first metatarsal, a second metatarsal and lateral metatarsal bones, a lateral longitudinal arch, a medial longitudinal arch and a border therebetween, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region therebetween, wherein the improvement comprises: at least one but no more than six transversely spaced forefoot flow deflectors in the proximal forefoot region of said bladder at least two but no more than seven forefoot [metatarsal] flow passages between said flow deflectors and between the lateral and medial peripheral margins of the proximal forefoot region of said bladder, said forefoot flow passages being spaced transversely across the forefoot [metatarsal] region of said bladder, one said forefoot flow passage matched to substantially underlie the first metatarsal bone of the wearer's foot, a second of said forefoot flow passages to substantially underlie the second metatarsal bone [s] of the wearer's foot, and the remaining flow passages, wholly or individually, matched to substantially underlie the remaining metatarsal bones of the wearer's foot, at least one of said forefoot flow passages extending between the proximal forefoot region and the midfoot region of said bladder, at least one hindfoot flow passage in the hindfoot region of said bladder, at least one hindfoot flow passage extending from the hindfoot region to the midfoot region of said bladder, a pair of hindfoot flow restrictors in the distal end of the hindfoot region of said bladder, one of said hindfoot flow restrictors adjacent the medial peripheral margin of said bladder and the other adjacent the peripheral lateral margin, said pair of hindfoot restrictors defining a substantially longitudinal hindfoot flow channel there between, said hindfoot channel having a transverse width of between 10 and 30 per cent of the maximum straight transverse width of the hindfoot region of said bladder ; and an elongated flow controller at least partially in the midfoot region of said bladder, the elongation of said flow controller substantially matching the border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said controller for controlling flow from said hindfoot region to said forefoot region and vice versa, and defining a semi-enclosed volume in which accumulation of liquid occurs when fluid flows into said medial arch region, said accumulation forming at least partially a liquid pillow substantially matching the medial longitudinal arch area of the wearer's foot.

CLAIM 23: (Addition) An improved insole adapted to be worn beneath the wearers foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region therebetween, wherein the improvement comprises: a plurality of metatarsal pads in the proximal forefoot region, said metatarsal pads being located substantially proximal to the metatarsal heads at least two, but no more than seven forefoot flow passages between said metatarsal pads and the lateral and medial margins of the proximal forefoot region of said bladder, and between said metatarsal pads and at least one of said forefoot flow passages extending between the proximal forefoot region and the midfoot region of said bladder ; no more than five transversely spaced flow deflectors in the hindfoot region of said bladder at least one but not more than six flow passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the lateral and medial margins of said bladder, and at least one of said hindfoot flow passages extending from the hindfoot region into the midfoot region of said bladder A pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent of the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel therebetween.

CLAIM 24: (Addition) An improved insole adapted to be worn beneath the wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region therebetween, wherein the improvement comprises: . a plurality of metatarsal pads in the proximal forefoot region, said metatarsal pads being located substantially proximal to the metatarsal heads, and one of said pads located substantially proximal to the first metatarsal head of the wearer's foot, a second metatarsal pad in said forefoot region located substantially proximal to the second metatarsal head of the wearer's foot, and further metatarsal pads, as a whole or individually, are located substantially proximal to the remaining metatarsal heads of the wearer's foot at least two, but no more than seven forefoot flow passages between said metatarsal pads and the lateral and medial margins of the proximal forefoot region of said bladder, and between said metatarsal pads and at least one of said forefoot flow passages extending between the proximal forefoot region and the midfoot region of said bladder ; no more than five flow deflectors in the hindfoot region of said bladder at least one but not more than six flow passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the lateral and medial margins of said bladder, said hindfoot flow passages having substantially equal transverse dimension, and at least one of said hindfoot flow passages extending from the hindfoot region into the midfoot region of said bladder a pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent of the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel therebetween.

CLAIM 25: (Addition) 25. An insole adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border therebetween, comprising a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, flexible material ; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, foot-shaped configuration having a distal forefoot region, a proximal forefoot region and a midfoot region therebetween, and a liquid barrier between said distal forefoot region and said proximal forefoot region; and at least one but no more than six forefoot flow deflectors between said upper material layer and said lower material layer in said proximal forefoot region; forefoot flow passages between said forefoot flow deflectors and between said forefoot flow deflectors and the medial and lateral margins of said bladder, and one of said forefoot flow passages is matched to substantially underlie the first metatarsal bone of the wearer's foot, a second of said metatarsal flow passages matched to substantially underlie the second metatarsal bone of the wearer's foot, and the remaining longitudinal flow passages, as a whole or individually, are matched to substantially underlie the remaining metatarsal bones of the wearer's foot. at least one of said forefoot flow passages extending between said proximal forefoot region and said midfoot region; no more than five transversely spaced hindfoot flow deflectors between said upper material layer and said lower material layer in said hindfoot region; hindfoot flow passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the medial and lateral margins of said bladder, each said hindfoot flow passage having a substantially equal transverse dimension; at least one of said hindfoot flow passages extending between said hindfoot and midfoot regions; a sterile, heavy, viscous liquid within said bladder, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa and flowable through said forefoot flow passages and said hindfoot flow passages, and said distal forefoot region being substantially liquid free; and an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for controlling flow from said hindfoot region to said forefoot region and vice versa, and defining a semi- enclosed volume in which accumulation of liquid occurs when fluid flows into the medial longitudinal arch area.

CLAIM 26: (Addition) 26. An insole adapted to underlie the anatomical structure of the wearer's foot, the foot having a lateral longitudinal arch, a medial longitudinal arch and a longitudinal border therebetween, comprising a lower layer of substantially impermeable, flexible material; an upper layer of substantially impermeable, flexible material ; said upper and lower layers being sealingly joined to one another at their peripheral margins, said upper and lower layers forming a substantially fluid tight bladder, said bladder having a generally planar, foot-shaped configuration having a distal forefoot region, a proximal forefoot region and a midfoot region therebetween, and a liquid barrier between said distal forefoot region and said proximal forefoot region; and at least one but no more than six forefoot flow deflectors between said upper material layer and said lower material layer in said proximal forefoot region; AND one of said forefoot flow deflectors is located substantially proximal to the first metatarsal head of the wearer's foot, a second of said metatarsal flow deflectors located substantially proximal to the second metatarsal head of the wearer's foot, and the remaining of said flow deflectors, as a whole or individual, are located substantially proximal to the remaining metatarsal heads of the wearer's foot forefoot flow passages between said forefoot flow deflectors and between said forefoot flow deflectors and the medial and lateral margins of said bladder, at least one of said forefoot flow passages extending between said proximal forefoot region and said midfoot region; no more than five transversely spaced hindfoot flow deflectors between said upper material layer and said lower material layer in said hindfoot region; hindfoot flow passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the medial and lateral margins of said bladder, at least one of said hindfoot flow passages extending between said hindfoot and midfoot regions; a sterile, heavy, viscous liquid within said bladder, said liquid flowable from said hindfoot region to said proximal forefoot region and vice versa and flowable through said forefoot flow passages and said hindfoot flow passages, and said distal forefoot region being substantially liquid free; and an elongated flow controller bridging the forefoot and midfoot regions of said bladder, the elongation of said flow controller substantially matching the longitudinal border between the medial longitudinal arch and the lateral longitudinal arch of the wearer's foot, said arch flow controller for restricting flow from said hindfoot region to said forefoot region and vice versa, and defining a semi- enclosed volume in which accumulation of liquid occurs when fluid flows into the medial longitudinal arch area.

CLAIM 27: (Addition) An improved insole adapted to be worn beneath the wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region therebetween, wherein the improvement comprises : a pair of flow restrictors in the proximal end of said proximal forefoot region, one said restrictor substantially adjacent the medial peripheral margin of said bladder and the other substantially adjacent the lateral peripheral margin, said pair of restrictors defining substantially a longitudinal flow channel therebetween, said channel extending between the proximal forefoot region and the midfoot region of said bladder. and at least one of said forefoot flow passages extending between the proximal forefoot region and the midfoot region of said bladder ; no more than five transversely spaced flow deflectors in the hindfoot region of said bladder at least one but not more than six flow passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the lateral and medial margins of said bladder, and at least one of said hindfoot flow passages extending from the hindfoot region into the midfoot region of said bladder a pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent of the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel therebetween.

CLAIM 28: (Addition) An improved insole adapted to be worn beneath the wearer's foot, said insole of the type in which a bladder is filled with a fluid, said bladder having a generally foot-shaped configuration with a proximal forefoot region, a hindfoot region and a midfoot region therebetween, wherein the improvement comprises: A plurality of flow deflectors and resulting flow passages that are substantially arranged in a shape that laterally, medially, transversely and longitudinally matches the anatomical structure of one or more of the metatarsal bones, said shape being arranged in an arc, a semicircle, an elongated semicircle or a trapezoid, the convex side of said shape facing in a distal direction, at least one but no more than seven forefoot flow passages between said flow deflectors and the lateral and medial margins of the proximal forefoot region of said bladder, and between said forefoot flow deflectors, and at least one of said forefoot flow passages extending between the proximal forefoot region and the midfoot region of said bladder ; no more than five transversely spaced flow deflectors in the hindfoot region of said bladder at least one but not more than six flow passages between said hindfoot flow deflectors and between said hindfoot flow deflectors and the lateral and medial margins of said bladder, and at least one of said hindfoot flow passages extending from the hindfoot region into the midfoot region of said bladder a pair of flow restrictors at the distal end of the hindfoot region of said bladder, one of said restrictors adjacent of the medial peripheral margin of said bladder and the other adjacent the lateral peripheral margin of said bladder, said pair of restrictors defining a longitudinal flow channel therebetween.