This application claims the benefit of priority from U.S. provisional application no. U.S. 61/457,252 filed February 10, 201 1 , the entire contents of which are incorporated by reference herein.

FIELD OF THE INVENTION

[0001] The present invention relates to an insole for a shoe. In particular, the present invention relates to an insole device that can rehabilitate a foot by stimulating a proprioceptive reflex response in the wearer's foot.

BACKGROUND OF THE INVENTION

[0002] Professionals dealing with gait related pathologies generally accept that a large majority of persons will, at some time in their lives, suffer some form of gait related pain or dysfunction. It is also well accepted that, in the majority of cases, the mechanism underlying the pathology, injury, or dysfunction is biomechanically related to the foot's musculoskeletal capabilities during the interface between the foot and the ground, during the initial contact, support, and propulsion phases of the gait cycle.

[0003] It has been proposed that providing a device to create a proprioceptive, or internal, feedback stimulus to a user's foot can directly target the underlying pathology, injury, or dysfunction. Such devices are disclosed in U.S. Pat. No. 5,404,659 to Burke et al., in U.S. Pat. No. 6,301 ,807 to Gardiner, and in U.S. Pat. No. 6,732,457 to Gardiner.

[0004] As disclosed in U.S. Pat. No. 5,404,659, an arch rehabilitative catalyst stimulates the Golgi tendon organ, which in turn, stimulates the musculoskeletal structure of the foot to rehabilitate the foot structure. The catalyst is an asymmetrically domed hump, which creates a mild to strong discomfort to initially stimulate the Golgi tendon organ.

[0005] However, it has been found that the device disclosed in U.S. Pat. No.

5,404,659 does not function as described, and that the majority of users find the device too uncomfortable to use. In particular, when subjected to conventional vertical compressive forces of a person walking in the range of 2.5 times body weight, the device is designed to deflect between 40% and 60% of its maximum height, and when subject to only one times a person's weight, there should be no deflection. In addition, as disclosed in U.S. Pat. No. 5,504,659, the device has an ideal apex height of 5.25% to 7.6% of the total foot length. A device built according to these dimensions and deflection capabilities results in an overly high arch height, and can cause severe discomfort, and possible injury, to a wearer. It is further disclosed that the absolute, non-weight bearing height of the device should be the same regardless of body weight and arch height. This is clearly wrong, since different wearers will have different comfort thresholds and arch heights.

[0006] In general, the device disclosed in U.S. Pat. No. 5,404,659 does not function as described. Users would find the device too hard to use successfully, and rather than stimulating a proprioceptive response, the device would cause pain and discomfort at each step. The pain engendered in the foot of a wearer would, in fact, cause the user to limit the pressure applied to the foot to avoid the discomfort, rather than exercising the foot by creating an imperceptible stimulation as is its stated goal.

[0007] As disclosed in U.S. Pat. No. 6,301,807 and in U.S. Pat. No. 6,732,457, an arch rehabilitative catalyst stimulates the Golgi tendon organ, which in turn, stimulates the musculoskeletal structure of the foot to rehabilitate the foot structure. The catalyst is an asymmetrically domed structure having a said maximum height at it apex from 1% to 5% of the length of the foot. The catalyst does not provide a bracing function but instead, proprioceptive feedback. The plantar aspect of the catalyst has a receptacle for receiving an interchangeable insert. Many forms thereof, are disclosed. The catalyst is resiliently deformable to apply an upwardly directed pressure to stimulate the Golgi tendon organ, and deflects from between 40% and 100% of its maximum height in response to the vertical forces of a person standing at rest.

[0008] As disclosed in U.S. Pat. No. 6,301,807, the plantar aspect of the device is also characterized by a substantially domed shaped catalyst with a receptacle with vertical walls for removeably accommodating a resilient member with corresponding vertical walls. [0009] As disclosed in U.S. Pat. No. 6,732,457, the plantar aspect of the devise is also characterized by a substantially domed shaped catalyst with a cavity or receptacle for removeably accommodating an insert which acts between the catalyst and an underlying surface to control the resilient deformability of the catalyst; and that the cavity and insert have an engagement means for resisting separation of the insert from the insole and lateral shifting therebetween.

[0010] However, it has been found that the devices disclosed in U.S. Pat. No.

5,404,659, in U.S. Pat. No. 6,301 ,807, and U.S. Pat. No. 6,732,457 have a number of limitations that inhibit the devices' optimal positioning and the degree of stimulus provided to the plantar surface of the foot while the foot is interfacing with the ground, during the initial contact, support, and propulsion phases of the multidirectional bipedal activity gait cycles.

[0011] In general the devices disclosed in U.S. Pat. No. 5,404,659, in U.S. Pat.

No. 6,301,807, and U.S. Pat. No. 6,732,457 incorporate dome shaped catalysts the positioning of which is fixed. This fixed positioning of the dome shaped catalysts restricts the stimulus to the center of the foot's arch apex to only those times when users of the devices are standing perfectly erect on perfectly horizontal terrain. In instances when the users are engaging in multidirectional bipedal activities during which their lower limbs are not perpendicular to the terrain whether the terrain is horizontal or not, users of the devices would experience stimulus to less than optimal locations around the periphery of the center of the arch apex as the foot moves about the dome shape. This less than optimal location of the stimulus to the sole of the foot results in a less than optimal proprioceptive reflex response and a less stable musculoskeletal arch system and ankle.

[0012] In addition, the devices disclosed do not allow for any degree of adjustability in the relative positioning of the dome shaped catalyst to accommodate users who have feet of identical length but have variances in foot type. For example one person could have a longer arch and shorter toes and another have a shorter arch and longer toes, yet both could have the same foot length. In another example one person could have a wide foot and another a narrow foot, yet both could have the same foot length as the aforementioned persons. Therefore, the devices disclosed would fail to provide stimulus at the optimal location for one of the individuals.

SUMMARY OF THE INVENTION

[0013] A catalyst device configured to fit the profile of the human foot to promote dynamic proprioceptive stimulation of the mechanoreceptors and nocioreceptors in the skin of the sole of the foot at the anatomical apex of the foot's arch system. The anatomical apex of the foot's arch system being defined as the highest part of the midfoot's boney structure when viewed from the mid-foot's medial to lateral aspect between the calcaneous (heel) and metatarsal heads (forefoot).

[0014] The catalyst device has an anchoring system for locating the catalyst device central to the foot's anatomical arch apex. The catalyst device may be a resilient ellipsoidal or spherically shaped biofeedback device that presents to the plantar aspect of the foot at a location found to be the anatomical apex of the foot's arch system.

[0015] The resilient ellipsoidal or spherically shaped biofeedback catalysts display physical properties as to dynamically stimulate the body's natural neuromuscular reflex mechanisms that effectively optimally align and stabilize the foot's musculoskeletal arch system and ankle. The plantar aspect of the ellipsoidal and spherically shaped biofeedback catalysts encourages the catalysts to dynamically roll and pivot about their plantar apexes as they mirror the foot's movement through multidimensional activities. This dynamic movement ensures that the ellipsoidal and spherically shaped biofeedback catalysts' dorsal aspect apexes always optimally align with anatomical apex of the foot's arch system regardless of the angle at which the foot contacts the ground.

[0016] The net result is a more structurally sound foot capable of optimally managing the forces generated during all bipedal activities with the most efficient use of muscular energy and the lowest degree of injury inducing stress. With regular use, the stimulated neuromuscular activity results in the foot's musculoskeletal structure becoming progressively stronger and less susceptible to injury. The catalyst device provides rehabilitative, preventive, and performance enhancing benefits. [0017] The resilient ellipsoidal or spherical biofeedback catalysts display physical properties such that they do not provide functional bracing or support to the plantar aspect of the foot.

[0018] The catalyst device has the ability to receive and interchange the resilient ellipsoidal or spherical biofeedback catalyst components, as well as having the anchoring provision to ensure proper placement in a shoe or other foot shodding article of the catalysts relative to the user's anatomical arch apex.

DESCRIPTION OF THE DRAWINGS

[0019] Preferred embodiments of the invention are illustrated below with reference to the accompanying illustrations.

Figure 1 a is a top plan view of a first embodiment of the present invention;

Figure 1 b is a bottom plan view of an anchor positioning piece component of the present invention;

Figure lc is the section line c-c of Figure la; Figure Id is a section on line d-d of Figure lc;

Figure 1 e is an end elevation showing an anchor positioning piece in association with a variety of catalysts;

Figure 2a is a top plan view of a second embodiment of the insole device of the present invention;

Figure 2b is a section on line b-b of Figure 2a; Figure 2c is a section on line c-c of Figure 2b;

Figure 3a is a top plan view of an anchor positioning piece with anchor attached according to a third embodiment of the present invention;

Figure 3b is a bottom plan view corresponding to Figure 3a without the anchor positioning piece and catalyst installed; Figure 3 c is a top plan view of a top layer of an insole device according to the present invention;

Figure 3d is a section on line d-d of Figure 3c;

Figure 3e is a bottom plan view corresponding to Figure 3c;

Figure 3f is bottom plan view corresponding to Figure 3a;

Figure 3g is an exploded view of the third embodiment of the insole device;

Figure 4a is a top plan view of a fourth embodiment of an insole device according to the present invention;

Figure 4b is a bottom plan view corresponding to Figure 4a;

Figure 4c is a section on line c-c of Figure 4a;

Figure 4d is a section on line d-d of Figure 4a;

Figure 4e is an exploded view corresponding to Figure 4c;

Figure 5a is a top plan view of a fifth embodiment of an insole device according to the present invention;

Figure 5b is a bottom plan view corresponding to Figure 5a;

Figure 5c is a section on line c-c of Figure 5a;

Figure 5d is a section on line d-d of Figure 5a;

Figure 5e is an exploded view corresponding to Figure 5c;

Figure 6a is a top plan view of a sixth embodiment of an insole device according to the present invention;

Figure 6b is a bottom plan view corresponding to Figure 6a; Figure 6c is a section on line c-c of Figure 6a; Figure 6d is a section on line d-d of Figure 6a;

Figure 6e is an exploded view corresponding to Figure 6c;

Figure 7a is a top plan view of a seventh embodiment according to the present invention; Figure 7b is a section on line b-b of Figure 7a;

Figure 8a is a top plan view of an eighth embodiment of an insole device according to the present invention;

Figure 8b is a bottom plan view corresponding to Figure 8a;

Figure 8c is a section on line c-c of Figure 8a;

Figure 8d is a section on line d-d of Figure 8a;

Figure 8e is an exploded view corresponding to Figure 8c;

Figure 9a is a top plan view of a ninth embodiment of an insole device according to the present invention;

Figure 9b is a bottom plan view corresponding to Figure 9a;

Figure 9c is a section on line c-c of Figure 9a;

Figure 9d is a section on line d-d of Figure 9a;

Figure 9e is an exploded view corresponding to Figure 9c;

Figure 10a is a midsole according to the present invention;

Figure 10b is a top plan view of a midsole cavity with a catalyst mounted therein;

Figure 10c is an end elevation of the catalyst of Figure 1 Ob;

Figure lOd is a front elevation of the catalyst of Figure 10b;

Figure lOe is a top plan view of a height adjustment shim portion of the midsole of Figure 10a; Figure 1 Of is a front elevation corresponding to Figure lOe; Figure lOg is an end elevation corresponding to Figure lOe;

Figure 1 1 is an axial sectional view corresponding to Figure 10a but with catalysts removed;

Figure 12a is an alternate embodiment of a midsole according to the present invention;

Figure 12b is a top plan view of a midsole cavity of the midsole of Figure 12a with a catalyst mounted therein;

Figure 12c is an end elevation of the catalyst of Figure 12b; Figure 12d is a front elevation of the catalyst of Figure 12b;

Figure 12e is an end elevation showing a height adjustable platform with a catalyst positioned thereon;

Figure 12f is a top plan view corresponding to Figure 12e;

Figure 13a corresponds to Figure 12a but shows the height adjustment mechanism in its lowest position;

Figure 13b illustrates a height adjustable platform;

Figures 13c, 13d and 13e illustrate height adjustable platform screw mechanisms according to the present invention;

Figure 14a is a top plan view of a further alternate embodiment of a midsole design according to the present invention;

Figure 14b is a top plan view of an interchangeable catalyst mechanism and anchoring means in accordance with the Figure 14a embodiment;

Figure 15 is a side elevation corresponding to Figure 14b;

Figures 16 through 23 are axial sectional views of different embodiments of midsole designs according to the present invention. Figure 24a is a top plan view of an anchor positioning piece with anchor attached according to a still further embodiment of the present invention;

Figure 24b is a bottom plan view corresponding to Figure 24a without the anchor positioning piece and catalyst installed;

Figure 24c is a top plan view of a top layer of an insole device according to the present invention;

Figure 24d is a section on line d-d of Figure 24c;

Figure 24e is a bottom plan view corresponding to Figure 24c;

Figure 24f is bottom plan view corresponding to Figure 24a;

Figure 24g is an exploded view of the third embodiment of the insole device.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0020] A dynamic arch stabilization and rehabilitative insole device is generally illustrated by reference 30 in the Figures. The insole device 30 consists of a flexible insole body having an outer portion 32 defining an upwardly extending dome 34 located central to the foot's anatomical arch apex. The dome 34 receives interchangeable substantially ellipsoidal and spherically shaped catalysts 40 for interfacing with the plantar aspect of a human foot.

[0021] The catalysts 40 have an apex 42 on the dorsal surface for aligning with a target area within the foot, the target area being defined by the anatomical arch apex.

[0022] The plantar aspect (bottom) 44 of the catalysts, in concert with the flexible insole body encourage the catalysts to dynamically roll and pivot about their plantar apexes as they mirror the foot's movement through multidimensional activities.

[0023] The catalysts 40 are resiliently deformable to apply an upwardly directed pressure to stimulate the nocioreceptors and mechanoreceptors in the skin of the sole of the foot in response to downward pressure on the catalyst 40 by the foot. The ellipsoidal or spherically shaped catalysts 40 provide resilient deformability to allow the catalyst 40 to deflect from between 10% and 100% of their maximum height in response to vertical forces of a person standing at rest being applied to the catalyst 40.

[0024] The catalysts' 40 resilient deformability may be selected so as to provide constant or variable resistance in response to vertical forces of a person standing at rest being applied to the catalyst. For example the catalyst may provide a constant or progressively increased or decreased compressive resistance relative to the degree of deformation.

[0025] The catalysts 40 may be of varied sizes and shapes relative to foot length, width and arch height.

[0026] The dorsal aspect (top) 43 of the catalysts 40 may have varied radii or apexes 42 at different locations relative to their horizontal midline to accommodate for a variety of foot types of the same foot length and ensure the optimal location of the stimulus provided.

[0027] The dorsal aspect 43 of the catalysts 40 may have varied radii or apexes at different locations relative to their frontal plane midline to accommodate for a variety of foot types of the same foot length and ensure the optimal location of the stimulus provided.

[0028] The plantar aspect 44 of the catalysts 40 may have varied radii or apexes at different locations relative to their horizontal midline such as for example shown in Figures 10c, lOd and lOe to optimize the dynamic rolling and pivoting motion specific to requirements of different bipedal activities or pathologies.

[0029] The plantar aspect 44 of the catalysts 40 may have varied radii or apexes at different locations relative to their frontal plane midline to optimize the dynamic rolling and pivoting motion specific to requirements of different bipedal activities or pathologies.

[0030] The catalysts 40 resilient deformability may be achieved by a variety of mechanical spring-like mechanisms or the use of resiliently deformable materials or a combination thereof. [0031] The catalysts 40 may be comprised of a variety of materials, densities, and resiliencies such as foams, rubbers, plastics, or other flexible materials. The catalysts may be comprised of one piece made from one material or comprised of a number of pieces made from different materials. Catalysts 40 comprised of a number of pieces may be preassembled as one unit or may be comprised of a number of interchangeable interlocking pieces that can be assembled by the user. The catalysts may be hollow and pressurized to varying degrees with gas, for example air or nitrogen.

[0032] The flexible insole body 30 may be comprised from a variety of materials such as foams, rubbers, and plastics as well as synthetic and natural fabrics. The insole body 30 may be comprised of one piece made from one material or may be comprised of a number of pieces made from different materials. Insole bodies made of a number of pieces may be preassembled as one unit or may be comprised of a number of interchangeable interlocking pieces that can be assembled by the user. The catalysts may also incorporate a mechanical spring (spiral or leaf) comprised of metal or a metal alloy.

[0033] The flexible insole body and catalysts 40 may have a variety of cooperating engagement means 50 for securing interchangable ellipsoidal and spherically shaped catalysts to the insole body. The co-operating engagement 50 means may include detent means for resisting separation of the ellipsoidal and spherically shaped catalysts 40 from the insole body 32 and may allow or restrict shifting therebetween.

[0034] In the Figures la to le embodiment an anchored positioning piece 60 which is securable to the insole body 32 on an underside of the insole body 32 maintains the catalyst in place. A flexible anchoring means 50 extends from the anchor positioning piece 60 and engages the catalyst through a protrusion in the form of a flexible anchor which is received in a correspondingly shaped receptacle in the catalyst, the protrusion being narrower adjacent the anchor positioning piece 60 than at an end distal the anchor positioning piece 60.

[0035] In the Figures 2a to 2c embodiment, the anchor positioning piece 60 is integral with an upper part 90 of the catalyst 40 which receives a lower part 92. The lower part 92 has a curved lower surface 94 upon which the catalyst 40 can pivot or roll. A flexible anchor 50 is provided on the lower part 92 which is basically a protrusion received in a corresponding recess in the upper part 90. Figures 7a and 7b illustrate a similar arrangement but with a different interaction between the positioning piece 60 and the insole 32 in a heel region 33 of the insole 32.

[0036] Figures 3a to 3g comprise further views of an insole 32 similar to the figure 2 embodiment.

[0037] Figure 24a through 24f illustrates an insole body 32 similar to the Figure 2 embodiment but having heel and forefoot cushioning members 70 and 72 respectively depending downwardly from an underside thereof.

[0038] Figures 4a to 4e show the use of a removable dome 34 on the insole body

32. The removable dome includes interactive engaging means such as knob ended protrusions 100 which are received in corresponding recesses in the insole body 30. In the Figure 4 embodiment the catalyst is trapped in a pocket 102 beneath the removable dome.

[0039] Figures 5a to 5e illustrate an alternate embodiment of the removable dome

34 which is generally similar to the Figures 4a to 4e embodiment except that the catalyst is integral with the removable dome 34 and accordingly held in place by the interactive engaging means 100 which in this case also act as an anchoring means.

[0040] Figures 6a to 6e is an embodiment very similar to the Figures 4a to 4e embodiment except that the pocket 102 which receives the catalyst 40 also extends into the insole body 32.

[0041] Figures 8a to 8e is a view similar to the embodiment of Figures 4a to 4e but showing a different mechanism for maintaining the removable dome in place. According to the Figures 8a to 8e embodiment the insole body 32 has a recess 108 extending into its upper surface and surrounded by an inwardly extending lip 1 12. The lip 112 registers with an overlies a correspondingly profiled edge 1 10 of the removable dome 34. [0042] Figures 9a to 9e illustrate an embodiment similar to the Figures 4a to 4e embodiment but showing a differently shaped pocket 102.

[0043] The catalyst may be incorporated into the midsole of a shoe rather than the insole as illustrated in the remaining figures.

[0044] Figures 10a to lOg illustrate catalyst 40 between an insole body 32 and a midsole 120. The anchor 50 engages the midsole 120 at heel and forefoot regions 80 and 82 respectively thereof. The height of the catalyst may be adjusted using height adjustment shims 130 placed between the catalyst 40 and the midsole 120 in a receptacle or pocket 132 as illustrated.

[0045] Figure 11 illustrates the Figures 10a to lOg embodiment in a lower position without the presence of adjustment shims. The shims would typically be placed in a cavity 130 in the midsole which has a shape that prevents unwanted movement of the catalyst.

[0046] Figures 12a to 12f illustrate an alternate mechanism for adjusting the height of the cavity utilizing a screw mechanism 140 having a screw 150 mounted in the midsole with a screw head 152 visible through the outsole. The screw 150 threadedly engages a platform 154 which is moveable toward and away from the outsole in response to rotation of the screw 150. The screw acts between the midsole 120 and the platform 154.

[0047] Figure 13a corresponds to Figure 12 which shows the platform 154 at its lowest position whereas the platform 154 in Figure 12a is shown at its highest position.

[0048] Figure 13b illustrates the platform 154.

[0049] Figures 13c, 13d and 13e illustrate height adjustable platform screw mechanisms.

[0050] Figures 14a, 14b and Figure 15 correspond to Figures 13a to 13e and show a plan view of the midsole. The midsole has indentations 160 extending into an upper face thereof which receives the anchoring means 50 associated with the catalyst 40. [0051] Figures 16, 17 an 18 illustrate alternate interactive engagement means for securing the catalyst 40 to the midsole 120. Figure 16, 17 and 18 also show the use of a removable dome 42 which instead of engaging a body of an insole engages the midsole 120 in a manner analogous to that described above with reference to Figure 8.

[0052] Figures 19 through 23 illustrate catalysts of varying shapes and density for providing a variety of compression (stimulus) characteristics for different foot-type requirements and/or activities.

[0053] The foregoing description of the preferred embodiments and examples of the apparatus and process of the invention have been presented to illustrate the principles of the invention and not to limit the invention to the particular embodiments illustrated. It is intended that the scope of the invention be defined by all of the embodiments encompassed within the claims and/or their equivalents.