BACKGROUND OF THE INVENTION The treatment of lymphedema or edema by use of a brace or sleeve has been disclosed in the patent literature.

For example, United States Letters Patent No. 4,215,687 (Shaw) discloses a body or limb encircling therapeutic device. The device is made up of a kit and when assembled it includes a plurality of body or limb encircling bands. Each band is individually adjustable for its length to apply the desired pressure or to provide desired support to the body or limb of humans or animals.

A band anchoring tape is provided that is long enough to bridge two or more adjacent bands and to maintain them in proper edge-to-edge relationship. The combination or kit also includes a plurality of splicing elements having an interlocking fabric material on one surface which interlocks with interlocking fabric on the outer surface of the band and on one surface of the anchoring tape so that in the event it is necessary to cut the band angularly to obtain conformity of the band with body or limb contour to shorten the band by removing a span thereof, the band ends with the band anchoring tape between them can be locked together by the application of the splicing element.

United States Letters Patent No. 5,125,400 (Johnson, Jr.) discloses an ankle brace comprising at least one outer shell member and at least first and second pressurizable chambers, e. g., multiple separate inflatable aircells or airbags, juxtaposed therewith in an overlapping manner for providing a supporting cushion between the outer shell member and a body part or limb, e. g., the ankle. One of the chambers is coextensive with substantially the entire inner surface of the one outer shell member for engagement with a corresponding portion of the body part or limb, while the other of the chambers is coextensive with a portion of the first chamber. In one preferred embodiment the separate inflatable airbags are of different sizes and are disposed on the outer shell member with the smaller airbag positioned coextensively with the bottom portion of the larger airbag and between the larger airbag and the inner surface of the outer shell member. In alternatively preferred embodiments, the first and second chambers are integrally formed from a single inflatable liner having two compartments divided by a common wall, at least one of the compartments being selectively inflatable through integral valve means formed at least in part by the common wall.

United States Letters Patent No. 5,916,183 (Reid) discloses a method and apparatus for treating edema and other swelling disorders by means of a sleeve or other article for encircling the affected portion of the body. The sleeve has a plurality of inwardly projecting elastomeric fingers and a plurality of externally fitted pressure adjusting circular bands. When the sleeve is fitted to a patient's limb, the fingers impose a grid pattern of pressure points against the skin of the swollen limb. The space around and between the pressure points provide channels under the skin through which lymphatic fluids are able to migrate up the arm to the shoulder where healthy nodes process it and channel it to the large veins. Similar applications are applied to other limbs, hands and feet with sleeves, and the shoulder, chest wall and back with vests.

United States Letters Patent No. 5,976,099 (Kellogg) discloses a method and apparatus for the alleviation of an undesirable fluid accumulation in a body area of a patient is provided. The apparatus, or static reaction system, has enclosure containing a multiplicity of particles that are pressed against the body area. The shape of the enclosure and the physical qualities of the particles affect the suitability of specific versions of the invention to particular conditions and body areas. Pockets are included in some versions of the enclosure to capture and isolate subsets of the multiplicity of particles. An optional directional flow pattern feature is established by the orientation, sizes and shapes of the optional pockets and thereby affects the rate at which the fluid accumulation is reduced. Lightweight and flexible materials are used to manufacture various comfortable, transportable and storable models of the invention. The enclosure is optionally constructed with low friction, porous and breathing fabrics and materials to improve patient comfort and patient compliance. The enclosure is pressed, held and/or forced against a selected body area by means of a detachable compression cover, a pneumatic pack, compressive bandaging or wrapping, and made with VELCRO@ stretch fabric and/or with VELCRO@ strapping or other suitable means. Certain versions of the invention are applied by a capable and competently trained patient and with reduced need of constant professional supervision.

Various wrap-around, sleeve-like, braces are commercially available and/or disclosed in the patent literature, particularly for use on the knee.

Examples of such braces are disclosed in United States Letters Patent Nos.: 3,463,147 (Stubbs), 3,831,467 (Moore), 4,090,508 (Gaylord, Jr.), 4,651,722 (Karczewski), 4,378,009 (Rowley et al.), 5,024,216 (Hiono), 5,086,761 (Ingram), 5,221,252 (Caprio et al.), 5,399,153 (Caprio et al.), 5,451,201 (Prengler), and 5,472,413 (Detty).

While the devices of the foregoing devices may be generally suitable for their intended purposes, they never the less leave something to be desired from one or more of the standpoints of simplicity of construction, ease of use, effectiveness, etc. SUMMARY OF THE INVENTION This invention relates to a brace or other wrap including an insert bladder for effecting lymphatic drainage of the portion of the anatomy of the being to which the brace is applied.

The brace or wrap (e. g., a sleeve formed of an elastic material, such as fabric covered Neoprene) for covering the desired portion of the anatomy of the being. The brace or wrap has an inner surface arranged to be disposed immediately adjacent the skin of the portion of the anatomy of the being. The bladder is a hollow member that is releasably secured, e. g., via cooperating VELCRO@ type fasteners, to a portion of the inner surface of the sleeve. The bladder comprises first and second flexible sheets, e. g., solid polyurethane or polyurethane coated nylon, that are secured to each other along plural seal (e. g., RF or heat seal) lines to form a plurality of inflatable chamber sections.

Each of the chamber sections is bounded by one or more of the plural seal lines and are in fluid communication with one another. The first and second flexible sheets are also secured to each other at plural discrete contact points, e. g., small circular areas. Each of the inflatable sections includes at least one of the contact points.

The bladder is arranged to be filled with a fluid, e. g., a hot or cold liquid, a hot or cold gas, etc., whereupon the fluid flows through the communicating chamber sections to inflate the sections and cause portions of the first and second sheets to separate from each other except at the seal lines and the contact points to thereby produce discrete areas of varied high and low pressure points on the skin and underlying tissue of the being. In accordance with one aspect of this invention the discrete contact points may be equidistantly spaced from each other or may be randomly spaced.

In accordance with another aspect of this invention the brace may be configured to be used on various portions of the anatomy. For example, the brace may be configured for use on the thigh/hamstring, or on the knee, or on the ankle, or on the elbow or on the shoulder, or any other portion of the being's body.

The fluid for inflating the bladder may be provided on a continuous or continual basis at regular or irregular intervals to inflate the bladder and may be cooled or heated to provide additional therapeutic effects.

DESCRIPTION OF THE DRAWING Fig. 1 is an isometric view of a back brace embodiment of this invention shown in place on a person; Fig. 2 is an enlarged plan view of the exterior side of the embodiment shown in Fig. 1; Fig. 3 is a plan view, like Fig. 2, but showing the interior side of that embodiment; Fig. 4 is an enlarged plan view of the exterior side of an inflatable bladder forming a portion of the embodiment of Figs. 1-3; Fig. 5 is an enlarged sectional view taken along line 5-5 of Fig. 3; Fig. 6 is a plan view of the exterior side of a knee brace embodiment of this invention; Fig. 7 is a plan view of the interior side of the knee brace embodiment of Fig. 6 showing its bladder in place therein; Fig. 8 is a plan view of the exterior side of a bladder constructed in accordance with this invention for use in a wrist brace; and Fig. 9 is a plan view of the exterior side of a bladder constructed in accordance with this invention for use in an ankle brace.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawing where like reference numerals refer to like parts there is shown at 20 in Fig. 1 a back brace constructed in accordance with this invention for use on the back of a person 10. In the exemplary embodiment 20 shown, the brace basically comprises a generally planar sheet 22 of flexible material (see Figs. 2 and 3) which is arranged to be wrapped around the upper torso of the person covering the portion of the person's back to be treated and which releasably mounts on its interior surface an inflatable bladder 100 (Fig.

3-also to be described later). The bladder 100 serves to apply pressure at discrete points within the area of the portion of the person's back to be treated.

It must be pointed out at this juncture that the brace 20 is merely exemplary of various types, shapes and sizes of braces which can be used with an inflatable bladder for application to any portion of the anatomy of a person in accordance with this invention. Thus, the subject invention can be in the form of any type of brace or wrap for use on the thigh/hamstring, knee, ankle, elbow, wrist, shoulder, or any other portion of the body, of a person to treat or prevent lymphedema or edema. Depending upon the construction of the brace or wrap, it may also serve to provide support for the affected portion of the person's body.

The planar sheet 22 of the embodiment 20 shown in Figs. 1-13 includes a central section 24 and two side mounting tabs 26 and 28. The central section is of a general trapezoidal shape to conform to the shape of the back of the wearer. The side mounting tabs are used to mount the brace on the person's back, e. g., with the central section located over the lower portion of the back, and with the mounting tabs 26 and 28 wrapped around the person's abdomen and secured to each other to hold the brace in place. Owing to the construction of the tabs 26 and 28, the wearer can readily tighten the brace to the desired degree of compression, irrespective of the size of the person or the shape of the person's anatomy.

The central section 24 is preferably formed of a blank of elastomeric material which is die cut into the desired shape (in this case an inverted trapezoid). The material forming the sheet is most preferably a plush fabric- coated neoprene. In particular the sheet has an inner surface to which a fabric layer 30 (Fig. 5) is secured, e. g., glued, to form the inner surface of the brace.

The outer surface of the sheet has a fabric layer 32 (Fig. 5) secured, e. g., glued, to it to form the outer surface of the brace. The neoprene sheet is of a substantial thickness, e. g. approximately 0.125 inch (3.2 mm) thick, to provide cushioning, support and thermal retention. The fabric layer 32 forming the inner surface of the brace is selected to be comfortable and non-chafing, e. g., is smooth lycra/nylon. One particularly suitable fabric covered neoprene for forming the central section 24 is that sold by CR-Uno Corporation of Taiwan.

The central section 24 has a longitudinal central or mid-line axis 36, a first lateral side 38 located on one side of the axis and a second lateral side 40 located on the opposite side of the axis. The mounting tab 26 is a generally planar sheet formed of a blank of slightly elastomeric material which is die cut into the desired shape (in this case a truncated triangle). The material forming the sheet is most preferably a plush fabric (e. g., nylon)-covered foam, such as sold under the trade designation VELCROO Sport Loop. In particular the sheet has an inner surface to which a fabric layer 42 is secured, e. g., glued, to form the inner surface of the brace. The outer surface of the sheet has a fabric layer 44 secured, e. g., glued, to it to form the outer surface of the brace. The sheet also provides cushioning, support and thermal retention. In accordance with the preferred aspect of the invention, the fabric forming the outer surface 44 of the brace is tufted or plush, e. g., is a UBL (unbroken loop) fabric, compatible with VELCRO@ multi-hook fastening components, to act as the multiple loop fastening component of a VELCRO@ fastening system to facilitate the releasable securement of the two tabs 26 and 28 together to hold the brace in place on the wearer's body. The fabric layer 42 forming the inner surface of the brace's mounting tabs is relatively smooth to be comfortable and non-chafing.

The side mounting tab 26 is fixedly secured, e. g., sewn, by a line of stitches 34 to the marginal side edge 38 of the central section so that its tapered end 46 constitutes its free end. The other mounting tab 28 is shaped and constructed identically to the side mounting tab 26, but is fixedly secured, e. g., sewn by a line of stitches 34, to the marginal side edge 40 of the central section and with its tapered end 48 constituting its free end. A generally rectangular patch 50 (Fig. 3) of a multi-hook VELCROO component is fixedly secured, e. g., sewn by a line of stitches 34 around its perimeter, to the inner surface of the side mounting tab 28 at the free end 48.

The brace 20 is arranged to be mounted on the upper torso of the wearer by placing the inner surface of the central section 24 over the portion of the wearer's back to be treated. The side mounting tab 26 is then pulled (e. g., stretched) and wrapped around the person's torso so that its free end 46 is located over the person abdomen. The tab is held in place at that position while the side mounting tab 28 is wrapped around the person's torso from the opposite direction until the patch 50 on the free end of the side mounting tab 28 overlies the plush fabric 44 outer surface at the free end 46 of the side mounting tab 26. By bringing those two portions into engagement, e. g., pushing the mounting tab 28 down onto the mounting tab 26, the multiple hooks of the VELCRO@ patch 50 of the side mounting tab 28 releasably engage the plush fabric outer surface of the side mounting tab 26.

As will be appreciated by those skilled in the art, since the brace is elastic, the amount of overlap of the mounting tab 28 on the tab 26 is adjustable to accommodate various sizes/shapes of persons. In particular, the patch 50 of multi-hooks is quite large so that it can engage the plush outer surface 44 of the mounting tab 26 at various places thereover. Thus, the wearer 10 can readily establish the desired degree of tightness or compression provided by the brace 20. In order to facilitate the wrapping and stretching of the side mounting tab 28 over the being's body so that it can be releasably secured to the side mounting tab 26, a loop 52 (Fig. 3) of a webbing, such as that sold under the trade designation VELCROO Texline, is fixedly secured, e. g., sewn by a line of stitches 34 to the free end of the side mounting tab 28 adjacent the patch 50.

The loop 52 on the mounting tab 28 helps the wearer to pull it in place over the underlying mounting tab 26 to put the brace on. In addition it facilitates the grasping of the free end 48 of the overlying mounting tab 28 to disconnect that tab from the underlying mounting tab 26 when the brace is to be removed.

As can be seen in Fig. 2 a generally rectangular, elongated patch 54 is fixedly secured, e. g., sewn by a line of stitches 34 around its periphery, to the outer surface of the center section 24 centered over the central longitudinal axis 36. The patch 54 is made up of a fabric covered neoprene, similar to the material making up the section 24, except that it is thicker, e. g., 0.25 inch (6.4 mm). The patch 54 with its underlying central section 24 forms a triple thickness area of the brace that is centered along the longitudinal axis of the center section 24 and is coincident with the wearer's spine to bring (e. g., force) the bladder 100 into closer conformity with the natural depression of the wearer's back along the wearer's spine when the bladder is in place within the brace.

As can be seen in Figs. 2 and 3 a strip 56 of a multi-loop VELCROO component (Fig. 3) is fixedly secured, e. g., sewn around its periphery by a line of stitches 34 (Fig. 2), to the inner surface of the central section 24 of the brace immediately below the patch 54, i. e., adjacent the bottom edge of the brace. A similar multi-loop VELCROO component strip 58 (Fig. 3) is fixedly secured, e. g., sewn around its periphery by a line of stitches 34 (Fig. 2), to the inner surface of the central section 24 of the brace immediately above the patch 54, i. e., immediately adjacent the top edge of the brace. The strips 56 and 58 serve to releasably mount the bladder 100 in the brace, as will be described later.

As best seen in Figs. 1 and 2 a pair of straps 60 and 62 are fixedly secured to the outer surface of the brace along respective marginal edges 38 and 40 of the central section 24 at the junction with the side mounting tabs 26 and 28, respectively. The straps 60 and 62 are elastic, e. g., a woven elastic fabric such as that available from RX Textiles. A generally rectangular patch 64 of a multi-hook VELCRO@ component is fixedly secured, e. g., sewn around its perimeter by a line of stitches 34, to the surface of the strap 60 facing the side mounting tab 26 at the free end of the strap 60. An identical patch 66 of a multi-hook VELCRO@ component is fixedly secured, e. g., sewn around its perimeter by a line of stitches 34, to the surface of the strap 62 facing the side mounting tab 28 at the free end of the strap 62. The elastic straps 60 and 62 enable the wearer 10 of the brace 20 to provide additional tension to the brace.

In this regard either one or both of the straps 60 and 62 can be adjusted, e. g., stretched and/or positioned, over any portion of the brace that their associated multi-hook VELCROO patches 64 and 66 can reach to be releasably secured thereto. This enables the user to adjust the brace to his/her particular anatomy, in the interest of functionality without sacrificing wearer comfort.

Referring now to Figs. 3-5 the details of an exemplary embodiment of an inflatable bladder 100 for use with the back brace 20 will now be described.

However, before doing that, it should be pointed out that bladders in accordance with this invention can take forms other than the exemplary embodiment 100.

Thus, other shapes and sizes can be used for a back brace. In fact other shapes and sizes can be used for any brace envisioned by this invention for use on any portion of a person's body, e. g., the thigh/hamstring, knee, ankle, elbow, wrist, shoulder, etc.

As can best be seen in Figs. 4 and 5 the bladder 100 is a hollow member that is releasably secured by means (to be described later) to the plush or multi- loop strips 56 and 58 on the inner surface of the central section 24 of the brace 20. The bladder basically comprises a pair of identically shaped thin planar, flexible sheets 102 and 104. The shape or profile of the sheets making up the exemplary bladder 100 of Fig. 1 is generally trapezoidal, with slightly rounded corners, but this shape is merely exemplary of various shapes that can be used in accordance with this invention. Moreover, the sheets 102 and 104 can be of any suitable flexible material which is impervious to the passage of a fluid, e. g., water or some other liquid or a gas therethrough, since the bladder is arranged to be inflated with such a fluid and to retain the fluid therein (as will be described later). Two particularly suitable materials for making up either or both of the sheets 102 and 104 are polyurethane covered nylon fabric or urethane. In the case where the bladder is formed of the polyurethane covered nylon fabric, the covering may be a clear 4.0 mil polyether polyurethane on 200 denier nylon 6,6, such as that available from Highland Industries, Inc. If the bladder is to be made of urethane sheets, the urethane may be clear or partially transparent or translucent to enable the user to see the fluid within it (assuming that the fluid itself is colored or is otherwise visible to the naked eye). Each sheet can be approximately 10 mil thick.

Irrespective of the type of material making up the bladder, its two sheets 102 and 104 are fixedly secured to each other along plural seal lines (to be described shortly) to form a plurality of inflatable chamber sections in the bladder. Each of the chamber sections is bounded by one or more of the plural seal lines. The multiple chambers are preferably in fluid communication with one another so that fluid introduced into the bladder at one or more locations can flow throughout the various chambers to inflate them all. The fluid may, if desired, be circulated into, through and out of the bladder (as will also be described later). If desired, sections of the bladder may be isolated from other sections, so long as each section is arranged to be inflated with a fluid.

In addition to being secured together along their seal lines, the two sheets 102 and 104 of the bladder are fixedly secured to each other at plural discrete contact points spread throughout virtually the entire extent of the bladder. In accordance with one aspect of this invention each of the inflatable sections of the bladder includes at least one, and preferably several, of the discrete contact points. As will be disclosed later, when the bladder is inflated, i. e., a fluid is introduced therein, the fluid flows through the communicating chamber sections to inflate them, whereupon portions of the sheets 102 and 104 separate from each other except along the length of the seal lines and at the location of the plural discrete contact points. This action results in the production of numerous discrete high and low surface areas spread across the area encompassed by the bladder. Thus, when the inflated bladder 100 is in place within the brace 20 and the brace is tightened, the high points on the bladder (i. e., the areas between the seal lines and discrete contact points) apply higher pressure to the skin and underlying tissue engaged thereby, while the low points on the bladder (i. e., the areas at and immediately contiguous with the seal lines and discrete contact points) apply less pressure to the skin and underlying tissue. This application of multiple areas of higher pressure separated by multiple areas of lower pressure should prove to be quite effective for effecting lymphatic drainage and/or reducing lymphedema or edema.

The two sheets 102 and 104 of the bladder 100 are fixedly secured, e. g., thermally bonded, ultrasonically bonded, etc., to each other along the entire periphery of the bladder by a peripheral seal 106. The portion of the seal line 106 extending along the"bottom"edge of the bladder (the portion that will be located closest to the wearer's waist) is designated by the reference number 106A, the portion of the seal line 106 extending along the"top"edge of the bladder is designated by 106B, while the portions along the sides of the bladder are designated as 106C and 106D, respectively. Other suitable means, e. g., an adhesive, can be used to secure the two sheets together along their periphery, providing that the joint is fluid (or leak)-proof.

In the exemplary embodiment shown, the bladder 100 is broken up into eleven inflatable sections 100A, 100B, 100C, 100D, 100E, 100F, 100G, 100H, 1001, 100J and 100K by the heretofore mentioned seal lines. In particular, the bladder 100 includes a central longitudinal linear seal line 108 extending down the center of the bladder. A pair of linear seal lines 110 and 112 extend inward from the bottom edge portion 106A of the peripheral seal 106 towards the central seal line 108 but spaced slightly therefrom. A similar pair of linear seal lines 114 and 116 extend inward from the opposite or top edge portion 106B of the peripheral seal 106 toward the central seal line, but spaced slightly therefrom. Three transverse linear seal lines 118, 120 and 122 intersect the central seal line 108 and extend toward their respective portions 106A and 106B of the peripheral seal 106, but are spaced slightly therefrom. A pair of arcuate seal lines 124 and 126 merge with the transverse seal line 122. The left most portion of the seal line 122 and contiguous portions of the central seal line 108, the side seal line 106D, and the top seal line portion 106B define the heretofore identified bladder section 100A, with the gap between the end of the seal line 122 and the top seal line portion 106B forming an entrance/outlet for that section. In a similar manner the seal line 116 and contiguous portions of the top seal line portion 106B, the seal line 122, and contiguous central seal line 108 define the heretofore identified bladder section 1 OOB, with the gap between the end of the seal line 116 and the central seal line 108 forming an entrance/outlet for that section. The seal line116 and contiguous portions of the top seal line portion 106B, the seal line 120, and the contiguous central seal line 108 define the heretofore identified bladder section 100C, with the gap between the end of the seal line 120 and the top seal line portion 106B forming an entrance/outlet for that section. In a similar manner the seal line 120 and contiguous portion of the central seal line 108, the seal line 114 and the contiguous portion of the top seal line portion 106B, define the heretofore identified bladder section 100D, with the gap between the end of the seal line 114 and the central seal line 108 forming an entrance/outlet for that section. The seal line 114 and contiguous portion of the top seal line portion 106B, the seal line 118, and the contiguous portion of the central seal line 108 define the heretofore identified bladder section 1 OOE, with the gap between the end of the seal line 118 and the top seal line portion106B forming an entrance/outlet for that section. The seal line 118, the adjacent top seal line portion 106B, the adjacent side seal line 106C and the adjacent bottom seal line portion 106A define the heretofore identified bladder section 100F, with the gap between the end of the seal line 118 and the top seal line portion 106B forming one entrance/outlet for that section and with the gap between the other end of the seal line 118 and the bottom seal line portion106A forming another entrance/outlet for that section. The sections 100G, 100H, 1001, 100J and 100K are constructed similarly to sections 1 OOA, 100B, 100C, 100D and 100E, respectively. The section 100F extends virtually the full height of the bladder along the side edge 106C between the top seal line portion 106B and the bottom seal line portion 106A.

As mentioned earlier the two sheets 102 and 104 are fixedly secured to each other at plural discrete contact points spread throughout the bladder.

Those contact points are designated by the reference number 140. In the embodiment shown in Figs. 1-4 each contact point 140 is in the form of a small circular, e. g., 0.125 inch (3.2 mm) diameter, area which is preferably formed in the same manner and at the same time as the formation of the seal lines described above. The discrete contact points are located throughout virtually the entire area of the bladder and can be randomly spaced or equidistantly spaced from one another. Alternatively, some of the discrete contact points 140 may be spaced by the same distance from each other while others of the discrete contact points may be spaced by different distance (s) from each other, like that shown in Fig. 4.

In order to enable the bladder to be inflated, it includes at least one port into which an inflation fluid may be introduced, and if desired exhausted (if the bladder is to be deflated or if the bladder is desired to be continuously or continually inflated-as will be discussed later). The embodiment of the bladder 100 includes a pair of ports (not shown) located in the sheet 104 for that purpose. The ports are located in the areas bounded by the arcuate seal lines 124 and 126 and each is arranged to receive a respective flanged, right-angle shaped hollow connector therein. To that end one connector 146 extends through the port bounded by seal line 124, with the connector's flange 150 fixedly secured, e. g., welded or adhesively secured, to the inner surface of the bladder sheet 102 about the periphery of that port. That port is in fluid communication with the bladder section 100A and is also in fluid communication with the hollow interior of the connector 146. In a similar manner a flanged, right-angle shaped hollow connector 148 extends through the port bounded by the arcuate seal line 126, with the connector's flange 150 fixedly secured, e. g., welded or adhesively secured, to the inner surface of the bladder sheet 102 about the periphery of that port. That port is in fluid communication with the bladder section 1 OOK. In accordance with a preferred embodiment each of the connectors 146 and 148 is formed of a rigid, yet slightly flexible material, e. g., urethane. One particularly suitable commercial connector is available from Halkey-Roberts. Each connector 146 and 148 includes a hollow free end which receives one end of short section of a flexible plastic tube 152, e. g., clear PVC tubing of 5/16 inch (7.9 mm) outside diameter and 3/16 inch (4.8 mm) inside diameter, such as available from Laird Plastics under the designation Uniflex 650. A respective conventional shut-off valve 154 is mounted on each of the tubes 152. Each valve includes an inlet/outlet connector having a port 156 arranged to be connected via any tube or conduit (not shown) to a source of inflation fluid. The shut-off valve, is of conventional construction, such as that sold by Air-Oil Products, Corp. The inflation fluid for the bladder is arranged to flow under pressure from the fluid source (not shown), through the port 156 into either valve, through the valve 148 into its associated tube 152, from whence it flows through the associated connector 146/148 into the interior of the bladder to inflate the bladder when the valve is actuated. To that end each valve includes an manually operable actuator on the outside of the valve which is coupled to a valve element (not shown) within the valve to open the valve when the actuator is manually actuated (e. g., pressed).

When the bladder 100 is inflated through the valves 154, as just described, the fluid flows into the inlet ports of the bladder and then through the communicating chamber sections 100A-100K to inflate them, whereupon the bladder's two sheets 102 and 104 separate from each other as described earlier to form the high and low points on the bladder. In Fig. 5 the high and low points are shown as being somewhat symmetrical and evenly spaced. In actuality the shape of the bladder between the high points and the low points will vary depending upon various factors, e. g., the degree of inflation, the amount of compression provided by the brace or wrap, etc.

It should be pointed out at this juncture that the bladder 100 is preferably inflated once the brace or wrap is in position on the wearer's body (as will be discussed later). However, if desired, the bladder may be inflated first, then mounted in the brace, then the brace may be placed about the patient's body part to be treated. In either case, when the inflated bladder is within the brace and the brace is in place and tightened, e. g., compression applied, the high and low areas resulting from the inflation of the bladder will create corresponding varied high and low pressure points on the skin and underlying tissue of the wearer that the bladder engages. This action can be extremely effective to reduce lymphedema and/or edema and to provide lymphatic drainage. For example, if the bladder is inflated when in place on the body of the being the flow of fluid through the bladder to create the varying high and low pressure points opens up initial lymphatic vessels through skin movement, thereby facilitating lymphatic drainage. This lymphatic drainage action can be expedited further by keeping the bladder inflated by circulating the inflation fluid through it on a continuous or continual basis. In particular, fluid can be introduced into the bladder through one of the valves and its associated port so that the fluid will flow through the communicating chambers and will exit the other port and that other port's valve either continuously for a predetermined or indeterminate period of time or can be accomplished on a continual basis, e. g., at regular or irregular intervals.

The type of fluid used to inflate the bladder 100 can provide additional benefit (s). For example, the fluid may be in the form of cold water or some other cooled liquid (e. g., a mixture of propylene glycol and water) or a gas (e. g., air) to cool the affected area for some desired therapeutic effect, or may be in the form of a heated liquid or gas to heat the affected body part if a heated therapeutic effect is desired.

The continuous or continual passage of fluid through the bladder to keep it inflated can be carried out by any means, e. g., a recirculating fluid supply.

That supply may be an integrated self-contained system (not shown) comprising a small, electrically operated pump, a battery or AC power supply to provide electricity to power the pump, an electronic controller (e. g., circuit board with integrated circuit chip) for controlling the operation of the pump, a bag or reservoir for the inflation fluid, a heat sink in the form of tubing (e. g., copper or stainless steel) through which the inflation fluid flows to be cooled, and a chamber for ice and water through which the heat sink tubing extends. With such an arrangement the inflation fluid is pumped by the pump under the control of the circuit board from the reservoir through the heat-sink tubing, whereupon it is cooled by the ice and water surrounding the tubing. The cooled fluid then flows through one of the valves 154 and the associated bladder port into the bladder to inflate the bladder and then exits the bladder through the other port and associated valve 154, whereupon it is carried back to the reservoir for re- cooling. This recirculating fluid supply system enables the bladder of this invention to maintain the person's back (or whatever body part the bladder is used on) at desired, consistent, cool temperature for an indefinite period of time so long as the fluid is cooled and circulated. Moreover, since the material making up the brace itself, e. g., neoprene, is a good thermal insulator, the brace is quite effective in retaining the cooling effect provided by the inflation fluid for a substantial period of time.

Further still, the elastomeric nature of the exemplary brace should also provide substantial support for the body part being treated.

In order to releasably secure the bladder 100 in the brace 20, as best seen in Figs. 3 and 5, the bladder includes a pair of multi-hook VELCRO@ fastening tapes162 and 164 fixedly secured, e. g., adhesively secured, to the outer surface of the bladder panel 104 along the bottom and top edges, respectively. These multi-hook strips are arranged to releasably engage the multi-loop or plush strips 56 and 58, respectively, on the inner surface of the brace's central section 24.

In the interest of comfort and to enable ready access to the valve (s) for inflating or deflating the bladder or connecting them to a recirculating fluid supply system like that described above, it is preferable that the valves and associated conduits be located outside the outer surface of the brace or wrap.

To that end in order to enable the right-angle connectors 146 and 148 to gain egress from the interior of the brace 20 to its exterior the central section 24 of the planar sheet 22 includes a pair of openings or holes through which those connectors extend so that the valves can be mounted thereon by the associated conduits. In the embodiment shown the holes through which the connectors extend are located to the right of the centerline 36, but such an arrangement is merely exemplary. Thus, the connectors could extend through holes on the left side of the centerline or at other locations.

In Figs. 6 and 7 there is shown an alternative brace 200 constructed in accordance with this invention. The brace 200 is for use on a knee and is of conventional construction, such as that sold by Pro Orthopedic Devices, Inc. and as shown and described in United States Letters Patent No. 5,865,777, whose disclosure is incorporated by reference herein. It should be pointed out at this juncture that the brace 200 is merely exemplary of numerous types of knee braces that may be constructed in accordance with this invention to accommodate a bladder.

The brace 200 includes a bladder 300 constructed in accordance with this invention. In the interest of brevity the construction of the brace 200 will not be described in detail, but rather will be described generally. To that end as can be seen the brace 200 is a generally planar sheet of elastomeric material having a central portion 202 and three mounting tabs 204,206, and 208. The material forming the sheet is most preferably a plush fabric-coated neoprene. The neoprene sheet is of a substantial thickness, e. g. approximately 4 mm. thick, to provide cushioning, support and thermal retention. The fabric forming the outer surface of the brace is tufted or plush, e. g., is a UBL (unbroken loop) fabric, compatible with VELCROO. multi-hook fastening components so that it can act as the multiple loop fastening component of a VELCRO@ fastening system to facilitate the mounting of the brace on the person's knee. The fabric layer forming the inner surface of the brace is selected to be comfortable and non-chafing, e. g., is a smooth nylon tricot. The central portion 202 is of a generally rectangular shape having a longitudinal central or mid-line axis 209 and a pair of lateral sides located on opposite sides of the axis. A pair of spaced mounting tabs, namely an upper tab 204 and a lower tab 208, extend from one lateral side of the brace perpendicular to the longitudinal axis and contiguous with the top and bottom edges, respectively, of the brace. The tabs 204 and 208 are arranged to be wrapped about the thigh region and the calf region, respectively, from the same direction. An intermediate mounting tab 206 extends from the opposite lateral side of the brace perpendicular to the longitudinal axis and between the upper and lower mounting tabs 204 and 208, respectively. The intermediate mounting tab 206 is arranged to be stretched and wrapped around the back of the person's knee in the opposite direction than the upper and lower tabs. The width of the intermediate mounting tab is such that it may fit within the space between the upper and lower mounting tabs to minimize any tendency for the brace to bunch up behind the knee, particularly when the knee is bent.

To secure the upper mounting tab 204 in place after it has been wrapped around the back of the thigh region a generally triangular VELCRO@ multi-hook ear 210 is provided, e. g., sewn in place by a line of stitches 212 to engage the plush outer surface of the brace to releasably secure the mounting tab in place.

The lower mounting tab 208 is similarly constructed with a triangular ear 210 to releasably secure the lower mounting tab 208 in place on the brace. The amount of overlap of the tabs is adjustable to accommodate legs of various sizes. The intermediate mounting tab 206 is similarly constructed to include a VELCRO (IN) multi-hook ear 210 on its free end so that it can be stretched and wrapped in the opposite direction behind the knee as the upper and lower mounting tabs. Accordingly, the multiple hooks of the ear 210 of the intermediate tab 206 releasably engage the plush fabric of brace between the upper and lower mounting tabs 204 and 208, with the amount of overlap also being adjustable to accommodate knees of various sizes.

In the embodiment shown herein the brace 200 includes four reinforcing stays mounted in the central portion of the brace. Each stay is an elongated strip of resilient material, e. g., a thin plastic strip or a flattened coil of aluminum or other metal, to provide additional stability to the knee and/or to keep the brace from collapsing on the knee when the knee is flexed. The stays are in two pairs, with each pair being located in the central portion of the brace 200 on opposite the side of the central longitudinal axis. The stays are located under respective strips 214 of the same material as that of the brace portion 202. The strips 214 are secured, i. e., sewn in place by respective lines of stitches 216, with the stays interposed between those strips and the underlying material making up the central portion 202.

The brace 200 also includes a pair of adjustment straps 218 and 220 to enable the wearer to customize the tension or tightness applied by the brace to the thigh region and the calf region, respectively. The two adjustment straps are constructed identically to each other. Each is an elongated flexible web of inelastic fabric, e. g., nylon, having a first end portion 222 fixedly secured, e. g., sewn by a portion of the stitch line 216, to the outer surface of the central portion of the brace approximately midway between the longitudinal axis 208 and the side of the brace from which the intermediate tab 206 extends. Thus, the straps are secured to the brace between the pair of stays on that side of the brace. The free end portion 224 of each of the adjustment straps is arranged to be extended through a respective buckle 226 and 228 mounted on the brace to tighten the brace around the portion of the leg at which the strap is located.

The undersurface of the free end portion 224 of each adjustment strap is in the form of a VELCROO multi-hook patch while the rest of the undersurface is in the form of a VELCROS) plush or multi-loop material. A pair of buckles 226 and 228 are mounted on the outer surface of the brace opposite the adjustment straps 218 and 220. In particular, they are secured by respective webs of inelastic fabric sewn to the brace between the pair of stays on the side of the brace from which the upper and lower mounting tabs 204 and 208, respectively, extend. Each buckle includes a central opening for receipt of the free end portion of the associated adjustment strap therethrough.

Each strap can be secured to its associated buckle and tightened to the desired degree of tightness by extending the multi-hook free end portion 224 of it across the center portion of the brace and through the opening in the associated buckle. The desired amount of tension can be readily applied by pulling on the free end portion of the adjustment strap and folding it back over itself to bring the multi-hookfree end component into engagement with the plush or multi-loop component of that strap.

The bladder 300 for the knee brace will now be described with reference to Fig. 7. As can be seen therein, the bladder 300 is somewhat similar in construction to the bladder 100 described heretofore, except for its over-all shape and the number and shape of its chamber sections. Thus, in the interest of brevity the common components of the bladders 300 and 100 will be given the same reference numbers and the details of their construction and operation will not be reiterated. The bladder 300 is arranged to be releasably secured to the inner surface of the central section 202 of the brace 200. The bladder basically comprises a pair of identically shaped thin planar, flexible sheets 102 and 104. The shape or profile of the sheets making up the exemplary bladder 300 of Fig. 7 is generally square, with slightly rounded corners, The two sheets 102 and 104 are fixedly secured to each other along plural seal lines (to be described shortly) to form a plurality of inflatable chamber sections in the bladder. In the embodiment shown there are twenty-four chamber sections 300A, 300B, 300C, 300D, 300E, 300F, 300G, 300H, 3001, 300J, 300K, 300L, 300M, 300N, 3000,300P, 300Q, 300R, 300S, 300T, 300U, 300V and 300X.

Each chamber section is bounded by one or more of plural seal lines 302, similar to those described earlier, but of a different shape as shown in Fig. 7.

The details of the shape of the various seal lines will not be discussed since such shapes are readily discernable from that figure. The multiple chambers are preferably in fluid communication with one another so that fluid introduced into the bladder 300 at one or more locations can flow throughout the various chambers to inflate them all. In addition, the two sheets 102 and 104 of the bladder 300 are fixedly secured to each other at plural discrete contact points 140 spread throughout virtually the entire extent of the bladder. The bladder 300 includes a plurality, e. g., six, slits 304,306,308,310,312 and 314 extending inward from respective marginal edges of the bladder 300 toward the center thereof. These slits form six wedge shaped sectors, each of a general triangular shape, with one sector being defined between slits 304 and 306, and with another sector being defined between slits 306 and 308. Another sector is defined between slits 308 and 310. Another sector is defined between slits 310 and 312. Another sector is defined between slits 312 and 314 and the last sector is defined between slits 314 and 304. The sectors are disposed diametrically opposite each, with the corner sectors being four sided and the top and bottom sectors being triangular. Essentially the diametrically disposed sectors are mirror images of each other.

The bladder 300, being arranged for use on the knee, includes a central opening 316 which is arranged to be located concentric with a patellar opening 230 (Fig. 6) in the brace 200 to accommodate the wearer's patella when the bladder is releasably mounted within the brace 200 and the brace is in position.

A central, circular seal line 316A extends about the periphery of the opening 316. A foam donut (not shown) is mounted on the inside of the brace around the opening 230 and is covered by a felt donut sewn thereover by a circular stitch line 232 (Fig. 6).

As should be appreciated by those skilled in the art the slits 304-314 in the bladder enable the bladder to closely conform to the wearer's knee (the slits act as"darts"enabling portions of the bladder to readily assume orientations in somewhat different planes and/or directions).

The bladder 300 can be modified to be used as part of a shoulder brace in accordance with this invention.

As discussed earlier the two sheets 102 and 104 forming the bladder 300, like those forming the bladder 100, are fixedly secured to each other at plural discrete contact points 140, e. g., small circular 0.125 inch (3.2 mm) diameter areas, spread throughout the bladder. The discrete contact points are located throughout virtually the entire area of the bladder and can be randomly spaced or equidistantly spaced from one another. Alternatively, some of the discrete contact points may be spaced by the same distance from each other while others of the discrete contact points may be spaced by different distance (s) from each other. The bladder includes a pair of arcuate seal lines bounding respective ports for receipt of respective flanged right-angle connectors 146 and 148 through the respective ports in sheet 104. The arrangement and location of the port (s) for the bladder 100 is also exemplary of various types of arrangements which can be used in any of the braces/wraps/bladders of this invention. Thus, one or more ports can be placed at any desired location in the bladder.

When the bladder 300 is inflated, the fluid introduced under pressure flows into the inlet ports of the bladder and through the communicating chamber sections 300A, 300B, 300C, 300D, 300E, 300F, 300G, 300H, 3001, 300J, 300K, 300L, 300M, 300N, 3000,300P, 300Q, 300R, 300S, 300T, 300U, 300V and 300X to inflate them, whereupon the bladder's two sheets 102 and 104 separate from each other as described earlier to form the varied high and low points on the bladder.

In order to releasably secure the bladder 300 in the brace 200, the bladder includes a pair of multi-hook VELCRO@ fastening tapes (like tape 162 and 164 described earlier) fixedly secured, e. g., adhesively secured, to the outer surface of the bladder panel 104 along the top and bottom marginal edges.

These strips are arranged to releasably engage multi-loop or plush strips 56 and 58 on the inner surface of the central section of the brace 200.

In the interest of comfort and to enable ready access to the valve (s) for inflating or deflating the bladder, it is preferable that the valves and associated conduits be located outside of the brace. To that end the central portion of the brace includes a pair of holes adjacent its top edge through which the connectors 146 and 148 extend so that the valves can be mounted thereon by the associated conduits. As mentioned above, the arrangement and location of the port (s) for the bladders of this invention as shown herein are exemplary of various types of arrangements which can be used in any of the braces/wraps/bladders of this invention. Thus, one or more ports can be placed at any desired location in the bladder.

In Fig. 8 there is shown a plan view of a bladder 400 suitable for use in a wrist brace (not shown). The wrist brace may be of any conventional construction, e. g., a fabric covered neoprene member similar to the braces 20 and 200, but shaped to accommodate the wrist. The bladder 400 is constructed similarly to the bladders 100 and 300, except for its overall peripheral shape, e. g., a rectangle with a bulbous projection from the center of one of its long sides, and the shape of its various seal lines and interposed chambers. In the interest of brevity the details of the shape of the seal lines and various chambers will not be discussed. Suffice it to state that the two sheets 102 and 104 of the bladder 400 are sealed together along a peripheral seal line 402 extending about the entire periphery of the bladder and along a pair of intersecting seal lines 404 and 406. The seal line 404 extends parallel to the longitudinal axis of the bladder, approximately centered between the top and bottom edges and its ends terminate spaced from the peripheral seal along the side edges of the bladder. The seal line 406 extends transversely to the seal line 404 approximately centered between the sides of the bladder. The ends of the seal line 406 are spaced from the peripheral seal along the top and bottom edges of the bladder. The ports for the connectors 146 and 148 in sheet 104 are bounded by respective arcuate seal lines 408 and 410.

The two sheets 102 and 104 of the bladder 400 are also fixedly secured to each other at the plural discrete contact points 140, e. g., small circular 0.125 inch (3.2 mm) diameter areas, spread throughout the bladder 400. The discrete contact points are located throughout virtually the entire area of the bladder and can be randomly spaced or equidistantly spaced from one another.

Alternatively, some of the discrete contact points may be spaced by the same distance from each other while others of the discrete contact points may be spaced by different distance (s) from each other.

In Fig. 9 there is shown a plan view of a bladder 500 suitable for use in an ankle brace (not shown). In fact, with slight modification the bladder can be suitable for use in an elbow brace. The ankle or elbow brace may be of any conventional construction, e. g., a fabric covered neoprene member similar to the braces 20 and 200, but shaped to accommodate the ankle or elbow (as the case may be). The bladder 500 is constructed similarly to the bladders 100,300 and 400 except for its overall peripheral shape and the shape of its various seal lines and chambers. Thus, in the interest of brevity the details of the shape of the various chambers, seal lines, etc. will not be discussed since they are readily discernable from Fig. 9. Suffice it to state that the two sheets 102 and 104 of the bladder 500 are sealed together along a peripheral seal line 502, and along plural seal lines 504 some of which intersect each other and some of which intersect the peripheral seal line 502. The ports for the bladder 500 bounded by respective arcuate seal lines 506 and 508. Respective connectors 146 and 148 are mounted in the ports, like described heretofore.

The two sheets 102 and 104 of the bladder 500 are also fixedly secured other at the plural discrete contact points 140, e. g., small circular 0.125 inch (3.2 mm) diameter areas, spread throughout the bladder 500. The discrete contact points are located throughout virtually the entire area of the bladder and can be randomly spaced or equidistantly spaced from one another. Alternatively, some of the discrete contact points may be spaced by the same distance from each other while others of the discrete contact points may be spaced by different distance (s) from each other.

As should be appreciated from the foregoing the bladders of the subject invention can be readily used with braces like those discussed above or with other patented or commercially available wrap-around or sleeve like braces.

The bladders can be releasably mounted by either VELCRO@ fastening systems or other releasably securable means, e. g., snaps, tapes, etc., or if desired can be fixedly secured within the brace or made integral therewith.

Moreover, the bladders may be inflated and sealed so that they are not deflatable, although the ability to deflate and then inflate the bladder would appear to offer various advantages, e. g., the ability to customize the amount of inflation, the ability to keep the brace at a desired temperature either intermittently or continuously, etc. However, if cost and simplicity of construction are of paramount concern and the ability to deflate the bladder is not of concern the bladder can be filled and sealed, thereby obviating the need for the angled connectors, conduits and valves. Such an arrangement can still be viable, particularly if the bladder is removable from the brace (although it needn't be removable).

Depending upon the portion of the anatomy the bladder is to contact it may include slits, like those described above, or not in the interest of good conformance.

It should be pointed out at this juncture that the bladders of this invention need not be used with elastic braces or sleeves like those described above.

Thus, the bladders of this invention can be used with other types of braces or any type of wrap, e. g., a strip or web of material that can be placed about an area of the body to cover it and apply pressure to it, a splinte wrap or brace, etc. Moreover, it should be appreciated that while the subject invention was described with reference to use on human beings, that usage is also exemplary.

Thus, the subject invention can be used on any living being.

Without further elaboration the foregoing will so fully illustrate my invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.