EP1845909A2

EP1845909A2 - Viscoelastic foam for orthopedic supports and method of using same

Info

Publication number: EP1845909A2
Application number: EP06734386A
Authority: EP
Inventors: Scott D. Mccormick; Edward L. Ii Weaver; Beth Gramza
Original assignee: Beiersdorf Inc
Current assignee: 3M Innovative Properties Co
Priority date: 2005-02-04
Filing date: 2006-02-02
Publication date: 2007-10-24
Also published as: WO2006084220A3; WO2006084220A2

Abstract

A wrist support (10) for supporting a wrist of a wearer is provided and includes a sheet of flexible material (12) having a distal edge (24) configured to extend at least partially around a hand of a wearer, a proximal edge (22) configured to extend at least partially around a forearm of a wearer, and a pair of opposing lateral edges (18, 20) configured to at least partially enclose the hand and forearm so that the sheet extends around the wrist of the wearer. The wrist support includes at least one lateral edge strap (14) attached to the sheet (12) and configured to extend over one of the lateral edges and attach to itself so as to secure the sheet.(12) about the wrist. The wrist support (10) further includes a viscoelastic pad located on an inner surface of the sheet.

Description

VISCOELASTIC FOAM FOR ORTHOPEDIC SUPPORTS AND METHOD OF USING SAME

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention is related to the field of orthopedic supports, and more particularly, to orthopedic supports having viscoelastic foam for increasing comfort and support for the wearer during use..

Description of Related Art

Different types of padding for orthopedic braces maybe used for increased comfort, protection, and/or fit. Types of padding that are typically used for orthopedic applications include, for example, rubber, air bladders, gel, polyurethane, and other foam materials.

Similarly, viscoelastic materials have been employed for energy absorption. Viscoelastic materials behave like a spring and dashpot in series such that the material exhibits both viscous and elastic properties, which facilitates increased protection and comfort under various loads. For instance, viscoelastic materials tend to exhibit an increase in viscosity with an increase in shear loading, which is useful for protection under high loading. This behavior has led to the incorporation of viscoelastic pads and inserts to provide shock and impact absorption, such as for protective helmets and the like. For example, U.S. Patent No. 5,599,290 to Hayes et al. ("the Hayes '290 patent") discloses a bone fracture prevention garment and method. The garment 2 includes a membrane enclosure 18 having a number of flexible and compliant envelopes 4 containing a shear-thickening 22 or dilatant material. The envelopes 4 are separated by bonds 5, and each envelope is filled with shear-thickening material to create a small amount of stretch within the membrane material. In one embodiment, the shear-thickening material 22 includes the suspension of relatively uniform-sized solid particles (e.g., untreated or modified starch granules, polyurethane, polystyrene, or polyvinylchloride) in a viscous fluid (e.g., water, silicon, or mineral oil). m another embodiment of the Hayes '290 patent, one or several layers of elastic or viscoelastic foam material (e.g., Ensolite®) may be used instead of the shear-thickening material. The viscoelastic and shear-thickening materials are arranged in the shape of a horseshoe, where the horseshoe is generally positioned on a wearer's hip to reduce the risk of bone fracture due to impact forces The Hayes '290 patent also discloses that the viscoelastic material may be used with a customizable protective device for protection from bone fractures, as well as shin guards.

The garment, shear-thickening material, and viscoelastic foam material provide increased protection from impact injuries. Despite these improvements, additional innovations in orthopedic supports to promote better comfort and support for the wearer are also desired.

It would therefore be advantageous to have an orthopedic support that provides increased comfort and support for the wearer. In addition, it would be advantageous to provide an orthopedic support that is easy to use. It would also be desirable to provide an orthopedic support that is capable of rehabilitating the supported area.

BRIEF SUMMARY OF THE INVENTION The present invention addresses the above needs and achieves other advantages by providing an orthopedic support for supporting a portion of a limb of the wearer. The orthopedic support generally includes a sheet of flexible material for conforming to a portion of the wearer's anatomy, as well as straps and associated fastening elements for securing the sheet of material on the wearer. The support includes a viscoelastic pad that may be positioned at various locations on the sheet of material to provide comfort and support and also rehabilitate the supported area. The viscoelastic pad is preferably a foam material exhibiting both viscous and elastic properties.

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AttyDkt. 104035/306807 In another embodiment, a wrist support is provided that includes a sheet of flexible material that overlies and supports a wrist of the wearer. The wrist support includes a pair of lateral edge straps and a longitudinal strap, with each strap having a fastening element thereon. Once positioned, the lateral edge straps and longitudinal strap may be tensioned, and the fastening elements attached to the sheet of material to securely position the wrist support on the wrist. The wrist support also includes a viscoelastic pad that applies pressure to a portion of the hand, wrist, and/or forearm when the orthopedic support is worn.

In various aspects of the wrist support, the sheet of flexible material has a distal edge configured to extend at least partially around a hand of a wearer, a proximal edge configured to extend at least partially around a forearm of a wearer, and a pair of opposing lateral edges configured to at least partially enclose the hand and forearm so that the sheet of material extends around the wrist of the wearer. The sheet of material may include a thumb opening to accommodate a thumb of a wearer that is defined in the distal edge and extends proximally within the sheet of material. Furthermore, the sheet of material may include panels of durable material attached to the sheet and positioned adjacent to a respective splint.

The wrist support includes a pair of lateral edge straps attached proximate to each of the distal and proximal edges on the sheet of material, where each lateral edge strap is configured to extend over one of the lateral edges and attach to itself so as to secure the sheet of material about the wrist. In particular, the wrist support preferably includes a pair of rings attached to the sheet of material, where each of the lateral edge straps extends through a respective opening in each of the rings. Each of the lateral edge straps extends through the opening and loops back and attaches to an outer surface of the lateral edge straps. Each lateral edge strap may include a slide guard that prevents the straps from sliding out of the opening in respective rings.

The wrist support also includes a longitudinal strap that is generally located midway between the proximal and distal edges and attached to the sheet of material. The longitudinal strap extends outwardly from an opposite lateral edge than that of the lateral edge straps and is configured to extend over one of the lateral edges and circumferentially about the sheet of material. The longitudinal

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AttyDkt. 104035/3068C7 strap is of a sufficient length to encircle the wearer's wrist and attach to itself so as to further secure the sheet of material about the wrist.

The wrist support also includes a longitudinal splint positioned within a pocket defined in the sheet of material. The longitudinal splint extends substantially between the proximal and distal edges and is configured to conform to a portion of the wearer's palm. In an additional aspect, the wrist support includes a pair of dorsal splints that extend substantially between the proximal and distal edges for providing additional support to the wearer's wrist.

The wrist support further includes a viscoelastic pad located on an inner surface of the sheet of material. The viscoelastic pad may be positioned adjacent to a portion of a longitudinal splint, such as a palmar splint, so that the viscoelastic pad is capable of applying pressure to a portion of the wearer's palm when the wrist support is worn by a wearer. Additionally, the viscoelastic pad is positioned adjacent to the thumb opening defined in the sheet of material and is configured in a trapezoidal configuration. The viscoelastic pad may be various materials, such as a polyurethane foam that may be secured to the sheet of material with an additional piece of sheet material.

In yet another embodiment of the present invention, a back support includes a lumbar support panel and a strapping system. The strapping system includes a pair of main straps and an outer strap that extend around the waist of a wearer to secure the lumbar support panel to the wearer's back. A plurality of viscoelastic pads are located at various positions on the lumbar support panel to provide increased comfort and support for the musculature of the wearer's back. In one variation of the back support, the main straps are attached at respective lateral edges of the lumbar support panel. Each of the main straps includes complementary fastening elements that facilitate the attachment of the main straps to one another. The outer strap extends along an outer surface of one of the main straps and provides for further adjustment of the lumbar support panel. As such, the outer support strap also includes a fastening element on a free end that attaches to a complementary fastening element on one of the outer straps.

The lumbar support panel of the back support includes a plurality of raised pads extending from a base surface and formed of a viscoelastic material. In one

AttyDkt. 1Q4035/306807 aspect, the lumbar support panel includes a plurality of medial and lateral pads. Each of the medial pads may be elliptical in configuration and generally spaced along a median axis of the lumbar support panel between the proximal and distal edges. Each of a pair of lateral pads is preferably positioned on either side of the medial pads and extends substantially between the proximal and distal edges of the lumbar support. Ih one example, each of the lateral pads includes a plurality of fingers that flare angularly from a base portion of the pads. Furthermore, each of the base portions of the lateral pads may be attached to a semi-rigid splint, while another pair of splints may be positioned longitudinally between the medial and lateral pads. The viscoelastic pads are typically a polyurethane foam that is secured to the lumbar support panel with, for instance, gluing.

In another embodiment, a knee support of the present invention includes a sheet of material including a plurality of straps for securing the sheet of material about a wearer's knee. The knee support includes an inflatable bladder, as well as viscoelastic pads that cooperate to provide support and comfort to the wearer's knee.

The sheet of material, according to one variation of the present invention, is generally rectangular and includes opposing lateral edges and opposing top and bottom edges. The sheet of material is configured to wrap about a wearer's knee between the thigh and calf, and may include a patellar opening for accommodating a wearer's patella.

The knee support includes a plurality of straps that are preferably formed integral to the sheet of material. Typically, a pair of straps extends from a first lateral edge and proximate to each of the top and bottom edges of the sheet of material, while a third strap extends from an opposite lateral edge approximately midway between the top and bottom edges. Each of the straps includes fastening elements on a free end that attaches to complementary fastening material on the sheet of material.

The knee support may include a plurality of flexible stays that are positioned between the sheet of material and stay covers. In one aspect, each of the stay covers includes fastening material that is complementary to the fastening elements on each of the straps. The stays are longitudinal and preferably extend on

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AttyDkt. 10403₅/306807 medial and lateral sides of the wearer's knee. Moreover, the stays may include a curvature that conforms to the natural curvature of the knee between the thigh and calf.

The knee brace may also include an inflatable bladder that is configured to substantially encircle the wearer's patella. The inflatable bladder includes a plurality of bladders interconnected with conduit that carries air supplied by a pump to each of the interconnected bladders. Thus, the pump is in fluid communication with the bladder to operably inflate the bladder to a desired pressure. In one variation;, the knee support includes a bladder cover that encloses the bladder and secures the bladder in a predetermined position. The knee support may also include an outer cover attached to the sheet of material that is located on an opposite side of the sheet as the bladder cover. The outer cover includes a slot for facilitating the insertion of the pump within a pocket defined between the outer cover and the sheet of material. The inflatable bladder also includes a release valve for selectively releasing pressure from the bladder.

Furthermore, the knee support includes a pair of viscoelastic pads that attach to an inner surface of the sheet of material and extend on medial and lateral sides of the knee. In one aspect, the pair of viscoelastic pads is positioned on an opposite surface of the sheet of material as the stays and substantially conforms to the configuration of the stays. Thus, each of the viscoelastic pads are positioned adjacent to respective stays and include a curvature similar to that of the stays. The viscoelastic pads are typically a polyurethane foam that is attached to the sheet of material with, for example, stitching.

Thus, the viscoelastic pads of the present invention are adaptable to various orthopedic supports for providing increased comfort and support for the wearer. As such, the viscoelastic pads are not only applicable to wrist, back, and knee supports, but any orthopedic support where increased comfort and support is desired. In addition, viscoelastic pads may be positioned adjacent to stiff joint support members, such as stays or splints that are incorporated into the orthopedic support, hi this regard, the viscoelastic pads provide a buffer material between the stays or splints and the wearer's skin that reduces the possibility of irritation or discomfort during use of the orthopedic support. As described above, each of the

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AttyDkt. 104035/306807 wrist, back, and knee supports may provide one or more viscoelastic pads that is positioned adjacent to at least a portion of one or more splints or stays.

Moreover, the viscoelastic pad is advantageously capable of being positioned at various locations on an orthopedic support for applying pressure to a portion of the wearer's anatomy but also allowing for motion. Thus, the viscoelastic pads deform and recover in a manner that more closely duplicates the movement of the joint being supported, resulting in a massaging and rehabilitative effect. Therefore, as a result of the placement, configuration, and material properties of the viscoelastic pads, the pads provide advantages in addition to impact protection.

The present invention has many advantages. As discussed previously, viscoelastic pads could be positioned adjacent to flexible stays such that the orthopedic support provides support without sacrificing comfort. The viscoelastic pads may be positioned at various locations on orthopedic supports for any desired amount of support. In addition, the positioning of the viscoelastic pads is capable of increasing the rehabilitative effects of the various supports, such as by protecting or massaging an injured area. Furthermore, the viscoelastic pad is adaptable for various orthopedic supports, such as a wrist, back, or knee support. A wrist support includes a palmar pad of viscoelastic material that is capable of providing pressure to a wearer's palm to provide increased comfort and support. In particular, the palmar pad is positioned adjacent to a palmar splint in the region of the wearer's palm. With respect to a back support, medial and lateral pads of viscoelastic material could be incorporated into a lumbar support panel to provide support for the musculature of the wearer's back. Moreover, viscoelastic pads could be incorporated into a knee support and positioned on the medial and lateral sides of the knee and adjacent to flexible stays.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

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AttyDlct. 104035/3068Q7 FIG. 1 is a perspective view of a wrist support assembled on a left hand, according to one embodiment of the present invention;

FIG. 2 is another perspective view of the wrist support shown in FIG. 1; FIG. 3 is a plan view of an outer surface of the wrist support shown in FIG. 1;

FIG. 4 is a plan view of an inner surface of the wrist support shown in FIG.

1;

FIG. 5 is an enlarged view of a viscoelastic pad located on the inner surface of the wrist support shown in FIG. 1; FIG. 6 is a perspective view depicted from a distal edge of the wrist support shown in FIG. 1;

FIG. 7 is a plan view of an inner surface of a back support, according to another embodiment of the present invention;

FIG. 8 is a plan view of an outer surface of the back support shown in FIG. 7;

FIG. 9 is an enlarged view of medial and lateral pads located on the inner surface of the back support shown in FIG. 7;

FIG. 10 is a perspective view of the medial and lateral pads depicted from a bottom edge of the back support shown in FIG. 7; FIG. 11 is a cross sectional view of the lumbar support panel of the back support shown in FIG. 7;

FIG. 12 is a perspective view of the back support shown in FIG. 7 worn by a user;

FIG. 13 is a plan view of an inner surface of a knee support, according to an additional embodiment of the present invention;

FIG. 14 is an enlarged view of an outer surface of the knee support shown in FIG. 13; and

FIG. 15 is a perspective view of the knee support shown in FIG. 13 worn by a user.

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AttyDkt. 1^Q4035/306807 DETAILED DESCRIPTION OF THE INVENTION The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

Generally, the present invention provides an orthopedic support that includes a sheet of flexible material for wrapping about and conforming to a portion of a wearer's anatomy. One or more straps having a fastening element thereon is configured for securing the sheet of material about the wearer's anatomy. In addition, the orthopedic support includes a viscoelastic pad, such as a viscoelastic foam, that may be positioned at various locations on the sheet of material. The viscoleastic material provides both viscous and elastic properties that provide the wearer with increased comfort and rehabilitative effects in the area proximate to the viscoelastic pad. The viscoelastic pad is adaptable for use with various orthopedic supports. Thus, the orthopedic support could be worn on a limb or portions of a limb of a wearer, such as, for example, on a wrist, knee, back, arm, forearm, leg, or thigh. Embodiments of the present invention directed to a wrist support 10, back support 100, and knee support 200 will be discussed in further detail below.

A wrist support 10 according to one embodiment of the present invention is illustrated in Figures 1-6 and includes a sheet of material 12 for extending around and supporting a wrist of a wearer, a pair of lateral edge straps 14 for securing the sheet of material about the wrist and a longitudinal strap 16 to further secure the wrist support, as is shown, for example, in Figures 1 and 2. The wrist support 10 shown in Figures 1-6 is preferably worn on a left hand of the wearer, although the wrist support may be configured for right hand use in additional embodiments. In one embodiment of the present invention, the sheet of material 12 has lateral edges 18, 20, proximal edge 22, and distal edge 24, as is shown in Figure 3. The lateral edges 18, 20 are spaced from each other across the body of the sheet of material 12. Each of the lateral edges 18, 20 includes a slight curvature that

-9- AttyDktl04035/306807 extends inwardly in the sheet of material 12. In addition to the curvature, each of the lateral edges 18, 20 tapers slightly from the proximal edge 22 to the distal edge 24.

The proximal edge 22, so defined due to its more proximal anatomical position on the wrist when worn, is generally linear. The distal edge 24 (again defined by its relative anatomical position when worn) is slightly shorter in length than the proximal edge 22 and includes a thumb opening 26. In particular, the thumb opening 26 is defined by an opening in the distal edge 24 that extends proximally within the sheet of material 12 and is capable of accommodating the thumb of the wearer. Generally, the thumb opening 26 is configured to expose the thumb such that the opening aligns with the base of the thumb and proximate to the wearer's wrist (See Figure 2). On each side of the thumb opening 26, each portion of the distal edge 24 extending from respective lateral edges 18, 20 curves slightly upwards to the thumb opening. In addition, the thumb opening 26 could be located at various positions along the distal edge 22 to correspond to different anatomical thumb placements. In still other embodiments of the present invention, the thumb opening 26 could be defined as a hole or various shaped openings, such as an elliptical opening, within the sheet of material 12 between the lateral edges 18, 20 and distal 22 and proximal 24 edges. In one embodiment, the thumb opening 26 is approximately 1 inch in width and 3 to 3-54 inches in length.

Moreover, the wrist support 10 may include a thumb strap 27 that extends across the thumb opening 26. The thumb strap 27 is typically stitched to opposing sides of the thumb opening 26 so that the strap extends between the wearer's thumb and index finger during use. However, it is understood that the thumb strap 27 could include a fastener such that the thumb strap may attach to fastening material on the sheet of material 12 or the strap and be adjustable. The thumb strap 27 is typically a soft, skin friendly material and may be stretchable to accommodate various hand sizes.

It should be noted that the sheet of flexible material 12 could include any number or combination of elastic or inelastic materials, as long as it is capable of conforming to, and providing support for, the wrist of the wearer. Although the illustrated embodiment shows the sheet of material 12 as having proximal 22,

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AttyDkt. 104035/3C6807 distal 24, and lateral edges 18, 20 in a generally rectangular shape, the sheet of material of the present invention should not be considered limited to any particular number of edges with any particular shape. For example, the sheet 12 of flexible material could have a circular shape wherein the edges 18, 20, 22 and 24 are arc portions of an outer circular edge and are still capable of extending at least partially around the hand, wrist, and forearm of a wearer and supporting the wrist of the wearer. Moreover, it is understood that the sheet of material 12 could be arranged as a continuous sleeve of material, either by attaching the lateral edges 18, 20 together or integrally forming the sheet as a sleeve. Furthermore, the sheet of material 12 may be various sizes and thicknesses in additional embodiments of the present invention to accommodate wearers of different sizes and proportions.

When the wrist support 10 is applied to a wearer's wrist, the distal edge 24 aligns with the wearer's hand below the fingers, the proximal edge 22 aligns with the wearer's forearm, and the opposing lateral edges 18, 20 wrap about the hand and forearm of the wearer to encircle the wrist of the wearer, as illustrated in Figures 1 and 2. Wrapping the lateral edges 18, 20 generally adjacent to one another, therefore, results in a generally cylindrical tube which extends over the hand, wrist, and forearm of the wearer.

In another aspect, the sheet of material 12 may include multiple panels or portions. For instance, in the illustrated embodiment the sheet of material 12 includes a laminate material having a fabric moisture wicking layer adjacent to the skin and bonded to a mesh layer. As depicted in Figures 2 and 3, the mesh material of the sheet of material 12 may have a plurality of ventilation holes 28 defined therein. The ventilation holes 28 are defined in a portion of the outer surface of the sheet of,material 12 to promote breathability of the wrist support 10. Moreover, the outer surface of the sheet of material 12 typically includes non- stretchable and durable material portions 32, 34, 36 that enclose a palmar splint and a pair of dorsal splints on the sheet of material, respectfully, as will be explained in further detail below. The durable material portions 32, 34, 36 may be any suitable material that is capable of enclosing the splints and attaching to the sheet of material 12, such as vinyl, leather, or any suitable woven or non- woven material.

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AttyDkt. 104035/306807 As another option, the sheet of material 12 may include a pocket 38 for accommodating an elongated palmar splint (not shown), where the pocket is defined between the durable material portion 32 and the outer surface of the sheet of material 12. The pocket 38 is preferably located on the outer surface of the sheet of material 12 and is positioned generally along a medial portion of the sheet of material and adjacent to the thumb opening 26. Preferably, the pocket 38 is sufficiently long in the proximal-distal direction to extend substantially from the proximal edge 22 to the distal edge 24 of the sheet of flexible material 12. This allows the pocket 38 to accommodate a relatively long palmar splint. It should be noted that although the illustrated embodiment is shown as having a pocket 38 and palmar splint, the pocket and splint may not even be necessary for wrist brace embodiments where lesser amounts of immobilization are preferred (e.g., for chronic injuries).

Preferably, an opening 40 is defined in the material of the pocket 38 so as to allow insertion, removal, and reversal of the orientation of the elongated palmar splint. For instance, in the illustrated embodiment the opening 40 is defined in the pocket 38 adjacent the proximal edge 22, as shown in Figure 3. Of course the opening 40 could be defined elsewhere in the pocket 38, but its position in the illustrated embodiment facilitates easy insertion of one end of the elongated splint. The opening 40 could also be defined adjacent the distal edge 24 and still advantageously allow similar end-wise insertion of the palmar splint.

The palmar splint for insertion into the pocket 38 could be any suitable elongated shape of a rectangular sheet of rigid material (e.g., aluminum) using a stamping process. For example, the palmar splint may be of the form disclosed by U.S. Design Patent No. D499,184, assigned to the present assignee and incorporated herein by reference. Thus, the splint could include a generally longitudinal and planar portion, as well as crown and arc portions at a distal end of the splint. When the palmar splint is positioned within the pocket 38 the crown and arc portions align with the wearer's palm and wrist, respectively, to maintain the wearer's hand in extension relative to the wrist. The planar portion extends along the wearer's forearm. Such a position is typically considered anatomically neutral so as to reduce strain on the wrist. It should be noted that if employed, the

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AttyDkt. 10403S/3Q6807 palmar splint could have any number of shapes, sizes and materials (steel, wood, plastic, etc.) so as to accommodate different wrist sizes, as well as to adjust the desired amount of immobilization. For instance, the palmar splint could be planar along its length, as opposed to the shaped splint described above. Similarly, the wrist support 10 includes dorsal splints (not shown) that are enclosed between the durable material portions 34, 36 and the outer surface of the sheet of material 12. The dorsal splints are elongated and extend generally between the proximal 22 and distal 24 edges. In addition, the dorsal splints are preferably rigid to provide dorsal support for the wearer when the wrist support 10 is worn. Although the wrist support 10 of the present invention depicts dorsal splints and durable material portions 34, 36, it is understood that the dorsal splints are optional, as there may be instances where lesser amounts of immobilization are desired.

The lateral edge straps 16 are spaced apart from each other and extend from the lateral edge 20 of the embodiment illustrated in Figures 3-4. In particular, a first lateral edge strap 16 extends proximate to the proximal edge 22, while a second lateral edge strap is defined proximate to the distal edge 24. Each of the lateral edge straps 16 are attached along an edge of the pocket 38. Thus, at least a portion of each of the lateral edge straps 16 extends underneath the durable material portion 32 that defines the pocket 38. In this regard, when the durable material portion 32 is attached to the sheet of material to form the pocket 38, the ends of the lateral edge straps 16 are also attached and secured to the sheet. Similarly, portions of the lateral edge straps 16 are also attached at locations on the durable material portion 36 on either side of a dorsal splint when the durable material portion is attached to the outer surface of the sheet of material 12. In one embodiment, the lateral edge strap 16 proximate to the distal edge 24 is approximately 8-10 inches in length, while the other lateral edge strap is approximately 6-8 inches in length. The width of the lateral edge straps 16 is approximately Vz to 1-¹A inches. Figures 2 and 4 demonstrate that the lateral edge strap 16 defined along the proximal edge 22 is slightly longer than the lateral edge strap defined along the distal edge 24. Having a slightly longer lateral edge strap 16 accommodates the

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AttyDkt. 104035/306807 larger circumference of the forearm, while the shorter lateral edge strap accommodates the circumference of the hand. In one embodiment of the present invention, the longer lateral edge strap 16 extends outwardly about 1-3 inches further than the shorter lateral edge strap. Although the aspects of the lateral edge straps 16 discussed above are preferred, these preferred aspects are not necessarily meant to be limiting, as there may be various modifications of the invention that are within the purview of the present invention. Thus, it is understood that any number of sizes and configurations of the lateral edge straps 16 may be employed and still be within the scope of the present invention, hi addition, although a pair of lateral edge straps 16 is illustrated, there maybe any number of lateral edge straps 16 (e.g., 1, 3, 4, etc.) in additional embodiments of the present invention. Thus, the wrist support 10 of the present invention could have one or more lateral edge straps 16 depending upon the desired fit and security of the sheet of material 12 around the wrist of the wearer. In addition, the lateral edge straps 16 may be attached at various locations on the sheet of material 12 or along the lateral edge 20. Furthermore, although the lateral edge straps 16 are depicted as having different lengths, the lateral edge straps may be the same length.

The lateral edge straps 16 support fastening elements 42 and each include a base end attached to the sheet of material 12, as shown in Figures 3 and 4, and a free end extending outwardly from the lateral edge 20. Preferably, the base end of each of the lateral edge straps 16 is stitched to the sheet of material 12, although each lateral edge strap may be attached adjacent to the pocket 38 and durable material portion 36 of the sheet, as described above, or to the sheet of material using radio frequency (TRF) welding, adhesive, or similar techniques, that provide a robust connection for repeated attachment, removal and reattachment of the fastening elements 42 supported by their free ends.

Preferably the lateral edge straps 16 are constructed of a flexible and non- stretchable material allowing them to conform to the shape of the wearer's hand, wrist, and forearm. However, the lateral edge straps 16 may also be constructed of stretchable materials, hi addition, the lateral edge straps 16 preferably have a

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AttyDkt. 104Q3₅/306807 width, height, or other combination of dimensions, that provide a surface area sufficiently large enough to accommodate the fastening elements 42.

An outer surface of the lateral edge straps 16 is a fastening material having fastening elements that are complementary to the fastening elements 42 supported by the lateral edge straps. Preferably, the fastening elements 42 of the lateral edge straps 14, as well as the fastening material on the outer surface of the lateral edge straps, are constructed of a complementary hook and loop material such as VELCRO®. However, the term "fastening element," as used herein, denotes any type of chemical, mechanical or other fastener that allows connection of two separate components, such as snaps, hook and loop connectors, adhesives, snaps, buckles, etc. Notably, the fastening elements 42 (hooks) of the lateral edge straps 16 and the fastening elements (loops) of the outer surface of the lateral edge straps mate to, and attach with, one another when brought into contact. These fastening elements, therefore, are referred to herein as being complementary. In one optional aspect of the present invention, a pair of rings 44 is attached to the sheet of material 12, where the rings extend proximate to each of the proximal 22 and distal 24 edges. Each of the rings 44 include a strap 46 that is attached along an edge of the durable material portion 34. Thus, at least a portion of each of the straps 46 extends proximate to, and preferably partially underneath, the durable material portion 34 that encloses a dorsal splint. In this regard, when the durable material portion 34 is attached to the sheet of material 12 to enclose the dorsal splint, the ends of the straps 46 are also attached and secured to the sheet. Each of the rings 44 includes a ring opening 48, where each of the lateral edge straps 16 may extend through a respective opening. Thus, each of the fastening elements 42 attached to respective lateral edge straps 16 may extend through the ring opening 48 and loop back and attach to the outer surface of the lateral edge straps, such as shown in Figure 1.

Optionally, to prevent the fastening elements 42 attached to respective lateral edge straps 16 from sliding out of the ring opening 48, each of the lateral edge straps includes a slide guard 50. As shown in Figures 3 and 6, the slide guards 50 are typically formed by looping over an end of the fastening element 42 and attaching the loop to the tree end of the lateral edge straps 16. Thus, when the

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AttyDkt. 10403₅/306807 wrist support 10 is positioned on the wearer's hand, wrist, and forearm, the wearer may manipulate the wrist support without having to first insert the fastening elements 42 through respective ring openings 48. The wearer could slide the wrist support 10 on with the lateral edge straps 16 already positioned within the rings 44. Thus, when the wrist support 10 is in a desired position, the lateral edge straps 16 may simply be tensioned or readjusted to secure the wrist support. In addition, the lateral edge straps 16 may be adjusted or the wrist support 10 repositioned on the wearer's hand, wrist, and forearm without risking the inconvenience of the lateral edge straps sliding out of the rings 44 and having to reinsert the straps within the rings. This provides the user with a user-friendly wrist support 10 that is easily positioned and adjusted.

The wrist support 10 also includes a longitudinal strap 14 that is attached adjacent to the pocket 38. As described above, the base of the longitudinal strap 14 would preferably be attached to the sheet of material 12 when attaching the durable material portion 32 to the sheet of material. The longitudinal strap 14 is sufficiently long to completely encircle the wearer's wrist. For instance, as shown in Figure 1, the longitudinal strap 14 wraps circumferentially about the wearer's ^"wrist and attaches to itself. In one embodiment, the longitudinal strap 14 is approximately 2 inches in width and 10 inches in length. Although the aspects of the longitudinal strap 14 discussed above are preferred, these preferred aspects are not necessarily meant to be limiting, as there may be various modifications of the invention that are within the purview of the present invention. Thus, it is understood that any number of sizes and configurations of the longitudinal strap 14 may be employed and still be within the scope of the present invention. In addition, although a single longitudinal strap 14 is illustrated, there may be any number of longitudinal straps 14 in additional embodiments of the present invention. Thus, the wrist support 10 of the present invention could have one or more longitudinal straps 14 depending upon the desired fit and security of the sheet of material 12 around the wrist of the wearer. In addition, the longitudinal strap 14 may be attached at various locations on the sheet of material 12.

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AttyDkt. 104Q35/30₆807 Similar to the lateral edge straps 16, the longitudinal strap 14 supports a fastening element 42 and includes a base end attached to the sheet of material 12, as shown in Figures 3 and 4, and a free end extending outwardly over the lateral edge 18. Preferably, the base end of the longitudinal strap 14 is stitched to the sheet of material 12, although the longitudinal strap may be attached adjacent to the pocket 38 of the sheet, or to various other positions on the sheet of material using RF welding, adhesive, or similar techniques, that provide a robust connection for repeated attachment, removal and reattachment of the fastening elements 42 supported by their free ends. The longitudinal strap 14 is preferably constructed of a flexible and stretchable material allowing it to conform to the shape of the wearer's hand, wrist, and forearm. However, the longitudinal strap 14 may also be constructed of non- stretchable materials. In addition, the longitudinal strap 14 preferably has a width, height, or other combination of dimensions, that provide a surface area sufficiently large enough to accommodate the fastening elements 42.

An outer surface of the longitudinal strap 14 is a fastening material having fastening elements that are complementary to the fastening element 42 supported by the longitudinal strap. Preferably, the fastening element 42 of the longitudinal strap 14, as well as the fastening material on the outer surface of the longitudinal strap, are constructed of a complementary hook and loop material, as described above.

Positioned on the interior surface of the sheet of material 12 and adjacent to the thumb opening 26 is a palmar pad 52. As shown in Figure 5, the palmar pad 52 preferably extends from the distal edge 24 substantially along the length an edge of the thumb opening 26. Figure 6 demonstrates that the palmar pad 52 includes a height extending upwardly away from the base of the sheet of material 12. The palmar pad 52 is generally trapezoidal in shape, with a longer side of the trapezoid adjacent to the thumb opening 26. When the wrist brace 10 is worn, the palmar pad 52 is positioned within the palm of the wearer's hand, thus providing additional support and cushioning in the palmar region. The palmar pad 52 is typically positioned proximate to a portion of a palmar splint. For example, where the palmar splint includes a crown and arc portions as described above, the palmar

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AttyDkt 104Q35/306807 pad 52 is preferably positioned adjacent to the crown and arc portions at a distal end of the of the palmar splint. In one embodiment, the palmar pad 52 is approximately ³Λ of an inch in width, 3 inches in length along one side, 2 inches in length along the opposite side, and ¹A of an inch in height. The palmar pad 52 is a viscoelastic foam material such that the palmar pad

52 exhibits both viscous and elastic properties. For example, the viscoelastic foam could be a polyurethane foam such as Visco-cel™ (Rubberlite Inc., Huntington, WV). The palmar pad 52 is preferably enclosed within a pocket formed by an additional sheet of material stitched to the sheet of material 12, distal edge 24, and thumb opening 26. Although a palmar pad 52 of viscoelastic material is preferred, it is understood that various materials could be used for the pad, such as foams (e.g., polyurethane, polyvinyl chloride), gels, air bladders, or any other suitable cushioning or padding material.

As depicted in Figures 3 and 4, the length of the palmar pad 52 is generally the length of one edge of the thumb opening 26, although the pad could be various sizes and configurations in additional embodiments of the present invention. For example, the palmar pad 52 could extend the entire distance between the proximal 22 and distal 24 edges and could be various sizes and configurations. Thus, the palmar pad 52 could extend substantially along, and adjacent to, the palmar splint. In addition, a viscoelastic pad could be employed at other locations on the sheet of material 12, such as circumferentially about the wearer's wrist, along the entire palm of the wearer's hand, or along a dorsal portion of the wearer's hand and adjacent to the dorsal splints. Moreover, although only one pad 32 is shown in Figures 4, 5, and 6, there may be any number of pads attached to the inner surface of the sheet of material 12. The pad 52 could be positioned in various orientations to apply pressure to any desired location on the wearer's hand, wrist, and forearm during use of the wrist support 10. Thus, the palmar pad 52 is capable of spreading pressure away from high pressure areas, such as areas adjacent to the palmar splint. During use, the wrist support 10 is manipulated from an open position, such as is shown in Figure 3, to being secured on the hand, wrist, and forearm of a wearer as shown in Figures 1 and 2. Generally, the wearer wraps the sheet of material 12 such that the proximal edge 22 is positioned on the forearm, and the

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AttyDkt. 104035/306807 distal edge 24 is positioned above the wrist and on the hand. The palmar splint is positioned within the pocket 38 and along the palm, wrist, and forearm of the wearer. The lateral edges 18, 20 are wrapped about the wearer's hand, wrist, and forearm until the lateral edges are positioned substantially adjacent to one another. As shown in Figure 1, the lateral edges 18, 20 are generally positioned along the dorsal portion of the wearer's hand, wrist, and forearm. The lateral edge straps 16 are then tensioned, and the fastening elements 42 of the lateral edge straps are brought into contact with the complementary fastening material on the outer surface of the lateral edge straps. Once the lateral edge straps 16 are properly secured on the wearer's hand and forearm, the longitudinal strap 14 is tensioned and wrapped circumferentially about the wearer's wrist. The fastening element 42 of the longitudinal strap 14 is then brought into contact with the complementary fastening material on the outer surface of the longitudinal strap to secure the wrist support to the wearer's wrist. Furthermore, any one of the lateral edge straps 16 or longitudinal strap 14 could be adjusted for varying the amount of support of the wrist support 10.

A back support of another embodiment of the present invention is shown in Figures 7-12. Generally, the back support 100 includes a lumbar support panel 102 supported by a strapping system that includes a pair of main straps 104 and an outer strap 106, as shown in Figures 7 and 8. The straps 104, 106 extend around the waist of a wearer and support the lumbar support panel 102 at a position over the lower lumbar area of the wearer, as shown in Figure 12.

The main straps 104 each have a fixed end 108 and a free end 110, as shown in Figure 7. The fixed end 108 of each of the main straps 104 is attached to one of a pair of respective lateral edges 112 of the lumbar support panel 102. Each of the main straps 104 extend outwardly from the lumbar support panel 102. In particular, each of the main straps 104 attaches at a fixed end 108 to a respective lateral edge 112, extends outwardly to a free end 110, is folded over upon itself, and attaches at a second end to the same respective lateral edge. As shown in Figure 7, when folded upon itself, each of the main straps 104 defines an angular portion that extends upwardly from the free ends 110 to the lumbar support panel 102. A free end 110 of one of the main straps 104 includes a hook material patch

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AttyDkt. 104035/3^Q68Q7 113 on an inner surface of the main straps. Figure 8 illustrates that an outer surface of the other main strap 104 includes a loop material patch 115. Each of the hook 113 and loop 115 material patches is shown as being rectangular, but could include any suitable shape capable of attaching to a complementary fastening material. The outer strap 106 also has a fixed end 114 and a free end 116, as shown in Figure 8. The outer strap 106 attaches at the fixed end 114 to a lateral edge 112 of the lumbar support panel 102 and extend outwards therefrom over an outside surface of one of the inner straps 104. The free end 116 of the outer strap 106 includes a fastening element 118. The fastening element 118 is illustrated as having a rectangular shape, but may have a range of other geometric shapes, such as a trapezoid. The outer strap 106 extending outwards, and generally perpendicular to, the lumbar support panel 102. Furthermore, the outer strap 106 is approximately the same length as one of the main straps 104.

Each of the main straps 104 and outer strap 106 includes elastic material that is preferably stretchable in at least one direction. For example, the straps 104, 106 could be a monofilament material including a combination of nylon and elastic materials. For example, each of the straps 104, 106 may be stretched to vary the length and tension when securing the back support 100 on the wearer. It is understood that various materials could be employed with the present invention, including non-stretchable materials, and materials stretchable in more than one direction.

It should be noted that although the strapping system of the illustrated embodiment, including the main straps 104 and outer strap 106, is preferred, the strapping system may include more, or fewer straps, such as a single strap that completely encircles the wearer's waist. The design of the strapping system depends upon factors such as the desired amount of pressure exerted on the back, the need for adjusting the pressure and the desired wearing position. For instance, the strapping may be thinner to be worn under clothes for sports activities, or may be thicker for firmer support outside the clothing for use as a lifting belt. In addition, the materials used in the construction of the strapping system may also be varied to achieve the same objective of positioning and tensioning the lumbar support panel 102 at the lumbar region of the wearer's back.

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AttyDkt. 104035/306807 Moreover, the size and configuration of each of the main straps 104 and outer strap 106 may be employed and still be within the scope of the present invention. For instance, although the straps 104, 106 are shown as being generally elongate and rectangular in shape, the straps could be trapezoidal or any other shape suitable for extending about the wearer's back and securing the lumbar support panel 102 thereto. Furthermore, each of the straps 104, 106 are typically attached at respective fixed ends 108, 114 with stitching, although any fastening technique suitable to attach the straps to the lumbar support panel 102 may be utilized, such as RF welding. Similarly, the hook material patch 113, the loop material patch 115, and fastening element 118 should not be limited to hook and loop fasteners, as various fastening elements could be employed to secure the back support 100 on the wearer, such as snaps, buckles, and the like. An example of an alternative strapping system, according to another embodiment of the present invention, is disclosed in U.S. Patent Application Publication 20040077981, "Back Support Panel with Convex Surfaces for Muscle Support," assigned to the present assignee and incorporated herein by reference.

The lumbar support panel 102 includes a generally straight bottom edge 120 and a pair of lateral edges 112. Opposite the bottom edge 120, which extends between bottom ends of the lateral edges 112, is a top edge 122, which extends between the top ends of the lateral edges. The lateral edges 112 of the support panel 102 are angled inwards as they extend upwards, slightly converging at their tops. Similarly, the top edge 122 includes a pair of curved edges that each extend from the top ends of the lateral edges 112 to a plateau. In one embodiment, the curved edges of the top edge 122 extend at approximately 45 degrees from the lateral edges 112 to the plateau. Together, the top 122, lateral 112, and bottom 120 edges form an outer peripheral edge of the lumbar support panel 102. Generally, the curvature of the lumbar support panel 102 along the bottom edge 120 and portions of lateral edges 112 help to prevent the corners of the lumbar support panel from irritating the wearer during use. hi addition, the curved edges of the top edge 122 form a plateau that focuses on the muscle groups of the wearer for increased comfort and support during use.

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AttyDkt. 104035/306807 The lumbar support panel 102 is preferably constructed of a relatively soft conforming material or materials that are breathable and generally "skin friendly," such as by having moisture wicking properties and smooth, soft and non-abrasive surfaces. Typically, these materials will include one or more of cotton, polyester, or nylon. Preferably, the skin-adjacent surface of the lumbar support panel 102 is covered with a 100% textured polyester. The lumbar support panel 102 also preferably includes one or more layers of foam laminated between the outer and inner surfaces of the lumbar support panel. For example, the lumbar support panel 102 could include a laminate of fabric, polyurethane foam, and cellulose board that is positioned within a sealed cavity or injection molded within the cavity. In addition, the skin-adjacent surface of the lumbar support panel 102 could be attached with various techniques, and could be secured about the perimeter of each of the medial 128 and lateral 130 pads (discussed below). For example, the skin- adjacent surface could be RF welded about the perimeter of the lumbar support panel 102 and pads 128, 130.

Figures 9 and 10 illustrate the lumbar support panel 102, which includes a base surface 124 and several raised pads extending from the base surface. As shown in Figure 10, the pads protrude outwardly from the base surface 124. More specifically, the lumbar support panel 102 includes four medial pads 128 spaced apart, and arranged generally along a median axis, between the bottom 120 and top 122 edges. Each of the medial pads 128 are generally oval in shape, with a smaller oval medial pad positioned adjacent to the bottom edge 120, and two slightly larger oval pads positioned distally of the first medial pad. The fourth medial pad is positioned adjacent to the top edge 122 and is generally oval in shape. The fourth medial pad includes a longitudinal axis that extends generally between the lateral edges 112 and perpendicular to the longitudinal axis of the remaining three medial pads. In one embodiment, the medial pad closest to the bottom edge 120 includes dimensions of about 1-1/4 to 1-3/4 inches in length and 54 to 1 inch in width. The next largest medial pad is approximately 1-3/4 to 2-1/4 inches in length and % to 1- 1/4 inches in width, while the largest medial pad is about 2 to 2-1/2 inches in length and 1 to 1-1/2 inches in width. The medial pad proximate to the top edge

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AttyDkt. 104Q35/306807 122 is about % to 1-1/4 inches in length and 1 to 1-1/2 inches in width. Each of the medial pads 128 is approximately ¹A inch in thickness.

In addition, the lumbar support panel 102 includes a pair of lateral pads 130 positioned on opposite sides of the medial pads 128 and proximate to the lateral edges 112. Each of the lateral pads 130 include three fingers 132 that flare outwardly and at an angle (e.g., 45 degrees) from a base portion 134. In addition, the fingers 132 of each lateral pad 130 extend towards respective lateral edges 112, with the finger proximate to the bottom edge 120 being the longest of the three fingers. The base portion 134 of the lateral pads 130 extends generally along a longitudinal axis extending between the bottom 120 and top 122 edges. In one embodiment, the base portion 134 is approximately 5 inches in length, while each of the fingers 132 could extend about 1 to 2 inches in length from the base portion and at about a 45 degree angle from the base portion. The medial 128 and lateral 130 pads are arranged on the lumbar support panel 102 to reduce high pressure points and spread pressure away from the wearer's spine. In addition, the fingers 132 of each of the lateral pads 130 act to pull upwards and resist downward force during use to increase support.

Each of the raised pads is a viscoelastic foam, such as that described above with respect to the wrist support 10. As such, the medial 128 and lateral 130 pads exhibit slow recovery properties that provide added comfort and support when the back support 100 is worn by a wearer. As also mentioned previously, the viscoelastic material may be any suitable viscoelastic material, but is preferably a polyurethane foam. Furthermore, although medial 128 and lateral 130 pads of viscoelastic material are preferred, it is understood that various materials could be used for the pad, such as foams, gels, air bladders, or any other suitable cushioning or padding material.

Figure 11 illustrates that the lumbar support panel 102 includes portions of one or more layers of a laminate material that is cut away from the base surface 124 and that substantially corresponds to the configuration of each of the medial 128 and lateral 130 pads. Thus, the medial 128 and lateral 130 pads are easily located for attaching the pads to the lumbar support panel 102 within the openings,

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AttyDkt. 1Q4035/306807 although the pads could be placed directly on an outer surface of the base surface 124 if desired.

As shown in Figure 11, the lumbar support panel 102 includes a plurality of semi-rigid splints arranged on the base portion 134. Each of the lateral pads 130 are preferably mounted to a semi-rigid splint 126 substantially along the length of the base portion 134. The base portions 134 could be adhered or secured with any suitable fastening technique to respective splints 126. Moreover, semi-rigid lumbar splints 136 are preferably included to increase the stability of the lumbar support panel 102. Each of a pair of the lumbar splints 136 is positioned within the lumbar support panel 102 and between the medial 128 and lateral 130 pads. Each of the lumbar splints 136 preferably extends substantially between the bottom 120 and top 122 edges. The splints are typically a semi-rigid polymeric material, although any suitable semi-rigid or rigid material could be utilized, such as metal. The splints are approximately % to 54 in width, although various sizes of splints may be employed in additional embodiments of the present invention. Due to the nature of the viscoelastic foam of the medial 128 and lateral 130 pads, the splints 126, 136 provide additional stiffness in the areas proximate to the pads and to the overall stiffness of the lumbar support panel 102.

Although each of the features described above with respect to the lumbar support panel 102 are preferred, the lumbar support panel 102 may include various sizes and configurations in alternative embodiments of the present invention. For instance, each of the medial 128 and lateral 130 pads may be any size and configuration and located at various positions on the lumbar support panel 102. Thus, portions of the base surface 124 may include viscoelastic pads, or the entire surface of the lumbar support panel could be padding. Furthermore, the splints 126, 136 described above, although preferred, are optional as ranges of support may be desired for various back supports 100. Thus, there could be no splints or several splints employed in additional embodiments.

During use, the wearer grips the main straps 104 of the back brace 100 and encircles his (or her) waist. The free ends 110 of the main straps are brought forward, over the wearer's hips and are secured together by attaching the hook material panel 113 on the inner surface of one of the free ends to the loop material

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AttyDkt. 104Q35/306807 patch 115 on the outer surface of the other one of the free ends. While encircling the waist, or after attachment of the free ends 110 of the main straps 104, the wearer positions the lumbar support panel 102 in a position such as that shown in Figure 12. The lumbar support panel 102 is positioned over the lower back region so that the medial pads 128 are positioned along the axis of the wearer's spine, and the lumbar pads 130 are positioned on opposite sides of the wearer's spine.

Tension is applied to the straps during overlapping attachment of the main straps 104, and additional tension is adjusted or supplied by adjustment of the outer strap 106. In particular, the fastening element 118 of the outer strap 106 is removed from the loop material patch 115 of the outer surface of the free end 110 of the main strap 104 and further stretched and reattached. Application and adjustment of the tension using the strapping system controls the amount of pressure applied to the lower back musculature by the lumbar support panel 102, and in particular the medial 128 and lateral 130 pads on the erector spinae musculature. In particular the medial 128 and lateral 130 pads generally contact the L1-L4 vertebrae and a portion of the Sl vertebrae of the wearer's spine. The pressure can then be varied to adjust the stability and comfort of the back brace, or just to allow evaporation of perspiration.

An additional embodiment of the present invention is depicted in Figures 13-15. In particular, a knee support 200 is shown, where the knee support is designed to wrap around a wearer's knee between the wearer's thigh and calf. The knee support 200 is adjustable with a plurality of straps that allow the knee support to be custom fitted depending on the size of the wearer's leg. In addition, the knee support 200 is easy to fit and remove, as the knee support is a generally planar structure that is wrapped around the wearer's leg instead of being pulled up the wearer's leg like a sleeve.

As shown in Figure 14, the knee support 200 according to one embodiment includes a sheet of material 202 constructed of a laminate material having multiple plies, including a soft, skin-friendly inner layer, a foam middle layer, and an outer layer 24. Advantageously, the inner layer is worn against the skin and has a low skin irritant, soft feel, and can have moisture-wiclάng properties, while portions of the outer layer allows attachment of hook type fasteners, as discussed below. For

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AttyDkt. 104035/3Q6807 example, the sheet of material 202 could be a laminate of polyurethane hook engaging loop material, a polyurethane foam, and a polyurethane jersey material.

The sheet of material 202 includes opposing lateral edges 204, 206 and opposing top and bottom edges 208, 210, respectively. According to one embodiment, the area defined by the lateral ends and edges is approximately 1 l"xll", although the sizing may vary depending on the application and desired wearer of the knee support 200. However, it is preferred that the sheet of material 202 as defined above remains generally square in dimension. The lateral edge 206 is relatively flat or linear and preferably forms right angles to the top 208 and bottom 210 edges. In one embodiment, the opposing top 208 and bottom 210 edges are substantially parallel to one another, although a slight taper occurs at a pair of integral straps 212, 214, as discussed below. The sheet of material 202 also defines a patellar opening 216 that is located generally in the center of the sheet of material. The knee support 200 also includes a pair of laterally extending top and bottom straps 212, 214, respectively, that are integral with the sheet of material 202 and extend from the lateral edge 204 of the sheet of material and define a gap 218 therebetween. In one embodiment, each of the integral straps has a fastening element 220 attached thereto. The fastening element 220 preferably includes hook material on one surface for mating with complementary loop material. As mentioned above, the integral straps 212, 214 have a slightly tapering outer edge. The inner edge of the integral straps 212, 214 is also tapering or curved such that the straps meet to define the lateral edge 204 of the sheet of material 202. The gap 218 according to one embodiment is about 4 inches at the widest point, which is near the fastening element 220 of integral strap 212 and measured perpendicular to integral strap 214. Furthermore, integral strap 212 is slightly shorter than integral strap 214. In this regard, integral strap 214 is typically placed above the knee and about the wearer's thigh, while the shorter integral strap 212 is positioned below the knee and about the wearer's calf. Ih one embodiment, integral strap 212 is about 5 inches in length measured from lateral edge 204, while integral strap 214 is about 7 inches in length.

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AttyDkt. 10403₅/306807 The knee support 200 also includes a third, integral strap 222 that extends from the lateral edge 206 of the sheet of material 202 in a direction opposite the integral straps 212, 214 and arranged to wrap behind a wearer's knee and overlap the lateral edge 204 in the gap 218 defined by the upper and lower integral straps. Like the integral straps 212, 214, the middle integral strap 222 is integrally formed with the sheet of material 202. In addition, the middle integral strap 222 of the knee support 200 includes a fastening element 220 sewn to its free end. In one embodiment, the middle integral strap 222 is approximately 3-4 inches in length measured from the lateral edge 206. The aforementioned features of the knee support 200 are not meant to be limiting, as there may be many modifications in alternative embodiments of the present invention. For instance, there may be any number of integral straps 212, 214, 222 in various embodiments of the present invention to provide a range of support for the wearer. Thus, there could be one or more integral straps 212, 214 defined along the lateral edge 204, and one or more medial integral strap 222 defined along the lateral edge 206. Furthermore, each of the integral straps 212, 214, 222 maybe various sizes and configurations for accommodating different sizes of wearers. For example, although the middle integral strap 222 is shown as being formed out of the sheet of material 202, the strap could be formed of a separate material and affixed, such as by sewing or similar attachment technique. More specifically, the middle integral strap 222 could be secured to the outer surface of the sheet of material 202 such that the proximate end of the strap is interposed between one of the stay covers 224 and the sheet, whereby the middle integral strap and the stay cover share the same stitching. The knee support 200 also includes a plurality of flexible stays (not shown) that are housed or encapsulated, according to one embodiment, in respective stay covers 224. It is also possible that the flexible stays are integrated into the sheet of material 202 or fastened or secured using other devices, such as additional straps, pads of hook material on the stays, or the like. However, the flexible stays are encapsulated in respective stay covers 224 that are sewn or otherwise secured to the outer surface of the sheet of material 202, such as with RF welding. The stay

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AttyDkt. 104035/306807 covers 224 are constructed of a loop material, such as a polyester, and are preferably compatible with fastening elements 220 as described herein.

Referring to Figure 14, the stay covers 224 may have a straight or curved shape for receiving the stays, and the stay covers preferably extend along the medial and lateral sides of the patellar opening 216. In one embodiment, the stay covers 224 have a curved or angled shape extending toward the patellar opening 216. Moreover, the stay covers 224 also include a V-shaped portion 225 defined at each end. Each of the V-shaped portions 225 of the stay covers 224 is partially secured proximate to the outer perimeter of an outer cover 236 (discussed below). Other shapes are possible for the stay covers 224 and the pockets formed by the stay covers so as to fit varying sizes and shapes of stays. For example, each stay cover 224 may be separated, such as by stitching, into a pair of pockets for receiving a respective one of a pair of flexible stays.

The flexible stays are at least partially, and preferably completely, encapsulated or housed inside the stay covers 224. In this manner, the stays are rendered relatively immobile on the medial and lateral sides of the body 10 and provide reinforcement for the knee. The flexible stays are preferably formed of a metal or polymer, such as nylon or polyethylene. For example, the flexible stays could include an overlapping metal coil that is straight or somewhat arcuate or curved for allowing flexion of the knee and a normal leg position. Similarly, another example for the flexible stay includes an elongate polymeric member having a plurality of ribs or ridges along a straight or curved or arcuate shape that allows for flexion and a curve resembling normal leg position. As shown, the stay covers 224 have a somewhat biased shape, such as a 5°-15° bend on each end, biased toward the patellar opening 216 such that when the knee support 200 is around the wearer's knee the stays conform to a more natural position compared to flat or linear stays. However, it may also be possible for the stays to be straight, but held in a bent or curved shape by the stay covers 224. Furthermore, there may be any number of flexible stays, including none, in alternative embodiments of the present invention, as the flexible stays may not even be necessary for knee support embodiments where lesser amounts of immobilization are preferred (e.g., for chronic injuries).

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AttyDkt. 104035/306807 The knee support 220 also includes an inflatable bladder. The inflatable bladder is positioned on an inner surface of the sheet of material 202 and encased, or otherwise enclosed, by a bladder cover 228. As such, the bladder cover 228 prevents the inflatable bladder from moving out of a predetermined position. The bladder cover 228 may be any suitable skin-friendly material, such as polyester, or a polyester/spandex blend. Figure 13 demonstrates that the bladder cover 228 surrounds the patellar opening 116 and also includes a portion extending upwardly from the patellar opening and towards the top edge 208. The inflatable bladder substantially surrounds the patellar opening 116, and may include various configurations of interconnected bladders in fluid communication with one another. The bladder cover 228 is shown as being stitched to the sheet of material 202, although the bladder cover could be attached to the sheet of material with any suitable technique, such as RF welding, gluing, etc.

Figure 14 illustrates a pump 230 that is in fluid communication with the inflatable bladder. Also shown in Figure 14 is a slot 232 that facilitates the insertion of the pump 230 within a pocket 234 defined between an outer cover 236 and the outer surface of the sheet of material 202. An additional conduit slot 238 is also defined in the outer cover 236 and the sheet of material 202 such that that the conduit extends from the pump 230 and to the inflatable bladder. Therefore, the conduit (not shown) carries air supplied by the pump 230 to the inflatable bladder. The outer cover 236 substantially conforms to the configuration of the bladder cover 228 and, thus, encircles the patellar opening 216 and includes a flaring portion extending from the patellar opening 216 and upwardly towards the top edge 208. As described above, the outer cover 236 is typically stitched to the outer surface of the sheet of material 202, although RF welding or a similar technique known to those skilled in the art may be employed. In addition, the inflatable bladder could be directly attached to the inner surface of the sheet of material 202, such as with RF welding or stitching. The outer cover 236 is typically the same or a similar material as that of the bladder cover 228. When the wearer wishes to use the pump 230, the pump may be removed from the pocket 234 and utilized to inflate the inflatable bladder. Thus, the wearer simply folds the pump 230 and inserts the pump through the slot 232 and into the

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AttyDkt. 10403₅/306807 pocket 234 when not in use. A small opening is preferably defined in the outer cover 236 for readily locating and accessing a release valve 240. Moreover, the pump 230 also includes a small hole 242 that corresponds to the size of the release valve 240, such that when the pump is stowed in the pocket 234, the release valve may protrude through the hole to remain accessible by the wearer.

The pump and bladder system is formed by RF welding layers of air impermeable material to form the shape shown in Figure 13. The pump 230 includes a flexible thermoplastic material enclosing an open-cell foam and having an air inlet hole defined in a surface of the pump. The pump 230 operates by covering the air inlet and squeezing the pump such that air is forced into the inflatable bladder. Air is forced through a check valve, and pressure within the bladder causes the check valve to close to prevent air from escaping the bladder through the check valve. The pump 230 is replenished by uncovering the air inlet hole. Typically, the inflatable bladder is filled by repeatedly squeezing the pump 230 until a desired amount of pressure is achieved. Air is released from the bladders by depressing the release valve 240.

The knee support 200 also advantageously includes a pair of pads 244 positioned on an inner surface of the sheet of material 202. As shown in Figure 13, each of the pads 244 are in substantially the same configuration as the stay covers 224, as described previously. In this regard, each of the pads 244 has a curved shape that extends along the medial and lateral sides of the patellar opening 216. Moreover, the pads 244 also include V-shaped portion 246 defined at each end. Therefore, the pads 244 lie adjacent to the flexible stays, although on opposite sides of the sheet of material 202, to provide increased comfort and support for the wearer.

As also described above with respect to each of the wrist 10 and back 100 supports, the pads 244 are a viscoelastic foam that exhibit slow recovery properties. The pads 244 act as a dashpot having a slow recovery when deformed, which is unlike the spring-like return of typical foams or pads. Thus, the slow recovery properties enable the pads 244 to spread pressure applied to the knee to a larger area to reduce pressure points. The pads 244 are secured to the sheet of material 202 by directly stitching, RF welding, or using a similar technique to

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AttyDkt. 104035/306807 attach the pads to the sheet. The pads 244, inflatable bladder, and/or the entire inner surface of the sheet of material 202 could be covered with a backing material. The backing material could be RF welded, stitched, or otherwise attached about the perimeter of the pads 244, inflatable bladder, and/or sheet of material 202. Thus, the backing material could be employed for aesthetic purposes or to secure each of the pads 244 and/or inflatable bladder to the inner surface of the sheet of material 202.

It is understood that the pads 244 and inflatable bladder should not be limited to any particular size or configuration shown in Figures 13-15. For instance, each of the pads 244 could extend adjacent to the flexible stays, as well as about the patellar opening 116. As such, the inflatable bladder is optional, but could also include various sizes and configurations, including multiple interconnected bladders and chambers. Thus, the inflatable bladder could be positioned adjacent to the flexible stays, and a pad 244 could be positioned about the patellar opening 116. Furthermore, the entire inner surface of the sheet of material 202 could comprise a pad 244 in alternative embodiments, or there could be any number of pads positioned in designated locations on the sheet of material. As described above, although a pad 244 of viscoelastic material is preferred, it is understood that various materials could be used for the pad, such as foams, gels, air bladders, or any other suitable cushioning or padding material.

The knee support 200 is applied to a wearer's knee area by positioning the support such that the patella registers with the patellar opening 216, and then wrapping the integral straps 212, 214 about the wearer's leg such that the upper strap 214 is positioned above the popliteal region of the knee and attaches to the sheet of material 202, and the lower strap 212 is positioned below the popliteal region and attaches to the sheet of material. The middle integral strap 220 is then wrapped behind the knee until the fastening element 220 of the middle strap overlaps lateral edge 204 and is secured to the complementary fastening material on the outer surface of the sheet of material 202. hi one embodiment, the stay covers 224 have a loop material outer surface, such that the fastening elements 220 having hook material thereon can be secured to the outer surface of the sheet of material 202 and/or the outer surface of the stay covers 224. In this regard, the

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AttyDkt. 104035/306807 fastening elements 220 of the integral straps 212, 214 can be adjusted to the wearer's leg size by releasably securing the fastening elements 220 to the outer surface of the sheet of material 202 and/or the outer surface of the stay covers 224. As shown in Figure 15, when properly positioned, the inflatable bladder provides cushioning and support about the wearer's patella. The flexible stays provide resilient bending resistance with flexion of the knee in order to support the knee area and prevent excessive movement thereof. Furthermore, the pads 244 provide increased cushioning and support on an opposite surface of the flexible stays. The present invention has many advantages. As described above, viscoelastic pads could be positioned adjacent to flexible stays such that the orthopedic support provides support without sacrificing comfort. The viscoelastic pads may be positioned at various locations on orthopedic supports for any desired amount of support. In addition, the positioning, material properties, and texture/feel of the viscoelastic pads increase the rehabilitative effects of the various supports, such as by protecting or massaging an injured area. The slow recovery properties of the viscoelastic material spread pressure away from high pressure points, which is dissimilar to the spring-like return exhibited in typical pads. Furthermore, the viscoelastic pad is adaptable for various orthopedic supports, such as a wrist 10, back 100, or knee 200 support. A wrist support 10 includes a palmar pad 52 of viscoelastic material that is capable of providing pressure to a wearer's palm to provide increased comfort and support. In particular, the palmar pad 52 is positioned adjacent to a palmar splint in the region of the wearer's palm. With respect to a back support 100, medial 128 and lateral 130 pads of viscoelastic material could be incorporated into a lumbar support panel 102 to provide support for the musculature of the wearer' s back. Moreover, viscoelastic pads 244 could be incorporated into a knee support 200 and positioned on the medial and lateral sides of the knee and adjacent to flexible stays.

Many modifications and other embodiments of the invention set forth herein will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other

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AttyDkt. 104Q35/306807 embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

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AttyDkt. 1.04035/306807

Claims

THAT WHICH IS CLAIMED:

1. An orthopedic support comprising: a sheet of flexible material having a distal edge configured to extend at least partially around a distal portion of a joint, and a proximal edge configured to extend at least partially around a proximal portion of the joint; at least one splint secured to the sheet of material; and at least one viscoelastic pad secured to an inner surface of the sheet of material and adjacent to at least a portion of the splint.

2. The orthopedic support according to Claim 1, wherein the splint comprises a palmar splint configured to extend along a palmar portion of a wearer's hand, wrist, and forearm.

3. The orthopedic support according to Claim 1, further comprising a plurality of splints configured to extend on a medial and a lateral side of a wearer's knee.

4. The orthopedic support according to Claim 1, wherein the viscoelastic pad comprises a polyurethane foam.

5. The orthopedic support according to Claim 1, further comprising at least one strap attached to the sheet of material and configured to secure the sheet about the j oint.

6. An orthopedic support comprising: a sheet of material configured to at least partially enclose a portion of a wearer's anatomy; at least one strap attached to the sheet of material and configured to secure the sheet to the portion of the wearer's anatomy; and a plurality of viscoelastic pads secured to an inner surface of the sheet of material.

7. The orthopedic support according to Claim 6, further comprising a plurality of splints configured to extend on a medial and a lateral side of a wearer's knee and adjacent to a respective viscoelastic pad.

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AttyDkt. 1040₃5/306807

8. The orthopedic support according to Claim 6, further comprising a plurality of splints configured to extend on a medial and a lateral side of a wearer's spine and adjacent to a respective viscoelastic pad.

9. The orthopedic support according to Claim 6, wherein the plurality of viscoelastic pads are configured to extend along a medial and lateral portion of the wearer's anatomy.

10. The orthopedic support according to Claim 6, wherein the viscoelastic pad comprises a polyurethane foam.

11. A wrist support comprising: a sheet of flexible material having a distal edge configured to extend at least partially around a hand of a wearer, a proximal edge configured to extend at least partially around a forearm of a wearer, and a pair of opposing lateral edges configured to at least partially enclose the hand and forearm so that the sheet extends around the wrist of the wearer; at least one lateral edge strap attached to the sheet and configured to secure the sheet about the wrist; and a viscoelastic pad secured to an inner surface of the sheet of material.

12. The wrist support according to Claim 11, wherein the sheet of material comprises a thumb opening defined in the distal edge and extending proximally within the sheet of material.

13. The wrist support according to Claim 12, wherein the viscoelastic pad is positioned adjacent to the thumb opening.

14. The wrist support according to Claim 11, further comprising a pair of lateral edge straps attached proximate to each of the distal and proximal edges of the sheet of material, wherein each lateral edge strap is configured to extend over one of the lateral edges and attach to itself so as to secure the sheet of material about the wrist.

15. The wrist support according to Claim 14, further comprising a pair of rings attached to the sheet of material, wherein each of the lateral edge straps is

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AttyDkt. 1Q4O3₅/3Q68Q7 capable of extending through a respective opening in each of the rings and attaching to an outer surface of the lateral edge strap.

16. The wrist support according to Claim 15, wherein each lateral edge strap comprises a slide guard that is capable of preventing the straps from sliding out of the opening in respective rings.

17. The wrist support according to Claim 14, further comprising a longitudinal strap attached to the sheet of material approximately midway between the proximal and distal edges.

18. The wrist support according to Claim 17, wherein the longitudinal strap extends outwardly from an opposite lateral edge than that of the lateral edge straps and is configured to extend over one of the lateral edges and circumferentially about the sheet of material.

19. The wrist support according to Claim 11, further comprising a longitudinal splint positioned within a pocket defined in the sheet of material, wherein the longitudinal splint extends substantially between the proximal and distal edges and is configured to conform to a portion of the wearer's palm.

20. The wrist support according to Claim 19, wherein the viscoelastic pad is positioned adjacent to a portion of the longitudinal splint.

21. The wrist support according to Claim 20, wherein the viscoelastic pad is positioned proximate to a distal end of the longitudinal splint such that the viscoelastic pad is configured to conform to a portion of the wearer's palm.

22. The wrist support according to Claim 11, further comprising at least one dorsal splint positioned within a respective pocket in the sheet of material, wherein each dorsal splint extends substantially between the proximal and distal edges and is configured to provide support to a dorsal portion of the wearer's wrist.

23. The wrist support according to Claim 11, wherein the viscoelastic pad is trapezoidal in configuration.

24. The wrist support according to Claim 11, wherein the viscoelastic pad comprises a polyurethane foam.

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AttyDkt. 104035/306807

25. A method for securing a wrist support on a wearer's wrist comprising: positioning a sheet of material on the wearer's wrist such that a viscoelastic pad secured to the sheet is positioned adjacent to the wearer's skin; wrapping the sheet of material about the wearer's wrist such that a proximal edge is positioned along the forearm, a distal edge is positioned above the wrist and along the hand, and opposed lateral edges are positioned substantially adjacent to one another; and attaching at least one lateral edge strap to secure the sheet of material about the wearer's wrist.

26. A back support comprising: a strapping system extending at least partially around a waist of a wearer; and a lumbar support panel connected to the strapping system and supported by the strapping system at the lower back region of the wearer, the support panel having an interior surface adjacent to the wearer's back; and at least one viscoelastic pad positioned on the interior surface of the support panel.

27. A knee support comprising: a sheet of material having opposing lateral edges and opposing top and bottom edges configured to wrap about a wearer's knee between the thigh and calf; at least one strap for securing the sheet of material about a wearer's knee; and at least one viscoelastic pad positioned on an inner surface of the sheet.

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AttyDkt. 1Q4035/3068Q7