WO2005087150A1

WO2005087150A1 - Orthotic device including adaptive support structure

Info

Publication number: WO2005087150A1
Application number: PCT/US2005/008138
Authority: WO
Inventors: Robert Gilmour
Original assignee: Omni Life Science, Inc.
Priority date: 2004-03-10
Filing date: 2005-03-10
Publication date: 2005-09-22

Abstract

An orthotic device includes a substantially rigid support in combination with rigid yet malleable support members (13, 14) that can be initially conformed by hand to the general contour of the portion of the user’s body to be supported by the orthotic device. Flexible, semi-rigid adaptive support members (43, 46) are provided intermediate the rigid malleable support members and the user’s body, to more substantially conform to the unique shape of the user’s body to provide an enhanced grip and fit. A relatively soft liner (49, 52) is further provided intermediate the adaptive support members and the user’s body for even more substantial conformity with the user’s body. The orthotic device can include an ankle brace (10) and a knee brace (60).

Description

TITLE ORTHOTIC DEVICE INCLUDING ADAPTIVE SUPPORT STRUCTURE

BACKGROUND OF THE INVENTION Field of the invention:

[0001] The invention relates to orthotic devices, and in particular to orthotic braces that include adaptive support structures to facilitate conforming the engagement portions of the brace with the body portion of the user which is to be supported.

Description of the Prior Art:

[0002] The human ankle consists of three bones (i.e., the tibia or shin bone, the fibula and the talus or ankle bone) bound together and to the bones of the foot by ligaments. The fibula and tibia are held tightly together by ligaments and form a mortice for reception of the talus. No muscle or tendons attach to the talus. The three bones are independently configured and relatively oriented and spaced to provide freedom of movement of the foot in several degrees relative to the lower leg. The ligaments serve as elastic restrainers to limit that movement. As such, it is generally meant only for up and down movement, or movement in dorsiflexion and plantar flexion. Ankle injuries are common among humans who engage in athletic and other strenuous activities. [0003] The ankle is not meant to rotate from side to side, or to tilt inward and outward.

Injuries result when the strains placed on the ankle exceed the normal limits of movement. These injuries vary widely in severity from simple ligament pulls to ligament ruptures and bone fractures. The most common injuries result from what are known as eversion and inversion of the ankle. Eversion results when the foot rolls over and the ankle moves outwardly relative to the foot. Inversion results when the foot rolls in the opposite direction causing the ankle to move inwardly relative to the foot.

[0004] When the ankle is injured and during healing, or in order to prevent further injury to the ankle and allow healing, it is desirable to restrain the ankle bone structure in proper relationship. To effect this end, various braces and wraps in the prior art have been provided.

However, there is sometimes a need for more substantial immobilization of the ankle joint during the healing process. For individuals, particularly athletes who have had a past history of weak or injured ankles, it has been a common practice to tape their ankles with medical adhesive tape to provide added support thereto against eversion and inversion. Taping, though generally recognized as effective in supporting a weak ankle, has several drawbacks. First, medical adhesive tape is expensive, and also not normally reusable. It can thus be extremely costly to use for individuals who regularly engage in activities requiring ankle support, and for organizations that supply such individuals. It is also generally difficult for an individual to apply adhesive tape to his or her own ankle. Taping is thus, on many occasions, not used when it should be used because of the unavailability of a second individual to apply the tape. Also, one who applies tape to another's ankle must generally have a reasonable degree of skill or experience in that regard, for the improper application of the tape can render the taping ineffective and result in other injuries to the ankle and foot, such as irritations of the skin or poor circulation. Moreover, when tape is applied to prevent eversion and inversion of the ankle, it also tends to restrict the forward flexibility of the foot relative to the ankle and thus to limit the ankle's performance. [0005] Because of the aforementioned drawbacks, fabric ankle wraps are occasionally used as a substitute for taping. Fabric wraps have the advantage of being reusable and thus tend to be more economical to use. Wraps, however, do not generally provide the support that is provided by properly applied adhesive tape. Typically, the wrap material is such that it tends to slip easily relative to the skin. Slippage causes loosening of the wrap with time and gradually diminishes the amount of support provided by the wrap.

[0006] A variety of support structures for the ankle and other parts of the body have been previously proposed as substitutes for medical taping and wraps. These structures vary widely in complexity and cost. None of these structures has found any widespread use or acceptance. Most of the simpler structures provide no real support against eversion and inversion of the ankle. The more complicated structures are generally more effective in this regard but also typically expensive and difficult for an individual to apply to his or her own ankle. [0007] Orthotic devices generally include a substantially rigid biomechanical element which forms the basis of the skeletal support that is required for most orthopaedic devices such as braces, supports and splints. This element is generally fashioned or shaped in such a way as to facilitate engagement of the apparatus with the relevant portion of the user's anatomy. A liner is usually attached to the rigid element for comfortable engagement of the device with the body of the user. Such a construction is disclosed in United States Patent 5,713,837 in which the structure of the device is moulded as a unitary item of a shape which is intended to generally conform to the relevant part of the user's anatomy. The support includes a thick moulded portion which provides substantial rigidity, and relatively thinner portions which are intended to conform to or partially enclose the part of the anatomy to be supported. [0008] In yet other systems the rigid member has no flexibility whatsoever, but is moulded or formed in a shape that is intended to assist it to conform to the body of the user. A simple resilient or soft liner is then attached to the rigid body to assist engagement with the body of the user and provide some comfort. [0009] The disadvantage with these known devices is that the overall shape of the rigid element cannot be designed to accommodate all users. The general contour or shape of the part of the human anatomy, to which an orthotic device is to be connected, can vary considerably from one individual to another. Therefore, a shape which is generally functional may be arrived at by making compromises, this shape can be uncomfortable or lack the required support for some users.

[0010] Thus, there is a need for an orthotic device which will at least go some way toward overcoming disadvantages of existing constructions, or which will at least provide the public a useful alternative.

SUMMARY OF THE INVENTION

[0011] As described previously, conventional orthotic devices, for example ankle and knee braces, typically comprise rigid, inflexible support members, or biomechanical elements, for controlling the affected joint. Some conventional orthotic devices also provide a liner between the biomechanical elements and the body of the user. [0012] According to the invention, rigid support members are designed to be optimally biomechanical and the liner is designed to provide a near perfect interface with the individual's unique anatomy. Between the rigid support members and the liner, intermediate components are provided which are designed to link the two together, and are designed specifically in terms of material selection and shape to make the orthotic device maximally adaptive to a unique individual anatomy, and the mobility of the same.

[0013] More particularly, mouldable intermediary components are designed to be positioned between the rigid support members and the liner, and/or incorporated with the rigid support members, so that such components, some of which can be termed "adaptive" enable the orthotic device be adjusted by hand to better conform to the contours of the user's body.

[0014] In accordance with the preceding, one aspect the invention provides an orthotic device having substantially rigid support members to providing a rigid supporting action, and adaptive support members, which are preferably constructed from a semi-rigid material, are provided between the rigid support and the part of the anatomy to be supported. The adaptive support members are sufficiently flexible to better conform to the shape of the part of the anatomy to be supported. Preferably, a rigid but malleable component is provided in combination with the rigid support members such that the rigid malleable component permits the orthotic device to be manually conformed to the general contour of the associated body portion. A soft liner is preferably provided intermediate the adaptive support members and the user's body to provide an even more substantially conforming interface adjacent the user's body. A manner of securing the orthotic device about the part of the anatomy to be supported is also provided, which may comprise straps. [0015] Preferably the semi-rigid material comprises a thermoplastic elastomer or a thermoplastic rubber material.

[0016] Preferably the device further includes a liner for location between the adaptive support and the part of the anatomy to be supported.

[0017] Preferably the liner is constructive from a substantially soft resilient material. [0018] Preferably the rigid support is constructed from a metallic material, such as aluminum.

[0019] Preferably the rigid support is constructed so as to be sufficiently malleable, or incorporates a rigid yet malleable material, such as to enable shaping the rigid support by hand by a human user and substantially retain the desired shape. [0020] In one embodiment the device comprises an ankle brace.

[0021] Preferably the ankle brace comprises a clam shell ankle brace.

[0022] In a further respect the invention provides a knee brace having a first arm and a second arm which are hingedly connected together so as to be retain or relative to each other through a predetermined range of movement, the arms being rigid, and an adaptive support which is constructed from a semi-rigid material and is dependent from the first arm or the second arm for location about a part of the leg of a user, the adaptive support being sufficiently flexible to adapt to a contour of the leg, and securing means to secure the device about the part of the anatomy to be supported. [0023] Preferably the adaptive support includes a rigid but malleable material. [0024] Further aspects of the invention will become apparent from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Various other objects, features and advantages of the present invention will become readily apparent by reading the following description in conjunction with the drawings, which are shown by way of example only, wherein:

[0026] Figure 1 is a perspective view of a part of a clam shell ankle brace;

[0027] Figure 2 is a perspective view of the ankle brace shown in Figure 1 but further including adaptive support elements; [0028] Figure 3 is a side elevation of the ankle brace shown in Figure 2 but further including liner elements;

[0029] Figure 4 is a perspective view of a knee brace;

[0030] Figure 5 is a plan view of the knee brace of Figure 4;

[0031] Figure 6 is a front plan view of a further embodiment of one half of a clam shell type ankle brace;

[0032] Figure 7 is a perspective view of the embodiment shown in Figure 6; and

[0033] Figures 8 and 9 are front plan views of a further embodiment of respective upper and lower adaptive support members of a knee brace

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Referring now to the drawings in detail, wherein like reference characters refer to like elements, there is shown in Figures 1-3 of the drawings, components relating to a clam shell type ankle brace 10. [0035] As shown in Figure 1, two (2) substantially rigid support members 13, 14 are provided interconnected at their lower ends 16 by a flexible foot strap 19. In use, foot strap 19 passes beneath the user's foot, and engagement straps 25 and 28 wrap around the apparatus to secure it about the ankle and lower leg, respectively, of the user. One end of each strap 25,28 is preferably fixed to the rigid support members 13, 14 and the opposite, free end is wrapped around the users ankle and lower leg and fastened in place in any conventional manner.

[0036] The rigid support members 13, 14 provide the mechanical, or skeletal support that is required to provide the inherent structure that is necessary in the brace 10. The preferred material from which these are constructed is aluminum, but other materials may be selected, for example, plastics materials, fibre based materials or combinations thereof. Aluminum is most preferred because it has sufficient rigidity when provided in an appropriate thickness (for example, on the order of about 1-2 millimetres thick), but is also sufficiently malleable to allow it to be deformed or manipulated by a user to easily change its fundamental shape should this be necessary to generally conform to the user's unique body shape, thus ensuring adequate support.

[0037] Referring now to Figure 2, the rigid support members 13, 14 of Figure 1 are shown together with adaptive support members 43 and 46. The adaptive support members 43, 46 are located adjacent to an interior surface 47 (Figure 1) of each of the rigid support members 13, 14. In the preferred embodiment shown, the adaptive support members 43,46 are attached to the interior surface 47 of each of the rigid support members 13, 14 either permanently, such as by gluing, or removably, such as by hook and loop fasteners (i.e., VELCRO). However, in alternative embodiments (not shown), the adaptive support members 43,46 may be constructed such that they fit over or about the rigid support members 13, 14. For example the adaptive members 43,46 may include a pocket, sleeve or channel (not shown) for location over the rigid support members 13, 14. Furthermore, the adaptive support members 43,46 could be constructed about the rigid support members 13, 14, for example by moulding in order to produce a substantially unitary article (although constructed of different materials). [0038] The adaptive support members 43,46 are preferably constructed from a semi-rigid material that is selected to provide support, but which has sufficient flexibility to enable it to adapt to the soft tissue of the user in the area of the anatomy at which the brace 10 is to be applied. A preferred material for construction of the adapted support members 43,46 is a thermoplastic elastomer such as thermoplastic rubber. Thermoplastic rubber has an advantage in that the hardness or resilience of the material may be varied or controlled by steps taken during moulding operations, for example via temperature control.

[0039] The adaptive support members 43,46 preferably extend beyond the periphery of the rigid support members 13, 14 as shown in Figure 2, which shield the users body from the edges of the rigid support member 13, 14. The adaptive support members 43,46 are sufficiently flexible in use to allow the straps 25,28 to assist with forming the adaptive support members 43,46 around the surface of the soft tissue of the body portion of the user.

[0040] Turning to Figure 3 a side elevation view of the ankle brace 10 shows liners 49 and 52 which are provided on an internal surface 55 (Figure 2) of each adaptive support member 43,46. The liners 49,52 may be attached to the adaptive support members 43,46, or simply be maintained in position by the engagement straps 25,28 which apply pressure to the remainder of the construction which sandwiches the liners 49,52 between the adaptive support members 43,46 and the portions of the anatomy which are being supported by the orthotic device 10. [0041] The liners 49,52 are preferably constructed from a substantially soft resilient material such as foam, or a fluid filled bladder, such as an air or water bladder, in order to provide a desired cushioning effect adjacent to the user's flesh. The liners 49,52 may include a fluid or gel which can be heated or cooled yet is still resilient and conforming, so as to provide an additional therapeutic benefit to the user. [0042] Another embodiment of the invention is illustrated in Figures 4 and 5, in which a knee brace 60 is illustrated. The knee brace 60 has a biomechanical element with a first, or upper, arm 63 and a second, or lower, arm 66 which are interconnected by a hinge 69 that allows the arms 63,66 to rotate relative to each other within a predetermined range of movement that corresponds to a desired flexion-extension range of movement for a user's knee. The first and second arms 63,66 are preferably constructed from a rigid material that is capable of providing skeletal support. In the preferred embodiment this comprises an metal, such as aluminum plate or rod, having material properties such that it cannot be easily bent, flexed or otherwise manipulated by a user. [0043] An upper adaptive support member 75 is provided in connection with the upper arm 63 and a lower adaptive support member 78 is provided dependent from the lower arm 66. The adaptive support members 75,78 may be constructed in a variety of different ways from different materials. However, in this example, the adaptive support members 75,78 are moulded about upper and lower arms 63,66. The material from which the adaptive support members 75,78 are constructed can be the same as the materials set forth in relation to the clam shell ankle brace 10 described previously.

[0044] Upper 81 and lower 82 engagement straps (which may also comprise a VELCRO fastening material, or other conventional fastening means) can be engaged about the user's leg and connected to the extremity 84,87 of each adaptive support members 75,78, respectively, to securely engage the adaptive support members 75, 78 with the relevant portion of the leg of the user adjacent to the knee 72. Additional upper 90 and lower 91 straps may be provided to engage directly around the user's leg to help further secure the knee brace 60 to the user's leg. [0045] Being constructed of a semi-rigid material, the adaptive support members 75,78 can be conformed to the shape of the leg, and make a suitable engagement with the leg so that the knee brace 60 as a whole can provide the required support for the user's knee.

[0046] The adaptive members 75,78 preferably further each include a rigid but malleable material 93. In the preferred embodiment the malleable material 93 comprises a metallic material, such as aluminum, which is sufficiently thin (for example, on the order of about 1-2 millimetres thick) to enable it to be adjusted or shaped by a user using only his or her hands to initially conform the knee brace 60 to the user's unique leg shape.

[0047]

[0048] The malleable material allows the desired shape of the knee brace 60 to be substantially maintained after being initially conformed to the user's body. Consequently, the malleable component 93 provides the user further control over the shape of the adaptive support members 75,78.

[0049] In the preferred embodiment, the adaptive support members 75,78 further include a liner 96 of a substantially soft material, such as a foam material or a fluid filled bladder, that makes direct contact with the user to provide more comfortable engagement with the user's leg. The relatively soft liner 96 even more substantially conforms to the unique shape of body portion of the user which is associated with the orthotic device.

[0050] The adaptive support members 75, 78 can vary according to the shape and mobility of the underlying anatomy. For example, different materials may be utilized for the adaptive support member 75 above than for the adaptive support member 78 below the knee, in order to maximize the adaptiveness of each support member 75, 78. Accordingly, it can be understood that the design of the adaptive support members 75, 75 is driven by adaptive fit, rather than by structural integrity.

[0051] Referring now to Figures 6 and 7, there is illustrated a further embodiment of one half of a clam shell type ankle brace, such as the clam shell ankle brace 10 illustrated in Figures 1-

3, having a certain preferred construction. As shown, an adaptive support member 100 for an ankle brace can comprise a flexible rubber shell 103, which can be made from a material commonly referred to as "TPR," combined with a malleable aluminum spine 106 to form a shaped-medial or lateral, right or left sided brace. The flexible TPR shell 103 provides a relatively soft, conforming layer, including a soft conforming edge profile, whereas the malleable aluminum spine 106 provides rigidity and the ability to be manually conformed to initially better fit the contours of the user's body, and be maintained in that shape. Thus, the TPR shell 103, or a shell made from a similar material, will maximise grip and fit, and the aluminum spine 106, which can be a thin strip of aluminium, will enable customization of the adaptive performance of that component to user's unique anatomy. The TPR shell 103 and aluminum spine 106 can be joined together in a number of known ways, including, for example, by gluing the TPR shell 103 to the aluminum spine 106, or by melding the TPR shell 103 about the aluminum spine 106.

[0052] Turning to Figures 8 and 9, there is illustrated a further preferred embodiment of upper 1 10 and lower 1 13 adaptive support members of a knee brace, such as the knee brace 60 illustrated in Figures 4-6, having a certain preferred construction. As shown, both the upper 110 and lower 1 13 adaptive support members can each comprise a flexible rubber shell 1 10, which can be made from a material commonly referred to as "TPR," combined with a malleable aluminum spine 119. The flexible TPR shell 1 16 provides a relatively soft, conforming layer, including a soft conforming edge profile, whereas the malleable aluminum spine 1 19 provides rigidity and the ability to be manually conformed to initially better fit the contours of the user's body, and be maintained in that shape. Thus, the TPR shell 1 16, or a shell made from a similar material, will maximise grip and fit, and the aluminum spine 1 19, which can be a thin strip of aluminium, will enable customization of the adaptive performance of that component to user's unique anatomy. The TPR shell 1 16 and aluminum spine 1 19 can be joined together in a number of known ways, including, for example, by gluing the TPR shell 1 19 to the aluminum spine 119, or by melding the TPR shell 1 16 about the aluminum spine 1 19.

[0053] In the preceding description of certain embodiments, it should be understood that when reference has been made to specific components or integers of the invention having known equivalents, then such equivalents are herein incorporated as if individually set forth.

[0054] Moreover, while certain specific embodiments of the invention have been shown in the drawings and described in detail, it will be appreciated by those skilled in the art that various modifications and alternatives would be developed in light of the overall teachings of the disclosure. Such changes and modifications may be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages.

[0055] Therefore, the particular embodiments disclosed herein are meant to be illustrative only, and not limiting as to the scope of the invention, which is to be given the full breadth of the appended claims and in any and all equivalents thereof.

Claims

CLAIMSWhat is claimed is:

1. An orthotic device comprising: a rigid support member adapted to be secured to a body portion of a user; an adaptive support member disposed between an interior surface of said rigid support member and the body portion; and a strap for securing said orthotic device to the body portion such that said adaptive support member conforms to the body portion.

2. The orthotic device of claim 1 further comprising a resilient liner disposed between said adaptive support member and the body portion wherein said resilient liner more substantially conforms to the body portion.

3. The orthotic device of claim 1 wherein said rigid support member is made of a metallic material sufficiently malleable as to be adjusted manually by a person to conform to the shape of the body portion of the user.

4. The orthotic device of claim 3 wherein said malleable metallic material is aluminum.

5. The orthotic device of claim 1 wherein said rigid support member is made of a substantially rigid malleable material so that said adaptive support member is generally conformed to the body portion of the user, and further comprising a resilient liner disposed between said adaptive support member and the body portion so that said resilient liner more substantially conforms to the body portion.

6. An ankle brace comprising: a pair of rigid support members adapted to be secured to an ankle of a user, said rigid members being joined by a first strap; a pair of adaptive support members, one of each of said adaptive support members disposed between each of said rigid support members and the users ankle; and a second strap for securing said ankle brace to the users ankle such that said adaptive support members conform to the users ankle.

7. The ankle brace of claim 6 wherein said rigid support member is made of a substantially rigid malleable material so that said adaptive support member is generally conformed to the body portion of the user.

8. The ankle brace of claim 7 wherein said substantially rigid malleable material is aluminum.

9. The ankle brace of claim 6 further comprising a resilient liner disposed between said adaptive support member and the body portion so that said resilient liner more substantially conforms to the body portion.

10. The ankle brace of claim 7 further comprising a resilient liner disposed between said adaptive support member and the body portion so that said resilient liner more substantially conforms to the body portion.

11. The ankle brace of claim 6 wherein said resilient liner is comprised of a foam material.

12. The ankle brace of claim 6 wherein said resilient liner comprises a fluid filled bladder.

13. A knee brace comprising; an upper rigid arm and a lower rigid arm interconnected by a hinge assembly; an upper rigid support member secured to said upper rigid arm and adapted to fit snugly around an upper leg of a user; a lower rigid support member secured to said lower rigid arm and adapted to fit snugly around a lower leg of the user; at least one strap for securing said knee brace the user such that said hinge assembly is adjacent a knee of the user; an upper adaptive support member connected to an internal surface of said upper rigid surface to provide a snug fit between said upper rigid support and the upper leg of the user; and an lower adaptive support member connected to an internal surface of said lower rigid surface to provide a snug fit between said lower rigid support and the lower leg of the user.

14. The knee brace of claim 13 further comprising an upper resilient liner disposed between said upper adaptive member and the upper leg of the user, and a lower resilient liner disposed between said lower adaptive support member and the lower leg of the user.

15. The knee brace of claim 14 wherein each of said upper and lower resilient liners are comprised of a foam material.

16. The knee brace of claim 14 wherein each of said upper and lower resilient liners are comprised of a fluid filled bladder.