WO2005087150A1 - Appareillage orthopedique comprenant une structure de maintien adaptative - Google Patents

Appareillage orthopedique comprenant une structure de maintien adaptative Download PDF

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Publication number
WO2005087150A1
WO2005087150A1 PCT/US2005/008138 US2005008138W WO2005087150A1 WO 2005087150 A1 WO2005087150 A1 WO 2005087150A1 US 2005008138 W US2005008138 W US 2005008138W WO 2005087150 A1 WO2005087150 A1 WO 2005087150A1
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WO
WIPO (PCT)
Prior art keywords
rigid
user
support member
body portion
adaptive
Prior art date
Application number
PCT/US2005/008138
Other languages
English (en)
Inventor
Robert Gilmour
Original Assignee
Omni Life Science, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Omni Life Science, Inc. filed Critical Omni Life Science, Inc.
Publication of WO2005087150A1 publication Critical patent/WO2005087150A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0106—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0111—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the feet or ankles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0123—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations for the knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F2005/0132—Additional features of the articulation
    • A61F2005/0165—Additional features of the articulation with limits of movement

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • conventional orthotic devices 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the semi-rigid material comprises a thermoplastic elastomer or a thermoplastic rubber material.
  • the device further includes a liner for location between the adaptive support and the part of the anatomy to be supported.
  • the liner is constructive from a substantially soft resilient material.
  • the rigid support is constructed from a metallic material, such as aluminum.
  • 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.
  • the device comprises an ankle brace.
  • the ankle brace comprises a clam shell ankle brace.
  • 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.
  • the adaptive support includes a rigid but malleable material.
  • Figure 1 is a perspective view of a part of a clam shell ankle brace
  • Figure 2 is a perspective view of the ankle brace shown in Figure 1 but further including adaptive support elements;
  • Figure 3 is a side elevation of the ankle brace shown in Figure 2 but further including liner elements;
  • Figure 4 is a perspective view of a knee brace
  • Figure 5 is a plan view of the knee brace of Figure 4.
  • Figure 6 is a front plan view of a further embodiment of one half of a clam shell type ankle brace
  • Figure 7 is a perspective view of the embodiment shown in Figure 6;
  • Figures 8 and 9 are front plan views of a further embodiment of respective upper and lower adaptive support members of a knee brace
  • FIG. 1 components relating to a clam shell type ankle brace 10.
  • FIG. 1 two (2) substantially rigid support members 13, 14 are provided interconnected at their lower ends 16 by a flexible foot strap 19.
  • 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.
  • 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.
  • 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.
  • 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).
  • the adaptive support members 43,46 may be constructed such that they fit over or about the rigid support members 13, 14.
  • the adaptive members 43,46 may include a pocket, sleeve or channel (not shown) for location over the rigid support members 13, 14.
  • 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).
  • 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.
  • 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.
  • FIG. 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.
  • 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.
  • FIGs 4 and 5 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the adaptive members 75,78 preferably further each include a rigid but malleable material 93.
  • 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.
  • 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.
  • 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.
  • a substantially soft material such as a foam material or a fluid filled bladder.
  • 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.
  • 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.
  • FIG. 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-
  • 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.
  • 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.
  • 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.
  • the TPR shell 1 16, or a shell made from a similar material will maximise grip and fit
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne un appareillage orthopédique comprenant un support essentiellement rigide associé à des éléments de maintien rigides mais malléables (13, 14) pouvant être préalablement façonnés à la main pour s'adapter au contour général de la portion du corps de l'utilisateur qui doit être maintenue par l'appareillage orthopédique. Des éléments de maintien adaptatifs souples et semi-rigides (43, 46) sont disposés entre les éléments de maintien rigides malléables et le corps de l'utilisateur, afin de mieux s'adapter à la forme unique du corps de l'utilisateur et de permettre une meilleure pose et un meilleur maintien. Une doublure relativement souple (49, 52) est également placée entre les éléments de maintien adaptatifs et le corps de l'utilisateur afin de permettre une meilleure adaptabilité avec le corps de l'utilisateur. L'appareillage orthopédique peut comprendre un manchon de cheville (10) et un manchon de genou (60).
PCT/US2005/008138 2004-03-10 2005-03-10 Appareillage orthopedique comprenant une structure de maintien adaptative WO2005087150A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NZ53170404 2004-03-10
NZ531704 2004-03-10

Publications (1)

Publication Number Publication Date
WO2005087150A1 true WO2005087150A1 (fr) 2005-09-22

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2301488A1 (fr) * 2009-09-24 2011-03-30 MIC & Partners GmbH Rail de mise au repos
AU2009246628B2 (en) * 2008-05-14 2013-01-24 3M Innovative Properties Company Ankle support with splint and method of using same
US8986235B2 (en) 2009-03-31 2015-03-24 3M Innovative Properties Company Ankle brace
US9925083B2 (en) 2009-03-31 2018-03-27 3M Innovative Properties Company Wrist brace

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5358469A (en) * 1990-02-09 1994-10-25 Ultraflex Systems, Inc. Dynamic splint
US5415625A (en) * 1992-07-01 1995-05-16 Smith & Nephew Donjoy, Inc. Orthopedic brace having a system of alternately inflatable or deflatable pneumatic pads for adjustable fitting of the brace to the body
US5951504A (en) * 1993-07-29 1999-09-14 Royce Medical Products Ankle brace with adjustable heel strap
US6554785B1 (en) * 2000-10-13 2003-04-29 Jon W. Sroufe Therapeutic combination gel and air bladder pack
US20030171703A1 (en) * 1996-08-29 2003-09-11 Royce Medical Products Self-equalizing resilient orthopaedic support

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5358469A (en) * 1990-02-09 1994-10-25 Ultraflex Systems, Inc. Dynamic splint
US5415625A (en) * 1992-07-01 1995-05-16 Smith & Nephew Donjoy, Inc. Orthopedic brace having a system of alternately inflatable or deflatable pneumatic pads for adjustable fitting of the brace to the body
US5951504A (en) * 1993-07-29 1999-09-14 Royce Medical Products Ankle brace with adjustable heel strap
US20030171703A1 (en) * 1996-08-29 2003-09-11 Royce Medical Products Self-equalizing resilient orthopaedic support
US6554785B1 (en) * 2000-10-13 2003-04-29 Jon W. Sroufe Therapeutic combination gel and air bladder pack

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2009246628B2 (en) * 2008-05-14 2013-01-24 3M Innovative Properties Company Ankle support with splint and method of using same
US8622947B2 (en) 2008-05-14 2014-01-07 3M Innovative Properties Company Ankle support with splint and method of using same
US8986235B2 (en) 2009-03-31 2015-03-24 3M Innovative Properties Company Ankle brace
US9925083B2 (en) 2009-03-31 2018-03-27 3M Innovative Properties Company Wrist brace
EP2301488A1 (fr) * 2009-09-24 2011-03-30 MIC & Partners GmbH Rail de mise au repos

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