Knee brace with dynamic load dispersion

Abstract

A knee brace including an upper frame for supporting an upper part of a user's leg, a lower frame for supporting a lower part of the user's leg, the lower frame being hingedly coupled to the upper frame, wherein the lower frame comprises an inner frame member and an outer frame member, and wherein the frame members are spanned by a flexible webbing. The webbing may be formed in a relatively flexible material.

Description

[0001] KNEE BRACE

[0002] TECHNICAL FIELD

[0003] The present invention relates to a knee brace. More particularly the invention relates to a functional knee brace with a rigid upper frame and a deformable lower frame for dynamic load dispersion and / or injury treatment to provide injury prevention capabilities.

[0004] BACKGROUND

[0005] Knee braces are designed to support the knee joint of the wearer and may serve in preventative or rehabilitation roles. In injury prevention, knee braces are designed to support and stabilise the natural range of motion of the healthy knee joint, reducing the likelihood of an injury due to undue stress. The most common injurious forces are caused by excessive movement of the knee joint beyond its normal range of motion and include, hyperextension or front load (strain from overextension i.e., impact to knee cap), medial and lateral side load (strain on the outside of the knee i.e., impact to side of knee), rotational load (strain caused by twisting of lower leg relative to the upper). In such injury loading scenario, the role of a knee brace in injury prevention is to create an alternate load path to the knee joint, transferring injurious force away from the knee joint capsule to more robust areas of the leg. In rehabilitation roles, knee braces generally (but not exclusively) strengthen an injured knee by providing corrective assistance to promote healing.

[0006] Typically, existing knee braces may be custom made or "off the shelf' devices, and may comprise rigid upper and lower frames that interconnect by one or more hinge joints located at the medial and / or lateral sides of the knee joint for stability. The frame(s) and associated hinge system are secured to the upper and / or lower leg(s) via one or more strap(s) and the cuffs may be adjustable to conform to the shape of the wearer's leg. In addition to restraining knee movement and stabilising the knee, braces may also further decrease the risk of injury during impact force via the attachment of joint protectors.

[0007] Knee braces are common in daily locomotor activities and in sports and in order to effectively work, it is desirable that the knee brace be adjustable to precisely fit the shape of the wearer's leg(s) while conforming to leg shape changes over time and under different dynamic activities. In brief, the knee joint consists of two major joints, the patellofem oral joint that connects the knee cap (patella) with the thigh bone (femur), and the tibiofemoral joint that connects the femur with the tibia (shinbone). Considering that the skeletal arrangement of the knee bones forms a functional fulcrum, which deciphers the actions of the flexor and extensor knee muscles, variations in the anatomy of this system will translate into changes in knee dynamics and consequently mechanics.

[0008] Typically, the knee joint enables the lower leg to have a natural range of motion in three planes:

[0009] Sagittal plane, wherein the leg extends - straightens to 0 degrees and flexes - bends to 140 degrees;

[0010] Coronal Plane, wherein the leg abducts - moves away from the centre up to 25 degrees and adducts back to centre up to 10 degrees;

[0011] Transverse plane, wherein the leg rotates- internally up to 5 degrees, externally up to 15 degrees.

[0012] A key element to the functional stability of the knee joint, is the rotation of the tibia relative to the femur. This rotational component occurs at the end of knee extension, between full extension (zero degrees) and 20 degrees of knee flexion. Under this biomechanical event, the tibia rotates internally during the open chain movements (swing phase) and externally during closed chain movements (stance phase). External rotation occurs during the terminal degrees of knee extension and results in the tightening of both cruciate ligaments, which locks the knee. The tibia is then in the position of maximal stability with respect to the femur. In result, a knee brace's ability to maintain functional integrity at the knee j oint during the entire natural range of motion of the knee joint, is an essential prerequisite for overall knee stability.

[0013] Traditional functional knee braces with metal hinges and rigid frames allow motion solely in the sagittal plane and are limited in their ability to mimic the knee's multifaceted natural range of motion. Such biomechanical limitations compromise the ability of the knee joint to dampen injurious forces placing the tibiofemoral joint under unnatural pressure. Another limitation of knee braces with rigid frames is their inability to deform with the leg in response to external load forces or changing muscle form. In result, knee braces with rigid frames and metal hinges may reduce support at the knee joint allowing the leg to move / slip inside the rigid brace form. These shortcomings may be acceptable for rehabilitation use, but for athletes competing in dynamic sports and therefore exposed to injurious forces, knee braces with rigid frames do not meet their needs for comfort, performance, or protection. Further, due to anatomical and developmental variations of the knee joint, the range of motion of the knee joint varies amongst subjects. In this context, there is need for improved knee brace apparatuses that securely conform to the wearer's leg anatomy and dynamics to effectively maximise their supportive and protective aspects, reduce injuries and trauma, and enhance locomotor performance.

[0014] Conventional knee brace systems vary in materials and designs and some may be deficient in securing a firm interface between the wearer's limb and the brace itself, despite the number of straps. Moreover, the rigid lower frame of some knee braces inhibits the multiaxial range of motion of the knee joint and / or impedes the skin during hyperextension causing discomfort and / or pain to the lower leg. In cases when the lower frame of the knee brace is secured to the leg via straps circumferentially to the calf, they might cause muscle cramping and / or numbness of the lower leg and foot. In general, rigid lower frames of contemporary knee braces do not provide a secure interface between the brace and the lower leg. As a result, as the leg moves inside the brace, the rigid elements of the brace skeleton may create pressure points, changing knee mechanics and compromising the potential effectiveness of the device.

[0015] For example conventional knee braces with rigid frames reach terminal extension with the upper frame, hinge and lower frame uniting to become a rigid element. As the leg extends beyond this point, the knee joint begins to strain against the straps and move away from the brace, at the same time the contact area of leg to the rigid knee brace frame reduces to the extreme ends of the rigid element. The increasing force and reduced area creates pressure points on the thigh and in direct contact with the tibia, which enhances the risk of fracture to the tibia and damage to the knee joint. Thus, a need exists for a knee brace with an adaptive frame architecture that can predictably change form to positively secure the lower leg and provide dynamic resistance to injurious forces.

[0016] One previously proposed knee brace has attempted to overcome the drawbacks of braces which have rigid upper and lower frames. It has an elastomeric web which in use engages the anterior side of the leg of the wearer above and below the patella. The web is held in place by upper and lower fabric straps. The straps pass through slots in slender clasps or buckles which are connected to the upper and lower medial sides of the web and to the upper and lower lateral sides of the web. The medial clasps or buckles are connected together by a bi-axial hinge and the lateral clasps or buckles are hinged in the same way. The elastomeric web is intended to provide knee support and have shock absorbing capabilities. This type of support does not have a rigid upper or lower frame. The hinged clasps or buckles do not really provide any functional support for the knee because of their location and relatively small size.

[0017] Examples of the present invention seek to provide a knee brace which overcomes deficiencies of previously proposed braces.

[0018] SUMMARY

[0019] According to one aspect of the invention there is provided a knee brace which includes an upper frame, a lower frame, and hinge means for connecting the frames together characterized in that the upper frame is relatively rigid and the lower frame is elastically deformable under load.

[0020] The lower frame is relatively elastically deformable and the upper frame is relatively rigid, one relative to the other.

[0021] Examples of the invention can be considered to be a functional knee brace with adaptive frame architecture using a combination of rigid and resiliently flexible elements maintain positive contact with the leg during the natural range of motion of the knee joint, providing dynamic support and resisting injurious motion in all three planes of the knee’s range of motion.

[0022] Compared to a traditional rigid frame, which provides sudden and unyielding resistance to injurious force, the adaptive frame architecture can provide dynamic resistance to injurious loads. As the knee reaches the limits of its natural range of motion, the lower frame begins deforming to progressively increase its resistance to the injurious load as well as maintain contact with the surfaces of the leg to effectively secure the leg and support the knee joint. The progressive loading of the knee brace and increased contact with the leg distributes the force over a larger area and time, improving the comfort and effectiveness of the brace. Compared to a previously proposed brace which utilises an elastomeric web, referred to above, the knee brace of the present invention provides a far greater level of support and is therefore much better at preventing injury than the previously proposed brace.

[0023] The dynamic supporting properties of the brace of examples of the invention may also make it suitable for injury treatment in addition to injury prevention.

[0024] According to another aspect of the invention, there is provided a joint support apparatus for supporting the knee joint of a subject, comprising: an anterior rigid upper frame, and an anterior lower frame, each frame including a rigid medial arm and a rigid lateral arm, the medial arm of the upper frame and the medial arm of the lower frame being pivotally interconnected by a hinge; the lateral arm of the upper frame and the lateral arm of the lower frame being pivotally interconnected by a hinge; and at least one attachment means for connecting each frame to the subject; wherein the upper frame is rigid and lower frame is a combination of components that are rigid, semirigid or elastically deformable in response to load.

[0025] In one example, the attachment means is the femoral proximal posterior support and the femoral distal posterior support. In another example, the attachment means is the tibiofibular proximal posterior support and the tibiofibular distal posterior support.

[0026] As used herein the term 'semi-rigid' refers to a structure formed from at least two different materials, one of which may be substantially rigid having a high amount of stiffness and / or toughness and another material that may be more flexible. The stiffer material may provide better structural support for the joint of the subject and the more flexible material may be able to conform more readily to the dynamic changes of the wearer's leg shape during an activity, while maintaining locomotor performance and minimising the risk of injuries.

[0027] In one embodiment, at one of the frames may have an anterior part that is formed from a flexible elastomeric material, and the medial and lateral arms of the frame may be formed from a stiffer material, that is, one material relative to the other material.

[0028] At least one of the upper and lower frames, and / or the at least one hinge may include a lining which has anti-slip surface. In accordance with another aspect, there is provided a joint support apparatus for supporting the joint of a subject, comprising: an upper frame and a lower frame, each frame including a medial arm and a lateral arm, the medial and lateral arms respectively being pivotally interconnected by at least one hinge; at least one attachment means for connecting each frame to the subject; and a lining for at least one of the upper frame, the lower members and the at least one hinge, wherein the lining has an anti-slip surface.

[0029] A lining having anti-slip surface may assist in securely locating and fitting the joint support apparatus on the subject. The lining may also provide padding having shock absorbing properties.

[0030] In some embodiments, at least one of the upper and lower frames may include a joint protector. The at least one joint protector may attach to the hinges via at least one flexible element.

[0031] In another aspect, there is provided joint support apparatus for supporting the knee joint of a subject, comprising: an upper frame and a lower frame, each frame including a medial arm and a lateral arm, the medial and lateral arms respectively being pivotally interconnected by a respective hinge; at least one anterior joint protector, wherein the at least one joint protector interconnects and attaches to the hinges via at least one flexible element; and at least one attachment means for connecting each frame to the subject.

[0032] The use of at least one flexible element may assist in providing an adaptive frame architecture and multiaxial hinge system that may collectively support motion in up to six degrees of freedom while providing dynamic linear resistance to injurious force.

[0033] At least one of the joint protectors may include a lining, which has a lattice form and / or antislip properties.

[0034] In some embodiments, the upper frame may be a femoral frame and the lower frame may be a tibiofibular frame, thereby forming a knee brace, wherein the upper frame is substantially rigid and the lower frame is semi-rigid, or both frames are semi-rigid. At least one of the upper and lower frames may include a knee protector, wherein the knee protector may interconnect and attach to the hinges via at least one flexible element. The attachment of the at least one knee protector to the hinges via at least one flexible element may control the independent movement of the knee protector when the knee undergoes flexion and or extension.

[0035] In another aspect, there is provided a knee brace for supporting the knee joint of a subject, comprising: an upper (femoral) frame and a lower (tibiofibular) frame, each frame including a medial arm and a lateral arm, the medial and lateral arms respectively being pivotally interconnected by at least one hinge; each of the upper and lower frames including a knee protector; wherein the knee protectors are interconnected and attach to the hinges via at least one flexible element; and at least one attachment means for connecting each frame to the subject.

[0036] In one embodiment, at least one of the frames has an anterior part that is formed from a flexible elastomeric material, and the medial and lateral arms of the frame are formed from a stiffer material.

[0037] At least one of the upper and lower frames, and / or the at least one hinge may include a lining which has a lattice form and / or anti-slip properties.

[0038] The opposed medial and lateral arms of the upper and lower frames may be respectively interconnected internal of medial and lateral joint housing by medial and lateral tensioned, resilient ligaments, wherein the ligaments may pass through channels between opposite facing bearing surfaces inside the medial and lateral joint housing.

[0039] The medial and lateral resilient ligaments respectively may hold opposed ends of the medial and lateral arms in mutual articulatory bearing arrangement with corresponding opposite facing bearing surfaces inside the medial and lateral joint housing.

[0040] The structural arrangement of the medial and lateral resilient ligaments may restrain and dampen flexion and extension of the femoral and tibiofibular frames. The medial and lateral tensioned, resilient ligaments may respectively include a tensioned filament looped over a spaced pair of spools, and wound on an elongate inter-spool segment. Each ligament may further include a resilient over moulding over the inter-spool segment, the radially wound tensioned filament, and side edges of the spools.

[0041] Opposing facing bearing surfaces inside the medial and lateral housings respectively may provide hyperflexion and hyperextension stops.

[0042] The tibiofibular frame may have rear proximal and distal supports for supporting a rear of the wearer's leg, wherein the proximal rear support may pass exclusively above the gastrocnemius muscle.

[0043] The structural arrangement of the proximal rear support of the tibiofibular frame in relation to the gastrocnemius muscle may provide a secure interface between the wearer's lower leg and the knee brace without creating artificial pressure points on the gastrocnemius muscle that may cause muscle cramping and or numbness of the lower leg and foot and in extreme cases compromise the potential effectiveness of the brace by altering knee dynamics.

[0044] The tibiofibular frame may comprise distally an anterior segment for supporting a front of the wearer's leg, where the anterior segment is configured to be located in situ below the tibial tuberosity. The anterior segment may have a flat surface with ridges parallel to its proximal and distal edges and asymmetric arms vertically placed at its medial and lateral proximities.

[0045] The anterior segment of the lower frame may be positioned anterior to the tibia and fibula and due to its flat configuration and increased surface area, it may reduce impact stresses and protect the proximal aspect of the leg bones from avulsion and direct trauma. More preferably, the flat configuration and material properties of the anterior segment of the lower frame may prevent unnatural movement at the knee joint and indirectly protect the knee ligaments from injury.

[0046] The anterior segment may comprise thermoplastic urethane, a melt-processable thermoplastic elastomer. Preferably, the anterior segment of the lower frame exhibits properties like abrasion / scratch resistance that may increase the durability of the knee brace, soft touch for comfort, UV resistance, ventilation, great flexibility over a wide temperature range, excellent impact strength and flexibility. The medial arm of the anterior segment of the tibiofibular frame may have an antler-like configuration, with its distal end and mid body moulded into the urethane and its proximal end extending superior-medially and diagonally to the proximal edge of the urethane. The lateral arm of the anterior segment of the tibiofibular frame may be asymmetrical, its distal and mid body may be moulded into the urethane and its proximal end may extend superiorly and laterally to the proximal edge of the urethane.

[0047] The knee brace may have at least one knee protector, each with opposed proximal and distal sides extending between opposed proximal and distal arcuate edges and releasably connected via releasable fasteners.

[0048] The at least one knee protector may have opposed proximal and distal sides extending between opposed proximal and distal arcuate edges and releasably connected via releasable fasteners.

[0049] In another aspect, there is provided a frame component for use in a knee brace, wherein the frame component is moulded in a flat or generally flat shape and is elastically deformed into a curved shape when assembled in the knee brace.

[0050] In accordance with another example, there is provided a method of making a frame component for a knee brace, wherein the frame component is moulded in a flat or generally flat shape.

[0051] In some embodiments, there is provided a method of making a knee brace having upper and lower frames coupled together for rotational movement, the method including the steps of moulding one of the frames in a generally flat shape and elastically deforming said one frame into a curved shape in the assembled knee brace.

[0052] The moulding method, wherein said one frame includes relatively stiff lateral components and the method includes the steps of locating the lateral components in a mould and over moulding said components with a relatively flexible web.

[0053] In one aspect, the knee brace includes an upper frame for supporting an upper part of a user's leg, a lower frame for supporting a lower part of the user's leg, the lower frame being hingedly coupled to the upper frame, wherein the lower frame comprises an inner frame member and an outer frame member, and wherein the frame members are spanned by a flexible webbing. The knee brace comprises frame members each of which are formed in a relatively rigid material, and wherein the webbing is framed in a relatively flexible material.

[0054] For example, in the event of an injurious frontal load, the deformable lower frame can change form to secure the lower leg in three unique ways. Firstly, in response to an external frontal force the brace reaches its preset extension limit with the upper frame, hinge and lower frame uniting to become a load bearing surface and the adaptive strap ensures the leg is optimally secured to the load bearing surface. Secondly, as the leg extends beyond this point the rigid “antlers” provide resistance on either side of the lower leg, securing the leg in the brace, while the resilient segment begins deforming predictably under load providing a resistive force. Third, as the injurious force increases, the resilient segment further deforms to maintain full contact with the leg while providing an increasing resistive force. The gradually increasing resistance and increased contact surface area enhance the effectiveness of the knee brace, reducing the risk of injury to the knee and significantly decreasing the chances of bone fracture.

[0055] Further, traditional rigid braces require manual adjustment as range of motion increases. The need for continuous adjustment and the excessive rigidity detract from the knee brace benefit. To make matters worse, if such knee braces are not adjusted properly, they may exacerbate pathologies or injuries. In contrast, a functional knee brace with adaptive frame architecture will automatically adapt to the user ensuring optimal fit and function. Both in the short term, muscles contracting and expanding, and in the long term, muscle growth or weight loss.

[0056] BRIEF DESCRIPTION OF THE FIGURES

[0057] Examples of the invention are described by way of non-limiting example only and with reference to the accompanying drawings, in which:

[0058] Figure l is a perspective anterior view of a knee brace of the invention, for the right lower limb;

[0059] Figure l is a perspective posterior view of a knee brace, for the right lower limb;

[0060] Figure 3 is a perspective lateral view of the knee brace when the knee joint is at or near full flexion; Figure 3A is a schematic view of a cover plate of a hinge housing;

[0061] Figure 3B is a more detailed view of an upper joint protector;

[0062] Figure 3C is a cross-sectional view of the upper joint protector taken on the line 3-3;

[0063] Figure 3D is a more detailed view of a lower joint protector;

[0064] Figure 3E is a cross-sectional view of the lower joint protector taken on the line 4-4;

[0065] Figure 3F is a schematic anterior view of the tibiofibular frame;

[0066] Figure 4 is a schematic anterior view of the knee brace, excluding the joint protectors and all lining;

[0067] Figure 5 is a schematic side view of the knee brace, excluding the joint protectors and all lining;

[0068] Figure 6 is another schematic side view of the knee brace, excluding the joint protectors and all lining;

[0069] Figure 7 is a schematic posterior view of the knee brace, excluding the joint protectors and all lining;

[0070] Figure 8 is a schematic anterior view of an anterior segment and arms of a tibiofibular frame, excluding lining, padding and all rear supports;

[0071] Figure 8A is a schematic cross-sectional view along the line 8-8 shown in Figure 8, of an anterior segment substantially similar in accordance with another example of the present invention;

[0072] Figure 9 is a schematic anterior view illustrating the flexibility of a semi-rigid tibiofibular frame of the knee brace for the right lower limb, excluding lining, padding and all rear supports;

[0073] Figure 10 is a schematic anterior medial view of a tibiofibular frame, with a proximal rear support in situ;

[0074] Figure 11 is a schematic lateral view of a tibiofibular frame, with proximal and distal rear supports in situ;

[0075] Figure 12 shows an un-braced leg experiencing hyperextension and a braced leg, depicting load being dispersed across the leg and away from the knee joint;

[0076] Figure 13 is a schematic lateral view of the lower limb fitted with a knee brace of the invention, when the lower leg is in a straight position, extended and in hyperextension; Figure 14 is a schematic lateral view of the lower limb fitted with a traditional knee brace with metal hinges and rigid frames, when the lower leg is in a straight position, extended and in hyperextension;

[0077] Figure 15 schematically shows side load applied to the leg which may result in MCL injury;

[0078] Figure 16 is a schematic anterior view of the lower limb fitted with a knee brace of the invention, when the lower leg is subjected to side load;

[0079] Figure 17 is a schematic anterior view of the lower limb fitted with a traditional knee brace with a rigid lower frame, when the lower leg is subjected to side load;

[0080] Figure 18 schematically shows torsional load applied to the leg which may result in injury; and

[0081] Figure 19 shows a graph of transverse plane rotational force versus angle of the lower leg.

[0082] DETAILED DESCRIPTION

[0083] For brevity, the illustrations and examples below are described in relation to the right knee. It will be appreciated that a person skilled in the art would readily understand how to modify the examples provided herein for use with the left lower limb, and to accommodate morphological variations of the human knee joint and lower limbs. Briefly a left knee brace is essentially a mirror image of the right knee brace.

[0084] In the description herein, certain directional terminology may be used which, unless the context clearly requires otherwise, should be considered with reference to general anatomical terms for the human body. The terms proximal and distal refer to locations of the brace that correspond to the locations of the attachment points of the apparatus to the legs in use, relative to the knee joint. That is, "proximal" refers to positions on the brace that in use will be closer to the knee joint, while "distal" refers to positions on the brace that in use will be further away from the knee joint.

[0085] The terms upper and lower respectively refer to areas at the top and bottom relative to the knee. The embodiments of the knee brace can also be considered to fall within anterior and posterior sections relative to the coronal or frontal plane, which is a vertical plane that passes through the body longitudinally but perpendicular to the sagittal plane. Therefore, an anterior side or element is located in front of the coronal plane, whereas a posterior side or element is located behind the coronal plane in use.

[0086] The terms medial and lateral are relative terms indicative of locations in relation to the midline or the midsagittal plane of the human body, wherein medial and lateral refer to elements or locations respectively towards and away from the midline of the body.

[0087] As used herein the term "rigid1refers to a structure formed of substantially rigid materials having a high amount of stiffness and / or toughness and are generally devoid of flexibility. Rigid materials can break when deformed past their breaking point. The term "flexible" is intended to denote materials that deform elastically under a normal operating range of stresses and can return to their original form when the applied stress is removed. The term "resilient" refers to materials that absorb energy when deformed elastically, and release said energy when unloading.

[0088] Referring to Figures 1 and 2, a knee brace 10 according to one example comprises an upper (femoral) frame 20, a lower (tibiofibular) frame 30 with anterior (shown in Figure 1) and posterior (shown in Figure 2) surfaces and upper medial arm 40, lower medial arm 50, upper lateral arm 60, and lower lateral arm 70 (shown in Figures 1 and 2). The frames 20 and 30 are connected together by medial and lateral hinges 11 and 13, as will be described in more detail below. The medial arms 40, 50 and lateral arms 60, 70 are made of long glass fiber reinforced nylon with tensile strength 228 MPa, tensile elongation 2% to 3%, tensile modulus 18,000 MPa, flexural strength 335 MPa and flexure modulus 16,500 MPa. The medial and lateral arms may also be made of short glass fiber reinforced nylon with tensile strength 173MPa, flexure strength 240 MPa and flexural modulus 8,000 MPa. The hinges 11 and 13 medial and lateral joint housings 80 and 90 respectively.

[0089] The brace 10 further comprises an upper joint protector 100, and a lower joint protector 110. The upper and lower joint protectors 100, 110 interconnect with each other and are configured to be positioned in use over the patella bone. The joint protectors 100, 110 attach to the hinge joint housings 80, 90 via a medial flexible member 120 and lateral flexible member 121 which will be described in more detail below (shown in Figures 1 to 3). Referring to Figure 2, linings 101, 102, 103, 104 and / or 105 with shock absorbing properties are provided on the posterior faces of the joint protectors 100, 110, and the femoral 20 and tibiofibular 30 frames, and on the inner faces of the medial 80 and lateral 90 hinge joint housings.

[0090] Referring to Figure 3 the femoral 20 and tibiofibular 30 frames have an arcuate configuration (dotted lines) to conform to the wearer's lower limb.

[0091] The femoral frame includes proximal 21 and distal 22 segments interconnected via an anterior rigid body 23. The distal segment 22 comprises medial 24 and lateral 25 portions extending substantially perpendicularly to the long axis 15 of the distal segment 22 of the femoral frame 20.

[0092] The lateral portion 25 includes a retainer 26 for attaching femoral distal posterior support 29a to the lateral portion 25. In the illustrated example, the retainer 26 is triangular tab, with one vertex secured to / near the lateral end of the lateral portion 25 via at least one fastener 27. Opposite the fastener 27 is a rectangular aperture 28a aligned parallel to the base of the triangular retainer 26 for the insertion of the lateral part of the femoral distal posterior support 29a (shown in Figures 2 and 3) to the femoral frame 20. The femoral distal posterior support 29a secure the femoral frame 20 circumferentially to the wearer's thigh (shown in Figure 3). Referring to Figure 2, the lateral portion 25 of the distal segment 22 of the femoral frame 22 includes the lining 101 having a lattice grip surface.

[0093] Referring to Figures 4 and 6, the medial portion 24 of the distal segment 22 of the femoral frame 20 has a longitudinal aperture 28b for attaching the femoral distal posterior support 29a to the medial portion.

[0094] The femoral distal posterior support 29a may comprise a fabric strap configured to be wrapped behind the wearer's thigh, thereby securing the femoral frame 20 to the front of the wearer's thigh. The length of the strap may be adjustable, for example via a hook and loop fasteners.

[0095] Referring to Figures 1, 3, 5 and 6, the proximal segment 21 of the femoral frame 20 extends to medial 40 and lateral 60 arms that interconnect with the respective medial 50 and lateral 70 arms of the tibiofibular frame 30 via hinges 1 land 13. The medial 40 and lateral 60 arms of the femoral frame 20 also interconnect posteriorly via a femoral proximal posterior support 29b (shown in Figures 2 and 3), wherein the femoral proximal posterior support 29b respectively attaches to the medial 40 and lateral 60 arms via medial 41 and lateral 61 triangular retainers. Referring to Figures 5 to 7, one vertex of each of the retainers 41 and 61 is respectively secured to the medial 40 and lateral 60 arms by fasteners 42 and 62. Opposite to the fastener of each retainer is a rectangular aperture 43, 63 for the insertion of the femoral proximal posterior support 29b (shown in Figures 2 and 3). The femoral proximal posterior support 29b may comprise a strap that configured to be wrapped behind the wearer's thigh. The length of the strap may be adjustable, for example via a hook and loop fasteners, to conform to the wearer's thigh.

[0096] Figures 1 to 3 respectively show anterior, posterior and lateral views of the brace with the joint protectors and its two components 100 and 110 in situ. The distal end of the upper joint protector 100 attaches to the proximal segment 21 of the femoral frame 20. The upper joint protector 100 has one or more apertures adjacent to its distal edge for the insertion of fasteners to secure it to the femoral frame 20 as will be described in more detail below. Other means for attaching the upper joint protector 100 to the femoral frame 20 may be provided.

[0097] The distal part of the lower joint protector 110 is connected to the proximal end of the tibiofibular frame 30. The lower joint protector 110 has one or more apertures for the insertion of fasteners to secure the joint protector 110 to the tibiofibular frame 30 as will be described in more detail below. Other means for attaching the lower joint protector 110 to the tibiofibular frame 30 may be provided.

[0098] The upper joint protector 100 extends anteriorly over the lower joint protector 110 for a partial overlap (see Figure 3). As described previously, the upper 100 and lower 110 joint protectors interconnect and attach to the hinge housings 90, 80 by the flexible elements 120 and 121.

[0099] As best seen in Figure 3, one end of the medial flexible element 120 is attached to the posterior and proximal aspect of the upper joint protector 100 and passes freely through an opening 130 formed through the lower joint protector 110. The other end of the flexible element 120 is attached to the medial joint housing 80. Similarly, one end of the lateral flexible element 121 is connected to the lower part of the upper joint protector 100 and freely passes through an opening 131 formed through the lower joint protector 110. The other end of the element 121 is connected to the lateral joint housing 90.

[0100] In the illustrated embodiment the flexible elements 120 and 121 are slack i.e. not under tension when the wearer's leg is straight. When flexure of about 60° to 80° of the knee joint of the wearer occurs the elements 120 and 121 become taught and exert resilient bias which tends to resist further flexure of the knee joint.

[0101] The flexible elements 120 and 121 can be formed from elastomeric material sheathed in braided fabric. The elements 120 and one 121 can be formed as a loop which is held captive in the respective housings 80 and 90 as will be described in more detail below.

[0102] Figure 3 A is a schematic view of an internal cover plate 123 for the housing 80. It is moulded from rigid plastics material and the lining 102 bonded to its outer face. Its inner face is formed with locating bosses 125 and 127 and interlock projections 129 and 133. The bosses 125 and 127 and projections 129 and 133 cooperate with complementary openings (not shown) in the housing 80. The looped element 120 passes around the projection 129 and so is held captive relative the housing 80 when the cover plate 123 is in position in the housing. The flexible element 121 and housing 90 are of similar construction and need not be described in detail.

[0103] This configuration allows multiaxial movement at the knee joint and additionally secures the position of the joint protectors over the knee joint preventing the patella bone from injurious force by absorbing impact energy and redistributing it towards the hinges 11 and 13.

[0104] The joint protectors 100 and 110 are made of flexible materials for example high durometer TPU with tensile strength 55 MPa and tensile elongation 440% so as to not inhibit natural joint dynamics. Other equivalent materials may also be used.

[0105] The structure of the upper joint protector 100 is shown in more detail in Figures 3B and 3C. In one example, the protector 100 is moulded from the high durometer material as a relatively thin walled generally shield shaped body 150 having a wall thickness which reduces from about 2mm at its curved top edge 151 to about 1mm at its concavely curved lower edge 153. The lining 104 is bonded to the posterior surface of the body 150, as best seen in Figure 3C. The body 150 is formed with two mounting tabs 154 and 155 each provided with respective elongate openings 156 and 157. A further bore 158 passes through the body 150 and lining 104 adjacent to the centre of the top edge 151. A connector 159 such as a stud, rivet or screw passes through the bore 158 and anchors the body 150 to the proximal segment of the femoral frame as shown in Figure 2.

[0106] The fasteners 42 and 62 pass through the elongate openings 156 and 157 respectively so that the fasteners 42 and 62 couple the upper part of the body 150 to the femoral frame 20 in a manner which enables limited relative movement between the sides of the body 150 and the femoral frame 20. This effectively avoids excessive stress being applied to the knee joint of the wearer.

[0107] The lining 104 is formed with openings 160 and 162 adjacent to the lower edge 153 to permit the flexible elements 120 and 121 to pass therethrough and to be securely fixed to the body 150 by means of adhesives as bonding.

[0108] The structure of the lower joint protector 110 is shown in detail in Figures 3D and 3E. In one example, the protector 110 is moulded from the high durometer material as a relatively thin walled generally shield shaped body 170 having a wall thickness which reduces from about 2mm at its curved lower edge 172 to about 1mm at its curved upper edge 174. The lining 105 is bonded to the posterior surface of the body 170 as seen in Figure 3E. The body 170 is integrally formed with two mounting tabs 176 and 178 each provided respective with bores 180 and 182. The bores permit medial and lateral fasteners 184 and 186 respectively to pass therethrough for connection to the lower medial arm 50 and lower lateral arm 70 respectively, as shown in Figures 5 and 6. The relatively narrow mounting tabs 176 and 178 permit limited rotation of the protector 110 relative to the arms 50 and 70 by resilient flexure of the tabs 176 and 178.

[0109] The body 170 is integrally formed with an interlocking tab 188 at the centre of its lower edge 172. The tab 188 has laterally extending projections 190. In the assembled brace, the tab 188 passes into a slot 191 formed centrally and adjacent to the upper edge 193 of an anterior segment 33 of the frame 30, as shown in Figure 8. The lateral projections 190 hold the tab 188 captive in the slot 191 whilst permitting limited movement of the protector 110 relative to the segment 33 in the direction of line 4 - 4 shown in Figure 3D or the axis 15 of the wearer's tibia, as shown in Figure 16.

[0110] The protectors 100 and 110 are both curved about the axis 15 and the protector 110 has a somewhat smaller radius of curvature about the axis 15 relative to that of the protector 100 so that it can snugly underlie the upper joint protector 100 in the assembled brace.

[0111] The medial 50 and lateral 70 arms of the tibiofibular frame 30 connect posteriorly via an adjustable tibiofibular proximal 31 and distal 32 support, for supporting the rear of the wearer's leg and the tibiofibular proximal posterior support 31 passes above the gastrocnemius muscle (as shown in Figures 2 and 3).

[0112] The proximal 31 and distal 32 tibiofibular supports support the rear of the wearer's leg. Specifically, the proximal rear support 31 includes a fabric strap 55 (see Figure 10) which passes exclusively above the gastrocnemius muscles of the wearer. The lateral end of the strap 55 passes through a slot 189 formed in an extension 79 from the lateral arm 70 of the tibiofibular frame 30. The strap 55 is provided with hook and loop fasteners for fixing the lateral end to the extension 79. The medial end of the strap 55 is connected to a medial retainer 192 which is pivotally connected to the lower medial arm 50 by means of a fastener 200. The medial end of the strap 55 is also provided with hook and loop fasteners for fixing the strap to the retainer 172.

[0113] The distal tibiofibular support 32 includes a fabric strap 194 as seen in Figure 11. The medial end of the strap 194 passes through the aperture 37 and is fixed to the anterior segment 33 by means of hook and loop fasteners provided on the strap 194. The other end of the strap 194 is connected to the distal lateral retainer 77 by means of the hook and loop fasteners on the strap.

[0114] Figure 3F is a schematic anterior view of the tibiofibular frame 30. It will be seen that the lining 103 generally conforms to the shape of frame 30 except that it has a medial extension 196 which functions as a flexible strap. It is located adjacent to the proximal medial retainer 192 and underlies the strap 55 when the brace is fitted to the wearer. The posterior face of the extension 196 may be provided with patches of hook or loop fasteners for cooperation with complementary fasteners on the strap 55 to assist in retaining the strap 55 in position. Referring to Figures 4 to 7, the medial 50 and lateral 70 arms of the tibiofibular frame 30 connect anteriorly via an anterior segment 33 located in situ below the tibial tuberosity of the wearer. In reference to Figures 8 and 8 A, the anterior segment 33 includes a flat surface 34 with ridges generally parallel to its proximal 35 and distal 36 edges. The anterior segment connects with the opposed nylon asymmetrical arms 50, 70 at its medial and lateral edges respectively. The lateral arm 70 of the tibiofibular frame 30 is wider than the medial arm 50 and nests, in use, above the anterior dorsiflexor and lateral fibular muscle groups of the lower leg of the wearer.

[0115] Preferably, the relatively rigid lower arms 50 and 70 are initially formed and the anterior segment 33 is co-moulded about them. This composite moulding has a generally flat shape and is elastically deformed about the axis 15 in the assembled apparatus to a curved shape and is retained in the curved shape when the proximal ends of the arms 50 and 70 are coupled to hinges interconnecting the frames 20 and 30. The anterior segment 33 is made of high durometer thermoplastic urethane, a melt-processable thermoplastic elastomer with 440% tensile elongation and ~55 MPa tensile strength. The moulding method coupled with the material properties of thermoplastic urethane increase the flexibility of the anterior segment (as schematically illustrated in Figure 9) and impact strength. Nonetheless, other comparably flexible elastomeric materials can be used.

[0116] The flat or generally flat configuration of the anterior segment 33 coupled with its increased surface area may reduce impact stresses and protect the proximal aspect of the tibia and fibula from avulsion and direct trauma. More preferably, the flat configuration and material properties of the anterior segment 33 may prevent unnatural movement at the knee joint and indirectly protect the knee ligaments from injury.

[0117] With reference to Figures 8 and 10, the medial arm 50 of the tibiofibular frame 30 has an antler-like configuration with its distal end 51 and mid body 52 moulded into the urethane material of the anterior segment 33, and its proximal end 53 extending medially and diagonally to the proximal edge of the anterior segment 33. The proximal end 53 of the medial arm 50 of the tibiofibular frame 30 includes at least one aperture 54 for the insertion of a fastener that connects the medial arm 50 to the hinge 11. The body of the medial arm 50 is an attachment point of the strap 55 for the attachment of the medial edge of the proximal support 31 of the tibiofibular frame, as previously described. With reference to Figures 8 and 11, the lateral arm 70 of the tibiofibular frame 30 is asymmetrical, and its distal end 71 and mid body 72 are moulded into the urethane of the anterior segment 33 and its proximal end 73 extends laterally and above the upper edge 193 of the anterior segment 33. The proximal end 73 of the lateral arm 70 includes an aperture 74 for connection with part of the hinge 13.

[0118] The hinges 11 and 13 and their components are described in detail in the applicant’s WO 2006 / 053391 and WO 2008 / 061300 which are hereby incorporated in their entirety by reference. The illustrated apparatus includes hinge joint housings 80 and 90 each having an outer cover 91 having vertically spaced apertures 92 for the insertion of fasteners which connect the respective arms 50 and 70 to the hinges 11 and 13.

[0119] Figures 12 to 14 diagrammatically show the effects of hyperextension on an unbraced leg, and legs braced with the brace 10 of the invention and a prior art brace. Figure 16 diagrammatically shows an unbraced leg and a braced leg when subjected to hyperextension. The left image shows an unbraced leg and the arrow 280 represents forces applied along the tibia and fibula. The left image shows the leg with a brace 282 and in this case arrow 284 representing forces applied to the leg being transmitted through the brace thereby substantially bypassing the knee, thereby reducing the possibility for injury to the knee.

[0120] Figure 13 shows the functionality of the adaptive semi-rigid tibiofibular frame 30 of the knee brace 10 of the invention when the lower leg moves from a straight position 140 to full extension 141 and hyperextension 142. The combination of a semi-rigid or elastically deformable tibiofibular frame 30, flexible posterior rear support 31, and multiaxial hinges 11 and 13 allows the dynamic knee brace of the invention to maintain the natural range of motion of the knee joint at all points in the flexion / extension cycle. In doing this, the semirigid or elastically deformable tibiofibular frame 30 can deform and remain securely applied to the wearer's leg ensuring the latter does not move inside the frame during a full flexion extension cycle. The proximal support 31 is capable of limited resilient expansion to support and stabilise the rear of the wearer's leg.

[0121] The performance of the brace of an example of the present invention as the leg moves from straight to hyperextension includes the following stages: 1. The frames 20 and 30 lock so that there is no more rotation about the hinges 11 and 13;

[0122] 2. Leg moves away from frame;

[0123] 3. The antler shaped medial and lateral arms 50 and 70 clamp on the leg;

[0124] 4. The deformable or anterior segment 33 elongates to maintain contact with the leg; and

[0125] 5. TPU closure elongates and fails predictably.

[0126] This is in contrast to a typical rigid frame 250 as shown diagrammatically in Figure 14 when subjected to similar loading as described above. Briefly the loading causes the frames to lock preventing further rotation, then the leg moves inside the frames and straps whereby the load and pressure are applied to the bones instead of being borne by the frames. This can result in possible strap failure and bone fracture.

[0127] Figures 15, 16 and 17 diagrammatically illustrate side forces being applied to a brace of the invention and a previously proposed form of brace with rigid frames. In Figure 15 arrows 290 and 292 show the direction of forces applied medially and laterally respectively to the leg. Figure 16 diagrammatically shows medial lateral forces being applied to the leg. The image on the right shows the tibiofibular frame 30 deformed whilst still providing support to the knee joint. The deformation is primarily possible due to the elasticity of the anterior element 33. More particularly, the anterior segment 33 elastically deforms while allowing the medial and lateral arms 50 and 70 (antlers) to be displaced and with the lining 103 remain in contact with the leg whereby the arms 50 and 70 bear the side load and help to prevent injury.

[0128] Figure 17 diagrammatically shows performance of a prior art brace 260 under side load. The brace 260 has a rigid upper frame 262, rigid lower frame 264, an upper strap 266, lower strap 268 which is connected to the lower frame 264 by a resilient cuff 270. The frames are connected together by medial and lateral hinges 272 and 274. When brace 260 is subjected to side loading the leg tends to slip relative to the rigid lower frame 264 causing potentially injury causing pressure adjacent to anterior side of upper strap 266 and the adjacent to the lateral hinge 274. Figure 18 diagrammatically shows torsional forces as indicated by bi-directional arrow 294. Torsional forces in either direction can be injury causing and the brace of the invention is also capable of protecting the knee against excessive torsional forces. The inclusion of the resilient segment 33 enables deformation thereof whilst the lining 103 snugly remains in engagement with the leg of the wearer. Figure 9 diagrammatically shows the range of deformations of the segment 33. In contrast, previously proposed braces with rigid upper and lower frames, tend to permit movement of the leg within the frames thereby increasing the likelihood of injury to the knee.

[0129] Figure 19 is a graph showing rotational force applied to the lower leg versus rotation of the lower leg as measured in the transverse plane. Line 296 shows the performance of the brace of the invention whereas the line 298 shows the performance of a typical brace with rigid frames. As can be seen from the graph up to about 3 kg of rotational force, the rotational angle of the lower leg is the same. For higher forces, there is reduced rotation in the rigid braces. This increases the possibility of injury in existing braces at higher levels of torsional loading.

[0130] As will be appreciated from the above, the brace of the invention supports the natural range of motion of the leg and can be used for injury treatment or prophylactically to reduce injury. They can support an unstable knee joint by providing an alternate load path around the knee joint, they reduce injury by transferring injurious force away from the knee joint to more robust parts of the leg. So the knee brace has the ability to secure the leg and to predictably absorb load with engineered failure points (crumple zones) determines how effective they are in reducing injury.

[0131] As described above, in relation to Figures 12 to 18, the present invention seeks to solve the problems with previously proposed rigid frames in that their rigidity and simple motion in the sagittal plane, limits their ability to mimic the knee’s natural range of motion. Further to this, the rigid frames inability to change form under three common injurious front, side and torsional loads scenarios, significantly reduces their ability to dampen these forces and reduce the incidence and significance of knee joint injuries. As described above the braces of the present invention respond to these load scenarios in a way that existing knee braces do not. Table 1 below shows example materials which may be selected for manufacture of knee braces in accordance with an example of the present invention. In particular, the arms 50 and 70 (or antlers) of the lower frame may be formed of one or more of the rigid strut materials; shown in columns 1 to 3. The anterior segment 33 (or bridge) may be formed of the flexible material shown in column 4 The upper frame 20 may be formed of one or more of the rigid strut materials.

[0132] While various features of embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not by way of limitation. It will be apparent to a person skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the present invention should not be limited by any of the above described exemplary embodiments.

[0133] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

[0134] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

[0135] TABLE 1

[0136]

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. A knee brace which includes an upper frame, a lower frame, and hinge means for connecting the frames together characterized in that the upper frame is relatively rigid and the lower frame is elastically deformable under load.

2. A brace for supporting the knee joint of a subject, comprising: an anterior rigid upper frame, and an anterior lower frame, each frame including a rigid medial arm and a rigid lateral arm, the medial arm of the upper frame and the medial arm of the lower frame being pivotally interconnected by a hinge; the lateral arm of the upper frame and the lateral arm of the lower frame being pivotally interconnected by a hinge; and at least one attachment means for connecting each frame to the subject; wherein the upper is rigid and lower frame is a combination of components that are rigid, semi- rigid or elastically deformable in response to load.

3. A brace according to claim 2, wherein the lower frame has an anterior part (or bridge) that is formed from a flexible elastomeric material, and the medial and lateral arms of the lower frame are formed from material which is stiffer than said flexible elastomeric material.

4. A brace according to claim 2, wherein the anterior part of the lower frame comprises varying thickness for dispersing load predictability.

5. A brace according to any one of the preceding claims, wherein the upper frame has a flexible anterior joint protector, and the lower frame has a flexible joint protector that extends one of the joint protectors at least partially overlapping the other.

6. A brace according to claim 5, wherein the upper joint protector overlies the lower joint protector.

7. A brace according to claim 5 or claim 6, wherein the at least one flexible load bearing leg restraining element is attached posteriorly to the hinges via at least one flexible element with engineered failure mode.

8. A brace for supporting the knee joint of a subject, comprising: an upper frame and a lower frame, each frame including a medial arm and a lateral arm, the medial and lateral arms respectively being pivotally interconnected by a respective hinge; at least one anterior joint protector, wherein the at least one joint protector interconnects and attaches to the hinges via at least one flexible element; and at least one attachment means for connecting each frame to the subject.

9. A brace according to any one of the preceding claims wherein the upper frame is a femoral frame and the lower frame is a tibiofibular frame thereby forming a knee brace.

10. The brace of claim 9, wherein the tibiofibular frame is semi-rigid or elastically deformable.

11. The brace of claim 9, wherein the femoral frame is substantially rigid.

12. The brace of claim 9 or claim 10, wherein the femoral frame is semi-rigid.

13. The brace according to any one of claims 9 to 12, further including at least one conformable knee protector.

14. A brace according to claim 13, wherein each of the upper and lower frames includes an overlapping conformable knee protector connected with an elastic retention strap.

15. The brace according to claim 14, wherein the knee protectors interconnect and attach to the hinges via at least one flexible element.

16. A knee brace for supporting the knee joint of a subject, comprising: an upper (femoral) frame and a lower (tibiofibular) frame, each frame including a medial arm and a lateral arm, the medial and lateral arms respectively being pivotally interconnected by at least one hinge; each of the upper and lower frames including a knee protector; wherein the knee protectors are interconnected and attach to the hinges via at least one flexible element; and at least one attachment means for connecting each frame to the subject.

17. A knee brace according to claim 16, wherein at least the lower frame is semi-rigid.

18. The knee brace according to claim 16 or claim 17, wherein the opposed medial and lateral arms are respectively interconnected internal of medial and lateral joint housings by medial and lateral tensioned, resilient ligaments.

19. The knee brace of claim 18, wherein the ligaments pass through channels between opposite facing bearing surfaces inside the medial and lateral joint housings.

20. The knee brace as claimed in claims 18 or 19, wherein the medial and lateral resilient ligaments respectively hold the opposed ends of the medial and lateral arms in mutual articulatory bearing engagement with corresponding opposite facing bearing surfaces inside the medial and lateral joint housings.

21. The knee brace according to any one of claims 18 to 20, wherein the medial and lateral resilient ligaments resiliently restrain and dampen flexion and extension of the femoral and tibiofibular frames.

22. The knee brace according to claim 20, wherein the opposite facing bearing surfaces inside the medial and lateral joint housings respectively provide hyperflexion and hyperextension stops.

23. The knee brace according to any one of claims 16 to 22, wherein the tibiofibular frame has rear proximal and distal supports in the form of flexible co-moulded elements with unique form and engineered load bearing properties for supporting a rear of the wearer's leg - the knee brace may include a TPU strap which deforms predictably and a ratchet system which fails under load, in contrast to typical fabric straps which do not adapt to load - while a tibiofibular frame with two straps may have been previously proposed, it is the shape, material selection and engineered failure of the rear proximal strap that is unique to aspects of the present invention.

24. The knee brace according to claim 23, wherein the proximal rear support of the tibiofibular frame is in the form of a flexible member with an engineered load failure point that is narrow on the medial side then widens to increase contact on the lateral side to ensure it passes exclusively above the gastrocnemius muscle connected laterally to a rigid extension from the lateral frame - it may be relatively narrow on the medial side to nest above the muscle but wider on the lateral side to capture the leg.

25. The knee brace according to claim 23 or claim 24, wherein the proximal rear support is in the form of a flexible member connected at one end to the medial arm of the tibiofibular frame and connected at the opposite end to the lateral arm of the tibiofibular frame.

26. The knee brace according to any one of claims 18 to 25, wherein the tibiofibular frame comprises distally an anterior segment for supporting a front of the wearer's leg, where the anterior segment is configured to be located in situ below the tibial tuberosity that changes dynamically under load.

27. The knee brace according to claim 26, wherein the anterior segment includes a pair of opposed semi rigid nylon asymmetrical arms at its medial and lateral edges.

28. The knee brace according to any one of claims 18 to 27, wherein edge portions of the medial and lateral arms of the femoral and tibiofibular frames respectively contain medial and lateral flexible members retainers.

29. The knee brace according to claim 27 or claim 28, wherein the anterior segment includes a rear support in the form of a flexible member interconnecting the medial and lateral nylon arms of the anterior segment.

30. The knee brace according to any one of claims 27 to 29, wherein the anterior segment is flat, comprises thermoplastic urethane and is elastically deformable.

31. The knee brace according to any one of claims 16 to 30, wherein at least one knee protector has opposed proximal and distal sides extending between opposed proximal and distal arcuate edges and releasably connected via releasable fasteners.

32. A frame component for use in a joint support apparatus, wherein the individual frame components are moulded in a flat or generally flat shape to produce a united component that is elastically deformed into a curved shape when assembled in the joint support apparatus.

33. A method of making a frame component for a joint support apparatus with multiple elements with various material properties, wherein the frame component is moulded in a flat or generally flat shape.

34. A method of making a joint support apparatus having upper and lower frames coupled together for rotational movement, the method including the steps of moulding one of the frames in a generally flat shape and elastically deforming said one frame into a curved shape in the assembled support apparatus.

35. A method as claimed in claim 34, wherein said one frame includes relatively stiff lateral components and the method includes the steps of locating the lateral components in a mould and over moulding said components with a relatively flexible web.

36. A knee brace including an upper frame for supporting an upper part of a user's leg, a lower frame for supporting a lower part of the user's leg, the lower frame being hingedly coupled to the upper frame, wherein the lower frame comprises an inner frame member and an outer frame member, and wherein the frame members are spanned by a flexible webbing.

37. A knee brace as claimed in claim 36, wherein the frame members are each formed in a relatively rigid material, and wherein the webbing is framed in a relatively flexible material.

38. A joint support apparatus for supporting the knee joint of a subject, comprising: an upper frame and a lower frame, each frame including a medial arm and a lateral arm, the medial arm of the upper frame and the medial arm of the lower frame being pivotally interconnected by a hinge; the lateral arm of the upper frame and the lateral arm of the lower frame being pivotally interconnected by a hinge; and at least one attachment means for connecting each frame to the subject; wherein at least one of the upper and lower frames is semi-rigid or elastically deformable in response to load.

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