AU2005203062B2 - Hinge assembly for an orthopedic knee brace and knee brace incorporating the hinge assembly - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT Name of Applicant: Actual Inventors: Address for Service: Invention Title: DJ Orthopedics LLC Dylann CERIANI Theodore V. TILLINGHAST Richard E. GILDERSLEEVE Scott P. SELIGMAN DAVIES COLLISON CAVE, Patent Attorneys, 1 Nicholson Street, Melbourne, 3000 "Hinge assembly for an orthopedic knee brace and knee brace incorporating the hinge assembly" The following statement is a full description of this invention, including the best method of performing it known to us.

Q:\OPER\SASUUL-DEC 200!UULY\126360 195 DIV.DOC 1417/05 00 0 C HINGE ASSEMBLY FOR AN ORTHOPEDIC KNEE BRACE AND KNEE BRACE INCORPORATING THE HINGE ASSEMBLY Backoround of the Invention Field of the Invention 00 0 The present invention relates generally to orthopedic braces and, in particular, to orthopedic knee braces.

Description of the Related Art SOsteoarthritis is a degenerative joint disease that results in chronic pain in an affected joint when the joint is statically or dynamically loaded. In an affected knee joint, osteoarthritis pain is often caused by an unbalanced loading Son the medial or lateral compartment of the knee, which can reduce the clearance space between the condyles of the Sfemur and tibial plateau. When there is increased pressure between the femoral and tibial surfaces in an affected S0 compartment of the knee joint, and particularly dynamic pressure, cartilage degeneration can occur at the contact surface producing pain in the joint.

Orthopedic knee braces are commonly applied to the leg to treat osteoarthritis in the knee. Such braces typically include an upper support portion for securing to the upper leg of the wearer, a lower support portion for securing to the lower leg, and one or more hinge assemblies pivotally interconnecting the upper and lower support portions. In a two-sided knee brace, a hinge assembly is located at each side of the knee when the brace is worn. A condyle pad is typically located between each hinge assembly and side of the knee.

Knee braces of the type described serve to reduce osteoarthritis pain in the knee joint by applying a threepoint load to the leg. A force is applied to the side of the knee opposite the affected compartment by causing the adjacent condyle pad to forcibly contact the side of the knee. This is typically accomplished by increasing the 3 thickness of the adjacent condyle pad or by moving the pad coser to the knee using a jackscrew or other means.

Alternatively, a force is sometimes applied opposite the affected compartment of the knee by means of an adjustable force strap which extends around the leg in a helical fashion from the upper support portion to the lower support portion. In either case, counteracting forces are applied to the leg in the medial/lateral plane above and below the knee on the side of the affected compartment by the upper and lower support portions. The resulting three-point load on the leg serves to reduce osteoarthritis pain in the knee joint by reducing the load in the affected compartment of the knee.

While such knee braces have proven effective in relieving osteoarthritis pain in the knee joint, the upper and lower support portions of such braces lack sufficient adjustability for optimal fit on various leg shapes and for various loads to relieve osteoarthritis pain. The upper and lower support portions are typically relatively rigid and are not adapted to conform to the leg shape of the wearer. As a result, such braces are often bulky, uncomfortable, and ill.

fitting. In addition, when such braces are adjusted to apply a force to the knee or to fit the leg of a patient, stress is generated in the hinge assemblies of the knee braces. This stress causes wear on the components of the hinge assemblies and, in extreme cases, can result in binding of the hinge assemblies.

P\OPER.DWf2638640 paldc-1/02R200a 00 -2c Summary of the Invention 00 In accordance with the invention, there is provided an orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lowuper leg cuff mountable to the leg of the wearer belowve the knee; San upplower leg cuff mountable to the lending from the weuppaer below the knee;uff; 5 an upplower support arm extending from the uplower leg cuff; and ~a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly Sbeing configured to allow at least one of the upper and lower support arms to articulate relative to the Shinge assembly in at least two perpendicular planes; wherein at least one of the upper support arm and the lower support arm includes a tab at an end thereof proximate the hinge assembly, the tab including an aperture defining an axis of rotation of the hinge assembly, the tab further being bent out of plane with respect to a portion of the support arm adjacent the tab; and a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge assembly.

In another aspect, there is provided an orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly being configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; and wherein the hinge assembly further comprises an upper gear member having first and second shoulders for abutting first and second shoulders of the upper support arm.

In another aspect, there is provided an orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly P:OPERDM)263M640 spal d Voc /2lOO$S 00 -3- 1C T. being configured to allow at least one of the upper and lower support arms to articulate relative to the 00 hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the Shinge; and wherein the hinge assembly further comprises an upper gear member having a sloped surface, t' the sloped surface enabling the upper support arm to articulate relative to the upper gear member about I an axis that is substantially perpendicular to an axis of rotation of the upper gear member.

In another aspect, there is provided an orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly being configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; andwherein the hinge assembly further comprises a lower gear member having first and second shoulders for abutting first and second shoulders of the lower support arm.

In another aspect, there is provided an orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly being configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; and wherein the hinge assembly further comprises a lower gear member having a sloped surface, the sloped surface enabling the lower support arm to articulate relative to the lower gear member about an axis that is substantially perpendicular to an axis of rotation of the lower gear member.

In another aspect, there is provided an orthopedic knee brace, comprising: an upper leg cuff mountable above the knee of a wearer; a lower leg cuff mountable below the knee of the wearer; P:XOPERDFH\126)8640 spa ldo-I1O2f S 00 -4- San upper support arm extending from the upper leg cuff; 00 a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms; wherein the hinge assembly comprises means for allowing at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes without generating stress in the hinge assembly; at least one of the upper support arm and the lower support arm includes a tab at an end thereof Sproximate the hinge assembly, the tab including an aperture defining an axis of rotation of the hinge assembly, the tab further extending at a non-zero angle from an adjacent portion of the support arm; and a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge assembly.

These and other embodiments of the present invention will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments having reference to the attached figures, the invention not being limited to any particular preferred embodiment(s) disclosed.

Brief Description of the Drawings Having thus summarized the general nature of the invention and its essential features and advantages, certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which: FIGURE 1 is a front view of a knee; FIGURE 2 is an exploded perspective view of the lateral hinge assembly of the knee brace of FIGURE 1; FIGURE 3 is a perspective view of the gear members of the lateral hinge assembly of FIGURE 2; FIGURE 4 is a left side view of the upper and lower lateral support arms and first and second gear members of the knee brace of FIGURE 1; FIGURE 5A is a front view of the upper lateral support arm and first gear member of the knee brace of FIGURE 1, with the upper lateral support arm at a first position relative to the first gear member; FIGURE 5B is a front view of a first alternative embodiment of the upper lateral support arm and first gear member of the knee brace of FIGURE 1, with the upper lateral support arm at a first position relative to the first gear member; FIGURE 5C is a front view of a second alternative example of the upper lateral support arm and first gear member of the knee brace of FIGURE 1, with the upper lateral support arm at a first position relative to the first gear member; p. OPERM-DH 12638640 spa I doc-I1fl'/20 00 -4a- FIGURE 6 is a front view of the upper lateral support arm and first gear member of the knee 00 brace of FIGURE 1, with the upper lateral support arm at a second position relative to the first gear member; C FIGURE 7 is a front view of the lateral hinge assembly and upper and lower lateral support arms of the knee brace of FIGURE 1; FIGURE 8 is a right side view of the knee brace of FIGURE 1; ~nFIGURE 9 is a cross-sectional view of the upper adjustment device of the knee brace of FIGURE 1, taken along the line 9-9 in FIGURE 8; FIGURE 10 is a front view of the knee brace of FIGURE 1 applied to the right leg of a wearer; FIGURE 11 is a perspective view of an upper adjustment device of an alternative preferred example of a knee brace; and FIGURE 12 is a graph showing the effect of medial and lateral movement of the tibia relative to the femur on the treatment forces applied by the braces of FIGURE 1 and FIGURE 11.

Detailed Description of the Preferred Embodiments An orthopedic knee brace 10 is illustrated in FIGURE 1. The particular knee brace 10 illustrated is configured to be applied either to the right leg of a wearer to treat osteoarthritis in the medial compartment of the right knee, or to the left leg to treat osteoarthritis in the lateral compartment of the left knee. However, it will be apparent to those skilled in the art that the knee brace 10 can also be modified to treat osteoarthritis in the lateral compartment of the right knee or the medial compartment of the left knee. For purposes of discussion herein, it will be assumed that the brace 10 is to be applied to the right leg of the wearer to treat osteoarthritis in the medial compartment of the right knee.

Referring to FIGURE 1, the knee brace 10 includes an upper support portion 12, a lower support portion 14, and medial and lateral hinge assemblies 16, 18. The upper and lower support portions 12, 14 are pivotally connected to one another via the medial and lateral hinge assemblies 16, 18. The upper support portion 12 includes an upper leg 00 r cuff 20 for positioning over the front of the thigh of the wearer (see FIGURE 10) and medial and lateral support arms S22, 24 extending from the upper leg cuff 20 to the medial and lateral hinge assemblies 16, 18. The lower support portion 14 includes a lower leg cuff 26 for positioning over the calf of the wearer and medial and lateral support arms 00 28, 30 extending from the lower leg cuff 26 to the medial and lateral hinge assemblies 16, 18. A first adjustment device 32 is located between the upper leg cuff 20 and the upper lateral support arm 24, and a second adjustment Sdevice 34 is located between the lower leg cuff 26 and the lower lateral support arm The upper support portion 12 is secured to the upper leg of the wearer with adjustable straps 36 which O extend around the back of the upper leg. The lower support portion 14 is secured to the lower leg by adjustable straps t n 38 which extend around the front and back of the lower leg. For ease of adjustment, the straps 36, 38 are preferably O fastened with a hook and pile fastener such as VELCRO".

The upper and lower support portions 12, 14 are preferably made of aluminum, but can be made from any light-weight, high-strength metal, plastic, or composite material. The interior surface of each of the upper and lower support portions 12, 14 is covered with padding 40 to provide a comfortable fit against the leg of the wearer. The padding 40 is preferably made from a resilient foam material. However, inflated bladders, gels or other types of padding may also be used.

FIGURE 2 is an exploded perspective view of the lateral hinge assembly 18 of the knee brace 10. On a side of the lateral support arms 24, 30 adjacent the knee, the hinge assembly 18 comprises a condyle pad holder 50, an inner hinge plate 52, and an inner bearing plate 54. On a side of the support arms 24, 30 opposite the knee, the hinge assembly 18 comprises a first gear member 56, a second gear member 58, an outer bearing plate 60, and an outer hinge plate 62. First and second hinge pins 64, 66 extend from the condyle pad holder 50 to the outer hinge plate 62 through openings 68 provided in the support arms 24, 30 and each of the components of the hinge assembly 18. The hinge pins 64, 66 are attached to the outer hinge plate 62, preferably by swaging the ends thereof, and serve to fasten the hinge assembly 18 together and provide pivotal securement of the arms 24, FIGURE 3 is a perspective view of the first and second gear members 56, 58 of the lateral hinge assembly 18. In the illustrated example, the first and second gear members 56, 58 are generally cylindrical in shape and have a number of involute gear teeth 70 on adjacent perimeters thereof. Each of the first and second gear members 56, 58 includes a generally recessed area 72. The recessed area 72 is defined by a wall surface 74 and a base surface 76. The wall surface 74 includes a curvilinear portion 78, an anterior bearing surface 80, and a posterior bearing surface 82. The base surface 76 includes an inclined portion 84, a plateau 86, and a declined portion 88, together defining an articulating surface.

Referring to FIGURE 4, each of the support arms 24, 30 has a tab 90 at an end thereof and anterior and posterior shoulders 92, 94 on either side of the tab 90. The tab 90 of the upper support arm 24 has a shape that generally corresponds with the shape of the curvilinear portion 78 of the wall surface 74 of the first gear member 56.

The tab 90 of the lower support arm 30 has a shape that generally corresponds with the shape of the curvilinear portion 78 of the wall surface 74 of the second gear member 58. The ends of the upper and lower support arms 24, 00 C 30 fit within the recessed areas 72 of the first and second gear members 56, 58 as shown. The anterior and posterior shoulders 92, 94 of the support arms 24, 30 abut the anterior and posterior bearing surfaces 80, 82 of the gear 0members 56, 58, preferably with a slight gap 96 being formed between each tab 90 and the curvilinear portion 78 of 00 the wall surface 74 to allow medialllateral rocking or articulation of the support arms 24, FIGURE 5A is a front view of the first gear member 56 and the upper support arm 24 with the upper support Sarm 24 at a first extreme position. An outer surface 101 of the support arm 24 rests against the base surface 76 of Sthe gear member 56. In the first extreme position, the tab 90 of the support arm 24 rests against the plateau 86 and Sthe declined portion 88 of the base surface 76. Preferably, tab 90 is bent slightly toward the base surface 76 of the n gear member 56 to roughly parallel the declined portion 88.

FIGURE 6 is a front view of the first gear member 56 and the upper support arm 24 with the upper support arm 24 at a second extreme position. In the second extreme position, the outer surface of the support arm 24 rests against the inclined portion 84 and the plateau 86 of the base surface 76. The tab 90 of the support arm 24 does not contact the declined 88 portion of the base surface 76. Because the tab 90 is bent slightly toward base surface 76, the end of the tab 90 does not extend out of the recessed area 72 and thus will not tend to pry the hinge assembly 18 apart when fully assembled.

Those skilled in the art will appreciate that the upper support arm 24 articulates on the base surface 76 of the first gear member 56 between the first and second extreme positions. The anterior and posterior shoulders 92, 94 of the upper support arm 24 pivot on the anterior and posterior bearing surfaces 82 of the wall surface 74. Because of the small gap 96 between the end of the tab 90 and the curvilinear portion 78 of the wad surface 74, the end of the tab 90 advantageously does not interfere with the curvilinear portion 78 of the wall surface 74 as the upper support arm 24 articulates between the first and second positions. The lower support arm 30 articulates on the base surface 76 of the second gear member 58 in a manner similar to that of the upper support arm 24 and first gear member 56.

The particular illustrated configuration of the gear members 56, 58 and support arms 24, 30 described above is merely a preferred example -thereof. It is to be understood that the gear members 56, 58 and support arms 24, 30 can alternatively be constructed and configured in a wide variety of other ways giving due consideration to the goals of providing a hinged connection between the upper and lower arms of the brace while facilitating a predetermined amount of medial and lateral articulation of the arms relative to the hingelgear assembly.

FIGURE 5B illustrates an alternative example of the first gear member 56 and upper support arm 24 in the first extreme position of FIGURE 5A. In this alternative example., the base surface 76 of the first gear member 56 is generally planar, with the exception of a raised bump 53 provided thereon. The support arm 24 articulates on the bump between the first and second extreme positions. FIGURE 5C illustrates a second alternative example of the first gear member 56 and upper support arm 24, wherein the base surface 76 of the first gear member 56 is planar, and a bump 55 is provided on the support arm 24. Those skilled in the art wil readily appreciate that suitable articulating surfaces may be provided on either the support arm, the gear member, or both, as desired.

00 FIGURE 7 is a front view of the lateral hinge assembly 18 and the upper and lower lateral support arms 24, 30 of the knee brace 10. The first and second gear members 56, 58 are sandwiched between the inner and outer 00 bearing plates 54, 60 and hinge plates 52, 62. The bearing plates 54, 60 are preferably fabricated from a durable, 0 low-friction plastic such as ABS, nylon. DELRIN', or TEFLON" to provide a low-friction interface between the gear members 56, 58 and bearing plates 54, 60. A condyle pad 98 is removably attached to the condyle pad holder 50 with IN a hook and pile or other type of fastener. The condyle pad 98 is preferably made from a resilient foam or other ccushioning material. However, an inflatable bladder can also be used.

The first gear member 56 rotates about the first hinge pin 64 (not shown) with the upper lateral support arm S24 engaged therewith. The second gear member 58 rotates about the second hinge pin 66 (not shown) with the lower c1 lateral support arm 30 engaged therewith. The gear teeth 70 of the first and second gear members 56, 58 mesh to provide a controlled rotation of the gear members 56, 58 and the upper and lower support arms 24, 30. The upper and lower support arms 24, 30 are allowed to articulate between the first and second positions on the base surfaces 72 of the first and second gear members 56, 58 in a plane perpendicular to the plane of rotation.

If desired, flexion and/or extension stops can be provided in the hinge assembly 18 to limit the flexion and/or extension of the leg. An extension stop 91 is shown in FIGURE 2 located anterior to the first and second gear members 56. 58. The extension stop 91 is fastened to the hinge assembly 18 by a threaded fastener 93 which engages a threaded hole 95 in the inner hinge plate 52 and extends through a hole 97 in the extension stop 91. When the desired extension limit is reached, the anterior shoulders 92 of the upper and lower support arms 24, 30 abut the ends of the extension stop 91 to prevent further rotation of the support arms 24, 30. Similarly, a flexion stop (not shown) can be located posterior to the first and second gear members 56, 58 and fastened to the hinge assembly 18 by a second threaded fastener 99 if desired to limit flexion of the leg. Alternatively, or in addition to the flexion and extension stops 91, the gear members 56, 58 themselves can be configured to limit flexion and extension by providing interfering portions on the perimeters thereof. A wide variety of other suitable structures may also be used as will be readily apparent to these skilled in the art.

FIGURE 8 is a lateral side view of the knee brace 10 showing the first and second adjustment devices 32, 34. In a preferred, example the adjustment devices 32, 34 are of a type described in U.S. Patent No. 5,766,140 assigned to the assignee of the present invention and hereby incorporated by reference herein.

FIGURE 9 is a cross-sectional view of the first adjustment 32 device taken along the line 9.9 in FIGURE 8.

Referring to FIGURES 8 and 9, the first adjustment device 32 comprises a hinge pin 100 having first and second hinge portions 102, 104 rotatably mounted thereon. Each of the first and second hinge portions 102, 104 includes an inner member 106 and an outer member 108. The first hinge portion 102 is fastened to the upper leg cuff 20 by rivets 110 which extend from the outer member 108 to the inner member 106 of the first hinge portion 102 through openings formed in the upper leg cuff 20. The second hinge portion 104 is fastened to the upper support arm 24 by rivets 110 which extend from the outer member 108 to the inner member 106 of the second hinge portion 104 through openings formed in the upper support arm 24.

(A rectangular opening 112 is provided, in the upper leg cuff 20 between the inner and outer members 106, 108 of the first hinge portion 102. A second rectangular opening 114 is provided in the upper support arm 24 between the inner and outer members 106, 108 of the second hinge portion 104. An arch bar 116 extends from the rectangular opening 112 in the upper leg cuff 20 to the rectangular opening 114 in the upper support arm 24. Each end of the arch bar 116 has a guide pin 118 extending therethrough. The guide pins 118 are movably confined in the rectangular Cl openings 112, 114 by the inner and outer members 106, 108 of the first and second hinge portions 102, 104.

0 The hinge pin 100 has a right-hand threaded hole 120 extending through its axial midpoint. The arch bar 116 has a left.hand threaded hole 122 located over the right.hand threaded hole 120 in the hinge pin 100. A single V')adjustment screw 124 having a left-hand threaded end 126 and a right.hand threaded end 128 engages both the left.

hand threads of the arch bar 116 and the right-hand threads of the hinge pin 100.

The left-h;nd threaded end 126 of the adjustment screw 124 is adapted to receive a tool such as a screwdriver or Allen-type wrench for turning the adjustment screw 124. When the adjustment screw 124 is turned counterclockwise, the hinge pin 100 is moved away from the arch bar 116. The guide pins 118 at the ends of the arch bar 116 pull against the outer members 108 of the first and second hinge portions 102, 104 causing the first and second hinge portions 102, 104 to rotate about the hinge pin 100. When the adjustment screw 124 is turned clockwise, the hinge pin 100 is moved toward the arch bar 116 and the guide pins 118 push against the inner members 106 of the first and second hinge portions 102, 104. Thus, by adjusting the distance between the arch bar 116 and the hinge pin 100, the angle between the first and second hinge portions 102, 104 is affected. Because the first hinge portion 102 is fastened to the upper leg cuff 20 and the second hinge portion 104 is fastened to the upper support arm 24, the angle between the upper leg cuff 20 and the upper support arm 24 can be adjusted by turning the adjustment screw 124.

The second adjustment device 34 is identical to the first 32 except that the hinge portions 102, 104 of the second adjustment device 34 are coupled to the lower leg cuff 26 and the lower lateral support arm 30. Thus, the angle between the lower leg cuff 26 and the lower support arm 30 can also be adjusted by turning the adjustment screw 124 of the second adjustment device 34.

FIGURE 10 is a front view of the knee brace 10 applied to the right leg of a wearer. The femur 130, tibia 132, and fibula 134 of the right leg are shown. To treat osteoarthritis in the medial compartment of the right knee, the brace 10 is fitted to the right leg with the support arms 24, 30 and adjustment devices 32, 34 located on the lateral side of the leg. The medial support arms 22, 28 can be bent or otherwise shaped, as desired or necessary, to comfortably fit the shape of the wearer's leg. A force is then applied to the opposite (lateral) side of the knee by turning the adjustment screws 124 of the first and second adjustment devices 32, 34 clockwise. The hinge pins 100 of the adjustment devices 32, 34 are thereby drawn toward the arch bars 116 causing the upper and lower support arms 24, 30 to rotalte toward the leg relative to the upper and lower leg cuffs 20, 26.

The lateral hinge assembly 18 is moved toward the knee by the rotation of the upper and lower support arms 24, 30. As the hinge assembly 18 moves toward the knee, the ends of the upper and lower support arms 24, 00 C1 articulate on the base surfaces 76 of the first and second gear members 56, 58. The lateral hinge assembly 18 applies a force to the lateral side of the knee via the condyle pad 98. Counteracting forces are applied above and below the Sknee on the medial side of the leg by the upper and lower leg cuffs 20, 26. The resulting three.point load on the leg 00 serves to reduce the load in medial compartment of the knee.

By adjusting the first and second adjustment devices 32, 34, the knee brace 10 can be fitted to a varus (bowlegged) or

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vulgus (knock-kneed) leg. Once fitted, the adjustment devices 32, 34 can be further adjusted to apply a corrective load O to the leg. The medial and lateral adjustability of the support arms 24, 30 allows the brace 10 to accommodate a Swide variety of leg shapes and sizes.

SBecause the upper and lower support arms 24, 30 are allowed to articulate on the base surfaces 76 of the first and second gear members 56, 58 (FIGURE adjustment of the adjustment devices 32, 34 does not generate stress in the hinge assembly 18. The first gear member 56 is maintained in substantially the same plane as the second gear member 58 regardless of the angle of the support arms 24, 30 relative to the leg cuffs 20, 26. Because coplanarity of the first and second gear members 56, 58 is maintained, binding of the hinge assembly 18 is prevented even when the angle between the support arms 24,-30 and leg cuffs 20, 26 is relatively great Wear on the gear teeth of the first and second gear members 56, 58 is thus minimized.

In a preferred example, the medial hinge assembly 16 is the mirror image of the lateral hinge assembly 18 except that the gear members 136, 138 of the medial hinge assembly 16 are located on a side of the medial support arms 22, 28 adjacent the knee. The upper and lower medial support arms 22, 28 articulate on the gear members 136, 138 of the medial hinge assembly 16 in a manner similar to that of the lateral support arms 24, 30 and gear members 56, 58 of the lateral hinge assembly 18. As the adjustment devices 32, 34 are adjusted to increase the treatment force applied to the lateral side of the knee, the medial support arms 22, 28 can be bent or otherwise allowed to articulate on the gear members 136, 138 of the medial hinge assembly 16 away from the side of the knee. As a result, the force applied by the medial hinge assembly 16 on the medial side of the knee is relatively small and thus has little effect in counteracting the treatment force applied to the lateral side of the knee.

In the illustrated example the gear members 56, 58 of the lateral hinge assembly 18 are located on a side of the lateral support arms 24, 30 opposite the knee. However, it will be apparent to those skilled in the art that the gear members 56, 58 of the lateral hinge assembly 18 can alternatively be located on a side of the support arms 24, 30 adjacent the knee. When the brace 10 is so configured, the support arms 24, 30 articulate from the second extreme position (wherein the support arms 24, 30 contact the inclined surfaces 84 and plateaus 86 of the first and second gear members 56, 58) to the first extreme position (wherein the support arms 24, 30 contact the plateaus 86 and declined surfaces 88 of the first and second gear members 56, 58) as the lateral hinge assembly 18 moves toward the medial hinge assembly 16. Simnlary, it will be apparent that, while the gear members 136, 138 of the medial hinge assembly 16 are located on a side of the medial support arms 22, 28 adjacent the knee in the illustrated embodiment, the gear members 136, 138 can alternatively be located on a side of the support arms 22, 28 opposite the knee.

Thus, in an alternative example the medial and lateral hinge assemblies 16, 18 may be mirror images of one -9- 00 0 another. Advantageously, this would allow the same hinge assembly configuration to be used for both the medial and 0 lateral sides.

An alternative preferred example of the knee brace has a first adjustment device 37 and a second 00 adjustment device. In this example the first adjustment device 32', illustrated in FIGURE 11, comprises a first part 140 coupled to the upper leg cuff 20 and a second part 142 coupled to the upper lateral support arm 24. The second part 142 of the adjustment device 32' includes a hollow casing 144 having anterior and posterior side walls I 146, 148, as shown in FIGURE 11.

n A portion of the hollow casing 144 has been cut away in FIGURE 11 to show the interior components of the C adjustment device 32'. A shaft 150 extends across the hollow casing 144 and is rotatably mounted at its ends to the 0 0 anterior and posterior side walls 146, 148 of the hollow casing 144. A driven gear 152 is fixedly mounted on the Cl shaft 150 for rotation therewith. A worm gear 154 is rotatably mounted in the casing 144 perpendicular to the shaft 150 and mates with the driven gear 152 to turn the driven gear 152 and shaft 150. A torsion spring 156 is coiled around the shaft 150 and has first and second ends 158, 160 attached to thefirst part 140 of the adjustment device 32'. The driven gear 152 engages a center portion 162 of the torsion spring 156.

The worm gear 154 is adapted to receive a screwdriver or Allen-type wrench for turning the worm gear 154 in the casing 144. The worm gear 154 drives the driven gear 152 which, depending on the direction of rotation, coils or uncoils the torsion spring 156. The coils of the torsion spring 156 and the shaft 150 extending therethrough provide a spring-loaded hinge about which the first and second parts 140, 142 of the adjustment device 32' can rotate. When the torsion spring 156 is coiled by turning the worm gear 154 in a first direction, the upper lateral support arm 24 is biased toward the leg of the wearer, thereby increasing the amount of pressure applied to the knee.

When the torsion spring 156 is uncoiled by turning the worm gear 154 in an opposite direction, the bias of the upper lateral support arm 24 is reduced and the amount of pressure applied to the knee is decreased. The amount of bias can therefore be adjusted by turning the worm gear 154. The second adjustment device is identical to the first 32' except that the first part 140 of the second adjustment device is coupled to the lower leg cuff 26 and the second part 142 is coupled to the lower lateral support arm One advantage of the adjustment devices of the knee brace of the alternative preferred example is that they allow a more constant treatment force to be applied to the knee throughout the range of flexion and extension of the leg. In the normal leg, the tibia swings slightly relative to the femur in the mediallateral plane as the leg moves between flexion and extension. In the knee brace 10 of the previous embodiment, the angle of the upper and lower lateral support arms 24, 30 is moreor-less fixed relative to the upper and lower leg cuffs 20, 26 once adjusted by the adjustment devices 32, 34. The support arms 24, 30 may flex spmewhat, however, depending upon the type material from which they are made.

Because the upper and lower leg cuffs 20, 26 are secured to the upper and lower parts of the leg, the treatment force applied to the lateral side of the knee is affected by the medial and lateral movement of the tibia relative to the femur. Specifically, the treatment force applied to the lateral side of the knee via the lateral support 00

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arm 24, 30 and hinge assembly 18 is increased as the tibia moves medially relative to the femur, and decreased as r. the tibia moves laterally relative to the femur.

00 FIGURE 12 is a graph showing the effect of the medial and lateral movement of the tibia relative to the

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femur on the treatment force applied to the knee. Assume that the angle between the tibia and femur of a given patient in the medial/lateral plane varies over a range typically about 7 degrees, as the patient's leg moves between N flexion and extension. Because the angle of the lateral support arms 24, 30 is more-or-less fixed (subject to stiffness r n of the material) in the medial lateral plane relative to the upper and lower leg cuffs 20, 26, the treatment force in the N medial/lateral plane applied to the lateral side of the knee via the lateral support arms 24, 30 and hinge assembly 18 Svaries by an amount F, from flexion to extension.

C i In the modified knee brace of the alternative preferred example, the angle between the upper and lower lateral support arms 24, 30 and the upper and lower leg cuffs 20, 26 is not determined by the first adjustment device 32 and second adjustment device. The torsion springs 156 of the first adjustment device 32' and second adjustment device bias the lateral support arms 24, 30 toward the leg of the wearer, but the lateral support arms 24, 30 are not rigidly connected to the leg cuffs 20, 26. Thus, the treatment force applied to the lateral side of the knee via the lateral support arms 24, 30 and hinge assembly 18 is generated in the torsion springs 156.

The torsion springs 156 are coiled and uncoiled slightly as the angle of the tibia relative to the femur changes during flexion and extension of the leg, allowing the support arms 24, 30 to effectively follow the motion of the leg.

Preferably, the torsion springs 156 are selected andlor preloaded so that this slight coiling and uncoiling does not vary greatly the amount of force generated in the torsion springs 156. As a result, the amount of force applied to the lateral side of the knee is varied only by an amount F, as the angle between the tibia and femur of the patient varies over the range Thus, the knee brace of the alternative preferred example allows an even more constant treatment force to be applied to the knee throughout the range of flexion and extension of the leg. For this reason, the knee brace of the alternative preferred example may be preferable for some patients.

By way of example, both of the knee braces described herein have been adapted to treat osteoarthritis in the medial compartment of the right knee joint. However, it should be evident that both braces are readily adaptable for treatment of osteoarthritis in either compartment of either knee joint by obvious modifications thereof. It should also be evident that the hinge assembly described herein would be operable in other knee brace configurations, including, for example, a one-sided knee brace having a hinge assembly and support arms on only one side of the leg. Similarly, it should be evident that the hinge assembly described herein would also be operable in other type braces, such as neck, back, elbow, wrist, ankle and the like.

Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other altemative embodiments andlor uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments descibed above, but should be determined only by a fair reading of the daims that follow.

-1I- P:\OPER\SAS\Jul-Dc 05\1 263816I0 claim, doc-14/07/05 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 N integer or step or group of integers or steps.

0 5 The reference to any prior art in this specification is not, and should not be taken as, an 0 acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

(N

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Claims (22)

1. An orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly being configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein at least one of the upper support arm and the lower support arm includes a tab at an end thereof proximate the hinge assembly, the tab including an aperture defining an axis of rotation of the hinge assembly, the tab further being bent out of plane with respect to a portion of the support arm adjacent the tab; and a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge assembly.

2. The knee brace of Claim 1, wherein the hinge assembly is configured to allow articulation of the upper and lower support arms relative to the hinge assembly without generating stress in the hinge assembly.

3. An orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly being configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; and wherein the hinge assembly further comprises an upper gear member having first and second shoulders for abutting first and second shoulders of the upper support arm.

4. The knee brace of Claim 3, wherein engagement of the upper gear member shoulders with the upper support arm shoulders aligns an aperture in the upper support arm with an aperture in the upper P:,OPER\DM{I26'3640 I.docw-I10220 00 -14- gear member. 0 00

5. An orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; C a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; an upplower support arm extending from the uplower leg cuff; and a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly Sbeing configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; and wherein the hinge assembly further comprises an upper gear member having a sloped surface, the sloped surface enabling the upper support arm to articulate relative to the upper gear member about an axis that is substantially perpendicular to an axis of rotation of the upper gear member.

6. An orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms, the hinge assembly being configured to allow at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes; wherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; and wherein the hinge assembly further comprises a lower gear member having first and second shoulders for abutting first and second shoulders of the lower support arm.

7. The knee brace of Claim 6, wherein engagement of the lower gear member shoulders with the lower support arm shoulders aligns an aperture in the lower support arm with an aperture in the lower gear member.

8. An orthopedic knee brace, comprising: an upper leg cuff mountable to the leg of a wearer above the knee; a lower leg cuff mountable to the leg of the wearer below the knee; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and P.\OPERDHIA1263MO40 spa I d-/02200S 00 T. a hinge assembly connected to both the upper and lower support arms, the hinge assembly 00 being configured to allow at least one of the upper and lower support arms to articulate relative to the 0 hinge assembly in at least two perpendicular planes; Swherein a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge; and Swherein the hinge assembly further comprises a lower gear member having a sloped surface, Sthe sloped surface enabling the lower support arm to articulate relative to the lower gear member about 0an axis that is substantially perpendicular to an axis of rotation of the lower gear member.

9. An orthopedic knee brace, comprising: an upper leg cuff mountable above the knee of a wearer; a lower leg cuff mountable below the knee of the wearer; an upper support arm extending from the upper leg cuff; a lower support arm extending from the lower leg cuff; and a hinge assembly connected to both the upper and lower support arms; wherein the hinge assembly comprises means for allowing at least one of the upper and lower support arms to articulate relative to the hinge assembly in at least two perpendicular planes without generating stress in the hinge assembly; at least one of the upper support arm and the lower support arm includes a tab at an end thereof proximate the hinge assembly, the tab including an aperture defining an axis of rotation of the hinge assembly, the tab further extending at a non-zero angle from an adjacent portion of the support arm; and a first plane of the at least two perpendicular planes comprises a plane of rotation of the hinge assembly.

The knee brace of Claim 9, wherein the upper and lower leg cuffs are constructed of flexible fabric.

11. The knee brace of Claim 1, wherein at least one of the upper support arm and the lower support arm includes an end portion that is bent slightly with respect to an adjacent portion of the same support arm.

12. The knee brace of Claim 11, wherein the end portion includes an opening that receives a hinge pin of the hinge assembly, such that the support arm is pivotable about the hinge pin.

13. The knee brace of Claim 11, wherein the end portion is received between first and second hinge plates of the hinge assembly.

14. The knee brace of Claim 1, further comprising an adjustment assembly configured to cooperate with the at least one of the upper and lower support arms and a respective one of the upper and lower P:IOPER)DHI{1263] 40 sp l.do- 1022008 -16- cuffs to control articulation of the arm in a medial/lateral plane.

The knee brace of Claim 14, wherein the adjustment assembly includes at least one threaded member, and rotation of the threaded member in a first direction induces articulation of the arm in the medial direction, and rotation of the threaded member in a second direction induces articulation of the arm in the lateral direction.

16 The knee brace of Claim 1, wherein the hinge assembly further comprises an upper gear member having a raised bump, the raised bump enabling the upper support arm to articulate relative to the upper gear member about an axis that is substantially perpendicular to an axis of rotation of the upper gear member.

17. The knee brace of Claim 1, wherein the hinge assembly further comprises an upper gear member, and the upper support arm includes a raised bump, the raised bump enabling the upper support arm to articulate relative to the upper gear member about an axis that is substantially perpendicular to an axis of rotation of the upper gear member.

18. The knee brace of Claim 1, wherein the hinge assembly further comprises a lower gear member having a raised bump, the raised bump enabling the lower support arm to articulate relative to the lower gear member about an axis that is substantially perpendicular to an axis of rotation of the lower gear member.

19. The knee brace of Claim 1, wherein the hinge assembly further comprises a lower gear member, and the lower support arm includes a raised bump, the raised bump enabling the lower support arm to articulate relative to the lower gear member about an axis that is substantially perpendicular to an axis of rotation of the lower gear member.

The knee brace of Claim 1, wherein the hinge assembly further comprises at least one articulation surface, the at least one articulation surface enabling at least one of the upper support arm and the lower support arm to articulate relative to the hinge assembly about an axis that is substantially perpendicular to an axis of rotation of the upper support arm or the lower support arm.

21. The knee brace of Claim 20, wherein the at least one articulation surface comprises at least one of a sloped surface and a raised bump.

22. An orthopedic knee brace, substantially as described with reference to the drawings and/or examples.