Orthopaedic brace having a pneumatic pad and associated pump

ORTHOPAEDIC BRACE HAVING A PNEUMATIC PAD

AND ASSOCIATED PUMP

The present invention relates to an orthopaedic brace, and particularly to an orthopaedic brace having a pneumatic pad and associated pump attachable to the brace for adjustably fitting the brace against the body of a user.

Hinged orthopaedic braces are commonly employed to stabilize a skeletal joint of a user whan the joint has bean weakened by injury or other infirmity. The brace typically has a structural frame that is made up of a plurality of rigid or stiffened support components dynamically linked together by one or more hinges to support the joint during user activity. The frame is mounted on the body of a user such that the hinges traverse the joint being stabilized, while the support components are secured to the body by a system of pliant straps. Solid elastomeric pads or fluid-filled pneumatic pads are attached to the inside of the frame to cushion the user’s body from the frame and provide a stable base of support for the frame against the user's body.

Despite such pads, the user frequently experiences discomfort from painful point loads while wearing a closely-fitted brace because of the high forces the brace applies to the body during routine or rehabilitative physical activity. The discomfort is attributable to improper compression characteristics in conjunction with improper sizing and configuration of the pads. Known pads are generally not configured in conformance with the structure of the brace and the contours of the body. Furthermore known pads are not readily adaptable to transient changes that body tissue undergoes, such as swelling or shrinkage, during routine or rehabilitative physical activity.

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Elastomeric or pneumatic pads configured in conformance with the patella have been utilized in pliant or soft knee braces. U.S. Patents 4,201,203 and 4,777,946 disclose soft knee braces having an elastomeric patella pad. U.S. Patents 4,378,009 and 4,938,207 disclose soft knee braces having Inflatable pneumatic patella pads. Pneumatic pads adequately conformed to the body, however, have not been utilized in hinged orthopaedic braces having rigid or stiffened frames. U.S, Patent 5,125,400 discloses an orthopaedic brace having inflatable pneumatic pads positioned between the ankle of the user and the rigid support components of the brace. U.S. Patent 5,107,823 discloses a thigh guard having an inflatable pneumatic pad positioned between the thigh and a rigid protective shell. In both instances, however, the pads are not significantly configured in conformance with the corresponding body contours.

Some hinged orthopaedic braces have specifically addressed the problem of closely fitting the rigid frame of the brace with the knee or elbow joint of the body while simultaneously cushioning the body from the rigid frame. French patent publication FR 2627-381-A discloses a brace having a pair of disk-shaped fluid-filled pads positioned on the frame of the brace to abut the knee or elbow condyles. U.S. Patent 3,581,741 discloses a brace having a doughnut-shaped solid felt or rubber pad positioned between the rigid frame of the brace and the medial meniscus of the knee. Yet, the art does not disclose pneumatic pads configured in substantial conformance with the contours of the user's body for use with hinged orthopaedic braces having rigid or stiffened frames.

Accordingly, it is an object of the present invention to provide an orthopaedic brace having a rigid or stiffened structural frame that can be secured to the body of a user with both a high degree of stable support and a high degree of user comfort. It is a further object of the present invention to provide a lightweight pneumatic pad attachable to the frame of an orthopaedic brace that comfortably stabilizes the frame against the body of the user by dynamically conforming to and firmly gripping the contours of the body while fully cushioning the body contours from the rigid or stiffened support components of the frame. It is yet another object of the present invention to provide a pump associated with the pad to facilitate selective inflation of the pad when desired, thereby enhancing the comfort of the user and the stability of the frame against the body.

It is another object of the present invention to provide an off-theshelf orthopaedic brace that can be adapted to fit the body contours of any number of users. It is another object of the present invention to provide a custom orthopaedic brace that is readily configured to changing body contours of a specific individual user. It is still another object of the present invention to provide an orthopaedic brace having a fit that can be instantaneously adapted to the requirements of different activities by the user. It is a further object of the present invention to provide an orthopaedic brace having a fit that can be instantaneously adjusted to transient conditions of the body such as localized tissue swelling or shrinkage.

In accordance with one embodiment, the present invention is a hinged orthopaedic brace having a structural frame, at least one pneumatic pad engaging the frame, and a pump in fluid communication with the pneumatic pad. The frame comprises a plurality of rigid or stiffened support components and a hinge dynamically connecting the support components. The pneumatic pad comprises a fluid-containing bladder formed from a flexible skin that is shaped into a containment configuration to enclose a quantity of fluid therein. The pneumatic pad provides secure and comfortable support for the brace when the frame is mounted on the body of a user.

According to the present invention there is provided an orthopaedic brace positionable on a body of a user about a joint comprising: a substantially rigid or stiffened upper support component having an inside face positionable proximal to the body of the user above the joint; a substantially rigid or stiffened lower support component having an inside face positionable proximal to the body of the user below the joint; a hinge rotatably connecting said upper and lower support components; a pad having a bladder forming a loop substantially encircling an interior opening wherein said interior opening is optionally centrally offset from said loop and, said pad engaging said inside face of said upper or lower support component and positionable against the body of the user above or below the joint; and a means adapted for addition of a fluid to said bladder, wherein said means is in fluid communication with said bladder.

The degree of support the pneumatic pad provides the brace is adjustable by the selective addition of fluid to the bladder or the selective release of fluid from the bladder. Accordingly, the bladder is provided with means for such selective addition and release of fluid. Such means include one or more valves and or one or more pumps, in fluid communication with said bladder. The selective fluid addition and release means, in accordance with a preferred embodiment of the present invention, is a pair of fluid ports. One port is a fluid-addition port providing a bladder inlet in fluid communication with the pump that is adapted to enable the selective addition of fluid to the bladder. The other port is a fluid-release port providing a bladder outlet in fluid communication with the external environment that is adapted to enable the selective release of fluid from the bladder.

The pump is substantially any fluid drive means in fluid communication with the bladder for injecting fluid therein. A preferred pump is a manually-powered mechanism for driving ambient air from the external environment into the bladder. Such a pump includes an elastic bulb enclosing a pump chamber inflatable with air. The bulb is formed from a compressible elastomeric material exhibiting good memory characteristics. The bulb has a pump inlet selectively providing fluid communication between the pump chamber and an external environment of ambient air. The bulb also has a pump outlet selectively providing fluid communication between the pump chamber and the bladder inlet. A one-way injection valve is provided downstream of the pump chamber to permit air flow between the chamber and bladder only in the direction of the bladder. A release valve is also provided at the bladder outlet to enable the selective release of pressurized air from the bladder to the external environment as desired by the user.

With the brace in place on the body of a user, the thickness of the pneumatic pad or the corresponding air pressure therein is systematically adjustable by inflating or deflating the bladder of the pad as desired to closely fit the structural frame of the brace with the specific contours of the body of the user. The pneumatic pad permits the user to instantaneously adapt the fit of the frame to different user activities or to changing conditions of the user's body. Thus, for example, if swelling is experienced by the user, the bladder can be deflated by the release of fluid therefrom to reduce the thickness or air pressure of the pad, thereby reducing the pressure of the brace on the body of the user and enhancing the comfort of the user. In contrast, if undesirable movement of the brace is experienced relative to the body of the user during vigorous physical activity, the user can inflate the bladder by the addition of fluid thereto to increase the thickness or air pressure of the pad, thereby increasing the pressure of the brace on the body of the user and providing a tighter fit of the frame to the body.

Fluid addition to the bladder is effectuated by cycling the pump through an intake mode and a discharge mode while maintaining the release valve at the fluid-release port closed. During the intake mode the bulb is inflated by elastic expansion, while maintaining the injection valve at the fluid-addition port closed. Inflation draws air under ambient pressure from the external environment into the pump chamber via the pump inlet. During the discharge mode the pump inlet is closed and the bulb is deflated by compression. Deflation urges air at elevated pressure against the injection valve causing the valve to open. The air consequently flows from the pump chamber into the bladder via the pump outlet and bladder inlet. Fluid release is effectuated simply by opening the release valve at the fluid-release port, thereby allowing the pressurized air in the bladder to flow into the external environment at a lower ambient pressure via the bladder outlet.

It is readily apparent to the skilled artisan that alternate configurations of the above-described pump and bladder inlets and outlets are possible within the scope of the present invention by appropriately modifying the port and valving configuration of the bladder and pump. For example, the selective addition and release means for the bladder can be integrally contained within a single unitary port, rather than within separate fluid-addition and fluid-release ports. The single port alternately serves as either the bladder inlet or bladder outlet depending on the selective setting of a valve provided at the port that is adapted to alternately enable fluid addition to the bladder and fluid release from the bladder. By providing appropriate valving within the purview of the skilled artisan, the pump outlet, in concert with the pump inlet, can selectively function as the bladder outlet to enable the present configuration.

A preferred embodiment of the present invention comprises an orthopaedic brace positionable on a body of a user about a joint comprising; a substantially rigid or stiffened upper support component having an inside face positionable proximal to the body of the user above the joint; a substantially rigid or stiffened lower support component having an inside face positionable proximal to the body of the user below the joint; a hinge rotatably connecting said upper and lower support components; a pad having a bladder, said pad engaging said inside face of said upper or lower support component and positionable against the body of the user above or below the joint; and a pump in fluid communication with said bladder adapted for addition of a fluid to said bladder.

In another embodiment of the invention there is provided an orthopaedic brace positionable on a body of a user about a joint comprising; a substantially rigid or stiffened upper support component having an inside face positionable proximal to the body of the user above the joint; a substantially rigid or stiffened lower support component having an inside face positionable proximal to the body of the user below the joint; a hinge rotatably connecting said upper and lower support components having a substantially rigid or stiffened inside face positionable proximal to the body of the user at the joint; a pad having a bladder, said pad engaging said inside face of said hinge and positionable against the body of the user at the joint; and a pump in fluid communication with said bladder adapted for addition of a fluid to said bladder.

The above-described embodiment of a hinged orthopaedic brace and its alternate configurations are particularly applicable to a hinged orthopaedic knee brace mountable on the leg of a user to stabilize the knee joint by restricting the motion thereof. The orthopaedic knee brace comprises a structural frame made up of a hinge and a plurality of substantially rigid or stiffened upper and lower support components. The upper support components are engagable with the upper leg above the knee joint and the lower support components are engagable with the lower leg below the knee joint, The hinge is positicnable at the knee joint and rotatably connects the upper and lower support components to pivot them about the hinge in correspondence with flexion and extension of the knee joint as permitted by setting the rotation range of the hinge.

The present orthopaedic knee brace further comprises a pneumatic knee condyle pad, a plurality of pneumatic upper and lower support pads, and means adapted for addition of a fluid in fluid communication with the condyle and support pads enabling inflation thereof. Such means include one or more valves and or one or more pumps as hereinbefore described. The knee condyle pad is attached to the inside face of the hinge, providing a stable base of support for the brace against the knee of the user. The knee condyle pad also cushions the lateral or medial knee condyle from the hinge or other proximate support components of the frame and diminishes point loads to the knee condyle when the brace is mounted on the leg of the user. The upper and lower support pads are attached to the inside faces of the upper and lower support components, respectively, enhancing the base of support for the brace against the upper and lower legs of the user. The support pads also cushion the upper and lower legs from the upper and lower support components of the frame, respectively, and diminish point loads to the upper and lower legs when the brace is mounted on the leg of the user. Separate pumps can be attached directly to the bladder inlet of each pad or integrally formed therewith, providing each pad with its own exclusive pump for selective adjustment of the pad. Alternatively, each of the one or more pumps can be In selective fluid communication with a plurality of pads by means of a network of valves and tubing, thereby enabling selective adjustment of a plurality of pads with a single pump.

In a further embodiment the orthopaedic knee brace of the present invention comprises a hinge plate positionable opposite a knee condyle on the (eg of the user adaptable to apply pressure to the knee condyle; and a fluid-containing primary bladder forming a substantially closed-curve loop encircling an interior opening, said primary bladder having a distal portion and a proximal portion radially opposite said distal portion, wherein the plan width of said distal portion Is substantially less than the plan width of said proximal portion, and further wherein said primary bladder is positionable between said hinge plate and the knee condyle with said loop adaptable in size to circumscribe the knee condyle and said interior opening adaptable in size to receive a bony protrusion of the knee condyle, thereby alleviating pressure applied to the bony protrusion from said hinge plate.

In another embodiment, the present invention is a pneumatic padding assembly comprising a pump and a specifically configured pneumatic knee condyle pad that is in fluid communication with the pump and is attachable to the above-described structurai frame of an orthopaedic knee brace. The pneumatic knee condyle pad is a fluidcontaining bladder configured to conform to the inside face of the hinge and to the surface of the body overlying the lateral or medial knee condyle. Accordingly, the bladder has a loop configuration with an interior opening. The bladder is sized such that it circumscribes the periphery of the condyle and the interior opening is depressed relative to the bladder to receive the apex of the condyle. The interior opening has a number of alternate configurations including a void space, a continuous sheet of a planar material or a secondary bladder having a considerably smaller volume than the loop-configured bladder.

In a preferred embodiment the present invention provides a pneumatic padding assembly positionable on a substantially rigid or stiffened frame of an orthopaedic knee brace to support the frame against a knee condyle when the frame is mounted on the leg of a user, said assembly comprising: a bladder forming a loop substantially encircling an interior opening, wherein said bladder is positionable between the frame and the knee condyle with said loop adaptable in size to substantially circumscribe the knee condyle and said interior opening adaptable in size to receive a bony protrusion of the knee condyle, thereby alleviating pressure applied to the bony protrusion by said frame; a fluid pump; a port connecting said fluid pump and said bladder to provide fluid communication therebetween; and an injection valve between said bladder and said fluid pump for selectively opening and closing said bladder to said fluid pump.

In a further embodiment the bladder forms a loop substantially encircling an interior opening wherein said interior opening is optionally centrally offset from said loop.

The term optionally offset is intended to include an orthopaedic brace of the present invention where the interior opening of said loop is centrally offset, and an orthopaedic brace of the present invention where the interior of said loop is centrally set.

The loop-configured bladder is a closed curve, having the interior opening positioned either substantially at the center of the bladder or centrally offset toward the distal portion of the bladder. Alternatively, the loop-configured bladder is a partially opened curve having, in addition to the interior opening, a peripheral opening positioned in the distal portion of the bladder that is continuous with the interior opening. The partially opened-curve or centrally offset closed-curve configuration of the bladder provides the distal portion of the bladder with a reduced volume and reduced surface area relative to the proximal portion thereof. Accordingly, the distal portion of the bladder avoids excessive pressure, and the pain associated therewith, on the peroneal nerve and fibuiar head proximal to the lateral knee condyle, while effectively gripping the knee condyle and simultaneously cushioning the knee condyle from the frame.

In yet another embodiment, the present invention is a pneumatic padding assembly comprising a pump and a specifically configured pneumatic upper or lower support pad that is in fluid communication with the pump and is attachable to the above-described structural frame of an orthopaedic knee brace. The pneumatic upper or lower support pad is a fluid-containing bladder configured to conform to the inside face of at least a portion of the upper or lower support component of the frame, as well as to a portion of the surface of the upper or lower leg, respectively. Accordingly, the bladder has an elongated configuration with a right-angle bend formed therein. The bladder also has an interior seam formed in alignment with the longitudinal axis of the bladder.

In a further embodiment the present invention provides a pneumatic padding assembly positionable on a substantially rigid or stiffened frame of an orthopaedic knee brace to support the frame against the upper or lower leg when the frame is mounted on the leg of a user, said assembly comprising: a bladder having an elongate configuration with a longitudinal axis and a substantially right angle bend formed therein, wherein said bladder is positionable between the frame and the upper or lower leg, thereby alleviating pressure applied to the upper or lower leg by said frame; a fluid pump; a port connecting said fluid pump and said bladder to provide fluid communication therebetween; and an injection valve between said bladder and said fluid pump for selectively opening and closing said bladder to said fluid pump.

The construct of the condyle and support pads is substantially the same, wherein a first sheet of an elastically deformable skin overlays a second sheet of the skin. The two sheets are peripherally joined together by at least one seam that defines the plan profile of the bladder and seals the interior of the bladder from the external environment. The bladder is provided with one or two selectively sealable ports as described above through the skin that enable selective fluid communication between the bladder and the pump for adding fluid to the bladder and enable selective fluid communication between the bladder and the external environment for releasing fluid from the bladder.

The pad may further be provided with a pliant facing that is affixed to the outside of one sheet and with a pliant backing that is affixed to the outside of the other sheet. The facing provides a soft, absorbent surface for engagement with the user's body and the backing provides added cushion between the bladder and the support components of the frame. The backing is preferably formed from a hook component or a loop component of a conventional fabric hook and loop fastener coupling, with the remaining component of the fabric coupling being positioned on the inside face of the hinge, facilitating removable attachment of the pad to the brace frame.

A preferred pump has a bulb constructed by molding an elastomeric material into the desired shape of the bulb or by joining two sheets of an elastically deformable skin in the manner described above to form the desired shape of the bulb. The bulb can be integrally constructed coextensive with the bladder or can be constructed separate therefrom and integrally connected to the bladder by means of a tubular port providing a substantially permanent sealed connection therebetween,

The present invention will be further understood, both as to its structure and operation, from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts.

Figure 1 is a perspective view of a structurai frame for a knee brace of the present invention.

Figure 2 is a frontal view of the knee brace of the present invention in place on the leg of a user.

Figures 3 and 3a are plan views of a knee condyle pad of the present invention attachable to the knee brace of Figure 2.

Figures 4 and 4a are cross-sectional views of the knee condyle pad of Figures 3 and 3a as seen along line 4-4.

Figures 5 and 5a are cross-sectional views of an alternate knee condyle pad of the present invention attachable to the knee brace of Figure 2.

Figures 6 and 6a are plan views of another alternate knee condyle pad of the present invention attachable to the knee brace of Figure 2.

Figures 7 and 7a are plan views of yet another alternate knee condyle pad of the present invention attachable to the knee brace of Figure 2.

Figure 8 is a plan view of a support pad of the present invention attachable to the knee brace of Figure 2.

Figure 9 is a cross-sectional view of the support pad of Figure 8 as seen along line 9-9.

Figure 10 is a cross-sectional view of a pump of the present invention integrally connected to a pad of Figure 2.

Figure 11 is a cross-sectional view of a release valve of the present invention integrally connected to a pad of Figure 2.

Referring initially to Figure 1, an orthopaedic knee brace is shown by way of example, it being understood that the present invention applies generally to orthopaedic braces mountable on numerous joints of the body, wherein the brace has a hinged structural frame formed from rigid or stiffened components. The term ’‘rigid¹’ as used herein refers to a component that is substantially inflexible. The term stiffened refers to a component that is only somewhat more flexible than a rigid component and, thus, like the rigid component, is sufficiently stiff to significantly resist flexion when positioned on the body of a user. In either case, both the rigid and stiffened components are capable of causing the user discomfort by contact when positioned directly against the body during periods of prolonged activity.

The orthopaedic knee brace shown herein has a structural frame generally designated (10). The frame (10), shown by way of example, is a conventional design having a plurality of rigid or stiffened support components including medial upper and lower arms (12), (14), a medial hinge plate (16), lateral upper and lower arms (18), (20), a lateral hinge plate (22), an upper leg cuff (24), and a lower leg cuff (26). The upper and lower leg cuffs (24), (26) have a curved shape providing them with concave inside faces, while the medial and lateral hinge plates (16), (22), the medial upper and lower arms (12), (14), and the lateral upper and lower arms (18), (20) are generally straighter providing them with relatively flatter inside faces. The upper leg cuff (24) and the lower leg cuff (26) are aligned substantially perpendicular to the upper arms (12), (18) and the lower arms (14), (20), respectively.

In practice, the upper support components (12), (13), (24) can be integrally formed in a unitary structure from a high-strength material, such as a plastic, metal or composite. The lower support components (14), (20), (26) can likewise be integrally formed in a unitary structure from similar materials. The hinge plates (16), (22) are generally defined as the rigid or stiffened portion of the frame (10) integral with or proximal to the rotary hinge mechanism, such as the external housing of the rotary hinge mechanism. Portions of the arms (12), (14), (18), (20) proximal to the hinge mechanism, or other proximal components integrally functioning with the hinge mechanism can also be included within the term hinge plates as defined herein. The hinge mechanism (obscured from view by the hinge plates (16), (22)) is typically a conventional rigid pivot member, such as a pin or rivet, rotatably engaging an upper or lower support component of the frame (10). The term hinge as used herein comprises the entire assembly proximal to the intersection of the upper and lower support components including the hinge plates and hinge mechanism.

Referring to Figure 2, an orthopaedic knee brace of the present invention, having the above-described structural frame (10), is generally designated (28). The knee brace (28) is shown operably positioned on the left leg (30) of a user, wherein the support components of the frame (10) engage the leg (30) at a plurality of contact points. In particular, support of the brace (28) against the leg (30) is provided by engagement of the inside faces of the medial and lateral upper arms (12), (18) and upper leg cuff (24) with the upper leg (32) and engagement of inside faces of the medial and lateral lower arms (14), (20) and lower leg cuff (26) (obscured from view in Figure 2) with the lower leg (34). Support of the brace (28) against the leg (30) is further provided by engagement of the inside face of the medial hinge plate (16) with the medial knee condyle (36) and engagement of the inside face of the lateral hinge plate (22) with the lateral knee condyle (38).

To facilitate conforming engagement of the frame support components with the leg (30), while simultaneously promoting the comfort of the user, the orthopaedic knee brace (28) is provided with a

2149889 plurality of pneumatic pads that removably attach to the inside faces of the frame (10) at the points of compression contact with the leg (30). In particular, a medial upper support pad (40) is attached to the inside faces of the medial upper arm (12) and upper leg cuff (24). A lateral upper support pad (42), that is substantially a mirror image of the medial upper support pad (40), is attached to the inside faces of the lateral upper arm (18) and upper leg cuff (24). The upper support pads (40), (42) reside in compression between the upper leg (32) and frame (10) when the frame (10) engages the upper leg (32) as shown. Medial and lateral lower support pads (44), (46) substantially similar to the upper support pads (40), (42) are attached to the inside faces of the medial and lateral lower arms (14), (20) and lower leg cuff (26), respectively, to reside in compression between the lower leg (34) and the frame (10) when the frame (10) engages the lower ieg (34).

The brace (28) is further provided with pneumatic medial and lateral knee condyle pads (48), (50). The medial knee condyle pad (48) is attached to the inside face of the medial hinge plate (16) to reside in compression between the medial knee condyle (36) and the medial hinge plate (16) when the plate (16) engages the medial knee condyle (36). The lateral knee condyle pad (50) is substantially a mirror image of the medial knee condyle pad (48) and is attached to the inside face of the lateral hinge plate (22) to reside in compression between the lateral knee condyle (38) and the lateral hinge plate (22) when the plate (22) engages the lateral knee condyle (38).

Each pneumatic pad (40), (42), (44), (46), (48), (50) is shown to have a pump (52) associated therewith. More particularly, in accordance with the present embodiment, each pneumatic pad (40), (42), (44), (46), (48), (50) has a pump (52) integrally connected therewith to provide a substantially permanent, sealed fluid passageway between the pump (52) and the respective pneumatic pad.

Each pump (52) has substantially the same configuration and construction as is described hereafter. Although not shown in Figure 2, the brace (28) is also provided with a plurality of adjustable pliant straps engaging the arms (12), (14), (18), (20) and wrapping around the leg (30). The configuration and placement of the straps is conventional and well known to the skilled artisan. The straps secure the frame (10) to the leg (30) of the user by increasing the compression force at the contact points between the frame (10) and leg (30). It is further noted that the present orthopaedic knee brace (28) lias been described above as positioned on the left leg (30). It is understood by the skilled artisan, however, that the orthopaedic knee brace (28) is readily adaptable for positioning on the right leg as well within the scope of the present invention.

The configuration and construction of preferred pneumatic knee condyle pads (88) and (50) are described hereafter with reference to Figures 3-7. Referring initially to Figures 3 and 4, a first embodiment of a lateral knee condyle pad (50) is shown to comprise a fluid-containing, closed-curve primary bladder (54) having an outer plan perimeter and an inner plan perimeter defined by a primary seam (56) and a secondary seam (58), respectively. The primary seam (56) continuously surrounds the primary bladder (54) following an ovalshaped, closed-loop pathway, thereby defining the entire peripheral outer plan perimeter of the primary bladder (54). The secondary seam (58) also follows a continuous, somewhat oval-shaped, closed-loop pathway and is encircled by the primary seam (56). The secondary seam (58), however, is centrally offset from the primary seam (56). The secondary seam (58) defines the inner pian perimeter of the primary bladder (54) and also defines the outer plan perimeter of an interior opening that isa depression substantially encircled by the primary bladder (54). The interior opening has a number of alternate configurations as described hereafter, but in all cases the interior ¹⁸ opening is characterized as having a substantially lesser height or thickness than the primary bladder (54) when the lateral knee condyle pad (50) is not compressed against the body of the user.

The primary and secondary seams (56), (58) are fluid-tight to effectively seal the selected fluid contained within the interior of the primary bladder (54) from the external environment. The fluid contained within the primary bladder (54) is preferably a gas at ambient temperature, such as air. The fluid enables the uncompressed primary bladder (54) to retain a substantially irregular toroid shape. The configuration of the primary bladder (54) is termed an irregular toroid because its radial cross-section is not uniform about the entire rotation of the primary bladder (54) due to the off center position of the secondary seam (58).

A tubular fluid-addition port (60) having a one-way injection valve (62) positioned therein is provided having one end extending through the primary bladder (54), and in particular, having one end extending through the primary seam (56) and substantially permanently seafingly engaged thereby, to form a bladder inlet (64). The other end of the tubular fluid-addition port (60) substantially permanently sealingly engages the pdrnp (52) to form a pump outlet (66). The fluid-addition port (60) enables selective fluid communication between the interior of the primary bladder (54) and the interior of the pump (52). Accordingly, when the injection valve (62) is closed, there is substantially no fluid communication between the primary bladder (54) and the pump (52). When the injection valve (62) is opened, fluid communication exists between the primary bladder (54) and pump (52) enabling the addition of fluid to the primary bladder (54) as desired to increase the volume of the primary bladder (54).

A tubular fluid-release port (68) having a release valve (70) positioned therein is also provided having one end extending through the primary seam (56) and substantially permanently sealingly engaged thereby. The other end of the tubular fluid-release port (68) opens to the external environment, forming a selectively openable bladder outlet (72). The fluid-release port (68) enables selective fluid communication between the interior of the primary bladder (54) and the external environment. Accordingly, when the release valve (70) is closed, there is substantially no fluid communication between the primary bladder (54) and external environment. When the release valve (70) is opened, fluid is releasedfrom the primary bladder (54) as desired to increase the volume of the primary bladder (54).

As can be appreciated by the skilled artisan, the volume or pressure of thé primary bladder (54) is modified to enhance the fit of the brace (28) Against the leg (30) or to enhance the cushioning effect of the pad (50). The injection valve (62) is substantially any conventional one-way valve configured to enable fluid flow into, but not out of, the primary bladder (54) via the fluid-addition port (60). The injection valve (62) is preferably a check valve that opens when a sufficient fluid pressure is applied to it from the pump side of the valve, but remains closed when fluid pressure is applied to it from the primary bladder side of the valve, The release valve (70) is substantially any conventional valve permitting fluid flow across it in either direction when open, and permitting substantially no flow across it in either direction j

when closed, the release valve (70) is preferably a manually operated valve that is spring biased in a closed position.

In a further embodiment as shown in Figures 3a, 4a and 5a, a lateral knee condyle pad (51) and (85) with a bladder, said bladder forming a substantially closed-curve loop encircling an interior opening wherein said interior opening is centrally offset from said loop; and tubular port (130) having a selectively openable and closeable valve (131) (not shown in Figure 3a) positioned therein is provided through the primary bladder (54), and in particular through the primary seam (56), to enable selective fluid communication between the interior of the primary bladder (54) and the external environment. Accordingly, when the valve (131) is closed, there is substantially no fluid communication between the interior of the primary bladder (54) and the exterior. When the valve (131 )hs opened, fluid can be added to or withdrawn from the primary bladder (54) as desired to modify the volume of the primary bladder (54). The valve (131 ) is a duckbill valve or other conventional valve configured to receive the injection needle of a manual fluid pump through port (130).

in accordance with the embodiment of the lateral knee condyle pad (50) shown in Figures 3 and 4, the interior opening is occupied by a secondary bladder (74) that is in fluid isolation from the primary bladder (54). The plan perimeter of the secondary bladder (74) is defined by the secondary seam (58) and the secondary bladder (74)

Ï has a substantially continuous radial cross section. The secondary bladder (74) contains a lesser quantity of fluid than the primary bladder (54) and is substantially less thick than the primary bladder (54) when the lateral knee condyle pad (50) is not compressed against the body of the user. Unlike the primary bladder (54), the secondary bladder (74) is substantially permanently sealed, having no ports therein, such that the quantity of fluid within the secondary bladder (74) is substantially constant throughout the life of the pad (50).

The primary and secondary seams (56), (58) of the lateral knee condyle pad (50) are configured such that the secondary bladder (74) is centrally offset from the primary bladder (54) toward the distal portion of the pad (50) that is radially opposite the proximal portion of the pad (50). The term centrally offset refers to the fact that the primary and ²¹ secondary bladders (54), (74) do not share a common center. The terms proximal and distal, as used in describing the pad (50), are relative to the midsection of the body of a user on which the orthopaedic knee brace (28) is positioned. Accordingly, the plan width of the proximal portion of the primary bladder (54) Is substantially greater than the plan width of the distal portion of the primary bladder (54), wherein the plan width is defined as the distance between the outer plan perimeter and the inner plan perimeter of the primary bladder (54), as shown in Figure 3. Correspondingly, the distal portion of the primary bladder (54) has a substantially reduced volume and surface area relative to the proximal portion of the primary bladder.

The present configuration of the lateral knee condyle pad effectively reduces excessive pressure on the peroneal nerve and fibular head, which are in the distal region of the lateral knee condyle (38) shown in Figure 2.

Specifically referring to Figure 4, the lateral knee condyle pad (50) Is shown to have a laminar construction cumprising a facing (70) and a backing (78). It is noted that the thickness of the laminate layers have been exaggerated for purposes of illustration. The facing (76) is a sheet of a soft, pliant, absorbent material, such as synthetic suede or chamois, anteriorly laminated to both the primary and secondary bladders (54), (74). The backing (78) is likewise a sheet of pliant material posteriorly laminated to the bladders (54), (74) in substantially the same manner as the facing (76). A preferred backing (78) is the loop component of a hook and loop fastener, commonly termed VELCRO, configured as a cloth patch. A doth patch of the hook component (not shown) is similarly laminated to the inside face of the lateral hinge plate (22) opposite the backing (78). It is understood that the positions of the hook and loop components can alternatively be reversed such that the loop component is laminated to the inside face of the lateral hinge plate (22) and the hook component is laminated to the outside of the bladders (54), (74).

In a preferred construction of the lateral knee condyle pad (50), the primary and secondary bladders (54), (74) are shown in Figure 4 to be integrally formed from two continuous sheets (80), (82) of a film-like skin. The skin is a highly-flexibie, elastically-collapsible, fluidimpervious material such as a plastic, e.g., polyurethane or polyvinyl chloride. Construction of the lateral knee condyle pad (50) is initiated by laminating the facing (76) onto the outside of the first sheet (80) and correspondingly laminating the backing (78) onto the outside of the second sheet (82) by an adhesive such as a conventional glue. The bladders (54), (74) are then constructed by overlaying the first sheet (80) atop the second sheet (82). Hie primary seam (56) is formed by positioning the fluid-addition port (60) and the fluid-release port (68) between the two sheets (80), (82) at the outer plan perimeter thereof and joining the sheets (80), (82) around the ports (60), (68) and along the continuous ovai path of the outer plan perimeter using conventional means, such as radio frequency (r.f.) welding. The secondary seam (58) is formed in substantially the same manner as the primary seam (56), but absent the ports, such that the secondary seam (68) is positioned off center from the primary seam (56) and encircled thereby.

It is noted that when the primary and secondary seams (56), (58) are formed, a quantity of fluid, typically ambient air, can be trapped within the interiors of the seams (56), (58). The fluid retained within the interior of the secondary seam (58) remains therein without the further addition or withdrawal of fluid for substantially the life of the pad. The fluid within the interior of the primary seam (56), however, can subsequently be supplemented by injecting additional fluid via the fluidaddition port (60) and injection valve (62) in the manner described above to achieve a desired increase in the thickness or fluid pressure of the primary bladder (54). Consequently, the distance separating the first and second sheets (80), (82) within the primary bladder (54) is substantially greater than the distance of separation within the secondary bladder (74).

Although not shown, the lateral knee condyle pad (50) of Figure 4 can alternately be configured by evacuating the secondary bladder (74) and laminating the inside of the first sheet (80) to the inside of the second sheet (82) across the entire interior opening. Thus, the secondary bladder is excluded from this embodiment and the interior opening is occupied by the resulting laminate comprising the first and second sheets (80), (82), facing (76), and backing (78).

Referringto Figure 5 and 5a having substantially the same crosssectional view las Figure 4 and 4a, another embodiment of a lateral knee condyle pad is shown and generally designated (84) for Figure 5 and (85) for Figure 5a. Identical reference characters are used to identify elements common to both the lateral knee condyle pad (84) and (85), and the lateral knee condyle pad (50) and (51 ) insofar as the lateral knee condyle pad (84) and (85) are configured substantially the same as the lateral knee condyle pad (50) and (51) with the exception of the interior opening. The lateral knee condyle pad (84) and (85) exclude the secondary bladder from the interior opening and substitute an interior void space (86) therefor. Accordingly, the pad (84) and (85) contains only one bladder, i.e., the primary bladder (54).

Referring to Figure 6 and 6a, yet another embodiment of a lateral knee condyle pad is shown and generally designated (88) and (89). Identical reference characters are used to identify elements common to the above-described lateral knee condyle pads (50), (51), (84), (85) and the present embodiment of the lateral knee condyle pad (88) and (89). Like the iaterai knee condyle pad (84), the lateral knee condyle

2119689 pad (88) and (89) excludes the secondary bladder from the interior opening and substitutes an interior void space (90) therefor. The pad (88) and (89) also has a primary bladder (92) that is substantially toroid-shaped. The primary bladder (92), however, is a partially opened curve having a relatively limited peripheral opening in the distal portion thereof that is occupied by a peripheral void space (94) continuous with the interior void space (90). Accordingly, the lateral knee condyle pad (88) and (89) has a horseshoe-shaped plan perimeter defined by a single close-looped primary seam (96).

Because of the peripheral void space (94), the interior void space (90) can be substantially concentric with the primary bladder (92), or alternatively centrally offset therefrom, without defeating the function of the pad (88) and (89) to alleviate pressure on the fibuiar head and peroneal nerve. It is also noted that the lateral knee condyle pad (88) and (89) has the 6ame laminar construction as the above-described lateral knee condyle pads (50), (84), comprising two sheets of film-like skin, a facing, and a backing.

Referring to Figure 7 and 7a, a further embodiment of a lateral knee condyle pad is shown and generally designated (98) and (99). Identical reference characters are used to identify elements common to the lateral knee condyle pads (50), (51 ), (84), (85), (88) and (89) and the lateral knee condyle pad (98) and (99). The lateral knee condyle pad (98) and (99) is configured substantially the same as the lateral knee condyle pad (88) with the exception of the peripheral and interior openings. In addition to the primary bladder (92) and primary seam (96), the lateral knee condyle pad (98) and (99) includes a secondary bladder (100) positioned within the peripheral and interior openings thereof and having a similar construction to the secondary bladder (74) of the lateral knee condyle pad (50) shown in Figures 3 and 4. The pad (98) and (99) also includes a secondary seam (102), extending

CA 02149689 2005-01-14 across the distal plan perimeter of the secondary bladder (100) and having two ends intersecting the primary seam (96).

Although _;not shown, the lateral knee condyle pad (98) and (99) of Figure 7 and 7a can alternately be configured by evacuating the secondary bladder (100) and laminating the insides of the two film-like sheets forming the secondary bladder (100) together across the entire peripheral and interior openings. Thus, the secondary bladder is excluded from this embodiment and the peripheral and interior openings are occupied by the resulting laminate comprising the two film-like sheets, a facing, and a backing.

Although only lateral knee condyle pads have been shown and described above, it is understood that the descriptions of the lateral knee condyle pads apply equally to medial knee condyie pads which are mirror images of the lateral knee condyle pads. It Is also understood that other embodiments of knee condyle pads, in addition to those shown and described above, are possible within the scope of the present invention. For example, the present invention encompasses alternate embodiments of knee condyie pads that are substantially identical to the above-described embodiments, but which exclude the facing or backing from the pad.

The present invention further provides for alternate embodiments of knee condyle pads, wherein the primary bladder of the knee condyle pad has a regular toroid shape such that the interior opening is concentric with the primary bladder, as disclosed in U.S. Patent Nos. 5,316,547 and 5,415,625.

Alternatively, the primary bladder of the knee condyle pad has substantially any shape defining a closedcurve or partially opened-curve loop that conforms to the perimeter of a knee condyle and provides an interior opening for receiving the apex of

CA 02149689 2005-01-14

I the knee condyle. In all cases, it is preferred that sufficient fluid is placed In the primary bladder to maintain the height of the primary bladder greater than the height of the knee condyle received therein during use of the brace to prevent substantial compressive contact of the knee condyle with the rigid or stiffened support components of the brace to which the pad is attached, it is further preferred that the primary bladder of the lateral knee condyle pad does not excessively impinge on the fibular head and peroneal nerve in the region of the lateral knee condyle.

Alternative means for producing the knee condyle pad are also provided within the scope of the present invention. For example, the primary bladder can be formed from a single sheet of film-like material, rather than two sheets as disclosed above, by joining the edges of a single sheet together and welding the resulting joint, thus, forming a biadder sealed at the weld or welds. In other production alternatives, the primary bladder may be formed by blow molding or other conventional molding methods available to one skilled in the art.

The configuration and construction of preferred upper and lower support pads (40), (42), (44), (46) are described hereafter with reference to Figures 8 and 9. The upper and lower support pads all have a substantially identical configuration and construction. Therefore the upper and lower support pads are described only with reference to the medial upper support pad (40), it being understood that the description applies likewise to the remaining support pads. In addition, identical reference characters are used to identify elements common to both the medial upper support pad (40) and the lateral knee condyle pad (50) insofar as both pads (40), (50) have substantially the same fluid-addition and fluid-release port structures. It is noted that upper and lower support pads having a similar configuration to those shown herein are described in U.S. Patent No. 5,415,625.

and that upper and lower support pads of alternate configuration, but having utility with the brace (28) of the present invention are described in U.S. Patent No. 5,316,547.

Referring now to Figures 8 and 9, the medial upper support pad (40) is shown to include a bladder (104) having a peripheral seam (106) defining the outer plan perimeter of the bladder ( 104). The configuration of the bladder (104) is characterized as elongate with a substantially right-angle bend along its longitudinal axis. The bladder (104) has an interior seam (108) following at least a substantial portion of the longitudinal axis of the bladder (104) surrounded by, but not intersecting, the peripheral seam (106).

The peripheral seam (106) is fluid-tight to effectively seal the selected fluid contained within the interior of the bladder (104), preferably ambient air, from the external environment. The fluid within the bladder (104) enables the bladder (104) to retain a substantially opened curve tubular shape when the bladder is not compressed against the leg of the user. It is also apparent that when the medial upper support pad (40) is free standing, independent of the stiffened or rigid frame (10), the pad (40) is substantially planar. However, when attached to the medial upper arm (12) and upper leg cuff (24) of the frame (10) as shown in Figure 2, the medial upper support pad (40) is twistable to a three-dimensional configuration conforming to the frame (10). The conformed medial upper support pad (40) substantially covers the inside face of the medial upper arm (12) and the inside face of a portion of the upper leg cuff (24) corresponding to one quadrant of a circle defined by the upper leg cuff (24). The remaining support pads (42), (44), (46) similarly conform to the inside faces of the respective support members of the frame (10) as shown in Figure 2.

The presence of the interior seam (108) on the bladder (104) facilitates conformance of the medial upper support pad (40) to the inside face of the frame ( 10), thereby enhancing the fit of the frame (10) to the upper leg (32). The interior seam (108) also functions to desirably increase the contact interface between the bladder (104) and the frame (10), further enhancing the fit of the frame (10) to the upper leg (32). The interior seam (108) essentially bifurcates the substantially convex, tubular-shaped bladder (104), thereby significantly increasing the contact surface of the medial upper support pad (40) relative to a similar pad configuration absent the interior seam (108),

Like the lateral knee condyle pad (50), the bladder (104) of the medial upper support pad (40) is provided with a tubular fluid-addition port (60) having a one-way injection valve (62) positioned therein. One end of the fluide-addition port (60) extends through the peripheral seam (106) of the bladder (104) to form a bladder inlet (64) and the other end sealingly engages the pump (52) integrally connected with the medial upper support pad (40) to form a pump outlet (66). The bladder (104) is also provided with a tubular fluid-release port (68) having a release valve (70) positioned therein. One end of the fluid-release port extends through the peripheral seam (106) and the other end opens to the external environment, forming a selectively openable bladder outlet (72). The fluid-addition port (60), fluid-release port (68), and associated valves (62), (70) function in substantially the same manner as described above with respect to the lateral knee condyle pad (50), thereby enabling selective fluid communication between the interior of the bladder (104) and the interior of the pump (52) and enabling selective fluid communication between the interior of the bladder (104) and the external environment, respectively.

The medial upper support pad (40) is also constructed in substantially the same manner from the same materials as described

CA 02149689 2005-02-02 above with respect to the lateral knee condyle pad (50). Accordingly, i

the medial uppter support pad (40) has a laminate construction Including two sheets (SO), (82) of film-like skin, a facing (76). and a backing (78).

The configuration and construction of a preferred pump (52) and release valve (70) is described hereafter with reference to Figures 10 and 11. Although the pump (52) and release valve (70) are described In association with the lateral knee condyle pad (50), it is understood that the pump (52) and release valve have utility with any of the abovedescribed pneumatic pads. The pump (52) and release valve (70) are conventional, being substantially as disclosed in U.S. Patent No. 5,113,590. Referring to Figure 10, the pump (52) comprises a buna (i 1 o) enclosing a pump chamber (112). The bulb (110) is formed from an elastomeric material having good memory characteristics and preferably hemispherically shaped to facilitate manual pumping when the fiat side of the bulb (110) is positioned against a relatively rigid surface. The bulb (110) Is constructed from one or more sheets formed in the desired hemispherical shape substantially In the manner described above with respect to construction of the primary bladder (54), Alternatively, the bulb (110) is formed by conventional molding techniques. In any case, the skin of the bulb (110) Is typieally thicker than the skin of the primary bladder (54) to provide the (110) with the desired memory characteristics.

The pump outlet (66) is provided at one end of the chamber (112) In sealed engagement with the fluid-addition port (60) of the pad (50). The pump outlet (66) is in selective fluid communication with the primary bladder (54) by means of the bladder inlet (64) and injection valve (62). A pump inlet (414} is provided at the opposite end of the chamber (112) having a one-way valve (116) positioned therein to provide selective fluid communication between the chamber (112) and the external environment, but only in the direction of the pump chamber (112). The pump inlet valve (116) is preferably a check valve having substantially the same construction as the injection valve (62).

Manual operation of the pump (72) enables the addition of pressurized air to the primary bladder (54) by cycling the pump (72) through an intake mode and a discharge mode while maintaining the release valve (70) in a closed position. The intake mode begins with the user initially maintaining the bulb (110) in a compressed, flattened condition by manually squeezing it. The user then releases the bulb (110), allowing the bulb (110) to return to its memorized hemispherical shape, thereby filling the pump chamber (112) with ambient air from the external environment via the pump inlet (114) and the check valve (116) while maintaining the injection valve (62) closed. After the pump chamber (112) is frilly inflated, the user initiates the discharge mode by regrasping the bulb (110) and manually squeezing it. The air pressure within the pump chamber (112) opens the injection valve (62) while maintaining the pump inlet valve (116) closed. Consequently, the air is displaced at elevated pressure from the pump chamber (112) into the primary bladder (54) via the pump outlet (66) and the bladder inlet (64). When the bulb (110) is substantially flattened, the intake/discharge cycle can be repeated as often as desired until the primary bladder (54) achieves the desired size or internal air pressure.

Referring to Figure 11, the release valve (70) is shown to be integral with the fluid-release port (68) and is preferably positioned proximal to the pump (52) to facilitate manual adjustment of the air pressure in the lateral knee condyle pad (50) by the user. The release valve (70) comprises a valve plunger (118) biased by a spring (120) against a valve seat (122) when the valve (70) is in the closed position as shown, thereby blocking fluid communication between the interior of

CA 02149689 2005-02-02 the primary bladder (54) and the external environment via frie bladder outlet (72). The release valve (70) is placed in the open position In a manner apparent to the skilled artisan, by displacing the valve plunger (118) away from the valve seat (122) into the valve chamber (124), thereby enabling fluid communication between the interior of the primary bladder (54) and the external environment via the bladder outlet (72). Since the air pressure is typically higher in the primary bladder (54) than In the external environment, air flows out of the primary bladder (54) Into the external environment, rather than vice versa, when the release valve (70) is opened.

it is readily apparent to the skilled artisan that alternate configurations cif the above-described pump are possible within the scope of the present invention. For example, the pump inlet can be an unobstructed valve-4ree orifice that is maintained open during the pump intake mode, but is covered by the fingertip of the user during the pump discharge mode to prevent the escape of air from the pump chamber into the external environment. Alternatively, the pump can have a beilows configuration as disclosed in U.S. Patent No. 4,378,009.

It is likewise apparent that alternate configurations of the above-described release valve are also possible within the scope of the present invention. The release valve can be essentially any conventional valve having a selectively open and closed position, such as a gate valve, a needle valve, or the like.

It is further apparent to the skilled artisan fries alternate configurations of the above-described network of pump, valves and ports are possible within the scope of the present invention. For example, the bladder outlet and bladder inlet can be integrally contained within a single unitary port The single port is provided with a valve that enables the port to function as the bladder inlet when the valve is set in one position and enables the port to function a« the bladder outlet when the valve is set in another position. It is still further apparent that by providing appropriate valving within the purview of the skilled artisan, the pump outlet and pump inlet can be placed in selective fluid communication with the external environment when the single port is functioning as the bladder outlet. It is also apparent that the pump can be coextensively constructed as an integral unit with the bladder, wherein the fluid-addition port is provided with a single opening between the pump chamber and the interior of the bladder, thereby obviating a tubular port It is additionally apparent that although the orthopaedic knee brace (28) of Figure 2 is shown having a separate pump (52) for each pad, it is within the purview of the skilled artisan to provide an orthopaedic knee brace having a single pump in selective fluid communication with a plurality of pads using a network of valves and tubing, thereby enabling selective inflation of the plurality of pads by means of the single pump simply by repositioning one or more valves.

While the foregoing preferred embodiments of the invention have been described and shown, it is understood that alternatives and modifications, such as those suggested and others, may be made thereto and fall within the scope of the present invention.