Orthopedic device

An orthopedic device has a main body panel including a longitudinal length with a curved cross-section, and opposed lateral and medial sides. A posterior panel is secured to the lateral and medial sides of the main body panel, and is sized longitudinally shorter than the main body panel in a non-stretched condition. The posterior panel is secured to the main body panel in a pretensioned condition and spans the longitudinal length of the main body panel along the lateral and medial sides thereof.

FIELD OF THE DISCLOSURE

This disclosure relates to an orthopedic device, and more particularly to a knee brace having at least a posterior contour adapted to a natural contour of a leg, a plurality sections having different pretensioning, and a patella buttress for supporting a patella.

BACKGROUND

Various orthopedic devices have been developed and are available for stabilizing and protecting injured or infirm knees. Many of these supports are made from flexible resilient materials that are arranged to stretch over the knee and provide support by compression about the knee of the wearer.

Certain problems exist with many known devices in that some of the devices are formed from closed cell elastomer materials that have poor thermal conductivity and are unable to absorb or wick perspiration from the area supported by the device. These devices also have the tendency to bunch up over the popliteal region of the knee when the leg is flexed, and have seams over the popliteal region causing irritation to the wearer.

Although past efforts have been made to remedy these problems, commercially available devices typically fall short in avoiding the problems. As a result, wearers of the devices are often reluctant to consistently wear the devices, which can lead to future complications or continued discomfort.

Notably, many of these known devices provide uniform circumferential compression about the knee when the device is stretched. The compression applied by the device can be painful to the wearer if areas of the leg and knee are sensitive to pressure.

Some of the known devices include a front central opening that allow for the wearer's patella or kneecap to project. The front central opening relieves pressure that would otherwise be exerted on the patella, particularly when the knee is bent or in flexion. These devices may include a pad or buttress located about the front central opening so as to provide a restraining force to the patella and additional support, such as preventing lateral or medial displacement of the patella in the femoral groove.

Despite known solutions, many devices fail to maintain the patella pad in a proper position on the support so the opening or pad can prevent patella displacement.

Accordingly, there is a need for a knee brace that at least provides means for stabilizing and supporting the patella, as well as provide means for maintaining the brace in proper position on the leg in a comfortable manner so as not to interfere with the normal use of the leg.

SUMMARY

In accordance with the various exemplary orthopedic device embodiments of the disclosure, a knee brace is provided having a highly breathable construction for increasing patient comfort without sacrificing durability or compression of the knee brace. The knee brace can control ligament extension and flexion, and may be used to treat strains, sprains or instabilities of the anterior, medial, lateral and posterior collateral ligaments. The knee brace may also be designated for post-operative care following meniscal repairs and other reconstructive surgeries of the knee.

The various knee brace embodiments provide multiple features arranged to treat medical necessities with measurable consequences. In one example, the knee brace employs a three-dimensionally shaped contrast fabric behind the knee joint that reduces bunching, which in turn allows for greater comfort and conformance to the leg, as well as maintain compression about the leg. The contrast fabric provides for soft-tissue compression so as to offer edema control and reduce swelling.

The contrast fabric is preferably located on the posterior aspect of the knee brace, and eliminates the necessity of cutting out a section at the popliteal portion of the knee or brace, and allows for better compression over known braces having a popliteal cut-out. In particular, the knee brace is arranged to stretch in extension and relax back to a natural or predetermined shaped in flexion, thereby minimizing popliteal bunching (along the posterior side of the knee) that causes skin irritation.

Various materials and combinations thereof are employed in embodiments of the knee brace to provide for an intimate fit, reduce heat retention and sweat, and allow application of the knee brace for application from the left or right sides of the leg. These benefits are achieved by the selection of particular materials including those having breathable and quick-drying properties, stitching patterns, and pre-tensioning of certain fabric sections.

In another feature, the knee brace may include rigid uprights connected to the hinge that are malleable allowing for enhanced medial-lateral stability in a knee brace. The malleable rigid uprights also provide patient perception of enhanced stability of the knee brace. Some embodiments include pull tabs for facilitating donning and doffing of the knee brace, as well as easy fitting and maintaining the location of the hinge. Various pocket constructions are used to house the uprights and may also include the hinge as well.

In yet another feature, the knee brace may include dual lower cruciate straps that enable fine-tuned control of the anterior-posterior hinge placement and cinch the knee brace above the gastroc to reduce migration of the brace over the leg. Additionally, the knee brace includes a reversible strapping system by way of individual straps for both the anterior and posterior aspects of the leg. This enables the brace to be set up to pull laterally-to medially, medially-to-laterally, or a combination of both, depending on specific treatment objectives of the wearer of the knee brace.

Certain patella buttresses may be used in combination with embodiments of the knee brace. According to various embodiments described herein, the buttress may employ various textile combinations having different properties and locations which lead to improved support about the buttress. Certain patella buttresses are located on the exterior surface of the knee brace, as opposed to on a posterior surface as in known braces. These embodiments include the concept of providing an intermediate layer lacking stretchability so as to prevent excessive stretching of the buttress and effectively yielding to the movement of the wearer without providing adequate support.

Alternatively, patella buttress embodiments may be arranged to direct a buttress toward the knee or be arranged with a combination of materials and stitching types to minimize or enhance localized stretching of the patella buttress and particularly direct the buttress.

In yet another embodiment, the patella buttress may be securable about an opening formed by the knee brace. The patella buttress is configured and dimensioned so that it can be removably mounted at a plurality of locations about the circumference of the opening, thereby allowing the wearer to place the patella buttress at a location best suited for supporting an individual wearer's patella.

It should be noted that the drawing figures are not necessarily drawn to scale, but instead are drawn to provide a better understanding of the components thereof, and are not intended to be limiting in scope, but rather to provide exemplary illustrations. It should further be noted that the figures illustrate exemplary configurations of a knee brace, and in no way limit the structures or configurations of a liner thereof according to the present disclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

Numerous knee brace embodiments and components for use therewith are described herein, with particular focus given to supports and components directed to the knee joint and surrounding areas. The knee brace embodiments may serve in protective, preventative or remedial capacities. While the knee brace is described within the context of preferred embodiments that are directed to supporting a knee joint, many of the features described herein may be extended to other supports and components that bear or secure other joints and body parts, such as the wrist, elbow, shoulder, ankle and neck.

The knee brace embodiments and components for use therewith may be dimensioned to accommodate different types, shapes and sizes of human joints and appendages. These embodiments may be modified to orient principal forces exerted by the leg.

As is well understood, the primary movements of the knee comprise flexion, i.e., rearward rotational movement of the tibia relative to the femur, and extension, i.e., forward rotational movement of the tibia relative to the femur.

For explanatory purposes, each knee brace or component thereof described herein may be divided into sections which are denoted by general anatomical terms for the human body. Such anatomical terms are provided to distinguish various elements of the leg support embodiments from one another, but which are not to be considered to limit the scope of the invention.

The terms “proximal” and “distal” generally refer to locations of the knee brace that correspond to the location of leg relative to the point of attachment of the leg to the body. The terms “upper” and “lower” may be used in combination with “proximal” and “distal” to connote gradations in location of “proximal” and “distal.” The location at where the support corresponds to the knee joint is used herein to generally delimit the proximal and distal, or upper (U) and lower (L) sections spaced by a center section (C) of the knee brace.

The embodiments of the leg support can also be considered to fall within “anterior” and “posterior” sections by an anterior-posterior plane. The anterior-posterior plane generally corresponds to the coronal or frontal plane of a human leg which lies along the central longitudinal axis of a body. A posterior side or element is therefore located behind this anterior-posterior plane, whereas an anterior side or element is located in front of the anterior-posterior plane.

The terms “inwardly” or “inner” commonly used herein to distinguish the side of the leg support that may be directed to the posterior side of the support and specifically adjacent to the leg of the wearer of the support. On the other hand, the term “outwardly” or “outer” are used to denote the side of the support that is opposite to the inwardly side.

The terms “medial” and “lateral” are relative terms that are generally understood as indicating location near the midsaggital plane or midline. Therefore, elements that are located near the midline are referred to as “medial” and those elements that are further from the midline are considered to be “lateral.” The term “central” is used to denote the area along the midline including portions of the medial and lateral regions.

FIGS. 1-3illustrate an embodiment of the knee brace10. The knee brace10includes a main body panel12and a posterior panel14. The posterior panel14is secured to the main body panel12along its longitudinal length by longitudinal seams16such as inner and outer parallel seams located on both lateral and medial sides of the knee brace. The main body panel and the posterior panel together form an elongate, tubular body adapted to anatomically conform to the thigh, knee and calf, with the main body panel generally forming a curved or arcuate cross-section. The brace flares at the thigh or upper portion (U) of the brace and tapers below the knee or central (C) to the calf or lower portion (L).

The knee brace resembles a leg in extension when in a rest or unworn condition. The posterior panel14is pretensioned or has greater tensioning relative to the main body panel12which may or may not have any particular pretensioning. From the tension of the posterior panel14, the knee brace has a posterior contour32that reflects a natural shape of a leg in extension. By virtue of the tension of the posterior panel14, the knee brace also defines upper and lower inclined edges22,24, sloping downwardly from the anterior aspect of the knee brace to the posterior aspect of the knee brace.

The posterior panel14defines upper and lower portions28,30that space the entirety of opposed sides of the main body panel12from one another. The upper and lower portions28,30narrow toward the upper and lower edges22,24from a larger center portion26. The upper and lower portions28,30have a sufficient spacing width18,20from the main body panel that allows for a portion of the posterior panel14to form part of the upper and lower edges22,24. This spacing width18,20forms a clearance between opposed sides of the main body panel, and minimizes any unraveling of the stitching securing the posterior panel to the main body panel. The spacing width further eliminates any potential pressure points by gradually and evenly distributing pressure on the posterior aspect of the leg.

The center portion26generally corresponds to the popliteal of a wearer's knee. The configuration of the posterior panel14removes the need to for a single seam located along the posterior center of the brace and minimizes patient irritation on the popliteal area of the wearer's knee. Alternatively, the knee brace may be provided with a popliteal opening29that corresponds to the popliteal section of the knee brace. The popliteal opening is preferably, but not limited, to be formed by the posterior panel14, and may have its periphery reinforced with stitching or other means such as an additional fabric edging so as to mitigate fraying about the opening.

The knee brace includes first and second hinges34,36located on lateral and medial sides of the brace. The hinges34,36have upper and lower struts68,70extending from opposed sides of a hinge mechanism66that are retained on the main body panel by upper and lower pockets62,64. The struts68,70may be formed from a malleable material, such as aluminum, that allows for some customization to the wearer's body shape, while remaining sufficiently strong to avoid bending while the knee brace is in use by the wearer.

As depicted inFIG. 3, the hinge mechanism66may be adjustably secured to the main body panel12at fastening points82so that the placement of the hinge mechanism can be shifted either posteriorly or anteriorly for anterior-posterior placement. This allows for the hinge to be placed at a particular location, and permits some minor adjustment to secure the hinge mechanism anteriorly or posteriorly at particular locations. For example, at an initial fitting by a clinician, the hinge location is set according to the particular anatomy of the patient because the strap is locked by the hook on both sides and the patient does not have to adjust this again. This allows for repeated and consistent donning.

The brace depicted inFIGS. 1-3is considered a long version of the knee brace (a shorter version is found inFIGS. 8-10). The knee brace may include a plurality of circumferential straps. The straps may include an upper thigh strap38having a strap loop or pull tab78for guidance, a lower thigh strap40, and a lower calf strap44. Each of the straps may be removable to allow for the brace to be customized to the patient for directional leverage.

For example, the upper thigh strap38is removably mounted on the outer surface of the hinge cover62, such as by a hook and loop system, and includes a buckle39at one end. The strap38can be reversed in orientation, meaning the direction of the pull of the strap. This reversible strapping system allows the brace to be set up to pull laterally-to-medially, medially-to-laterally, or a combination of both, as exemplified inFIG. 3by the arrows under the various straps, by modifying the orientation of the upper thigh strap38relative to the lower thigh strap40.

The brace may include separate anterior and posterior straps41,42located along any portion of the knee brace. For example, the brace may have an anterior strap41that extends only about the anterior side of the brace. The anterior strap is secured to buckles74located on lateral and medial sides of the brace. A posterior strap42extends only about the posterior side of the brace, and is secured to buckles76located on lateral and medial sides of the brace. Because the hinge mechanism has anterior-posterior placement, the anterior posterior straps41,42have fine-tuned control thereby allowing the knee brace to be cinched above the wearer's gastroc to reduce migration.

As shown inFIG. 4, the posterior panel14is sized shorter than the main body panel12prior to securing the panels to one another. The main body panel12has longitudinal edges84,86along which longitudinal edges85,87of the posterior panel14respectively secure. The main body panel12has an affixation point88upon which a corresponding affixation point90of the posterior panel14secures.

The posterior panel14is sewn along the longitudinal edges to the main body panel12from the upper portion28to the center portion26, particularly to the affixation points88,90. The posterior panel14is then sewn from the center portion26to the lower portion30. From this configuration, tension is formed in the posterior panel14, and imparts the natural contour32to the shape of a knee in a naturally bent position. The affixation points88,90, serve as a point of inflection for the natural contour32about the center or knee portion of the brace. This natural contour shape is in contrast to the conical shape of conventional tubular braces. The tensioning of the posterior panel will also reduce material bunching behind the knee whether the knee is in flexion or extension.

According to one variation, the material forming the posterior panel is thinner than the material forming the main body panel prior to being secured to the main body panel. This variation allows for a more stretchable posterior panel. According to another variation, the material forming the posterior panel has the same thickness as the material used to form the main body panel.

The posterior panel may have the same stretch properties as the main body panel so as to avoid sharp wrinkles behind the knee that may cause irritation. When the posterior and main body panels have the same stretch properties, the knee brace can provide a more consistent or even circumferential compression. It follows that if the posterior panel is easier to stretch than the main body panel, the posterior panel may tend to stretch to its maximum width before the main body panel has stretched sufficiently to provide necessary compression.

The material used to form the main body and posterior panels is preferably a three-dimensional double faced spacer material having a circular knit. The knit of the spacer material is linked which allows for a gradual stretch until there is a complete extension of the material and hence the brace itself. The spacer material has high breathability that allows sweat to evaporate and heat to dissipate. The breathability of the spacer material provides an environment inhospitable to bacteria growth. The spacer material moves with the body, and does not cause unneeded resistant to range of motion. The spacer material is preferably latex and neoprene free, and therefore the material may form the entire thickness of the brace without additional layers.

The spacer material is constructed with a fine gauge yarn and has a tight knit pattern leading to a smooth finish that is cool to the touch and is comfortable for wear. In many known knee braces, typical materials are manufactured with thicker yarns and looser knit patterns having a coarse texture that leads to skin irritation or discomfort.

The material construction of the main body panel and posterior panel of the knee brace in accordance with the embodiments herein is particularly advantageous in that it facilitates donning and doffing of the brace. The main body and posterior panels preferably are placed in contact with the skin of the wearer, and there is sufficient friction to maintain the brace against the skin of the wearer without the brace sliding off the leg.

Because the spacer material has natural compressibility, the brace is preferably provided without additional foam padding along either the outer or inner surfaces of the main body panel. This allows for improved breathability over known knee braces thereby minimizing sweat and heat build-up, and also has improved air permeability so as to reduce moisture and bacteria accumulation.

The patella buttress is depicted in greater detail inFIGS. 5-7. The buttress46surrounds a patella opening48formed by the main body panel12. The buttress46includes an outer covering50, an intermediate layer52secured to an inner surface of the outer covering50, and a buttress element or flexible rod56. The outer covering50and the intermediate layer52are secured to the main body panel12about their inner and outer peripheral edges by a stitching (preferably a zigzag formation) to allow for some stretching of the buttress46relative to the main body panel12. The combination of the outer covering50and intermediate layer52forms a pocket106between the main body panel12, and the rod56is securely located within the pocket106.

The outer covering50forms first and second apertures58,60located on opposed sides of the buttress46. The apertures58,60allow for access to the rod56, whereby a portion of the rod56can be removed for modification. For example, in an initial configuration, the rod56generally conforms to the shape of a horseshoe. The rod56can be pulled in a direction81from the aperture60and have an end portion80severed so as to reduce its length. The rod56is then pulled in another direction63toward a top portion61of the buttress so as to form a J-shape. The J-shape or lateral “J” is a shape that allows for a greater concentration of support about the patella. From the two apertures58,60, either side of the rod can be configured to form the J-shape.

The intermediate layer52has a configuration of multiple zones that are located about the pocket106of the buttress. In the illustrated example, the intermediate layer52has first side zone94, second side zone96and lower zone98. Each of the zones94,96,98is preferably connected to one another by a tether100,102,104, and spaced by a clearance92that maintains the zones in proper spacing with one another. The zones are arranged to minimize or inhibit stretching of the length, width, and expansion of circumference of the outer layer relative to the main body panel.

The top portion61of the buttress is shaped so as to better contour and adapt to the shape of patella in order to reduce stretch of the buttress (as evidenced by the shorter tether104than tethers100,102). This will reduce the stretch of the buttress so it does not bow significantly radially outwardly and thereby better and stably hold the rod about the knee of the wearer. The rod is preferably formed from a silicone closed-cell sponge cord, however is may be constructed from other suitable materials that can be used to support the patella in a similar fashion to a silicone closed-cell sponge or foam insert.

As depicted inFIG. 7, the buttress46forms a bulge72(seen also inFIG. 2) about the periphery of the opening48, whereby a portion of the outer covering50and the intermediate layer52wraps about the rod around the periphery of the opening48. From this construction, the intermediate layer limits stretching of the opening48in order to securely retain the patella of the wearer. The buttress46gradually tapers from the bulge72to the outer peripheral edges108of the outer covering50and intermediate layer52.

The outer layer is preferably formed from the same material used to form the main body panel. The intermediate layer may be formed from a material that has little or no stretchability, such as a rigid textile. The lack of stretchability of the intermediate layer prevents excessive stretching of the buttress so as to prevent the buttress from stretching too much and effectively yielding to the movement of the wearer without providing adequate support.

For example, the intermediate layer directs the rod inwardly toward the patella of the wearer, effectively drawing the rod toward the patella despite movement by the wearer (as evidenced by arrows inFIG. 7). In areas of the buttress without the rod, as shown inFIG. 7, these areas are also reinforced by the intermediate layer so as to inhibit stretching outward relative to the patella of the wearer.

In the illustrated three zone construction inFIG. 6, the intermediate layer is configured to achieve the desired stretch properties within the buttress. The zones are strategically located to provide a combination of optimal stretch and direct a posterior force toward the patella in critical areas. The tethers100,102,104may allow for some radial stretching of the buttress, as depicted by arrows100A,102A,104A, thereby permitting some radial adjustment of the buttress about the patella of the wearer, whereas the zones inhibit radial stretching due to their larger material portions, as evidenced byFIG. 6.

Variations of the stitching may be configured such that in areas including the stitching65about the opening48, the stitching is in a looser zigzag formation in order to allow for some stretching of the opening48, whereas the stitching67on the outer periphery54of the buttress is tighter, whether or not it is in a zigzag configuration, so as to inhibit stretching of the outer periphery54of the buttress. Of course, even on the outer periphery stitching67, the tightness of the stitching may be varied if more stretching is desired, such as providing a looser stitching at the apertures58,60.

In another embodiment of the patella buttress,FIGS. 8-11show an alternative patella buttress120that allows for removal of patella buttress from the inside of the knee brace.

As shown inFIG. 8, the patella buttress includes an inner layer122having a horseshoe configuration oriented oppositely in direction to the horseshoe shaped buttress124. A fastener material126is removably securable to the buttress124and an interlining or intermediate layer128. An outer layer130forms an opening132that is axially aligned along axis A-A with the inner layer122, the buttress124, and the intermediate layer128. The outer layer may be a separate layer from the main body panel, or may merely be the main body panel described in connection with the embodiment ofFIGS. 1-3.

The inner layer122is preferably formed from a stretchable jersey type fabric, thereby allowing the buttress124to yield toward the knee of a wearer. The buttress124is shaped by having a generally flat surface142that faces the outer layer130or outermost surface of the knee brace. The buttress has a rounded surface144that is oriented toward the inner layer122, and may be constructed from any suitable material providing compressibility, such as foam with a textile covering.

The intermediate layer128is preferably non-stretchable, as in the intermediate layer described above in connection to the embodiment ofFIGS. 5-7. Further, the intermediate layer128may be formed from or include an unbroken loop material134thereby permitting the fastener material126to be secured thereon.

According toFIG. 9, the inside surface of the patella buttress120is shown generally as it would appear in the knee brace. The inner layer122is oriented oppositely to the buttress124so as to form an opening146between the intermediate layer128and likewise the outer layer130and define a pocket for retaining the buttress124at stitching136located on opposed sides of the opening146.

The stitching148around the opening132is provided more tightly than the outer edge stitching138around the inner layer and the stitching136. For example, the stitching148may be a zigzag stitching having 11-13 stitches per 3.0 cm. On the other hand, the stitching136,138may also be a zigzag stitching having 9-11 stitches per 3.0 cm, which is looser than the stitching148and allows for more stretching, thereby allowing the buttress to flex outwardly relative to the opening.

In reference toFIG. 10, the intermediate layer128is secured to the outer layer130by a single needle stitch which generally prevents flexing of the intermediate layer128. Suitable stitching may be used to secure the intermediate layer128to the outer layer130, or alternatively, the intermediate layer may be laminated or otherwise adhered to the outer layer.

Turning toFIG. 11, the outer layer130has greater padding or cushioning toward the opening132in part due to the outer layer130being less or not compressed at this location. The outer layer is more compressed as it approaches the outer edge stitching138. The buttress124is biased toward the inside of the brace or wearer's knee, with the rounded surface144being directed toward the inside of the brace.

From the stitching types, and the material properties of the various layers, the patella buttress provides ample compression about the knee, while allowing for some accommodation of stretching in certain directions while inhibiting stretching in other directions.

The basic principles described herein in regard to using materials having different properties and different stitching patterns and stitches per cm may be employed in any of the aspects of the knee brace to either inhibit or enhance stretchability.

As illustrated inFIGS. 12A-12D, an alternative embodiment of patella buttress156is shown that is adjustably and removable secured to an inner surface150of the knee brace about the circumference of a patella opening152formed thereby. The border154has a loop material that can engage hook material located along a surface of the buttress156.FIGS. 12A-12Dexemplify how the buttress156can be attached to the inner surface150of the knee brace among a plurality of orientations. Moreover, if it is not desired to include the buttress, it can be easily removed without significantly interfering with the remainder of the brace. The buttress may be formed from a variety of materials such as foam, and may include a suitable cover. It may also be trimmed according to the needs of the wearer.

Turning to the embodiments ofFIG. 13, a short version of the knee brace200may be provided with a hinge retainer204that conceals one of the lateral or medial hinges. The hinge retainer204includes a main pocket216and a flap222that covers the proximal end (or alternatively the distal end) of the main pocket216. The main pocket216is formed so as to snugly accommodate the hinge224.

The knee brace200is configured as a “wraparound” brace by being adapted to wrap about the leg of the wearer with a wrap configuration206having wrap tabs208,210that secure to a main body202of the brace200. The strap tabs208,210are located above and below the knee of the wearer so as to provide additional circumferential tightening of the knee brace.

FIGS. 14-15shows an alternative knee brace embodiment201of the knee brace200ofFIG. 12wherein portions of the hinges212are exposed on the outer surface of the brace, such as instances wherein the hinges are range-of-motion hinges requiring adjustment. The hinges212are secured similarly as shown in connection with the knee brace embodiment10ofFIGS. 1 and 2. Particularly, the hinges212are retained by pockets214,215, and having openings218,220for receiving arms of the hinges212.

The knee brace201includes a strap loop or pull tab224that serves the dual purposes of retaining a strap, and as a tab for assisting in the donning of the knee brace. Particularly, the pull tab224does not extend or only minimally extends beyond the proximal end226of the main body202so as to avoid interfering or catching on any objects. The pull tab224may be connected to the main body202by zigzag stitching to allow and formed from a stretchable material to allow for some stretching as the wearer dons the brace.

Those skilled in the art will recognize the interchangeability of various disclosed features. In addition to the variations described herein, other known equivalents for each feature can be mixed and matched by one of ordinary skill in this art to construct suspension liner in accordance with principles of the present invention.