Patent Publication Number: US-2021177635-A1

Title: Orthopedic device and method for securing the same

Description:
FIELD OF THE DISCLOSURE 
     The present disclosure relates to an orthopedic device, and more particularly to an orthopedic device that provides stability, protection, support, rehabilitation, and/or unloading to a portion of the human anatomy in a streamlined and light manner. 
     BACKGROUND 
     Known orthopedic devices are used for providing stability, protection, support, rehabilitation and/or unloading a portion of the human anatomy. Known devices, however, are often considered as being physically bulky, heavy, and costly requiring numerous manufacturing processes to be produced. 
     An example of an orthopedic device is a knee brace. As is well understood, knee braces are widely used to treat a variety of knee infirmities. Such braces may be configured to impart forces or leverage on the limbs surrounding the knee joint to relieve compressive forces within a portion of the knee joint, or to reduce the load on that portion of the knee. If knee ligaments are weak and infirm, a knee brace may stabilize, protect, support, unload, and/or rehabilitate the knee. 
     The knee is acknowledged as one of the weakest joints in the body and serves as the articulating joint between the thigh and calf muscle groups. The knee is held together primarily by small but powerful ligaments. Knee instability arising out of cartilage damage, ligament strain, and other causes is relatively commonplace since the knee joint is subjected to significant loads during the course of almost any kind of physical activity requiring legs. 
     A healthy knee has an even distribution of pressure in both its medial and lateral compartments. It is normal for a person with a healthy knee to place a varus moment on the knee when standing so pressure between the medial and lateral compartments is uneven but still natural. 
     Compartmental osteoarthritis is a problematic type of knee infirmity. It may arise when there is a persistent uneven distribution of pressure in one of the medial and lateral compartments of the knee. 
     Compartmental osteoarthritis can be caused by injury, obesity, misalignment of the knee, or due to aging of the knee. A major problem resulting from osteoarthritis is that smooth cartilage lining the inside of the knee wears away. This leads to a narrowing of the joint space due to the development of cysts and erosions in the bone ends. Because of the narrowing of the joint, bone comes directly in contact with bone, and an uneven distribution of pressure develops across the knee, which may cause the formation of bone spurs around the joint. All of these changes ultimately lead to increasing pain and stiffness of the joint. 
     While there are no cures to osteoarthritis, there are many treatments. Individuals who have a diagnosis of isolated lateral or medial compartmental osteoarthritis of the knee are confronted with a variety of treatment options such as medications, surgery, and nonsurgical interventions. Nonsurgical interventions include using canes, lateral shoe wedges, and knee braces. 
     Knee bracing is useful in providing compartment pain relief by reducing the load on the compartment through applying an opposing external valgus or varus moment about the knee joint. Unloading knee braces have been shown to significantly reduce osteoarthritis knee pain while improving knee function. 
     While known knee braces succeed at reducing pain or at stabilizing a knee joint, many users find these braces to be bulky, difficult to don, complicated to configure, and uncomfortable to wear. The exemplary embodiments described have streamlined features capable of providing relief for medial or lateral compartmental osteoarthritis, or functional stability of the knee without the attendant drawbacks of known unloading knee braces. 
     The concepts described with the exemplary knee brace embodiments may be extended to a variety of wearable devices configured to be secured to and/or support numerous portions of anatomy. 
     SUMMARY 
     The embodiments of the orthopedic device are described in the context of a knee brace for providing relief to users with complications of the knee, such as with osteoarthritis. The embodiments offer a knee brace having a low profile and simpler to use than conventional braces aimed at treating osteoarthritis of the knee. The knee brace embodiments define a sleeve-like configuration concealing and confining certain brace components such as straps and portions of the frame. In this manner, the hidden mechanics provide a discreet appearance with easy access, with or without the zipper described below, for initial fit requirements and adjustment. 
     The embodiments offer a lighter and more versatile knee brace, and may include a soft inner sleeve segment that makes the brace easier to don and doff. A single adjustment mechanism allows for a plurality of straps to be simultaneously adjusted without the necessity for adjustment of other straps. Zipper configurations assist the user to don and doff the brace, especially those with irregular or disproportionate body types and/or with poor hand dexterity in their hands. The combination of a sleeve and zipper simplifies the donning and doffing process, particularly in view of the user being able to slide the brace on in its entirety. The zipper allows access to various components of the brace ordinarily concealed during normal use of the brace. The components of the brace are trimmable and adjustable to allow for use across a spectrum of user profiles and anatomies. 
     In an embodiment, the orthopedic device includes an inner sleeve segment having interior and exterior surfaces, a frame applied over the outer surface of the inner sleeve, at least one strap connected to the frame, and an outer sleeve segment connected to the inner sleeve segment and having interior and exterior surfaces with the interior surface facing the interior surface of the inner sleeve segment. A portion of the frame may be confined within a space defined between the outer and inner sleeve segments forming a definitive sleeve. 
     The outer sleeve segment may extend over only a portion of the inner sleeve to define a pocket into which a portion of the frame extends, such as a frame shell. The pocket may include openings to permit elements of the knee brace to extend outwardly from the shell within the pocket, and such elements may include a strap, strut, hinge or other brace component. The outer sleeve segment may include reinforcement edging about the openings and/or the periphery of the outer sleeve segment to improve durability of the periphery of the outer sleeve segment and improve the ornamental appearance of the device. 
     The inner and outer sleeve segments are preferably formed from latex-free fabrics. The interior surface of the inner sleeve segment is soft and comfortable to the touch and provides a barrier from the frame for skin-sensitive users. The inner sleeve segment may include padding incorporated therewith and associated with the frame to eliminate a necessity for additional padding that may attribute to increased weight. 
     In a variation, the orthopedic device may include multiple outer sleeve segments for concealing or covering various components over certain lengths over the inner sleeve segment. 
     The inner sleeve segment may extend the entire length of the orthopedic device, only over a portion of the length of the orthopedic device, or may have multiple segments defining various sections of an inner periphery of the orthopedic device. 
     In a variation, the outer sleeve segment may extend the entirety of the length of the inner sleeve segment, and the combination of the inner and outer sleeve segments may define an entirety of the length of the orthopedic device. 
     The frame is selectively accessible from the outer surface of the outer sleeve in that a user or clinician can withdraw portions of the frame from the sleeve for adjustments. From this arrangement, the orthopedic device is easily modifiable and can be adjusted during the treatment of a user, including changing the length of the at least one strap and customizing the frame to suit the anatomy of a user. 
     The orthopedic device may include a tensioning mechanism coupling a first end of the at least one strap to the frame. The tensioning mechanism provides incremental adjustment of the first end of the at least one strap relative to the frame among a plurality of predetermined settings. The tensioning mechanism may be mounted to an outer surface of the frame and is preferably accessible from and through the exterior surface of the outer sleeve segment. 
     The tensioning mechanism may include a rotary ratchet and a winding mechanism. The first end of the at least one strap may be coupled to the tensioning mechanism by a cable windable about the winding mechanism; the rotary ratchet keeps the winding mechanism from releasing unless the winding mechanism is selectively released by the user. The tensioning mechanism allows for simple and repeatable dosing of pain-relieving forces, particularly simplifying the adjustment process so two straps can be finely tensioned simultaneously. 
     The frame may define upper and lower shells, with a hinge that connects and spaces them apart. The upper and lower shells may be rigid or semi-rigid, or alternatively may be flexible but become semi-rigid when the at least one strap is tensioned and the orthopedic device is placed snugly over the leg of the user. When semi-rigid, the shells may accommodate movement of the leg of the user, but also firmly secure to the leg and reinforce the leg. The shells are of a low profile type, thereby reducing the weight of the knee brace. 
     The frame preferably defines a “single upright frame” in that struts connect the upper and lower shells to one another along a single side of the brace. The knee brace is considered lightweight in that it preferably has a weight in the range of 200-500 grams. The struts may be thinner over conventional struts, particularly since they combine with the sleeve to secure over the leg of the user. The struts are connected to one another by a hinge. 
     The at least one strap may be adjustable in length within the space between the outer and inner sleeve segments. The at least one strap may have first and second ends connecting to and spiraling between the upper and lower shells. The first and second ends may connect at a first side of the upper and lower shells, and extend over a second side of the brace located opposite to the first side at which the hinge is located. 
     In a variation, the at least one strap has first and second ends connected to the frame, the first end of the least one strap is adjustably movable relative to the frame and the second end of the at least one strap is anchored to the frame. The orthopedic device may further comprise a bracket connected to and extending from the at least one strap. The tensioning mechanism may be connected to the frame and couple the first end of the at least one strap to the frame by the bracket. The tensioning mechanism may be arranged to simultaneously adjust the at least one strap relative to the frame. The tensioning mechanism includes a winding mechanism, and at least one cable extends from the winding mechanism and couples to the bracket. 
     The bracket may define a channel through which first and second portions of the at least one cable extend. The first cable portion secures to the frame at an anchor point, and the second cable portion operatively engages the tensioning mechanism to allow for selective reduction in length of the second cable portion for adjusting the at least one strap relative to the frame. The channel permits more uniform pulling or movement of the at least one strap by the cable by distributing the tension of pulling more uniformly across the width of the at least one strap. 
     Alternatively or in combination with the channel, the bracket may define an opening through which the cable may also extend and pull the bracket and strap from a single point at the bracket. In this manner, a pull angle of the at least one cable may adjust according to the angle the strap is at any point in adjustment of the at least one strap. 
     In an embodiment, the at least one strap defines first and second straps. The at least one cable operatively engages first and second brackets extending respectively from said first and second straps. The tensioning mechanism is arranged to operatively wind the at least one cable so the first and second straps are adjusted simultaneously. 
     A guide may be on the frame and extend between the bracket and the winding mechanism. The guide routes the second cable portion to the winding mechanism. In a variation, the guide may be pivotally secured to the frame and pivot according to the angle at which the at least one strap is arranged relative to the axis or axes of the first and second struts. The guide may be also initially adjusted at an angle and secured and maintained at the angle. 
     The orthopedic device may also have a strap tab bearing tightening indicia and at the first end of the at least one strap. The strap tab is arranged for substantial adjustment of a length of the at least one strap, and the tensioning mechanism is arranged for finer adjustment of the at least one strap relative to the frame. 
     At least one of the upper and lower shells may define a flexible edge portion located along a periphery. The upper and lower shells may each be formed from a main body, and the flexible edge portion may also be formed from the main body. The flexible edge portion may only be formed along a side of the upper and lower shells opposite to a side adjacent the hinge. 
     A first zipper may be on the outer sleeve and secured to opposed edges of the outer sleeve to separate the opposed edges and provide access to the frame and the at least one strap. The first zipper may be at the lower portion of a first side of the orthopedic device, and the at least one strap may be connected to the frame at the first side of the orthopedic device. 
     The outer sleeve segment may be defined by at least first and second material sections. The first material section may generally correspond in shape to the frame, and the second material section may be secured to the first material section such that the second material section covers portions of the at least one strap extending past the frame. The first material section may have padding and breathability features different from the second material section. 
     The numerous advantages, features, and functions of embodiments of the orthopedic device will become readily apparent and better understood in view of the following description and accompanying drawings. The following description is not intended to limit the scope of orthopedic device, but instead merely provides exemplary embodiments for ease of understanding. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front elevational view according to an outer configuration of an embodiment of the orthopedic device. 
         FIG. 2  is a front elevational view according to an inner configuration of the embodiment of  FIG. 1 . 
         FIG. 3  is a detail view of detail III in  FIG. 2  showing a flexible edge portion. 
         FIG. 4  is a schematic view showing a medial side of the orthopedic device of  FIG. 1  in an open thigh mode. 
         FIG. 5  is a schematic view showing a lateral side of the orthopedic device of  FIG. 1  in a closed calf mode. 
         FIG. 6  is a schematic view showing the lateral side of  FIG. 5  in an open calf mode. 
         FIG. 7  is a detailed view of the outer surface of the upper shell and tensioning mechanism of  FIG. 2 . 
         FIG. 8  is a detailed view of the inner surface of the upper shell and tensioning mechanism of  FIG. 2 . 
         FIG. 9  is a front elevational view of another embodiment of the orthopedic device having a sleeve. 
         FIG. 10  is a front elevational view of the embodiment of  FIG. 9  without the sleeve. 
         FIG. 11  is a schematic view of a pocket on the sleeve of the orthopedic device of  FIG. 9 . 
         FIG. 12  is a detailed view of the inner surface of an upper shell in the orthopedic device of  FIG. 9 . 
         FIG. 13  is a detailed view showing a strap tab including tightening indicia. 
         FIG. 14  is a detailed view showing attachment of a strap onto a lower shell in the orthopedic device of  FIG. 9 . 
     
    
    
     The drawing figures are not necessarily drawn to scale, but instead are drawn to provide a better understanding of the components, and are not intended to be limiting in scope, but rather to provide exemplary illustrations. The figures illustrate exemplary configurations of an orthopedic device, and in no way limit the structures or configurations of an orthopedic device and components according to the present disclosure. 
     DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS 
     A. Environment and Context 
     An embodiment of an orthopedic device in the form of a knee brace is provided to reduce the effect of osteoarthritis in a knee joint and/or stabilize a knee joint weakened by injury or other infirmities. Although the illustrated embodiments show a hinge positioned on the medial side of the knee brace and the straps positioned on the lateral side of the knee brace, it will be understood that the knee brace may be configured to reduce or cure both medial and lateral knee joint infirmities. The hinge may be positioned on the lateral side of the knee brace and the straps may be positioned on the medial side of the knee brace. 
     The knee brace embodiments of the disclosure are adapted for a human knee joint, and may be dimensioned to accommodate different types, shapes, and sizes of human joints, appendages, and other anatomical portions. Embodiments may be provided to orient principal forces exerted by strap systems of the embodiments at any desirable location to treat knee infirmities. 
     For explanatory purposes, the knee brace embodiments are described and divided into sections denoted by general anatomical terms for the human body. Each of these terms is used in reference to a human leg divided in similar sections with a proximal-distal plane extending along the meniscus of the knee between the femur and tibia (i.e., femoral and tibial leg portions, respectively). 
     The embodiments of the knee brace are also divided into 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. Each of the anterior and posterior sections is further divided about the center of the knee by a transverse or proximal-distal plane and median, sagittal, or lateral-medial planes. 
     The anatomical terms described are not intended to detract from the normal understanding of such terms as readily understood by one of ordinary skill in the art of orthotics. It will also be understood that, while the invention is discussed with a knee brace, the principles described can be extended to a variety of orthopedic and prosthetic devices, and any other device that would be wearable and employ the features described. 
     B. Embodiments of the Orthopedic Device 
       FIG. 1  shows an outer configuration of an orthopedic device  10  in the form of a knee brace for securing about a knee K. The device  10  has an outer sleeve  12  covering various brace components, as disclosed in  FIG. 2 , and including a plurality of straps  28 ,  30  extending about lateral L and medial M sides of the device and underneath the outer sleeve  12 . A tensioning mechanism  18  protrudes from a first side, such as lateral side L, of the device  10 . 
       FIG. 2  shows an inner configuration of the knee brace  10 . The brace  10  includes an inner sleeve segment  22  having inner and outer surfaces, a frame comprising upper and lower shells  24 ,  26 , respectively connected to and spaced apart by upper and lower struts  38 ,  40 , respectively, secured to a hinge  16 , and the first and second straps  28 ,  30  connecting to the upper and lower shells  24 ,  26 . The frame, straps, and hinge with the struts are preferably confined within a space defined between the inner and outer sleeves  12 ,  22 , and concealed along both interior and exterior peripheral surfaces of the device  10 . 
     The shells  24 ,  26  include padding  44  extending along the inner surface of the shells and located adjacent to an outer surface of the inner sleeve segment  22 . The padding  44  is sandwiched between the shells  24 ,  26  and the inner sleeve segment  22 . The padding  44  preferably extends beyond the peripheral edges of the shells and along the entirety of the inner surface of the shells. 
     As shown in detail III depicted in  FIG. 3 , at least one of the upper and lower shells  24 ,  26  defines a flexible edge portion located along a periphery. The lower shell  26  defines the flexible edge portion  42  at a lowermost edge opposite the upper most edge adjacent to the hinge  16 . The flexible edge portion  42 , in this variation, is formed by a plurality of gaps  46  extending a distance into the lower shell from the periphery of the lower shell  26 . A plurality of individually flexible sections  47  is formed between each of the gaps  46  to form the flexible edge portion  42 . 
     According to this variation, the lower shell is formed from a main body, and the flexible sections  47  are formed from the main body itself (as opposed to being a structural element apart or separate from the main body). Alternatively, the flexible edge portion may be formed from an overmold having softer properties than the main body, as taught in U.S. Pat. No. 7,198,610, granted Apr. 3, 2007, and incorporated herein by reference. 
     The flexible edge portion  42  may be only formed along a side of the upper and lower shells opposite to a side adjacent the hinge  16 , or may be arranged at any other location along the shells  24 ,  26 . The flexible edge portion  42 , at least in the embodiment of  FIG. 3 , extends short of the padding  44 , and beyond the peripheral edge of the shell  26 . 
     Each of the shells may be formed from a flexible, thin, and soft plastic enabling trimming of the dimensions of each of the shells. 
     Referring to  FIG. 2 , each of the first and second straps  28 ,  30  has first and second ends connecting to and spiraling between the upper and lower shells  24 ,  26 . The first and second ends of the straps connect at the first side, such as the lateral side L, of the upper and lower shells. The straps  28 ,  30  also extend over to the second side, such as the medial side M, of the brace located opposite to the first side at which the hinge  16  is located. The orientation of the brace can be reversed so that the straps are arranged in an opposite orientation. 
     The straps are arranged in an orientation so as to treat osteoarthritis, as principally taught in U.S. Pat. No. 7,198,610. The brace is not limited to two straps and may only include a single strap connecting the upper and lower shells, as likewise taught in U.S. Pat. No. 7,198,610. 
     Each of the straps  28 ,  30  is adjustable in length and tensionable within the space between the outer and inner sleeve segments  12 ,  22 . 
     According to the embodiment of  FIG. 2 , the straps  28 ,  30  may each include an elastic segment  34  at a first end and connecting to the upper shell  24 , and a non-elastic segment  32  extending from the elastic segment  34 . The non-elastic segment  32  preferably forms a majority of the length of the straps. Each of the straps may include an anchor segment  36  at a second end of the straps and is pivotally attached to the lower shell  26 . The anchor segment  36  is preferably more rigid than the non-elastic segment  32 . The elastic segment allows for gentle adjustment of the strap over the user&#39;s leg, whereas the non-elastic segment is provided to resist movement of the knee to sufficiently unload a compartment of the knee. 
     The anchor segment  36  may form a segment of the length of the straps, or may alternatively be formed as a reinforcement part which extends over at least a portion of the second end of the non-elastic segment  32 . Preferably, the anchor segment  36  pivotally connects at an anchoring pivot point  48  to the lower shell to provide adjustability of the second of the strap relative to the lower shell. The anchor segment may be more rigid than the non-elastic segment, and may be formed by a flexible plastic piece whereas the non-elastic segment may be formed from a textile. Examples of the non-elastic segment may be found in U.S. Pat. No. 7,198,610 by way of the force and stability straps discussed in the patent. 
     The second end of the straps is preferably trimmable in length. According to an embodiment, the anchor segment  36  is removably attached to the non-elastic segment  32  via a hook and look attachment. The second end of the non-elastic segment  32  can be removed from the anchor segment  36 , trimmed in length, and then reattached to the anchor segment  36 . 
     As shown in  FIG. 4 , the brace  10  includes an upper zipper  20  secured to the outer and inner sleeve segments  12 ,  22  and arranged to separate opposed edges of the outer and inner sleeve segments at a second or medial side M of an upper portion of the knee brace. The brace  10  is therefore operable at its upper portion corresponding to the user&#39;s thigh, and assists the user when the brace is donned and doffed. The user can unzip the upper portion of the brace when donning the brace to accommodate the thigh and facilitate correct placement of the brace over the user&#39;s knee. Because the outer and inner sleeve segments  12 ,  22  have some flexibility, the brace can be tightly secured over the thigh T after the upper zipper  20  is zipped. 
       FIG. 5  shows a lower zipper  50  in a closed configuration and provided on the outer sleeve  12  to secure opposed edges of the outer sleeve or separate the opposed edges to provide access to the frame and the straps, as shown in  FIG. 6 . The lower zipper  50  is on the first or lateral side L of the brace to allow for better access of the brace components for resizing and adjustment. In this embodiment, the lower zipper  50  is preferably only on the outer sleeve and may only travel within a section of the lower portion of the outer sleeve and may be spaced away from the lower peripheral edge of the outer sleeve, as depicted in  FIG. 6 . 
     In a variation, the lower zipper  50  may extend along any segment or length of the outer sleeve segment. It may extend between the uppermost and lowermost peripheral edges of the outer sleeve. Other variants are envisioned in that the lower zipper may not be confined within the length (corresponding to longitudinal length of the leg), and may split open the outer sleeve much in a manner shown and described with the upper zipper. 
     Multiple zipper configurations may be arranged in that a first zipper segment extends from the uppermost periphery of the outer sleeve to a hinge region generally corresponding to the hinge, and another zipper extends from the lowermost periphery of the outer sleeve to the hinge region. The zipper or zippers on the outer sleeve may be provided along any side of the brace and is/are not limited to only the lateral side. 
     The outer sleeve  12  may define first and second material sections  13 ,  14 . The first material section  13  generally corresponds in shape to a frame of the brace, and the second material section  14  is secured to the first material section. The second material section  14  covers portions of the straps  30 ,  32  extending past the frame. 
     The first material section has padding and breathability features different from the second material section. The first material section may be formed from a spacer material comprising a three-dimensional knit structure covered by a mesh that provides sufficient breathability, insulation, compression, durability, and recovery. An exemplary material is produced by Gehring Textiles under product numbers SHR 701, SHR 714 or SHR 754F. 
     The second material section and the inner sleeve segment may be constructed of the same or different fabrics. Exemplary fabrics include spandex, Lycra, nylon, polyester, OUTLAST, COOLMAX, AEROSPACER, microfiber, three-dimensional fabrics, and other suitable fabrics. The sleeve is preferably constructed from a latex-free fabric that provides a fabric-lined inner surface preferably providing a soft and comfortable feel and a barrier from the brace for skin-sensitive users. 
     The sleeve may have various treatments incorporated therein including antibacterial, scenting, and moisture wicking agents. Frictional features may be at various locations along the inner surface of the inner sleeve segment. Silicone bands, dots, segments or other configurations may be at the uppermost section of the upper portion of the inner sleeve segment to prevent slippage of the brace on the thigh of the user. Alternatively, frictional features may be provided along the inner surface of the inner sleeve segment corresponding to the shells. 
     The inner and outer sleeves may have elasticity to allow for the brace to be tightly and comfortably secured over the leg, particularly by application of the upper zipper. The elasticity of the inner and outer sleeves may remove necessity for circumferential straps provided besides the aforementioned straps  28 ,  30 . 
     Referring to  FIGS. 7 and 8 , the tensioning mechanism  18  couples a first end of the straps  28 ,  30  to the frame. The tensioning mechanism  18  provides incremental adjustment of the first end of the straps relative to the frame among a plurality of predetermined settings. The tensioning mechanism may be a dial tensioning device, a ladder strap or other suitable incremental tensioning mechanism, as taught in U.S. Pat. No. 7,198,610. 
     The tensioning mechanism may include a rotary ratchet and winding mechanism. The first ends of the straps are each coupled to the tensioning mechanism  18  via a cable  52  having a first end windable about the tensioning mechanism  18  and a second end  60  anchored to the upper shell. The cable  52  has segments  52 A,  52 B extending from the tensioning mechanism  18  routed through cable guides  54  to a bracket  58  mounted on the elastic segments  34 A,  34 B and placed through openings  56  formed by the upper shell  24  to anchor to the shell. A knob  119  is operatively connected to the rotary ratchet and the winding mechanism may protrude outwardly from the knee brace and outside the sleeve. 
     From the arrangement in  FIGS. 7 and 8 , the first and second straps are each coupled to and simultaneously adjustable by the tensioning mechanism, permitting the straps to be adjusted with a single mechanism. The elastic segment allows for some ease in the strap to compensate for the inelasticity of the non-elastic segment preferably provided to apply a greater amount of pressure against the knee as the tensioning mechanism is used to apply tension in the straps over the user&#39;s leg. The combination of the elastic and non-elastic segments in combination with the tensioning mechanism provides a balance in maintaining sufficient tension in the strap to make the straps more comfortable to the user. 
     Referring to the orthopedic device  100  of  FIGS. 9 and 10 , the device  100  includes upper and lower shells  102 ,  104 , respectively connected to one another by a strut assembly including upper and lower struts  106 ,  108  connected to one another by a hinge  110 . The longitudinal axis or axes (when the hinge is bent) of the brace may be considered to generally extend parallel to the upper and lower struts. First and second straps  112 ,  114  spiral between the upper and lower shells  102 ,  104 . Either of the straps  112 ,  114  may be incrementally adjusted by a tensioning mechanism  118  connected to a cable  120  routed about one of the upper and lower shells. 
     Brackets or tab elements  150 ,  152  carried by first end portions of the straps  112 ,  114  are coupled to the cable  120  and permit adjustment relative to the upper and lower shells  102 ,  104 . Second end portions of the straps  112 ,  114  may include fastener tabs  144 ,  148  coupling to openings  142 ,  146 , such as those having a keyhole configuration with one end having a smaller diameter than another end of the opening. At least one end of the strap includes a strap tab  132  including tightening indicia. 
     A lower stability strap  116  may circumferentially extend about a lower portion of the device in combination with the lower shell  104 . The stability strap  116  may have a first end carrying a fastener tab  138  engageable with an opening  140 , and a second end looped about an opening defined by the lower shell  104 . 
     The shells are of a low profile type and are preferably constructed from plastic, thereby reducing the weight of the knee brace. While the shells are preferably constructed from plastic, whether it is rigid, semi-rigid or flexible, the shells may be constructed from other known structural materials that are rigid, semi-rigid or flexible. The shells preferably have a thickness within the range of 1.0 mm to 5.0 mm and more particularly, within the range of 1.5 mm to 2.5 mm. The struts may be thinner over conventional struts particularly since they combine with the sleeve to secure over the leg of the user, and may be constructed from a plastic or metal. An aim of the device is to provide a lightweight orthopedic device, and the overall weight of the device is preferably within the range of 200 to 500 grams. 
     In this embodiment, the lower shell  104  defines a plurality of flexible edge tabs  176  spaced apart by gaps  178 , and extend from the main body portion  174  and along the periphery of the lower shell  104 . The flexible edge tabs are preferably oriented to generally descend downwardly toward the periphery of the lower shell, but can be oriented in a variety of directions to provide optimal pressure relief along the periphery of any shells used in the brace. The gaps may be uniformly spaced or alternative may be varied in width according to a desired degree of pressure relief sought in the brace. 
     It is preferable that the shell is thin so the flexible edge tabs  176  can flex over the leg of the user when the brace is worn and the flexible edge tabs can extend continuously from the main body portion without interruption. The flexible edge tabs may be formed when the lower shell is created by injection molding or other molding techniques using a polymer and forming the flexible edge tabs with the other portions of the lower shell in the same process step, preceding or subsequent process step. In this manner, the flexible edge tabs  176  provide greater comfort to the user over braces without flexible edges. The flexible edge tabs may have a thickness substantially the same as the remainder of the main body portion, or may taper in thickness as they extend to the periphery of the lower shell. 
     In a variation, the flexible edge tabs may be initially formed in a connected manner in that material extends between each of the tabs, without the gaps. For example, the tabs may be formed with thinned sections therebetween which enable a clinician to easily cut the thinned sections or selectively cut certain thinned sections to separate the tabs from one another and thereby form gaps. 
     As shown in  FIG. 9 , the device may include a sleeve  101  having upper and lower pockets  122 ,  124 , respectively, adapted to hold the upper and lower shells  102 ,  104 . The pockets  122 ,  124  are secured to a sleeve body  126 . The pockets  122 ,  124  may be constructed by a thicker or more padded material than the sleeve body  126  which may be substantially flexible and breathable, and have characteristics of other sleeve embodiments discussed. 
     The pockets  122 ,  124  may include reinforcement edging  128 ,  130  about the pockets and may also include a surface of hook material for engaging opposing material of the pockets. In a preferred embodiment, the reinforcement edging may be less flexible and have greater toughness than material forming the outer sleeve segment. The pockets may include various openings  131 ,  134 ,  136  for permitting the straps and stability strap to extend about the exterior of the sleeve  101  and be secured to the shells. 
       FIG. 11  exemplifies the pocket  122  having an outer flap  123  arranged for opening and exposing at least part of the shell. The pocket  122  includes an inner rim  158  bearing fastener elements over a surface and engageable with a hook-receivable surface along the outer flap  123 . Alternative fasteners may be used such as zippers, buttons, hooks, etc. The inner rim  158  is preferably flexible to permit entry of the shell into the pocket  122  and extends over at least a portion of the shell to retain the shell in the pocket. The pocket includes a cavity into which a portion of the shell extends beyond the outer flap. 
     The outer flap  123  may include an opening or slit  156  through which the strap  112  may extend when coupled to the shell. The strap  112  may be coupled to the shell via a coupling element, such as a clamping tab  154  with hook elements engageable with a hook-receivable surface on the straps, to a bracket or tab coupled to the cable. 
     Referring to  FIG. 12 , a tightening system may include the tensioning mechanism  118  for adjusting the cable  120  by rotary motion. In this embodiment, as with the embodiment of  FIG. 7 , both of the straps  112 ,  114  are preferably singularly adjusted by the tensioning mechanism  118 . The ends of the cable  120  at a first portion (not shown) are anchored at points  164 ,  166  corresponding respectively to the straps  112 ,  114 . 
     Each of the straps includes the brackets  150 ,  152  through which the cable  120  extends from the anchor points  164 ,  166 , and the cable has a second portion  123  which thereafter the cable is routed by guides  160 ,  162  toward the tensioning mechanism in an appropriate manner, such as the manner depicted in  FIG. 12 . The guides  160 ,  162  may either be secured in orientation against the frame, or pivotally secured by pivot pin  161 . 
     The brackets  150 ,  152  may each include a channel  165  through which the cable  120  extends transversely relative to the strap length to distribute tension across the width of the strap when the strap is tensioned. The clamping tabs  132 , secure to the straps and extend from the brackets to permit sizing of the length of the straps. The brackets  150 ,  152  may also define a central opening  167  at an end portion located opposite the end secured to the straps. The central opening  167  provides means through which the cable may pass and slide according to the orientation of the strap relative to an axis of the brace. 
     The shells may be configured to receive an end portion of the struts, such that strut  106  is received in a cavity  170  formed by the shell. In this manner, the strut and inner surface of the shell define a continuous surface without protruding relative to one another along the interior of the shell and are intended to be adjacent to the leg of the user. In a variation, an indent may be provided in the shell only equal to half of the strut thickness, and the strut is not flush with the shells. 
       FIGS. 12 and 13  show the strap tab  132  as a clamping tab bearing indicia  168  the user may employ to understand relative settings of the strap  112 . The clamping tab  132  includes hook material  172  on both flaps clamped onto an end of the strap  112 . The border of the sleeve at the slit may serve as an indicator at which the indicia falls when the strap  112  is adjusted. 
       FIG. 14  exemplifies how the strap  114  may couple to the lower shell  104  when the lower shell  104  is placed into the pocket  124 . The strap  114  carrying the fastener tabs  144  secures to the opening  142 . The strap  114  extends through the slit or opening  134  defined by the pocket  124  and is preferably formed about the reinforcement edging  130  located about the periphery of the pocket  124 . 
     Various methods for donning and doffing the brace may be permitted in combination with the various features and components discussed in view of the embodiments of the knee brace. A method for donning the brace may include unzipping the upper zipper prior to placing the brace over the user&#39;s leg to open at least the thigh section, and then subsequently zipping the upper zipper once the knee brace is properly on the user&#39;s leg to close the brace. The lower zipper may be unzipped to provide access to the shells and straps to allow for trimming of the shells and straps. The straps may be adjusted simultaneously to tension the straps over the user&#39;s leg. 
     Of course, it is to be understood that not necessarily all objects or advantages may be achieved in accordance with any particular embodiment of the disclosure. Thus, for example, those skilled in the art will recognize that the orthopedic device may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. 
     The skilled artisan 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 an orthopedic device in accordance with principles of the present disclosure. Additionally, it will be understood by the skilled artisan that the features described herein may be adapted to other types of orthopedic devices. Hence this disclosure and the embodiments and variations thereof are not limited to knee braces, but can be utilized in any orthopedic devices. 
     Although this disclosure describes certain exemplary embodiments and examples of an orthopedic device, it therefore will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed knee brace embodiments to other alternative embodiments and/or uses of the disclosure and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present disclosure should not be limited by the particular disclosed embodiments described above, and may be extended to orthopedic devices and supports, and other applications that may employ the features described herein.