Patent Description:
Known orthopedic devices are used for providing stability, protection, support, rehabilitation and/or unloading of a portion of the human anatomy. These known devices, however, are often considered as being uncomfortable, physically bulky, heavy, not durable, tedious and/or difficult to adjust, 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 many 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. 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.

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 physical activity requiring legs.

Compartmental osteoarthritis is a problematic 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. These changes ultimately lead to increasing pain and stiffness of the j oint.

While there are no cures to osteoarthritis, there are many treatments. Individuals with a diagnosis of isolated lateral or medial compartmental osteoarthritis of the knee are confronted with many treatment options such as medications, surgery, and nonsurgical interventions. Nonsurgical interventions include using canes, lateral shoe wedges, and knee braces.

Meniscal tears, or tears in the meniscus, are another common knee ailment that impede proper knee function. These meniscal tears are frequently remedied through partial meniscectomy, which is one of the most common orthopedic procedures in the U. as about a third of men older than <NUM> have asymptomatic meniscal tears. Acute tears may be treated conservatively, and recent evidence suggest that surgery, including partial meniscectomy, may be unnecessary for degenerative tears. Nonsurgical treatment of meniscal tears may involve a period of non/reduced weight bearing.

Degenerative tears are often associated with osteoarthritis changes in the knee. Osteoarthritis and degenerative meniscal tears share many of the same risk factors and biological processes. It may difficult to ascertain if one condition precedes the other, or whether they occur independently or simultaneously.

Knee bracing is useful in providing compartment pain relief resulting from osteoarthritis and/or meniscal tears by reducing the load on the injured meniscus or tear, and/or knee compartment through applying an opposing external valgus or varus moment about the knee j oint. 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/or adjust, not durable, and uncomfortable to wear.

Orthopedic device frames may cause pressure points, be uncomfortable around the edge, have poor breathability, look and feel bulky and/or aesthetically unattractive, be difficult to adjust in shape, and lack durability among other problems.

Strapping systems are commonly used to secure orthopedic devices to the user's anatomy. Few changes have been made to strapping systems, and little focus has been given to improving strapping. Rather, the emphasis in orthopedic devices often relates to the frame structure and methods for preventing migration on the user during use, and strapping systems are typically off-the-shelf products, with little to no focus devoted thereto.

Current strap designs typically involve aggressive hook and loop systems with a tendency to tear soft-good type braces or make it difficult for corresponding areas on a hard frame to maintain hook or loop patches for receiving straps bearing corresponding locking hook or loop. These straps may have a single property regarding elasticity; they are elastic or inelastic, but rarely do they include both elasticities arranged at strategic locations.

Sizing of many current strap designs may allow for severing the length of the strap to fit a user's anatomy at a time, but such strap designs often lack means for lengthening or reducing length, as desired by a user or set by a clinician. Current strap designs do not possess means for quickly attaching and removing the strap systems from a frame of the orthopedic device. As the strap systems are often not given much design consideration, they cause complaints due to discomfort and difficulty of adjustment. They may be formed from nylon or other inexpensive textile materials lacking sufficient pressure distribution or breathability. Such materials can also lack desired durability. There is a need for strap systems that are injection molded and free of textiles. Current straps also lack designs and/or implements to improve durability of the strap itself. Hook and loop fasteners are commonly used for adjusting strap length but can wear out, causing durability issues. Hook and loop fasteners have the additional disadvantage of frequently coming undone during normal use and being imprecise to adjust, making it difficult to ensure a sure fit.

Strap systems and frames may be designed in a way that allows migration of one or more straps along a user's anatomy during use, which migration further adds to discomfort, poor fit, and difficulty of adjustment.

Orthopedic frames and strap systems may be adjustable in size by various means by tensioning a cable, but a problem is that the adjustment systems add bulk and discomfort to the device. Attachments and structures for routing tensioning cables may protrude from one or more shells of the frame, adding bulk, reducing comfort, and reducing durability as the protruding attachments and structures for routing the cables may be more prone to breaking or malfunctioning. There may be too few of such attachments and structures to route the cable, leading to uneven tensioning and/or discomfort. Adjustment systems, such as dial tensioners, may contribute to migration of the frame against the user as the adjustment system is actuated. Cables that terminate on straps rather than within the dial tensioner may reduce durability by causing maintenance problems.

Orthopedic braces, including knee braces, are frequently designed for heavy duty and/or immediate post-operative use, and require of heavy frame elements and robust tensioning elements to severely unload a joint and/or prevent unwanted motion in certain directions to protect a joint. Braces in heavy duty and/or immediate post operative use that incorporate robust dynamic tensioning straps (and the accompanying adjustment mechanisms) are only suitable and configured for single-strap tensioning. A brace with two or more dynamic tensioning straps, therefore, disadvantageously requires two or more adjustment mechanisms, which increases cost and difficulty of adjustment. There is a need for a transition brace suitable for users in a later stage of recovery, allowing the brace to be lighter in weight and be easier to adjust with a single adjustment mechanism governing multiple dynamic tensioning straps.

An example of an orthopedic device in the form of a knee brace for osteoarthritis is generally taught in <CIT>, and a strapping system and method for using the same is in <CIT>.

It is known from <CIT>, <CIT> and <CIT> to provide systems involving "alligator-type" tabs to secure a strap member. The document <CIT> discloses a strap system according to the preamble of claim <NUM>.

There is need of an orthopedic device suitable for treating osteoarthritis and/or meniscal tears and reduces knee pain, improves knee function, reduces compartmental knee loads, and offers ease of application and adjustment while overcoming the problems of existing braces.

The exemplary embodiments have streamlined features capable of providing relief for degenerative meniscal tears, and/or medial or lateral compartmental osteoarthritis, and/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 many wearable devices configured to be secured to and/or support numerous portions of anatomy. The embodiments are aimed at improving the life and mobility of affected users by reducing knee pain, improving knee function, reducing compartmental knee loads, and offering ease of application and adjustment.

The exemplary embodiments also include various strap systems that provide versatility in sizing of length, quick and efficient attachment to the frame of the orthopedic device, enhanced durability, improved fit, and enhanced comfort over known strap systems in orthopedic devices.

According to the embodiments of the orthopedic device, as will be evident by the features of the orthopedic and variations thereof, enable an orthopedic device that is easy to apply and adjust, particularly by a single adjustment mechanism for at least two straps. The orthopedic device has a frame, a strap system including first and second straps connecting to the frame, and an adjustment mechanism coupling to the first and second straps, and simultaneously regulating tension in the first and second straps by moving the first and second straps relative to the frame. This provides a substantial advantage over existing single-strap tensioning systems, which make a brace difficult to adjust.

The frame comprises a first shell, a second shell, and a hinge connecting the first and second shells. The first and second straps connect to the first and second shells. First and second struts connect to the hinge and the first and second shells, respectively. The frame is easy to apply and adjust, in part by providing the hinge which is a custom fit hinge in that the struts may be cold-formable, such as by a malleable aluminum. The shells may define channels that protrude from the shell, and through which the struts may be secured to maintain a smooth inner surface of the shells, contributing to the comfort in wearing the brace. The shells may be smaller than in prior orthopedic devices, in part due to a flexible edge area, but also in view of the features, such as the channel formed by the shells. These features allow for a brace that is relatively light-weight and suitable as a transitional brace. The hinge is further strengthened by providing a portion of each strut as part of the hinge; this provides for a stronger hinge without adding greater bulk.

For additional stability, comfort, migration control, and ease of donning and doffing the orthopedic device, a third strap secures to opposed sides of the second shell, extending horizontal or lateral relative to a vertical or longitudinal direction of the orthopedic device.

The first strap may have a first end slidably connecting to the first shell and a second end secured to the second shell. The second strap may have a first end slidably connecting to the first shell and a second end secured to the second shell. The adjustment mechanism may be mounted to the first shell and coupled to first ends of the first and second straps.

To improve ease of adjustment and fit of the orthopedic device, the first shell defines a tension relief slot proximate the adjustment mechanism. The tension relief slot mitigates migration or rotation of the orthopedic device on the user, since adjustment of the adjustment mechanism tensions the straps about the user. The tension relief slot is formed by the first shell and localizes forces on the first shell. The tension relief slot may define an arcuate shape generally matching a shape of the adjustment mechanism. The first shell may form a base for the adjustment mechanism such that the adjustment mechanism is rotatable therein.

At least one of the first and second shells defines a relief zone arranged generally proximate to at least one of the struts. The relief zone may be defined as an arcuate recess along a side of the first or second shell proximate the hinge, and is arranged to mitigate pinching of a user when the orthopedic device is arranged in flexion of the orthopedic device.

A cable having first and second ends is received by the adjustment mechanism, and segments of the cable between the first and second ends slidably engage the first and second straps. The first ends of the first and second straps, respectively, are generally oriented in reversed directions relative to one another. The opposed directions of the first ends of the first and second straps may be generally oriented obliquely in non-perpendicular and non-parallel directions relative to a proximal-distal axis of the orthopedic device in an extension configuration.

In addition to the channel for the struts, the shells may form other features, such as those being molded from and being integrally formed from the shells, as opposed to being attached to the shells. Another example of such features can be a plurality of cable guides through which the cable extends. The cable guides may protrude from an outer surface of the shells, and the shells may define a substantially smooth inner surface devoid of protrusions extending therefrom. The inner surface of the shells is preferably smooth so they are comfortable on the wearer, particularly as the shells bend about the anatomy of the user. The cable guides define a plurality of differently shaped individual guides. The individual guides may have different shapes such that some guides may be substantially straight, and some guides may be curved or arcuate. A larger number of guides is provided to facilitate better routing of the cable, which results in easier adjustment and a closer fit.

The shell may define a base for an adjustment mechanism to maintain a minimal profile. The adjustment mechanism receives both ends of the cable, which results in easier adjustment and enhanced durability. The ability to adjust both ends of the cable simultaneously enables more consistent tensioning of the straps, and simplifies the process for tightening the straps. It offers a solution to inconsistent tensioning of one strap over the other, and assures that the user does not improperly incur more force on the leg from one strap over the other.

A sleeve extends about and over the first and second shells, and a first and second segments of the first and second straps, respectively, extending over the sleeve between the first and second shells. The sleeve has a stitchless construction, which aids in both comfort and ease in donning and doffing.

Either of the shells may define a shell body, and such shell bodies may define the aforementioned features. A flexible perimeter edge may be secured along a perimeter of the shell body to provide greater comfort to a user. The shell body is preferably formed from a more rigid material than a material formed by the flexible perimeter edge.

In another feature formed by the shells, the shells may define an elongate channel arranged to receive one of the first and second struts. The elongate channel may define a length at least half of a height of the first or second shell. The elongate channel may only protrude from the outer side of one of the first and second shells. At least one of the first and second shells may define an elongate slot and a bar extending over the elongate slot over the outer side, such that the third strap is adapted to extend about the bar. The elongate channel minimizes the profile of the brace and improve durability by providing a more secure connection between the struts and shells.

In another feature defined by the shells, the second shell may define a first keyhole adapted to receive a second end of the second strap. The second shell may define a calf anti-migration portion protruding from a remainder of the second shell. The calf anti-migration portion is generally in correspondence with the second shell channel within the channel length. At least one of the keyholes is located within the calf anti-migration portion. The calf anti-migration feature minimizes migration without comprising comfort or durability.

At least one of the first and second shells may define a plurality of ventilation openings arranged in a pattern. The pattern may be defined to enlarge ventilation openings.

In another feature defined by the shells, the shell bodies may be overmolded with overlay features that advantageously accommodate various features such as struts and straps. The overlay feature provides flexible edges for greater comfort and also receives a terminal of one or more straps. This feature reduces unwanted migration of the strap, improves durability by protecting the strap and the terminal of the strap from damage, and enhances the aesthetic quality of the brace. The same benefits are also afforded to the strut which is received by the overlay features. The overlay can also cover and conceal other features on the shell body, such as cable and/or guides. This also improves durability and comfort.

The straps comprise loop strap material for a soft feel. The straps may include a length adjustment system, and the length adjustment system includes a section having a plurality of openings and a mounting bracket having fasteners selectively engageable with different openings among the plurality of openings. The mounting bracket defines a cable channel for slidably receiving the cable segment. A tab may secure to the first end of the first strap, and the tab defines a cable channel for slidably receiving the cable segment.

In an embodiment of the strap system, the strap system includes an elongate strap having a fixed length, and defines first and second ends. A length adjustment system is connected to the first end of the elongate strap, and the length adjustment system includes a belt segment having a first end secured to the first end of the elongate strap and defines a plurality of openings arranged along a portion of a length of the belt segment to a second end thereof. A bracket is selectively engageable with different opening among the plurality of openings to adjust the length of the length adjustment system.

The belt segment has a first end defining an attachment portion receiving the first end of the elongate strap, and the belt segment may be integrally secured to the first end of the elongate strap. The attachment portion may be molded over the first end of the elongate strap.

The belt segment may define a transition portion proximate the first end and be located adjacent the attachment portion. The transition portion may be defined as a reduced thickness portion extending to the second end of the sleeve. The belt segment may be substantially elastic along its length. The belt segment may trimmable from the second end thereof, thereby enabling a reduction in the plurality of openings. The belt segment may define at least one elongate slot defined between the first end and the plurality of openings.

The at least one elongate slot may extend through the belt segment. The bracket may define a fastener engageable to at least one opening among the plurality of openings. The fastener is preferably defined by an extension portion generally having a length corresponding to a thickness of the belt segment, and a flange portion extending from the extension portion for securing against a surface of the belt segment.

The belt segment may define a plurality of lateral recesses defined between the plurality of openings. The lateral recesses may be defined along and in opposed pairs along inner and outer surfaces of the belt segment.

The length adjustment system of the belt segment defines a plurality of openings, such that each of the openings may form a keyhole shape for receiving a fastener of the mounting bracket. The keyhole shape may define an insertion portion and a locking portion located in a direction of a second of the belt segment opposite of the elongate strap. A seat portion may be defined about the locking portion, and is preferably formed by a recess sized and configured for receiving a flange portion of the mounting bracket.

An anchor bracket is preferably secured to a second end of the strap section. The anchor bracket may define an attachment portion into which the strap section extends and secures. The anchor bracket defines a fastener pin extending therefrom generally perpendicularly to the attachment portion.

The mounting bracket may define an opening at a first end thereof adapted for grasping with a finger for tensioning or pulling the strap. The mounting bracket may define a transition portion located between the fastener and the opening. The transition portion is defined as a tapering between a flattened head portion carrying the fastener and the cable channel and the first end of the mounting bracket. The anchoring bracket defines an anchoring pin and an extension portion extending from a generally flattened body carrying a fastener.

Another embodiment of a strap system comprises a first strap segment having first and second ends, a second strap segment having first and second ends, a buckle secured to the first end of the second strap segment. The buckle preferably carries a pin. A band is preferably secured to the second end of the first strap segment and the second end of the second strap segment. The band forms apertures arranged for securely and removably receiving the pin. The buckle may include a head extending beyond the first end of the second strap segment. The head preferably carries the pin. The second strap segment may form a loop between the first and second ends.

As shown in <FIG>, the orthopedic device <NUM> is in the form of a knee brace and builds on the basic description of a knee brace in <CIT>, issued on June <NUM>, <NUM>. The orthopedic device <NUM> relates to and functions, at least in part, similarly to the orthopedic device discussed in <CIT>, issued on April <NUM>, <NUM>.

Referring to <FIG>, the orthopedic device <NUM> is shown with a sleeve <NUM> connecting and covering the shells described in connection with <FIG>. The shells are located within first and second pockets <NUM>, <NUM> formed by the sleeve <NUM>, and inserted externally of the sleeve <NUM> through openings <NUM> formed by the pockets <NUM>, <NUM>. The struts <NUM>, <NUM> and hinge <NUM> generally extend over the exterior surface of the sleeve <NUM>. The first and second straps <NUM>, <NUM>, and the third strap <NUM> generally extend over the exterior surface of the sleeve <NUM>, and their engagement with first and second shells occurs within the pockets <NUM>, <NUM> by entering the pockets <NUM>, <NUM> by openings <NUM> so corresponding brackets, pins, and cable are not exposed on the exterior surface of the orthopedic device <NUM>.

The sleeve <NUM> includes regions of different material or laminates. The pockets <NUM>, <NUM> include a pocket material <NUM>, such as Lycra, that extends mostly if not completely about the shells, and is elastic to enable insertion of the shells therein but retains the shells once they are inserted by contracting over such shells. A reinforcement edging <NUM> surrounds the pockets <NUM>, <NUM> and serves to reinforce the pocket material <NUM>. The pocket material <NUM> of the pockets <NUM>, <NUM> may be the same as sleeve material <NUM> forming a continuous tubular shape upon which the pockets <NUM>, <NUM> are formed. The sleeve material <NUM> is preferably stretchable but has resilience to secure and maintain a position over the user's leg without migration.

An interior surface of the sleeve <NUM>, and thus the sleeve material <NUM>, is continuous in that there is no interruption and provides improved comfort to the user. The end portions <NUM>, <NUM> of the sleeve <NUM> may be only formed from the sleeve material <NUM>, since the elasticity of the sleeve material <NUM> may hold the sleeve <NUM> and orthopedic device <NUM> on the leg of the user without additional means such as silicone or other frictional materials commonly applied to an interior surface of a sleeve to minimize migration.

The sleeve <NUM> may have a stitchless construction wherein the pockets <NUM>, <NUM> are welded onto the sleeve material, and the end portions <NUM>, <NUM> may be without or only minimal stitching. The generally stitchless construction allows for a more comfortable orthopedic device <NUM> by removing potentially skin irritating stitching, and by facilitating donning and doffing.

Additional reinforcement elements <NUM>, <NUM> may be provided along the sleeve material <NUM> to minimize migration of the straps <NUM>, <NUM>, <NUM> over the surface of the sleeve <NUM> or minimize wear of the sleeve material <NUM>. The reinforcement elements <NUM>, <NUM> may be similar to the reinforcement edging <NUM> and may merge therewith in certain locations. The reinforcement elements <NUM>, <NUM> may be provided at strategic locations to counteract tensioning of the straps <NUM>, <NUM>, <NUM> to provide better form fitting over the user's leg. For example, the reinforcement elements <NUM>, <NUM> may have stretchability less than the sleeve material <NUM> and impede elasticity of the sleeve <NUM> at such locations where the reinforcement elements <NUM>, <NUM> are located.

The reinforcement elements <NUM>, <NUM> may have additional functional features in addition to providing counteracting or contrasting elasticity. The reinforcement element <NUM> may form a support area <NUM> for the adjustment mechanism <NUM> to prevent bunching or migration of the sleeve material <NUM>, as the adjustment mechanism <NUM> is actuated. The support area <NUM> may also form a plurality of openings <NUM> that show a relative degree of tensioning or travel of the second strap <NUM> adjusted by the adjustment mechanism <NUM> by a marker carried by the second strap <NUM>.

Referring to <FIG>, the orthopedic device <NUM> includes a first shell <NUM>, a second shell <NUM>, and a hinge <NUM> connecting the first and second shells <NUM>, <NUM>. A first strap <NUM> having a first end slidably connects to the first shell <NUM> and a second end is removably anchored to the second shell <NUM>, and a second strap <NUM> has a first end slidably connecting to the first shell <NUM>, and a second end removably anchored to the second shell <NUM>. The first and second straps <NUM>, <NUM> may be "dynamic force" straps, similarly described in <CIT> and <CIT>, for unloading compartmental arthritis of a knee. The dynamic force strap <NUM>, <NUM> may apply a counteracting force to the adduction moment, and tensions as the leg extends. A third strap <NUM> securing to opposed sides of the second shell <NUM> may be included to provide stability over the calf of the user.

The first strap <NUM> is preferably arranged for having its length defined between attachment points to the first and second shells <NUM>, <NUM> adjustable linearly. Adjusting the length linearly implies that the length is not reduced by looping the strap over a D-ring or similar bracket or slot, but rather a linear length of the strap between attachment points (i.e., anchor points to both the first and second shells <NUM>, <NUM>) is reduced.

The orthopedic device <NUM> includes first and second struts <NUM>, <NUM> connecting to the hinge <NUM> and the first and second shells <NUM>, <NUM>, respectively. Both the first and shells <NUM>, <NUM> define an elongate channel <NUM>, <NUM> arranged to receive one of the first and second struts <NUM>, <NUM>. The elongate channels <NUM>, <NUM> are preferably formed by the material forming the shells <NUM>, <NUM>, and may be molded into shape when the shells <NUM>, <NUM> are formed. Preferably, the struts <NUM>, <NUM> are slidable into the elongate channels <NUM>, <NUM> and are securely retained thereby.

The elongate channels <NUM>, <NUM> are preferably arranged to reduce a length of the struts <NUM>, <NUM> located between the first and second shells <NUM>, <NUM> to provide a more streamlined profile of the orthopedic device <NUM>. The elongate channels <NUM>, <NUM> may define a length at least half of a height <NUM> of the first or second shell <NUM>, <NUM>, as they are preferably arranged to extend deeper into the shells <NUM>, <NUM> for providing the more streamlined profile and better secure to the shells <NUM>, <NUM>. The shells <NUM>, <NUM> may likewise be sized smaller than conventional braces in part due to greater extension of the struts <NUM>, <NUM> versus their overall length over the shells <NUM>, <NUM>. Consistent with the more streamlined profile and to maintain smooth, flat surfaces on an inner side I of the first and second shells <NUM>, <NUM>, the elongate channels <NUM>, <NUM> only protrude from the outer side O of the first and second shells <NUM>, <NUM>, thereby providing a smooth inner surface of the shells <NUM>, <NUM>.

Referring to the variation of first shell <NUM> in <FIG>, the first shell <NUM> is preferably molded over strut <NUM> to assure that it interlocks therewith without the necessity of an adhesive or fasteners. Both the first shell <NUM> and the strut <NUM> may include alignment holes <NUM>, <NUM> that allow for the first shell <NUM> to align with the strut <NUM> as the first shell <NUM> is formed. The material of the first shell <NUM>, which is preferably an injection moldable polymeric material such as nylon, may interlock with the strut <NUM> in that the polymeric material surrounds a periphery of the alignment hole <NUM> formed by the strut <NUM>, which is metal. The polymeric material of the first shell <NUM> may therefore extend through the alignment hole <NUM> of the strut <NUM>, and coat the strut <NUM> about the periphery of the alignment hole <NUM>. The first shell <NUM> and the strut <NUM> may include at least one set of coaxial holes <NUM>, <NUM>, and preferably include at least two sets of coaxial holes <NUM>, <NUM>.

While the interlocking of the first shell <NUM> to the strut <NUM> sufficiently holds, if it is desired for greater attachment of the strut <NUM> to the first shell <NUM>, the first shell <NUM> likewise includes the alignment hole <NUM> that aligns with the alignment hole <NUM> of the strut <NUM>. A fastener (not shown) may extend through the coaxial alignment holes <NUM>, <NUM> to enhance the attachment of the first shell <NUM> to the strut <NUM>.

While <FIG> exemplifies the relation of the channel length <NUM> to the shell height <NUM>, <FIG> exemplifies how the channel <NUM> may have a greater channel length <NUM> (as in <FIG>) than a length <NUM> of the strut <NUM> outside of the channel <NUM>. The length <NUM> of the strut <NUM> outside the channel may include a portion of the strut <NUM> forming a portion <NUM> of the hinge (not shown). It is not necessary, however, that the strut <NUM> form a portion <NUM> of the hinge, although it may aid in stability, reduce parts and provide greater durability to the hinge. The arrangement of the lengths of the shell <NUM>, its channel <NUM>, and the strut <NUM> enable a simplified hinge arm shape, while providing a more streamlined brace. The struts may be shortened for a sleeker and less bulky shape of the brace, particularly as the shells are generally retained within a sleeve, as shown in <FIG>.

The first and second shells <NUM>, <NUM> include shell bodies <NUM>, <NUM> and flexible perimeter edges <NUM>, <NUM> secured along perimeters <NUM>, <NUM> of the shell bodies <NUM>, <NUM>. The shell bodies <NUM>, <NUM> may be rigid or semi-rigid, thereby maintaining their shape according to movement of the user when or once the orthopedic device <NUM> is secured onto the user. The flexible perimeter edges <NUM>, <NUM>, alternatively, are flexible upon movement of the user, thereby providing a pressure-relieving edge. The flexible perimeter edges <NUM>, <NUM> may extend over a substantial entirety of the first and second shells <NUM>, <NUM>, but may be interrupted by the channels <NUM>, <NUM>, as depicted in <FIG> and <FIG>. The flexible perimeter edge <NUM>, <NUM> may be formed similarly to the processes described in <CIT>, and <CIT>.

Referring to <FIG>, second shell <NUM> is shown with a flexible perimeter edge <NUM> having varying first, second, and third widths <NUM>, <NUM>, <NUM>. Widths <NUM>, <NUM>, <NUM>, denoted by w1, w2, and w3, respectively, impart varying degrees of flexibility. The width of the flexible perimeter edges <NUM>, <NUM> may be uniform around the perimeters <NUM>, <NUM> of the shell bodies <NUM>, <NUM>, or the width of the flexible perimeter edges <NUM>, <NUM> may vary according to pre-determined locations about the perimeters <NUM>, <NUM> of the shell bodies <NUM>, <NUM>. The flexible perimeter edges <NUM>, <NUM> varying in width according to pre-determined areas, as depicted in <FIG>, advantageously allows the shell bodies <NUM>, <NUM> to have varying degrees of flexibility in desired areas, which increases comfort for a user by reducing pressure points.

The second shell <NUM> defines an anti-migration portion <NUM> generally in correspondence with the second shell channel <NUM> within a channel length <NUM> thereof. The anti-migration portion <NUM> is arranged to protrude from a remainder <NUM> of the second shell <NUM> and is adapted to extend laterally from the second shell remainder <NUM> and over at least a portion of a calf of the user. The anti-migration portion <NUM> may include at least one keyhole <NUM>, <NUM> for receiving a bracket from one of the first and second straps <NUM>, <NUM>, and preferably a keyhole <NUM> for receiving an end of the third strap <NUM> adapted to secured over the calf of the user.

The first and second shells <NUM>, <NUM> define relief zones <NUM>, <NUM>, <NUM>, arranged generally proximate to at least one of the struts <NUM>, <NUM>. The relief zones <NUM>, <NUM>, <NUM> are defined as an arcuate recess along sides of the first or second shell <NUM>, <NUM> proximate to the struts <NUM>, <NUM>, and face the hinge <NUM>. The relief zones <NUM>, <NUM>, <NUM> are generally arcuate in shape and contoured to correspond to anatomy of the leg. The relief zones <NUM>, <NUM>, <NUM> are provided to mitigate pinching of a user's leg or skin when the orthopedic device <NUM> is arranged in flexion. The relief zones <NUM>, <NUM> are preferably located on the posterior side of the hinge <NUM> as such areas corresponding to user's leg in full flexion of the orthopedic device <NUM> are tensioned and prone to tightening.

The first and second shells <NUM>, <NUM> define a plurality of ventilation openings <NUM> arranged in a pattern <NUM> and may be defined as enlarging ventilation openings <NUM> toward outer perimeters opposite the hinge <NUM>, since these areas correspond to enlarging of the profile of the user's leg away from the knee; for example, as rays of ventilation openings <NUM> flaring in size toward the outer perimeter. The ventilation openings <NUM> may cause the first and shells <NUM>, <NUM> to have greater bendability aside from semi-rigid or rigid characteristics of the material forming the first and second shells <NUM>, <NUM>, thereby better accommodating the leg profile of individual users of the orthopedic device <NUM>.

<FIG> show the second shell <NUM> without the flexible perimeter edge <NUM> in <FIG>. According to the embodiment of <FIG>, the flexible perimeter edge <NUM> may be formed from a different material from a main body <NUM> of the second shell <NUM>, particularly a material that is more flexible than the main body <NUM> and/or with functional features to enhance flexibility as in a substantially thinner thickness than the main body <NUM>. Alternatively, the main body <NUM> may be functionally formed to have a flexible perimeter edge <NUM>, which may be imparted by a thinned perimeter edge with or without suitable breaks along the perimeter edge accounting for contour changes of the main body <NUM>.

The second shell <NUM> of <FIG> is adapted to receive a separate flexible perimeter edge <NUM>, or may be formed functionally with the flexible perimeter edge. A thinned zone <NUM> is formed about generally an entirety of the periphery <NUM> of the main body <NUM>, aside from at the elongate channel <NUM>. Alternatively, however, the thinned zone <NUM> can be placed in a plurality of separate segments and is not limited to being about a general entirety of the periphery <NUM> of the main body <NUM>. A ledge <NUM> leading to the thinned zone <NUM> results from a taper from opposed sides (outer and inner) of the main body <NUM> to the thinned zone <NUM>. In the event of a flexible perimeter edge attached to the main body, the flexible perimeter edge <NUM> preferably abuts the ledge <NUM> against the main body <NUM>.

<FIG> illustrates the ledge <NUM> as not being concentric with the periphery <NUM> of the main body <NUM>, but rather it is eccentric relative to the periphery <NUM> of the main body <NUM>. The eccentricity is due to a need for variable flexibility of the second shell <NUM> about its periphery <NUM>, as evidenced in <FIG> by the different widths w1, w2 and w3. A plurality of breaks <NUM> are defined from the periphery <NUM> and short of the ledge <NUM> to facilitate bending about the periphery <NUM> of the second shell <NUM>, particularly in view of its non-uniform contour. The plurality of breaks <NUM> effectively form tabs within the thinned zone <NUM>. The breaks <NUM> are depicted as extending into the shell <NUM> a distance short of the width of the thinned zone <NUM> so as to provide sufficient rigidity to any flexible perimeter edge <NUM> applied thereover.

Alternatively, the second shell <NUM> may be provided without a separate and discrete flexible perimeter edge, and the thinned zone <NUM> may itself form a flexible perimeter edge. The first shell <NUM> may be formed similarly to the second shell <NUM> vis-à-vis the thinned zone <NUM>, whether with or without a separate and discrete flexible perimeter edge <NUM>.

<FIG> contrasts the thickness t1 of the main body <NUM> from the thickness t2 at the thinned zone <NUM>. The thinned zone <NUM> preferably is within the middle of the main body <NUM>, although in variations it may be located flush which the inner surface I so there is no ledge on the inner surface I, particularly if the thinned zone <NUM> itself solely defines the flexible perimeter edge <NUM>, or vice versa with the outer surface O. The elongate channel <NUM> may define inner and outer walls <NUM>, <NUM> that have a thickness t3 which may be less than the main body <NUM>.

The second shell <NUM> defines an elongate slot <NUM> and a bar <NUM> extending over the elongate slot <NUM> over the outer side O of the second shell <NUM>. The third strap <NUM> is adapted to extend about the bar <NUM> located at a first side of the second shell and extend to the keyhole <NUM> on a second side of the second shell <NUM> to form a circumference in combination with the second shell <NUM>. The third strap <NUM> is arranged to extend over the anterior leg and over at least a part of the posterior leg, including the user's calf.

The second shell <NUM> may include other keyholes <NUM>, <NUM> for receiving brackets from the first and second straps <NUM>, <NUM>. The second shell <NUM> defines a first keyhole <NUM>, <NUM>, <NUM> adapted to receive a second end of the second strap <NUM>. The keyholes <NUM>, <NUM>, <NUM> may be configured similarly to the locking keyholes formed by the first and second shells <NUM>, <NUM>, and described at least in connection with <FIG> and <FIG> of <CIT>.

As depicted in <FIG>, the first and second shells <NUM>, <NUM> define substantially smooth inner surfaces <NUM>, <NUM> devoid of protrusions extending therefrom. The inner surfaces <NUM>, <NUM>, in combination with spacer material or other suitable padding, enables a breathable and lightweight feel for the user, with assistance from the ventilation openings <NUM>.

An adjustment mechanism <NUM> is preferably mounted to the first shell <NUM> and coupled to the first and second straps <NUM>, <NUM> for simultaneously adjusting the first ends of the first and second <NUM>, <NUM> straps relative to the first shell <NUM>. To better integrate the adjustment mechanism <NUM> to the first shell <NUM> and create a more streamlined profile of the orthopedic device <NUM>, the first shell <NUM> forms a base <NUM> for the adjustment mechanism <NUM> such that the adjustment mechanism <NUM> is rotatable therein. Such a configuration eliminates the need to add an entire adjustment mechanism to an outer surface of the first shell <NUM>, and thereby reducing bulging of the adjustment mechanism <NUM> from the first shell <NUM>.

Consistent with the base <NUM>, the first shell <NUM> defines a tension relief slot <NUM> proximate the adjustment mechanism <NUM>. The tension relief slot <NUM> defines an arcuate shape generally matching a shape of a portion of the adjustment mechanism <NUM>. The tension relief slot <NUM> accommodates movement of the adjustment mechanism <NUM> as is it rotated in the base <NUM>, and mitigates migration of the first shell <NUM> on the leg of the user as the adjustment mechanism <NUM> is turned by user.

A cable <NUM> has first and second ends received by the adjustment mechanism <NUM>, and cable segments <NUM> between the first and second ends slidably engaging the first and second straps <NUM>, <NUM>. The cable <NUM> is selectively lengthened by and relative to the adjustment mechanism <NUM>, and unlike in prior art devices, the cable <NUM> does not terminate on the first shell <NUM>, but rather the ends of the cable <NUM> terminate within the adjustment mechanism <NUM>. First ends <NUM>, <NUM> of the first and second straps <NUM>, <NUM>, respectively, are generally oriented in reversed directions A, B relative to one another by the cable segments <NUM>. Specifically, the opposed directions of the first ends <NUM>, <NUM> of the first and second straps <NUM>, <NUM> are generally oriented obliquely in non-perpendicular and non-parallel directions relative to a proximal-distal axis of the orthopedic device in an extension configuration.

A plurality of cable guides <NUM> are preferably formed by the first shell <NUM> itself rather than being secured to the first shell. The cable guides <NUM> may only protrude from an outer surface O of the first shell <NUM>, as shown from <FIG>, <FIG>, and <FIG>. The cable <NUM> slidably extends through the cable guides <NUM> and defines a cable route according to an arrangement of the cable guides <NUM>, which define a plurality of different shaped individual guides <NUM>, <NUM>. At least one individual cable guide <NUM> is substantially straight, and wherein at least one individual cable guide <NUM> is arcuate. The first shell <NUM> may include many more cable guides <NUM> over the prior art, in part because they are formed directly from the shell body and material thereof. This is advantageous since there is no need to include fasteners for securing the cable guides <NUM>, and which add bulk to the cable guides <NUM> and the first shell <NUM>.

The first strap <NUM> includes a length adjustment system <NUM>. According to the embodiments of <FIG>, the length adjustment system <NUM> includes a section having a plurality of openings <NUM> and a mounting bracket <NUM> having fasteners <NUM> selectively engageable with different openings among the plurality of openings <NUM>, and enables a unitary strap so the first strap <NUM> is functionally equivalent among any of the plurality lengths available in view of the selective placement of the mounting bracket <NUM> among the plurality of openings <NUM>. The mounting bracket <NUM> preferably defines a cable channel <NUM> for slidably receiving the cable segment <NUM>. The first strap <NUM> is adapted to slide along the outer surface O of the first shell <NUM> according to adjustment of the cable <NUM> according to adjustment of the adjustment mechanism <NUM>.

The second strap <NUM> includes a mounting bracket <NUM> securing to the first end <NUM> of the second strap <NUM>. The mounting bracket <NUM> defines a cable channel <NUM> for slidably receiving the cable segment <NUM>, however the mounting bracket <NUM> is arranged without being in combination with a length adjustment system <NUM>, and is slidable along the surface of the first shell <NUM> according to adjustment of the cable <NUM> according to adjustment of the adjustment mechanism <NUM>.

<FIG> show variations of strap systems that can be used in combination with the orthopedic device of <FIG>, or in other applications. In each instance, the strap systems employ means which enable and facilitate easy length adjustment. These variations allow for strap systems that avoid the attendant drawbacks of known strap systems, particularly in orthopedic devices, that solely rely on hook and loop fasteners for securing and adjusting straps, and including D-rings or other bulky and heavy brackets used to redirect or mount straps thereto. The variations rely on features that facilitate bending and are formed of materials and configurations that provide greater comfort, contouring, and breathability for users.

In an example, the first strap <NUM> has an adjustable length including an elongate strap <NUM> having a fixed length L1, and defining first and second ends. A length adjustment system <NUM> connects to the first end <NUM> of the elongate strap <NUM>. The length adjustment system <NUM> includes a belt segment <NUM> having a first end secured to the first end <NUM> of the elongate strap <NUM> and defines a plurality of openings <NUM> arranged along a portion of a length of the belt segment <NUM> to a second end <NUM> thereof. A bracket <NUM>, <NUM> selectively engages with different openings among the plurality of openings <NUM> to adjust the length L2 of the length adjustment system <NUM>.

The belt segment <NUM> has a first end <NUM> defining an attachment portion <NUM> receiving the first end <NUM> of the elongate strap <NUM>. The belt segment <NUM> is preferably integrally secured to the first end <NUM> of the elongate strap <NUM>. The attachment portion <NUM> may be molded over the first end <NUM> of the elongate strap <NUM>, thereby forming an overmold connection defined by the mixture or melding of the material forming the attachment portion <NUM> with a material forming the elongate strap <NUM>. The elongate strap <NUM> may be formed from a polymeric material or a textile, such as a brushed loop material providing superior compressive and breathable properties. The elongate strap <NUM> may comprise a nylon webbing, or may comprise a soft loop material laminated and sewed with a thin nylon/polyester strap in a center core.

The belt segment <NUM> defines a transition portion <NUM> proximate the first end <NUM> thereof and adjacent the attachment portion <NUM>. The transition portion <NUM> is formed as a reduced thickness portion extending to the second end <NUM> of the belt segment <NUM>. The belt segment <NUM> may be substantially elastic along its length L2, or alternatively may be inelastic yet flexible and resilient so as to bend according to the anatomy of the user although it may not yield under tension on the user. The belt segment <NUM> may be trimmable from the second end <NUM> thereof, thereby enabling a reduction in the plurality of openings <NUM>. The belt segment <NUM> is preferably a stretchable plastic material arranged to eliminate the need for an elastic element or band to be sewed in the elongate strap <NUM> and for elastic to be sewed to the bracket <NUM>.

The belt segment <NUM> defines at the first end <NUM> a curved end <NUM> to ease in bending of the elongate strap <NUM>. A plurality of holes <NUM> are formed by the belt segment <NUM> at the first end <NUM> to at least maintain the belt segment <NUM> in position with the elongate strap <NUM>, if and when the belt segment <NUM> is molded over the elongate strap <NUM>. The first end <NUM> of the belt segment <NUM> is arranged to close tightly around the elongate strap <NUM> so the material forming the belt segment <NUM> does not flow out onto the elongate strap <NUM>.

In the embodiment of <FIG>, the belt segment <NUM> defines at least one elongate slot <NUM> defined between the first end <NUM> and the plurality of openings <NUM>, which facilitates bending of the belt segment <NUM> and improves breathability of the belt segment <NUM> against the user as the belt segment <NUM> may be formed from a polymeric material. The at least one elongate slot <NUM> may extend completely through the belt segment <NUM>, or may comprise a recessed portion extending from at least one of the sides of the belt segment <NUM>.

<FIG>, <FIG> show a bracket <NUM>, which serves as a bracket for mounting the aforementioned cable thereto. The bracket <NUM> includes at least one fastener <NUM>, preferably but not limited to first and second fasteners 156A, 156B, defined by an extension portion <NUM> generally having a length corresponding to a thickness of the belt segment <NUM>, and a flange portion <NUM> extending from the extension portion <NUM> for securing against a surface of the belt segment <NUM>. The mounting bracket <NUM> defines an opening <NUM> at a first end thereof adapted for grasping with a finger for tensioning or pulling the strap <NUM>. The bracket <NUM> defines a transition portion <NUM> located between the fastener <NUM> and the opening <NUM> such that the transition portion <NUM> is defined as a tapering between a flattened head portion carrying the fastener <NUM> and the cable channel <NUM> and the first end of the mounting bracket <NUM>. The transition portion <NUM> enables the bracket <NUM> to be arranged at an end portion of the belt segment <NUM> and overlap its edge at the first end thereof.

<FIG> and <FIG> show an embodiment of the bracket <NUM> that defines a fastener <NUM> engageable to at least one opening among the plurality of openings <NUM>. This bracket <NUM>, which serves as an anchoring bracket to anchor the corresponding strap <NUM> to one of the first and second shells <NUM>, <NUM>, defines an anchoring pin <NUM> and an extension portion <NUM> extending from a generally flattened body <NUM> carrying a fastener <NUM>. The anchoring pin <NUM> is adapted to engage to a shell <NUM>, <NUM> by one of the aforementioned keyholes.

<FIG> exemplify variations of the first and second straps <NUM>, <NUM> of <FIG>, with first and second straps <NUM>, <NUM>. The first and second straps <NUM>, <NUM> each include a belt segment <NUM> having an attachment portion <NUM> that is removably attached to a surface <NUM> of a strap <NUM>. The attachment portion <NUM> has first and second flaps <NUM>, <NUM> that bear hook material engageable to hook receivable material of a first end <NUM> along the surface <NUM> of the strap <NUM>. Alternatively, the flaps <NUM>, <NUM> may have other suitable fastener elements or means to engage with the strap <NUM>. Mounting brackets <NUM>, <NUM> may be permanently secured to a second end of the strap <NUM>, similar to the embodiments of <FIG>.

A first end <NUM> of the belt segment <NUM> defines at least one opening <NUM> defined similarly to openings <NUM> in <FIG>. For example, the first end <NUM> of the belt segment <NUM> may receive a bracket <NUM>, as in <FIG>, or may receive a mounting bracket (not shown attached), as in the embodiment of <FIG>.

<FIG> exemplifies how the strap <NUM> may be removable from the belt segment <NUM>. The clinician can reduce the length of the strap <NUM> in a simplified manner by cutting a segment <NUM> of the strap <NUM> from the first end <NUM>. Because the attachment portion <NUM> is removable from the strap <NUM>, the clinician may be able to permanently shorten the length of the strap <NUM>. While <FIG> exemplify the brackets <NUM>, <NUM> as being permanently secured to the strap <NUM>, belt segments <NUM> may likewise be attached to the second end <NUM> of the strap <NUM>, thereby enabling a selection of different mounting brackets to be secured to either the first and second ends of the strap <NUM> by the belt segments <NUM>.

<FIG> shows an exemplary belt segment <NUM>, having the cooperating flaps <NUM>, <NUM> with the hooks of each facing the opposing flap so as to form an "alligator" or clamp onto the hook receivable or loop surface of the strap (on both sides). The flaps <NUM>, <NUM> are preferably permanently secured to the attachment portion <NUM> in that they are not removable without destroying or damaging the attachment portion <NUM>. A transition portion <NUM> from the attachment portion <NUM> tapers to a main section <NUM> of the belt segment <NUM>, preferably on an outer side of the belt segment <NUM>, in part to increase flexibility of the belt segment <NUM> and to account for the securement of the flaps <NUM>, <NUM> to the attachment portion <NUM>. The first end <NUM> of the belt segment <NUM> preferably defines a thickened end <NUM> so as to provide reinforcement to the openings <NUM>, as shown in <FIG>.

Referring specifically to <FIG>, the belt segment <NUM> defines a plurality of lateral recesses <NUM> defined between the plurality of openings <NUM> for receiving the at least one fastener <NUM>, and are located in opposed pairs along inner and outer surfaces of the belt segment <NUM> to facilitate bending of the belt segment <NUM>.

The belt segment <NUM> defines a plurality of openings <NUM>, whereby each of the openings preferably forms a keyhole shape <NUM> for receiving a fastener or anchoring bracket <NUM> of the mounting bracket <NUM>. The keyhole shape <NUM> forms an insertion portion <NUM> and a locking portion <NUM> located in a direction of a second of the belt segment <NUM> opposite of the elongate strap <NUM>. A seat portion <NUM> is defined about the locking portion <NUM>, and is formed by a recess sized and configured for receiving the flange portion <NUM> of the mounting bracket <NUM>.

The belt segment <NUM> may be molded over a reinforcing substrate (not shown) with a greater toughness than the belt segment <NUM>, or alternatively the seat portions <NUM> may comprise individual inserts <NUM> over which the belt segment is molded. The inserts <NUM> may have a toughness greater than the belt segment <NUM>. <FIG> show how each of the inserts <NUM> preferably have a profile <NUM> having an outer periphery fully encased or over-molded by the material of the belt segment <NUM>, with an inner periphery of the inserts <NUM> generally forming the border of the insertion portion <NUM>. The inserts <NUM> may also be located within or between the lateral recesses <NUM> so as not to compromise bending and the overall flexibility of the belt segment <NUM>. The inserts <NUM> may have a color contrast with the belt segment <NUM>, thereby adding visual identification as to where the fasteners <NUM> may secure.

<FIG> depicts a variation of the anchoring bracket <NUM>, and is shown by example in <FIG> as being secured to a second end of the strap section <NUM>. The anchoring bracket <NUM> defines an attachment portion <NUM> into which the strap section <NUM> extends and secures. The anchoring bracket <NUM> has a fastener pin or hook <NUM> extending therefrom generally perpendicularly to the attachment portion <NUM>.

<FIG> depicts a variation of the mounting bracket <NUM> without the at least one fastener. Both the mounting bracket <NUM> and the anchoring bracket <NUM> define a low profile and minimize protruding from the first and second shells. In any of the embodiments of the brackets described herein, the brackets may be modified to include any of the features described herein.

<FIG> depict an embodiment of the third strap <NUM> in connection with <FIG>. Specifically, the third strap <NUM> comprises a first strap segment <NUM> having first and second ends <NUM>, <NUM>, a second strap segment <NUM> having first and second ends <NUM>, <NUM>, a buckle <NUM> secured the first end <NUM> of the second strap segment <NUM>. The buckle <NUM> carries a pin <NUM>, and a band <NUM> secured to the second end <NUM> of the first strap segment <NUM>. The second end <NUM> of the second strap segment <NUM>, the band <NUM> forms apertures <NUM> arranged for securely and removably receiving the pin <NUM>. The buckle <NUM> includes a head <NUM> extending beyond the first end <NUM> of the second strap segment <NUM>, and the head <NUM> carries the pin <NUM>. The second strap segment <NUM> forms a loop <NUM> between the first and second ends <NUM>, <NUM>, and is particularly adapted to extend about the bar <NUM> formed by the second shell <NUM>. An anchoring bracket <NUM>, which may be similar to the anchoring bracket <NUM>, may be secured to the first strap end <NUM> in a manner similar to the embodiment of <FIG>.

The first and second strap segments <NUM>, <NUM> are preferably formed from a textile such as having a construction comprising a loop laminate with a nylon webbing in the center core, similar to the elongate strap <NUM>. The band <NUM> is preferably formed by a polymeric material but likely non-stretchable although flexible to bending. The buckle <NUM> may be formed similarly to the band <NUM>. The pin <NUM> is preferably a rigid plastic material arranged for repeated securement or removal.

<FIG> illustrates how the third strap <NUM> extends over the second shell <NUM>. The third strap <NUM> loops or extends about the bar <NUM>. The third strap <NUM> is intended to extend over the calf antimigration portion <NUM> in order for the second shell <NUM> to provide additional reinforcement at such location when extending over the leg of the user. The anchoring bracket <NUM> will secure to the second keyhole <NUM>, shown in <FIG>, such that the third strap <NUM> is tensioned between the second keyhole <NUM> and the bar <NUM> when the buckle <NUM> secures to the band <NUM> by the pin <NUM> engaging the band <NUM> at one of the apertures <NUM>. <FIG> exemplifies how the buckle <NUM> and the band <NUM> may include attachment portions <NUM>, <NUM> that enable the buckle <NUM> and the band <NUM> to be molded and interlock to the first and second strap segments <NUM>, <NUM>.

<FIG> exemplify a strap assembly embodiment <NUM> including a tightening mechanism <NUM> for adjusting at least one strap segment <NUM>, <NUM> relative thereto. First and second molded segments <NUM>, <NUM> connect the tightening mechanism <NUM> to first and second strap segments <NUM>, <NUM>. The molded segments <NUM>, <NUM> may be elastic or inelastic, however they are preferably formed from a polymeric material. The molded segments <NUM>, <NUM> have attachment portions <NUM>, <NUM> that are molded over and integrally secured to the strap segments <NUM>, <NUM> such that molded segments <NUM>, <NUM> may be molded over the strap segments <NUM>, <NUM>. The attachment portions <NUM>, <NUM>, as in preceding embodiments, preferably secure above the strap segments <NUM>, <NUM>, which may be formed from a textile in that the material of the attachment portions <NUM>, <NUM> mixes or spreads to interlock with fibers of the textile of the strap segments <NUM>, <NUM>.

The tightening mechanism <NUM> includes a base <NUM> upon which a dial <NUM> of the tightening mechanism <NUM> rotates to wind or unwind a cable <NUM> engaging the first molded segment <NUM>. A sleeve <NUM> shrouds or encloses at least part of the molded segment <NUM>, in that the first molded segment <NUM> carries a marker or indicia <NUM> that is present within a window <NUM> of the sleeve <NUM> to enable an understanding of tightening of the strap assembly <NUM>. A part of the first molded segment <NUM> extends and slides over a portion <NUM> of the base <NUM>, and the base <NUM> may be similarly flexible as the molded segments <NUM>, <NUM> to enable the strap assembly <NUM> to yield to a shape of a user's body.

The cable <NUM> extends through grooves <NUM> defined by protrusions <NUM> formed by the first molded segment <NUM> such that when the sleeve <NUM> extends over the first molded segment <NUM>, a loop of the cable <NUM> extends above the protrusions <NUM> and securely holds the first molded segment <NUM> relative to the tightening mechanism <NUM>. The base <NUM> forms guides <NUM> that likewise direct the cable <NUM> for winding and unwinding by the tightening mechanism <NUM>, and therefore moving the first molded segment <NUM> and the accompanying first strap segment <NUM> relative to the tightening mechanism <NUM>. The base <NUM> may be integrally secured to the second molded segment <NUM> by interlocking holes <NUM> formed by the base <NUM>, and through which material of the second molded segment <NUM> may extend. The molded segment <NUM> may be adhered to the base <NUM>.

The reinforcement edging and elements may be a film that is laminated over the sleeve <NUM> or pocket material, or other suitable materials may be employed. Suitable padding may be incorporated into the sleeve, although not shown in the drawings. Along an inside portion of the pockets or along the sleeve material, either the exterior surface or interior surface, pads may be provided that particularly correspond to the shape of the shells. In another variation, the pocket material may be formed by spacer material that has compressive and padding properties, and may be along one side of the pocket or both sides of the pocket so the shells are enclosed by the spacer material to provide padding to the user. The spacer material may have less stretchability and elasticity of the sleeve material to provide reinforcement to the area of the sleeve <NUM> at which the shells are located.

Claim 1:
A strap system having an adjustable length, the strap system comprising:
a strap (<NUM>) having a first, predetermined length, and defining first and second ends (<NUM>, <NUM>), the strap (<NUM>) comprising hook-receivable material;
a length adjustment system (<NUM>) connected to the first end (<NUM>) of the strap (<NUM>), the length adjustment system including a belt segment (<NUM>) having a first end removably secured to the first end (<NUM>) of the strap, the belt segment defining at least one opening (<NUM>) at a second end thereof, the belt segment (<NUM>) formed from a stretchable plastic material; and
a first bracket (<NUM>) selectively engageable with the at least one opening (<NUM>) of the belt segment (<NUM>); characterised in that
the first end of the belt segment (<NUM>) is arranged to clamp the strap (<NUM>) and the length adjustment system (<NUM>) includes first and second flaps (<NUM>, <NUM>) arranged to engage a surface of the strap (<NUM>) and permanently secured to the belt segment (<NUM>), the belt segment (<NUM>) forms an overmold connection with the flaps (<NUM>, <NUM>) such that the flaps have a portion extending from the belt segment (<NUM>) and include fastener means arranged to engage the hook-receivable material of the strap (<NUM>).