Patent ID: 12186222

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings and the characters of reference marked thereon,FIGS.1-4illustrate a preferred embodiment of the orthopedic device of the present invention, designated generally as10, shown positioned on the leg of the user, shown in phantom lines12. The orthopedic device10includes a wrap, designated generally as14, an articulating frame designated generally as16(in phantom), a strap designated generally as18, and a clip designated generally as20.

As can be best seen inFIG.4, the wrap14includes multiple panels designed to contour to the leg and means to secure to itself creating a sleeve structure. The wrap14includes a main panel, designated generally as22. The main panel includes two layers, an inner layer and a thicker outer layer. The main panel is sewn along three sides, creating a pocket for the articulating frame16. The open end can be sealed with a strip of loop engageable hook along seam26. A posterior panel24is secured to a first end of the main panel22by a posterior seam (i.e. stich)26. The posterior panel24includes three pieces28,30,32for shaping the device to the user's anatomy. A front thigh closure34is connected to a second end of the main panel (by an anterior seam36). The front thigh closure34includes a thigh loop surface. A front calf closure38is connected to the second end of the main panel (by the anterior seam36). The front calf closure38includes a calf loop surface. A thigh fastening tab40extends from the posterior panel24which includes a thigh hook material. A calf fastening tab42extends from the posterior panel24which includes a calf hook material.

Functionally, the strap18can be defined in terms of segments and sub-segments. As can best be seen inFIGS.4and4A, the strap18includes a calf end segment44. The calf end segment44is securely attachable to a calf portion46of the articulating frame16. (The calf portion46of the articulating frame16can best seen inFIGS.4and5.) A suspension segment48is adjacent to the calf end segment44. A thigh end segment50is securely attachable to a thigh portion52(best seen inFIGS.5and6) of the articulating frame16. A spiraling segment54is adjacent to the thigh end segment50. An intermediate segment56is between the suspension segment48and the spiraling segment54.

The calf portion46of the articulating frame16includes a calf D-ring62configured to adjustably engage the calf hook sub-segment58and the calf loop sub-segment60. Similarly, the thigh end segment50comprises a thigh hook sub-segment64adjacent a thigh loop sub-segment66. The thigh portion52of the articulating frame16includes a thigh D-ring68configured to adjustably engage the thigh hook sub-segment64and the thigh loop sub-segment66.

As will be further described below, during use the suspension segment48lays across the top part of the calf muscle to provide vertical support to minimize migration of the orthopedic device10. The intermediate segment56facilitates movement of the strap18through a D-ring portion72of a clip20to provide adjustment of the spiraling segment54and the suspension segment48.

As best seen inFIGS.4A and7, the strap18includes a strap stopper65sewn onto the strap18at one end of the suspension segment48and adjacent to the calf hook sub-segment58. The strap stopper65comprises raised material. Another stopping portion67at the thigh end segment50comprises build up material to encourage strap retention.

The hook and loop type fasteners may be of the type trademarked as VELCRO® or similar hook and loop fasteners manufactured by Paiho North America. In a preferred embodiment, the strap18has one continuous substrate77of webbing material other than the two hook sub-segments58,64. The two loop sub-segments60,66are comprised of loop strips (patches) sewn onto the continuous substrate of webbing material. The intermediate segment56is formed of the bare substrate of webbing material which provides easy sliding. This webbing material is preferably nylon. The thigh hook sub-segment64may be formed of a laminate of molded vinyl and hook material. The calf hook sub-segment60may be formed of a laminate of molded nylon hook material over loop material.

In the embodiment shown the thigh loop sub-segment66comprises a substantial portion of the spiraling segment54. Also, the calf loop sub-segment60comprises a substantial portion of the suspension segment48. However, it is understood that these sub-segments60,66may have different lengths as long as they are sufficiently long to engage their respective hook sub-segments.

The clip20includes the D-ring portion72for engaging the intermediate segment56. The clip20is engageable with a clip receptacle74positioned on the calf portion46of the articulating frame16. In a preferred embodiment and as shown the D-ring portion72has a rectangular opening74that minimizes bunching and provides lubricious movement of the strap.

Referring now toFIGS.5-6, the articulating frame16includes a thigh portion52, a calf portion46and a center hinge76. The thigh portion52includes a semi-flexible curved thigh cuff78with a first thigh side80and a second thigh side82. The first thigh side80and the second thigh side82are symmetrical about a central axis and are configured to wrap partially anteriorly and partially posteriorly to the leg. Similarly, the calf portion46includes a semi-flexible curved calf cuff84with a first calf side86and a second calf side88. The first calf side86and the second calf side88are symmetrical about a central axis configured to wrap partially anteriorly and partially posteriorly to the leg. The center hinge76connects the thigh portion52and the calf portion46.

The semi-flexible curved thigh cuff78has a teardrop shape. The semi-flexible curved calf cuff84has an upside-down teardrop shape. Such a teardrop shape is defined by a series of positive curves from a wide end inflecting to a negative curve approaching a narrow end. As can be seen in this figure, to further enhance flexibility of the cuff, the thicknesses of the cuffs around the perimeter have been thinned out. This helps the cuffs conform to the leg and minimizes the cuff edges from “digging” into the user. The term “semi-flexible” as used herein relative to each cuff refers to the ability of each cuff to conform to the curvature profile of the user's leg. Each cuff is preferably formed of a polyester elastomer plastic approximately 3 mm thick. An example material that can be used is sold by Dupont under the trademark Hytrel® 7246 which is a high modulus grade with nominal hardness of 72D.

The thigh D-ring68is rotatably connected to the thigh cuff78by, for example, a rivet79. Similarly, the calf D-ring62is rotatably connected to the calf cuff84by, for example, a rivet81. A calf receptacle74is rotatably connected to the calf cuff84by, for example, a rivet83. Other suitable rotatable fastening means could be utilized other than the rivets discussed about for these items.

The thigh portion52includes an upright thigh bar90having an upright thigh bar first end92and an upright thigh bar second end94. The upright thigh bar first end92is connected to the center hinge76. The semi-flexible curved thigh cuff78includes a thigh cuff pocket96for securing the upright thigh bar second end94therewithin.

The calf portion46includes an upright calf bar98having an upright calf bar first end100and an upright calf bar second end102. The upright calf bar first end100is connected to the center hinge76. The semi-flexible curved calf cuff84includes a calf cuff pocket104for securing the upright calf bar second end102therewithin. The pockets96,104provide the capability of the upright thigh bar90and the upright calf bar92to be secured using only one rivet apiece.

As noted above, the center hinge76is configured to connect the upright thigh bar90and the upright calf bar98. The collective nature of this metal portion of the articulating frame16provides spring properties that apply an unloading pull-force in the transverse plane. This cooperates with the helical nature of the strap to provide annular compression to the leg and subsequent knee stability during the leg extension phase of the gait. The center hinge76includes inserts106at each side for limiting flexion and extension. The center hinge76shown is a polycentric hinge; however, a monocentric hinge can be substituted.

The components of the articulating frame16are designed to create left and right leg configurations. This is a result of symmetry of the cuffs78and84designed to receive either the upright thigh bar90and/or the upright calf bar92.

Referring now toFIG.7, the strap18is shown being anchored at the calf portion46of the frame16via the calf D-ring62. The calf end segment44includes the calf hook sub-segment58spaced from a calf loop sub-segment60. Substrate webbing77includes a substrate sub-segment43located between the calf hook sub-segment58and the calf loop sub-segment60. The strap stopper65is located on the webbing sub-segment43.

Referring now toFIG.8, the strap18is shown being anchored at the thigh portion52of the frame16via the calf D-ring68. The thigh end segment50includes the thigh hook sub-segment64spaced from a thigh loop sub-segment66. Substrate webbing77includes a substrate sub-segment75located between the thigh hook sub-segment64and the thigh loop sub-segment66.

Referring now toFIGS.9A-9D, the pushbutton clip20and pushbutton receptacle74provide quick attachment or release of the strap18from the articulating frame16for donning and doffing. The pushbutton assembly is illustrated, which collectively includes the receiver component (i.e. receptacle74) that gets riveted to the calf cuff84and a pushbutton clip20(i.e. chafe) that attaches to the strap18. The receptacle57has a hole108for the rivet to attach it to the brace (the articulating frame16) which it can rotate on, a thin area of plastic110between the rivet area and a push button area112that allows the receiver to flex in order to match the circumference of the anatomy. The area around the rivet hole includes a boss (raised rim)111for clearance. The push button area112has a slot114for the pushbutton clip to slide into, a hole116for a button118to snap into and retain the chafe20plus a dished-out area120that allows the finger to easily navigate to the button that also helps prevent accidental pressing of the button. The bottom side of the slot has a ribbed exterior section122to keep the bottom from flexing too much that the button cannot accidently disengage. The pushbutton clip has a slot124(in the D-ring portion72) for the strap to attach through, a thin area of plastic126between the slot124and the button118that allows the pushbutton clip to flex in order to match the circumference of the anatomy. The button118has a round shape that allows the pushbutton clip to rotate so that the strap can follow the shape of the anatomy. The concave button118in the middle of this round shape has a dished out area128that helps prevent accidental pressings which is also more intimate with the shape of the finger that allows for easier pressing. There is a dome130in the middle of this dish and a concentric ridge132on the exit side that helps the finger get a good grip to activate the button. This button has a flexible hinge area134that allows the button118to flex out of the way of the receiver hole's wall136for removal. The receiver hole's wall136has a lead-in chamfer138on the upper outside edge created by the slot opening114. The chamfer138assists an entry side140of the button118through slot114. It also has two stops142that allows the button to not get flexed up into the receiver's hole136too far so that the flexible hinge134does not get sprung. The height of the button118is lower on the entry side140so that it is easy to insert but is higher on an exit side144for retention. This graded height also flexes the receiver's top section with the hole136to slightly flex out of the way for insertion. The entry side140is still high enough that the button118doesn't accidently disengage itself when the pushbutton clip is rotated while in the receiver. The exit side144is high enough for retention, but still can slide through the slot opening114of the receiver when being activated. The location of the hinge134and stops142along with the exit side of the button144allows the button to flex up to remain intimate with the receiver's hole136wall when being flexed around the anatomy and when stronger forces are being applied from the strap so that the pushbutton clip does not get pulled out of the receiver (receptacle).

Referring now toFIG.10, during donning the user, with one hand, engages the thigh fastening tab40at the front thigh closure34. The two are pressed together.

Similarly, as shown inFIG.11, the calf fastening tab42, and the front calf closure38are engaged by the user at the calf. The two are pressed together.

Referring now toFIGS.12-14, the strap18wraps over and across the front of the leg. The strap18continues posteriorly and across the upper portion of the calf. The push button clip20at the intermediate segment56of the strap18engages the push button receptacle74.

Referring now toFIGS.15, The tension of the strap18can be adjusted by the thigh hook sub-segment64that provides adjustment to the strap length, as discussed above.

Thus, the spiraling segment54provides a helical annular force that is applied around the wrap, which provides additional compression and stabilization during leg extension in the load bearing phase of the gait. The routing nature of this single strap also affords an anti-migration quality during use. The suspension segment48lays across the top part of the calf muscle preventing vertical downward migration. As discussed above, the metal uprights and other configurations within the articulating frame benefits the user by providing proportional spring-back during the gait phase.

An eloquence of this orthopedic device is that the strap automatically spirals around the leg when the user holds the clip, moves it around the leg, and engages the receptacle. Both the suspension segment and the spiral segment concurrently position themselves without any user intervention.

The strap18is preferably not intended to be removed from the brace10. However, if it is removed, certain color coding and instructions can be used to provide guidance to the user regarding reapplying the strap18to the brace10.

As can be seen inFIGS.16A-16E, the strap18can be easily applied to the brace by use of color coding. In one embodiment three colors—yellow, blue, and orange can be used. The steps can be as follows: Referring toFIG.16A, first, lay out the strap18flat with thigh hook sub-segment64(yellow arrow146) and calf hook sub-segment58(blue arrow148) hooks facing upwards. The color tags at both ends of the strap will be visible. This is useful for ensuring the proper installation of the strap.

Referring toFIG.16B, orient the clip20(orange dot150) with color tag visible. Slide the D-ring portion72of the clip20over the calf end segment44(i.e. the calf hook sub-segment58with blue arrow148). Button118of the clip is visible and facing the open end of the strap. Draw the clip20to the intermediate segment56of the strap.

Referring toFIG.16C, flip the strap18over. With calf hook sub-segment58(with blue arrow148) facing downward, feed the strap over and thru the top of the calf D-ring62(with a blue arrow152) until the strap stopper65passes thru the D-ring62. The arrow directions establish proper orientation. Secure the calf hook sub-segment58to the calf loop sub-segment60located on the underside of the strap.

Wrap the strap18across the front of the brace and continue around the back. Referring toFIG.16D, engage the clip20(with orange dot150) into the clip receptacle74(with an orange dot154).

Referring toFIG.16E, wrap the strap18around the back of the brace and continue around the front. Feed the thigh hook sub-segment64(with yellow arrow146) of the strap thru the underside of the thigh D-ring68(yellow). Secure the strap end to the thigh loop sub-segment66of the strap.

As mentioned above, other embodiments and configurations may be devised without departing from the spirit of the invention and the scope of the appended claims.