The present invention relates generally to the field of orthopedic supports and braces, and more particularly to a knee brace with improvements in more intuitive donning, doffing and comfort.
Certain specialized orthopedic knee braces and supports are used to address osteoarthritis (OA). This is typically achieved by employing a plurality of rigid support members positioned adjacent to the body on either side of the skeletal joint being stabilized. The manner of fixation and articulation of the brace creates corrective forces that relieve condyle knee pain. Orthopedic braces are medical devices where design focus is mainly on function. While they can be effective, they are often bulky and heavy with excessive rigid framework. They typically employ a multitude of straps that require continuous lacing and unlacing each time, making it tedious to don and doff. Their overall size and coverage area over the limb can trap heat generated by activities of daily living making the brace uncomfortable to wear. These factors decrease patient compliance even against the benefits of pain relief and mobility.
As will be disclosed below, the present invention addresses all of these issues. The device is designed to be light by reducing the size of the framework. It uses a single sided framework made of light but strong metal components. The frame is integrated with plastic cuffs that are designed for toughness and a balance of flexibility and rigidity where necessary. The cuffs have significant openings to allow air flow.
The use of a multitude of straps is most effective in stabilization of the knee and migration of the brace. The straps are engineered with quick release attachments. This eliminates the need for threading the straps each time it is used. Additionally, it allows for the strap lengths to be preset, minimizing the need to adjust the straps.
Unloading is achieved by independently articulating the frame section directly adjacent to the knee joint. The present invention includes means to easily adjust the amount of unloading while providing minimal intrusion into site of the knee infirmity.
In one aspect, the present invention is embodied as an orthopedic device, including an articulating frame; and, a plurality of straps attachable to the articulating frame. The articulating frame includes a thigh portion, a calf portion, and a center hinge. The thigh portion includes a semi-flexible curved thigh cuff having an upper end configured to wrap anterior to the leg and a lower end. The calf portion includes a semi-flexible curved calf cuff having a lower end configured to wrap posterior to the leg and an upper end. The center hinge assembly connects the thigh portion and the calf portion. The center hinge assembly includes a center hinge element, a first Q-angle adjuster, and a second Q-angle adjuster. The first Q-angle adjuster is positioned between the center hinge element and the thigh portion and is configured to adjust a Q-angle of the thigh portion of the articulating frame. The second Q-angle adjuster is positioned between the center hinge element and the calf portion and is configured to adjust a Q-angle of the calf portion of the articulating frame.
Each Q-angle adjuster is configured to adjust the varus valgus corrective angle (i.e. Q-angle) of the articulating frame.
In a preferred embodiment, the thigh portion includes an upright thigh bar having an upright thigh bar first end and an upright thigh bar second end. The upright thigh bar first end is connected to the center hinge assembly. The upright thigh bar second end fits into a thigh pocket formed in the thigh cuff. The calf portion includes an upright calf bar having an upright calf bar first end and an upright calf bar second end. The upright calf bar first end is connected to the center hinge assembly. The upright calf bar second end fits into a calf pocket formed in the calf cuff.
While other soft braces with rigid internal components do exist, few if any, utilize a rigid upright (i.e. articulating frame) with the ability to adjust the that can significantly affect the 3-point pressure system that unloads the affected osteoarthritic compartment.
In one preferred embodiment the straps for both the thighs and calves preferably utilize pushbutton clips and receptacles that provide easy fastening. In another preferred embodiment double location latches, with levers having easy to engage loop ends provide this easy fastening.
In one aspect, the invention is a supplemental orthopedic support wrap used in conjunction with an orthopedic device (i.e. brace). The support wrap includes a substrate, at least one relocatable stay and a support wrap tab. The substrate includes an elastic layer, a loop material layer bonded to one side of the elastic layer, and a target area located on the loop material layer for defining a placement position for a thigh portion of an articulating frame of an orthopedic brace. At least one relocatable stay includes one side having hook material for engagement with the loop material layer. The at least one relocatable stay includes at least one strap engagement loop for engaging a thigh strap of the orthopedic brace.
In another aspect, the present invention is embodied as a tibia cuff extension used in conjunction with an orthopedic brace. The tibia cuff extension includes a tibia cuff liner, a thermoformable shell, and a fastening strip. The tibia cuff lines includes an attachment portion attachable to the inside of a calf cuff of an orthopedic brace, an upper calf strap portion extending from the attachment portion, and a lower calf strap portion extending from the attachment portion. The thermoformable shell is attached to the attachment portion and to the lower calf strap portion. The fastening strip is secured to the thermoformable shell. During use, a user attaches the tibia cuff extension to the inside of the calf cuff, applies heat to the thermoformable shell, and presses the lower calf strap portion against the tibia forming it over the tibia crest to enhance rotational control of the orthopedic brace
In another aspect, the present invention is embodied as a method for donning an orthopedic device. The method of donning the orthopedic device includes first providing the orthopedic device discussed above. The orthopedic device is pressed against the leg of the user. The first Q-angle adjuster and the second Q-angle adjuster are adjusted to fit a contour of the leg. The straps are wrapped around the leg, free ends of the straps are attached to the articulating frame, and the tension of the straps are adjusted as desired.
The same elements or parts throughout the figures of the drawings are designated by the same reference characters, while equivalent elements bear a prime designation.
Referring now to the drawings and the characters of reference marked thereon,
The articulating frame 14 includes a thigh portion 24, a calf portion 26, and a center hinge assembly 28. The thigh portion 24 includes a semi-flexible curved thigh cuff 30 having an upper end 32 configured to wrap anterior to the leg 12 and a lower end 40. The calf portion 26 includes a semi-flexible curved calf cuff 34 having a lower end 36 configured to wrap posterior to the leg 12 and an upper end 38. 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 an 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 semi-flexible curved thigh cuff 30 preferably includes a flexible strap anchor 31 at said upper end thereof which provides improved conformability to the leg.
The center hinge assembly 28 connects the thigh portion 24 and the calf portion 26. The center hinge assembly 28 includes a center hinge element 42, a first Q-angle adjuster 44, and a second Q-angle adjuster 46. The first Q-angle adjuster 44 is positioned between the center hinge element 42 and the thigh portion 24 and is configured to adjust the Q-angle of the thigh portion 24 of the articulating frame 14. The second Q-angle adjuster 46 is positioned between the center hinge element 42 and said calf portion 26 and is configured to adjust the Q-angle of the calf portion 26 of the articulating frame 14. The Q-angle adjusters 44, 46 are configured to adjust the Q-angle of the articulating frame 14 in the coronal (i.e. frontal) plane. The Q-angle adjusters 44, 46 apply an unload force in the transverse (i.e. horizontal) plane. They can be adjusted in towards the knee or out away from the knee to provide either a push or pull unloading force, respectively. The center hinge assembly 28 includes an insert at each side for limiting flexion and extension. The center hinge assembly 28 shown is a polycentric hinge; however, a monocentric hinge can be substituted.
The thigh portion 24 includes an upright thigh bar 48 having an upright thigh bar first end 50 and an upright thigh bar second end 52. The upright thigh bar first end 50 is connected to the center hinge assembly 28. The upright thigh bar second end 52 fits into a thigh pocket 54 formed in the thigh cuff 30. The calf portion 26 includes an upright calf bar 56 having an upright calf bar first end 58 and an upright calf bar second end 60. The upright calf bar first end 58 is connected to the center hinge assembly 28. The upright calf bar second end 60 fits into a calf pocket 62 formed in the calf cuff 34. The upright thigh bar second end 52 and the upright calf bar second end 60 are stepped to provide a low profile integration of frame to cuff.
The upper end 32 of the semi-flexible curved thigh cuff 30 includes an upper thigh slot 64 and an upper thigh attachment element 66. The lower end 40 of the semi-flexible curved thigh cuff 30 includes a lower thigh slot 68 and a lower thigh attachment element 70. The upper end 38 of the semi-flexible curved calf cuff 34 includes an upper calf slot 72 and an upper calf attachment element 74. The lower end 36 of the semi-flexible curved calf cuff 34 includes a lower calf slot 76 and a lower calf attachment element 78.
The first thigh strap 16 includes a first thigh strap anchor end 80 securely attachable to the upper thigh slot 64. A first thigh strap adjustment end 82 is securely attachable to the upper thigh attachment element 66. The second thigh strap 18 includes a second thigh strap anchor end 84 securely attachable to the lower thigh slot 68. A second thigh strap adjustment end 86 is securely attachable to the lower thigh attachment element 70. The first calf strap 20 includes a first calf strap anchor end 88 securely attachable to the upper calf slot 72. A first calf strap adjustment end 90 is securely attachable to the upper calf attachment element 74. The second calf strap 22 includes a second calf strap anchor end 92 securely attachable to the lower calf slot 76. A second calf strap adjustment end 94 is securely attachable to the lower calf attachment element 78.
In this embodiment the attachment elements 66, 70, 74, 78 are latch mechanisms, discussed below in detail.
The upper calf slot 72 is angled to follow the curvature of a user's upper calf to minimize migration of the orthopedic device.
Referring now to
The latch mechanism 66 includes a lever assembly 96, a draw bar 98, and, a chafe 100.
Each lever assembly 96 includes a lever 102 having a looped first end 103, a lever axle 104 depending from the lever 102 at a second end thereof, for securing the lever 102 to a support structure (e.g. upper end of thigh cuff 30) of the orthopedic device 10; and, a snap fit hook 110 projecting from the lever 102.
The draw bar 98 is pivotably attached to the lever 102. The chafe 100 is attached to the draw bar 98. A catch 106 extends from the support structure (i.e. upper end of thigh cuff 30) to receive the lever axle 104. A snap fit ledge 108 depends from the support structure 30 to engage and hold the snap fit hook 110. The catch 106 is configured to stand substantially above a nominal height of the support structure 30 such that the lever axle 104 is easily received by the catch 106 for fastening by the user. The nominal height is the height of the outside surface of support structure 30 at the region where the catch 106 extends from the support structure 30. Thus, the term “substantially above” refers to a height above the diameter/thickness of the lever axle 104. The chafe 100 is preferably a D-ring chafe.
A press location 112 is located on the lever 102 adjacent to looped first end 103.
To close the latch mechanism 66 the user engages the lever axle 104 against the catch 106, pushes down on the looped first end 103, presses at the press location 112, pushes down until the snap fit hook 110 engages the snap fit ledge 108, and pushes the draw bar 98 down.
To open the latch mechanism 66 the user pulls the looped first end 103 to disengage the snap fit hook 110 from the snap fit ledge 108. As can be seen in
Thus, separate locations are utilized for engagement and release of lever. This embodiment utilizes separate locations for engagement and release of lever 102. It provides mechanical advantage for snap fit hook 110 engagement. The press location 112 is at the approximate midline of lever 102. This ensures the snap fit hook 110 is engaged with a light tactile force. The location 112 is configured for intuitive use by its distinctive geometry differentiation from the surrounding area. The lever release, i.e. looped first end 103, is at an alternate location and is at the end of the lever 102. This looped first end 103 tab-like geometry is configured to flex and allow convenient access thereunder. This ensures the snap fit hook 110 is disengaged when intended. The flexion characteristic of the looped first end (i.e. end tab) 103 minimized undesired hook 110 engagement and encourages the user to the press location 112 to engage the lever 102.
Referring now to
Each of the straps 16, 18, 20, 22 has a pushbutton clip at a free end, i.e. strap clip engagement end 116 thereof. A strap pushbutton clip 118 includes a D-ring section. The strap pushbutton clip 118 provides means for quick attachment or release of the thigh strap 18 from the articulating frame 14 for donning and doffing.
Referring now to
Referring now to
Referring now to
The support wrap 150 includes at least one relocatable stay 160 with one side having hook material for engagement with the loop material layer 156. The relocatable stays 160 include at least one strap engagement loops 162 for engaging a thigh strap of the orthopedic brace. In the embodiment shown two strap engagement loop 162 are shown, one for each thigh strap. A support wrap tab 164 is secured to one end of the substrate 152, having hook material on one side thereof for engagement with the loop material layer 156. A finger opening 166 provides ease of applying the support wrap 150.
During use, the support wrap 150 is positioned between the user's thigh and the orthopedic brace 10 to contain excessive soft tissue during application of the orthopedic brace 10 minimizing skin impingement.
This support wrap 150 can be used with various types of orthopedic braces, for example, as described in U.S. Pat. No. 10,369,037.
Referring now to
A thermoformable shell 176 is attached to the attachment portion and to the lower calf strap portion 174. A fastening strip 178 is secured to the thermoformable shell 176.
During use the user attaches the tibia cuff extension 168 to the inside of the calf cuff 34, applies heat to the thermoformable shell 176, and presses the lower calf strap portion 174 against the tibia forming it over the tibia crest to enhance rotational control of the orthopedic brace 10. Application of heat to the thermoformable shell 176 can be provided by an adhesive exothermic heat pack or a heat gun while the lower part of the liner 169 remains in place. The lower part of the liner 169 protects the patient from the heated thermoformable shell 176 while being formed to the patient's tibia.
The tibia cuff extension 168 preferably includes lower strap control tabs 180 for maintaining the location of the straps. Additionally, the tibia cuff extension 168 preferably includes a movable upper tibia cuff strap control tab 182 for maintaining the position of the upper calf strap. The movable upper tibia cuff strap control tab 182 can be positioned to avoid the tibia crest on legs of different circumferences.
This tibia cuff extension 168 can be used with various types of orthopedic braces, for example, as described in U.S. Pat. No. 10,369,037.
During donning the user, in an initial fitting, presses the orthopedic device against his leg. The Q-angle adjusters are adjusted to fit the contour of his leg. The straps are wrapped around the leg, attaching free ends of the straps to the articulating frame, and adjusting the tension of the straps as desired. After this initial fitting the Q-angle adjusters can be adjusted accordingly to achieve pain relief.
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.
This patent application claims the benefit of U.S. Provisional Application No. 62/943,997 filed Dec. 5, 2019. The entire content of application Ser. No. 62/943,997 is incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/063432 | 12/4/2020 | WO |
Number | Date | Country | |
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62943997 | Dec 2019 | US |