US20210169675A1

US20210169675A1 - Orthopedic device

Info

Publication number: US20210169675A1
Application number: US17/089,347
Authority: US
Inventors: David K. Combs; Kevin R. Lunau; Carl J. Macchia
Original assignee: Vision Quest Industries Inc
Current assignee: Vision Quest Industries Inc
Priority date: 2019-12-05
Filing date: 2020-11-04
Publication date: 2021-06-10
Also published as: US20230009015A1; EP4069162A1; CN115052561A; WO2021113727A1; EP4072478A1; CA3160704A1; US20230000657A1; WO2021113729A1; CA3160561A1; US12186222B2; CA3160687A1; WO2021113456A1; CN115052564A; EP4069162A4; CN115052562A; EP4072478A4

Abstract

An orthopedic device, includes a wrap; an articulating frame; and, a plurality of straps attached to the wrap. The articulating frame is housed within the wrap and includes a thigh portion, a calf portion, and a center hinge. The thigh portion includes a semi-flexible curved thigh cuff configured to wrap anterior to the leg. The calf portion includes a semi-flexible curved calf cuff configured to wrap posterior to the leg. The center hinge connects the thigh portion and the calf portion. The orthopedic device combines the attributes of the rigid style single upright brace with a soft wrap that enhances ease of use and compliance. The anterior curved thigh cuff and the posterior curved calf cuff provide enhanced stability as the wrap concomitantly provides comfort.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of U.S. Provisional Application. No. 62/943,997 filed Dec. 5, 2019. The entire content of Application. No. 62/943,997 is incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to the field of orthopedic supports and braces, and more particularly to a knee wrap brace with improvements in more intuitive donning, doffing and comfort.

2. Description of the Related Art

Osteoarthritis (OA) braces can be broadly separated into the general categories of being constructed of either entirely rigid frame components or that of soft fabric/neoprene style braces with some smaller rigid internal components. The soft type braces are thought to be easier to use and thus, are met with better patient compliance, while the rigid devices tend to be more effective at creating the corrective forces that relieve pain. The latter however tend to be harder to use and considered by patients to be bulky and perhaps less desirable than a sleeve type brace. As will be disclosed below the present invention combines the benefits of rigid frame type braces and soft type braces.
A patent disclosing a soft type brace is U.S. Pat. No. 10,052,221 entitled “Orthopedic Device for Treating Osteoarthritis of the Knee”.
Various types of OA braces are disclosed in U.S. Pat. No. 10,369,037 entitled “Orthotic Device with Snap Fit Cuff and Latch Mechanism”; U.S. application Ser. No. 16/154,164 entitled “Orthopedic Device for Unloading a Knee”; U.S. application Ser. No. 15/178,840 entitled “Knee Brace Apparatus and Method”; U.S. application Ser. No. 15/316,924 entitled “A One-Size Fits All Unloading and/or Stabilizing Knee Brace For Use From Either the Inside or the Outside of the Left or Right Knee”; U.S. Pat. No. 9,220,622 entitled “Orthopedic Device”; U.S. application Ser. No. 14/263,023 entitled “Knee Brace”; U.S. application Ser. No. 14/169,786 entitled “Orthopedic Device Having Detachable Components for Treatment Stages and Method for Using the Same”; U.S. application Ser. No. 12/728,336 entitled “Knee Brace and Method for Securing the Same”; U.S. Pat. No. 7,122,016 entitled “Knee Brace Immobilizer”; U.S. application Ser. No. 10/609,986 entitled “Knee Unloading Orthotic Device and Method”; U.S. Pat. No. 5,857,989 entitled Dynamic Orthopedic Knee Brace Assembly”; and, U.S. Pat. No. 4,726,362 entitled “Double Hinged Knee Brace with Double Leg Wrap.”

SUMMARY OF THE INVENTION

In one aspect, the present invention is embodied as an orthopedic device, including a wrap; an articulating frame; and, a plurality of straps attached to the wrap. The articulating frame is housed within the wrap and includes a thigh portion, a calf portion, and a center hinge. The thigh portion includes a semi-flexible curved thigh cuff configured to wrap anterior to the leg. The calf portion includes a semi-flexible curved calf cuff configured to wrap posterior to the leg. The center hinge connects the thigh portion and the calf portion. This orthopedic device combines the attributes of the rigid style single upright brace with a soft wrap that enhances ease of use and compliance. The anterior curved thigh cuff and the posterior curved calf cuff provide enhanced stability as the wrap concomitantly provides comfort.
The orthopedic device 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 hinge. The semi-flexible curved thigh cuff extends from the upright thigh bar second end. Similarly, an upright calf bar has 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. The semi-flexible curved calf cuff extends from the upright calf bar second end.
The center hinge includes a Q-angle adjuster configured to adjust the Q-angle of the articulating frame. 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 varus valgus corrective angle (i.e. Q-angle) that can significantly affect the 3-point pressure system that unloads the affected osteoarthritic compartment.
The straps for both the thighs and calves preferably utilize pushbutton clips and receptacles that provide easy fastening.
The orthopedic device preferably includes a popliteal elastic panel in the proximity of the center hinge to minimize bunching during flexion.
The wrap preferably includes a main panel that secures to itself to create a closed sleeve around the leg of a user. The main panel includes a large panel and a small panel. The small panel is secured adjacent to the large panel. The small panel includes an upper finger pocket at a thigh end thereof and a lower finger pocket at a calf end thereof.
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 including a wrap; an articulating frame; and, a plurality of straps attached to the wrap. The articulating frame is housed within the wrap and includes a thigh portion, a calf portion, and a center hinge. The thigh portion includes a semi-flexible curved thigh cuff configured to wrap anterior to the leg. The calf portion includes a semi-flexible curved calf cuff configured to wrap posterior to the leg. The center hinge connects the thigh portion and the calf portion.
In this method of donning the orthopedic device the wrap is placed around the leg of the user. A thigh strap is then wrapped initially posteriorly around the hamstring continuing anteriorly over the thigh, and then attached to a thigh strap receptable on the thigh cuff. The calf strap is then wrapped posteriorly around the calf continuing anteriorly over the tibia, and then attached to a calf strap receptable on the frame.
In one embodiment the method of wrapping includes inserting a user's fingers from one hand into the upper finger pocket and pulling one end of the wrap around the leg and grasping the other end of the wrap with the user's alternate hand to fasten another end of the wrap; and, inserting a user's fingers from one hand into the lower finger pocket and pulling one end of the wrap around the leg and grasping the other end of the wrap with the user's alternate hand to fasten another end of the wrap.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front, left side perspective view of the orthopedic device of the present invention shown on the leg of a user.

FIG. 2 is a rear, right side perspective view of the orthopedic device of FIG. 1.

FIG. 3 is a front perspective view of the orthopedic device of FIG. 1.

FIG. 4 is a perspective view of the orthopedic device unstrapped on a level surface.

FIG. 5 is a front, side perspective view of the articulating frame of the orthopedic device.

FIG. 6 is a rear, side perspective view of the articulating frame of the orthopedic device.

FIG. 7 is a side perspective view of a portion of the orthopedic device, showing the thigh strap attachment on the underside of the articulating frame of the orthopedic device.

FIG. 8 is a perspective view of a portion of the orthopedic device, showing the calf strap extending through the belt loop attachment on the orthopedic device.

FIG. 9A is a perspective view of the underside of the thigh pushbutton clip of the present invention.

FIG. 9B is a top view of the thigh pushbutton clip and the thigh pushbutton receptacle shown detached.

FIG. 9C is a section view taken along line 9C-9C of FIG. 1, showing the user's finger detaching the thigh pushbutton clip from the thigh pushbutton receptacle.

FIG. 9D is a top view of the thigh pushbutton clip and the thigh pushbutton receptacle shown attached.

FIG. 10 illustrates use of the upper finger pocket at the thigh end of the orthopedic device.

FIG. 11 illustrates use of the lower finger pocket at the calf end of the orthopedic device.

FIG. 12 shows the thigh strap anchor point on the orthopedic device.

FIG. 13 shows the thigh strap being wrapped around the orthopedic device.

FIG. 14 shows the thigh strap pushbutton clip connecting to the thigh strap pushbutton receptacle.

FIG. 15 shows the calf strap being wrapped around the orthopedic device.

FIG. 16 shows the calf strap pushbutton clip connecting to the calf strap pushbutton receptacle.

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.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings and the characters of reference marked thereon, FIGS. 1-4 illustrate a preferred embodiment of the orthopedic device of the present invention, designated generally as 10, shown positioned on the leg of the user, shown in phantom lines 12. The orthopedic device 10 includes a wrap designated generally as 14, an articulating frame designated generally as 16, a thigh strap designated generally as 18, and a calf strap designated generally as 20.
The wrap 14 includes multiple panels designed to contour to the leg and means to secure to itself creating a sleeve structure. A main panel designated generally as 22 secures to itself to create a closed sleeve around the leg of a user. The main panel 22 comprises a large panel 24, and a small panel 26. The small panel 26 is secured adjacent to the large panel 24 by a posterior vertical anatomical stitch 28.
A thigh fastening patch 30 and a calf fastening patch 32, are each attached to the large panel 24. Each of the patches 30, 32 have hook type fasteners of a hook and loop type of fastening system such as VELCRO® fasteners or fasteners manufactured by Paiho North America.
The large panel 24 contains an anterior thigh pocket 34 and a posterior calf pocket 36 for housing the articulating frame 16.
The large panel 24 has a popliteal elastic panel 38 to reduce bunching during flexion. The vertical anatomical stitch 28 begins at the calf end near the sagittal plane, spirals upward around the popliteal elastic panel 38, and ends at the thigh end nearly opposite the anterior thigh pocket 34. The popliteal elastic panel 38 is in the proximity of a center hinge 40 of the articulating frame 16. The popliteal elastic panel 38 is preferably wider on the side of the wrap opposite of the articulating frame 16 (i.e. furthest from the center hinge). This wider side receives the most stretch. This feature is provided so that when worn the “trapezoidal” shape becomes a symmetrical ellipse that ensures that the popliteal area is properly covered by the thinner material minimizing bunching and discomfort caused by the thicker material on the anterior thigh pocket 34 and a posterior calf pocket 36. The width and length are proportional to the size of wrap and how much the wrap needs to stretch.
The small panel 26 includes an upper finger pocket 42 at a thigh end thereof and a lower finger pocket 44 at a calf end thereof. These finger pockets 42, 44 will be discussed below in more detail with respect to FIGS. 10-11.
Referring now to FIGS. 5-6, the articulating frame 16 includes a thigh portion 46, a calf portion 48 and the center hinge 40. The thigh portion 46 includes a semi-flexible curved thigh cuff 50 configured to wrap anterior to the leg. The calf portion 48 includes a semi-flexible curved calf cuff 52 configured to wrap posterior to the leg. The center hinge 40 connects the thigh portion 46 and the calf portion 48. The thigh portion 46 includes an upright thigh bar 54 having an upright thigh bar first end 56 and an upright thigh bar second end 58, the upright thigh bar first end 56 being connected to the center hinge 40. The semi-flexible curved thigh cuff 50 extends from the upright thigh bar second end 58. The semi-flexible curved thigh cuff 50 has a thigh strap push button receptacle 57 at an end thereof with a protective raised rim 59. 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 calf portion 48 includes an upright calf bar 60 having an upright calf bar first end 62 and an upright calf bar second end 64. The upright calf bar first end 62 is connected to the center hinge 40. The semi-flexible curved calf cuff 52 extends from the upright calf bar second end 64. The semi-flexible curved calf cuff 52 has a calf strap push button receptacle 61 at an end thereof with a protective raised rim 63.
The center hinge 40 includes a Q-angle adjuster 41 configured to adjust the Q-angle of the articulating frame 16 in the coronal (i.e. frontal) plane. The Q-angle adjuster 41 applies unload force in the transverse (i.e. horizontal) plane. It 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 40 includes an insert 43 at each side for limiting flexion and extension. The center hinge 40 shown is a polycentric hinge; however, a monocentric hinge can be substituted.
Referring now to FIG. 7, thigh strap 18 includes a thigh strap anchor end 66 securely attached to the wrap 14. The upright thigh bar 54 includes upright thigh bar hook material (i.e. hook patch) 68 for engagement with thigh loop material 70 on the thigh strap anchor end 66. This prevents migration or bunching of the large panel 24 when the thigh strap 18 is drawn tight. The thigh strap 18 is held next to the thigh pocket 34 by a thigh belt loop 71 attached to the inside of the thigh pocket 34. The thigh strap 18 wraps over and across the upright thigh bar 54. The thigh strap 18 continues posteriorly and upward and wraps around the anterior of the wrap 14.
Referring now to FIG. 8, the calf strap 20 includes a calf strap anchor end 72 securely attached to the wrap 14. The upright calf bar 60 includes upright calf bar hook material (i.e. hook patch) 74 for engagement with calf loop material 76 on the calf strap anchor end 72. This prevents migration or bunching of the large panel 24 when the calf strap 20 is drawn tight. The calf strap 20 is held next to the calf pocket 36 by a calf belt loop 73 attached to the inside of the calf pocket 36. The calf strap 20 wraps over and across the upright thigh bar 60. The calf strap 20 continues posteriorly and downward and wraps around the anterior of the wrap 14.
The belt loops 71, 73 aid in keeping the straps properly attached and point the straps in the correct posterior direction. The belt loops 71,73 maintain the straps attached to the pockets so when the frame is removed and replaced for adjustments/washing, the straps are not erroneously placed under the frame.
Referring back to FIGS. 1 and 4, the thigh strap 18 has a thigh strap pushbutton clip 78 at a free end, i.e. thigh strap clip engagement end 80 thereof. The thigh strap pushbutton clip 78 includes a D-ring section. The thigh strap pushbutton clip 78 provides means for quick attachment or release of the thigh strap 18 from the articulating frame 16 for donning and doffing.
Still referring back to FIGS. 1 and 4, the calf strap 20 has a calf strap pushbutton clip 82 at a free end, i.e. calf strap clip engagement end 84 thereof. The calf strap pushbutton clip 82 includes a D-ring section. The calf strap pushbutton clip 82 provides means for quick attachment or release of the calf strap 20 from the articulating frame 16 for donning and doffing.
The ends of the straps 80,84 preferably include hook fastening pads for providing adjustments to the strap lengths.
Referring now to FIGS. 9A-9D, a thigh pushbutton assembly is illustrated which collectively includes the receiver component (i.e. receptacle 57) that gets riveted to the thigh cuff and a pushbutton clip 78 (i.e. chafe) that attaches to the thigh strap. (The calf pushbutton assembly is constructed the same as will be described for the thigh pushbutton assembly, however, the calf pushbutton receptacle is attached to end of the frame.) The receptacle 57 has a hole 84 for a rivet to attach it to the brace (the articulating frame) which it can rotate on, a thin area of plastic 85 between the rivet area and the push button area 86 that allows the receiver to flex in order to match the circumference of the anatomy. The push button area 86 has a slot 87 for the pushbutton clip to slide into, a hole 88 for the button 89 to snap into and retain the chafe 78 plus a dished-out area 90 that 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 section 91 to keep the bottom from flexing too much so that the button cannot accidently disengage. The pushbutton clip has a slot 92 for the strap to attach through, a thin area of plastic 93 between the slot 92 and the button 89 that allows the pushbutton clip to flex in order to match the circumference of the anatomy and a button 89 that has a round shape that allows the pushbutton clip to rotate so that the strap can follow the shape of the anatomy, the concave button 89 in the middle of this round shape has a dished out area 94 that helps prevent accidental pressings which also is more intimate with the shape of the finger that allows for easier pressing. There is a dome 95 in the middle of this dish and a concentric ridge 96 on the exit side that helps the finger get a good grip to activate the button. This button has a flexible hinge area 97 that allows the button 89 to flex out of the way of the receiver hole's wall 88 for removal. The receiver hole's wall 88 has a lead-in chamfer 102 on the upper outside edge created by the slot opening 87. The chamfer 102 assists the entry side 99 of the button 89 through slot 87. It also has two stops 98 that allows the button to not get flexed up into the receiver's hole 88 too far so that the flexible hinge 97 does not get sprung. The height of the button 89 is lower on the entry side 99 so that is easy to insert but is higher on the exit side 100 for retention. This graded height also flexes the receiver's top section with the hole 88 to slightly flex out of the way for insertion. The entry side 99 is still high enough so that the button 89 doesn't accidently disengage itself when the pushbutton clip is rotated while in the receiver. The exit side 100 is high enough for retention, but still can slide through the slot opening 87 of the receiver when being activated. The location of the hinge 97 and stops 98 along with the exit side of the button 100 allows the button to flex up to remain intimate with the receiver's hole 88 wall 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 to FIG. 10, during donning the user, with one hand, engages the upper finger pocket 42 at the thigh end of the small panel 26. With the other hand the user engages the thigh fastening patch 30. The two are pressed together.
Similarly, as shown in FIG. 11, lower finger pocket 44, and calf fastening patch 32 are engaged by the user at the calf.
Referring now to FIGS. 12-14, the thigh strap 18 wraps over and across the articulating frame 16. The thigh strap 18 continues posteriorly and upward and wraps around the anterior of the wrap 14. The thigh push button clip 78 at end of the thigh strap 18 engages a thigh push button receptacle 57 at the end of the thigh cuff 50.
Referring now to FIGS. 15-16, the calf strap 20 wraps over & across the articulating frame 16. The calf strap 20 continues posteriorly and downward and wraps around the anterior of the wrap 14. The calf push button clip 82 at end of the calf strap 20 engages the calf push button receptacle 61 at the end of the articulating frame 16. The tension for each of the straps 18, 20 can be adjusted by the hook fastening pads that provide adjustments to the strap lengths, as discussed above.
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.

Claims

1. An orthopedic device, comprising:

a) a wrap;

b) an articulating frame housed within said wrap, comprising:

i. a thigh portion including a semi-flexible curved thigh cuff configured to wrap anterior to the leg;

ii. a calf portion including a semi-flexible curved calf cuff configured to wrap posterior to the leg; and,

iii. a center hinge connecting said thigh portion and said calf portion;

c) a plurality of straps attached to said wrap.

2. The orthopedic device of claim 1, wherein said wrap comprises a main panel that secures to itself to create a closed sleeve around the leg of a user, wherein said main panel comprises:

a) a large panel;

b) a small panel secured adjacent to said large panel, wherein said small panel includes an upper finger pocket at a thigh end thereof and a lower finger pocket at a calf end thereof.

3. The orthopedic device of claim 2, wherein said large panel comprises a popliteal elastic panel in the proximity of the center hinge to minimize bunching during flexion.

4. The orthopedic device of claim 2, wherein said large panel comprises a popliteal elastic panel in the proximity of the center hinge to minimize bunching during flexion, said popliteal elastic panel having a first side closest to the center hinge and a second side furthest from the center hinge, said second side being wider than the first side.

5. The orthopedic device of claim 2, further comprising a thigh fastening patch and a calf fastening patch, each attached to said large panel.

6. The orthopedic device of claim 2, wherein said large panel contains an anterior thigh pocket and a posterior calf pocket, and wherein said plurality of straps includes a thigh strap and a calf strap, the orthopedic device further comprising:

a thigh belt loop attached to said anterior thigh pocket; and,

a calf belt loop attached to said posterior calf pocket.

7. The orthopedic device of claim 1, wherein said plurality of straps includes a thigh strap having a thigh strap pushbutton clip at a thigh strap clip engagement end thereof; and, wherein said thigh cuff includes a thigh strap pushbutton receptacle at an end thereof with a protective raised rim, wherein said thigh strap pushbutton clip is concave.

8. The orthopedic device of claim 1, wherein said plurality of straps include a calf strap having a calf strap pushbutton clip at an end thereof; and, wherein said calf cuff includes a pivotal calf strap pushbutton receptacle at an end thereof.

9. The orthopedic device of claim 1, wherein said plurality of straps include a calf strap having a calf strap pushbutton clip at a calf strap clip engagement end thereof; and, wherein said calf cuff includes a calf strap pushbutton receptacle at an end thereof with a protective raised rim, wherein said calf strap pushbutton clip is concave.

10. The orthopedic device of claim 1, wherein said thigh portion includes an upright thigh bar having a upright thigh bar first end and a upright thigh bar second end, said upright thigh bar first end being connected to said center hinge, wherein said semi-flexible curved thigh cuff extends from said upright thigh bar second end.

11. The orthopedic device of claim 10, wherein said plurality of straps include a thigh strap including a thigh strap anchor end securely attached to said wrap; and, wherein said upright thigh bar includes upright thigh bar hook material for engagement with thigh loop material on the thigh strap anchor end.

12. The orthopedic device of claim 1, wherein said calf portion includes an upright calf bar having an upright calf bar first end and an upright calf bar second end, said upright calf bar first end being connected to said center hinge, wherein said semi-flexible curved calf cuff extends from said upright calf bar second end.

13. The orthopedic device of claim 12, wherein said plurality of straps include a calf strap including a calf strap anchor end securely attached to said wrap; and, wherein said upright calf bar includes upright calf bar hook material for engagement with calf loop material on the calf strap anchor end.

14. The orthopedic device of claim 1, wherein said center hinge includes a Q-angle adjuster configured to adjust the Q-angle of the articulating frame.

15. A method for donning an orthopedic device, comprising the steps of:

a) providing an orthopedic device, comprising:

i. a wrap;

ii. an articulating frame housed within said wrap, comprising:

a. a thigh portion including a semi-flexible curved thigh cuff configured to wrap anterior to the leg;

b. a calf portion including a semi-flexible curved calf cuff configured to wrap posterior to the leg; and,

c. a center hinge connecting said thigh portion and said calf portion;

iii. a plurality of straps attached to said wrap;

b) placing the orthopedic device around the leg of a user;

c) wrapping a thigh strap of said plurality of straps initially posteriorly around the hamstring continuing anteriorly over the thigh, and then attaching said thigh strap to a thigh strap receptable on the thigh cuff; and,

d) wrapping a calf strap of said plurality of straps initially posteriorly around the calf continuing anteriorly over the tibia, and then attaching said calf strap to a calf strap receptable on the frame.

16. The method of claim 15, wherein said wrap comprises a main panel that secures to itself to create a closed sleeve around the leg of a user, wherein said main panel comprises

a large panel and a small panel secured adjacent to said large panel, wherein said small panel includes an upper finger pocket at a thigh end thereof and a lower finger pocket at a calf end thereof, the method further comprising the steps of:

a) inserting a user's fingers from one hand into the upper finger pocket and pulling one end of the wrap around the leg and grasping the other end of the wrap with the user's alternate hand to fasten another end of the wrap; and,

b) inserting a user's fingers from one hand into the lower finger pocket and pulling one end of the wrap around the leg and grasping the other end of the wrap with the user's alternate hand to fasten another end of the wrap.

17. The method of claim 15, wherein said step of attaching said thigh strap comprises utilizing a thigh strap pushbutton clip; and wherein said step of attaching said calf strap comprises utilizing a calf strap pushbutton clip.