WO2018005931A1

WO2018005931A1 - A knee extension treatment apparatus for below-knee amputees

Info

Publication number: WO2018005931A1
Application number: PCT/US2017/040219
Authority: WO
Inventors: Annette SULLIVAN
Original assignee: Sullivan Annette
Priority date: 2016-06-30
Filing date: 2017-06-30
Publication date: 2018-01-04

Abstract

A knee extension treatment apparatus for an amputee with a below-the- knee amputated leg includes a frame in combination with a movable support for positioning below the amputated leg in order to maintain the amputated leg in an elevated position. The knee extension treatment apparatus further includes a panel which defines a clearance aperture for alignment over the knee of the amputated leg such that downward force can be applied without pressure directly on the upper surface of the knee. The tensioning of the leg is accomplished by the use of strap assemblies which are constructed and arranged for connection to the frame and receipt by the panel.

Description

A KNEE EXTENSION TREATMENT APPARATUS FOR BELOW- KNEE AMPUTEES

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Patent Application

No. 62/356,778 filed June 30, 2016, which is hereby incorporated by reference.

BACKGROUND

The present invention relates in general to treatment devices that are used to assist with and facilitate the healing and recovery of a patient-user. Such treatment devices may be used before or after surgery or in lieu of surgery. More specifically, the present invention relates to a knee extension treatment apparatus that assists the patient-user with exercising and stretching before and/or following knee surgery. In other instances, the treatment apparatus according to the present invention may be used in lieu of surgery.

It is important that patients recovering from knee surgery initiate knee exercise/stretching treatment promptly after surgery to maintain knee joint flexibility and shorten the period for recovery. Patient compliance with a predetermined physical treatment protocol is key to early patient recovery with optimal joint flexibility and function. In certain situations, benefits are derived by following a knee treatment protocol before surgery. In other situations, a knee treatment protocol may be used in lieu of surgery. While there have been many devices developed to provide knee extension and exercise treatment, each has its complexities or difficulties of use that have tended to reduce patient compliance with therapeutic or treatment protocols designed for early and effective recovery.

One device which has addressed the need for an improved knee extension treatment apparatus is disclosed in US patent number 8,343,080 which issued January 1, 2013 and is assigned to Kneebourne Therapeutic, LLC. The '080 patent is expressly incorporated by reference herein for its entire disclosure. The four figures of the '080 patent are included herein and marked as "prior art".

The device described in the' 080 patent provides a knee extension treatment apparatus that can be easily transported for patient home use, and one that can be used by the post-operative or post-trauma patient with minimal instruction and without assistance of attending medical practitioners, family members or friends. Similarly, the treatment apparatus may be used before or in lieu of surgery. This disclosed treatment apparatus provides a simple, effective, user adaptable knee extension treatment apparatus. The apparatus is configured to allow the patient- user to lie in a comfortable recumbent position during each treatment session. The apparatus provides an easy-to-use force translation system for efficient and effective delivery of knee straightening forces to areas on the top of the patient's leg.

The device of the '080 patent includes an ankle support 22 which functions in cooperation with T-section 33 to provide an adjustable support for the ankle of the user. When utilizing apparatus 20 for knee treatment, it is assumed that the leg of the user will be bent at the knee as the user rests in a recumbent position on seat 32 with the ankle supported in an elevated position by ankle support 22. The treatment process includes applying a knee-proximal downward force and a knee- distal downward force against the upper surface of the leg in an attempt to straighten the leg by taking out the bend at the knee. This process involves stretching of the muscles that affect the knee joint and requires being able to apply enough force for the required stretching and then maintaining that force level during the stretching process. This procedure also requires that as the leg begins to straighten, any slack that might be available in terms of the cable/strap

arrangement can be taken up (i.e., tightened), such that the overall length of that cable/strap arrangement is shortened by winding up some portion of strap 69 onto the ratcheted pulley 26. The disclosed cable/strap arrangement has been shown on the right side of the user. With the necessary and appropriate modifications the cable/strap arrangement can be placed on the left side of the user.

There is one user condition which is not addressed by the design and construction of apparatus 20 of the Ό80 patent. This one user condition is when the user is a below-knee amputee. When the knee of the affected leg could otherwise benefit from the exercising and stretching enabled by apparatus 20, apparatus 20 cannot be used in its intended manner as there is no user ankle to be supported by ankle support 22. If a prosthetic leg extension is attached to the amputee stump, the tensioning of the leg by apparatus 20, while permitted, puts too much stress on the junction between the prosthetic leg extension and the stump. Before any meaningful treatment of the knee can occur, the stress on the junction reaches an unacceptable level preventing proper treatment of the knee of the affected leg. These issues are applicable to any below-knee amputee weather of the left leg or the right leg.

It would be an improvement to knee extension treatment apparatus of the type presented by apparatus 20 of the '080 patent if modifications could be made and structures added to be able to properly and effectively treat below-knee amputees.

SUMMARY

A knee extension treatment apparatus for below-knee amputees according to one exemplary embodiment, includes a base frame assembly, a support member (bolster), a first strap assembly, a second strap assembly, and a panel for placement over the knee of the user/amputee. The support member is positioned on the base frame assembly beneath the stump. The first strap assembly is positioned proximal to the knee and is constructed and arranged to pull a proximal portion of the panel downwardly against the leg of the user at a location generally adjacent to the knee. The second strap assembly is positioned distal to the knee and is constructed and arranged to pull a distal portion of the panel downwardly against the leg of the user. The panel defines an aperture positioned between the proximal portion and the distal portion. The aperture is aligned with and positioned directly over the knee of the user to ensure that there is no downward force applied directly to the upper surface of the knee of the user/amputee. The panel further defines slots for receipt of the strap portion of each strap assembly.

As an alternate embodiment, see FIG. 13, the two-strap construction is replaced with four individual straps with one each being positioned through each corner slotted opening. This alternate embodiment does not have any strap extending completely over the upper surface of the panel from one side of the panel to the other. The downward force which is applied on the panel is applied by fixing two of the straps along one common side of the frame and then using the other two straps for tensioning by way of the control assembly.

The knee extension treatment apparatus according to an exemplary embodiment of the present invention provides a structure which is able to be used for knee extension treatment for below-knee amputees. The tensioning provided by the two strap assemblies has some similarity to what is disclosed in the '080 patent. Similar to what is disclosed in the Ό80 patent, the two strap assemblies attached at one end to the frame and are joined with a common cable which is under the control of the user. The alternate embodiment uses four straps with one at each corner of the panel.

There is one important difference between the exemplary embodiment of the present invention and what is disclosed in the Ό80 patent and this pertains to the placement of the strap assemblies and the manner of applying downward forces on both the proximal and distal sides of the knee. In the exemplary embodiment, those forces are applied to the panel rather than directly to the leg of the user. The two strap assemblies which have their corresponding straps received by the panel (extending through slot -like openings in the panel), when tensioned will apply a downward force on the panel allowing the panel to then provide and apply downward forces on the leg both at a proximal location above-the-knee and at a distal location below the knee. The support member and panel are of primary importance in being able to redesign a knee extension apparatus into an apparatus which is suitable for use by a below-knee amputee. A similar downward force via the panel is still applied by the alternate embodiment which uses four corner straps.

Further forms, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from a detailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a knee extension treatment apparatus according to a typical embodiment of the prior art invention.

FIG. 2 is an exploded perspective view of the FIG. 1 prior art knee extension treatment apparatus.

FIG. 3 is a side elevational view of the FIG. 1 prior art knee extension treatment apparatus with a leg of the user supported for treatment.

FIG. 4 is a side elevational view of the FIG. 1 prior art knee extension treatment apparatus as arranged into a folded configuration for transport or storage, according to the present invention.

FIG. 5 is an exploded perspective view of a knee extension treatment apparatus for below-knee amputees according to an exemplary embodiment of the present invention.

FIG. 6 is a top plan view of the FIG. 5 apparatus.

FIG. 7 is an exploded perspective view of the FIG. 5 apparatus.

FIG. 8 is a side perspective view of the FIG. 5 apparatus.

FIG. 9 is a perspective view of the FIG. 5 apparatus, as assembled, including the remaining parts and subassemblies.

FIG. 10 is a side elevational view of the FIG. 9 assembly.

FIG. 11 is a perspective view corresponding to FIG. 9, with a below-the knee amputee in position with the FIG 9 apparatus properly aligned.

FIG. 12 is a side elevational view of the FIG. 11 illustration with the below-the -knee amputee in position.

FIG. 13 is a perspective view of an alternate embodiment of the straps which are used for applying a force to the leg via a panel.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity.

Referring to FIGS. 1 and 2, there is illustrated a prior art knee extension treatment apparatus 20 that is constructed and arranged according to the invention of US 8,343,080. In the FIG. 1 illustration, the treatment apparatus 20 is opened or unfolded into what would be considered its ready-for-use condition. In this condition, it is ready for use by the individual that may either be a patient recovering from knee surgery, or a would-be patient contemplating knee surgery, or any other individual where some type of treatment for the knee has been recommended or suggested. The patient or would-be patient is the user of apparatus 20 and thus the terms "patient" and "user" or even "patient-user" can be used interchangeably.

The exploded view of FIG. 2 may be preferred in terms of explaining and describing a majority of the component parts that are required for treatment apparatus 20 and the cooperating assembly of those component parts. Once there is a thorough understanding of each component part of treatment apparatus 20 and how those parts are assembled to one another, it will be easy to understand what occurs when changing from the FIG. 1 orientation or arrangement into the folded orientation of FIG. 4 and then back to the FIG. 1 extended or opened arrangement.

With continued reference to FIGS. 1 and 2, it should be noted that the leg slipcover 28 and seat cushion 29 of FIG. 1 are omitted from the FIG. 2 illustration, simply for drawing clarity and to preclude other parts from being hidden from view. Treatment apparatus 20 includes a frame assembly 21, ankle support 22, first strap assembly 23, second strap assembly 24, cable system 25, and manually- adjusted ratcheted pulley 26 with a torque lever 27. Leg slipcover 28 is secured to frame assembly 21 and seat cushion 29 is secured to seat 32.

The frame assembly 21 includes a left-side tubular rail 30, a right-side tubular rail 31, seat 32, and T-section 33. The T-section 33 fits between the distal ends 30a and 31a of the left-side and right-side rails 30 and 31, respectively. The lower tube 34 of seat 32 extends between proximal ends 30b and 3 lb of the tubular rails 30 and 31, respectively.

Hollow tube 37 extends between rail 30 and rail 31 and functions as a brace for added strength and rigidity to frame assembly 21. A second brace is provided by hollow tube 38. Rod 39 is threaded at each end and is of a length sufficient to extend through tube 38 and at one end beyond the outer surface of rail 30 and at the other (opposite) end beyond the outer surface of rail 31. Each threaded end receives a flat washer 40a and an acorn hex nut 40b for securely tightening the rod 39 and tube 38 assembly to and into the two tubular rails 30 and 31.

Rod 41 is threaded at each end and is similar in construction and purpose to rod 39, except the rod 41 is longer than rod 39 and extends through tube 37. Flat washers 40a and acorn hex nuts 40b are used for securely tightening this rod and tube assembly to the two tubular rails 30 and 31. Rod 42 is threaded at each end and is constructed and arranged to extend through lower tube 34 and beyond the outer surfaces of each tubular rail 30 and 31. Flat washers 40a and acorn nuts 40b are used for securing the seat 32 to the tubular rails 30 and 31. Shouldered bushings 43 are used to facilitate the folding forward of the seat 32 relative to the remainder of the apparatus as will be described hereinafter.

The first strap assembly 23 is constructed and arranged similar to an automobile seat belt, including a primary strap portion 45 and a securing buckle 46. Buckle 46 is secured to tubular rail 30 by means of the flexible belt length 47 that includes a clearance hole 48 for receipt of rod 39. Strap portion 45 includes a belt length 49 that is threaded through tongue member 50. Belt length 49 provides for strap extension if added or increased length is needed. Attached end 52 includes a D-ring 53 and belt length 45 is sewn to itself after threading through D- ring 53. Cable 54 is used to securely connect to first strap assembly 23 using D- ring 53. The tip 55 of tongue member 50 is constructed and arranged to be inserted into buckle 46 by way of slot 56. The receipt of tip 55 by buckle 46 creates a secure connection that is easily releasable by manually lifting up on release lever 57.

The second strap assembly 24 has a construction that is virtually identical to first strap assembly 23, including the primary strap portion 45a and a securing buckle 46a. The reference numeral suffix of "a" is being used to designate like component parts of second strap assembly 24 that correspond to first strap assembly 23. Some of these primary component parts include belt length 49a, tongue member 50a, and D-ring 53a. Cable 61 is used to securely connect to second strap assembly 24 using D-ring 53a. Cables 54 and 61 are each wound around a cooperating roller 62 that is positioned inside of the hollow tubular rail 31. Rod 39 extends through the outer wall of rail 31 and then through roller 62. Rod 41 extends through the outer wall of rail 31 at an adjustable location closer to seat 32 and then through its corresponding roller 62. This location is made adjustable by providing four sets of spaced apart (through) clearance holes 63, four sets on each side of apparatus 20, defined as through-holes by rails 30 and 31.

Cables 54 and 61 are securely joined to main cable 64 that extends out of proximal end 3 lb of rail 31 such that pulling on main cable 64, as if to pull it out of end 31b, causes cable 54 and 61 to concurrently and uniformly pull on D-rings 53 and 53a, respectively. The connection of cables 54 and 61 to main cable 64 is performed in a way so as to equalize or balance the pulling force so that the tensioning of the first and second strap assemblies 23 and 24 is substantially equal in response to the single pulling force on main cable 64. End cap 65 closes proximal end 30b of rail 30 while end cap 66 is shaped with a central opening for clearance with cable 64.

The proximal end 64a of cable 64 is arranged with a tongue member 68 for receipt by buckle 70 that is received by the ratcheted pulley 26 via pulley strap 69. The connection of tongue member 68 to cable 64 is facilitated by creating a loop 71 in the end 64a of cable 64 for connection to tongue member 68. The pulley strap 69 is secured to the pulley 26 such that, as knob 72 is turned, the strap is wound up (i.e., shortened). Hub 27a fits securely over knob 72 so as to increase the moment arm for easier tuning of the ratcheted pulley 26. As the strap is wound up, the tension pulling on the first and second strap assemblies 23 and 24 tightens these assemblies and, as will be described, creates downward forces, one proximal to the knee and the other distal to the knee. This arrangement of the two strap assemblies 23 and 24 relative to the leg of the user is illustrated in FIG. 3. Similar to what has been described as part of the parent application, that application being incorporated by reference herein, the substantially horizontal force pulling on cable 64 in a direction that is substantially parallel to the frame assembly and seat, in the FIG. 1 orientation, is translated into downward forces, one downward force being proximal to the knee and the other being distal to the knee. Both forces are directed toward the frame assembly and are substantially normal to the frame.

Referring again to FIG. 1, leg slipcover 28 includes a fabric or nylon webbing panel 77 that includes three width-wise securing straps 78a-78c that are sewn to panel 77 at the three spaced-apart locations as illustrated in FIG. 1.

Additionally, there are four end strap lengths 78d-78g also sewn to panel 77, two strap lengths at each end. Each strap 78a-78c includes a free end strap length at each end and a VELCRO® brand combination that is used to secure each free end strap length to itself. Each strap length 78d-78g also includes a VELCRO® brand combination such that each strap length can be wound around a portion of frame assembly 21, as illustrated, and then secured to itself. Strap lengths 78d and 78e are each wrapped around lower tube 34 so as to help secure the leg slipcover 28 to frame assembly 21. Strap length 78f is wrapped around the tubular joint where T- section 33 inserts into distal end 30a. Strap length 78g is wrapped around the tubular joint where T-section 33 inserts into distal end 31a.

Seat cushion 29 is constructed and arranged into two connected pad portions 29a and 29b. Pad portion 29a is connected to seat frame 80 by the use of six strap lengths 79a-79f. Each of these strap lengths includes a VELCRO® brand combination such that each strap length 79a-79f can be wound around seat frame 80 and secured to itself.

Portion 29b is joined to portion 29a by flexible web 81. Depending on the desired seat cushion thickness for a particular user, portion 29b can be flipped over onto portion 29a for added thickness, or left as illustrated in FIG. 1 for less seat cushion thickness.

The structural configuration of treatment apparatus 20 includes a number of adjustments that are included in order to try and customize, at least to some extent, the treatment apparatus 20 to "fit" the end user who will be, for example, an individual trying to work with the knee in order to avoid knee surgery or an individual providing treatment to the leg/knee following a surgical procedure, or perhaps building up the knee prior to contemplated surgery.

The first two adjustments relate to ankle support 22 and its orientation relative to the remainder of treatment apparatus 20. Included as cooperative component parts for these two adjustments are T-section 33, distal ends 30a and 31a, and push pins 84 (handled). T-section 33 includes first and second reduced diameter portions 33a and 33b that insert into distal ends 30a and 31a, respectively. The first reduced diameter portion 33a includes a receiving hole 85 for one push pin 84. Distal end 30a includes a plurality of clearance holes 86 allowing T-section 33 to be rotated relative to the distal ends in order to change the angle of incline or tilt of the vertical axis 87 (see line 87) extending lengthwise through ankle support 22. When push pin 84 is removed, the ankle support 22 is collapsible by pivoting downwardly toward seat 32 for transport and/or storage. The spacing and the number of holes 86 determines the number of different settings and the amount or extent of incline in terms of the orientation of axis line 87. It will be noted that the location and number of holes 86 can be either clockwise or counterclockwise from vertical such that the ankle support 22 can be tilted off of true vertical toward the seat or tilted off of true vertical away from the seat. In terms of use of the ankle support 22 and its adjustment, once hole 85 is aligned with the selected one of the plurality of holes 86 for the desired angle of incline, push pin 84, which includes a handle-like head, is inserted through hole 86 and into hole 85 in order to fix the relationship between T-section 33 and the left-side and right-side tubular rails 30 and 31, respectively. In order to change the angle of incline, which of course could include a true vertical orientation, the user simply pulls out the push pin 84, selects another hole 86, and then aligns hole 85 with the selected hole 86, and reinserts the push pin 84. The second adjustment involves the height of ankle support 22 relative to the remainder of the frame 21 and importantly relative to the surface of seat 32 that is supporting the user. Ankle support 22 includes a reduced diameter portion 22a that inserts into tubular sleeve 89 of T-section 33. Portion 22a includes a plurality of clearance holes 90 and sleeve 89 includes a cooperating clearance hole 91. Push pin 84 is used to pin together portion 22a and sleeve 89 once the ankle support 22 is set at the desired height. The number and spacing of holes 90 determines the number of different height settings that are possible for ankle support 22. The different height settings are directed to the location of support surface 92 of ankle support 22 relative to frame assembly 21 and ultimately relative to the support surface 93 of seat 32. While support surface 93 is selected in FIG. 2 as the upper surface of support plate 96, the support surface 93 becomes the upper surface of cushion 29 if the cushion is used. As illustrated in FIG. 3, the desire is to try and position the ankle support surface 92 at a location or height above that surface where the user is "seated" (i.e., in a recumbent position) so as to take into consideration the anatomy of the user and the appropriate elevation of the leg for the selected treatment procedure. This particular adjustment enables the user of treatment apparatus 20 to configure that apparatus to better fit his or her anatomy.

Movement of portion 22a within tubular sleeve 89 is independent of any rotation of T-section 33 relative to distal ends 30a and 31a. While rotation of T- section 33 will result in a change of position for support surface 92, such rotation does not create relative movement between portion 22a and tubular sleeve 89. Movement of portion 22a within tubular sleeve 89 does not influence or create any rotational movement of T-section 33 relative to distal ends 30a and 31a.

Another point of adjustment is provided by the left-side and right-side tubular rails 30 and 31, respectively, relative to the location of second strap assembly 24. This in turn determines where the primary strap portion 45a will be positioned relative to the leg of the user, and more specifically where it will be positioned relative to the knee of the user.

Each tubular rail 30 and 31 includes a series of four spaced-apart clearance holes 63 that are aligned so as to receive threaded rod 41 that is inserted through hollow tube 37. As previously described, the second strap assembly 24 is assembled to frame assembly 21 by this rod and sleeve combination, including wing nuts 40b. Accordingly, the selection of a particular clearance hole in each tubular rail 30, 31 determines where the primary strap portion 45a will be located relative to seat 32, ankle support 22, and the first strap assembly 23.

A further point of adjustment is provided by the point of connection of the ratcheted pulley 26 relative to the support plate 96 that cooperates with frame 80 to form seat 32, without pad portions 29a and 29b. Plate 96 includes a series of four spaced-apart clearance holes 97 for the attachment of mounting plate 98. Bolts 99 and wing nuts 100 complete the assembly. Mounting plate 98 includes a shoulder bolt 101 for the attachment of the ratcheted pulley (and buckle) assembly 26.

Depending on the size of the user, and the positioning of the user's torso and right arm relative to the ratcheted pulley 26 location, there are three different positions that are available for the attachment of mounting plate 98 onto plate 96. More adjustment positions can be made available by increasing the number of clearance holes 97.

A further feature of the present invention that is enabled by its specific construction is the ability to fold the seat 32 forwardly and downwardly in the direction of the tubular rails 30 and 31, see FIG. 4. A related feature is the ability to fold the ankle support 22 and T- section 33 rearwardly and downwardly in the direction of the tubular rails 30 and 31, also illustrated in FIG. 4.

Folding of the seat 32 is enabled by the rod 42 and lower tube 34 assembly and the use of bushings 43. Since the seat is intended to be placed flat on the support surface used for treatment apparatus 20, this point of connection by way of rod 42 does not have to be fixed or secured in terms of pivoting or hinging, but rather should be hinged or pivotable for the forward folding of the seat.

The FIG. 1 prior art structure of apparatus 20 includes a tubular frame 21, a pair of strap assemblies 23 and 24 and an ankle support 22. In order to help explain the modifications made to apparatus 20 for use by a below-knee amputee, consider the partial apparatus 120 of FIGS. 5-8. These four partial views do not include the pair of strap assemblies 122 and 124 (see FIGS. 9-12) and their connection to control assembly 126. Omitting the pair of strap assemblies from FIGS. 5-8 and using exploded views for these drawing figures allows for the remainder of apparatus 120 to be more clearly illustrated. Control assembly 126 has an adjustable position relative to tubular frame 128 in support panel 130, based on its point of attachment to support panel 130. As would be well understood from a review of the '080 patent, each strap assembly 122 and 124 includes a strap portion 122a and 124a, respectively, with connecting structures at each end of the strap. At one end the straps are able to be secured to the frame and at the opposite end the straps are able to be connected to a common cable which is part of control assembly 126 for manipulation and tension management by the user/amputee.

As will be seen, the construction of apparatus 20 places the control assembly (i.e. manually-adjusted ratcheted pulley 26) on the right side of the user. In the construction of apparatus 120, the control assembly 126 is shown on the left side of the user. As shown by the two series of openings 127, the actual position of the control assembly 126 is adjustable so as to either shorten or increase the distance between the control assembly 126 and panel 142. The control assembly 126 may also be moved to the other side of support panel 130 (see FIGS. 9-12) where the other series of openings 127 is located. A change of sides for control assembly 126 also means a change in the tubular frame and in the arrangement of the strap assemblies. Whichever side is selected for control assembly 126, that is the side which needs to have the common cable and the hollow tubular members as disclosed herein.

The modifications of apparatus 20 as represented by apparatus 120 are specifically intended to create an apparatus which is at least similar to apparatus 20, and suitable for knee extension treatment for below-knee amputees.

Accordingly, while apparatus 120 does include a pair of strap assemblies 122 and 124 (see FIGS. 9-12), apparatus 120 does not need to include any ankle support structure such as ankle support 22. While FIGS. 5-8 happen to show an upright section 132a and sleeve 134, there is no ankle support. The T-section 132 helps to join together the two sides 128a and 128b of frame 128. In the exemplary embodiments of FIGS. 1-4 as well as FIGS. 5-8, the respective sleeves 89 and 134, are each a part of their corresponding T-sections 33 and 132. Further, the basic construction of frame 128 of apparatus 120 can be used as part of apparatus 20 and retaining T-section 132 and sleeve 134 as part of frame 128 simplifies the changeover of frame 128 from its arrangement for use as a part of apparatus 120 to a form suitable for use as a part of apparatus 20. Further, as shown in FIG. 13 the two-strap assemblies 122 and 124 can be replaced with four strap assemblies.

Apparatus 120, as intended, is constructed and arranged to be used for a below-knee amputee. In the design and construction of apparatus 120, any ankle support is removed, a bolster 140 is provided as a support member and included is a panel 142 for placement over the knee of the leg of the user which has been amputated below the knee. The two strap assemblies 122 and 124 which are used with frame 128 and panel 142 are shown as properly assembled in FIGS. 9 and 10 without the amputee (i.e. user) in position on apparatus 120 and in FIGS. 11 and 12 with the amputee in position. In the illustrations of FIGS. 11 and 12, the below- knee amputee is properly positioned on frame 128 and the bolster 140 is positioned directly beneath the distal end 144 of the stump of the amputated leg 146. A support pad 147 has been added to the embodiment of FIGS. 9-12.

Apparatus 120 is constructed and arrange for use for knee extension treatment for below-knee amputees. The treatment regimen incorporates having one strap 122a distal to knee 148 and the other strap 124a proximal to the knee 148. The bolster 140 is positioned distal to the knee 148 as illustrated FIGS. 11 and 12.

In order properly tension the leg 146 for treatment of knee 148 it is necessary to apply a downward force against the upper surface of the leg, preferably with downward force locations both proximal to the knee and distal to the knee. While these downward forces are able to be applied using the strap assemblies 122 and 124, most below-knee amputees do not have sufficient below- the-leg length to be able to receive the strap so as to apply the desire downward force in a manner of use comparable to how apparatus 20 is intended to be used. Considering for now FIG. 3 of the Ό80 patent, it will be seen that strap assembly 23 is distal of the knee and located at a point on the lower leg. This portion of the lower leg where strap assembly 23 is positioned may not exist for a below-knee amputee. In order to address this leg length reality, apparatus 120 provides a bolster 140 for support and panel 142 which effectively extends leg length so that a desired downward force can be applied at a location relative to the knee for suitable treatment.

Panel 142 has a generally rectangular form with slotted openings 150 for receipt of the straps 122a and 124a of strap assemblies 122 and 124, respectively, see FIGS. 9-12. Panel 142 defines aperture 156 which is located inside of the four slotted openings 150. Preferably there is symmetry to panel 142 with aperture 156 generally centered, but with other shapes, contours and patterns being

contemplated. Aperture 156 is constructed and arranged to be positioned over the knee 148 of the below-knee amputee. Preferably the aperture is aligned with and centered over knee 148. In the exemplary embodiment panel 142 is constructed and arranged such that aperture 156 has an oval shape with its length extending between proximal edge 158 and distal edge 160. Aperture 156 has a size which is suitable to essentially encircle the knee so that pressure is not applied directly to the upper surface of the knee. Instead, and importantly for this application, the downward forces via panel 142 are only applied at locations proximal to the knee and distal to the knee. The elongated nature of each slotted opening 150 has each slotted opening extending lengthwise between proximal edge 158 and distal edge 160. Panel 142 may have a generally uniform thickness and may be substantially flat on either or both surfaces or may have some slight curvature with a concave surface facing the leg of the below-knee amputee.

In use, apparatus 120 is arranged in position relative to the user as illustrated in FIGS. 11 and 12. With the user in position and with the bolster 140 properly located and aligned, the panel 142 is placed over the knee of the user. First ends of each strap assembly 122 and 124, respectively, are secured to the frame in a fixed manner. The opposite end of each strap 122a and 124a is configured to be secured to a common cable which is connected to pulley strap 168. The first ends may be secured by a loop construction, as is illustrated, or by a buckle and clip construction similar to that used for apparatus 20, see FIG. 1. The user is then able to tension the cables and maintain a desired tension for treatment of the knee, consistent with what is been illustrated and described for apparatus 20 and consistent with the design, construction and use of control assembly 126. The result is an apparatus 120 which is comparable to apparatus 20 in effectiveness but which is specifically designed for below-knee amputees.

As mentioned herein, one alternate construction is to replace the two- strap assemblies 122 and 124 with four separate strap assemblies. This alternate construction is illustrated in FIG. 13 where strap assemblies 172, 174, 176 and 178 are used. Panel 142 has the same construction as in the prior embodiments and includes the same four slotted openings 150 and the same centered aperture 156. In the FIG. 13 embodiment, the continuous straps which extend over the upper surface of panel 142 are replaced, allowing each corner of the panel 142 to receive its own separate strap as a part of the corresponding strap assemblies 172, 174, 176 and 178.

Strap assemblies 172 and 174 each extend through a corresponding slotted opening 150, extend over an edge of panel 142 and include a closed loop 172a for securement around the tubular component of frame 128, as illustrated. The closed loop 172a corresponds to strap assembly 172 and the second closed loop which corresponds to strap assembly 174 is not visible in the FIG. 13 drawing due to other components. Each strap assembly 172 and 174 includes a length adjustment buckle 172b and 174b, respectively. Strap assemblies 176 and 178 are similar in construction to strap assemblies 172 and 174 in terms of their threaded passage through a corner slotted opening 150 and having a length adjustment buckle 176b and 178b, respectively. The closed loops of strap assemblies 172 and 174 are now replaced with a secured ring 176a and 178a, respectively, and a cable connection 180 and 182, respectively.

Cable connections 180 and 182 connect to a common cable 184 which connects to pulley strap 168. A clip and buckle combination 186, similar to an automobile seat belt, is used for the connection of the common cable 184 to the pulley strap 168. As previously noted, with corresponding changes to the tubular frame, the cable adjustment construction can be switched from the right side of the user to the left side of the user. This shift would include changes to the cable connections and cable structures so as to be compatible.

While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the inventions defined by following claims are desired to be protected. All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

Claims

1. A knee extension treatment apparatus for a below-knee amputee comprising:

a frame;

a bolster constructed and arranged to support an amputated leg;

a panel defining an aperture;

a plurality of strap assemblies wherein each strap assembly is constructed and arranged for receipt by said panel; and

wherein with said panel placed over said amputated leg and with said aperture aligned over the knee, at least one strap assembly is adjustable for creating a downward force on an upper surface of the amputated leg.

2. The knee extension treatment apparatus of claim 1 wherein said amputated leg is positioned between said bolster and said panel.

3. The knee extension treatment apparatus of claim 2 wherein said panel further defines a pair of openings wherein each opening is constructed and arranged for receipt of a corresponding strap assembly.

4. The knee extension treatment apparatus of claim 3 wherein each strap assembly includes a length-adjust buckle.

5. The knee extension treatment apparatus of claim 4 wherein at least one strap assembly is connected to a common cable for pulling manipulation by the amputee to achieve a desired downward force on an upper surface of the amputated leg.

6. The knee extension treatment apparatus of claim 3 wherein one opening located proximal to said aperture.

7. A knee extension treatment apparatus for a below-knee amputee comprising:

a frame;

a bolster constructed and arranged to support an amputated leg;

a panel defining an aperture;

a strap which is constructed for receipt by said panel and is attachable to said frame; and

wherein with said panel placed over said amputated leg and with said aperture aligned over the knee, said strap is adjustable for creating a downward force on an upper surface of the amputated leg.

8. The knee extension treatment apparatus of claim 7 wherein said amputated leg is positioned between said bolster and said panel.

9. The knee extension treatment apparatus of claim 8 wherein said panel further defines a pair of slots which are constructed and arrange for receipt of said strap.

10. The knee extension treatment apparatus of claim 9 which further includes a second strap which is constructed and range for receipt by said panel and is attachable to said frame.

11. The knee extension treatment apparatus of claim 10 wherein said panel further defines a second pair of slots which are constructed and arrange for receipt of said second strap.

12. The knee extension treatment apparatus of claim 11 wherein each strap is connected to a common cable for pulling manipulation by the amputee to achieve a desired tension on each strap.

13. The knee extension treatment apparatus of claim 11 wherein one pair of slots is located proximal to said aperture and the other pair of slots is located distal to said aperture.

14. The knee extension treatment apparatus of claim 7 which further includes a second strap which is constructed arrange for receipt by said panel and is attachable to said frame.

15. The knee extension treatment apparatus of claim 14 wherein one strap is located proximal to said aperture and the other strap is located distal to said aperture.

16. The knee extension treatment apparatus of claim 15 wherein each strap is connected to a common cable for pulling manipulation by the amputee to achieve a desired tension on each strap.

17. The knee extension treatment apparatus of claim 16 wherein said panel further defines a pair of slots which are constructed and arranged for receipt of one strap.

18. The knee extension treatment apparatus of claim 17 wherein said panel further includes a second pair of slots which are constructed arrange for receipt of said other strap.

19. A knee extension treatment apparatus for an amputee with a below-the- knee amputated leg comprising:

a frame;

a movable support for positioning beneath said amputated leg;

a panel defining a clearance aperture for alignment over the knee of said amputated leg;

first and second strap assemblies which are constructed arrange for connection to said frame and for receipt by said panel, wherein said first strap assembly is received distal of said aperture and said second strap assembly is received proximal of said aperture.

20. The knee extension treatment apparatus of claim 19 wherein said first strap assembly includes a first strap and said second strap assembly includes a second strap, each strap being connected at one end to said frame.

21. The knee extension treatment apparatus of claim 20 wherein said panel further defines a first pair of slots which are constructed arrange for receipt of said first strap and a second pair of slots which are constructed arrange for receipt of said second strap.

22. The knee extension treatment apparatus of claim 21 wherein each strap is connected to a common cable for pulling manipulation by the amputee to achieve a desired tension on each strap.

23. The knee extension treatment apparatus of claim 22 wherein said amputated leg is positioned between said movable support and said panel.