Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/50—Prostheses not implantable in the body
  • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
  • A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump

Definitions

• This invention relates to liners for use in a prosthetic assembly. More particularly, the described invention relates to liners having a particular stitching such that the distal end of the liner has less stretch than the proximal end of the liner so as to reduce pistoning which incorporate low extensibility strips which reduce elongation in the longitudinal direction when applied to prosthetics and orthotics.
• Gel and urethane liners have also been used for prosthetic and orthotic purposes and, for the most part, have a fabric covering.
• the fabric covering is used to reinforce the underlying material (silicone, gel, urethane) and allows for extensibility to make it easier to don and doff the liner by rolling it on and off the residual limb.
• Older versions of fabric liners with lower longitudinal elongation at the distal end prevent pistoning but also constrain the knee flexion of the amputee. If a liner exhibits a high longitudinal elongation throughout its length, then the prosthesis will move up and down during ambulation. On the other hand, if there is no longitudinal elongation then the amputee will find it difficult to flex the knee. [0010] In order to overcome this issue, liners with a distal matrix were developed such as the liner described in U.S. Patent No.6,454,812, described above. These liners include an additional fabric matrix which is knit to minimal longitudinal elongation where the matrix is bonded to the interior of the external fabric of the liner.
• the arms have to radiate from the distal attachment plate or mounted to a peripheral edge of the distal attachment plate.
• the present invention allows for the use of low extensibility strips anywhere on or in the prosthetic/orthotic without being limited to a certain location on the device.
• the distal ends of locking liners require the fabric to be less extensible in the longitudinal direction or that a polymer or other solid implement be used in order to reduce pistoning of the prosthetic implement during ambulation or movement.
• Other regions may benefit from reduced extensibility of the fabric cover such as in the case the above the knee amputees who may exhibits unusually fleshy residual limbs.
• the present invention utilizes stitching with reduced stretch regions such that the distal end of the liner has less stretch than the proximal end so as to prevent pistoning. [0015] Therefore, it is an object of this invention to provide an improvement which overcomes the aforementioned inadequacies of the prior art devices and provides an improvement which is a significant contribution to the advancement of the liner art. [0016] Another object of the invention is to provide a liner for prosthetic assemblies that reduces pistoning of the residual limb when in use. [0017] Another object of the invention is to provide a liner for prosthetic assemblies that can also be used with a locking prosthetic assembly. [0018] Another object of the invention is to provide a liner that implements two or more stitching types.
• Another object of the invention is to provide a liner with less stretch capability at the distal end than at the proximal end. [0020] Another object of the invention is to provide a liner with variable stretch characteristics based on knit construction and stitching. [0021] Another object of the invention is to provide strips or other shapes of low extensibility material which can be applied to the exterior of fabric liners. [0022] Another object of the invention is to provide low extensibility material which, when applied to fabric liners, reduce extensibility in the longitudinal direction while maintaining extensibility in the transversal direction. [0023] Another object of the invention is to provide a fast and inexpensive way to reduce the extensibility of fabric liners in desired regions.
• Another object of the invention is to provide a customizable solution for patient comfort such that a prosthetist can adhere appropriate shapes in appropriate locations in order to support or contain a region or segment of the residual limb as required by patient clinical conditions.
• Another object of the invention is to contain the dynamic deformation of the residual limb during ambulation.
• Another object of the invention is to provide a low extensibility material which can be cut into customer or standard shapes.
• the present invention relates generally to a liner for use in a prosthetic assembly having variable stretch regions at a distal end providing different stretch regions incorporating low extensibility strips.
• the present invention relates to a prosthetic liner having a lower longitudinal stretch in the distal region than in either the proximal or optional intermediate region.
• the distal region may stretch anywhere from 0-30% vertically and 10-200% horizontally as compared to the proximal region's vertical stretch of 55-125% and 100-175% horizontally.
• the stretch of the liner at various pressure sensitive regions of a residual limb can also be lowered or heightened depending on the area. A variety of stitches may be used at the distal end to implement this lowered longitudinal stretch.
• the liner is made of a stretchable material.
• the liner also has an interior layer of elastomer gel. The design of this prosthetic liner is primarily to prevent the “pistoning” of the amputee's residual limb within the liner and for comfort over pressure- sensitive areas of the residual limb.
• the liner also includes the use of a low extensibility material which is adhered to the fabric portion of a prosthetic liner or orthotic liner either internally or externally and limits the longitudinal movement while allowing for transversal movement.
• the customizable nature of the invention allows for shaping and personalization depending on the needs of the user.
• Fig.1 is a cross-sectional view of the present invention for use with a locking prosthetic assembly comprising two different types of stitches showing the different relevant regions;
• Fig. 2 is a cross-sectional view of the present invention showing below-the-knee amputation pressure sensitive areas;
• Fig. 3 is a cross-sectional view of the present invention showing below-the-knee- amputation pressure tolerant areas;
• Fig.1 is a cross-sectional view of the present invention for use with a locking prosthetic assembly comprising two different types of stitches showing the different relevant regions;
• Fig. 2 is a cross-sectional view of the present invention showing below-the-knee amputation pressure sensitive areas;
• Fig. 3 is a cross-sectional view of the present invention showing below-the-knee- amputation pressure tolerant areas;
• FIG. 4 is a cross-sectional view of the present invention showing above-the-knee amputation pressure sensitive areas;
• Fig. 5 is a cross sectional view of the present invention showing above-the-knee amputation pressure tolerant areas;
• Figs.6A-6N are various stitching types that can be used in the distal region of the present invention to prevent pistoning;
• Fig.7 is a cross-sectional view of a liner incorporating the low extensibility material internally;
• Fig.8 is a top view of the low extensibility material in one preferred shape;
• Fig.9 is a top view of the low extensibility material in a second preferred shape; [0043] Fig.
• FIG. 15 is a perspective view of a back orthotic with the low extensibility material adhered externally;
• Fig.16A is a perspective view of an ankle orthotic with the low extensibility material adhered externally;
• Fig.16B is a cross-sectional view of the ankle orthotic shown in Fig.16A;
• Fig. 17 is a perspective view of a knee orthotic with the low extensibility material adhered externally;
• Fig.18 is a perspective view of an elbow orthotic with the low extensibility material adhered externally.
• the present invention relates to a liner 100 for use with prosthetic devices. As shown in Fig.1, the liner 100 for use with a prosthetic assembly comprises a plurality of types of stitching.
• the liner 100 comprises a distal region 50 with a distal region fabric covering 52, proximal region 60 with proximal region fabric covering 62, and an optional intermediate region 70 with intermediate region fabric covering 72.
• the distal region 50 that comprises the distal end 80 of the liner is constructed with a reduced vertical stretch when compared to the upper region 60 of the liner.
• the distal region 80 has a vertical stretch of 0-30% and a horizontal stretch of 10-200% as compared to the proximal region 60, which preferably has a vertical stretch of 55-125% and a horizontal stretch of 100-175%.
• the intermediate region 70 may have a vertical stretch of 15-40% and a horizontal stretch of 80-120% or it may have the same stretch characteristics of the proximal region 60.
• the reduced stretch of the distal region 50 is achieved on a flatbed knitting machine by use of a variety of different stitches as described below.
• the liner 100 is knit in a single piece construction with the proximal end 90 being open and the distal end 80 being closed.
• the two halves may be independently constructed and then sewn or attached together by another means to form the completed liner textile.
• the liner 100 is knit using computerized flatbed knitting machines that allow the use of several different yarns at the same time or sequentially in the same garment, including elastomeric fibers such as Lycra, latex, and silicone among others. These machines also allow the use of different stitch types in different areas of the same garment and controls the tension of each yarn being knitted.
• an interior gel layer 10 resides on a limb face 22 of exterior liner fabric layer 30 which is co-extensive throughout the length of the liner 100.
• the gel layer 10 may be any form of stretchable elastomer as known in the industry or later developed but is preferably a styrene-based polymer such as SEEPS or SEBS.
• the liner 100 comprises regions of differing horizontal and vertical stretch stitching depending on anatomical features related to the residual limb or mechanical features related to the prosthetic socket.
• the boundary 110 is preferably generally perpendicular to the central axis 120 of the liner 100.
• the distal end 70 may house a locking mechanism 130.
• the use of a locking mechanism 130 requires a construction that is strong enough for the distal attachment plate 140 to be retained by the fabric or else a catastrophic failure of the prosthesis may result.
• locking mechanisms 130 are secured to the fabric through the use of a grommet that bites into the fabric or other similar means of attachment.
• a grommet that bites into the fabric or other similar means of attachment.
• the construction of the knit at the distal end must be heavier and stronger than the rest of the fabric cover.
• Such construction cannot be used in the intermediate region 70 or proximal region 60 because it would impart poor functionality to the liner and limit the user's movement.
• the locking mechanism region fabric covering 152 in the locking mechanism region 150 must have little to no longitudinal elongation but high circumferential elongation in order to comfortably accommodate the residual limb.
• the locking mechanism region 150 is limited to the area juxtaposed to the locking mechanism 130.
• the thickness of the fabric in the locking mechanism region 150 should greater than the thickness of the fabric in the distal region 50.
• the distal region 50 as compared to the locking mechanism region 150, must have a greater degree of longitudinal elongation in order to facilitate knee flexion.
• the intermediate region 70 may have an even greater degree of longitudinal elongation and circumferential elongation than the distal region 50 to provide greater comfort to the amputee when sitting or moving.
• the liner textile comprises regions of differing horizontal and vertical stretch depending on anatomical features related to the residual limb or mechanical features related to the prosthetic socket.
• the pressure sensitive effective areas for below-the-knee amputations comprise the portions of the tibia 160 such as the anterior tibia 170 and the anterior tibial crest 180 as well as parts of the fibula 190 such as the fibular head and neck 200, and the fibular nerve These regions of the body exhibit sensitivity to pressure and therefore require a liner having greater longitudinal or circumferential elongation at those points.
• the pressure-tolerant effective areas for below-the- knee amputations comprise the patellar tendon 220, the medial tibia plateau 230, the tibial shaft 240, the fibular shaft 250, and the distal end 260 of tibia 160 and fibula 190. These regions may have more restricted longitudinal or circumferential elongation due to the tolerance these regions exhibit. [0061] Similarly, as shown in Figs. 4 and 5, above-the-knee amputations have similarly pressure sensitive and pressure tolerant areas.
• the pressure sensitive areas comprise the distolateral end 280 of the femur 270, the pubic symphysis 300 of the pelvic bone 290, and the perineal area 310310.
• the pressure tolerant areas comprise the ischial tuberosity 320 of the pelvic bone 290, the gluteals 330, the lateral sides 340 of the residual limb, and the distal end 350 of the femur 270.
• pressure sensitive areas of above-the-knee amputations require greater longitudinal or circumferential elongation at those points while the pressure tolerant areas may have more restricted longitudinal or circumferential elongation due to the tolerance those regions exhibit.
• the fabric of the liner can be constructed in a number of ways so as to provide the required functionality.
• the functionality can be altered by using different yams or deniers, different elastomers, different weights of elastomers, and different stitches, among other ways, to provide the right longitudinal and circumferential elongation along the length of the liner.
• Typical yam types include, but are not limited to, polyester, nylon, acrylic, cellulosic, aramid, natural fibers, and metal wires.
• Typical elastomers include Lycra/polyurethane, natural rubber, nitrile, and silicone.
• Typical stitch types, as shown in Figs. 6A-6N, include weft (Fig. 6A), warp (Fig.
• the present invention relates to a low extensibility material 400 for use with prosthetic or orthotic devices using the knit design described above.
• this low extensibility material 400 can be used with a prosthetic liner 100 having a distal attachment plate 140 at a distal end 80.
• the low extensibility material 400 for use with a prosthetic or orthotic assembly preferably comprises a strip of material 410 preferably made of strips of silk, fiberglass cloth, and other non- elastic materials like carbon fiber and thermoplastics.
• the strip of material 410 may also be a piece of fabric 412 having an inelastic backing 414 which can face the interior gel layer 10 or the exterior fabric liner layer 30 (as shown in Fig. 7, the inelastic backing 414 faces the interior gel layer 10 which is preferred).
• the prosthetic liner 100 comprises an elastomer layer 10 having a limb face 22 and a fabric face 20 wherein the fabric face 20 of the elastomer layer 10 is adhered to the external fabric 30 of the prosthetic liner 100.
• the low extensibility material 400 can be adhered to the fabric 30 either internally or externally and preferably up to six inches from the open proximal end. If internal placement is desired, the low extensibility material 400 is placed between the elastomer layer 10 and the fabric 30 in the desired region and adhered only to the fabric 30 as shown in the exploded view Part B.
• the low extensibility material 400 is placed at the distal end 80 of the prosthetic liner 100 and extends towards the proximal end 90 of the prosthetic liner 100.
• the low extensibility material 400 preferably extends upward towards the proximal end 90 of the prosthetic liner 100, stopping at least an inch from the proximal end 90, when placed at the distal end 80.
• the width of the low extensibility material 400 is between 0.5-4 inches such that it can be placed in a variety of locations and positions.
• Figs. 8-13 show the low extensibility material 400 is a variety of configurations. Fig.
• the low extensibility material 400 as a strip of material having a central aperture 420 with a bulged mid-region 430.
• the locking mechanism 130 as shown in Fig. 7, can be fed through the central aperture 420 if the low extensibility material 400 is adhered externally to the fabric 30.
• the low extensibility material 400 can also be configured to have multiple arms 440 extending radially outward from the central aperture 420.
• the central aperture 420 is optional.
• the low extensibility material 400 can be shaped such that a distal strip end 450 is convex while a proximal strip end 460 is concave.
• the low extensibility material 400 can be placed around the distal attachment plate 140 if desired or around the user's joint without impinging on joint movement.
• the low extensibility material 400 can be placed in a variety of configurations according to the needs of the user.
• the T-shape and single strip configuration shown are not the only configurations that would be helpful to a user and any configuration determined by a medical professional to be medically helpful can be used.
• Use of low extensibility material 400 as described herein has been tested and conclusively shows that use of the low extensibility material 400 limits the longitudinal stretch of the liner 100 while maintaining transversal stretch.
• transversal stretch was tested: [0067] R einforced Not Reinforced before after change % before after change % 77 62 77 05 [ was applied, and "after" refers to the liner at failure (i.e. until the strip tore). The number measured is circumference in inches. As can be seen from the test data, the transversal stretch was essentially the same whether the liner was reinforced with the low extensibility material 400 or not. [0069] A similar test was performed testing the longitudinal stretch: R einforced Not Reinforced 71 29 75 [0070] As can be seen from this test, the longitudinal stretch was reduced by more than half when the low extensibility material 400 was used.
• the low extensibility material 400 can also be used with orthotics which is useful to limit joint flexion both as a therapeutic aid in the case of injuries or as a means of injury prevention.
• the low extensibility material 400 works with a wrist brace 470 and can be adhered externally or internally as described above.
• the low extensibility material 400 can be integrated with a back brace orthotic 480.
• the low extensibility material 400 can be used with an ankle orthotic 490, as shown in Figs. 16A and 16B, where the low extensibility material 400 preferably has a thickness to prevent ankle movement.
• the low extensibility material 400 can be in a strip or in a specific shape, as determined by an orthotic physician, and be adhered to the fabric 30 either internally or externally.
• the low extensibility material 400 is first adhered to the fabric 30 on the fabric face 20 using conventional means and then the combination is placed in a mold wherein the gel, silicon, or urethane is molded over, creating a composite.

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• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Materials For Medical Uses (AREA)
• Prostheses (AREA)
• Knitting Of Fabric (AREA)

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• 2024
  • 2024-06-10 EP EP24823966.7A patent/EP4712914A2/de active Pending
  • 2024-06-10 WO PCT/US2024/033211 patent/WO2024258772A2/en not_active Ceased
  • 2024-06-10 CN CN202480052341.5A patent/CN121889115A/zh active Pending

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