[go: up one dir, main page]

WO2024191621A2 - Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité - Google Patents

Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité Download PDF

Info

Publication number
WO2024191621A2
WO2024191621A2 PCT/US2024/018124 US2024018124W WO2024191621A2 WO 2024191621 A2 WO2024191621 A2 WO 2024191621A2 US 2024018124 W US2024018124 W US 2024018124W WO 2024191621 A2 WO2024191621 A2 WO 2024191621A2
Authority
WO
WIPO (PCT)
Prior art keywords
liner
region
distal
stretch
low extensibility
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/018124
Other languages
English (en)
Other versions
WO2024191621A3 (fr
Inventor
Aldo Laghi
Nathaniel Vint
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alps South Europe sro
Original Assignee
Alps South Europe sro
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/120,465 external-priority patent/US20230210676A1/en
Application filed by Alps South Europe sro filed Critical Alps South Europe sro
Priority to CN202480018235.5A priority Critical patent/CN121099969A/zh
Publication of WO2024191621A2 publication Critical patent/WO2024191621A2/fr
Publication of WO2024191621A3 publication Critical patent/WO2024191621A3/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

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
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0106—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the knees
    • A61F5/0109—Sleeve-like structures
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0111—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the feet or ankles
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0118—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the arms, hands or fingers
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/02—Orthopaedic corsets
    • 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
    • A61F2002/7818—Stockings or socks 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 and which incorporates low extensibility strips which reduce elongation in the longitudinal direction when applied to prosthetics and orthotics. [0006] Description of the Background Art
  • Prosthetic liners have been in use since the 1970’s, mostly custom made, and made of various materials. Silicone liners have been used since the 1980s in the prosthetic industry such as those described in U.S. Pat. No. 4,923,474 granted to Klasson and Kristinsson. Other examples of such liners include U.S. Pat. No. 5,728,168 to Laghi et al., U.S. Pat. No. 5,830,237 granted to Kania, U.S. Patent No. 5,507,834 to Laghi et al., U.S. Patent No. 5,443,525 to Laghi et al., and U.S. Patent No. 5,728, 168 to Laghi et al.
  • 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
  • U.S. Patent No. 5,443,525, U.S. Patent No. 5,507,234, U.S. Patent No. 5,728,168, U.S. Patent No. 6,544,292, and U.S. Patent No. 6,764,631 each represent advances in the field of fabric covered liners and the disclosures of which are hereby incorporated by reference.
  • U.S. Patent No. 6,454,812 also hereby incorporated by reference, describes a liner comprising additional features attached to the liner textile to limit the vertical stretch at the distal end of a liner and is incorporated herein by reference.
  • This method has been used successfully within the field of prosthetics to provide the liner textile with a strengthened distal end, means for attaching a threaded mechanical feature, and a boundary layer that prevents the thermoplastic elastomer from undesirably passing through the textile during high pressure processing.
  • 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. [00010]
  • 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.
  • Liners such as those described in U.S. Pat. No. 9,216,099 to Laghi, U.S. Pat. No. 9,364,347, U.S. Patent 8,394,150, U.S. Pat. No. 8,852,291, U.S. Pat. No. 8,246,694, U.S. Pat. No. 8,808,294, U.S. Pat. No. 8,226,732, U.S. Pat. No. 8,357,206, U.S. Pat. No. 6,764,631, U.S. Pat. No. 6,544,292, U.S. Pat. No.
  • U.S. Patent No. 6,231,617 to Fay which is incorporated herein by reference, describes the a liner which incorporates elongate arms of a strip or ribbon shape.
  • Fay a limitation of Fay is that 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 end of locking liners requires 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.
  • prosthetic lock systems that are used to retain a patient in a socket are prone to distracting the distal end of the limb due to a singular attachment point at the distal peak.
  • Utilizing a reinforcement to control the stretch characteristics of the liner help support the limb and prevent skin breakdown due to movement of the tissue or redundant tissue by reducing fluid movement and build up within the limb.
  • Distal distraction is well known within the art to cause skin break down and vascular issues due to the milking effect the liner can have on the residual limb especially if redundant tissue is at the distal end of the limb.
  • Prevention of distal distraction is heavily desired for high activity patients to reduce the tissue from moving away from the residual limb. [00016] 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.
  • Another object of the invention is to provide a liner for prosthetic assemblies that reduces pistoning of the residual limb when in use.
  • Another object of the invention is to provide a liner for prosthetic assemblies that can also be used with a locking prosthetic assembly.
  • 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.
  • Another object of the invention is to provide a liner with variable stretch characteristics based on knit construction and stitching.
  • 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.
  • 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.
  • Another object of the invention is 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 single-piece strip that controls distal distraction of a residual limb while allowing for anterior and posterior stretch to accommodate the residual limb.
  • 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.
  • this prosthetic liner is primarily to prevent the “pistoning” of the amputee’s residual limb within the liner and for comfort over pressuresensitive 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.
  • This strip preferably extends from the distal end about 4-12 inches, preferably 5-7 inches, and is 8-24 inches in length, preferably 10-14 inches, and 0.5-4 inches in width in order to control distal distraction.
  • 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. 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
  • Fig. 10 is a top view of the low extensibility material in a third preferred shape and configuration
  • Fig. 11 is a top view of the low extensibility material in a second preferred configuration
  • Fig. 12 is a cross-sectional view of a liner with an alternative arrangement of low extensibility material placed either internally or externally;
  • Fig. 13 is a cross-sectional view with an alternative arrangement of low extensibility material placed either internally or externally;
  • FIG. 14 is a perspective view of a wrist orthotic with the low extensibility material adhered externally;
  • 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.
  • the liner 100 for use with a prosthetic assembly comprises a plurality of types of stitching.
  • the liner 100 comprises a distal region 50, proximal region 60, and an optional intermediate region 70.
  • 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% from a resting position and a horizontal stretch of 10-200% from a resting position as compared to the proximal region 60, which preferably has a vertical stretch of 55-125% from a resting position and a horizontal stretch of 100- 175% from a resting position.
  • stretch and “elongation” are considered synonymous.
  • resting position as used herein means that the liner has not been donned by a patient yet.
  • 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 yams 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 fabric layer 30.
  • 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.
  • 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.
  • such 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 fabric 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 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 210.
  • the pressure-tolerant 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.
  • 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 310.
  • 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 yarn 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 for reduced elongation, as shown in Figs. 6A-6N, include weft (Fig. 6A), warp (Fig.
  • the present invention further incorporates a low extensibility material 400 for use with prosthetic or orthotic devices using the knit design described above. As shown in Fig. 7, 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 knitted out of non-elastic materials like carbon fiber, thermoplastics, and polyester on an interior face 520 and a urethane backing 530 on an exterior face 540.
  • the interior face 520 can be made of strips of silk, fiberglass cloth, and other non-elastic materials.
  • 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 elastomer layer 10 may be silicone, a styrene-based elastomer such as SEEPS, or any other thermoplastic elastomer now known or to be discovered in the art.
  • the low extensibility material 400 can be adhered to the fabric 30 either internally or externally.
  • 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, forming a composite.
  • 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 low extensibility material 400 preferably extends from the distal end 80 about 4-12 inches, preferably 5-7 inches, and is 8-24 inches in total length, preferably 10-14 inches, and 0.5-4 inches in width in order to control distal distraction Similarly, 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.
  • a prosthetic liner 100 is generally about 18 inches in length prior to any modification made by a prosthetist or patient.
  • Figs. 8-13 show the low extensibility material 400 is a variety of configurations.
  • Fig. 8 shows 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. This allows for the low extensibility material 400 to 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.
  • 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. Alternatively, exterior use is performed by adhering the low extensibility material 400 onto the outside of the fabric 30 in the desired location.

Landscapes

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

Abstract

Manchon prothétique présentant un étirement longitudinal plus petit dans la région distale que dans la région intermédiaire proximale ou facultative. La région distale peut être étirée de 0 à 30 % verticalement et de 10 à 200 % horizontalement comparativement à l'étirement vertical de la région proximale de 55 à 125 % et à son étirement horizontal de 100 à 175 %. L'étirement du manchon au niveau de diverses régions sensibles à la pression d'un membre résiduel peut également être réduit ou augmenté en fonction de la zone. Diverses mailles peuvent être utilisées au niveau de l'extrémité distale pour assurer cet étirement longitudinal réduit. Préférentiellement, le manchon est constitué d'un matériau étirable. Le manchon comprend également une couche intérieure de gel élastomère. La conception de ce manchon prothétique vise principalement à empêcher l'effet de « piston » du membre résiduel de l'amputé dans le manchon et à assurer le confort au niveau de zones sensibles à la pression du membre résiduel. Le manchon comprend également l'utilisation d'un matériau à faible extensibilité qui est collé à la partie de tissu d'un manchon prothétique ou d'un manchon orthétique de manière interne ou externe et limite le mouvement longitudinal tout en permettant un mouvement transversal. La nature personnalisable de l'invention permet une mise en forme et une personnalisation en fonction des besoins de l'utilisateur.
PCT/US2024/018124 2023-03-13 2024-03-01 Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité Pending WO2024191621A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202480018235.5A CN121099969A (zh) 2023-03-13 2024-03-01 引入低延展性条带的具有差异化针织面料外表的针织假体衬垫织物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18/120,465 US20230210676A1 (en) 2017-08-11 2023-03-13 Knit Prosthetic Liner Textile With Differentiated Knit Fabric Exterior Incorporating Low-Extensibility Strips
US18/120,465 2023-03-13

Publications (2)

Publication Number Publication Date
WO2024191621A2 true WO2024191621A2 (fr) 2024-09-19
WO2024191621A3 WO2024191621A3 (fr) 2024-10-24

Family

ID=92755671

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/018124 Pending WO2024191621A2 (fr) 2023-03-13 2024-03-01 Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité

Country Status (2)

Country Link
CN (1) CN121099969A (fr)
WO (1) WO2024191621A2 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5534034A (en) * 1990-07-13 1996-07-09 Caspers; Carl A. Prosthetic polyurethane liner and sleeve for amputees
WO1998004218A1 (fr) * 1996-07-31 1998-02-05 Ohio Willow Wood Company Gel et dispositifs d'amortissement
US8535776B2 (en) * 2010-11-16 2013-09-17 Velcro Industries B.V. Breathable and elastic fabric lamination
US9993357B2 (en) * 2014-02-21 2018-06-12 Ossur Hf Prosthetic socket system
US20210186719A1 (en) * 2018-09-04 2021-06-24 Aldo Laghi Knit Prosthetic Liner Textile With Differentiated Knit Fabric Exterior Incorporating Low Extensibility Strips
WO2019126119A1 (fr) * 2017-12-20 2019-06-27 Ossur Iceland Ehf Revêtement possédant différentes régions d'allongement

Also Published As

Publication number Publication date
WO2024191621A3 (fr) 2024-10-24
CN121099969A (zh) 2025-12-09

Similar Documents

Publication Publication Date Title
US20210186719A1 (en) Knit Prosthetic Liner Textile With Differentiated Knit Fabric Exterior Incorporating Low Extensibility Strips
US20250177171A1 (en) Knitted interface
US8523951B2 (en) Prosthetic socket interface and assembly
US6964688B1 (en) Tube sock-shaped covering
US6149690A (en) Prosthesis suspension sleeve
US10966845B2 (en) Knit prosthetic liner textile with differentiated knit fabric exterior
US20050101693A1 (en) Gel and cushioning devices
US20100042227A1 (en) Prosthesis Comprising a Shank for Accommodating an Amputation Stump
US20070162153A1 (en) Prosthetic sock providing graduated thickness and tibial crest load reduction for an amputee limb remnant
US20240415677A1 (en) Prosthetic Liner Textile with Differentiated Knit Fabric Exterior Incorporating Low Extensibility Strips and Patches
JPH01503683A (ja) 整形用装具と共に使用する支持部材
US20230380997A1 (en) Knit Prosthetic Liner Textile with Differentiated Knit Fabric Exterior Incorporating Low Extensibility Strips
US9364347B2 (en) Pocketed double fabric prosthetic liner
US20230210676A1 (en) Knit Prosthetic Liner Textile With Differentiated Knit Fabric Exterior Incorporating Low-Extensibility Strips
US20240315855A1 (en) Knit Prosthetic Liner Textile with Differentiated Knit Fabric Exterior Incorporating Low Extensibility Strips
WO2024191621A2 (fr) Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité
WO2025255359A1 (fr) Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité
WO2013112342A1 (fr) Manche pourvue d'une épaisseur de renfort
US20210154030A1 (en) Low Extensibility Strips for Prosthetic and Orthotic Applications
WO2024258772A2 (fr) Textile de manchon prothétique tricoté présentant un extérieur de tissu tricoté différencié incorporant des bandes à faible extensibilité

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24771383

Country of ref document: EP

Kind code of ref document: A2

WWE Wipo information: entry into national phase

Ref document number: 2024771383

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2024771383

Country of ref document: EP

Effective date: 20251013