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WO2001021113A2 - Garniture prothetique a renforcement distal - Google Patents

Garniture prothetique a renforcement distal Download PDF

Info

Publication number
WO2001021113A2
WO2001021113A2 PCT/US2000/013613 US0013613W WO0121113A2 WO 2001021113 A2 WO2001021113 A2 WO 2001021113A2 US 0013613 W US0013613 W US 0013613W WO 0121113 A2 WO0121113 A2 WO 0121113A2
Authority
WO
WIPO (PCT)
Prior art keywords
liner
residual limb
reinforcement member
limb
prosthetic
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.)
Ceased
Application number
PCT/US2000/013613
Other languages
English (en)
Other versions
WO2001021113A3 (fr
Inventor
Carl A. Caspers
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.)
CASPERS-SCHNEIDER TECHNOLOGIES Inc DOING BUSINESS AS TEC INTERFACE SYSTEMS
Original Assignee
CASPERS-SCHNEIDER TECHNOLOGIES Inc DOING BUSINESS AS TEC INTERFACE SYSTEMS
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
Application filed by CASPERS-SCHNEIDER TECHNOLOGIES Inc DOING BUSINESS AS TEC INTERFACE SYSTEMS filed Critical CASPERS-SCHNEIDER TECHNOLOGIES Inc DOING BUSINESS AS TEC INTERFACE SYSTEMS
Priority to AU50252/00A priority Critical patent/AU5025200A/en
Publication of WO2001021113A2 publication Critical patent/WO2001021113A2/fr
Publication of WO2001021113A3 publication Critical patent/WO2001021113A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

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    • A61F2/00Filters 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
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    • A61F2/78Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
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    • A61F2/00Filters 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
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    • A61F2002/30383Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/005Rosette-shaped, e.g. star-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00035Other metals or alloys
    • A61F2310/00047Aluminium or Al-based alloys

Definitions

  • the present invention relates to prosthetic devices and more particularly to a distal cap for a prosthetic liner and socket.
  • Residual limbs come in various sizes and shapes with respect to the stump. That is, most new amputations are either slightly bulbous or cylindrical in shape while older amputations that may have had a lot of atrophy are generally more conical in shape. Residual limbs may further be characterized by their various individual problems or configurations including the volume and shape of a stump and possible scar, skin graft, bony prominence, uneven limb volume, neuroma, pain, edema or soft tissue configurations.
  • a below the knee residual limb 10 is shown and described as a leg 12 having been severed below the knee terminating in a stump 14.
  • the residual limb 10 includes soft tissue as well as the femur 16, knee joint 18, and severed tibia 20 and fibula 22.
  • a below the knee residual limb 10 has its stump 14 generally characterized as being a more bony structure while an above the knee residual limb may be characterized as including more soft tissue as well as the vascular routes and nerve bundles.
  • amputees who have lost part of their arm 26, which terminates a stump 28 may also be characterized as having vascular routes, nerve bundles as well as soft and bony tissues.
  • the residual limb 10 includes the humerus bone 30 that extends from below the shoulder to the elbow from which the radius 34 and ulna bones 36 may pivotally extend to the point of severance.
  • the humerus bone 30 are the biceps muscle 38 and the triceps muscle 40 which may still yet be connected to the radius 34 and the ulna 36, respectively.
  • the residual limb amputee that has a severed arm 26 does not have the pressure bearing considerations for an artificial limb but rather is concerned with having an artificial limb that is articulable to offer functions typical of a full arm, such as bending at the elbow and grasping capabilities.
  • An individual who has a paralyzed limb would also have similar considerations wherein he or she would desire the paralyzed limb to have some degree of mobility and thus functionality.
  • All of these various artificial limbs have sockets to put the amputee's stump 14 into.
  • Another category of sockets is a socket that utilizes a liner or insert. Both categories of sockets typically were open-ended sockets which had a hollow chamber in the bottom and no portion of the socket touched the distal end of the stump 14. The stump was supported about its circumferential sides as it fit against the inside wall of the sockets.
  • the suction liner produces a kind of Chinese finger trap action when the weight of the artificial limb pulls on the liner. That is, when the amputee is standing on the artificial limb (phantom lines), weight bearing forces the limb to take the shape of the socket. As the amputee begins to walk and goes into swing phase where the body's weight is off the artificial limb, gravity acts on the artificial limb and the attached suction liner L.
  • the liner L which is typically a somewhat collapsible tube with flexible walls and a closed chamber, has a tendency to draw the soft tissue at the end of the stump 14 toward the artificial limb, as shown by the downward arrow, causing the soft tissue to elongate and the residual limb to narrow. Also, the liner has a tendency to begin to stretch downwardly and as this occurs there is a compression inwardly as shown by arrows C. This also causes a pumping action which causes fluid to be drawn into the elongated and narrowed portion of the residual limb. Then, when the amputee goes back in to weight bearing phase, the soft tissue that was just elongated and narrowed now becomes compressed.
  • the distal end cap must simply be non-collapsing. It does not have to be rigid.
  • the distal end cap may be constructed of any semi-rigid, non-collapsing material, including without limitation plastics, thermoplastics, urethanes, carbon fibers, or aluminum.
  • the distal end cap may cover various portions of the residual limb, depending on the shape, bony structure, and volume of the residual limb. That is, in below the knee amputations, for example, the tissue in the distal end of the residual limb is primarily fluids. Closer to the knee joint, the tissue becomes more in the nature of ligaments, tendons, and white fiber.
  • the distal end cap system of the present invention has advantages over earlier systems that used a double wall socket with a suspension sleeve that holds the inner socket to the residual limb.
  • the suspension sleeve is stretched over the top of the inner socket.
  • the sleeve also has to stretch over the side walls of the socket, which tend to interfere with movement or to create more effort in bending the knee.
  • the knee is an eccentric joint that doesn't have a common center so that as the leg is moved from straight extended to 90° flexion or further, the diameter and shape of the knee changes rather dramatically and the internal socket is quite rigid and doesn't accommodate that motion. There is some displacement created or pressure created because of that shape change that is not accommodated well when the internal socket encompasses the whole knee capsule area. In contrast, the system of the present invention eliminates this
  • the liner has a flexible reinforcement member that is attachable to the distal portion to prevent the weight of the artificial limb, acting upon the liner, from compressing and stretching the residual limb.
  • the reinforcement member preferably has a central portion centrally attached to the distal portion of the liner, and a peripheral portion extending radially outwardly from the central portion over the distal portion of the liner.
  • a principal object and advantage of the present invention is that it prevents elongation and narrowing of the distal end of the residual limb due to the weight of the artificial limb pulling on the socket liner.
  • Another principal object and advantage of the present invention is that it prevents the build-up of fluids in the distal end of the residual limb due to the drawing effect of the weight of the artificial limb on the socket liner.
  • Another object and advantage of the present invention is that it prevents a shearing effect on the skin of the distal end of the artificial limb due to the drawing effect of the weight of the artificial limb on the socket liner.
  • Another object and advantage of the present invention is that the height of the reinforcement member can be varied to accommodate the structure of the residual limb.
  • Another object and advantage of the present invention is that it may be permanently attached to the socket liner.
  • FIG. 1 is a side elevational view of the tissue and skeletal structure of an amputee's residual limb.
  • FIG. 2 is a side elevational view of a residual limb in the form of an amputated arm showing the skeletal and muscular structure of the residual limb.
  • FIG. 3 is a perspective view of a reduced positive model of the socket as described in U.S. Patent No. 5,258,037.
  • FIG. 4 is a perspective view of a liner produced as described in U.S. Patent No. 5,258,037.
  • FIG. 5 shows a prior art liner with shuttle system attached to a residual limb, and showing the elongation forces exerted upon the residual limb as the wearer moves the artificial limb between swing phase and weight-bearing phase (shown in phantom).
  • FIG. 6 is a schematic cross-section of a first embodiment of a distal end cap of the present invention.
  • FIG. 7 illustrates how the distal end cap of FIG. 6 is heated, molded, and attached to the liner which in turn is in place on a reduced positive mold of the residual limb.
  • FIG. 8 illustrates further the process of FIG. 7, with the distal end cap now being conformed to the shape of the residual limb.
  • FIG. 9 shows the completed model ready for manufacture of the socket, with the distal end cap completely conformed to the shape of the residual limb and the valve and docking system removed.
  • FIG. 10 shows the completed artificial limb with the liner and distal end cap shown in phantom and with structure broken away to show the docking system.
  • FIG. 11 is a perspective view of the complete socket system in place on the residual limb, with some structure broken away to show internal components.
  • FIG. 12 is a schematic cross-section of a second embodiment of the distal end cap of the present invention.
  • FIG. 13 shows the embodiment of FIG. 12 in place on the residual limb.
  • FIG. 14 illustrates attachment of the distal end cap to the socket by means of a Velcro strap.
  • FIG. 15 illustrates attachment of the distal end cap to the socket by means of a lanyard and cleat.
  • FIG. 16 is a cross-section along the lines 16 of FIG. 11.
  • FIG. 17 is a plan view of the distal reinforcement member of the present invention.
  • FIG. 18 is a side elevational view of the liner of the present invention with the distal reinforcement member attached.
  • FIG. 19 is a cross-sectional view of the liner of the present invention, including a docking member, with the distal reinforcement member attached to the liner.
  • FIG. 20 is a plan view of another embodiment of the distal reinforcement member of the present invention.
  • FIG. 21 is a plan view of another embodiment of the distal reinforcement member of the present invention.
  • FIG. 22 is a plan view of another embodiment of the distal reinforcement member of the present invention.
  • FIG. 23 is a cross-sectional view of the distal reinforcement member before application to the liner.
  • the distal end cap of the present invention is generally designated in the Figures as reference numeral 110.
  • a first embodiment of the distal end cap 110 comprises a cap portion 112 constructed of a semi-rigid, non-collapsing material adapted to sustain the diameter of the residual limb without collapsing under load, and a docking portion 114 for connecting to the artificial limb socket.
  • the cap portion 112 may be made of any semi-rigid, non-collapsing material including, without limitation, plastics, thermoplastics, urethanes, carbon fibers, or aluminum.
  • the cap portion 112 is moldable to the shape of the distal end of the residual limb, as will be further discussed below.
  • the height H of the cap portion need only be enough to enclose the distal end of the residual limb.
  • the height H may be higher when the residual limb has a lot of soft tissue, as in above the knee (AK) residual limb, and the height H may be less when the residual limb is more bony, as in a below the knee (BK) residual limb.
  • the distal end cap 110 may also preferably include a one-way valve 116 traversing the distal end cap 110 and adapted to evacuate air from the liner L as the wearer dons the liner. As shown in Fig. 6, the valve 116 may traverse the cap portion 112, in which case it is shown as 116a. Alternatively, the valve 116 may traverse the docking portion 114 in which case it is shown as 116b.
  • the docking portion 114 preferably further comprises a mechanical interlocking linkage 114a releasably connecting the distal end cap 110 and the socket 104, as shown in Fig. 11.
  • the Figures show the mechanical interlocking linkage 114a as a cylindrical member with a number of ratchets therealong, for connecting to an appropriate orifice (not shown) in the socket 104.
  • any equivalent mechanical interlocking linkage may be used, as for example the ring 128 and pin disclosed in U.S. 5,258,037 or a smooth cylindrical member (not shown) with a cotter pin inserted therethrough.
  • the function of the docking portion 114 is to hold the distal end cap 110 to the socket 104, and any equivalent structure which accomplishes this task may be used.
  • the distal end cap 110 may include a strap 118 attached to the distal end cap 110 at one end and to the socket 104 at the other end of the strap, as seen in Figs. 14 and 15.
  • the strap 118 has a hook-and-loop fastener 118b attached to one end of the strap 118 and a matching hook-and-loop fastener 118a attached to the socket 104.
  • the strap 118 feeds out of the socket 104 through an opening 122.
  • the strap 118 attaches to the socket 104 by means of wrapping around a cleat 124.
  • the distal end cap 110 may also include an alignment system 130 for aligning the docking system 114 and valve 116 with corresponding structures in the socket 104.
  • the alignment system 130 may preferably comprise a tab, tongue, or protrusion 132 which mates with a groove or slot 134 in the wall of the socket 104.
  • valve V and docking shuttle S may be removed from the distal end cap, as shown in Fig. 9
  • the construction process then continues as described in U.S. Patent No. 5,258,037. It will be recognized that because the distal end cap 110 is in place on the model M, space will be left in the negative model of the socket to accommodate a distal end cap 110 when it is later donned by the wearer.
  • the end result of the construction process is the artificial limb shown in Fig. 10.
  • the artificial limb includes a socket 104, shin 106, and foot 108.
  • a prosthetic liner with flexible reinforcement member is generally shown in the Figures as reference numeral 210. Applicant has found that the reinforcement member may act equivalently as the distal end cap 110 for most applications.
  • the prosthetic liner 210 may appropriately be a liner as disclosed in U.S. Patent No. 5,534,034, herein incorporated by reference.
  • the prosthetic liner 210 suitably has a volume and a shape for receiving a substantial portion of an amputee's residual limb and fitting in the space between the socket of an artificial limb and the residual limb with the liner donned on the residual limb, the liner having a distal portion 212 adjacent the end of the residual limb.
  • the prosthetic liner 210 of the present invention particularly comprises a flexible reinforcement member 214 attachable to the distal portion 212 to prevent the weight of the artificial limb, acting upon the liner, from compressing and stretching the residual limb, as disclosed above.
  • the reinforcement member 214 further comprises a central portion 216 centrally attached to the distal portion 212 of the liner 210, and a peripheral portion 218 extending radially outwardly from the central portion 216 over the distal portion 212.
  • the peripheral portion 218 comprises a plurality of fingers 220 separated from one another by gaps 222.
  • the fingers 220 are of uniform width W along their radial extent R.
  • the fingers 220 increase in width W, W' as they extend radially outwardly from the central portion 216.
  • the reinforcement member 214 preferably comprises fabric 230, an adhesive 232 bonded to the fabric 230, and a removable backing paper 234 covering the adhesive.
  • the backing paper 234 is removed for attaching the reinforcement member 214 to the liner 210 by the adhesive 232.
  • the adhesive 232 may be any adhesive, such as ScotchTM 9690 Laminating Adhesive from 3M, St. Paul, Minnesota 55144-1000.
  • the prosthetic liner 210 may further comprise a docking member 240 at the distal portion 212, the docking member 240 being adapted to be connected to the artificial limb socket as discussed above.
  • the docking portion 114 may suitably be connected to the docking member 240.
  • the reinforcement member 212 has a central opening 250 encompassing the docking member 240.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une garniture prothétique dont la forme et le volume sont conçus de façon à recevoir une partie substantielle d'un moignon d'un amputé, et à ajuster la garniture enfilée sur le moignon, dans l'espace situé entre l'emboîture d'un membre artificiel et ledit moignon, ladite garniture possédant une extrémité distale adjacente à l'extrémité du moignon. Cette garniture possède un élément de renforcement souple que l'on peut fixer à sa partie distale afin que le poids du membre artificiel agissant sur la garniture ne comprime le moignon ou ne tire sur celui-ci. L'élément de renforcement comprend, de préférence, une partie centrale fixée centralement à la partie distale de la garniture, et une partie périphérique s'étendant radialement à l'extérieur de la partie centrale sur ladite partie distale de la garniture.
PCT/US2000/013613 1998-07-15 2000-05-18 Garniture prothetique a renforcement distal Ceased WO2001021113A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU50252/00A AU5025200A (en) 1998-07-15 2000-05-18 Prosthetic liner with distal reinforcement

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11505398A 1998-07-15 1998-07-15
US39970899A 1999-09-21 1999-09-21
US09/399,708 1999-09-21

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Publication Number Publication Date
WO2001021113A2 true WO2001021113A2 (fr) 2001-03-29
WO2001021113A3 WO2001021113A3 (fr) 2001-11-15

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PCT/US1999/001460 Ceased WO2000003665A1 (fr) 1998-07-15 1999-01-25 Coiffe prothetique distale, garniture et fourreau
PCT/US2000/013613 Ceased WO2001021113A2 (fr) 1998-07-15 2000-05-18 Garniture prothetique a renforcement distal

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PCT/US1999/001460 Ceased WO2000003665A1 (fr) 1998-07-15 1999-01-25 Coiffe prothetique distale, garniture et fourreau

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WO (2) WO2000003665A1 (fr)

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