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WO2003051241A1 - Revetement de prothese avec film de polymere - Google Patents

Revetement de prothese avec film de polymere Download PDF

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Publication number
WO2003051241A1
WO2003051241A1 PCT/SE2002/002434 SE0202434W WO03051241A1 WO 2003051241 A1 WO2003051241 A1 WO 2003051241A1 SE 0202434 W SE0202434 W SE 0202434W WO 03051241 A1 WO03051241 A1 WO 03051241A1
Authority
WO
WIPO (PCT)
Prior art keywords
liner
soft
residue
prosthetic
polymer film
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/SE2002/002434
Other languages
English (en)
Inventor
Kennet Hellberg
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.)
Centri AB
Original Assignee
Centri AB
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 Centri AB filed Critical Centri AB
Priority to AU2002358395A priority Critical patent/AU2002358395A1/en
Publication of WO2003051241A1 publication Critical patent/WO2003051241A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D165/00—Coating compositions based on macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain; Coating compositions based on derivatives of such polymers
    • C09D165/04—Polyxylylenes
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30065—Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/30217—Three-dimensional shapes conical hollow cones, e.g. tubular-like cones
    • 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
    • A61F2/5044—Designing or manufacturing processes
    • A61F2/5046—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
    • A61F2002/5053—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. casting model or mould
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • the present invention relates to a prosthetic liner externally coated with a friction reducing skin, and more specifically to a soft and elastic prosthetic liner having a polymer film deposited on the exterior of the liner.
  • prosthetic socks and liner members from synthetic elastic materials and thermoplastic elastomer materials, such as sili- con rubber and other synthetic rubbers, and copolymers based on vinyl chloride, styrene block copolymers, etc. , for padding and protecting the amputated limb that is inserted into a rigid sleeve carrying an artificial leg/ foot or an artificial arm /hand.
  • synthetic elastic materials and thermoplastic elastomer materials such as sili- con rubber and other synthetic rubbers, and copolymers based on vinyl chloride, styrene block copolymers, etc.
  • a problem in connection with prosthetic soft liners is the adhering surface properties of certain elastomer or gel materials that may cause difficulties when applying the liner onto the amputated limb (donning), such as by rolling the liner upwards from the end of the limb.
  • this problem is handled by spraying the surface of the liner with water or alcohol, or by applying talcum powder to the surface before the liner is applied about the amputated limb, thus avoiding the liner surface to adhere to itself, to skin, or to clothing.
  • Another conventional way of handling the sticky surface of the liner includes a layer of fabric that is attached about the outer side of the liner in order to facilitate donning.
  • the object is met in a soft and elastic prosthetic liner as defined in claim 1 , in a method of production as defined in claim 6 and by the use of a polymer film as defined in claim 9.
  • the invention suggests a friction reducing skin to be applied through polymerization of a polymer film on the exterior surface of a soft and elastic prosthetic liner in a vapor phase deposition process.
  • a soft and elastic prosthetic liner according to the invention is molded from a synthetic material for longitudinal and transversal elasticity.
  • the liner has an elongate, generally tubular shape with an open upper end and a closed bottom end, the length and periphery of the liner being determined for enclosing a portion of the residue of an amputated limb in firm contact thereabout for protecting and for fixation of the residue in a rigid prosthetic sleeve.
  • the liner has a friction reducing polymer film deposited on the exterior thereof, the film being applied in a vapor phase deposition polymeriza- tion process.
  • the term "soft and elastic prosthetic liner” refers to liners, prosthetic socks and prosthetic liners, to be carried on an amputated limb that is to be inserted into a rigid sleeve member carrying an artificial leg or arm/foot or hand.
  • the liners referred to are elastic elements, produced from elastic and elastomer materials as mentioned above such as various synthetic rubbers, silicon, polyvinyl chloride plastics (PVC), copolymers based on vinyl chloride, thermoplastic elastics (TPE) and thermoplastic elastomers such as styrene block copolymers, e.g.
  • Thermoplastic rubbers based on sty- rene block copolymers to be considered may involve polybutadiene [or poly- isoprene, poly (ethylene-butene), or poly (ethylene-propene)] tipped with polystyrene end blocks.
  • a prosthetic sock or liner for enclosing the distal end of an amputated limb is produced from materials based on polystyrene -butadiene- polystyrene-block copolymers (SBS), or from poly- styrene-ethylene-butylene-polystyrene-block copolymers (SEBS).
  • SBS polystyrene -butadiene- polystyrene-block copolymers
  • SEBS poly- styrene-ethylene-butylene-polystyrene-block copolymers
  • suitable materials are the SEBS thermoplastic elastomers sold under the trade name
  • Prosthetic soft liners are often adapted to the shape of the residue of the amputated limb by being molded on a copy of the residue.
  • the term "molded" is widely contemplated to include any procedure wherein the prosthetic liner is formed, with or without heating, on a negative or positive model of the limb, such as by dip molding, injection molding, thermo- forming, etc.
  • a mould or model for forming the liner may be a true copy of the amputated limb.
  • the liner of the present invention preferably is preformed from a thermoplastic elastomer material as discussed above, with a capacity to be reshaped in adaptation to changes in the shape of the amputation stump, occurring over time. Reshaping the liner involves thermoform- ing on a modified copy of the amputated limb, wherein the changes in shape have been considered in the copy.
  • a polymer film is applied to cover the external side of the soft liner through polymerization in a vapor phase deposition process.
  • the polymer film is a poly-paraxylylene film.
  • the process of coating the liner involves vaporization of a cyclic dimer, which contains the desired repeating unit such as cyclic di-paraxylylene, e.g., under vacuum and at a temperature of about 150° C.
  • the vaporized dimer is then heated to a temperature of about 650° C in a pyrolysis step, under same or similar vacuum conditions.
  • the benzylic carbon breaks to carbon bonds to provide a paraxylylene monomer, remaining in the vapor state.
  • the vaporous monomer is introduced in a vacuum chamber at ambient temperature of about 20°-30° C, containing the soft liner, where the monomer polymerizes on the exposed surface of the liner to provide a poly- paraxylylene film having a thickness of about 0,5 to a few micrometer.
  • the coating process typically is preceded by a cleaning step for removing dust particles and fat from the surface of the liner.
  • a monomerized paraxylylene dimer is preferred.
  • paraxylylene is a generic term applied to the family of unsubstituted and substituted poly-paraxylylenes.
  • the polymers can be homo-polymers or copolymers depending on whether they are derived from one particular dimer or a mixture of different dimer s.
  • the substituents can be any organic or in- organic group, which can normally be substituted on aromatic nuclei. Of the substituents, the preferred groups are the lower alkyls having 1 to 10 carbon atoms.
  • the substituent groups selected are generally functionally inert under process conditions.
  • the poly-paraxylylene film has been found to produce a layer of substantially continuous thickness effectively adhering to the elastic /elastomer material, without affecting the elastic properties of the soft elastic liner.
  • the applied poly-paraxylylene film has also unexpectedly been found to withstand the frequent tensioning of a liner that is repeatedly rolled on and off an amputated limb, without notably degrading or changing its protective efficiency and friction reducing properties also when subjected to repeated local elongation of up to about ten (10) times the original dimension of the liner.
  • the soft and elastic liner as disclosed maintains it's aesthetic appearance, repels dust and dirt, and avoids the use of talcum powder, water or alcohol for solving the problems caused by the adhering properties of certain elastic and elastomer materials.
  • the polymer film facilitates donning and extends the operational life of the liner. Reshaping the liner by thermoforming on a modified copy of the amputated limb is fully available with the polymer film applied to the liner.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials Engineering (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne l'application d'un film de polymère réduisant le frottement sur un revêtement de prothèse souple et élastique, par polymérisation d'un monomère cyclique dans un processus de vaporisation. L'invention concerne un procédé pour produire un revêtement de prothèse souple et élastique avec un film de polymère réduisant le frottement, et l'utilisation d'un film de polymère pour réduire le frottement de surface sur un revêtement de prothèse doux et élastique. Le film de polymère préféré est un film de polyparaxylylène.
PCT/SE2002/002434 2001-12-19 2002-12-19 Revetement de prothese avec film de polymere Ceased WO2003051241A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002358395A AU2002358395A1 (en) 2001-12-19 2002-12-19 Prosthetic liner with polymer skin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE0104301-7 2001-12-19
SE0104301A SE0104301D0 (sv) 2001-12-19 2001-12-19 Prosthetic device with polymer skin

Publications (1)

Publication Number Publication Date
WO2003051241A1 true WO2003051241A1 (fr) 2003-06-26

Family

ID=20286401

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2002/002434 Ceased WO2003051241A1 (fr) 2001-12-19 2002-12-19 Revetement de prothese avec film de polymere

Country Status (3)

Country Link
AU (1) AU2002358395A1 (fr)
SE (1) SE0104301D0 (fr)
WO (1) WO2003051241A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007013116A1 (fr) * 2005-07-29 2007-02-01 Leone S.P.A. Procede permettant de produire des appareils orthodontiques et appareil orthodontique
EP1814480A4 (fr) * 2004-11-22 2008-01-23 Freedom Innovations Inc Revetement ameliore pour chemisage de protheses, produits et parapluies ameliores
DE102008063818A1 (de) 2008-12-19 2010-06-24 Otto Bock Healthcare Gmbh Orthopäisches Polster und Verfahren zu seiner Herstellung
US11312071B2 (en) 2018-11-12 2022-04-26 Ossur Iceland Ehf Additive manufacturing system, method and corresponding components for making elastomeric structures
US11883306B2 (en) 2019-11-12 2024-01-30 Ossur Iceland Ehf Ventilated prosthetic liner

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9155636B1 (en) 2011-06-01 2015-10-13 Ray Fikes Prosthetic socket liner

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06313059A (ja) * 1993-04-30 1994-11-08 Nippon Pariren Kk シリコーンゴム弾性体
JPH07188438A (ja) * 1993-12-27 1995-07-25 Toshiba Silicone Co Ltd 表面処理されたシリコーンゴム成形品およびその製造方法
JP2001224611A (ja) * 2000-02-21 2001-08-21 Sato Giken:Kk 義手及びその製造方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06313059A (ja) * 1993-04-30 1994-11-08 Nippon Pariren Kk シリコーンゴム弾性体
JPH07188438A (ja) * 1993-12-27 1995-07-25 Toshiba Silicone Co Ltd 表面処理されたシリコーンゴム成形品およびその製造方法
JP2001224611A (ja) * 2000-02-21 2001-08-21 Sato Giken:Kk 義手及びその製造方法

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 199504, Derwent World Patents Index; Class A26, AN 1995-027723 *
DATABASE WPI Week 199538, Derwent World Patents Index; Class A26, AN 1995-290505 *
DATABASE WPI Week 200175, Derwent World Patents Index; Class A26, AN 2001-650826 *

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8070828B2 (en) * 2004-11-22 2011-12-06 Shannon Donald T Enhanced multiple viscosity liner
EP1814480A4 (fr) * 2004-11-22 2008-01-23 Freedom Innovations Inc Revetement ameliore pour chemisage de protheses, produits et parapluies ameliores
WO2007013116A1 (fr) * 2005-07-29 2007-02-01 Leone S.P.A. Procede permettant de produire des appareils orthodontiques et appareil orthodontique
US8999428B2 (en) 2008-12-19 2015-04-07 Otto Bock Healthcare Gmbh Orthopedic cushion and method for production thereof
CN102256632A (zh) * 2008-12-19 2011-11-23 奥托·博克保健有限公司 矫形垫及其制造方法
WO2010078924A3 (fr) * 2008-12-19 2010-12-16 Otto Bock Healthcare Gmbh Coussin orthopédique et son procédé de fabrication
US20110320011A1 (en) * 2008-12-19 2011-12-29 Otto Bock Healthcare Gmbh Orthopedic cushion and method for production thereof
DE102008063818B4 (de) * 2008-12-19 2012-12-13 Otto Bock Healthcare Gmbh Verfahren zur Herstellung eines orthopädischen Polsters
DE102008063818A1 (de) 2008-12-19 2010-06-24 Otto Bock Healthcare Gmbh Orthopäisches Polster und Verfahren zu seiner Herstellung
CN102256632B (zh) * 2008-12-19 2015-08-05 奥托·博克保健有限公司 矫形垫及其制造方法
RU2561032C2 (ru) * 2008-12-19 2015-08-20 Отто Бок Хелткэр Гмбх Ортопедическая прокладка и способ ее получения
US11312071B2 (en) 2018-11-12 2022-04-26 Ossur Iceland Ehf Additive manufacturing system, method and corresponding components for making elastomeric structures
US11390025B2 (en) 2018-11-12 2022-07-19 Ossur Iceland Ehf Medical device including a structure based on filaments
US12157269B2 (en) 2018-11-12 2024-12-03 Ossur Iceland Ehf Medical device including a structure based on filaments
US12415312B2 (en) 2018-11-12 2025-09-16 Ossur Iceland Ehf Additive manufacturing system, method and corresponding components for making elastomeric structures
US11883306B2 (en) 2019-11-12 2024-01-30 Ossur Iceland Ehf Ventilated prosthetic liner

Also Published As

Publication number Publication date
AU2002358395A1 (en) 2003-06-30
SE0104301D0 (sv) 2001-12-19

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