EP0195012A1 - Implant article et son usage - Google Patents

Implant article et son usage

Info

Publication number
EP0195012A1
EP0195012A1 EP19850903404 EP85903404A EP0195012A1 EP 0195012 A1 EP0195012 A1 EP 0195012A1 EP 19850903404 EP19850903404 EP 19850903404 EP 85903404 A EP85903404 A EP 85903404A EP 0195012 A1 EP0195012 A1 EP 0195012A1
Authority
EP
European Patent Office
Prior art keywords
poly
fibres
lactide
article according
implant article
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
EP19850903404
Other languages
German (de)
English (en)
Inventor
Jan Willem Leenslag
Albert Johan Pennings
René Pieter Hendrick VETH
Henricus Wilhelm Bernhard Jansen
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.)
Rijksuniversiteit Groningen
Original Assignee
Rijksuniversiteit Groningen
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 Rijksuniversiteit Groningen filed Critical Rijksuniversiteit Groningen
Publication of EP0195012A1 publication Critical patent/EP0195012A1/fr
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix

Definitions

  • the present invention relates to an implant article for treatment in reconstructive surgery of damage caused to bony material.
  • the meniscus is an important component of the knee-joint in case of injuries the repair or preservation of the undamaged part of which is preferred over the surgical removal of the meniscus .
  • a damaged, e.g. torn, meniscus can only be healed if vascularisation of the injury is possible.
  • implantation of carbon fibres has proved to be a promising method of treating damaged menisci, technical deficiencies have become apparent, in most cases relating to a tendency to dislocation of the bundle of carbon fibres.
  • an implant article of the above-mentioned type which is characterised by a composite of fibre material which may or may not be bio-degradable and is incorporated in a porous matrix of a biodegradable organic polymer material.
  • the bio-degradable organic polymer material used for the matrix may be a polyurethane material, e.g., a polyether urethane, a polyester urethane and a polyether urea urethane; a polylacti.de material, e.g., a poly(L-lactide), a poly(D-lactide) and a poly (D,L-lactide); a polyglycolide material, e.g., a polyglycolic acid and copolymers composed of the different lactide materials, glycol materials and other hydroxycarboxylic acids, as well as homopolymers and copolymers of amino acids.
  • the individual polymer materials of mixtures thereof may be used, if required, with other bio-degradable polymer materials, e.g., with a porous polyamide material.
  • the fibre material for reinforcing the composite according to the invention may be incorporated in the matrix as loose fibres, however, also as a woven fabric, a knitted fabric or another coherent combination of fibres.
  • the fibres to be used according to the invention may or may not be bio-degradable and comprise, e.g., carbon fibres; sufficiently strong polyethylene fibres; poly (L-lactide fibres), if required, with additives, e.g., low-molecular additives or bio-degradeble homopolymers and/or copolymers; polyglycolide fibres; polyaramide fibres, e.g., poly(p-aminobenzoic acid) fibres; polyamide fibres, e.g., nylon fibres, or fibres of glycolide lactide copolymers.
  • the composite according to the invention may also include, e.g., materials capable of accelerating the bio-degradability of the matrix and the bio-degradability of the fibres, promoting ingrowth of tissue, having antibacterial activity and/or analgetic activity.
  • materials capable of accelerating the bio-degradability of the matrix and the bio-degradability of the fibres, promoting ingrowth of tissue, having antibacterial activity and/or analgetic activity are citric acid, sodium citrate, salicylic acid, aspirin, tartaric acid, magnesium chloride and calcium phosphate. It has turned out that the composite according to the invention is a product which, in addition to bio-degradable and bio-compatible properties, is also microporous and is therefore eminently suitable for effecting vascularisation or ingrowth of tissue, without which properties the repair of torn bone material, such as cartilage material of the meniscus, must be ruled out.
  • a composite according to the invention useful in practice for the repair of large wedge-shaped tears of the meniscus in dogs has appeared to be an implant article made of a polyurethane-poly(L-lactide) organic polymer material as the matrix, in combination with carbon fibres.
  • the composite formed therefrom was bio-degradable and bio-compatible and further microporous.
  • the invention is illustrated by the following example.
  • the polyurethane was reprecipitated 5 times (3 times from N,N-dimethylformamide (DMF) , then 1 time from tetrahydrofuran (THF) and finally, 1 more time from DMF) .
  • The.precipitant used was demineralised water. Reprecipitation was carried out at room temperature.
  • the composite involved in the in vivo examination was prepared from a 4% w /vsolution. (For uses requiring larger pores this could be achieved by further diluting the polymer solutions.
  • the final composite was built up of layers of the porous sheets as obtained under C., the polymer sheets with and without carbon fibres being alternately processed in the final composite.
  • the different layers were bonded together with a 1% w /v polymer solution, using the process mentioned under C.
  • the composite was brought to the required dimensions from which the final meniscus prosthesis could be cut to size.
  • DMF/THF 75:25% v /v e.g., also DMF/1.4-dioxane mixtures (75-25% V /v) (or other ratios) may be used.
  • Suitable solvents are further dimethylacetamide and dimethylsulfoxide.
  • a composite was prepared on the basis of a mixture composed of 95 wt.% polyurethane and 5 wt.% poly (L-lactide), using the process described under C.2. (a).
  • the resulting composite was microporous with a pore size of 35-50 /um.
  • the composite was folded double and sewed together, then adapted to the actual size of the damaged meniscus to be treated, placed in the incision and sewed together therein with 3-0 Dexon sewing-thread.
  • the wound was closed and the dogs were given an opportunity to get on their legs again as soon as possible.
  • the progress of the healing process was evaluated arthroscopically, morphologically and histologically in the manner appropriate therefor from a medical point of view. It turned out that all the implant elements except one had remained in position, and that ingrowth of fibrous fibro-cartilaginous material had taken place over a substantial distance from the place where the implant element is in contact with the surrounding meniscus. In two cases the meniscus proved to have healed already completely.
  • the composite according to the invention proves to be easy in handling owing to applying the organic polymer matrix and conducive to ingrowth of tissue and vessels because of the micro porous condition thereof. These last-mentioned properties are necessary for enabling a damaged meniscus to heal, as appears from

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Composite Materials (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (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)

Abstract

Article d'implant pour le traitement d'os endommagés en chirurgie reconstructive, l'article comprenant un composite à base d'un matériau fibreux pouvant être ou non bio-dégradable et est incorporé dans une matrice poreuse d'un matériau organique polymère bio-dégradable.
EP19850903404 1984-07-10 1985-07-10 Implant article et son usage Ceased EP0195012A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL8402178A NL8402178A (nl) 1984-07-10 1984-07-10 Entstuk, geschikt voor behandeling door reconstructieve chirurgie van beschadigingen van beenachtig materiaal.
NL8402178 1984-07-10

Publications (1)

Publication Number Publication Date
EP0195012A1 true EP0195012A1 (fr) 1986-09-24

Family

ID=19844197

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19850903404 Ceased EP0195012A1 (fr) 1984-07-10 1985-07-10 Implant article et son usage

Country Status (5)

Country Link
EP (1) EP0195012A1 (fr)
JP (1) JPS62500981A (fr)
AU (1) AU4607885A (fr)
NL (1) NL8402178A (fr)
WO (1) WO1986000533A1 (fr)

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GB2181438B (en) * 1985-10-07 1989-10-11 South African Inventions Biocompatible material
US5904717A (en) * 1986-01-28 1999-05-18 Thm Biomedical, Inc. Method and device for reconstruction of articular cartilage
US4781183A (en) * 1986-08-27 1988-11-01 American Cyanamid Company Surgical prosthesis
DE3644588C1 (de) * 1986-12-27 1988-03-10 Ethicon Gmbh Implantat und Verfahren zu seiner Herstellung
JPH0781204B2 (ja) * 1987-04-21 1995-08-30 株式会社バイオマテリアルユニバ−ス ポリ乳酸繊維
JP2820415B2 (ja) * 1988-03-14 1998-11-05 ティーエイチエム・バイオメディカル・インコーポレイテッド 生分解性および骨形成性を有する移植骨片代用組成体
GB2215209B (en) * 1988-03-14 1992-08-26 Osmed Inc Method and apparatus for biodegradable, osteogenic, bone graft substitute device
CA1302140C (fr) * 1988-03-23 1992-06-02 Melvin Bernard Herrin Methode d'assemblage d'ebauches de boites composites
US5092884A (en) * 1988-03-24 1992-03-03 American Cyanamid Company Surgical composite structure having absorbable and nonabsorbable components
US6323307B1 (en) 1988-08-08 2001-11-27 Cargill Dow Polymers, Llc Degradation control of environmentally degradable disposable materials
US5444113A (en) * 1988-08-08 1995-08-22 Ecopol, Llc End use applications of biodegradable polymers
US5502158A (en) * 1988-08-08 1996-03-26 Ecopol, Llc Degradable polymer composition
US5252642A (en) * 1989-03-01 1993-10-12 Biopak Technology, Ltd. Degradable impact modified polyactic acid
US5216050A (en) * 1988-08-08 1993-06-01 Biopak Technology, Ltd. Blends of polyactic acid
JPH0623260B2 (ja) * 1989-11-08 1994-03-30 工業技術院長 微生物崩壊性熱可塑性樹脂成形物及びその製造方法
US5026589A (en) * 1989-12-28 1991-06-25 The Procter & Gamble Company Disposable sanitary articles
PH31064A (en) * 1990-09-07 1998-02-05 Nycomed As Of Nycoveten Polymers containing diester units.
AU4923793A (en) * 1992-09-22 1994-04-12 Biopak Technology, Ltd. Degradation control of environmentally degradable disposable materials
JP3447289B2 (ja) 1992-10-02 2003-09-16 カーギル, インコーポレイテッド 溶融安定性ラクチドポリマー繊維及びその製造方法
US6005019A (en) * 1993-07-21 1999-12-21 United States Surgical Corporation Plasticizers for fibers used to form surgical devices
CA2175049A1 (fr) * 1993-10-28 1995-05-04 Timothy Ringeisen Procede et dispositif ameliores permettant de traiter et guerir une cavite osseuse
US5981825A (en) 1994-05-13 1999-11-09 Thm Biomedical, Inc. Device and methods for in vivo culturing of diverse tissue cells
US5756651A (en) * 1996-07-17 1998-05-26 Chronopol, Inc. Impact modified polylactide
DE19701912C1 (de) * 1997-01-10 1998-05-14 Jenapharm Gmbh Injizierbares Implantat
US6179840B1 (en) 1999-07-23 2001-01-30 Ethicon, Inc. Graft fixation device and method
CA2365376C (fr) 2000-12-21 2006-03-28 Ethicon, Inc. Utilisation d'implants en mousse renforces ayant une meilleure integrite pour la reparation et la regeneration de tissus mous
US6599323B2 (en) * 2000-12-21 2003-07-29 Ethicon, Inc. Reinforced tissue implants and methods of manufacture and use
US20040062753A1 (en) * 2002-09-27 2004-04-01 Alireza Rezania Composite scaffolds seeded with mammalian cells
US20040078090A1 (en) 2002-10-18 2004-04-22 Francois Binette Biocompatible scaffolds with tissue fragments
AU2004209554B2 (en) * 2003-02-04 2010-08-12 Warsaw Orthopedic, Inc. Polyurethanes for osteoimplants
US8197837B2 (en) 2003-03-07 2012-06-12 Depuy Mitek, Inc. Method of preparation of bioabsorbable porous reinforced tissue implants and implants thereof
US20040197375A1 (en) * 2003-04-02 2004-10-07 Alireza Rezania Composite scaffolds seeded with mammalian cells
US8226715B2 (en) 2003-06-30 2012-07-24 Depuy Mitek, Inc. Scaffold for connective tissue repair
US7931695B2 (en) 2003-07-15 2011-04-26 Kensey Nash Corporation Compliant osteosynthesis fixation plate
US10583220B2 (en) 2003-08-11 2020-03-10 DePuy Synthes Products, Inc. Method and apparatus for resurfacing an articular surface
US7699879B2 (en) 2003-10-21 2010-04-20 Warsaw Orthopedic, Inc. Apparatus and method for providing dynamizable translations to orthopedic implants
US20050136764A1 (en) * 2003-12-18 2005-06-23 Sherman Michael C. Designed composite degradation for spinal implants
US11395865B2 (en) 2004-02-09 2022-07-26 DePuy Synthes Products, Inc. Scaffolds with viable tissue
US7837913B2 (en) * 2004-08-11 2010-11-23 California Institute Of Technology High aspect ratio template and method for producing same
US20100318108A1 (en) * 2009-02-02 2010-12-16 Biomerix Corporation Composite mesh devices and methods for soft tissue repair

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US3463158A (en) * 1963-10-31 1969-08-26 American Cyanamid Co Polyglycolic acid prosthetic devices
US3739773A (en) * 1963-10-31 1973-06-19 American Cyanamid Co Polyglycolic acid prosthetic devices
AT352867B (de) * 1976-05-12 1979-10-10 Battelle Institut E V Knochenersatz-knochenverbund-oder prothesen- verankerungswerkstoff und verfahren zu seiner herstellung
FR2364644B1 (fr) * 1976-09-20 1981-02-06 Inst Nat Sante Rech Med Nouveau materiau de prothese osseuse et son application
US4164794A (en) * 1977-04-14 1979-08-21 Union Carbide Corporation Prosthetic devices having coatings of selected porous bioengineering thermoplastics
FR2439003A1 (fr) * 1978-10-20 1980-05-16 Anvar Nouvelles pieces d'osteosynthese, leur preparation et leur application
US4411027A (en) * 1979-04-27 1983-10-25 University Of Medicine And Dentistry Of New Jersey Bio-absorbable composite tissue scaffold
EP0050215B1 (fr) * 1980-10-20 1987-11-19 American Cyanamid Company Modification de l'acide polyglycolique pour obtenir des propriétés physiques "in vivo" variables
NL8202893A (nl) * 1982-07-16 1984-02-16 Rijksuniversiteit Biologische verdraagbaar, antithrombogeen materiaal, geschikt voor herstellende chirurgie.

Non-Patent Citations (1)

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Title
See references of WO8600533A1 *

Also Published As

Publication number Publication date
NL8402178A (nl) 1986-02-03
WO1986000533A1 (fr) 1986-01-30
JPS62500981A (ja) 1987-04-23
AU4607885A (en) 1986-02-10

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Legal Events

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RIN1 Information on inventor provided before grant (corrected)

Inventor name: JANSEN, HENRICUS, WILHELM, BERNHARD

Inventor name: LEENSLAG, JAN, WILLEM

Inventor name: PENNINGS, ALBERT, JOHAN

Inventor name: VETH, RENE, PIETER, HENDRICK