EP0195012A1 - Implant article et son usage - Google Patents
Implant article et son usageInfo
- 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
Links
Classifications
-
- 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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite 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
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) |
Families Citing this family (40)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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. |
-
1984
- 1984-07-10 NL NL8402178A patent/NL8402178A/nl not_active Application Discontinuation
-
1985
- 1985-07-10 AU AU46078/85A patent/AU4607885A/en not_active Abandoned
- 1985-07-10 JP JP50301785A patent/JPS62500981A/ja active Pending
- 1985-07-10 EP EP19850903404 patent/EP0195012A1/fr not_active Ceased
- 1985-07-10 WO PCT/NL1985/000027 patent/WO1986000533A1/fr not_active Application Discontinuation
Non-Patent Citations (1)
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
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AT BE CH DE FR GB IT LI LU NL SE |
|
17P | Request for examination filed |
Effective date: 19860729 |
|
17Q | First examination report despatched |
Effective date: 19880929 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION HAS BEEN REFUSED |
|
18R | Application refused |
Effective date: 19911118 |
|
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 |