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FR2510394A1 - Ligament or tendon prosthesis stimulating tissue regrowth - comprises fibrous material, e.g. carbon fibres, coated with collagen - Google Patents

Ligament or tendon prosthesis stimulating tissue regrowth - comprises fibrous material, e.g. carbon fibres, coated with collagen Download PDF

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Publication number
FR2510394A1
FR2510394A1 FR8114840A FR8114840A FR2510394A1 FR 2510394 A1 FR2510394 A1 FR 2510394A1 FR 8114840 A FR8114840 A FR 8114840A FR 8114840 A FR8114840 A FR 8114840A FR 2510394 A1 FR2510394 A1 FR 2510394A1
Authority
FR
France
Prior art keywords
ligament
collagen
fibers
tendon
coated
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.)
Granted
Application number
FR8114840A
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French (fr)
Other versions
FR2510394B1 (en
Inventor
Michel Bercovy
Daniel Goutallier
Daniel Blanquaert
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.)
Ceraver SA
Original Assignee
Ceraver SA
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 Ceraver SA filed Critical Ceraver SA
Priority to FR8114840A priority Critical patent/FR2510394A1/en
Publication of FR2510394A1 publication Critical patent/FR2510394A1/en
Application granted granted Critical
Publication of FR2510394B1 publication Critical patent/FR2510394B1/fr
Granted legal-status Critical Current

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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • 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
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments

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

Abstract

Ligament or tendon prosthesis which induces growth of replacement connective tissue is made of biodegradable fibrous material (A) having a coating, also made of biodegradable material and consisting at least in part of collagen. The collagen coating is pref. 0.2-5mm thick. (A) may be of carbon fibres, esp. of dia. about 7 microns and made up into bundles of about 10000 fibres, or they are natural silk fibres. The devices can be used in humans or animals e.g. to repair ligament of the knee or ankle, the Achilles tendon and ligaments of the acromio-claricular articulation. Compared with known prostheses, they are less fragile in the initial stage (before growth of replacement tissue), resist abrasion by bones and induce rapid tissue regrowth.

Description

Ligament ou tendon prothétique, et procédés de fabrication de ceuxci.Prosthetic ligament or tendon, and methods of making the same.

La présente invention concerne un ligament ou tendon prothétique en fibres d'un matériau biodégradable, muni d'un revêtement également biodégradable, et induisant la formation d'un tissu fibroconjonctif de remplacement. Elle s'étend également à des procédés de fabrication de ceux-ci. The present invention relates to a prosthetic ligament or tendon made of fibers of a biodegradable material, provided with a coating which is also biodegradable, and inducing the formation of a replacement fibroconjunctive tissue. It also extends to methods of manufacturing these.

On a déjà tenté de remplacer les ligaments ou tendons naturels gravement endommagés par des ligaments ou tendons entièrement prothétiques. Les ligaments ou tendons entièrement prothétiques, non biodégradables, notamment en fils d'acier inoxydable ou de polyester revêtus de silicone, en polyéthylène, n'ont pas donné de résultats satisfaisants de façon durable. Attempts have already been made to replace severely damaged natural ligaments or tendons with fully prosthetic ligaments or tendons. The entirely prosthetic, non-biodegradable ligaments or tendons, in particular in stainless steel or polyester wires coated with silicone, in polyethylene, have not given satisfactory results in a lasting manner.

On a aussi proposé de remplacer ces ligaments ou tendons naturels par des ligaments ou tendons en fibres d'un matériau biodégradable, notamment des fibres de carbone, revêtues d'un matériau non biodégradable, tel que le pyrocarbone, ou biodégradable, tel que l'acide polylactique, et permettant une réhabitation par du tissu conjonctif, d'où la formation d'un néo-ligament ou néo-tendon. It has also been proposed to replace these natural ligaments or tendons with ligaments or tendons made of fibers of a biodegradable material, in particular carbon fibers, coated with a non-biodegradable material, such as pyrocarbon, or biodegradable, such as polylactic acid, and allowing rehabitation by connective tissue, hence the formation of a neo-ligament or neo-tendon.

Ces ligaments ou tendons présentent une fragilité mécanique dans la phase initiale précédant la formation du tissu conjonctif de remplacement. En effet, après fixation et mise en tension, le ligament ou tendon prothétique vient frotter contre les surfaces articulaires et les parties osseuses, et peut se dégrader par abrasion. These ligaments or tendons exhibit mechanical fragility in the initial phase preceding the formation of replacement connective tissue. In fact, after fixation and tensioning, the prosthetic ligament or tendon rubs against the articular surfaces and the bone parts, and can be degraded by abrasion.

La présente invention a pour but de remédier à cette fragilité initiale, et de procurer un ligament ou tendon synthétique qui résiste à une abrasion par les surfaces articulaires ou osseuses avec lesquelles il vient en contact, et qui induise rapidement la formation d'un tissu conjonctif de remplacement reformant un nouveau ligament ou tendon dont les caractéristiques mécaniques, notamment la résistance et l'allongement à la rupture, soient proches de celles du ligament ou du tendon naturel. The aim of the present invention is to remedy this initial fragility, and to provide a synthetic ligament or tendon which resists abrasion by the articular or bone surfaces with which it comes into contact, and which rapidly induces the formation of connective tissue. replacement reforming a new ligament or tendon whose mechanical characteristics, in particular resistance and elongation at break, are close to those of the natural ligament or tendon.

Le ligament ou tendon prothétique selon l'invention est caractérisé en ce que le revêtement biodégradable de ses fibres est formé au moins en partie de collagène.  The prosthetic ligament or tendon according to the invention is characterized in that the biodegradable coating of its fibers is formed at least in part from collagen.

Il répond en outre de préférence à au moins l'une des caractéristiques suivantes
- Ses fibres sont en carbone.It also preferably meets at least one of the following characteristics
- Its fibers are carbon.

- Les fibres de carbone ont un diamètre d'environ 7 microns et sont groupées en tresses d'environ 10000 fibres. - Carbon fibers have a diameter of about 7 microns and are grouped in braids of about 10,000 fibers.

- Ses fibres sont en soie naturelle. - Its fibers are made of natural silk.

- L'épaisseur du revetement de collagène est comprise entre 5 microns et 3 mm. - The thickness of the collagen coating is between 5 microns and 3 mm.

L'invention s'étend en outre à des procédés de fabrication de ces ligaments ou tendons prothétiques. The invention further extends to methods of making these prosthetic ligaments or tendons.

Selon un premier procédé, on prépare des tresses de fibres de matériau biodégradable, les revêt au moins une fois d'une couche de collagène, sèche celle-ci, puis effectue le toronnage des tresses revêtues de collagène. According to a first method, braids of fibers of biodegradable material are prepared, coated at least once with a layer of collagen, dries it, then strands the braids coated with collagen.

Selon un autre procédé, on toronne ensemble des tresses de fibres de matériau biodégradable, revêt le faisceau des tresses au moins une fois d'une couche de collagène, puis sèche celle-ci. According to another method, braids of fibers of biodegradable material are twisted together, the bundle of braids is coated at least once with a layer of collagen, and then the latter is dried.

On effectue de préférence le séchage de la couche de collagène par lyophilisation. The collagen layer is preferably dried by lyophilization.

Bien que l'invention ne soit pas limitée à un mécanisme particulier de formation du néo-ligament ou néo-tendon, il semble que les fibres de matériau biodégradable induisent la formation de tissu conjonctif tout en se fragmentant, chaque fragment de fibre produisant lui-même une réaction tissulaire d'enrobage par du tissu conjonctif. Although the invention is not limited to a particular mechanism for forming the neo-ligament or neo-tendon, it seems that the fibers of biodegradable material induce the formation of connective tissue while fragmenting, each fragment of fiber producing itself even a tissue coating reaction with connective tissue.

En fin de compte, le tissu naturel du ligament ou tendon initial se reconstitue, cependant que les fibres de matériau biodégradable se résorbent. La croissance de tissu conjonctif nta par contre pas lieu lorsque les fibres sont revetus d'un matériau non poreux ou peu poreux, par exemple avec des fibres de carbone revêtues de pyrocarbone. In the end, the natural tissue of the initial ligament or tendon is reconstituted, while the fibers of biodegradable material are absorbed. By contrast, the growth of connective tissue does not take place when the fibers are coated with a non-porous or low-porous material, for example with carbon fibers coated with pyrocarbon.

Le collagène s'obtient de façon connue à partir de collagène d'origine animale, notamment de bovins. On peut éventuellement l'additionner d'un autre matériau biodégradable, par exemple d'acide polylac tique.  Collagen is obtained in a known manner from collagen of animal origin, in particular from cattle. It is optionally possible to add another biodegradable material, for example polylactic acid.

L'invention s'applique notamment chez l'homme â la réparation des ligaments latéraux et croisés du genou, du ligament latéral externe de la cheville, du tendon d'Achille, des ligaments de l'articulation acromio-claviculaire. Elle s'applique également à la réparation de ligaments ou tendons chez l'animal.  The invention is particularly applicable in humans to the repair of the lateral and crossed ligaments of the knee, of the lateral lateral ligament of the ankle, of the Achilles tendon, of the ligaments of the acromioclavicular joint. It also applies to the repair of ligaments or tendons in animals.

Claims (8)

REVENDICATIONS 1/ Ligament ou tendon prothétique en fibres d'un matériau biodégradable muni d'un revêtement également biodégradable, et induisant la formation d'un tissu conjonctif de remplacement, caractérisé en ce que le revêtement biodégradable est formé au moins en partie de collagène.1 / Ligament or prosthetic tendon made of fibers of a biodegradable material provided with a also biodegradable coating, and inducing the formation of a replacement connective tissue, characterized in that the biodegradable coating is formed at least in part from collagen. 2/ Ligament ou tendon prothétique selon la revendication 1, caractérisé en ce que ses fibres sont en carbone.2 / Ligament or prosthetic tendon according to claim 1, characterized in that its fibers are carbon. 3/ Ligament ou tendon prothétique selon la revendication 2, caractérisé en ce que les fibres de carbone ont un diamètre d'environ 7 microns et sont groupées en tresses d'environ 10000 fibres.3 / Ligament or prosthetic tendon according to claim 2, characterized in that the carbon fibers have a diameter of approximately 7 microns and are grouped in braids of approximately 10,000 fibers. 4/ Ligament ou tendon prothétique selon la revendication 1, caractérisé en ce que ses fibres sont en soie naturelle.4 / Ligament or prosthetic tendon according to claim 1, characterized in that its fibers are made of natural silk. 5/ Ligament ou tendon prothétique selon l'une des revendications 1 à 4, caractérisé en ce que l'épaisseur du revêtement de collagène est comprise entre 0,2 et 5 mm.5 / Ligament or prosthetic tendon according to one of claims 1 to 4, characterized in that the thickness of the collagen coating is between 0.2 and 5 mm. 6/ Procédé de fabrication d'un ligament ou tendon prothétique selon la revendication 1, caractérisé en ce que l'on prépare des tresses de fibres de matériau biodégradable, les revêt au moins une fois d'une couche de collagène, sèche celle-ei , puis effectue le toronnage des tresses revêtues de collagène. 6 / A method of manufacturing a prosthetic ligament or tendon according to claim 1, characterized in that braids of fibers of biodegradable material are prepared, coated at least once with a layer of collagen, dries it , then strands the collagen-coated braids. 7/ Procédé de fabrication d'un ligament ou tendon prothétique selon la revendication 1, caractérisé en ce que l'on toronne ensemble des tresses de fibres de matériau biodégradable, revêt le faisceau des tresses au moins une fois d'une couche de collagène, puis sèche celle-ci.7 / A method of manufacturing a prosthetic ligament or tendon according to claim 1, characterized in that we braid together plaits of fibers of biodegradable material, coating the bundle of plaits at least once with a layer of collagen, then dry it. 8/ Procédé selon les revendications 6 ou 7, caractérisé en ce que l'on effectue le séchage de la couche de collagène par lyophilisation. 8 / A method according to claims 6 or 7, characterized in that one performs the drying of the collagen layer by lyophilization.
FR8114840A 1981-07-30 1981-07-30 Ligament or tendon prosthesis stimulating tissue regrowth - comprises fibrous material, e.g. carbon fibres, coated with collagen Granted FR2510394A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
FR8114840A FR2510394A1 (en) 1981-07-30 1981-07-30 Ligament or tendon prosthesis stimulating tissue regrowth - comprises fibrous material, e.g. carbon fibres, coated with collagen

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Application Number Priority Date Filing Date Title
FR8114840A FR2510394A1 (en) 1981-07-30 1981-07-30 Ligament or tendon prosthesis stimulating tissue regrowth - comprises fibrous material, e.g. carbon fibres, coated with collagen

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FR2510394A1 true FR2510394A1 (en) 1983-02-04
FR2510394B1 FR2510394B1 (en) 1983-11-10

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0161086A2 (en) * 1984-05-09 1985-11-13 The Board Of Trustees Of The Leland Stanford Junior University Collagen coated soft tissue prostheses
FR2573979A1 (en) * 1984-12-04 1986-06-06 Ceraver Prosthetic ligament or tendon based on carbon fibres
EP0238223A2 (en) * 1986-03-17 1987-09-23 Minnesota Mining And Manufacturing Company Tissue augmentation device
EP0306018A1 (en) * 1987-09-04 1989-03-08 Bio-Products, Inc. Tendon/ligament substitutes composed of long, parallel, non-antigenic tendon/ligament fibers
FR2651994A1 (en) * 1989-09-19 1991-03-22 Laboureau Jacques Philippe Prosthetic ligament comprising a network of synthetic or natural fibres impregnated with collagen
US5026398A (en) * 1988-07-01 1991-06-25 The Minnesota Mining And Manufacturing Company Abrasion resistant prosthetic device
US5263984A (en) * 1987-07-20 1993-11-23 Regen Biologics, Inc. Prosthetic ligaments

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3276448A (en) * 1962-12-14 1966-10-04 Ethicon Inc Collagen coated fabric prosthesis
US3526228A (en) * 1969-03-24 1970-09-01 Ethicon Inc Collagen lamina dural prosthesis
US3949073A (en) * 1974-11-18 1976-04-06 The Board Of Trustees Of Leland Stanford Junior University Process for augmenting connective mammalian tissue with in situ polymerizable native collagen solution
FR2415456A1 (en) * 1978-01-25 1979-08-24 Bentley Lab IMPLANT FOR PROSTHESIS

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3276448A (en) * 1962-12-14 1966-10-04 Ethicon Inc Collagen coated fabric prosthesis
US3526228A (en) * 1969-03-24 1970-09-01 Ethicon Inc Collagen lamina dural prosthesis
US3949073A (en) * 1974-11-18 1976-04-06 The Board Of Trustees Of Leland Stanford Junior University Process for augmenting connective mammalian tissue with in situ polymerizable native collagen solution
FR2415456A1 (en) * 1978-01-25 1979-08-24 Bentley Lab IMPLANT FOR PROSTHESIS
GB2014475A (en) * 1978-01-25 1979-08-30 Bentley Lab An Implant Device

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0161086A2 (en) * 1984-05-09 1985-11-13 The Board Of Trustees Of The Leland Stanford Junior University Collagen coated soft tissue prostheses
EP0161086A3 (en) * 1984-05-09 1987-09-30 The Board Of Trustees Of The Leland Stanford Junior University Collagen coated soft tissue prostheses
FR2573979A1 (en) * 1984-12-04 1986-06-06 Ceraver Prosthetic ligament or tendon based on carbon fibres
EP0238223A2 (en) * 1986-03-17 1987-09-23 Minnesota Mining And Manufacturing Company Tissue augmentation device
EP0238223A3 (en) * 1986-03-17 1988-06-08 Minnesota Mining And Manufacturing Company Tissue augmentation device
US4834752A (en) * 1986-03-17 1989-05-30 Minnesota Mining And Manufacturing Tissue augmentation device and method of repairing a ligament or tendon
US5263984A (en) * 1987-07-20 1993-11-23 Regen Biologics, Inc. Prosthetic ligaments
EP0306018A1 (en) * 1987-09-04 1989-03-08 Bio-Products, Inc. Tendon/ligament substitutes composed of long, parallel, non-antigenic tendon/ligament fibers
US5026398A (en) * 1988-07-01 1991-06-25 The Minnesota Mining And Manufacturing Company Abrasion resistant prosthetic device
FR2651994A1 (en) * 1989-09-19 1991-03-22 Laboureau Jacques Philippe Prosthetic ligament comprising a network of synthetic or natural fibres impregnated with collagen

Also Published As

Publication number Publication date
FR2510394B1 (en) 1983-11-10

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