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
  • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
  • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
  • A61L2/08—Radiation
  • A61L2/081—Gamma radiation
• • 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
  • A61F2/28—Bones
• • 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
  • A61L27/14—Macromolecular materials
  • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
  • A61L27/225—Fibrin; Fibrinogen
• • 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
  • A61L27/14—Macromolecular materials
  • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
  • A61L27/24—Collagen
• • 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
  • A61L27/56—Porous materials, e.g. foams or sponges
• • 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
  • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
  • A61F2310/00005—The prosthesis being constructed from a particular material
  • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
• • 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
  • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
  • A61F2310/00005—The prosthesis being constructed from a particular material
  • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
  • A61F2310/00377—Fibrin
• • 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
  • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
  • A61L2103/05—Living organisms or biological materials

Definitions

• the present invention relates to bone reconstruction after trauma or bone resection, especially for long bones, short or flat, and aims to provide a new filling material from a deficit or 5 of a solution of continuity in the said bones or intended to compensate for partial bone non-formation in the case of agenesis or dysplasia in particular.
• the materials used are asked to be biocompatible, to present a healthy, clean, vascularized terrain, to be sufficiently rigid, to have an optimal congruence with the recipient site and to avoid as far as possible the laying of elements. external solidarity or restraint.
• the object of the invention is to overcome these drawbacks by proposing a new material capable of constituting grafts for osteocartilaginous reconstruction ensuring total homogenization between the recipient bone and the graft and whose qualities, in particular mechanical, allow a suitable, easy, fast and solid reconstruction.
• the subject of the invention is a graft for osteocartilaginous reconstruction, characterized in that it consists of the association of a collagen matrix of porous structure impregnated with a slow setting fibrin glue , the proportions, by volume, of the fibrin glue relative to the collagen matrix being at least 1/4.
• the subject of the invention is also a process for preparing such a graft, characterized in that it consists in taking a block of collagen in spongy form, in depositing on this block slow-setting fibrin glue, in the form viscous, at the rate of at least one part, by volume, of fibrin glue for four parts, by volume, of collagen, and to dry the whole until elimination of practically all the evaporable water.
• the material thus obtained is directly usable as a graft. It is in the form of a rigid structure which can be cut and shaped at will to constitute a graft easily put in place.
• a collagen matrix for example the product sold by the company BRAUN under the trade name "OSTEOVIT", which is a cut sponge block consisting of a skeletal structure.
• a block of collagen for example a cube of four cm3, at least 1 cm3 of a slow setting fibrin glue is deposited on the upper face.
• This glue is obtained by the following process.
• an assay is carried out in the known manner so as to obtain a glue for slow setting and more precisely an adhesive whose setting is obtained after a time of contact with the collagen equal to or greater than 5 minutes.
• the mixture thus obtained is viscous. Once deposited on the bonding matrix, the fibrin glue will, by creep, gradually colonize the porous mass of collagen.
• the operation takes place for example at room temperature and in a sterile environment and lasts the time necessary for the drying of the whole, that is to say the disappearance of practically all the evaporable water. Such drying lasts several hours and depends on the volume of the block of impregnated collagen.
• the product obtained is a rigid, non-elastic block and remains so even if it is rewetted. It can be kept in this state as long as the starting constituents, and preferably under sterile condition.
• the storage temperature has no particular effect on storage.
• the operation of impregnating the block of collagen with fibrin glue can also be carried out in a non-sterile medium, in which case, after drying, a sterilization with gamma rays of the material will be carried out, before its use, which does not alter not the quality of the association of glue + collagen.
• the collagen block can, before its impregnation with fibrin glue, be cut or shaped according to the shape of the graft to be produced.
• the block of collagen is not previously cut or shaped, it can be after impregnation and drying, at any time before use.
• the proportion, by volume, of fibrin glue, relative to the collagen matrix is at least one part for four parts respectively. Below this threshold, the quantity of adhesive is insufficient and the final structure is not rigid and tends to become plastic, but not elastic, if it is rewetted. On the other hand, the proportion of fibrin glue can be substantially greater than 1/4, and go as far as saturation of the porous structure of the collagen matrix.
• the material obtained in accordance with the invention has a homogeneous structure, can be sculpted at will and allows the passage and fixation in particular of the osteoblasts which thus have, from the start, a virgin, hypoallergenic and solid frame.
• the bone grafted in accordance with the invention is thus consolidated much faster than with usual materials which allows, from the radiological observation of consolidation, to remove any osteosynthesis material much earlier (after 3 to 4 months in general, instead of two years at least with coral or hydroxyapatite grafts).
• the graft according to the invention permanently retains good rigidity, it is possible in certain cases to avoid associating temporary added external elements, of attachment or restraint.

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

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Cited By (3)

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• 1992
  • 1992-02-19 EP EP92904707A patent/EP0626868A1/de not_active Ceased
  • 1992-02-19 WO PCT/EP1992/000344 patent/WO1993016739A1/fr not_active Ceased

Non-Patent Citations (1)

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