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
  • A61L27/14—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
  • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
  • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
  • A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• • 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
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/005—Ingredients of undetermined constitution or reaction products thereof
• • 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
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/04—Macromolecular materials
  • A61L31/043—Proteins; Polypeptides; Degradation products thereof
  • A61L31/044—Collagen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P19/00—Drugs for skeletal disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P19/00—Drugs for skeletal disorders
  • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• • 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
  • A61L2430/06—Materials or treatment for tissue regeneration for cartilage reconstruction, e.g. meniscus
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
  • Y10S623/902—Method of implanting
  • Y10S623/908—Bone

Definitions

• the present invention relates to the field of repairing meniscal tears.
• Meniscal tears in a joint of a subject are frequent injuries.
• a torn meniscus often was partially or completely removed.
• techniques have been developed for repairing meniscal tears, including the use of arthroscopically placed tacks or suturing the torn edges.
• a method of repairing a meniscal tear of a subject comprises providing a sheet of collagen membrane material, the sheet having on one side thereof a smooth barrier face which inhibits cell adhesion thereon and inhibits passage of cells therethrough, the sheet having a fibrous face opposite the smooth barrier face, the fibrous face allowing cell growth thereon, the collagen of said sheet being predominantly collagen I.
• the sheet of collagen membrane material is fixed over the meniscal tear so that the fibrous face is oriented toward the meniscal tear.
• Fig. 1 is a side elevation schematic view showing covering of one side of a meniscus tear in accordance with one embodiment of the invention.
• Fig. 2 is a schematic sectional view showing both sides of a meniscal tear treated according to another embodiment.
• synovial cells that contribute to the reparative process of a torn meniscus are from adjacent synovial tissue.
• synovial cells In addition to contributing to the reparative process in a torn meniscus, synovial cells have the capability to degrade connective tissues and to contract. For example, synovial tissue can break down typical collagen I scaffolds.
• the predominantly collagen I membrane of the present invention is able to maintain its integrity when in contact with synovial tissue, and also serve as a scaffold into which synovial cells can migrate to facilitate healing of a meniscal tear.
• a sheet of collagen membrane material utilized in accordance with the present invention has on one side thereof a smooth barrier face which inhibits cell adhesion thereon and inhibits passage of cells therethrough.
• the collagen sheet has a fibrous face opposite the barrier face, the fibrous face allowing cell growth thereon.
• the collagen of a membrane utilized in accordance with the present invention is predominantly collagen I 1 i.e., greater than 50% collagen I by weight.
• the collagen I content of a membrane sheet utilized in accordance with the present invention may be greater than 60% by weight, greater than 70% by weight, greater than 80% by weight or greater than 90% by weight.
• the collagen of a membrane sheet utilized in accordance with the present invention is approximately 95% by weight collagen I.
• the collagen of such a membrane may comprise approximately 5% by weight collagen III.
• the collagen utilized in the present invention is of porcine or bovine origin.
• the sheet of collagen material utilized in the present invention is formed from a naturally occurring membrane of porcine or bovine origin, preferably from calves or piglets.
• a preferred source is naturally occurring single-layered sheets of peritoneum membrane, most preferably from piglets.
• Peritoneum membranes from young pigs aged 6-7 weeks old (weighing 60-80 kg) are especially preferred.
• One such material is described in U.S. Patent No. 5,837,278, incorporated herein by reference.
• the dry thickness of a membrane for use in the present invention may be between about 0.1-5.0 mm, preferably between about 0.1-1.0 mm, or about 0.5 mm, but can be influenced by swelling of the material when exposed to moisture.
• a sheet of collagen membrane material utilized in accordance with the present invention is fixed over a meniscal tear so that the fibrous face of the membrane is oriented toward the meniscal tear.
• the sheet may be fixed by any suitable means, including sutures, a physiologically acceptable adhesive (e.g., fibrin glue), or a combination thereof.
• the membrane preferably completely covers at least one side of the tear, and the fibrous face preferably contacts the tear.
• a sheet of collagen membrane material utilized in accordance with the present invention may be fixed over one side of a meniscal tear, or additionally a second sheet of collagen membrane material may be fixed on an opposite side of a meniscal tear, also with the fibrous face oriented toward the tear, so that the meniscal tear is sandwiched between two sheets of collagen membrane material.
• the membrane material 10 may be fixed over a meniscus tear 11 in meniscus 7 by adhesive or sutures 13 attached to meniscus 7.
• the membrane material 10 may be fixed over the meniscus tear 11 so as to cover the tear on opposite sides thereof, with the tear being sandwiched between the membrane material 10, to thereby provide a barrier against ingrowth of connective tissue into meniscus tissue 7 following the surgery.
• the sheet of collagen membrane material preferably is fixed over the area to be treated, for example, by adhesive bonding of the sheet, utilizing an organic glue, such as fibrin glue, or by sutures 13, or a combination thereof, or any other suitable method.
• the collagen membrane material 10 is comprised of at least one barrier layer having at least one smooth face 16 so as to inhibit cell adhesion thereon and act as a barrier to prevent passage of cells therethrough. See Fig. 3.
• the membrane 10 further has a fibrous face 18 opposite the smooth face 16, the fibrous face allowing cell growth thereon. Synovial cells 20 may contact the fibrous face 18 and migrate into the membrane to assist in healing of the tear.
• a collagen membrane material is utilized, wherein the membrane and/or the fibrous face are impregnated with chondrocytes, synovial fibroblast-like cells, mesenchymal stem cells, one or more glycosaminoglycans, and/or one or more growth factors.
• suitable glycosaminoglycans include hyaluronic acid, chondroitin 6-sulphate, keratin sulphate, dermatan sulphate or the like.
• suitable growth factors include, but are not limited to, those which are described as follows.
• Transforming growth factor-beta increases the proteoglycan synthesis of fibrochondrocytes isolated from different sections of the menisci in a dose dependent manner.
• Human platelet-derived growth factor (PDGF-AB), hepatocyte growth factor (HGF) and bone morphogenic protein-2 (BMP-2) increase DNA synthesis in meniscal cells.
• BMP-2, insulin-like growth factor-1 (IGF-I), and epidermal growth factor (EGF) stimulate migration of bovine fibrochondrocytes from the different parts of the menisci.
• osteogenic protein-1 OP-I).
• the present invention provides a smooth barrier face 16 in membrane 10 which protects the surgical site from ingrowth of unwanted cells during the healing process, and a fibrous face 18 for promoting growth of reparative cells adjacent the tear.
• the collagen membrane material 10 is gradually resorbed into the patient's body, avoiding any necessity of having to surgically remove the membrane after healing.
• a ChondroGide ® membrane may be applied to a torn meniscus to facilitate its repair.
• the cells that contribute to the reparative process are from the adjacent synovial tissue. In addition to contributing to the reparative process in a torn meniscus, these synovial cells have the capability to degrade connective tissues and to contract.
• the ChondroGide ® membrane will: (1) guide synovial cells to the tear in the meniscus by serving as a scaffold on which the cells can migrate, and (2) contain the cells in the defect during the reparative process.
• the ChondroGide ® membrane is able to maintain its integrity when in contact with synovial tissue, and also serve as a scaffold into which the synovial cells can migrate.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Epidemiology (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Medicinal Chemistry (AREA)
• Biomedical Technology (AREA)
• Surgery (AREA)
• Transplantation (AREA)
• Dermatology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Pharmacology & Pharmacy (AREA)
• Bioinformatics & Cheminformatics (AREA)
• General Chemical & Material Sciences (AREA)
• Organic Chemistry (AREA)
• Physical Education & Sports Medicine (AREA)
• Biophysics (AREA)
• Urology & Nephrology (AREA)
• Cell Biology (AREA)
• Zoology (AREA)
• Botany (AREA)
• Rheumatology (AREA)
• Immunology (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Materials For Medical Uses (AREA)
• Prostheses (AREA)

Priority Applications (7)

Applications Claiming Priority (2)

Publications (2)

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Cited By (8)

Families Citing this family (17)

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• 2006
  • 2006-09-01 JP JP2008529334A patent/JP5225844B2/ja not_active Expired - Fee Related
  • 2006-09-01 EP EP06802853.9A patent/EP1937293B1/en active Active
  • 2006-09-01 PL PL06802853T patent/PL1937293T3/pl unknown
  • 2006-09-01 ES ES06802853.9T patent/ES2439943T3/es active Active
  • 2006-09-01 AU AU2006287197A patent/AU2006287197B2/en not_active Ceased
  • 2006-09-01 WO PCT/US2006/034329 patent/WO2007028078A2/en not_active Ceased
  • 2006-09-01 CA CA2621153A patent/CA2621153C/en active Active
  • 2006-09-01 CN CNA2006800316648A patent/CN101252948A/zh active Pending
  • 2006-09-01 US US12/064,444 patent/US8084428B2/en active Active
  • 2006-09-01 RU RU2008112185/14A patent/RU2421173C2/ru active
• 2012
  • 2012-09-13 JP JP2012201621A patent/JP2012236112A/ja not_active Withdrawn

Non-Patent Citations (1)

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