Membrane for use in guided tissue regeneration

• US 20040234577A1
• Filed: 06/18/2004
• Published: 11/25/2004
• Est. Priority Date: 10/10/1997
• Status: Abandoned Application

• Current Assignee: ED. Geistlich Soehne AG Fuer Chemische Industrie
• Original Assignee: ED. Geistlich Soehne AG Fuer Chemische Industrie
• Inventors: Schlosser, Lothar, Geistlich, Peter, Eckmayer, Zdenek
• Application Number:
  US10/869,909
• Publication Number:
  US 20040234577A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue of bone tissue onto implantable joints A61F2002/30932
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30761 Support means for artificial cartilage, e.g. cartilage defect covering membranes
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00982 : Coating made of collagen
• CPC Class Codes: A61L 15/325 : Collagen
• CPC Class Codes: A61L 15/40 : containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 2300/252 : Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/608 : having two or more layers
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/14 : Macromolecular materials
• CPC Class Codes: A61L 27/20 : Polysaccharides
• CPC Class Codes: A61L 27/24 : Collagen
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3817 : Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3834 : Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/3843 : Connective tissue
• CPC Class Codes: A61L 27/3847 : Bones
• CPC Class Codes: A61L 27/3852 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/044 : Collagen
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 5/00 : Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 5/08 : Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

The invention provides a multi-layer membrane comprising a matrix layer predominantly of collagen II and having an open sponge-like texture, and at least one barrier layer having a close, relatively impermeable texture. Such a membrane is particularly suitable for use in guided tissue regeneration, in particular for use in vivo in the reconstruction of bone or cartilage tissue.

Claims

1. A membrane comprising a resorbable multi-layer membrane for use in vivo in the reconstruction of bone or cartilage tissue, said resorbable multi-layer membrane comprising a matrix layer having a matrix consisting essentially of collagen II and having an open sponge-like texture, and at least one barrier layer having a close, relatively impermeable texture, the at least one barrier layer consisting essentially of a barrier layer material selected from the group consisting of collagen I, collagen III and a mixture thereof, wherein said multi-layer membrane is formed by adhering of said matrix layer to said at least one barrier layer by non-sutured adhesive, so that said matrix layer is adhered firmly to and in direct contact with said at least one barrier layer.

2. A membrane as claimed in claim 1 in which the matrix layer is provided between two barrier layers.

3. A membrane as claimed in claim 1 in which the matrix layer is provided by collagen II material derived from natural cartilage.

4. A membrane as claimed in claim 3 wherein the collagen II material is derived from hyaline cartilage from pigs.

5. A membrane as claimed in claim 3 in which the collagen II material is physically cross-linked.

6. A membrane as claimed in claim 4 in which the at least one barrier layer is derived from peritoneum membrane from calves or pigs.

7. A membrane as claimed in claim 1 in which the matrix layer is impregnated with chondrocytes isolated from articular cartilage, periosteum, periocardium or mesenchymal stem cells from bone marrow.

8. A membrane as claimed in claim 1 in which the matrix layer, said at least one barrier layer, or each said layer is impregnated with a glycosaminoglycan.

9. A membrane as claimed in claim 8 wherein the glycosaminoglycan is hyaluronic acid, chondroitin 6-sulphate, keratin sulphate or dermatan sulphate.

10. A membrane as claimed in claim 1 in which the matrix and barrier layers are substantially free from proteoglycans.

11. A membrane as claimed in claim 1 in which the matrix layer, said at least one barrier layer, or each of the layers further comprise chondronectin, lectin, fibronectin, calcium alginate, anchorin II, growth factors or bone morphogenetic factors.

12. A process for the preparation of a membrane as claimed in claim 1 in which a collagen II slurry is applied to a surface of a barrier membrane having a close, relatively impermeable texture, followed by freeze-drying whereby to provide a matrix layer having an open sponge-like structure.

13. A method of treating a bone or cartilage defect in the human or non-human animal body, said method comprising application of a membrane as claimed in claim 1 to the defect, said membrane being oriented such that the barrier layer or layers prevent the ingrowth of undesirable tissue types into the area of bone or cartilage regeneration.

14. A method of treating a bone or cartilage defect in the human or non-human animal body, said method comprising application of a membrane as claimed in claim 1 to the defect, said membrane being oriented such that the barrier layer or layers prevent the ingrowth of undesirable tissue types into the area of bone or cartilage regeneration, and wherein the matrix layer of said membrane is impregnated with chondrocytes either immediately prior to or following application to the defect.

15. The method of claim 13 wherein said membrane is applied during arthroscopic surgery.

16. The method of claim 14 wherein said membrane is applied during arthroscopic surgery.

17. A membrane as claimed in claim 11 wherein the growth factors are cartilage inducing factor (CTF), insulin-like growth factor (IGF), or transforming growth factor (TGF ).

18. A membrane as claimed in claim 11 wherein the bone morphogenetic factors are human BMP-2, BMP-3, BMP-4 or BMP-7.

19. A membrane comprising a resorbable multi-layer membrane for use in vivo in the reconstruction of bone or cartilage tissue at a site of a defect in said tissue, said resorbable multi-layer membrane comprising a matrix layer having a matrix comprising collagen I, collagen III or a mixture thereof, and having an open sponge-like texture, and at least one barrier layer having a close, relatively impermeable texture, the at least one barrier layer comprising a barrier layer comprising collagen I, collagen III or a mixture thereof, wherein said multi-layer membrane is formed by application of said matrix layer to said at least one barrier layer as a slurry, so that said matrix layer is adhered firmly to and in direct contact with said at least one barrier layer, wherein firm adherence of the matrix layer to said at least one barrier layer results essentially solely from application of said slurry to said at least one barrier layer.

20. A membrane comprising a resorbable multi-layer membrane for use in vivo in the reconstruction of bone or cartilage tissue at a site of a defect in said tissue, said resorbable multi-layer membrane comprising a matrix layer having a matrix comprising collagen I, collagen II or a mixture thereof, and having an open sponge-like texture, and at least one barrier layer having a close, relatively impermeable texture, the at least one barrier layer comprising collagen I, collagen III or a mixture thereof, wherein said multi-layer membrane is formed by application of said matrix layer to said at least one barrier layer by non-sutured adhesive, so that said matrix layer is adhered firmly to and in direct contact with said at least one barrier layer.