Matrix structure and hybrid matrix system for inducing a neofacia, their use and method for generating a neofacia

• US 20050202067A1
• Filed: 10/27/2004
• Published: 09/15/2005
• Est. Priority Date: 10/28/2003
• Status: Abandoned Application

• Current Assignee: Gkss-Forschungszentrum Geesthacht GmbH
• Original Assignee: Gkss-Forschungszentrum Geesthacht GmbH
• Inventors: Kelch, Steffen, Buhr, Heinz Johannes, Ritz, Jorg-P., Germer, Christoph-Thomas, Isbert, Christoph, Reissfelder, Christoph, Lendlein, Andreas, Groth, Thomas, Lutzow, Karola
• Application Number:
  US10/974,541
• Publication Number:
  US 20050202067A1
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3843 Connective tissue
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

The invention is directed to a matrix structure for inducing a neofascia with at least one two-dimensional matrix of at least one biocompatible and resorbable polymer, wherein the surface of the matrix is designed to immobilize tissue cells, in particular autologous fibrocytes of the fascia transversalis, and to reduce a preferably three-dimensional tissue growth in vitro or in vivo. The invention is also directed to a hybrid matrix system, which includes the matrix structure and tissue cells immobilized thereon. The novel matrix as well as the fascia hybrid are characterized by a high biocompatibility and overcome the disadvantages of non-degradable implants, thereby promoting formation of a neofascia with native biomechanical properties.

Claims

1. Matrix structure for induction of a neofascia having at least one two-dimensional matrix of at least one biocompatible synthetic polymer, which can be broken down in vivo within a resorption time, wherein the matrix has a surface that is suitable to immobilize tissue cells and to induce formation of tissue on the surface in vitro and/or in vivo.

2. Matrix structure according to claim 1, characterized in that the matrix has selected mechanical properties, in particular a mechanical load-carrying capacity that match at least approximately the mechanical properties of the tissue to be generated.

3. Matrix structure according to claim 2, characterized in that the matrix has a tensile strength of at least 35 N, in particular at least 40 N, preferably at least 50 N.

4. Matrix structure according to claim 2, characterized in that the matrix has an elasticity of at least 2.5 N/cm, in particular at least 3.0 N/cm, preferably at least 4.0 N/cm.

5. Matrix structure according to claim 1, characterized in that the resorption time of the polymer in vivo is selected so that a change in the mechanical properties of the matrix due to resorption is at least approximately compensated by the tissue forming on the matrix.

6. Matrix structure according to claim 1, characterized in that the resorption time of the polymer in vivo is selected so that the matrix breaks down completely only when tissue capable of carrying a mechanical load is formed.

7. Matrix structure according to claim 1, characterized in that the resorption time is at most 12 months, in particular between 3 and 6 months.

8. Matrix structure according to claim 1, characterized in that the matrix is a membrane or a foil or has a mesh-type structure.

9. Matrix structure according to claim 1, characterized in that the matrix is capable of inducing oriented three-dimensional tissue growth on its surface.

10. Matrix structure according to claim 9, characterized in that the matrix has a surface structure that induces the oriented cell growth, that the surface of the matrix includes in particular straight or wavy, groove-like recesses or point-shaped recesses.

11. Matrix structure according to claim 1, characterized in that the matrix comprises pores.

12. Matrix structure according to claim 1, characterized in that the matrix is disposed on a resorbable support layer, in particular a support mesh.

13. Matrix structure according to claim 12, characterized in that the support layer is arranged between two matrices.

14. Matrix structure according to claim 1, characterized in that the matrix comprises a bio-active coating and/or composition.

15. Matrix structure according to claim 14, characterized in that the matrix is treated, in particular coated, with natural or synthetic inhibitors for enzymes that can breakdown the matrix, and/or with growth factors.

16. Matrix structure according to claim 1, characterized in that the synthetic polymer is a thermoplastic elastomer, in particular a polymer system thereof.

17. Matrix structure according to claim 16, characterized in that the synthetic polymer comprises a macro-diol made of at least one monomer, in particular a block-copolymer based on different macro-diols.

18. Matrix structure according to claim 17, characterized in that the at least one monomer is selected from the group consisting of ε

-caprolactone, di-glycolide, dilactide, (L,L-lactide or rac-dilactide) and p-dioxanone.

19. Matrix structure according to claim 1, characterized in that the synthetic polymer comprises a semi-crystalline or completely amorphous, covalently crosslinked polymer network system.

20. Matrix structure according to claim 19, characterized in that the semi-crystalline or completely amorphous polymer network system is based on poly(ε

-caprolactone)dimethylacrylate, in particular a photo-crosslinked network of poly α

-caprolactone) dimethyl.

21. Hybrid matrix system for inducing a neofascia, comprising a matrix structure according to claim 1, as well as tissue cells immobilized on the matrix surface.

22. Hybrid matrix system according to claim 21, characterized in that the immobilized tissue cells comprise fibrocytes, fibroblasts, myoblasts, immobile connective tissue cells, stem cells, or mixtures thereof.

23. Hybrid matrix system according to claim 21, characterized in that the tissue cells are cells of the fascia transversalis, the fascia lata, or of other fasciae, or cells of the skin or of the ligament motion apparatus.

24. Hybrid matrix system according to claim 21, characterized in that the tissue cells are autologous or allogenic or xenologic cells, in particular autologous cells.

25. Hybrid matrix system according to claim 21, characterized in that the tissue cells exist on the matrix individually, or form a cell carpet and/or form at least partially connected tissue structures.

26. Hybrid matrix system according to claim 21, characterized in that the matrix comprises the immobilized tissue cells and/or tissue structures on one side or on both sides.

28. Method for generating a neofascia, wherein a matrix structure according to claim 1 with at least one matrix made of at least one resorbable, synthetic, biocompatible polymer is used, and wherein a surface of the matrix is at least partially populated with tissue cells in vitro and/or in vivo, and wherein growth of the immobilized cells is induced on the matrix surface to form the neofascia.

29. Method according to claim 28, characterized in that the tissue cells are initially immobilized on the matrix in vitro, are cultivated in vitro, in particular until a cell carpet or at least partially connected tissue structures or an intact neofascia are formed, and the populated matrix is implanted.

30. Method according to claim 28, characterized in that the tissue cells are initially immobilized on the matrix in vitro, and that growth of the cells on the matrix is induced after implantation of the populated matrix to form a neofascia.

31. Method according to claim 28, characterized in that the tissue cells are immobilized in vivo, and that the tissue growth is induced in vivo after implantation of the unpopulated matrix structure.

32. Method according to claim 28, characterized in that oriented tissue growth of the matrix in a preferred direction is induced in vitro and/or in vivo by using a matrix structure with a structured surface.

33. Method according to claim 28, characterized in that oriented tissue growth of the matrix in a preferred direction is induced in vitro by applying a mechanical stimulus to the matrix structure, in particular by alternatingly stretching and relaxing the matrix structure.

34. Method according to claim 28, characterized in that tissue cells are used that are applied in the form of primary or conditioned and optionally immortalized cells.

35. Method according to claim 28, characterized in that the tissue cells comprise fibrocytes, fibroblasts, myoblasts, immobile connective tissue cells, stem cells, or mixtures thereof.

36. Method according to claim 28, characterized in that the tissue cells are cells of the fascia transversalis, the fascia lata, or of other fasciae, or cells of the skin or of the ligament motion apparatus.

39. Method for treatment of hernias, in particular of hiatal or inguinal hernias, wherein primary or conditioned tissue cells from a patient are immobilized, optionally cultivated, on a matrix structure according to claim 1, and wherein the matrix with the cells immobilized thereon is implanted.

27. (canceled)

37. (canceled)

38. (canceled)