Flat implant, method for its manufacture and use in surgery

• US 20040029478A1
• Filed: 08/12/2003
• Published: 02/12/2004
• Est. Priority Date: 11/10/1999
• Status: Abandoned Application

• Current Assignee: Deutsche Institute Fur Textil-Und Faserforschung Stuttgart Stiftung Des Oeffentlichen Rechts
• Original Assignee: Deutsche Institute Fur Textil-Und Faserforschung Stuttgart Stiftung Des Oeffentlichen Rechts
• Inventors: Arnold, Anette, Schmees, Hans-Gerd, Planck, Heinrich, Mueller, Erhard
• Application Number:
  US10/638,522
• Publication Number:
  US 20040029478A1
• Time in Patent Office: Days
• US Class Current: 442/318
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D04B 21/16 incorporating synthetic threads
• CPC Class Codes: D10B 2509/08 Hernia repair mesh
• CPC Class Codes: Y10T 428/169 Sections connected flexibly with external fastener
• CPC Class Codes: Y10T 428/233 Foamed or expanded material encased
• CPC Class Codes: Y10T 428/24165 Hexagonally shaped cavities
• CPC Class Codes: Y10T 428/2495 Thickness [relative or absolute]
• CPC Class Codes: Y10T 428/2929 Bicomponent, conjugate, composite or collateral fibers or filaments [i.e., coextruded sheath-core or side-by-side type]
• CPC Class Codes: Y10T 428/2931 Fibers or filaments nonconcentric [e.g., side-by-side or eccentric, etc.]
• CPC Class Codes: Y10T 428/2933 Coated or with bond, impregnation or core
• CPC Class Codes: Y10T 428/2935 Discontinuous or tubular or cellular core
• CPC Class Codes: Y10T 428/2938 Coating on discrete and individual rods, strands or filaments
• CPC Class Codes: Y10T 442/10 Scrim [e.g., open net or mesh, gauze, loose or open weave or knit, etc.]
• CPC Class Codes: Y10T 442/2057 At least two coatings or impregnations of different chemical composition
• CPC Class Codes: Y10T 442/40 Knit fabric [i.e., knit strand or strip material]
• CPC Class Codes: Y10T 442/488 Including an additional knit fabric layer
• CPC Class Codes: Y10T 442/494 Including a nonwoven fabric layer other than paper

Abstract

A flat implant with a flexible fabric formed from at least two textile fabric structures constructed substantially independently of one another and firmly interconnected over the entire surface area of the implant so as to form a composite structure, is made available for use in surgery.

Claims

1. Flat implant for use in surgery with a flexible fabric formed from at least two substantially independently constructed textile fabric structures, which are firmly interconnected over the entire surface of the implant to form a composite structure.

2. Implant according to claim 1, characterized in that substantially all the composite components are formed from monofilaments, preferably exclusively from monofilaments.

3. Implant according to claim 1, characterized in that a monofilament has a thickness of 10 to 500 μ

m, particularly 100 to 150 μ

m.

4. Implant according to claim 1, characterized in that the individual textile fabric structures are formed as net structures, particularly knitted net structures.

5. Implant according to claim 1, characterized in that the at least two nets have a substantially different structure, particularly a different binding construction.

6. Implant according to claim 1, characterized in that at least one fabric structure has openings with a preferably substantially hexagonal shape.

7. Implant according to claim 1, characterized in that the individual textile fabric structures have a pore structure with pore sizes of 0.1 to 10 mm, particularly 0.5 to 5 mm.

8. Implant according to claim 1, characterized in that the individual textile fabric structures are produced with different binding constructions.

9. Implant according to claim 1, characterized in that the textile fabric structures are interconnected by knitting.

10. Implant according to claim 1, characterized in that the textile fabric structures, particularly net structures, are so mutually associated that-their structure pores, particularly openings are not aligned and in particular overlap roughly by half.

11. Implant according to claim 1, characterized in that it is at least partly absorbable in vivo.

12. Implant according to claim 1, characterized in that at least one of the textile fabric structures, particularly one having hexagonal openings, is formed substantially from non-absorbable material and at least one other of the textile fabric structures is substantially formed from absorbable material.

13. Implant according to claim 1, characterized in that a filamentary material for joining the textile fabric structures is formed from absorbable material.

14. Implant according to claim 1, characterized in that the absorbable and non-absorbable materials are present in a ratio of 90:

10 to 10;

90, particularly in a ratio of 30;

70 to 70;

30 and preferably 50;

50.

15. Implant according to claim 1, characterized in that by the in vivo degradation of the absorbable material, it is possible to increase the pore size of openings of the implant.

16. Implant according to claim 1, characterized in that the non-absorbable material has a weight per unit area of up to 50 g/m, particularly up to 40 g/m.

17. Implant according to claim 1, characterized in that the non-absorbable material has a strength of 16 to 50 N/cm.

18. Implant according to claim 1, characterized in that it has a bursting pressure of 100 to 300 kPa.

19. Implant according to claim 1, characterized in that it has a bursting elongation of 20 to 50 mm.

20. Implant according to claim 1, characterized in that its extensibility measured in the longitudinal, transverse and diagonal directions in each case differs by no more than 50% and in particular has substantially identical values.

21. Implant according to claim 1, characterized in that its tearing strength measured in the longitudinal, transverse and diagonal directions in each case differs by no more than 50% and in particular has substantially identical values.

22. Implant according to claim 1, characterized in that the non-absorbable material is selected from the group comprising polypropylene, polytetrafluoroethylene, polytetrafluoroethylene-hexafluoropropylene copolymer, polyethylene terephthalate, polybutylene terephthalate, as well as their mixtures, copolymers and terpolymers.

23. Implant according to claim 1, characterized in that the absorbable material is selected from the group comprising polyglycolide, polylactide, polydioxanone, polyhydroxybutyric acid, polycaprolactone, polytrimethylene carbonate, polytetramethylene carbonate, as well as their mixtures, copolymers and terpolymers.

24. Implant according to claim 1, characterized in that it is in the form of a belt.

28. Use of the implant according to claim 1 in surgery, particularly for treating defects in body cavities, particularly for supporting and holding body organs.

29. Use of the implant according to claim 1 in surgery as a urinary incontinence belt for supporting the female urethra.

25. Method for the manufacture of an implant by forming at least two independent textile fabric structures and joining said textile fabric structures over their surface area to form a composite structure in the form of a flexible fabric.

26. Method according to claim 25, characterized in that the textile fabric structures in the form of knitwear are in particular produced by knitting.

27. Method according to claim 25, characterized in that the textile fabric structures are joined together by textile procedures, particularly by knitting during their joint production.

30. Flat implant for use in surgery with a flexible fabric formed from at least two substantially independently constructed textile fabric structures, which are firmly interconnected over the entire surface of the implant to form a composite structure.

31. Implant according to claim 30, wherein substantially all the composite components are formed from monofilaments.

32. Implant according to claim 31, wherein the composite components are formed exclusively from monofilaments.

33. Implant according to claim 30, wherein a monofilament has a thickness of 10 to 500 μ

m.

34. Implant according to claim 33, wherein the thickness is 100 to 150 μ

m.

35. Implant according to claim 30, wherein the individual textile fabric structures are formed as net structures.

36. Implant according to claim 35, wherein the fabric structures are knitted net structures.

37. Implant according to claim 30, wherein at least two nets are provided which have a substantially different structure.

38. Implant according to claim 37, wherein the nets have a different binding construction.

39. Implant according to claim 30, wherein at least one fabric structure has openings.

40. Implant according to claim 39, wherein the openings have a substantially hexagonal shape.

41. Implant according to claim 30, wherein the individual textile fabric structures have a pore structure with pore sizes of 0.1 to 10 mm.

42. Implant according to claim 41, wherein the pore sizes are 0.5 to 5 mm.

43. Implant according to claim 30, wherein the individual textile fabric structures are produced with different binding constructions.

44. Implant according to claim 30, wherein the textile fabric structures are interconnected by knitting.

45. Implant according to claim 30, wherein the textile fabric structures are so mutually associated that their structure pores are not aligned.

46. Implant according to claim 45, wherein the structure pores are openings and overlap roughly by half.

47. Implant according to claim 30, wherein the implant is at least partly absorbable in vivo.

48. Implant according to claim 47, wherein by in vivo degradation of an absorbable material, it is possible to increase pore sizes of openings of the implant.

49. Implant according to claim 30, wherein at least one of the textile fabric structures is formed substantially from non-absorbable material and at least one other of the textile fabric structures is substantially formed from absorbable material.

50. Implant according to claim 49, wherein a textile fabric structure having hexagonal openings is formed substantially from non-absorbable material.

51. Implant according to claim 47, wherein absorbable and non-absorbable materials are present in a ratio of 90:

10 to 10;

90.

52. Implant according to claim 51, wherein the materials are present in ratio of 30:

70 to 70;

30.

53. Implant according to claim 52, wherein the materials are present in ratio of 50:

50.

54. Implant according to claim 30, wherein a filamentary material for joining the textile fabric structures is formed from absorbable material.

55. Implant according to claim 30, wherein a non-absorbable material has a weight per unit area of up to 50 g/m².

56. Implant according to claim 55,.wherein the material weight per unit area is up to 40 g/m².

57. Implant according to claim 30, wherein a non-absorbable material has a strength of 16 to 50 N/cm.

58. Implant according to claim 30, wherein it has a bursting pressure of 100 to 300 kPa.

59. Implant according to claim 30, wherein it has a bursting elongation of 20 to 50 mm.

60. Implant according to claim 30, wherein its extensibility measured in longitudinal, transverse and diagonal directions in each case differs by no more than 50%.

61. Implant according to claim 60, wherein the extensibility values are substantially identical values.

62. Implant according to claim 30, wherein its tearing strength measured in longitudinal, transverse and diagonal directions in each case differs by no more than 50%.

63. Implant according to claim 62, wherein the strength values are substantially identical.

64. Implant according to claim.30, wherein a non-absorbable material is selected from the group comprising polypropylene, polytetrafluoroethylene, polytetrafluoroethylene-hexafluoropropylene copolymer, polyethylene terephthalate, polybutylene terephthalate, as well as their mixtures, copolymers and terpolymers.

65. Implant according to claim 30, wherein an absorbable material is selected from the group comprising polyglycolide, polylactide, polydioxanone, polyhydroxybutyric acid, polycaprolactone, polytrimethylene carbonate, polytetramethylene carbonate, as well as their mixtures, copolymers and terpolymers.

66. Implant according to claim 30, wherein the implant is in the form of a belt.

71. Use of the implant according to claim 30 in surgery for treating defects in body cavities.

72. Use according to claim 71, wherein the implant is used for supporting and holding body organs.

73. Use according to claim 71, wherein the implant is used as a urinary incontinence belt for supporting the female urethra.

67. Method for the manufacture of a flat implant by forming at least two independent textile fabric structures and joining said textile fabric structures over their surface area to form a composite structure in the form of a flexible fabric.

68. Method according to claim 67, wherein the textile fabric structures in the form of knitwear are produced by knitting.

69. Method according to claim 67, wherein the textile fabric structures are joined together by textile procedures.

70. Method according to claim 67, wherein the textile fabric structures are joined by knitting during their joint production.