Hernia implant, method for its manufacture and use in surgery

• US 6,737,371 B1
• Filed: 11/06/2000
• Issued: 05/18/2004
• Est. Priority Date: 11/10/1999
• Status: Expired due to Fees

• Current Assignee: Deutsche Institute Fur Textil-Und Faserforschung Stuttgart Stiftung Des Oeffentlichen Rechts
• Original Assignee: Deutsche Institute fur Textil-und Faserforschung Stuttgart Stiftung des offentlichen Rechts
• Inventors: Leibl, Bernhard, Schmees, Hans-Gerd, Planck, Heinrich, Mueller, Erhard, Arnold, Anette
• Primary Examiner(s): Juska, Cheryl A.
• Assistant Examiner(s): Salvatore, Lynda
• Application Number:
  US09/705,925
• Time in Patent Office: 1,289 Days
• Field of Search: 623/1, 623/11, 623/66, 623/13, 623/14, 428/373, 428/11, 428/374, 428/375, 428/376, 428/378, 442/1, 442/318, 442/319, 442/304, 442/66
• US Class Current: 442/304
• 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 hernia 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 hernia implant so as to form a composite structure, is made available for use in surgery.

Claims

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

wherein the composite components are formed from monofilaments having a thickness of about 10 to about 500 μ

m;

said textile fabric structures are formed as net structures with at least two net structures having a substantially different structure from each other and at least one of said textile fabric structures having a pore; and

said textile fabric structures are interconnected by knitting and are associated in a way that their structure pores are not aligned;

wherein said hernia implant is made of at least one material which is at least partly absorbable in vivo and where, by way of in vivo degradation of said absorbable material, pore sizes in said hernia implant increase; and

wherein said hernia implant has a bursting pressure of 100 to 300 kPa.

2. Hernia implant according to claim 1, wherein the thickness is 100 to 150 μ

m.

3. Hernia implant according to claim 1, wherein the fabric structures are knitted net structures.

4. Hernia implant according to claim 1, wherein the nets are produced by different binding procedures.

5. Hernia implant according to claim 1, wherein the openings have a substantially hexagonal shape.

6. Hernia implant according to claim 1, wherein the individual textile fabric structures have a pore structure with pore sizes of 0.1 to 10 mm.

7. Hernia implant according to claim 6, wherein the pore sizes are 0.5 to 5 mm.

8. Hernia implant according to claim 1, wherein the individual textile fabric structure are produced by different binding procedures.

9. Hernia implant according to claim 1, wherein the structure pores are openings and overlap roughly by half.

10. Hernia implant according to claim 1, wherein at least one of the textile fabric structures is formed substantially from non-absorbably material and at least one other of the textile fabric structures is substantially formed from absorbable material.

11. Hernia implant according to claim 10, wherein a textile fabric structure having hexagonal openings is formed substantially from non-absorbable material.

12. Hernia implant according to claim 1, wherein absorbable and non-absorbable materials are present in a ratio of 90:

10 to 10;

90.

13. Hernia implant according to claim 12, wherein the materials are present in ratio of 30:

70 to 70;

30.

14. Hernia implant according to claim 12, wherein the materials are present in ratio of 50:

50.

15. Hernia implant according to claim 1, wherein a filamentary material for joining the textile fabric structures is formed from absorbable material.

16. Hernia implant according to claim 1, wherein a non-absorbable material has a weight per unit area of up to 50 g/m².

17. Hernia implant according to claim 16, wherein the material weight per unit area is up to 40 g/m².

18. Hernia implant according to claim 1, wherein a non-absorbable material has a strength of 16 to 50 N/cm.

19. Hernia implant according to claim 1, wherein it has a bursting elongation of 20 to 50 mm.

20. Hernia implant according to claim 1, wherein its extensibility measures in longitudinal, transverse and diagonal directions in each case differs by no more than 50%.

21. Hernia implant according to claim 20, wherein the extensibility values are substantially identical values.

22. Hernia implant according to claim 1, wherein its tearing strength measured in longitudinal, transverse and diagonal directions in each case differs by no more than 50%.

23. Hernia implant according to claim 22 wherein the strength values are substantially identical.

24. Hernia implant according to claim 1, wherein a non-absorbable material is selected from the group comprising polypropylene, polytetrafluroethylene, polytetrafluoro-ethylene-hexafluoropropylene copolymer, polyethylene terephthalate, polybutylene terephthalate, as well as their mixtures, copolymers and terpolymers.

25. Hernia implant according to claim 1, 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.

29. Method for treating wall defects in a body cavity comprising the step of implanting in a patient in need thereof the hernia implant according to claim 1.

30. Method according to claim 29, wherein the hernia implant is used to treat abdominal wall defects.

26. Method for the manufacture of a hernia 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;

wherein the composite components are formed from monofilaments having a thickness of about 10 to about 500 microns;

said textile fabric structures are formed as net structures with at least two net structures having a substantially different structure from each other and at least one of said textile fabric structures having an opening; and

said textile fabric structures are interconnected by knitting and are associated in a way that their structure pores are not aligned;

wherein said hernia implant is made of at least one material which is at least partly absorbable in vivo and where, by way of in vivo degradation of said absorbable material, pore sizes of openings in said hernia implant increase; and

wherein said hernia implant has a bursting pressure of 100 to 300 KPa.

27. Method according to claim 26, wherein the textile fabric structures in the form of knitwear are produced by knitting.

28. Method according to claim 26, wherein the textile fabric structures are simultaneously joined together while each of said textile fabric structures are formed.