MESH IMPLANT FOR USE IN RECONSTRUCTION OF SOFT TISSUE DEFECTS

• US 20110112561A1
• Filed: 01/11/2011
• Published: 05/12/2011
• Est. Priority Date: 12/23/2004
• Status: Active Grant

• Current Assignee: Novus Scientific AB (Novus Scientific Pte., Ltd.)
• Original Assignee: Novus Scientific Pte., Ltd.
• Inventors: Magnusson, Henrik, Mathisen, Torbjörn
• Granted Patent: US 9,750,854 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

The present invention relates to a resorbable polymeric mesh implant, that is intended to be used in the reconstruction of soft tissue defects. The mesh implant comprises at least a first and a second material, wherein the second material is substantially degraded at a later point in time than the first material following the time of implantation. The mesh implant is adapted to have a predetermined modulus of elasticity that gradually is decreased until the mesh implant is completely degraded and subsequently resorbed. Due to the gradual decrease in the modulus of elasticity of the inventive mesh implant, the regenerating tissue may gradually take over the load applied to the tissue defect area.

Claims

1. A resorbable polymeric mesh implant whose implant configuration varies over time after implantation for use in reconstruction of soft tissue defects, wherein the resorbable polymeric mesh implant comprises:

at least a first material and a second material, wherein the second material is substantially degraded at a later point in time than the first material, wherein a modulus of elasticity of the first material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the first material in said implant configuration, wherein a modulus of elasticity of the second material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the second material in said implant configuration, and wherein;

the modulus of elasticity of the mesh implant is initially substantially constant and equal to the modulus of elasticity of the first material following a time of implantation and until said first material is substantially degraded, and wherein;

the modulus of elasticity of the mesh implant is substantially equal to the modulus of elasticity of the second material after the first material is substantially degraded, wherein the modulus of elasticity of the second material is less than half of the modulus of elasticity of the first material;

wherein a last substantially degraded material has a modulus of elasticity in its configuration that is compatible with the elasticity of a surrounding tissue such that the flexibility of said tissue is not restricted by the implant.

2. The resorbable polymeric mesh implant according to claim 1, wherein the mesh implant further comprises a third material that is substantially degraded at a later point in time than the second material and has a significantly lower modulus of elasticity than the second material, wherein a modulus of elasticity of the third material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the third material in said implant configuration, wherein the modulus of elasticity of the mesh implant is substantially equal to the modulus of elasticity of the third material after the second material is substantially degraded.

3. The resorbable polymeric mesh implant according to claim 1, wherein a first substantially degraded material is substantially degraded at a point in time within the time range of 14-30 days following implantation.

4. The resorbable polymeric mesh implant according to claim 1, wherein the last substantially degraded material is substantially degraded at a point in time within a time range of 3-18 months following implantation.

5. The resorbable polymeric mesh implant according to claim 1, wherein the mesh implant is provided with a further material, which is substantially degraded approximately at the same point in time as a first substantially degraded material.

6. The resorbable polymeric mesh implant according to claim 5, wherein the mesh implant is provided with still a further material, wherein the further material is substantially degraded approximately at a same point in time as any of the other materials present in the mesh implant.

7. The resorbable polymeric mesh implant according to claim 1, wherein the materials are chosen in order to construe a mesh implant that is tailored for a specific soft tissue defect to be reconstructed.

8. The resorbable polymeric mesh implant according to claim 1, wherein the mesh implant is provided with a resorbable film in order to prevent adhesion of the mesh implant onto surrounding tissue.

9. The resorbable polymeric mesh implant according to claim 8, wherein the resorbable film is a hydrophilic carbohydrate film.

10. The resorbable polymeric mesh implant according to claim 1, wherein a first substantially degraded material and/or a further material comprises or is incorporated into a woven or knitted, porous structure with a pore size in a range of 50-4000 microns.

11. The resorbable polymeric mesh implant according to claim 1, wherein a first substantially degraded material and/or a further material comprises or is incorporated into a non-woven structure.

12. The resorbable polymeric mesh implant according to claim 11, wherein the non-woven structure is an electro-spun structure.

13. The resorbable polymeric mesh implant according to claim 1, wherein the last substantially degraded material has a woven or knitted, porous structure with a pore size in the range of 0.5-4 mm.

14. A resorbable polymeric mesh implant kit, comprising:

at least a first and a second material, wherein the modulus of elasticity of the second material is lower than the modulus of elasticity of the first material and wherein the second material is substantially degraded at a later point in time than the first material,

wherein said materials are intended to be combined into a mesh implant according to claim 1 that is tailored for a specific soft tissue defect to be reconstructed.

15. The resorbable polymeric mesh implant kit according to claim 14, wherein the kit further comprises a third material that is substantially degraded at a later point in time than the second material and has a significantly lower modulus of elasticity than the second material, wherein a modulus of elasticity of the third material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the third material in said implant configuration.

16. A method of using a resorbable polymeric mesh implant in the reconstruction of a soft tissue defect, comprising the step of providing a resorbable polymeric mesh implant, wherein the implant is a resorbable polymeric mesh implant according to claim 1.

17. The method according to claim 16, wherein the soft tissue defect is an abdominal wall defect.

18. The method according to claim 17, wherein the abdominal wall defect is a result from a hernia.

19. A method of using a resorbable polymeric mesh implant kit in a reconstruction of a soft tissue defect, comprising the step of providing a resorbable polymeric mesh implant kit, wherein the kit is a resorbable polymeric mesh implant kit according to claim 14.

20. The method according to claim 19, wherein the soft tissue defect is an abdominal wall defect.

21. The method according to claim 20, wherein the abdominal wall defect is a result from a hernia.

22. The resorbable polymeric mesh implant according to claim 1, wherein, at the time of substantial degradation of the first and second materials, the mechanical strength of each of the first and materials is less than approximately 30% of an initial mechanical strength of the first and second materials.

23. The resorbable polymeric mesh implant according to claim 1, wherein the first and second materials each have a modulus of elasticity of 300 kPa to 3 GPa.

24. The resorbable polymeric mesh implant according to claim 1, wherein the last substantially degraded material is substantially degraded at a point in time within a time range of 6-12 months following implantation.

25. The resorbable polymeric mesh implant according to claim 1, wherein the implant initially has an elongation of 0-20%.

26. The resorbable polymeric mesh implant according to claim 1, wherein the implant initially has an elongation of 0-10%.

27. The resorbable polymeric mesh implant according to claim 1, wherein the implant has an elongation of 18-32% after the first material has substantially degraded.

28. The resorbable polymeric mesh implant according to claim 1, wherein the last substantially degraded material has a knitted structure with a pore size of 1-3 mm.

29. A resorbable polymeric mesh implant whose implant configuration varies over time after implantation for use in reconstruction of soft tissue defects, wherein the resorbable polymeric mesh implant comprises:

at least a first material and a second material, wherein the second material is substantially degraded at a later point in time than the first material, wherein a modulus of elasticity of the first material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the first material in said implant configuration, wherein a modulus of elasticity of the second material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the second material in said implant configuration, and wherein;

the modulus of elasticity of the mesh implant is initially substantially constant and equal to the modulus of elasticity of the first material following a time of implantation and until said first material is substantially degraded, and wherein;

the modulus of elasticity of the mesh implant is substantially equal to the modulus of elasticity of the second material after the first material is substantially degraded, wherein the modulus of elasticity of the second material is less than half of the modulus of elasticity of the first material.

30. A resorbable polymeric mesh implant whose implant configuration varies over time after implantation for use in reconstruction of soft tissue defects, wherein the resorbable polymeric mesh implant comprises:

at least a first material and a second material, wherein the second material is substantially degraded at a later point in time than the first material, wherein a modulus of elasticity of the first material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the first material in said implant configuration, wherein a modulus of elasticity of the second material includes both the modulus of elasticity of the material itself and also the elasticity due to a present structural configuration of the second material in said implant configuration, and wherein;

the modulus of elasticity of the mesh implant is initially substantially constant and equal to the modulus of elasticity of the first material following a time of implantation and until said first material is substantially degraded, and wherein;

the modulus of elasticity of the mesh implant is substantially equal to the modulus of elasticity of the second material after the first material is substantially degraded, wherein the modulus of elasticity of the second material is approximately 35%-65% of the modulus of elasticity of the first material;

wherein a last substantially degraded material has a modulus of elasticity in its configuration that is compatible with the elasticity of a surrounding tissue such that the flexibility of said tissue is not restricted by the implant.