Mesh implant for use in reconstruction of soft tissue defects

• US 8,083,755 B2
• Filed: 06/22/2006
• Issued: 12/27/2011
• Est. Priority Date: 06/22/2006
• Status: Active Grant

• Current Assignee: Novus Scientific AB (Novus Scientific Pte., Ltd.)
• Original Assignee: Novus Scientific Pte., Ltd.
• Inventors: Mathisen, Torbjörn, Magnusson, Henrik
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US11/472,563
• Publication Number:
  US 20070299542A1
• Time in Patent Office: 2,014 Days
• Field of Search: 606152-200, 606/213, 606110-112, 606/151, 602/43, 602/44, 604304-308, 623/11, 424422-426
• US Class Current: 606/151
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

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 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, wherein;

the modulus of elasticity of the mesh implant is 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

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 lower than the modulus of elasticity of the first material, and wherein the first substantially degraded material is substantially degraded at a point in time within a time range of 2-13 days following implantation,

wherein the modulus of elasticity of the first material is such that, before the first material is substantially degraded, an elongation of the mesh implant is in a range of 0 to 20% when subjected to a load of 16 N/cm,

wherein the elongation of the mesh implant is in a range of 18 to 32%, when subjected to a load of 16 N/cm, after the first material has substantially degraded.

2. A resorbable polymeric mesh implant according to claim 1, wherein the first substantially degraded material is substantially degraded at a point in time within a time range of 3-9 days following implantation.

3. A 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 the modulus of elasticity of the mesh implant is substantially equal to a modulus of elasticity of the third material after the second material is substantially degraded.

4. A resorbable polymeric mesh implant according to claim 1, wherein the last substantially degraded material has a modulus of elasticity that is compatible with the elasticity of surrounding tissue so that a flexibility of said tissue is not substantially restricted.

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

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

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

8. A resorbable polymeric mesh implant according to claim 6, wherein the first substantially degraded material and/or the further material has or is incorporated into a woven or knitted, porous structure with a pore size in the range of 50-4000 microns.

9. A resorbable polymeric mesh implant according to claim 6, wherein the first substantially degraded material and/or the further material has or is incorporated into a non-woven structure.

10. A resorbable polymeric mesh implant according to claim 9, wherein the non-woven structure is an electro-spun structure.

11. A resorbable polymeric mesh implant according to claim 1, wherein materials are chosen in order to construct a mesh implant that is tailored for a specific soft tissue defect to be reconstructed.

12. A 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 to surrounding tissue.

13. A resorbable polymeric mesh implant according to claim 12, wherein the resorbable film is a hydrophilic carbohydrate film.

14. A 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.

15. A resorbable polymeric mesh implant according to claim 1, wherein the modulus of elasticity of the first material is such that, before the first material is substantially degraded, the elongation of the mesh implant is in a range of 0 to 10%.

16. A resorbable polymeric mesh implant kit, comprising:

at least a first and second material,

wherein the modulus of elasticity of the second material is lower than a 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 the 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 an implant configuration, wherein the 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,

wherein the first and second materials are combined into a mesh implant,

wherein the modulus of elasticity of the mesh implant is 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,

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, and wherein the first substantially degraded material is substantially degraded at a point in time within a time range of 2-13 days following implantation,

wherein the modulus of elasticity of the first material is such that, before the first material is substantially degraded, and elongation of the mesh implant is in a range of 0 to 20% when subjected to a load of 16 N/cm,

wherein the elongation of the mesh implant is in a range of 18 to 32%, when subjected to a load of 16 N/cm, after the first material has substantially degrade, and

wherein the mesh implant is tailored for a specific soft tissue defect to be reconstructed.

17. A resorbable polymeric mesh implant kit according to claim 16, wherein the kit 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.