Mesh implant for use in reconstruction of soft tissue defects

• US 9,566,370 B2
• Filed: 12/23/2004
• Issued: 02/14/2017
• Est. Priority Date: 12/23/2004
• Status: Active Grant

• Current Assignee: Novus Scientific AB (Novus Scientific Pte., Ltd.)
• Original Assignee: Novus Scientific AB (Novus Scientific Pte., Ltd.)
• Inventors: Mathisen, Torbjrn, Magnusson, Henrik
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US11/019,534
• Publication Number:
  US 20060142786A1
• Time in Patent Office: 4,436 Days
• Field of Search: 606/151, 606/213, 606110-112, 602 43- 44, 604304-308
• US Class Current: 1/1
• 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 having a modulus of elasticity in a first direction, the resorbable polymeric mesh implant comprising:

a first resorbable material having a first modulus of elasticity in the first direction and a first time of substantial degradation; and

a second resorbable material having a second modulus of elasticity in the first direction and a second time of substantial degradation,

wherein the first modulus of elasticity is greater than the second modulus of elasticity,

wherein the second time of substantial degradation is longer than the first time of substantial degradation,

wherein from a time of implantation of the resorbable polymeric mesh implant in a surrounding tissue to the first time of substantial degradation;

the modulus of elasticity of the resorbable polymeric mesh implant in the first direction is equal to the first modulus of elasticity,

the resorbable polymeric mesh implant is configured to absorb a first load in the first direction,

the first load being substantially all of the load applied to the surrounding tissue in the first direction, and

the modulus of elasticity of the resorbable polymeric mesh implant in the first direction is configured to remain substantially constant as the load applied to the surrounding tissue in the first direction is varied,

wherein from the first time of substantial degradation to the second time of substantial degradation;

the modulus of elasticity of the resorbable polymeric mesh implant in the first direction is the second modulus of elasticity,

a portion of the first load is transferred from the resorbable polymeric mesh implant to the surrounding tissue,

the resorbable polymeric mesh implant is configured to absorb the remaining portion of the first load that is not transferred to the surrounding tissue, and

the modulus of elasticity of the resorbable polymeric mesh implant in the first direction is configured to remain substantially constant as the load applied to the surrounding tissue in the first direction is varied, and

wherein the modulus of elasticity of the resorbable polymeric mesh implant in the first direction is time-dependent irrespective of the load applied to the surrounding tissue in the first direction.

2. The resorbable polymeric mesh implant according to claim 1, wherein the remaining portion of the first load is greater than the portion of the first load transferred from the resorbable polymeric mesh implant to the surrounding tissue.

3. The resorbable polymeric mesh implant according to claim 1, wherein the second modulus of elasticity corresponds to an elongation of 18 to 32% in the first direction when subjected to a load of 16 N/cm.

4. The resorbable polymeric mesh implant according to claim 1, wherein the first modulus of elasticity corresponds to an elongation of no more than 20% as the load applied to the surrounding tissue is varied.

5. The resorbable polymeric mesh implant according to claim 1, wherein the first modulus of elasticity corresponds to an elongation of no more than 10% as the load applied to the surrounding tissue is varied.

6. The resorbable polymeric mesh implant according to claim 1, wherein the first time of substantial degradation is 14 to 30 days.

7. The resorbable polymeric mesh implant according to claim 1, wherein the second time of substantial degradation is 3 to 18 months.

8. The resorbable polymeric mesh implant according to claim 1, further comprising:

a third resorbable material having a third modulus of elasticity in the first direction and a third time of substantial degradation,

wherein the second modulus of elasticity is greater than the third modulus of elasticity,

wherein the third time of substantial degradation is longer than the second time of substantial degradation,

wherein from the second time of substantial degradation to the third time of substantial degradation;

a modulus of elasticity of the resorbable polymeric mesh implant in the first direction is the third modulus of elasticity,

a portion of the remaining portion of the first load is transferred from the resorbable polymeric mesh implant to the surrounding tissue, and

the modulus of elasticity of the resorbable polymeric mesh implant in the first direction is configured to remain substantially constant as the load applied to the surrounding tissue in the first direction is varied.

9. The resorbable polymeric mesh implant according to claim 8, wherein the third time of substantial degradation is 3 to 18 months.

10. The resorbable polymeric mesh implant according to claim 1, further comprising a resorbable film configured to prevent adhesion of the resorbable polymeric mesh implant onto the surrounding tissue.

11. The resorbable polymeric mesh implant according to claim 10, wherein the resorbable film is a hydrophilic carbohydrate film.

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

13. The resorbable polymeric mesh implant according to claim 1, wherein the first resorbable material comprises or is incorporated into a non-woven structure.

14. The resorbable polymeric mesh implant according to claim 13, wherein the non-woven structure is an electro-spun structure.

15. The resorbable polymeric mesh implant according to claim 1, wherein the second resorbable material comprises a woven or knitted, porous structure with a pore size in the range of 0.5-4 mm.