Mesh implant for use in reconstruction of soft tissue defects

• US 10,342,653 B2
• Filed: 06/28/2017
• Issued: 07/09/2019
• 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, Torbjorn, Magnusson, Henrik
• Primary Examiner(s): Yabut, Diane D
• Application Number:
  US15/635,812
• Publication Number:
  US 20170296320A1
• Time in Patent Office: 741 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• 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 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

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 has 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. Interstices between individual filaments of multifilaments create a capillary effect for cells within the body.

Claims

1. An at least partially resorbable mesh implant for use in reconstruction of soft tissue defects, wherein the mesh implant comprises:

a first material in a first arrangement of multifilaments; and

a second material in a second arrangement of multifilaments, wherein the second material is substantially degraded at a later point in time in a body than the first material,

wherein individual filaments of a multifilament of the first arrangement are in directly spun form and are not twisted relative to one another and the multifilament comprises interstices between the individual filaments prior to any degradation and prior to beginning implantation such that fibroblasts and macrophages may be received in the interstices,

wherein individual filaments of a multifilament of the second arrangement are in directly spun form and are not twisted relative to one another and the multifilament comprises interstices between the individual filaments prior to any degradation and prior to beginning implantation such that fibroblasts and macrophages may be received in the interstices.

2. The mesh implant according to claim 1, wherein at least one of the first or second materials comprises perforations.

3. The mesh implant according to claim 2, wherein at least some of the perforations are through-going with a size in the range of 50 μ

m to 4000 μ

m.

4. The mesh implant according to claim 1, wherein the first material comprises a multifilament with individual filaments having a cross-sectional area from about 75 μ

m² to about 8000 μ

m².

5. The mesh implant according to claim 1, wherein the second material comprises a multifilament with individual filaments having a cross-sectional area from about 75 μ

m² to about 8000 μ

m².

6. The mesh implant according to claim 1, wherein the first material is made from a copolymer composed of at least 80 weight-% glycolide monomer or para-dioxanone monomer.

7. The mesh implant according to claim 1, wherein the first material comprises a multifilament with 5 to 15 individual filaments and the multifilament has a linear density in the range of 60 denier to 240 denier.

8. The mesh implant according to claim 1, wherein the second material is made from a copolymer composed of at least 80 weight-% L-lactide monomer.

9. The mesh implant according to claim 1, wherein the second material comprises a multifilament with 60 to 100 individual filaments and the multifilament has a linear density in the range of 120 to 280 denier.

10. The mesh implant according to claim 1, further comprising a third material in a third arrangement of multifilaments, wherein the third material is substantially degraded at a later point in time in a body than the second material.

11. A method of manufacturing an at least partially resorbable mesh implant for use in reconstruction of soft tissue defects, wherein the method comprises:

providing a first material in a first arrangement of multifilaments;

providing a second material in a second arrangement of multifilaments, wherein the second material is substantially degraded at a later point in time in a body than the first material; and

forming the mesh implant by arranging the first material on the second material or by partly or fully incorporating the first material and the second material,

wherein individual filaments of a multifilament of the first arrangement are in directly spun form and are not twisted relative to one another and the multifilament comprises interstices between the individual filaments prior to any degradation and prior to beginning implantation such that fibroblasts and macrophages may be received in the interstices,

wherein individual filaments of a multifilament of the second arrangement are in directly spun form and are not twisted relative to one another and the multifilament comprises interstices between the individual filaments prior to any degradation and prior to beginning implantation such that fibroblasts and macrophages may be received in the interstices.

12. The method of claim 11,

wherein the first material is provided as a first layer,

wherein the second material is provided as a second layer separate from the first layer, and

wherein forming the mesh implant comprises arranging the first layer on top of the second layer.

13. The method of claim 11, further comprising providing a third material in a third arrangement of multifilaments, wherein the third material is substantially degraded at a later point in time in a body than the second material,

wherein forming the mesh implant further comprises arranging the third material on the second material, or partly or fully incorporating the third material into at least one of the first material or the second material.

14. The method of claim 11, wherein at least one of the first or second materials comprises perforations.

15. The method of claim 14, wherein at least some of the perforations are through-going with a size in the range of 50 μ

m to 4000 μ

m.

16. The method of claim 11,

wherein the first material comprises a multifilament with individual filaments having a cross-sectional area from about 75 μ

m² to about 8000 μ

m², and

wherein the second material comprises a multifilament with individual filaments having a cross-sectional area from about 75 μ

m² to about 8000 μ

m².

17. The method of claim 11, wherein the first material is made from a copolymer composed of at least 80 weight-% glycolide monomer or para-dioxanone monomer.

18. The method of claim 11, wherein the first material comprises a multifilament with 5 to 15 individual filaments and the multifilament has a linear density in the range of 60 denier to 240 denier.

19. The method of claim 11, wherein the second material is made from a copolymer composed of at least 80 weight-% L-lactide monomer.

20. The method of claim 11, wherein the second material comprises a multifilament with 60 to 100 individual filaments and the multifilament has a linear density in the range of 120 to 280 denier.