Mesh implant for use in reconstruction of soft tissue defects

• US 9,717,825 B2
• Filed: 04/07/2011
• Issued: 08/01/2017
• 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:
  US13/081,998
• Publication Number:
  US 20120184973A1
• Time in Patent Office: 2,308 Days
• Field of Search: 606151, 623 1111
• 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
• 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;

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 wherein the first arrangement and the second arrangement are in different patterns; and

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 that create a capillary effect for blood within the body such that fibroblasts and macrophages are present 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 that create a capillary effect for blood within the body such that fibroblasts and macrophages are present in the interstices,

wherein the first material is made from a copolymer composed of at least 80 weight-% glycolide monomer or para-dioxanone monomer,

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,

wherein the second material is made from a copolymer composed of at least 80 weight-% L-lactide monomer, and

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.

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

3. A 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. A 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. A 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. A mesh implant according to claim 1, wherein the first material comprises a multifilament with individual filaments having a cross-sectional area from about 180 μ

m² to about 2000 μ

m².

7. A mesh implant according to claim 1, wherein the multifilament of the first material has a linear density in the range of from about 100 denier to about 180 denier.

8. A mesh implant according to claim 1, wherein the second material comprises a multifilament with individual filaments having a cross-sectional area from about 180 μ

m² to about 2000 μ

m².

9. A mesh implant according to claim 1, wherein the multifilament of the second material has a linear density in the range of from about 140 denier to 200 denier.

10. A mesh implant according to claim 1, wherein at least one of the first and second arrangements comprises a multifilament comprising interstices between individual filaments of the multifilament configured to allow for infiltration of a cell belonging to the immune system.

11. A mesh implant according to claim 10, wherein at least one of the first and second arrangements comprises a multifilament comprising interstices between individual filaments of the multifilament configured to allow for infiltration of a monocyte.

12. 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;

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 wherein the first arrangement and the second arrangement are in different patterns; and

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 of the multifilament prior to any degradation and prior to beginning implantation dimensioned and arranged such that fibroblasts and macrophages within the body fit into 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 of the multifilament prior to any degradation and prior to beginning implantation dimensioned and arranged such that fibroblasts and macrophages within the body fit into the interstices,

wherein the first material is made from a copolymer composed of at least 80 weight-% glycolide monomer or para-dioxanone monomer,

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,

wherein the second material is made from a copolymer composed of at least 80 weight-% L-lactide monomer, and

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.

13. A mesh implant according to claim 12, wherein at least one of the first and second materials comprises a multifilament with interstices dimensioned and arranged such that connective tissue within the body grows into the interstices during the primary wound healing period.

14. 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;

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 wherein the first arrangement and the second arrangement are in different patterns; and

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 of the multifilament prior to any degradation and prior to beginning implantation dimensioned and arranged such that fibroblasts and macrophages within the body are drawn into 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 of the multifilament prior to any degradation and prior to beginning implantation dimensioned and arranged such that fibroblasts and macrophages within the body are drawn into the interstices,

wherein the first material is made from a copolymer composed of at least 80 weight-% glycolide monomer or para-dioxanone monomer,

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,

wherein the second material is made from a copolymer composed of at least 80 weight-% L-lactide monomer, and

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.