# US 9,750,854 B2 · Mesh implant for use in reconstruction of soft tissue defects

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- Number: US 9,750,854 B2
- Document ID: US9750854B2
- Status: Granted
- Kind: B2
- Application number: 13/004,530
- Filed: 2011-01-11
- Published: 2011-05-12
- Granted: 2017-09-05
- Earliest claimed: 2004-12-23
- Assignees: Novus Scientific AB
- Applicants: Torbjörn Mathisen; Henrik Magnusson
- Inventors: Torbjörn Mathisen; Henrik Magnusson
- Web page: https://patentgrep.com/patent/US9750854B2

## CPC

- A61L 27/58: Materials at least partially resorbable by the body
- A61L 27/48: with macromolecular fillers
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 31/125: {having a macromolecular matrix}
- A61L 31/129: {containing macromolecular fillers}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2210/0004: bioabsorbable
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/003: differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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 only 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 constant and equal to the modulus of elasticity of the second material after the first material is substantially degraded and until said second material is substantially degraded, wherein the modulus of elasticity of the second material is significantly lower than the modulus of elasticity of the first material;
wherein a last substantially degraded material has a modulus of elasticity in its configuration that is significantly lower than the modulus of elasticity of earlier degraded material during the time period when the last substantially degraded material is the only material remaining in the mesh implant, and the first material is substantially degraded at a point in time within the time range of 14-30 days following implantation,
wherein the last substantially degraded material has a modulus of elasticity that corresponds to an elongation of 18 to 32% when subjected to a tensile load of 16 N/cm.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 3)

The resorbable polymeric mesh implant according to claim 3, 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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

The resorbable polymeric mesh implant according to claim 6, wherein the resorbable film is a hydrophilic carbohydrate film.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 9)

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

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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 second materials is less than approximately 30% of an initial mechanical strength of the first and second materials.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 1)

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.

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 1)

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.

### Claim 17 (depends on 16)

The resorbable polymeric mesh implant kit according to claim 16, 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.

### Claim 18 (depends on 1)

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.

### Claim 19 (depends on 18)

The method according to claim 18, wherein the soft tissue defect is an abdominal wall defect.

### Claim 20 (depends on 19)

The method according to claim 19, wherein the abdominal wall defect is a result from a hernia.

### Claim 21 (depends on 16)

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 16.

### Claim 22 (depends on 21)

The method according to claim 21, wherein the soft tissue defect is an abdominal wall defect.

### Claim 23 (depends on 22)

The method according to claim 22, wherein the abdominal wall defect is a result from a hernia.
