Surgical implant and methods of use

• US 9,248,011 B2
• Filed: 12/11/2011
• Issued: 02/02/2016
• Est. Priority Date: 03/30/2001
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/316,507
• Publication Number:
  US 20120083651A1
• Time in Patent Office: 1,514 Days
• Field of Search: 606/151, 128/898, 424/423, 424/424, 424/443, 623 2372- 2374, 600/29, 600/30, 600/37
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• 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 2250/0071 breakable or frangible

Abstract

A method of treating a vaginal prolapse is provided. The method includes accessing a vaginal prolapse, inserting an implant comprising a knitted mesh into a patient, and securing the knitted mesh in place such that the implant supports the pelvic floor of the patient. The knitted mesh has a mass density of less than 20 g/m².

Claims

1. A mesh implant for providing support to a prolapsed area of a patient'"'"'s vagina, the mesh implant comprising a single mesh layer that is formed of strands and the strands are formed by monofilaments and the monofilaments are arranged to include pores that are formed between the monofilaments, where the mesh layer is planar and is configured for supporting at least one of the posterior wall and the anterior wall of the vagina to treat a prolapse selected from the group consisting of:

urethrocoele prolapse, cystocoele prolapse, vault prolapse, uterine prolapse, enterocoele prolapse, and rectocoele prolapse, wherein the mesh layer includes a plurality of circumferential strands that extend around a perimeter of the mesh layer, wherein the plurality of circumferential strands are concentrically arranged at different radial locations, and the mesh layer has a shape that is symmetrical about a longitudinal axis of the mesh layer, and the shape forms;

a narrowed region; and

a base region, the base region defining;

a lower edge that is substantially straight and orthogonal to the longitudinal axis of symmetry,

a first side edge that is substantially orthogonal to the lower edge and that includes a first portion that is substantially straight and located adjacent the lower edge and a second portion that curves inwardly toward the longitudinal axis of symmetry, and

a second side edge opposite the first side edge that is substantially symmetrical to the first side edge.

2. The mesh implant of claim 1, wherein the shape of the mesh layer forms broad apex opposite to the substantially straight lower edge.

3. The mesh implant of claim 1, wherein the shape of the mesh layer is characterized by an absence of any sharp corners.

4. The mesh implant of claim 1, wherein the mesh layer provides major spaces formed between adjacent strands, with the pores being smaller than the major spaces and configured to allow fibroblast growth through the mesh layer.

5. The mesh implant of claim 1, wherein the monofilaments are polypropylene filaments.

6. The mesh implant of claim 1, wherein the strands are spaced apart to form major spaces of about 1 mm to about 10 mm.

7. The mesh implant of claim 6, wherein the strands are less than about 600 μ

m in diameter.

8. The mesh implant of claim 6, wherein the monofilaments have diameters between about 0.02 mm to 0.15 mm.

9. The mesh implant of claim 6, wherein the pores are between about 50 μ

m and about 200 μ

m in diameter.

10. A method of providing support to a prolapsed area of a patient, the method comprising:

making an incision to access a prolapse selected from the group consisting of urethrocoele prolapse, cystocoele prolapse, vault prolapse, uterine prolapse, enterocoele prolapse, and rectocoele prolapse;

inserting through the incision an implant comprising a mesh comprising a single mesh layer having a first face and a second face opposite the first face, the mesh being formed of strands formed by monofilaments and the monofilaments are arranged to include pore spaces that are formed between the monofilaments, the mesh including a plurality of circumferential strands that extend around a perimeter of the mesh, wherein the plurality of circumferential strands are arranged concentrically at different radial locations, the mesh defining a mesh shape that is symmetrical about a longitudinal axis of the mesh and is configured for supporting at least one of the posterior wall and the anterior wall of the vagina, the mesh shape having a base region and a narrowed region, the base region defining a lower edge that is substantially straight and that extends orthogonal to the longitudinal axis of symmetry, the implant being inserted such that the entirety of the first face and the entirety of the second face of the mesh are exposed to tissue in order to allow for tissue ingrowth into the first and second faces of the mesh;

a first side edge that transitions from a first line segment that is substantially straight and orthogonal to the lower edge to a second line segment that curves inwardly toward the longitudinal axis, and a second side edge opposite the first side edge, the second side edge transitioning from a first line segment that is substantially straight and orthogonal to the lower edge to a second line segment that curves inwardly toward the longitudinal axis, the mesh shape being characterized by an absence of any sharp corners; and

implanting the mesh in the area of the prolapse to provide support to at least one of an anterior wall and a posterior wall of the patient'"'"'s vagina.

11. The method of claim 10, wherein implanting the mesh comprises implanting the mesh in a minimally invasive surgical procedure.

12. The method of claim 10, wherein implanting the mesh comprises implanting the mesh in a laparoscopic surgical procedure.

13. The method of claim 10, wherein the mesh provides major spaces formed in the mesh that are configured to allow blood to pass through the implant.

14. The method of claim 10, wherein the mesh provides major spaces formed between adjacent strands and the pore spaces are smaller than the major spaces and are configured to allow fibroblast growth through the mesh.

15. The method of claim 10, wherein the monofilaments are formed of polypropylene filaments.

16. The method of claim 10, wherein the strands are spaced apart to form major spaces of about 1 mm to about 10 mm.

17. The method of claim 10, wherein the strands are knitted to form a warp knitted mesh.

18. The method of claim 10, wherein the mesh has isotropic or near isotropic tensile strength.

19. The method of claim 10, wherein the mesh has a diamond net pattern.

20. The method of claim 10, wherein implanting the mesh comprises securing a portion of the mesh to the vaginal wall of the patient.

21. A mesh implant for providing support to a prolapsed area of a patient'"'"'s vagina, the mesh implant comprising a single mesh layer that is formed of strands and the strands are formed by monofilaments and the monofilaments are arranged to include pores that are formed between the monofilaments, the mesh layer is planar and is configured for supporting at least one of the posterior wall and the anterior wall of the vagina to treat a prolapse selected from the group consisting of:

urethrocoele prolapse, cystocoele prolapse, vault prolapse, uterine prolapse, enterocoele prolapse, and rectocoele prolapse, wherein the mesh layer has shape that is symmetrical about a longitudinal axis of the mesh layer and is characterized by an absence of any sharp corners, the mesh shape including a lower edge that is substantially straight and orthogonal to the longitudinal axis of symmetry, a first side edge that initially extends in a substantially straight line and then curves inwardly toward the longitudinal axis of symmetry, and a second side edge opposite the first side edge and symmetrical to the first side edge about the longitudinal axis of symmetry, such that the mesh shape forms broad apex opposite to the substantially straight lower edge, the mesh layer including a plurality of circumferential strands that extend around a perimeter of the mesh layer, wherein the plurality of circumferential strands are arranged circumferentially at different radial locations, and the mesh layer includes a transverse strand that extends along the longitudinal axis of symmetry of the mesh layer.