Surgical implant

• US 20040172048A1
• Filed: 04/26/2004
• Published: 09/02/2004
• Est. Priority Date: 03/30/2001
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Mpathy Medical Devices Incorporated
• Inventors: Browning, James
• Granted Patent: US 7,594,921 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• 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
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A surgical implant suitable for treatment of hernias is provided. The implant comprises a mesh having a residual maximum mass density of 50 g/m³. The mesh comprises strands forming spaces and the strands comprise filaments forming pores. The spaces and pores are sized to minimise foreign body mass for implantation and to encourage integration of the implant. The mesh may be delivered using Dual Phase Technology™ for ease of handling, cutting and placement. The Dual Phase Technology™ may include encapsulation or coating with hydrogel.

Claims

1. A surgical implant suitable for treatment of hernias, the implant comprising a mesh comprising strands having a maximum residual mass density of 50 g/m².

2. A surgical implant as claimed in claim 1 wherein the mesh has a maximum residual mass density of less than 30 g/m².

3. A surgical implant as claimed in claims 1 or 2 wherein the mesh comprises strands and includes major spaces and pores, the spaces existing between the strands and pores formed within the strands.

4. A surgical implant as claimed in any preceding claim wherein strands are formed from at least two filaments.

5. A surgical implant as claimed in any preceding claim wherein the strands are spaced apart to form major spaces of 1 to 10 mm.

6. A surgical implant as claimed in any preceding claim wherein the strands have a diameter of less than 600 μ

m.

7. A surgical implant as claimed in any preceding claim wherein the strands are arranged to form a warp knit diamond or hexagonal net mesh.

8. A surgical implant as claimed in any preceding claim wherein the strands are arranged to form a net mesh which has isotropic or near isotropic tensile strength and elasticity.

9. A surgical implant as claimed in any one of claims 4 to 8 wherein the filaments have a diameter of between 0.02 to 0.15 mm.

10. A surgical implant as claimed in any one of claims 4 to 9 wherein the filament of the mesh is of a diaimeter 0.05 to 0.1 mm.

11. A surgical implant as claimed in any preceding claim wherein a monofilament or at least two filaments are interwoven/knitted such that the strands of the mesh comprise pores.

12. A surgical implant as claimed in any preceding claim wherein the pores in the strands are of between 50 to 200 μ

m in diameter.

13. A surgical implant as claimed in any preceding claim further comprising rings of material comprising pores of between 50 to 200 μ

m adhered to on the strands of the mesh to provide pores.

14. A surgical implant as claimed in any preceding claim wherein the pores in the strands are of between 50 to 75 μ

m in diameter.

15. A surgical implant as claimed in any preceding claim wherein the filaments of the mesh comprise a plastics material.

16. A surgical implant as claimed in any preceding claim wherein the filaments of the mesh comprise a synthetic material.

17. A surgical implant as claimed in any preceding claim wherein the filaments of the mesh comprise an absorbable material.

18. A surgical implant as claimed in any of claims 1 to 16 wherein the filaments of the mesh comprise polypropylene.

19. A surgical implant as claimed in any of claims 1 to 16 wherein the filaments of the mesh comprise polyester.

20. A surgical implant as claimed in any preceding claim wherein the implant has an absorbable coating which degrades within 48 hours.

21. A surgical implant as claimed in claim 20 wherein the absorbable coating encapsulates the mesh of the surgical implant.

22. A surgical implant as claimed in claim 20 wherein the absorbable coating is applied to at least one face of the mesh.

23. A surgical implant as claimed in claims 20 to 22 wherein the absorbable coating comprises any suitable soluble and biocompatible material.

24. A surgical implant as claimed in claims 20 to 23 wherein the absorbable coating is a soluble hydrogel such as gelatin.

25. A surgical implant as claimed in claims 20 to 23 wherein the absorbable coating is a starch or cellulose based gel.

26. A surgical implant as claimed in claims 20 to 23 wherein the absorbable coating is an alginate.

27. A surgical implant as claimed in claims 20 to 26 wherein the coating is of a thickness greater than that of the mesh.

28. A surgical implant as claimed in any preceding claim comprising a backing strip wherein the backing strip is releasably attachable to the mesh.

29. A surgical implant as claimed in claim 28 wherein the backing strip is formed from plastics.

30. A surgical implant as claimed in claims 28 or 29 wherein the surgical implant is releasably attachable to the backing strip by adhesive.

31. A surgical implant as claimed in any preceding claim wherein the strands of the mesh are comprised of bicomponent microfibres.

32. A surgical implant as claimed in claim 31 wherein the bicomponent microfibres comprise a core and surface material.

33. A surgical implant as claimed in claim 32 wherein the surface material is capable of being absorbed by the body in a period of less than 48 hours.

34. A surgical implant as claimed in claims 32 or 33 wherein the core material is capable of remaining in the body for a period of time sufficient to enable tissue ingrowth.

35. A surgical implant as claimed in claim 32 wherein the surface material is polylactic acid and the core material is polypropylene.

36. A surgical implant as claimed in any preceding claim wherein the surgical implant comprises material that has memory.

37. A surgical implant as claimed in claim 36 wherein the surgical implant has memory which urges the surgical implant to adopt a flat conformation.

38. A surgical implant as claimed in any preceding claim wherein the implant has a generally curved perimeter.

39. A surgical implant as claimed in any preceding claim wherein the surgical implant is of width between 1 cm to 10 cm and of length between 1 cm to 10 cm.

40. A surgical implant as claimed in any preceding claim wherein the implant is any one of round, circular, oval, ovoid eliptical or truncated eliptical or some similar shape.

41. A surgical implant as claimed in any preceding claim wherein the mesh can be cut to any desired shape.

42. A surgical implant as claimed in any preceding claim wherein the mesh has at least one circumferential member which extends, in use, along at least part of the perimeter of the implant to provide a substantially smooth edge.

43. A surgical implant as claimed in claim 42 wherein at least part of the perimeter of the implant is defined by the circumferential member.

44. A surgical implant as claimed in claims 42 or 43 wherein at least 50% of the perimeter of the implant is defined by the circumferential member(s).

45. A surgical implant as claimed in claims 42 to 44 wherein at least 80% of the perimeter of the implant is defined by the circumferential member(s).

46. A surgical implant as claimed in claims 42 to 45 wherein 100% of the perimeter of the implant is defined by the circumferential member (s).

47. A surgical implant as claimed in claims 42 to 46 wherein the perimeter of the mesh is defined, in use, by one circumferential member.

48. A surgical implant as claimed in claims 42 to 47 wherein the mesh has a plurality of circumferential members arranged at different radial locations.

49. A surgical implant as claimed in claim 48 wherein the circumferential members are arranged to join with one another in order to form an integral mesh.

50. A surgical implant as claimed in claim 42 to 49 wherein the mesh comprises transverse members which extend across the circumferential members joining the circumferential members.

51. A surgical implant as claimed in claim 50 wherein the transverse members extend radially from a central point to the perimeter of the implant.

52. A surgical implant as claimed in claim 50 or 51 wherein the transverse members extend toward the perimeter of the implant.

53. A surgical implant as claimed in any preceding claim wherein the mesh can be glued in place using a biocompatible glue.

54. A surgical implant as claimed in any preceding claim comprising at least one capsule containing biocompatable glue for securing the implant in place.

55. A surgical implant as claimed in claim 54 comprising four capsules containing glue provided around the perimeter of the surgical implant.

56. A surgical implant as claimed in claims 54 or 55 wherein the capsules comprise hollow thin walled spheres of around 3 to 5 mm diameter including gelatin.

57. A surgical implant as claimed in claims 54 to 56 wherein the glue is a cyanoacrylate glue.

61. A surgical tool for delivering a surgical implant as described in claims 1 to 57 subcutaneously through an incision, the tool being adapted to radially confine the surgical implant during delivery and being operable to release the mesh in its intended position.

62. A surgical tool as claimed in claim 61 comprising a housing and unfurling means the housing and unfurling means insertable through an incision in the patient, the housing and unfurling means adapted to accommodate a rolled up mesh and separable to release the mesh, the unfurling means capable of unfurling the rolled up mesh without any significant movement around the area of the incision.

63. A surgical tool as claimed in claim 61 or 62 comprising two or more parts, the parts movable such that in a first position they house the mesh or surgical implant and, in a second position the mesh or surgical implant is released. More preferably the tool comprises two semi-circular channels, an inner channel having an external diameter suitable for fitting inside an outer channel.

64. Use of an implant as claimed in any of claims 1 to 57 in the treatment of inguinal hernia, incisional hernia or uterovaginal prolapse.

58. A minimally invasive method of treating uterovaginal prolapse, the method comprising the steps;

making a 1-2 cm length incision in the vaginal wall close to the opening of the vaginal cavity and,

making a subcutaneous cut, through the incision, over and surrounding the area of the prolapse, which cut is substantially parallel to the vaginal wall; and

inserting a mesh according to the present invention, through the incision, into the space defined by the cut.

59. A method of treating uterovaginal prolapse as claimed in claim 58 wherein the incision is at the posterior extremity of the prolapse sac of the vaginal cavity.

60. A method of treating uterovaginal prolapse as claimed in claim 58 wherein the incision is at the anterior extremity of the prolapse sac of the vaginal cavity.