Implantable prosthesis

• US 9,713,519 B2
• Filed: 01/04/2013
• Issued: 07/25/2017
• Est. Priority Date: 01/06/2012
• Status: Expired due to Fees

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Horton, Anthony R., Santos, Stephanie M.
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): KNAUSS, CHRISTIAN D
• Application Number:
  US13/734,554
• Publication Number:
  US 20130178875A1
• Time in Patent Office: 1,663 Days
• Field of Search: 606151, 606154, 623 2372, 623 2374
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0084 Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An implantable prosthesis can have a three-dimensional shape that is invertible, so as to assume either a right configuration or a left configuration, which can be substantially mirror images of each other, so as to eliminate the need for separately manufacturing a left prosthesis and a right prosthesis. An implantable prosthesis can be preformed to independently assume a contoured three-dimensional shape that more adequately fits the extraperitoneal laparoscopic inguinal space, while simultaneously maintaining a relatively large area for fixation of the prostheses (e.g., through suturing or integration with the surrounding tissue). An implantable prosthesis can have a three-dimensional contoured shape that is formed from a single piece of continuous material, such as a mesh, and can possess substantially uniform rigidity. An implantable prosthesis may be trimmed, cut, or altered at an outer perimeter with no detrimental effect on its ability to independently maintain a predetermined three-dimensional contoured shape.

Claims

1. An implantable prosthesis for repairing a defect in a muscle or tissue wall, the prosthesis comprising:

a seamless preformed flexible body having a three-dimensional contoured shape and comprising a first end, a second end opposite the first end, and a perimeter incorporating the first end and the second end;

wherein the preformed flexible body independently assumes the contoured shape, the contoured shape comprising

an open sided bowl at the first end of the preformed flexible body;

a substantially planar area at the second end of the preformed flexible body; and

a transitional area coupling the open sided bowl of the first end with the substantially planar area of the second end, the transitional area comprising an arch region coupled with a curved and banked region; and

wherein, following along the perimeter, the arch region leads to the open sided bowl which leads to the curved and banked region which leads to the substantially planar area which leads to the arch region, thereby completing the perimeter, wherein rigidity of the preformed flexible body is substantially uniform throughout.

2. The prosthesis of claim 1, wherein the preformed flexible body is constructed from a single, continuous piece of material that has no rigidified perimeter imparting structure to form the contoured shape, and wherein the bowl lacks any sharp points.

3. The prosthesis of claim 1, wherein the preformed flexible body maintains a shape memory and thus is configured in such a way as to deform under at least a minimum predetermined force typically experienced during implantation against the muscle or tissue wall, and re-assume the contoured shape upon a release of the force.

4. The prosthesis of claim 1, wherein the substantially planar area is shaped and dimensioned to be affixed to a portion of a pelvic wall.

5. The prosthesis of claim 1, wherein the arch region is shaped and dimensioned to accommodate one or more external iliac vessels.

6. The prosthesis of claim 1, wherein the open sided bowl is shaped and dimensioned to substantially replicate the shape of a lateral extraperitoneal space.

7. The prosthesis of claim 1, wherein the curved and banked region is shaped and dimensioned to substantially replicate a shape of an abdominal wall.

8. The prosthesis of claim 1, wherein the preformed flexible body of the prosthesis is sized and dimensioned to cover a large direct hernia defect while being affixed to a Cooper'"'"'s ligament.

9. The prosthesis of claim 1, wherein the perimeter is not rigidified relative to a remainder of the preformed flexible body.

10. The prosthesis of claim 1, wherein the perimeter has substantially the same rigidity as the preformed flexible body of the prosthesis.

11. The prosthesis of claim 1, wherein when an outer portion of the preformed flexible body is trimmed off, then the three-dimensional contoured shape of a remaining portion of the preformed flexible body does not substantially change.

12. The prosthesis of claim 1, wherein the preformed flexible body comprises a coated mesh that is preformed, the coated mesh including a non-polymeric bioabsorbable cross-linked fatty acid based material, the cross-links formed of ester bonds, lactone bonds, or both.

13. The prosthesis of claim 1, wherein the preformed flexible body further comprises a coating derived from eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

14. The prosthesis of claim 1, wherein the preformed flexible body further comprises a mesh having strands forming intersections, wherein a coating is at least partially disposed within the intersections.

15. The prosthesis of claim 1, wherein the preformed flexible body is invertible between a left orientation and a right orientation, the left orientation and the right orientation being substantially mirror images of each other.

16. The prosthesis of claim 1, wherein the preformed flexible body further comprises a mesh having strands forming a plurality of intersections, and wherein the three-dimensional contoured shape is maintained by interaction of the plurality of intersections with each other imparting structure to form and maintain the three-dimensional contoured shape.

17. An implantable prosthesis for repairing a defect in a muscle or tissue wall, the prosthesis comprising:

a preformed body configured to independently assume a predetermined three-dimensional contoured shape, the preformed body comprising

a single, seamless, and continuous piece of mesh having strands forming intersections;

a coating disposed at least partially within the intersections of the strands of the mesh; and

an inner portion and a perimeter surrounding the inner portion, wherein rigidity of the perimeter is substantially uniform.

18. The prosthesis of claim 17, wherein the three-dimensional contoured shape comprises:

an open sided bowl at a first end of the preformed body, wherein the bowl lacks any straight edges;

a substantially planar area at a second end of the preformed body opposite the first end; and

a transitional area coupling the open sided bowl of the first end with the substantially planar area of the second end, the transitional area comprising an arch region coupled with a curved and banked region;

wherein, following along the perimeter, the arch region leads to the open sided bowl which leads to the curved and banked region which leads to the substantially planar area which leads to the arch region, thereby completing the perimeter.

19. The prosthesis of claim 18, wherein the substantially planar area is shaped and dimensioned to be affixed to a portion of a pelvic wall.

20. The prosthesis of claim 18, wherein the arch region is shaped and dimensioned to accommodate one or more external iliac vessels.

21. The prosthesis of claim 18, wherein the open sided bowl is shaped and dimensioned to substantially replicate the shape of a lateral extraperitoneal space.

22. The prosthesis of claim 18, wherein the curved and banked region is shaped and dimensioned to substantially replicate a shape of an abdominal wall.

23. The prosthesis of claim 17, wherein the preformed body of the prosthesis is sized and dimensioned to cover a large direct hernia defect while being affixed to a Cooper'"'"'s ligament.

24. The prosthesis of claim 17, wherein the preformed body is constructed from a single, continuous piece of material that has no rigidified perimeter imparting structure to form the contoured shape.

25. The prosthesis of claim 17, wherein the preformed body maintains a shape memory and thus is configured in such a way as to deform under at least a minimum predetermined force typically experienced during implantation against the muscle or tissue wall, and re-assume the contoured shape upon a release of the force.

26. The prosthesis of claim 17, wherein the perimeter is not rigidified relative to a remainder of the preformed body.

27. The prosthesis of claim 17, wherein a rigidity of the inner portion is substantially uniform.

28. The prosthesis of claim 17, wherein the perimeter has substantially the same rigidity as the preformed body of the prosthesis.

29. The prosthesis of claim 17, wherein when an outer portion of the preformed body is trimmed off, the three-dimensional contoured shape of a remaining portion of the preformed body does not substantially change.

30. The prosthesis of claim 17, wherein the preformed body comprises a coated mesh that is preformed, the coated mesh including a non-polymeric bioabsorbable cross-linked fatty acid based material, the cross-links formed of ester bonds, lactone bonds, or both.

31. The prosthesis of claim 17, wherein the preformed body is invertible between a left orientation and a right orientation, the left orientation and the right orientation being substantially mirror images of each other.

32. The prosthesis of claim 17, wherein the three-dimensional contoured shape is maintained by interaction of the intersections with each other imparting structure to form and maintain the three-dimensional contoured shape.

33. An implantable prosthesis for repairing a defect in a muscle or tissue wall, the prosthesis comprising:

a preformed flexible body comprising a single, continuous piece of preformed coated mesh, wherein the preformed flexible body is configured to independently assume a predetermined three-dimensional contoured shape that possesses no sharp point, the shape comprising

a substantially planar area; and

one or more non-uniform curvatures deviating away from the substantially planar area;

wherein the preformed flexible body is invertible between a left orientation and a right orientation, the left orientation and the right orientation being substantially mirror images of each other, and wherein the preformed coated mesh comprises coated strands forming a plurality of intersections, and wherein the three-dimensional contoured shape is maintained by interaction of the plurality of intersections with each other imparting structure to form and maintain the three-dimensional contoured shape.

34. The prosthesis of claim 33, further wherein the shape of the preformed flexible body comprises:

an open sided bowl at a first end of the preformed flexible body;

the substantially planar area at a second end of the preformed flexible body opposite the first end; and

a transitional area coupling the open sided bowl of the first end with the substantially planar area of the second end, the transitional area comprising an arch region coupled with a curved and banked region;

wherein, following along a perimeter, the arch region leads to the open sided bowl which leads to the curved and banked region which leads to the substantially planar area which leads to the arch region, thereby completing the perimeter.

35. The prosthesis of claim 34, wherein the arch region is shaped and dimensioned to accommodate one or more external iliac vessels.

36. The prosthesis of claim 34, wherein the curved and banked region is shaped and dimensioned to substantially replicate a shape of an abdominal wall.

37. The prosthesis of claim 34, wherein the open sided bowl is shaped and dimensioned to substantially replicate the shape of a lateral extraperitoneal space.

38. The prosthesis of claim 34, wherein the perimeter is not rigidified relative to a remainder of the preformed flexible body.

39. The prosthesis of claim 33, wherein the preformed flexible body maintains a shape memory and thus is configured in such a way as to deform under at least a minimum predetermined force typically experienced during implantation against the muscle or tissue wall, and re-assume the contoured shape upon a release of the force.

40. The prosthesis of claim 33, wherein the substantially planar area is shaped and dimensioned to be affixed to a portion of a pelvic wall.

41. The prosthesis of claim 33, wherein the preformed flexible body of the prosthesis is sized and dimensioned to cover a large direct hernia defect while being affixed to a Cooper'"'"'s ligament.

42. The prosthesis of claim 33, wherein an entire perimeter has substantially the same rigidity as the preformed flexible body of the prosthesis.

43. The prosthesis of claim 33, wherein the shape comprises an outer portion extending along an entire perimeter and a remaining inner portion enclosed within the outer portion, wherein a rigidity of the inner portion is substantially uniform and further wherein a rigidity of the outer portion is substantially uniform, and further wherein the rigidity of the outer portion is substantially equal to the rigidity of the inner portion, such that the inner portion and the outer portion have substantially the same rigidity.

44. The prosthesis of claim 33, wherein when an outer portion of the preformed flexible body is trimmed off, the three-dimensional contoured shape of a remaining portion of the preformed flexible body does not substantially change.

45. The prosthesis of claim 33, wherein the coated mesh includes a non-polymeric bioabsorbable cross-linked fatty acid based material, the cross-links formed of ester bonds, lactone bonds, or both.

46. A method for fabricating an implantable prosthesis for repairing a defect in a muscle or tissue wall, the method comprising:

providing a coating to a single piece of mesh comprising strands forming a plurality of intersections, such that the coating is disposed at least partially within the intersections of the mesh;

curing the coating on the mesh at one or more predetermined temperatures for one or more predetermined times;

providing a template having a predetermined shape;

placing the mesh in the template;

heating the mesh in the template at one or more predetermined temperatures for one or more predetermined times so that the mesh retains the predetermined shape, thereby forming the implantable prosthesis; and

removing the implantable prosthesis from the template, wherein the implantable prosthesis comprises

a preformed flexible body comprising a single, continuous piece of preformed coated mesh, wherein the preformed flexible body is configured to independently assume a predetermined three-dimensional contoured shape that possesses no sharp point, the shape comprising

a substantially planar area; and

one or more non-uniform curvatures deviating away from the substantially planar area;

wherein the preformed flexible body is invertible between a left orientation and a right orientation, wherein the left orientation and the right orientation are substantially mirror images of each other, and wherein the preformed coated mesh comprises strands forming a plurality of intersections, and wherein the three-dimensional contoured shape is maintained by interaction of the plurality of intersections with each other imparting structure to form and maintain the three-dimensional contoured shape.

47. The method of claim 46, wherein the coating is provided by dipping, brushing, pumping, direct deposit via a conduit connected to a fluid reservoir.

48. The method of claim 46, wherein the mesh is heated at a temperature of about 130°

C. to about 800°

C. for a period of about 0.1 minutes to about 20 minutes.

49. The method of claim 46, wherein the coating on the mesh is cured at a temperature of about 50°

C. to about 121°

C. for a period of about 8 hours to about 48 hours.

50. The method of claim 46, further comprising cooling the mesh subsequent to heating the mesh.

51. The method of claim 46, further comprising cooling the mesh at a temperature of about 0°

C. to about 23°

C. for a period of about 1 minute to about 20 minutes.

52. The method of claim 46, further comprising subjecting the mesh to a force applied by a press while the mesh is being heated in the template.

53. The method of claim 46, wherein the predetermined shape of the prosthesis is maintained by interaction of the plurality of intersections with each other imparting structure to form and maintain the predetermined shape.