IMPLANTABLE PROSTHESIS

• US 20090198260A1
• Filed: 04/10/2009
• Published: 08/06/2009
• Est. Priority Date: 08/02/2002
• Status: Active Grant

• Current Assignee: Davol Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Torres, Donna Schultz, Ford, Steven Palmer
• Granted Patent: US 7,806,905 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• 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 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

An implantable prosthesis for repairing an anatomical defect, such as a tissue or muscle wall hernia, including an umbilical hernia, and for preventing the occurrence of a hernia at a small opening or weakness in a tissue or muscle wall, such as at a puncture tract opening remaining after completion of a laparoscopic procedure. The prosthesis includes a patch and/or plug having a body portion that is larger than a portion of the opening or weakness so that placement of the body portion against the defect will cover or extend across that portion of the opening or weakness. At least one tether, such as a strap, extends from the patch or plug and may be manipulated by a surgeon to position the patch or plug relative to the repair site and/or to secure the patch or plug relative to the opening or weakness in the tissue or muscle wall. The tether may be configured to extend through the defect and outside a patient'"'"'s body to allow a surgeon to position and/or manipulate the patch from a location outside the body. An indicator may be provided on the tether as an aid for a surgeon in determining when the patch or plug has been inserted a sufficient distance within the patient. A support member may be arranged in or on the patch or plug to help deploy the patch or plug at the surgical site and/or help inhibit collapse or buckling of the patch or plug. The patch or plug may be configured with a pocket or cavity to facilitate the deployment and/or positioning of the patch or plug over the opening or weakness.

Claims

1. An implantable prosthesis for repairing or augmenting an existing or potential tissue or muscle wall defect, the implantable prosthesis comprising:

a patch of repair fabric including a first layer of repair fabric and a second layer of repair fabric;

a support member located between the first and second layers of repair fabric to influence unfurling the patch into a deployed configuration; and

at least one strap extending from the patch to facilitate positioning and securement of the patch at the tissue or muscle wall defect, the strap having a cross-section with a width and thickness, the width being greater than the thickness.

2. The prosthesis according to claim 1, wherein the first and second layers include a mesh fabric.

3. The prosthesis according to claim 1, wherein the patch includes absorbable and non-absorbable materials.

4. The prosthesis according to claim 3, wherein the patch further includes a barrier layer to minimize tissue attachment to the patch, the second layer being located between the first layer and the barrier layer.

5. The prosthesis according to claim 4, wherein at least the second layer includes a non-absorbable material.

6. The prosthesis according to claim 5, wherein the second layer is fabricated from polypropylene.

7. The prosthesis according to claim 4, wherein at least the first layer includes an absorbable material.

8. The prosthesis according to claim 7, wherein the first layer is fabricated from polyglactin.

9. The prosthesis according to claim 4, wherein the barrier layer includes an absorbable material.

10. The prosthesis according to claim 9, wherein the barrier layer is fabricated from oxidized regenerated cellulose.

11. The prosthesis according to claim 4, wherein the patch includes a first surface that is to face the tissue or muscle wall defect and a second surface that is to face away from the tissue or muscle wall defect, the barrier layer being located at the second surface.

12. The prosthesis according to claim 11, wherein the patch is configured to allow tissue ingrowth from the first surface to at least one of the first and second layers.

13. The prosthesis according to claim 11, wherein the at least one anchoring strap includes a pair of anchoring straps that extend from the first surface of the patch at spaced apart locations.

14. The prosthesis according to claim 1, wherein the at least one anchoring strap includes a pair of anchoring straps.

15. The prosthesis according to claim 1, wherein the anchoring strap has a length sufficient to extend through the tissue or muscle wall defect when the patch is positioned over the defect.

16. The prosthesis according to claim 1, wherein the anchoring strap includes a layer of mesh fabric.

17. The prosthesis according to claim 1, wherein the support member includes a polymer ring.

18. A method of repairing or augmenting an existing or potential tissue or muscle wall defect in a patient, the method comprising acts of:

(a) introducing an implantable prosthesis into the patient, the implantable prosthesis including a patch and at least one anchoring strap extending from the patch, the at least one anchoring strap having a cross-section with a width and a thickness, the width being greater than the thickness;

(b) routing the at least one anchoring strap through the defect and to a region that is accessible from outside the patient;

(c) pulling the at least one anchoring strap from outside the patient to place the patch against tissue or muscle adjacent the defect; and

(d) securing the prosthesis in position at the defect.

19. The method according to claim 18, wherein act (d) includes securing the patch at a margin of the defect.

20. The method according to claim 18, wherein act (d) includes securing the patch through the at least one anchoring strap.

21. The method according to claim 18, further comprising removing excess length of the anchoring strap.

22. The method according to claim 18, further comprising folding the patch prior to introducing the prosthesis into the patient.

23. The method according to claim 22, further comprising unfurling the patch into a deployed configuration to cover the defect after introducing the prosthesis into the patient, the patch including a support member to facilitate unfurling the patch.

24. The method according to claim 23, wherein the support member includes a polymer ring.

25. The method according to claim 24, wherein the patch includes a barrier layer to minimize tissue attachment to the patch.

26. The method according to claim 18, wherein the anchoring strap includes a pair of straps that are connected to the patch at spaced apart locations.

27. The method according to claim 26, wherein the anchoring straps are connected to an inner portion of the patch.

28. The method according to claim 18, wherein the patch includes multiple layers of repair fabric.

29. The method according to claim 28, wherein the patch includes absorbable and non-absorbable layers.

30. The method according to claim 29, wherein the patch includes an absorbable mesh layer, a non-absorbable mesh layer, and an absorbable barrier layer to minimize tissue attachment to the patch, the non-absorbable mesh layer located between the absorbable mesh layer and the barrier layer.

31. The method according to claim 30, wherein the anchoring strap extends from a surface of the patch opposite the barrier layer.

32. A method of repairing or augmenting an existing or potential tissue or muscle wall defect in a patient, the method comprising acts of:

(a) introducing an implantable prosthesis into the patient, the implantable prosthesis including a patch and at least one anchoring strap extending from the patch, the at least one anchoring strap having a cross-section with a width and a thickness, the width being greater than the thickness;

(b) routing the at least one anchoring strap through the defect;

(c) manipulating the at least one anchoring strap to position the patch against the tissue or muscle wall defect;

(d) pulling the at least one anchoring strap to deploy the patch against the tissue or muscle wall defect; and

(e) securing the patch through the at least one anchoring strap.

33. The method according to claim 32, wherein act (e) includes securing the patch at a margin of the defect.

34. The method according to claim 32, further comprising removing excess length of the anchoring strap.

35. The method according to claim 32, further comprising folding the patch prior to introducing the prosthesis into the patient.

36. The method according to claim 35, further comprising unfurling the patch into a deployed configuration to cover the defect after introducing the prosthesis into the patient, the patch including a support member to facilitate unfurling the patch.

37. The method according to claim 36, wherein the support member includes a polymer ring.

38. The method according to claim 37, wherein the patch includes a barrier layer to minimize tissue attachment to the patch.

39. The method according to claim 32, wherein the anchoring strap includes a pair of straps that are connected to the patch at spaced apart locations.

40. The method according to claim 39, wherein the anchoring straps are connected to an inner portion of the patch.

41. The method according to claim 32, wherein the patch includes multiple layers of repair fabric.

42. The method according to claim 41, wherein the patch includes absorbable and non-absorbable layers.

43. The method according to claim 42, wherein the patch includes an absorbable mesh layer, a non-absorbable mesh layer, and an absorbable barrier layer to minimize tissue attachment to the patch, the non-absorbable mesh layer located between the absorbable mesh layer and the barrier layer.

44. The method according to claim 43, wherein the anchoring strap extends from a surface of the patch opposite the barrier layer.