Methods and devices for the endoluminal deployment and securement of prostheses

• US 20070050012A1
• Filed: 08/25/2006
• Published: 03/01/2007
• Est. Priority Date: 08/25/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Densford, Eric
• Granted Patent: US 8,771,340 B2
• Time in Patent Office: Days
• US Class Current: 623/1.230
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

Provided are methods, devices, and systems that can be used to deploy prosthetic devices within a bodily lumen of a patient. These methods and devices can include the securement of a prosthetic valve within a vascular lumen by driving one or more fasteners from a position on an expandable device through the valve and into or through a vascular wall.

Claims

1. A medical product for the securement of one or more prostheses within the vasculature of a patient, comprising:

a percutaneous device having a portion configured to expand within the vasculature of a patient;

at least one vascular prosthesis; and

one or more fasteners having a head portion and a body portion, wherein the one or more fasteners are positioned such that the head portion contacts the expandable portion of the percutaneous device and wherein the one or more fasteners are configured to secure the at least one vascular prosthesis to patient tissue when the expandable portion of the percutaneous device is expanded within the vasculature of a patient.

2. The medical product of claim 1, wherein the expandable portion of the percutaneous device comprises a balloon.

3. The medical product of claim 1, further comprising:

a sheath having a lumen, a distal end, and a proximal end, wherein the percutaneous device, the at least one vascular prosthesis, and the one or more fasteners are slidably received within the lumen of the sheath.

4. The medical product of claim 3, wherein the percutaneous device terminates in a tip that extends beyond the distal end of the sheath.

5. The medical product of claim 4, wherein the tip is atraumatic.

6. The medical product of claim 1, wherein the at least one vascular prosthesis comprises two biocompatible valve leaflets.

7. The medical product of claim 6, wherein the biocompatible valve leaflets comprise a synthetic material or a remodelable material.

8. The medical product of claim 7, wherein the synthetic material comprises a thromboresistant biocompatible polyurethane material.

9. The medical product of claim 7, wherein the remodelable material comprises a resorbable material or an extracellular matrix material.

10. The medical product of claim 9, wherein the extracellular matrix material comprises mammalian porcine submucosa.

11. The medical product of claim 1, wherein the one or more fasteners are arranged in a pattern.

12. The medical product of claim 11, wherein at least two of the one or more fasteners are connected.

13. The medical product of claim 12, wherein the connected fasteners comprise a tack strip and wherein the tack strip is releasably secured to the expandable portion of the percutaneous device.

14. The medical product of claim 13, wherein the at least one vascular prosthesis comprises one vascular prosthesis and wherein a portion of the vascular prosthesis overlays the tack strip.

36. A medical kit, comprising:

the medical product of claim 1 sealed within sterile medical packaging.

15. A medical product for securing a prosthesis within a bodily lumen, comprising:

an endoluminal delivery device having an expandable portion; and

one or more fasteners, each having a head portion and a body portion, wherein the one or more fasteners are arranged over the expandable portion of the delivery device and wherein the one or more fasteners are configured to be driven into patient tissue by the expansion of the expandable portion of the delivery device so as to secure a prosthesis within a bodily lumen.

16. The medical product of claim 15, further comprising an endoluminal prosthesis, wherein at least a portion of the endoluminal prosthesis overlays the one or more fasteners.

17. The medical product of claim 16, wherein the one or more fasteners terminate in a barb.

18. The medical product of claim 17, wherein the barb comprises an outwardly projecting protuberance at its tissue piercing end for resisting back out of the barb from patient tissue.

19. The medical product of claim 15, wherein the head portion of the one or more fasteners contacts the expandable portion of the delivery device.

20. The medical product of claim 19, wherein the head portion of the one or more fasteners is releasably secured to the expandable portion of the delivery device.

21. The medical product of claim 19, wherein the one or more fasteners are releasably secured using an adhesive.

22. The medical product of claim 21, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

23. The medical product of claim 15, wherein a number of the one or more fasteners are connected.

24. The medical product of claim 23, wherein the number of connected fasteners comprise a tack strip.

25. The medical product of claim 24, wherein the tack strip is releasably secured to the expandable portion of the delivery device.

26. The medical product of claim 25, wherein the tack strip comprises a remodelable material.

27. The medical product of claim 26, wherein the remodelable material comprises an extracellular matrix material.

28. The medical product of claim 27, wherein the tack strip is releasably secured to the expandable portion of the delivery device using fibrin glue.

29. The medical product of claim 15, wherein the one or more fasteners comprise a biocompatible material.

30. The medical product of claim 29, wherein the biocompatible material comprises a remodelable material.

31. A method for implanting prostheses within a bodily lumen of a patient, comprising:

providing a percutaneous device having a surface configured to expand within a bodily lumen of a patient, wherein at least one prosthesis is placed over the surface and wherein one or more fasteners having a head portion and a body portion are located between the surface and the prosthesis such that each fastener head contacts the expandable surface of the percutaneous device;

delivering the provided percutaneous device into a bodily lumen of a patient, wherein the surface is positioned at a site within the bodily lumen; and

securing the at least one prosthesis at the site by expanding the surface of the percutaneous device, wherein the one or more fasteners are driven into patient tissue so as to anchor the prosthesis to the patient tissue.

32. The method of claim 31, wherein the head portion of each fastener is temporarily secured to the expandable surface of the percutaneous device.

33. A method for securing a prosthesis within the vasculature of a patient, comprising:

providing a delivery device having an expandable segment and one or more fasteners having a head portion and a body portion, wherein the one or more fasteners are arranged over the expandable segment of the delivery device;

providing a vascular prosthesis;

locating the provided vascular prosthesis and the provided delivery device at a site within the vasculature of a patient; and

securing the located vascular prosthesis at the vascular site by expanding the expandable segment of the delivery device, wherein the one or more fasteners are driven into the located prosthesis so as to anchor the prosthesis at the vascular site.

34. The method of claim 33, wherein the head portion of the arranged fasteners contacts the expandable segment of the delivery device.

35. The method of claim 34, wherein the head portion of the fasteners is releasably arranged on the expandable segment of the delivery device.