Methods and devices for the endoluminal deployment and securement of prostheses

• US 8,771,340 B2
• Filed: 08/25/2006
• Issued: 07/08/2014
• Est. Priority Date: 08/25/2005
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Densford, Eric D.
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US11/510,321
• Publication Number:
  US 20070050012A1
• Time in Patent Office: 2,874 Days
• Field of Search: 623/1.14, 623/1.24, 623/1.32, 623/1.36, 623/2.38, 606/200
• US Class Current: 623/1.24
• 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 valve prostheses within the vasculature of a patient, comprising:

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

at least one vascular valve prosthesis positioned over the expandable portion, the at least one valve prosthesis including at least a first flexible leaflet having a bottom edge region for securement against a wall of a vessel of the vasculature in a first curved path extending partially circumferentially around and longitudinally along the wall of the vessel to form a curved bottom edge of a deployed leaflet configuration within the vessel;

a first band of bolster material layered on and in contact with the bottom edge region of the first flexible leaflet between the bottom edge region of the first flexible leaflet and the expandable portion;

the first band of bolster material having first and second ends and a first edge extending therebetween along a curvilinear path when the expandable portion is expanded within the vasculature of a patient so as to track the curved bottom edge of the deployed leaflet; and

a first plurality of fasteners having a head portion and a body portion, wherein the fasteners are positioned such that the head portion contacts the expandable portion between the first band of bolster material and the expandable portion and wherein the fasteners are configured to extend through both the first band of bolster material and the first flexible leaflet to secure the first band of bolster material and the bottom edge region of the first flexible leaflet to the wall of the vessel in the first curved path extending partially circumferentially around and longitudinally along the wall of the vessel to form the curved bottom edge of the deployed leaflet configuration when the expandable portion is expanded within the vasculature of a patient;

wherein at least two of the fasteners are connected; and

wherein the at least two connected fasteners and band of bolster material together comprise a tack strip.

2. 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.

3. The medical product of claim 2, wherein the percutaneous device terminates in a tip that extends beyond the distal end of the sheath.

4. The medical product of claim 1, wherein the body portion of the fasteners penetrates through the vascular valve prosthesis.

5. The medical product of claim 4, wherein the head portion of each fastener is releasably secured to the expandable portion of the endoluminal delivery device.

6. The medical product of claim 5, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

7. The medical product of claim 6, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

8. The medical product of claim 1, wherein the at least one vascular valve prosthesis also comprises:

a second flexible leaflet having a bottom edge region for securement against a wall of a vessel of the vasculature in a second curved path extending partially circumferentially around and longitudinally along the wall of the vessel to form a curved bottom edge of a deployed leaflet configuration for the second flexible leaflet within the vessel;

a second band of bolster material layered on and in contact with the bottom edge region of the second flexible leaflet between the bottom edge region of the second flexible leaflet and the expandable portion;

the second band of bolster material having first and second ends and a first edge extending therebetween along a curvilinear path when the expandable portion is expanded within the vasculature of a patient so as to track the curved bottom edge of the deployed second flexible leaflet; and

a second plurality of fasteners having a head portion and a body portion and positioned such that the head portion contacts the expandable portion between the second band of bolster material and the expandable portion and wherein the fasteners of the second plurality of fasteners are configured to extend through both the second band of bolster material and the second flexible leaflet to secure the second band of bolster material and the bottom edge region of the second flexible leaflet to the wall of the vessel in the second curved path extending partially circumferentially around and longitudinally along the wall of the vessel to form the curved bottom edge of the deployed leaflet configuration for the second flexible leaflet when the expandable portion is expanded within the vasculature.

9. The medical product of claim 8, wherein the first and second leaflets comprise a synthetic material or a remodelable material.

10. The medical product of claim 9, wherein the synthetic material comprises a thromboresistant biocompatible polyurethane material.

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

12. The medical product of claim 11, wherein the extracellular matrix material comprises mammalian porcine submucosa.

13. The medical product of claim 10, wherein the head portion of each fastener is releasably secured to the expandable portion of the endoluminal delivery device.

14. The medical product of claim 13, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

15. The medical product of claim 14, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

16. The medical product of claim 8, wherein the head portion of each fastener is releasably secured to the expandable portion of the endoluminal delivery device.

17. The medical product of claim 16, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

18. The medical product of claim 8, wherein:

the first and second flexible leaflets are independently securable against the wall of the vessel.

19. The medical product of claim 1, wherein the fasteners are arranged in a pattern.

20. The medical product of claim 19, and wherein the tack strip is releasably secured to the expandable portion of the percutaneous device.

21. A medical kit, comprising:

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

22. The medical product of claim 1, wherein the fasteners extend along the curved path along the bottom edge of the leaflet.

23. The medical product of claim 1, wherein the head portion of each fastener is releasably secured to the expandable portion of the endoluminal delivery device.

24. The medical product of claim 23, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

25. The medical product of claim 24, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

26. The medical product of claim 1, wherein:

the first band of bolster material has a second edge tracking the curved bottom edge of the deployed leaflet.

27. The medical product of claim 1, wherein:

the first flexible leaflet in the deployed leaflet configuration is secured against the wall of the vessel entirely by the first plurality of fasteners.

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

an endoluminal delivery device having an expandable portion;

an endoluminal valve prosthesis received on the expandable portion, the valve prosthesis including at least a first flexible leaflet having a bottom edge region for securement against a wall of the bodily lumen in a first curved path extending partially circumferentially around and longitudinally along the wall of the bodily lumen to form a curved bottom edge of a deployed leaflet configuration within the bodily lumen;

a first band of bolster material layered on and in contact with the bottom edge region of the first flexible leaflet between the bottom edge region of the first leaflet and the expandable portion;

the first band of bolster material having first and second ends and a first edge extending therebetween along a curvilinear path when the expandable portion is expanded within the vasculature of a patient so as to track the curved bottom edge of the deployed leaflet; and

a first plurality of fasteners that each have a head portion and a body portion, wherein the fasteners are arranged over the expandable portion of the endoluminal delivery device with at least a portion of the endoluminal valve prosthesis overlaying the one or more fasteners and with the head portion of the one or more fasteners contacting the expandable portion of the endoluminal delivery device between the first band of bolster material and the expandable portion, and wherein the fasteners are configured to extend through both the first band of bolster material and the first flexible leaflet and be driven into patient tissue by the expansion of the expandable portion of the endoluminal delivery device so as to secure the first band of bolster material and the bottom edge region of the first leaflet to the wall of the bodily lumen in said curved path extending partially circumferentially around and longitudinally along the wall of the bodily lumen to form the curved bottom edge of the deployed leaflet configuration;

wherein at least two of the fasteners are connected; and

wherein the at least two connected fasteners and band of bolster material together comprise a tack strip.

29. The medical product of claim 28, wherein the head portion of each fastener is temporarily secured to the expandable portion of the endoluminal delivery device.

30. The medical product of claim 29, wherein the fasteners terminate in a barb.

31. The medical product of claim 30, wherein the barb comprises an outwardly projecting protuberance at its tissue piercing end for resisting back out of the barb from patient tissue.

32. The medical product of claim 28, wherein the head portion of the fasteners is positioned on a first side of the endoluminal valve prosthesis, and wherein the body portion of the fasteners extends through the band of bolster material and penetrates through the endoluminal prosthesis and extends outwardly from a second side of the endoluminal prosthesis, said second side opposite said first side.

33. The medical product of claim 32, wherein the head portion of the fasteners is releasably secured to the expandable portion of the delivery device.

34. The medical product of claim 32, wherein the one or more fasteners are releasably secured to the expandable portion of the delivery device using an adhesive.

35. The medical product of claim 34, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

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

37. The medical product of claim 36, wherein the band of bolster material comprises a remodelable material.

38. The medical product of claim 37, wherein the remodelable material comprises an extracellular matrix material.

39. The medical product of claim 38, wherein the tack strip is releasably secured to the expandable portion of the delivery device using fibrin glue.

40. The medical product of claim 28, wherein the endoluminal prosthesis also comprises:

a second flexible leaflet having a bottom edge region for securement against the wall of the bodily lumen in a second curved path extending partially circumferentially around and longitudinally along the wall of the bodily lumen to form a curved bottom edge of a deployed leaflet configuration for the second flexible leaflet within the lumen;

a second band of bolster material layered on and in contact with the bottom edge region of the second flexible leaflet between the bottom edge region of the second flexible leaflet and the expandable portion;

the second band of bolster material having first and second ends and a first edge extending therebetween along a curvilinear path when the expandable portion is expanded within the vasculature of a patient so as to track the curved bottom edge of the deployed second flexible leaflet; and

a second plurality of fasteners having a head portion and a body portion and positioned such that the head portion contacts the expandable portion between the second band of bolster material and the expandable portion and wherein the fasteners of the second plurality of fasteners are configured to extend through both the second band of bolster material and the second flexible leaflet and secure the second band of bolster material and the bottom edge region of the second flexible leaflet to the wall of the bodily lumen in the second curved path extending partially circumferentially around and longitudinally along the wall of the bodily lumen to form the curved bottom edge of the deployed leaflet configuration for the second flexible leaflet when the expandable portion is expanded within the bodily lumen.

41. The medical product of claim 40, wherein the first and second bands of bolster material comprise a remodelable material.

42. medical product of claim 41, wherein the remodelable material comprises a resorbable material or an extracellular matrix material.

43. The medical product of claim 42, wherein the extracellular matrix material comprises mammalian porcine submucosa.

44. The medical product of claim 40, wherein the fasteners are releasably secured to the expandable portion of the endoluminal delivery device.

45. The medical product of claim 44, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

46. The medical product of claim 45, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

47. 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 valve prosthesis is placed over the surface, wherein the valve prosthesis includes at least one flexible leaflet having a bottom edge region for securement against a wall of the bodily lumen in a curved path extending partially circumferentially around and longitudinally along the wall of the bodily lumen to form a curved bottom edge of a deployed leaflet configuration within the bodily lumen, further wherein a band of bolster material is layered on and in contact with the bottom edge region of the at least one flexible leaflet between the bottom edge region of the leaflet and the surface configured to expand and has first and second ends and a first edge extending therebetween along a curvilinear path-when the expandable portion is expanded within the vasculature of a patient so as to track the curved bottom edge of the deployed leaflet, and further wherein a plurality of fasteners having a head portion and a body portion are located between the surface and the band of bolster material 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 valve 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 extend through both the band of bolster material and the bottom edge region of the leaflet and anchor the band of bolster material and the bottom edge region of the leaflet to the wall of the bodily lumen in said curved path extending partially circumferentially around and longitudinally along the wall of the bodily lumen to form the curved bottom edge of the deployed leaflet configuration;

wherein at least two of the fasteners are connected; and

wherein the at least two connected fasteners and band of bolster material together comprise a tack strip.

48. The method of claim 47, wherein the head portion of each fastener is temporarily secured to the expandable surface of the percutaneous device.

49. The method of claim 48, wherein the fasteners are releasably secured to the expandable portion of the endoluminal delivery device.

50. The method of claim 49, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

51. The method of claim 50, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

52. The method of claim 47, wherein the at least one valve prosthesis comprises a resorbable material or an extracellular matrix material.

53. The medical product of claim 52, wherein the extracellular matrix material comprises mammalian porcine submucosa.

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

providing a delivery device having an expandable segment and a plurality of fasteners having a head portion and a body portion, wherein the fasteners are arranged over the expandable segment of the delivery device, wherein with the head portion of the arranged fasteners contacts the expandable segment of the delivery device;

providing a vascular valve prosthesis that includes at least one flexible leaflet having a bottom edge region for securement against a wall a vessel of the vasculature in a curved path extending partially circumferentially around and longitudinally along the wall of the vessel to form a curved bottom edge of a deployed leaflet configuration within the vessel;

providing a band of bolster material layered on and in contact with the bottom edge region of the at least one flexible leaflet between the bottom edge region of the leaflet and the expandable segment of the delivery device and has first and second ends and a first edge extending therebetween along a curvilinear path when the expandable portion is expanded within the vasculature of a patient so as to track the curved bottom edge of the deployed leaflet;

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

securing the located band of bolster material and vascular prosthesis at the vascular site by expanding the expandable segment of the delivery device, wherein the fasteners are driven into the band of bolster material, the bottom edge region of the at least one flexible leaflet and the wall of the vessel so as to anchor the leaflet at the vascular site;

wherein at least two of the fasteners are connected; and

wherein the at least two connected fasteners and band of bolster material together comprise a tack strip.

55. The method of claim 54, wherein the body portion of the arranged fasteners comprises a barb.

56. The method of claim 55, wherein the head portion of the fasteners is releasably arranged on the expandable segment of the delivery device.

57. The method of claim 56, wherein the fasteners are releasably secured to the expandable portion of the percutaneous device using an adhesive.

58. The method of claim 57, wherein the adhesive comprises a pressure sensitive adhesive, a heat activated adhesive, or any suitable combination thereof.

59. The method of claim 54, wherein the vascular prosthesis and delivery device are located in tandem.

60. The method of claim 54 wherein the vascular prosthesis is delivered to the site separately from the delivery device having fasteners.

61. The method of claim 54, wherein the at least one valve prosthesis comprises a resorbable material or an extracellular matrix material.

62. The medical product of claim 61, wherein the extracellular matrix material comprises mammalian porcine submucosa.