Prosthetic Heart Valves, Support Structures and Systems and Methods for Implanting the Same

• US 20090132035A1
• Filed: 09/12/2008
• Published: 05/21/2009
• Est. Priority Date: 02/27/2004
• Status: Abandoned Application

• Current Assignee: AorTx, Inc. (Johnson & Johnson)
• Original Assignee: AorTx, Inc. (Johnson & Johnson)
• Inventors: Walsh, Brandon G., Ginn, Richard S., Heneveld, Scott, Roth, Alex T., Forster, David C., Beckey, Brian
• Application Number:
  US12/209,719
• Publication Number:
  US 20090132035A1
• Time in Patent Office: Days
• US Class Current: 623/2.140
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices may be adapted for use in minimally invasive or endovascular surgical procedures.

Claims

1. A medical device, comprising:

an expandable support structure comprising a plurality of panels and hinges located between the panels, the expandable support structure having an inner lumen, wherein each panel has at least one portion deflected in an outwardly radial fashion and wherein at least one of the hinges is formed at a junction between the deflected portions of two adjacent panels.

2. The medical device of claim 1, wherein each panel has an upper latitudinal edge and lower latitudinal edge, the edges forming the upper and lower peripheries of the support structure, and wherein each panel includes a pair of longitudinal edges, each longitudinal edge being generally perpendicular to the upper and lower latitudinal edges of each panel.

3. The medical device of claim 2, wherein the hinge has a length that is equal to the length of the longitudinal edge of the panel upon which the hinge is formed.

4. The medical device of claim 2, wherein the hinge has a length that is less than the length of the longitudinal edge of the panel upon which the hinge is formed.

5. The medical device of claim 4, wherein the hinge is tab-like.

6. The medical device of claim 5, wherein the tab-like hinge is a first tab-like hinge, the device further comprising a second tab-like hinge between the two adjacent panels.

7. The medical device of claim 6, wherein the portion of the longitudinal edges of each of the two adjacent panels located between the first and second tab-like hinges are unjoined.

8. The medical device of claim 5, wherein the tab-like hinge extends outwardly from the two adjacent panels in a non-perpendicular manner.

9. The medical device of claim 4, wherein one or more panels includes one or more slots formed in the panels adjacent to the hinge.

10. The medical device of claim 9, wherein the one or more slots are elongate slots oriented circumferentially in the panels.

11. The medical device of claim 1, further comprising an elastomeric element coupled with the deflected portions of the hinge.

12. The medical device of claim 11, wherein the elastomeric element is seated upon an indentation in a deflected portion of the hinge.

13. The medical device of claim 12, wherein the hinge is band-like and is circumferentially wrapped around the deflected portions of the hinge.

14. The medical device of claim 1, wherein a portion of the panel adjacent to the area where the deflected portions are joined to form the hinge curves radially.

15. The medical device of claim 1, wherein the junction between the deflected portions comprises a weld.

16. The medical device of claim 1, wherein the junction between the deflected portions comprises a rivet.

17. The medical device of claim 1, wherein each of the deflected portions includes a hole, the device further comprising a suture threaded through the holes.

18. The medical device of claim 1, wherein each of the deflected portions has complementary features configured to interlock with the features of the other deflected portion.

19. The medical device of claim 1, wherein the outer edge of the deflected portions comprise tissue engaging features.

20. The medical device of claim 1, further comprising a valvular body coupled with the expandable support structure.

21. The medical device of claim 2, wherein the length of the periphery of a first side of the support is less than the length of the periphery of a second side of the support structure.

22. The medical device of claim 1, wherein the support structure is foldable such that the support structure is contractable from an expanded state.

23. The medical device of claim 1, wherein the support structure is configured for placement within the aorta of a patient and further comprises a valvular body located within a lumen of the support structure.

24. A medical device, comprising:

an expandable support structure comprising a plurality of panels and hinges between the panels, the expandable support structure having a first end and a second end with an inner lumen therebetween, wherein each panel is curved in a convex fashion such that the diameter of the expandable support structure at either the first or second ends is less than the diameter of the expandable support structure at a central location between the ends.

25. The medical device of claim 24, wherein each panel has a radius of curvature, the radius of curvature of at least one of the panels being varying.

26. The medical device of claim 24, wherein each panel has a radius of curvature, the radius of curvature of at least one of the panels being constant.

27. A medical device, comprising:

an expandable support structure comprising a plurality of panels with hinges between the panels, the expandable support structure having a first end and a second end with an inner lumen therebetween, wherein each panel is curved in a concave fashion such that the diameter of the expandable support structure at a central location between the ends is less than the diameter of the expandable support structure at either the first end or second end.

28. The medical device of claim 27, wherein is the expandable support structure is hourglass-shaped.

29. The medical device of claim 27, wherein the diameter of the first end of the expandable support structure is equal to the diameter of the second end of the expandable support structure.

30. The medical device of claim 27, wherein the diameter of the first end of the expandable support structure is less than the diameter of the second end of the expandable support structure.

31. A medical device, comprising:

an expandable support structure comprising a plurality of panels with hinges between the panels, the expandable support structure having an inner lumen, wherein each panel surface includes at least one longitudinal depression, wherein the inner surface of the longitudinal depressions are relatively more adjacent to each other in the center of the expandable support structure when said expandable support structure is in a collapsed state.

32. A medical device of claim 31, wherein the depression has a length substantially equal to the longitudinal length of the panel and being generally perpendicular to the upper and lower latitudinal edges of each panel.

33. A medical device, comprising:

an expandable support structure comprising a plurality of panels,

wherein each panel includes a plurality of apertures, the density of the apertures in each panel forming a gradient where the density of apertures proximal to the lower periphery of the panel is greater than the density of apertures proximal to the upper periphery of the panel.

34. A medical device, comprising:

an expandable support structure comprising a plurality of panels and hinges between the panels, wherein each panel surface includes one or more ridges, each ridge facing in an outwardly or inwardly direction.

35. A medical device of claim 34, wherein the ridges are disposed such that inwardly facing ridges nest with outwardly facing ridges when the expandable support structure is in a contracted state.

36. A method of attaching a valve leaflet to an implantable support structure, comprising:

placing a valve leaflet between two plates, wherein the surfaces of the plates have a plurality of apertures arranged in pre-determined locations;

threading a plurality of wires through the pre-determined apertures of the plates;

tensioning the wires to transition the valve leaflet from a first state to a second state; and

attaching the valve leaflet to a curved portion of the support structure while tensioning the wires.

37. The method of claim 36, further comprising cutting the valve leaflet from a sheet of compliant material into a pre-determined shape prior to placing the valve leaflet between the plates.

38. The method of claim 36, further comprising removing the wires from the valve leaflet and support structure after the valve leaflet is attached to the curved portion of the support structure.

39. The method of claim 36, further comprising removing the wires from the valve leaflet and support structure as the valve leaflet is sewn to the curved portion of the support structure.

40. A method of transitioning an expandable support structure between states, comprising:

accessing a plurality of tethers threaded through an expandable support structure, wherein each tether is threaded through at least one aperture in a different panel of the support structure and an aperture in a stop structure of a delivery device;

tensioning the tethers to transition the support structure from an expanded state to a collapsed state.

41. The method of claim 40, wherein each tether is coupled to a retractable structure of the delivery device.

42. The method of claim 41 further comprising:

withdrawing the retractable structure of the delivery device such that the tethers are released and the support structure is free to transition from a collapsed state to an expanded state.

43. The method of claim 40, wherein each tether is threaded through a second aperture in the respective panel.

44. The method of claim 40, further comprising:

positioning a plurality of wrap pins over the collapsed end of the support structure and

advancing the wrap pins toward a second edge of each panel in the support structure to collapse the entire support structure.

45. The method of claim 40, further comprising attaching each tether to a pulley-type element attached to the delivery device.

46. A method of transitioning an expandable support structure between states, comprising:

accessing a plurality of tethers threaded through panels of an expandable support structure, wherein each tether is threaded through two apertures each in different panels of the support structure; and

tensioning the tethers to at least partially collapse the support structure.

47. The method of claim 46 further comprising:

positioning a plurality of wrap pins over the collapsed end of the support structure and

advancing the wrap pins toward a second end of the support structure so as to collapse the entire support structure.

48. The method of claim 46, further comprising tensioning the tethers with a pulley-type element.

49. The method of claim 46, wherein a first tether is routed through a first aperture in a first panel and a second aperture in a second panel, a second tether is routed through a third aperture in the second panel and a fourth aperture in a third panel, and a third tether is routed through a fifth aperture in the third panel and a sixth aperture in the first panel.

50. A medical device, comprising:

an expandable support structure comprising a plurality of panels and hinges located between the panels, wherein one or more removable needles, each having a proximal end and a distal end, and each having a length greater than the longitudinal length of the support structure, intersect the panel surface through one or more apertures in the panel surface, and

wherein a distal portion of a tether is coupled to the proximal end of each needle and a proximal portion of a tether is coupled to a delivery device.

51. The medical device of claim 50, further comprising a compliant frame having a locked state and an unlocked state, wherein the expandable support structure is locked to the compliant frame in the locked state, and

wherein the support structure is removable from the compliant frame when the compliant frame is in the unlocked state.