Method of treating a patient using a retrievable transcatheter prosthetic heart valve

• US 9,510,941 B2
• Filed: 03/22/2011
• Issued: 12/06/2016
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Bishop, Gordon B., Lashinski, Randall T.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/069,209
• Publication Number:
  US 20110213460A1
• Time in Patent Office: 2,086 Days
• Field of Search: 623/1.25, 623/2.14, 623/2.18, 623/2.42
• US Class Current: 1/1
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0059 : temporary
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

An implantable prosthetic valve has an in situ formable support structure. The valve comprises a prosthetic valve, having a base and at least one flow occluder. A first flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The first component extends proximally of the base of the valve. A second flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The second component extends distally of the base of the valve. At least one rigidity component combines with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

Claims

1. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable first carrier element and a first replacement valve endovascularly to a vicinity of the native heart valve, the first replacement valve configured to allow the flow of blood through the first replacement valve in a first direction and prevent the flow of blood through the first replacement valve in a second direction;

expanding the first carrier element from a collapsed delivery configuration to an at least partially expanded configuration in the vicinity of the native heart valve, wherein during expansion of the first carrier element, a distal end of the first carrier element is expanded prior to a proximal end of the first carrier element being expanded, the proximal end of the first carrier element being expanded without urging the proximal end of the first carrier element toward the distal end of the first carrier element, the first replacement valve allowing the flow of blood through the first replacement valve in a first direction and preventing the flow of blood through the first replacement valve in a second direction after expanding the distal end of the first carrier element and prior to expanding the proximal end of the first carrier element;

evaluating the position or function of the first carrier element and the first replacement valve;

at least partially collapsing the first carrier element from the at least partially expanded configuration to a moveable configuration;

completely removing the first carrier element and exchanging the first carrier element with a second carrier element having a second replacement valve, the second replacement valve configured to allow the flow of blood through the second replacement valve in the first direction and prevent the flow of blood through the second replacement valve in the second direction; and

expanding the second carrier element from a collapsed delivery configuration to an expanded configuration to secure the second carrier element in the vicinity of the native heart valve, wherein during expansion of the second carrier element, a distal end of the second carrier element is expanded prior to a proximal end of the second carrier element being expanded, the proximal end of the second carrier element being expanded without urging the proximal end of the second carrier element toward the distal end of the second carrier element, the second replacement valve allowing the flow of blood through the second replacement valve in a first direction and preventing the flow of blood through the second replacement valve in a second direction after expanding the distal end of the second carrier element and prior to expanding the proximal end of the second carrier element.

2. The method of claim 1, wherein the first and second replacement valves prevent the flow of blood through the valve in the direction and allows the flow of blood through the first and second replacement valves in the first direction during the expansion of the first and second carrier elements.

3. The method of claim 1, wherein evaluating the position or function of the first carrier element and the first replacement valve comprises monitoring the flow of blood through chambers of the patient'"'"'s heart using echocardiography.

4. The method of claim 1, wherein evaluating the position or function of the first carrier element and the first replacement valve comprises evaluating a position of a radiopaque portion of the first carrier element using fluoroscopy.

5. The method of claim 1, wherein evaluating the position or function of the first carrier element and the first replacement valve comprises monitoring the flow of blood using fluoroscopy.

6. The method of claim 5, wherein contrast is injected to enhance visualization by fluoroscopy.

7. The method of claim 1, wherein evaluating the position or function of the first carrier element and the first replacement valve comprises monitoring a blood pressure of the patient.

8. The method of claim 7, wherein the blood pressure includes a ventricular blood pressure.

9. The method of claim 1, wherein the first carrier element is at least partially expanded using an inflation media.

10. The method of claim 1, wherein expanding the first carrier element from the collapsed delivery configuration to the at least partially expanded configuration comprises unsheathing the first carrier element from a delivery sheath.

11. The method of claim 1, wherein the expandable first carrier element and the first replacement valve are delivered endovascularly to a vicinity of the native heart valve using a delivery catheter, and wherein at least partially collapsing the first carrier element from the expanded configuration to a moveable configuration comprises pulling the implant into a device other than the delivery catheter.

12. The method of claim 1, wherein the second carrier element has at least one of a different diameter, length or style than the first carrier element.

13. The method of claim 1, wherein a length of the first carrier element in the moveable configuration is substantially equal to or less than a length of the carrier element in the at least partially expanded configuration.

14. The method of claim 1 further comprising:

displacing the native heart valve with the first carrier element; and

displacing the native heart valve with the second carrier element,

wherein the distal end of the first carrier element is expanded prior to displacing the native heart valve with the first carrier element, and

wherein the distal end of the second carrier element is expanded prior to displacing the native heart valve with the second carrier element.

15. The method of claim 1, wherein the proximal end of the first carrier element is expanded after evaluating the position or function of the first carrier element and the first replacement valve.

16. The method of claim 1, wherein the first carrier element includes at least three struts spaced around the first carrier element and coupling the distal end of the first carrier element to the proximal end of the first carrier element.

17. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable carrier element and a replacement valve endovascularly to a vicinity of the native heart valve; and

expanding the carrier element from a collapsed delivery configuration to an expanded configuration to secure the carrier element in the vicinity of the native heart valve, wherein during expansion of the carrier element, a distal end of the carrier element is expanded prior to a proximal end of the carrier element being expanded, the proximal end of the carrier element being expanded without urging the proximal end of the carrier element toward the distal end of the carrier element,

wherein the replacement valve prevents the flow of blood through the valve in a first direction and allows the flow of blood through the replacement valve in a second direction during the expansion of the carrier element, after expanding the distal end of the carrier element, and prior to expanding the proximal end of the carrier element.

18. The method of claim 17, wherein the carrier element is expanded to the expanded configuration using an inflation media.

19. The method of claim 17, wherein the carrier element is configured to conform to the patient'"'"'s anatomy upon expansion.

20. The method of claim 17, wherein the only native anatomical feature displaced by the carrier element is the native valve.

21. The method of claim 17, wherein proximal and distal ends of the carrier element form a seal with respective native anatomical features proximate opposing sides of the native valve.

22. The method of claim 17, wherein the carrier element has a non-cylindrical profile in the expanded configuration.

23. The method of claim 17, wherein a proximal portion of the carrier element extends further radially outwardly than a central portion of the carrier element.

24. The method of claim 17 further comprising:

displacing the native heart valve with the carrier element,

wherein the distal end of the carrier element is expanded prior to displacing the native heart valve with the carrier element.

25. The method of claim 17 further comprising:

after expanding the distal end of the carrier element and evaluating the position or function of the carrier element and the replacement valve, expanding the proximal end of the carrier element.

26. The method of claim 25 further comprising:

after evaluating the position or function of the carrier element and the replacement valve and before expanding the proximal end of the carrier element, at least partially collapsing the carrier element to a moveable configuration;

repositioning the carrier element in the moveable configuration in the vicinity of the native heart valve; and

expanding the carrier element from the moveable configuration to a fully expanded configuration to secure the carrier element in the vicinity of the native heart valve.

27. The method of claim 17, wherein the carrier element includes at least three struts spaced around the carrier element and coupling the distal end of the carrier element to the proximal end of the carrier element.

28. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable carrier element and a replacement valve endovascularly to a vicinity of the native heart valve, the replacement valve configured to allow the flow of blood through the replacement valve in a first direction and prevent the flow of blood through the valve in a second direction; and

expanding the carrier element from a collapsed delivery configuration to an expanded configuration to secure the carrier element in the vicinity of the native heart valve, wherein during expansion of the carrier element, a distal end of the carrier element is expanded prior to a proximal end of the first carrier element being expanded, the carrier element being configured to conform to the patient'"'"'s anatomy upon expansion, the proximal end of the carrier element being expanded without urging the proximal end of the carrier element toward the distal end of the carrier element,

wherein the replacement valve prevents the flow of blood through the valve in a first direction and allows the flow of blood through the replacement valve in a second direction after expanding the distal end of the carrier element and prior to expanding the proximal end of the carrier element.

29. The method of claim 28, further comprising:

at least partially collapsing the carrier element from the expanded configuration to a moveable configuration;

repositioning the carrier element in the moveable configuration in the vicinity of the native heart valve; and

expanding the carrier element from the moveable configuration to the expanded configuration to secure the carrier element in the vicinity of the native heart valve, wherein the carrier element re-conforms to the patient'"'"'s anatomy upon expansion.

30. The method of claim 29, wherein the carrier element is initially expanded to the expanded configuration using a preinflation media.

31. The method of claim 30, wherein the preinflation media is substituted with a permanent inflation media once the carrier element is re-secured in the vicinity of the native heart valve.

32. The method of claim 29, wherein repositioning the carrier element includes moving at least three control wires removeably coupled to the carrier element.

33. The method of claim 29, wherein repositioning of the carrier element includes at least one of rotating or translating the carrier element.

34. The method of claim 29, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during collapsing of the carrier element.

35. The method of claim 29, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during repositioning of the carrier element.

36. The method of claim 28, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during expansion of the carrier element.

37. The method of claim 28, wherein the carrier element is expanded to the expanded configuration using an inflation media.

38. The method of claim 28, wherein the only native anatomical feature displaced by the carrier element is the native valve.

39. The method of claim 28, wherein proximal and distal ends of the carrier element form a seal with respective native anatomical features proximate opposing sides of the native valve.

40. The method of claim 28, wherein the carrier element has a non-cylindrical profile in the expanded configuration.

41. The method of claim 28, wherein a proximal portion of the carrier element extends further radially outwardly than a central portion of the carrier element.