Unstented heart valve with formed in place support structure

• US 8,377,118 B2
• Filed: 05/05/2005
• Issued: 02/19/2013
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/579,723
• Publication Number:
  US 20090082857A1
• Time in Patent Office: 2,847 Days
• Field of Search: 623/1.25, 623/1.26, 623 21- 219, 623/23.68, 623/904, 623/913
• US Class Current: 623/2.18
• 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 (100) has an in situ formable support structure. The valve comprises a prosthetic valve (104), 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 (126) extends proximally of the base of the valve. A second flexible component (128) 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 (300) 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 aortic heart valve in a heart, the method comprising:

delivering an implantable expandable carrier element and an implantable replacement valve having leaflets endovascularly to a vicinity of the native aortic heart valve while the heart is beating, the carrier element having proximal and distal ends, the replacement valve configured to allow the flow of blood through the replacement valve in a first direction and prevents the flow of blood through the replacement valve in a second direction;

positioning the proximal and distal ends of the carrier element proximate opposing sides of the native aortic heart valve;

expanding the carrier element from a collapsed delivery configuration to a first expanded configuration;

using the carrier element to exclude the native aortic heart valve in the first expanded configuration,

forming a seal between the carrier element and one or more native anatomical features in the first expanded configuration;

using the leaflets of the replacement valve to replace leaflet actuation of the native aortic heart valve in the first expanded configuration;

evaluating the position of the carrier element;

at least partially collapsing the carrier element from the first expanded configuration to a moveable configuration, a length of the carrier element in the moveable configuration being substantially equal to or less than a length of the carrier element in the first expanded configuration;

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

expanding the carrier element from the moveable configuration to a second expanded configuration to secure the carrier element in the vicinity of the native aortic heart valve, the proximal and distal ends of the carrier element being proximate opposing sides of the native aortic heart valve in the second expanded configuration;

using the carrier element to exclude the native aortic heart valve in the second expanded configuration;

forming a seal between the carrier element and one or more anatomical features in the second expanded configuration; and

using the leaflets of the replacement valve to replace leaflet actuation of the native aortic heart valve in the second expanded configuration.

2. The method of claim 1, wherein the carrier element is at least partially secured within the vicinity of the native aortic heart valve when in the first expanded configuration.

3. The method of claim 1, wherein the carrier element is expanded to the first and second expanded configurations using an inflation media.

4. The method of claim 1, wherein the carrier element is expanded to the first expanded configuration using a preinflation media and expanded to the second expanded configuration using a preinflation media, the method further comprising substituting the preinflation media with a permanent inflation media.

5. The method of claim 1, wherein repositioning of the carrier element includes at least one of rotating or translating the carrier element.

6. The method of claim 1, 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 the entire expansion of the carrier element to the first expanded configuration.

7. The method of claim 1, 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 at least partially during expansion of the carrier element to the second expanded configuration.

8. The method of claim 1, 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.

9. The method of claim 1, 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.

10. The method of claim 1, wherein the carrier element is configured to conform to the patient'"'"'s anatomy upon expansion.

11. The method of claim 1, wherein the only native anatomical feature displaced by the carrier element is the native aortic heart valve.

12. The method of claim 1, wherein a length of the carrier element in the first and second expanded configurations is less than a length of the carrier element in the collapsed delivery configuration.

13. The method of claim 1, wherein the carrier element has a non-cylindrical profile in the first and second expanded configurations.

14. The method of claim 1, wherein a proximal portion of the carrier element extends further radially outwardly than a central portion of the carrier element.

15. The method of claim 1, wherein delivering and repositioning the carrier element includes moving at least one control wire removeably coupled with the carrier element, the carrier element having a longitudinal axis being generally parallel to the at least one control wire in the collapsed delivery configuration and the first expanded configuration.

16. The method of claim 15 further comprising:

at least three control wires, each of the at least three control wires coupled with the carrier element at different radial locations around a periphery of the carrier element.

17. The method of claim 16, wherein the at least three control wires are substantially equally spaced apart from one another around the periphery of the carrier element.

18. The method of claim 1, wherein the carrier element includes a first carrier element and the method further comprising:

completely removing the first carrier element endovascularly and exchanging the first carrier element with an implantable second carrier element and an implantable second replacement valve having leaflets, the second replacement valve configured to allow the flow of blood through the second replacement valve in the first direction and prevents the flow of blood through the second replacement valve in the second direction, the second carrier element having at least one of a different diameter, length or style than the first carrier element; 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 aortic heart valve while the heart is beating, the proximal and distal ends of the second carrier element being proximate opposing sides of the native aortic heart valve in the expanded configuration;

using the second carrier element to exclude the native aortic heart valve in the expanded configuration;

forming a seal between the second carrier element and one or more anatomical features in the expanded configuration; and

using the leaflets of the second replacement valve to replace leaflet actuation of the native aortic heart valve in the expanded configuration.

19. The method of claim 1, wherein the carrier element displaces the native aortic heart valve and maintains the displacement of the native aortic heart valve while in the first and second expanded configurations.

20. The method of claim 19, wherein displacing the native aortic heart valve includes at least partially opening the native aortic heart valve.

21. The method of claim 1, wherein expanding the carrier element from a collapsed delivery configuration to a first expanded configuration includes expanding the distal end of the carrier element prior to expanding the proximal end of the carrier element.

22. The method of claim 1, wherein at least partially collapsing the carrier element from the first expanded configuration to a moveable configuration includes keeping the distal end expanded.

23. The method of claim 1, wherein at least partially collapsing the carrier element from the first expanded configuration to a moveable configuration does not include the distal end.