Device for the implantation and fixation of prosthetic valves

• US 10,363,134 B2
• Filed: 11/22/2017
• Issued: 07/30/2019
• Est. Priority Date: 10/28/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Figulla, Hans-Reiner, Ferrari, Markus, Damm, Christoph
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/821,012
• Publication Number:
  US 20180318072A1
• Time in Patent Office: 615 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2418 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient'"'"'s main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient'"'"'s ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient'"'"'s aorta relative the heart valve predefinable by the positioning stent (20).

Claims

1. A method of treating a native aortic valve, the method comprising:

positioning a first expandable stent component adjacent the native aortic valve, the first stent component including three struts, wherein the three struts include exactly one strut for placement between each leaflet of the native aortic valve and a wall of an aorta, wherein each strut includes an apex pointing in a proximal direction towards a native heart;

expanding the struts of the first stent component;

after expanding the struts, positioning each strut between the respective leaflet and the wall of the aorta, wherein the struts align the first stent component with the native aortic valve in an axial direction;

positioning a second expandable stent component radially inward of the leaflets of the native aortic valve and of the first stent component, wherein the second stent component includes a prosthetic heart valve; and

expanding the second stent component to press the leaflets of the native aortic valve radially outward toward the first stent component, such that the leaflets of the native aortic valve are positioned between the first stent component and the second stent component.

2. The method of claim 1, further comprising introducing the second stent component and the first stent component into the aorta via an artery while each of the second stent component and the first stent component is in a collapsed configuration.

3. The method of claim 1, wherein the second stent component is coupled to the first stent component via a plurality of attachment elements when the second stent component and the first stent component are expanded.

4. The method of claim 3, wherein the second stent component is coupled to the first stent component via three attachment elements.

5. The method of claim 1, further comprising introducing the first stent component into the aorta via a catheter before expanding the struts of the first stent component.

6. The method of claim 1, wherein each of the three struts is curved arcuately in the proximal direction.

7. The method of claim 1, wherein positioning the second stent component includes rotating the second stent component.

8. The method of claim 1, wherein positioning the second stent component includes moving the second stent component along the axial direction.

9. The method of claim 1, wherein the first stent component further includes stabilizing struts.

10. The method of claim 9, further comprising monitoring a location of at least one of the first stent component or the second stent component when positioning the respective first stent component or second stent component.

11. A method of treating a native aortic valve, the method comprising:

introducing a first self-expandable stent component in a collapsed configuration into an aorta, the first stent component including three struts, wherein the three struts include exactly one strut corresponding to each leaflet of the native aortic valve;

positioning each of the struts radially outward of each corresponding leaflet of the native aortic valve and radially inward of a vessel wall, wherein the struts rotatably align the first stent component with the native aortic valve;

positioning a second self-expandable stent component radially inward of the leaflets of the native aortic valve, wherein the second stent component includes a prosthetic heart valve; and

pressing the leaflets of the native aortic valve radially outward toward the first stent component, such that the leaflets of the native aortic valve are between the first stent component and the second stent component.

12. The method of claim 11, wherein each of the three struts is curved convexly in the proximal direction.

13. The method of claim 11, wherein each of the three struts is V-shaped with an apex pointing in the proximal direction.

14. The method of claim 13, wherein the apexes of the three struts are equidistant to one another.

15. The method of claim 11, wherein the three struts align the first stent component with the native aortic valve in an axial direction.

16. The method of claim 11, wherein pressing the leaflets of the native aortic valve radially outward includes expanding the second stent component.

17. The method of claim 11, wherein a radial strength of the second stent component presses the leaflets of the native aortic valve radially outward toward the first stent component.

18. The method of claim 11, wherein the second stent component is coupled to the first stent component via a plurality of retaining elements.

19. The method of claim 18, wherein the second stent component is coupled to the first stent component via three retaining elements.

20. The method of claim 11, wherein the first stent component further includes a plurality of stabilizing struts.

21. A method of treating a native aortic valve, the method comprising:

introducing a self-expandable first stent component in a collapsed configuration into an aorta, the first stent component including three struts, wherein the three struts include exactly one strut corresponding to each pocket of the native aortic valve, each pocket defined by a portion of the native aortic valve and a wall of the aorta;

positioning each of the struts into the corresponding pocket of the native aortic valve, wherein the struts align the first stent component with the native aortic valve in an axial direction and the struts rotatably align the first stent component with the native aortic valve;

positioning a self-expandable second stent component radially inward of the pockets of the native aortic valve and of the first stent component, wherein the second stent component includes a prosthetic heart valve; and

expanding the second stent component to press the portions of the native aortic valve radially outward toward the first stent component, such that the portions of the native aortic valve are positioned between the first stent component and the second stent component.

22. The method of claim 21, wherein the first stent component and the second stent component are coupled together by one or more attachment elements.

23. The method of claim 22, wherein the one or more attachment elements include three attachment elements.

24. The method of claim 21, further comprising introducing the second stent component and the first stent component into the aorta via a femoral artery while each of the second stent component and the first stent component is in a collapsed configuration.

25. The method of claim 21, wherein the first stent component and the second stent component comprise Nitinol.

26. The method of claim 21, wherein the first stent component further includes stabilizing struts.