Device for the implantation and fixation of prosthetic valves

• US 9,402,717 B2
• Filed: 05/11/2015
• Issued: 08/02/2016
• 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
• Application Number:
  US14/708,892
• Publication Number:
  US 20150342731A1
• Time in Patent Office: 449 Days
• US Class Current: 1/1
• 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 an expandable outer stent component adjacent the native aortic valve, the outer stent component including exactly three struts each having an apex pointing in a proximal direction towards a native heart;

expanding the exactly three struts of the outer stent component;

after expanding the exactly three struts, positioning each strut between a wall of an aorta and one of three respective portions of the native aortic valve, wherein the exactly three struts align the outer stent component with the native aortic valve in an axial direction;

positioning an expandable inner stent component radially inward of the portions of the native aortic valve and of the outer stent component, wherein the inner stent component includes a prosthetic heart valve; and

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

2. The method of claim 1, further comprising introducing the inner stent component and the outer stent component into the aorta via an artery, each of the inner stent component and the outer stent component being in a collapsed configuration.

3. The method of claim 1, wherein a distal end of the inner stent component is connected to a distal end of the outer stent component when the inner and outer stent components are expanded.

4. The method of claim 3, wherein the outer stent component includes a plurality of first elements complementary to a plurality of second elements of the inner stent component, such that the first elements engage the second elements to connect the outer stent component to the inner stent component.

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

6. The method of claim 1, wherein an orientation of the inner stent component relative the outer stent component is fixed in the axial direction when the inner and outer stent components are expanded.

7. The method of claim 1, wherein the prosthetic heart valve is coupled to a proximal end of the inner stent component.

8. The method of claim 1, wherein the exactly three struts are equidistant to one another.

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

10. The method of claim 1, wherein each strut of the exactly three struts is curved convexly in the proximal direction.

11. The method of claim 1, wherein each strut of the exactly three struts is V-shaped with an apex pointing in the proximal direction.

12. The method of claim 1, further comprising monitoring a location of at least one of the outer stent component and the inner stent component when positioning the respective outer stent component or inner stent component.

13. The method of claim 1, further comprising expanding a balloon to push portions of the native aortic valve radially outwards toward the wall of the aorta before positioning the outer stent component adjacent the native aortic valve.

14. The method of claim 1, wherein at least one of the outer stent component and the inner stent component is self-expandable.

15. The method of claim 1, wherein each of the outer stent component and the inner stent component is self-expandable.

16. The method of claim 1, wherein the outer stent component and the inner stent component comprise Nitinol.

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

introducing a self-expandable outer stent component in a collapsed configuration into an aorta, a proximal-most end of the outer stent component including exactly three struts;

positioning the exactly three struts into pockets of the native aortic valve defined by a wall of an aorta and portions of the native aortic valve, wherein the exactly three struts align the outer stent component with the native aortic valve in an axial direction and a radial direction;

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

pressing the portions of the native aortic valve radially outward toward the outer stent component.

18. The method of claim 17, wherein the exactly three struts are equidistant to one another.

19. The method of claim 17, further comprising introducing a balloon catheter into the native aortic valve and expanding a balloon to push portions of the native aortic valve radially outwards toward the wall of the aorta before positioning the outer stent component adjacent the native aortic valve.

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

expanding a balloon to push portions of the native aortic valve radially outwards;

introducing a self-expandable outer stent component in a collapsed configuration into an aorta, a proximal-most end of the outer stent component including exactly three struts equidistant from one another;

positioning each strut of the exactly three struts into a respective pocket of the native aortic valve between a wall of the aorta and a portion of the native aortic valve, wherein the exactly three struts align the outer stent component with the native aortic valve in an axial direction and a radial direction;

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

pressing the portions of the native aortic valve radially outward toward the outer stent component, such that the portion s of the native aortic valve are between the outer stent component and the inner stent component.