Device and method with reduced pacemaker rate in heart valve replacement

• US 10,709,555 B2
• Filed: 04/18/2016
• Issued: 07/14/2020
• Est. Priority Date: 05/01/2015
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Schreck, Stefan, Rangwala, Hussain S., Saffari, Payam
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/570,897
• Publication Number:
  US 20180289471A1
• Time in Patent Office: 1,548 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0056 W-shaped, e.g. M-shaped, sigma-shaped
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2250/0032 differing in radiographic density
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

The disclosure relates to heart valve prostheses with the reduced need of pacemaker implantation and improved means for positioning the replacement heart valve.

Claims

1. A heart valve prosthesis, comprising:

a stent component comprising a scaffold including cells proximate a proximal end of the stent component,

a valve component coupled to an inner surface of the stent component,

a seal coupled to an outer surface of the stent component,

at least one locator pointing in a proximal direction for positioning the prosthesis at a target site of an endogenous heart valve, and

an indicator extending in the proximal direction and configured to move relative to the locator upon contact with the target site,

wherein the prosthesis is expandable from a non-expanded state to an expanded state, a shortest distance from a proximal end of the locator to a proximal end of the prosthesis being less in the expanded state than a shortest distance from the proximal end of the locator to the proximal end of the prosthesis in the non-expanded state,

wherein, in the non-expanded state, the proximal end of the locator radially overlaps at least a portion of the cells, and

wherein, in the expanded state, the shortest distance between the proximal end of the locator and the proximal end of the prosthesis is greater than zero and less than 10 mm.

2. The prosthesis according to claim 1, wherein the locator comprises a probe.

3. The prosthesis according to claim 1, wherein the distance between the proximal end of the locator and the proximal end of the prosthesis varies in a circumferential direction of the prosthesis.

4. The prosthesis according to claim 1, wherein in the non-expanded state, the locator and the stent component extend along a tube perimeter, and in the expanded state, the locator extends at least partially outside an expanded tube perimeter.

5. The prosthesis according to claim 1, wherein the locator comprises an arch attached to, or forming an integral part of, the stent component, and wherein the shortest distance between the proximal end of the locator and the proximal end of the stent component in the expanded state as compared to the non-expanded state differs by 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm.

6. The prosthesis according to claim 5, wherein the arch of the locator has two ends, and wherein each end is attached to, or forms an integral part of, a fastening arch of the stent component.

7. The prosthesis according to claim 1, wherein the prosthesis is configured to not cover one or more coronary arteries when placed at the target site when in the expanded state.

8. The prosthesis according to claim 1, wherein the stent component comprises three sections including a first section that corresponds to a right coronary sinus (RCS), a second section that corresponds to a left coronary sinus (LCS), and a third section that corresponds to a non-coronary coronary sinus (NCS), wherein the three sections each comprise a distal end and a proximal end;

and wherein;

the proximal end of each section extends with an equal length so that the sections corresponding to the RCS, LCS, and NCS end at the same level, or

the proximal ends corresponding to the RCS and LCS sections are shorter than the proximal end of the NCS section.

9. The prosthesis according to claim 8, wherein the proximal end of each section extends with an equal length so that the sections corresponding to the RCS, LCS, and NCS end at the same level, and wherein the NCS proximal section comprises an indentation.

10. The prosthesis according to claim 1, wherein the indicator comprises one or more wires or antennas.

11. The prosthesis according to claim 1, wherein the indicator comprises a radiopaque material.

12. The prosthesis according to claim 1, wherein the stent component comprises a counterpart to the indicator.

13. The prosthesis according to claim 12, wherein the counterpart comprises the at least one locator, a feeler, a hook, or a rim;

and wherein the counterpart has a U, V, Y, M or W shape.

14. The prosthesis according to claim 13, wherein the indicator and the counterpart comprise the same materials.

15. The prosthesis according to claim 12, wherein the counterpart comprises a radiopaque material.

16. The prosthesis according to claim 1, wherein the stent component comprises nitinol, and the seal comprises soft fabric, textile, mammalian tissue, or a polymer.

17. The prosthesis according to claim 1, wherein the prosthesis is an aortic heart valve including three leaflets, or a mitral heart valve including two leaflets.

18. A heart valve prosthesis, comprising:

a stent component comprising a scaffold including cells proximate a proximal end of the stent component,

a valve component,

a seal configured to prevent reflux of blood between the prosthesis and an endogenous heart valve when the valve component is in a closed position,

at least one locator pointing in a proximal direction for positioning the prosthesis at a target site of the endogenous heart valve, the locator comprising an arch attached to, or forming an integral part of, the stent component, and

an indicator extending in the proximal direction and configured to move relative to the locator upon contact with the target site,

wherein the prosthesis is expandable from a non-expanded state to an expanded state, a shortest distance from a proximal end of the locator to a proximal end of the prosthesis being less in the expanded state than a shortest distance from the proximal end of the locator to the proximal end of the prosthesis in the non-expanded state,

wherein, in the non-expanded state, the proximal end of the locator radially overlaps at least a portion of the cells, and

wherein, in the expanded state, the proximal end of the locator does not radially overlap the cells and the shortest distance between the proximal end of the locator and the proximal end of the prosthesis is 1 mm to 5 mm.