Delivery systems and methods of implantation for replacement prosthetic heart valve

• US 10,172,709 B2
• Filed: 06/14/2016
• Issued: 01/08/2019
• Est. Priority Date: 02/16/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/181,695
• Publication Number:
  US 20160367362A1
• Time in Patent Office: 938 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A delivery system and method for positioning and partially deploying a replacement valve at an implantation site, verifying the location of the replacement valve relative to the implantation site, and retrieving the partially deployed stent for repositioning relative to the implantation site.

Claims

1. A delivery device for delivering a replacement prosthetic heart valve to a native heart valve region of a patient, the delivery device comprising:

an inner shaft;

an outer sheath positioned around the inner shaft;

wherein, in an extended position the outer sheath is configured to compressively retain the replacement prosthetic heart valve over the inner shaft and in a retracted position, the outer sheath is retracted proximally to expose the replacement prosthetic heart valve;

a first engagement member having a distal end configured to engage the replacement prosthetic heart valve when the replacement prosthetic heart valve is positioned over the inner shaft; and

a covering structure having a distal end and a proximal end;

wherein a maximum dimension of the covering structure at the distal end is greater than a maximum dimension of the covering structure at the proximal end;

and further wherein the covering structure has an extended position in which the covering structure covers the distal end of the first engagement member and a retracted position in which the covering structure is retracted proximally to expose the distal end of the first engagement member.

2. The delivery device of claim 1, wherein the distal end of the covering structure is tapered.

3. The delivery device of claim 1, wherein the first engagement member is configured to deform to release the replacement prosthetic heart valve from the delivery device.

4. The delivery device of claim 1, wherein the first engagement member has first and second portions extending from a common point, the first and second portions both configured to selectively engage and disengage the replacement prosthetic heart valve.

5. The delivery device of claim 1, wherein the first engagement member includes a protrusion that is configured to engage the replacement prosthetic heart valve.

6. The delivery device of claim 1, further comprising a second engagement member arranged to be selectively surrounded by the covering structure.

7. The delivery device of claim 1, wherein the first engagement member includes a delivery wire extending through the covering structure and configured to actuate release of the first engagement member from the replacement prosthetic heart valve from a delivery state in which the first engagement member is engaged with the replacement stented prosthetic heart valve to a full deployment state in which the first engagement member disengages the replacement stented prosthetic heart valve.

8. The delivery device of claim 1, wherein a cross-sectional shape of the distal end of the covering structure is generally rectangular.

9. A system for repairing a heart valve of a patient, the system comprising:

a replacement prosthetic heart valve including;

a self-expanding stent defining a proximal side opposite a distal side, and forming a first node at the proximal side, wherein the self-expanding stent is configured to self-expand from a compressed arrangement toward a normal, expanded arrangement,

a valve structure attached to the self-expanding stent; and

a delivery device including;

an inner shaft,

an outer sheath positioned around the inner shaft,

a first engagement member having a distal end, and

a covering structure at least partially surrounding the first engagement member, the covering structure having a distal end and a proximal end;

wherein a maximum dimension of the covering structure at the distal end is greater than a maximum dimension of the covering structure at the proximal end;

wherein the system is configured to provide;

a delivery state in which the replacement prosthetic heart valve is loaded over the inner shaft and is retained in the compressed arrangement by the outer sheath, the delivery state further including the first engagement member engaging the first node and the covering structure surrounding the first engagement member at a location of connection between the first engagement member and the first node, wherein the delivery state further includes the covering structure disposed within the outer sheath,

a partial deployment state in which the outer sheath is retracted from over the prosthetic heart valve, the partial deployment state further includes the first engagement member connected to the first node and the covering structure surrounding the first engagement member, the covering structure being partially retracted to expose the distal end of the first engagement member and the first node, and

a full deployment state in which the replacement prosthetic heart valve is released from the delivery device.

10. The system of claim 9, wherein the distal end of the covering structure is tapered.

11. The system of claim 9, wherein the first engagement member is configured to deform in the full deployment state to release the replacement prosthetic heart valve from the delivery device.

12. The system of claim 9, wherein the first engagement member has first and second portions extending from a common point, the first and second portions configured to both engage the replacement prosthetic heart valve in the delivery state and disengage the replacement prosthetic heart valve in the full deployment state.

13. The system of claim 9, wherein the first engagement member includes a protrusion that is configured to engage the replacement prosthetic heart valve in the delivery state.

14. The system of claim 9, further comprising a second engagement member connected to a second node at the proximal side, the second engagement member surrounded by the covering structure in the delivery state.

15. The system of claim 9, wherein the first engagement member includes a delivery wire extending within the covering structure that can actuate release of the first engagement member from the replacement prosthetic heart valve from the delivery state to the full deployment state.

16. The system of claim 9, wherein a cross-sectional shape of the distal end of the covering structure is generally rectangular.

17. The system of claim 9, wherein the first engagement member has first and second portions that overlap each other at the first node.

18. The system of claim 9, wherein the first engagement member includes a hook-shaped structure.