Catheter based apical approach heart prostheses delivery system

• US 10,080,657 B2
• Filed: 03/05/2014
• Issued: 09/25/2018
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Siegel, Robert James
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US14/771,704
• Publication Number:
  US 20160000562A1
• Time in Patent Office: 1,665 Days
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A delivery system for rapid placement of heart implants is provided that includes a delivery platform. The delivery system includes a tubular catheter body, a piercing member, and a delivery platform. The tubular catheter body is sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart. The piercing member is configured to create a transapical channel from an internal apical portion of a ventricle to an outside heart wall. The delivery system includes an elongate tension member and an enlargeable member disposed on a distal portion of the elongate tension member. The enlargeable member is configured to be enlarged in a pericardial space of an intact chest wall to cover an area of the outside heart wall surrounding an opening of the transapical channel. When tensioned, the tension member provides a stable zone for positioning a heart implant within the heart.

Claims

1. A delivery system for rapid placement of heart implants at a mitral valve, comprising:

a tubular catheter body being sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart;

a piercing member configured to be advanced from the tubular catheter body to create a transapical channel from an internal apical portion of a ventricle to an outside heart wall;

a delivery platform configured to be advanced from the tubular catheter body, the delivery platform comprising an elongate tension member and an enlargeable member disposed on a distal portion of the elongate tension member, the enlargeable member configured to be enlarged in a pericardial space of an intact chest wall to cover an area of the outside heart wall surrounding an opening of the transapical channel, wherein a portion of the elongate tension member is configured to extend proximally from the distal portion and to span the transapical channel when the enlargeable member is enlarged in the pericardial space; and

a heart valve implant catheter;

wherein at least a heart valve implant mounted on the heart valve implant catheter is separable from the delivery system such that the heart valve implant catheter, the elongate tension member, the piercing member, and the enlargeable member can be removed while leaving the heart valve implant in place.

2. The delivery system of claim 1, further comprising a heart valve procedure catheter independently advanceable from the tubular catheter body, the heart valve procedure catheter adapted to be positioned for procedures prior to placement of heart valve implant.

3. The delivery system of claim 2, wherein the heart valve procedure catheter comprises a retraction zone adapted to displace the anterior leaflet anteriorly against a heart wall.

4. The delivery system of claim 2, wherein the heart valve procedure catheter comprises a resection device configured to perform at least one incision on the anterior leaflet.

5. The delivery system of claim 4, wherein the heart valve procedure catheter is configured to bisect the anterior leaflet at a central zone of the leaflet.

6. The delivery system of claim 1, wherein the enlargeable member comprises an inflatable balloon.

7. A delivery system for rapid placement of heart implants at a mitral valve, comprising:

a tubular catheter body being sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart;

a delivery platform configured to be advanced from the tubular catheter body, the delivery platform comprising an elongate tension member and an enlargeable member disposed on a distal portion of the elongate tension member, the enlargeable member configured to be enlarged adjacent to the apex of the left ventricle to cover an area of the heart wall at the apex; and

a heart valve implant catheter having an implant zone and a registration portion extending distally from the implant zone, the implant zone configured to secure an implant mounted thereon in a first configuration in which the implant is longitudinally fixed relative to the heart valve implant catheter, the implant configured to move from the implant zone to a second configuration in which the heart valve implant catheter is longitudinally movable relative to the implant, thereby allowing the delivery system to be withdrawn from the heart while leaving the implant in the heart, the registration portion being configured to position the implant at the proper distance from the left ventricle apex.

8. The delivery system of claim 7, further comprising a heart valve procedure catheter independently advanceable from the tubular catheter body, the heart valve procedure catheter adapted to be positioned for procedures prior to placement of heart valve implant.

9. The delivery system of claim 8, wherein the heart valve procedure catheter comprises a retraction zone adapted to displace the anterior leaflet anteriorly against a heart wall.

10. The delivery system of claim 8, wherein the heart valve procedure catheter comprises a resection device configured to perform at least one incision on the anterior leaflet.

11. The delivery system of claim 8, further comprising a guidewire for advancement through the tubular catheter body across the aortic valve and into the descending aorta, the heart valve procedure catheter adapted to be advanced over the guidewire to be disposed along a path from the ascending aorta through the aortic and mitral valves and across the intra-atrial septum.

12. The delivery system of claim 7, wherein the enlargeable member comprises an inflatable balloon.

13. The delivery system of claim 7, wherein the tubular catheter body includes a steering system for adjusting a trajectory between a distal port of the tubular catheter body and the left ventricle apex.

14. A delivery system for rapid placement of heart implants at a mitral valve, comprising:

a tubular catheter body being sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart, the tubular catheter body comprising a distal port and a steering system for adjusting a positioning of the distal port;

a delivery platform configured to be advanced from the distal port of the tubular catheter body, the delivery platform comprising an elongate tension member and a heart wall interface disposed on a distal portion of the elongate tension member, the heart wall interface configured to engage tissue on an inside surface of the heart adjacent the apex of the left ventricle to counteract a tension applied to the elongate tension member, the distal portion of the elongate tension member configured to be substantially fixed relative to the tissue adjacent the apex of the left ventricle when the heart wall interface engages said tissue, a proximal portion of the elongate tension member extending proximally of the distal portion being pivotable about the heart wall interface by adjusting the positioning of the distal port;

wherein the delivery platform provides rapid and accurate orientation of a heart valve implant catheter delivered over the elongate tension member.

15. The delivery system of claim 14, wherein the heart wall interface comprises an enlargeable member configured to conform to the inside wall of the ventricle over the apex.

16. The delivery system of claim 15, wherein the enlargeable member is a concave structure configured to receive the elongate tension member of the delivery platform to guide the distal end thereof to an orientation enabling the elongate tension member to be closely proximate to perpendicular to a plane of a valve annulus of a patient being treated with the system.

17. The delivery system of claim 14, wherein the heart wall interface comprises at least one tine disposed on a distal end of the delivery platform.

18. The delivery system of claim 17, wherein the tine is actuatable from a low profile state to a heart wall tissue engaging state.

19. The delivery system of claim 18, wherein the tine is actuatable from the heart wall tissue engaging state to a removal state.

20. The delivery system of claim 17, wherein at least the tine of the heart wall interface is separable from the elongate tension member of the delivery platform.