System and method for transapical delivery of an annulus anchored self-expanding valve

• US 8,747,459 B2
• Filed: 12/06/2007
• Issued: 06/10/2014
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Nguyen, Than, Seguin, Jacques, Komatsu, Stan, Nguyen, Hung, Boertlein, Georg
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US11/952,080
• Publication Number:
  US 20080140189A1
• Time in Patent Office: 2,378 Days
• Field of Search: 623/2.11, 623/1.11, 623/1.12, 606/108, 606/194
• US Class Current: 623/2.11
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable prosthesis frame. The valve may be delivered transluminally or transmyocardially using a thorascopic or other limited access approach using a delivery catheter. Preferably, the initial partial expansion of the valve is performed against the native valve annulus to provide adequate anchoring and positioning of the valve as the remaining portions of the valve expand. The valve may be delivered using a retrograde or antegrade approach. When delivered using a retrograde approach, a delivery catheter with a pull-back sheath may be used, while antegrade delivery is preferably performed with a delivery catheter with a push-forward sheath that releases the proximal end of the valve first.

Claims

1. A replacement cardiac valve system, comprising:

a delivery catheter comprising;

a catheter body having an exterior surface;

a distal flange located at a distal end of the catheter body and extending radially outward from the exterior surface of the catheter body;

a retaining structure located proximally from the distal flange and extending radially outward from the exterior surface of the catheter body,

wherein a receptacle is formed between the distal flange and the retaining structure; and

a restraining sheath movably coupled to the distal end of the catheter body; and

an expandable heart valve having an inflow end and an outflow end, collapsible into the restraining sheath and coupled to the retaining structure of the delivery catheter at the outflow end of the expandable heart valve,

wherein the restraining sheath is configured to move between a proximal closed position that restrains the expandable heart valve and a distal exposed position that first exposes the inflow end of the expandable heart valve,

wherein the retaining structure is configured to restrict proximal longitudinal displacement of the expandable heart valve as the restraining sheath moves between the proximal closed position and the distal exposed position, and

wherein the distal flange is configured to restrict distal longitudinal displacement of the expandable heart valve.

2. The replacement cardiac valve system according to claim 1, wherein the delivery catheter further comprises a taper segment proximal to the restraining sheath.

3. The replacement cardiac valve system according to claim 1, wherein the restraining sheath is configured to move to a release position that exposes the retaining structure.

4. The replacement cardiac valve system according to claim 1, wherein the delivery catheter further comprises a taper segment distal to the restraining sheath.

5. The replacement cardiac valve system according to claim 1, wherein the retaining structure includes at least one protrusion component that is complementary to a receptacle component on the expandable heart valve.

6. A kit comprising:

a self expandable heart valve prosthesis having an inflow end and an outflow end; and

a catheter for delivering the heart valve prosthesis, the catheter comprising;

an elongate body;

a distal portion having an exterior surface, a section around which the heart valve prosthesis can be mounted, and a distal flange located at a distal end of the elongate body and extending radially outward from the exterior surface configured to restrict distal longitudinal displacement of the self expandable heart valve prosthesis; and

a sheath having a proximal end, and being movable over a prosthesis mounting section in a distal direction from a position substantially covering the prosthesis mounting section to a position substantially uncovering the prosthesis mounting section, such that, in use, movement of the proximal end of the sheath first exposes the inflow end of the heart valve prosthesis placed in the prosthesis mounting section; and

a retaining structure located proximally from the distal flange and extending radially outward from the exterior surface of the distal portion, configured to restrict proximal longitudinal displacement of the heart valve prosthesis as the sheath moves between the position substantially covering the prosthesis mounting section and the position substantially uncovering the prosthesis mounting section, wherein a receptacle is formed between the distal flange and the retaining structure, and wherein the outflow end of the heart valve prosthesis is coupled to the retaining structure.

7. The kit according to claim 6, wherein the distal portion of the catheter comprises a zone of reduced cross-section to form the prosthesis mounting section.

8. The kit according to claim 7, wherein the prosthesis mounting section comprises a proximal end, and wherein the catheter further comprises a projection adjacent the proximal end of the mounting section configured to cooperate with the proximal end of the sheath to minimize interference between the proximal end of the sheath and a deployed prosthesis when, in use, the catheter is withdrawn through the deployed prosthesis.

9. The kit according to claim 8, wherein the projection comprises an area of greater cross-section than that of the mounting section, a cross section of the projection extending around the catheter approximating a cross-section of the proximal end of the sheath.

10. The kit according to claim 9, wherein the projection comprises a sloping surface extending from adjacent the prosthesis mounting section towards an outer surface of the catheter.

11. The kit according to claim 6, wherein the catheter further comprises a distal tip, the tip being formed integrally with the sheath.

12. The kit according to claim 6, wherein the catheter further comprises a guidewire lumen extending along the longitudinal axis of the catheter.

13. The kit according to claim 6, further comprising a guidewire.

14. The kit according to claim 6, wherein the retaining structure includes at least one protrusion component that is complementary to a receptacle component on the heart valve prosthesis.