SYSTEM AND METHOD FOR TRANSAPICAL DELIVERY OF AN ANNULUS ANCHORED SELF-EXPANDING VALVE

• US 20080140189A1
• Filed: 12/06/2007
• Published: 06/12/2008
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Corevalve Incorporated (Medtronic Plc)
• Inventors: Komatsu, Stan, Boertlein, Georg, Nguyen, Than, Seguin, Jacques, Nguyen, Hung
• Granted Patent: US 8,747,459 B2
• Time in Patent Office: Days
• 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, a retaining structure attached to the distal end of the catheter body and a restraining sheath movably coupled to the distal end of the catheter body; and

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

wherein the restraining sheath comprises a proximal closed position configured to restrain the expandable heart valve and a distal exposed position that exposes at least a portion of the expandable heart valve.

2. The replacement cardiac valve system as in claim 1, further comprising a taper segment on the delivery catheter proximal to the restraining sheath.

3. The replacement cardiac valve system as in claim 1, wherein the restraining sheath further comprises a release position that exposes the retaining structure.

4. The replacement cardiac valve system as in claim 1, further comprising a taper segment on the delivery catheter distal to the restraining sheath.

5. A catheter for delivering a self expandable prosthesis, the catheter comprising

an elongate body;

a distal portion having a section around which the prosthesis can be mounted; and

a sheath having a proximal end, and being movable over the 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 exposes a prosthesis placed in the mounting section.

6. A catheter as in claim 5, wherein the distal portion comprises a zone of reduced cross-section to form the prosthesis mounting section.

7. A catheter as in claim 6, wherein the prosthesis mounting section comprises a proximal end and 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.

8. A catheter as in claim 7, wherein the projection comprises an area of greater cross-section than that of the mounting section, the cross section of the projection extending around the catheter approximating the cross-section of the proximal end of the sheath.

9. A catheter as in claim 8, wherein the projection extend by means of a sloping surface extending from adjacent the prosthesis mounting section towards an outer surface of the catheter.

10. A catheter as in claim 5, further comprising a distal tip, the tip being formed integrally with the sheath.

11. A catheter as in claim 5, further comprising a guidewire lumen extending along the longitudinal axis of the catheter.

12. A kit comprising a catheter for delivering a self expandable prosthesis, the catheter comprising:

an elongate body;

a distal portion having a section around which the prosthesis can be mounted; and

a sheath having a proximal end, and being movable over the 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 exposes a prosthesis placed in the mounting section;

the kit further comprising the prosthesis.

13. A kit as in claim 12, wherein the prosthesis is a heart valve.

14. A kit as in claim 13, further comprising a guidewire.

15. A method for delivering a self-expandable heart valve, comprising:

approaching an inflow side of a cardiac valve with a valve delivery catheter, wherein the delivery catheter comprising a proximal catheter body, a restraining sheath and a collapsed prosthetic valve having an expandable proximal end and an expandable distal end, wherein the cardiac valve comprises a valve orifice, a valve annulus and a plurality of valve leaflets;

positioning the prosthetic valve across the valve orifice;

expanding the proximal end of the prosthetic valve against the valve leaflets; and

expanding the distal end of the prosthetic valve after expanding the proximal end of the prosthetic valve.

16. The method for delivering a self-expandable heart valve as in claim 15, further comprising pushing the restraining sheath distally and exposing the proximal end of the prosthetic valve.

17. The method for delivering a self-expandable heart valve as in claim 16, further comprising pushing the catheter body through the prosthetic valve and contacting the restraining sheath.

18. The method for delivering a self-expandable heart valve as in claim 17, further comprising pulling the catheter body and the restraining sheath from the prosthetic valve while the catheter body and the restraining sheath remain contacted.