SYSTEM FOR IN SITU POSITIONING OF CARDIAC VALVE PROSTHESES WITHOUT OCCLUDING BLOOD FLOW

• US 20080147160A1
• Filed: 12/19/2006
• Published: 06/19/2008
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Shin, Dong Ik, Righini, Giovanni, Ghione, Laura, Rolando, Giovanni, Gaschino, Paolo, Manasse, Eric
• Granted Patent: US 8,057,539 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2/2436 Deployment by retracting a sheath

Abstract

An instrument for positioning a cardiac valve prosthesis in a vessel includes a wire element to slidingly guide the valve prosthesis towards an implantation site and an expandable element coupled to the wire element. The expandable element is expandable in the vessel to position the wire element in association with the implantation site. A method for positioning a cardiac valve prosthesis includes securing a delivery instrument at an appropriate location at the implantation site and delivering the valve prosthesis to the implantation site using the delivery instrument.

Claims

1. A device for use in positioning a cardiac valve prosthesis in a vessel, the device comprising:

a wire element to facilitate advancement of the valve prosthesis, the wire element including an abutment element configured to limit advancement of the prosthesis; and

an expandable element coupled to the wire element, the expandable element including an expanded configuration operable to axially secure the wire element with respect to an implantation site in the vessel, while not occluding blood flow through the vessel;

wherein the expandable element is disposed in a symmetrical fashion about the wire element, such that at least a portion of the wire element is generally positioned along a central longitudinal axis of the vessel.

2. The device of claim 1 wherein the cardiac valve prosthesis is an aortic valve prosthesis.

3. The device of claim 2 further including at least on reference element to facilitate relative positioning of the cardiac valve prosthesis with respect to an implantation site.

4. The device of 3 wherein the expandable element is made from a superelastic, self-expanding material and has a generally cage-like configuration.

5. A device for use in positioning a cardiac valve prosthesis in a vessel, the device comprising a wire element coupled to an expandable element, wherein the expandable element includes an expanded configuration operable to axially secure the wire element with respect to an implantation site in the vessel, while not occluding blood flow through the vessel.

6. The device of claim 5 wherein the expandable element is configured to expand symmetrically about the wire element, such that in the expanded configuration the wire element is disposed substantially in a longitudinal center of the lumen.

7. The device of claim 5 wherein the expandable element has a generally cage-like expanded configuration.

8. The device of claim 7 wherein the expandable element is formed from a tubular body having generally parallel slits disposed about its circumference, and further comprising a catheter slidable over the wire element to compress the tubular body thereby causing the expandable element into the expanded configuration.

9. The device of claim 5 wherein the expandable element is made from a superelastic, self-expanding material.

10. The device of claim 5 wherein the expandable element is an inflatable balloon.

11. The device of claim 5 wherein the expandable elements include a plurality of structures located along the wire element.

12. The device of claim 5 wherein the expandable element has an outside diameter less than an inside diameter of the lumen, such that the expandable element is substantially non-obstructive of the flow of blood in the lumen.

13. The device of claim 5 further including at least one reference structure coupled to the wire element to enable positioning of the valve prosthesis with respect to the implantation site.

14. The device of claim 13 wherein the reference structure is a radiopaque marker.

15. The device of claim 13 wherein the reference structure is an abutment coupled to the wire element at a selectively adjustable position with respect to the implantation site.

16. The device of claim 5 further comprising an entrapment device configured to capture embolic particles during implantation of the cardiac valve prosthesis.

17. A method of implanting a replacement aortic valve prosthesis at an implantation site, the method comprising:

advancing a positioning instrument having an expandable element and a wire element through an aortic annulus to an anchoring position distal to the Valsalva sinuses;

deploying the expandable element to secure the positioning instrument to the aortic wall, while not occluding blood flow through the aortic arch;

advancing the aortic valve prosthesis over the wire element to a reference point coupled to the wire element, such that the prosthesis is in a desired position with respect to the aortic annulus; and

expanding the aortic valve prosthesis, such that the prosthesis anchors to the aortic annulus and the Valsalva sinuses.

18. The method of claim 17 further comprising deploying a trap element to capture any particles released at the implantation site during the implantation procedure.

19. The method of claim 17 wherein the expandable element is deployed by retracting a sheath thereby allowing the self-expanding structure to expand against the aortic wall.

20. The method of claim 17 wherein the positioning instrument is advanced by inflating a balloon coupled to a distal end of the instrument in the left ventricle and allowing blood flow to carry the distal end through the aortic annulus.