TWO-STEP HEART VALVE IMPLANTATION

• US 20090281609A1
• Filed: 02/25/2009
• Published: 11/12/2009
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences (Edwards Lifesciences Corporation)
• Inventors: Spenser, Benjamin, Benichou, Netanel, Nguyen, Son V.
• Granted Patent: US 9,241,792 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A two-part implantable heart valve and procedure are disclosed that allow expansion and positioning of a first part of the implantable heart valve having a temporary or transient valvular structure. A second part of the implantable heart valve is deployed within the first part and attaches thereto. The valvular structure of the second part then acts to function as the heart valve replacement. A tool or system is provided for determining an adequate percutaneous heart valve size for a given stenotic valve. A balloon can be inflated inside the stenotic valve to a desired pressure. When this pressure is reached an angiographic image is taken and the balloon diameter is measured at a waist area created by contact between the balloon and the stenotic valve. The diameter represents the minimum percutaneous heart valve diameter to be implanted.

Claims

1. A method of implanting a cardiac valve, comprising:

advancing a radially-expandable temporary valve and a radially-expandable first stent into a patient in a collapsed position;

positioning the temporary valve and the first stent between leaflets of a native cardiac valve;

expanding the temporary valve and the first stent into the native cardiac valve so that the temporary valve becomes operational;

advancing a radially-expandable replacement valve and a radially-expandable second stent into the patient in a collapsed position;

positioning the radially-expandable replacement valve and radially-expandable second stent within the temporary valve; and

expanding the radially-expandable replacement valve and radially-expandable second stent so as to compress the temporary valve between the first stent and the second stent.

2. The method of claim 1, wherein the second stent has a top end and a bottom end and the temporary valve, in its compressed state between the first and second stents, extends either from the top end to the bottom end of the second stent or extends within the top end to the bottom end of the second stent so as to minimize paravalvular leakage.

3. The method of claim 1, wherein the first and second stents are advanced into a patient using a common delivery catheter and wherein the delivery catheter is deployed percutaneously or transapically.

4. The method of claim 1, wherein the first and second stents have mating geometrical configurations to assist with proper positioning of the first and second stents.

5. The method of claim 4, wherein the mating geometrical configurations include an indent located on the first stent for receiving a detent located on the second stent.

6. The method of claim 1, wherein expanding the temporary valve and the first stent includes inflating a first balloon on a delivery catheter and expanding the replacement valve and the second stent includes inflating a second balloon on the delivery catheter, the second balloon being spaced apart from the first balloon on the delivery catheter.

7. The method of claim 1, wherein the temporary valve is made of:

a) a biocompatible synthetic material, including one or more of the following;

polyester, polytetrafluoroethylene, or polyurethane;

or

b) biocompatible synthetic material that dissolves;

or

c) natural tissue, including pericardial tissue or other biological tissue.

8. The method of claim 1, further including determining a size of the replacement valve by inflating a test balloon inside the cardiac valve to a desired pressure and taking an angiographic image of the test balloon to determine its diameter.

9. The method of claim 1, wherein the temporary valve, in its compressed state between the first and second stents, serves as a friction barrier.

10. The method of claim 1, wherein the temporary valve is thinner than the replacement valve so as to minimize a crimp profile of the temporary valve.

11. The method of claim 1, wherein the first stent has a larger crimp profile than the second stent and the temporary valve has a smaller crimp profile than the replacement valve.

12. An apparatus for implanting a cardiac valve, comprising:

a catheter having first and second balloons spaced apart along a length thereof;

a first stent positioned on the first balloon;

a second stent positioned on the second balloon, the second stent having a smaller diameter than the first stent when each of the stents is in a crimped state;

a first valve coupled to the first stent, the first valve being a temporary valve that is designed to be compressed between the first and second stents upon deployment of the stents and their respective valves; and

a second valve coupled to the second stent, the second valve being a replacement valve that has a larger diameter than the first valve when each of the valves is in a crimped state;

wherein the apparatus has a minimized overall crimped profile by grouping the larger first stent with the smaller first valve and the smaller second stent with the larger second valve.

13. The apparatus of claim 12, wherein the first stent and second stent are formed from struts, wherein the struts of the first stent are thicker than struts of the second stent.

14. The apparatus of claim 12, wherein the first valve and second valve include leaflets, wherein the leaflets of the first valve are thinner than leaflets of the second valve.

15. The apparatus of claim 12, wherein the first balloon is thinner than the second balloon.

16. The apparatus of claim 12, wherein the first stent has a geometrical feature that mates with a geometrical feature of the second stent.

17. The apparatus of claim 16, wherein the mating geometrical features include an indent located on the first stent for receiving a detent located on the second stent.

18. The apparatus of claim 12, further including a tool for taking an angiographic image of a test balloon for determining a size of the first and second stents.

19. The apparatus of claim 12, wherein the first stent includes barbs to secure the first stent to the native valve.

20. A method of implanting a cardiac valve, comprising:

deploying a temporary valve and a first stent in the native valve; and

deploying a replacement valve and a second stent by inserting the replacement valve and the second stent into the temporary valve and by expanding the replacement valve and second stent so as to compress the temporary valve between the first and second stents.

21. The method of claim 20, wherein deploying the temporary valve and the first stent includes inflating a first balloon to a first pressure and expanding the replacement valve and the second stent includes inflating a second balloon to a second pressure, which is less than the first pressure.

22. The method of claim 20, wherein the second stent has a top end and a bottom end and the temporary valve, in its compressed state, extends either from the top end to the bottom end of the second stent or extends within the top end and the bottom end of the second stent so as to prevent paravalvular leakage.

23. The method of claim 20, wherein the first and second stents are advanced using a common delivery catheter having first and second balloons coupled in series.

24. The method of claim 20, wherein the first and second stents have mating geometrical configurations to assist with proper positioning of the first and second stents.

25. The method of claim 20, wherein the temporary valve is made of biocompatible synthetic material, including one of the following:

polyester, polytetrafluoroethylene, or a polyurethane.

26. The method of claim 20, wherein the temporary valve is made of a synthetic or biocompatible material that dissolves over time.

27. The method of claim 20, wherein the temporary valve is made of natural tissue, such as pericardial tissue (e.g. bovine, porcine or equine pericardium), or other biological tissue.

28. The method of claim 20, wherein the first stent has a larger crimp profile than the second stent and the temporary valve has a smaller crimp profile than the replacement valve.