Methods of conformal expansion of prosthetic heart valves

• US 10,667,906 B2
• Filed: 01/25/2018
• Issued: 06/02/2020
• Est. Priority Date: 11/25/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Oba, Travis Zenyo, Huntley, Tammy, Zeng, Qinggang, Yambao, August R., Pintor, Rafael
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/880,181
• Publication Number:
  US 20180147060A1
• Time in Patent Office: 859 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A system for expanding a device in a conduit or orifice of a human body includes a balloon member that is movable from a first configuration to a second configuration. External surfaces of the balloon member can collectively have a non-cylindrical cross-section relative to a main axis of the balloon member, such that the external surfaces of the balloon member generally conform to the anatomical shape of the conduit or orifice when the balloon member is in the second configuration.

Claims

1. A method of expanding a prosthetic heart valve within an aortic annulus of the human body, the method comprising:

providing an expansion device having a main axis and an outer mounting surface, the expansion device comprising an expansion member and a plurality of rigid shape-forming members forming a part of the outer mounting surface;

mounting the prosthetic heart valve on the outer mounting surface of the expansion device; and

expanding the expansion member to an expanded state to radially outwardly displace the shape-forming members and expand the prosthetic heart valve to an expanded shape having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device, wherein

the expansion member comprises a handle portion and a plunger portion, and the shape-forming members comprise a plurality of flexible finger portions connected to the handle portion but separated from one another via one or more slits, wherein the handle portion is configured with a bore extending longitudinally therethrough and the plunger portion is configured to be moveable longitudinally through the bore between a first position and a second position to cam the finger portions radially outward.

2. The method of claim 1, wherein the expanded shape of the prosthetic heart valve has a longitudinal profile that varies along its axial length with one end radially larger than the other end.

3. The method claim 2, wherein when the expansion member is in the expanded state, the external surfaces of the shape-forming members collectively define an envelope curve that generally conforms to the anatomical shape of the aortic annulus with the larger end positioned in the sinus region of the ascending aorta.

4. The method of claim 1, wherein the non-circular cross-sectional profile is a three-lobed shape in radial cross-section.

5. The method of claim 4, wherein the expansion member in the expanded state has a distal portion and a proximal portion separated by a center longitudinal portion, and wherein the distal and proximal portions each has a larger diameter than the center portion.

6. The method of claim 1, wherein the expansion member in the expanded state has a distal portion and a proximal portion separated by a center longitudinal portion, and wherein the distal and proximal portions each has a larger diameter than the center portion.

7. A method of expanding a prosthetic heart valve within an aortic annulus of the human body, the method comprising:

providing an expansion device having a main axis and an outer mounting surface, the expansion device comprising a balloon member and a balloon-restricting member surrounding at least a portion of the balloon member and forming a portion of the outer mounting surface, the balloon-restricting member having a plurality of openings through which portions of the balloon member bulge when the balloon is in an expanded state;

mounting the prosthetic heart valve on the outer mounting surface of the expansion device; and

inflating the balloon member from a deflated state to the expanded state, wherein the plurality of openings are configured so that the balloon member has an outer profile that is non-circular in cross section perpendicular to the main axis of the balloon member and the expanded shape of the heart valve has a non-circular cross-sectional profile perpendicular to the main axis of the expansion device.

8. The method of claim 7, wherein the balloon-restricting member comprises a tube in which is formed the plurality of openings.

9. The method of claim 8, wherein the balloon-restricting member has only three of the plurality of openings spaced approximately 120 degrees apart so as to expand the balloon member in a three-lobed shape.

10. The method of claim 7, wherein the balloon-restricting member comprises a wire frame.

11. The method of claim 10, wherein the wire frame comprises three wires that extend from a distal end of the shaft around the balloon member and join at a central point distal to the balloon member.

12. The method of claim 7, wherein the plurality of openings are configured so that the balloon member in its expanded state has three lobes distributed circumferentially that are shaped to conform to the aortic root at the aortic valve annulus.

13. The method of claim 12, wherein the balloon member is formed with three distinct chambers that each form one of the three lobes.

14. The method of claim 13, wherein the balloon member has four chambers including the three distinct chambers in a proximal portion and a distal portion with just one chamber.

15. A method of expanding a prosthetic heart valve within an aortic annulus of the human body, the method comprising:

providing an expansion device having a main axis and an outer mounting surface, the expansion device comprising an expansion member and a plurality of rigid shape-forming members forming a part of the outer mounting surface;

mounting the prosthetic heart valve on the outer mounting surface of the expansion device; and

expanding the expansion member to an expanded state to radially outwardly displace the shape-forming members and expand the prosthetic heart valve to an expanded shape having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device, wherein

the expansion member comprises a main shaft and a wedge member fixedly connected to a distal end thereof, and an inner shaft that extends through the main shaft and is connected at its distal end to a cap member, wherein the shape-forming members are in cooperating engagement between the wedge member and cap member such that relative longitudinal movement of the wedge member and cap member cams the shape-forming members radially outwards or radially inward, depending on the direction of relative longitudinal movement.

16. The method of claim 15, wherein the expanded shape of the prosthetic heart valve has a longitudinal profile that varies along its axial length with one end radially larger than the other end.

17. The method of claim 16, wherein when the expansion member is in the expanded state, the external surfaces of the shape-forming members collectively define an envelope curve that generally conforms to the anatomical shape of the aortic annulus with the larger end positioned in the sinus region of the ascending aorta.

18. The method of claim 15, wherein the non-circular cross-sectional profile is a three-lobed shape in radial cross-section.

19. The method of claim 18, wherein the expansion member in the expanded state has a distal portion and a proximal portion separated by a center longitudinal portion, and wherein the distal and proximal portions each has a larger diameter than the center portion.

20. The method of claim 15, wherein the expansion member in the expanded state has a distal portion and a proximal portion separated by a center longitudinal portion, and wherein the distal and proximal portions each has a larger diameter than the center portion.