APPARATUS AND METHOD FOR IN SITU EXPANSION OF PROSTHETIC DEVICE

• US 20100131039A1
• Filed: 11/13/2009
• Published: 05/27/2010
• Est. Priority Date: 11/25/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Pintor, Rafael, Oba, Travis, Zeng, Qinggang, Yambao, August, Huntley, Tammy
• Granted Patent: US 8,591,567 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• 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 an expansion device that is movable from a first configuration to a second configuration. External surfaces of the expansion device can collectively have a non-cylindrical cross-section relative to a main axis of the expansion device, such that the external surfaces of the expansion device generally conform to the anatomical shape of the conduit or orifice when the expansion device is in the second configuration.

Claims

1. An apparatus for radially expanding a prosthetic device in a conduit or orifice of a human body, the apparatus comprising:

an expansion device having a main axis and an outer mounting surface for mounting the prosthetic device in a crimped state thereon,

wherein the expansion device is configured to expand radially outwards from a first configuration to a second configuration to expand the prosthetic device to an expanded shape having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device.

2. The apparatus of claim 1, wherein the expansion device is configured to expand the prosthetic device to generally conform to an anatomical shape of the conduit or orifice.

3. The apparatus of claim 1, the expansion device further comprising a plurality of shape-forming members, the shape-forming members having a plurality of external surfaces that form at least a portion of the mounting surface of the expansion device,

wherein when the expansion device is in the second configuration, the external surfaces of the shape-forming members collectively have a non-circular cross-sectional profile perpendicular to the main axis of the expansion device.

4. The apparatus of claim 3, wherein the plurality of shape-forming members include three or more shape-forming members.

5. The apparatus of claim 3, wherein the external surfaces of the shape-forming members collectively generally conform to the trilobular shape of the aortic valve annulus when the expansion device is in the second configuration.

6. The apparatus of claim 3, wherein the shape-forming members are angularly spaced around the main axis.

7. The apparatus of claim 3, wherein the expansion device further comprises a balloon member, the balloon member being inflatable from a non-expanded state to an expanded state, the balloon member being configured to move the shape-forming members radially outwards from the first configuration to the second configuration.

8. The apparatus of claim 7, wherein the shape-forming members are adhered to an external surface of the balloon member.

9. The apparatus of claim 7, wherein the shape-forming members are configured to form a substantially closed ring shape when the balloon member is in the non-expanded state.

10. The apparatus of claim 3, the apparatus further comprising an elongated shaft, wherein the expansion device comprises one or more linkages connected to a distal end of the elongated shaft and to the shape-forming members.

11. The apparatus of claim 10, wherein the one or more linkages are pivotably connected to the distal end of the elongated shaft to permit radial expansion of the shape-forming members.

12. The apparatus of claim 11, wherein the one or more linkages are connected to an actuator located at a proximal end portion of the elongated shaft, the actuator being configured to radially expand the shape-forming members via the one or more linkages.

13. The apparatus of claim 1, wherein the expansion device comprises:

a balloon member, the balloon member being configured to expand from a non-expanded state to an expanded state; and

a balloon-restricting member surrounding at least a portion of the balloon member, the balloon-restricting member having a plurality of openings through which portions of the balloon member extend when the balloon is in the expanded state,

wherein the plurality of openings are configured so that when the balloon member is in the expanded state, the expansion device has an outer profile that is non-circular in cross section perpendicular to the main axis of the balloon member.

14. The apparatus of claim 13, wherein the balloon-restricting member comprises a wire frame.

15. The apparatus of claim 13, wherein the balloon-restricting member comprises a tube with a plurality of openings.

16. A delivery system for delivering a prosthetic device, comprising:

a prosthetic device comprising a frame member; and

an expansion device having a main axis and an outer mounting surface for mounting the prosthetic device in a crimped state thereon,

wherein the expansion device is configured to expand radially outwards from a first configuration to a second configuration to expand the prosthetic device to an expanded shape having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device.

17. The apparatus of claim 16, wherein the expansion device comprises a balloon member having a plurality of shape-forming members attached to an external surface of the balloon member.

18. A method of expanding a prosthetic device within a conduit or orifice of a human body, the method comprising:

providing an expansion device, the expansion device having a main axis and an outer mounting surface;

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

expanding the expansion device from a first configuration to a second configuration to expand the prosthetic device to an expanded shape having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device.

19. The method of claim 18, wherein the expansion device further comprises a balloon member and a plurality of shape-forming members at least partially surrounding the balloon member, and the step of expanding the expansion device comprises inflating the balloon member.

20. The method of claim 19, wherein when the expansion device is in the second configuration, the external surfaces of the shape-forming members collectively define an envelope curve that generally conforms to the anatomical shape of the orifice or conduit.