Apparatus and method for in situ expansion of prosthetic device

• US 8,591,567 B2
• Filed: 11/13/2009
• Issued: 11/26/2013
• Est. Priority Date: 11/25/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Oba, Travis, Huntley, Tammy, Zeng, Qinggang, Yambao, August, Pintor, Rafael
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/618,023
• Publication Number:
  US 20100131039A1
• Time in Patent Office: 1,474 Days
• Field of Search: 623/1.12, 623/2.11, 623/1.24, 623/1.26, 606/108, 606191-194, 606/159, 604/103.07, 604/103.08
• US Class Current: 623/1.12
• 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, the expansion device comprising a balloon member and a plurality of rigid shape-forming members positioned on an outer surface of the balloon member and having a plurality of external surfaces that form at least a portion of the mounting surface,

wherein the expansion device is configured to expand radially outwards from a first configuration to a second configuration upon inflation of the balloon member to, move the shape-forming members radially outwards from the first configuration to the second configuration and expand the prosthetic device to an expanded shape having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device and a longitudinal profile that varies along its axial length with one end radially larger than the other end, and

wherein when the expansion device is in the second configuration, the external surfaces of the shape-forming members collectively define an outer envelope having a non-circular cross-sectional profile perpendicular to the main axis of the expansion device and a longitudinal profile that varies along its axial length with one end radially larger than the other end, and 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.

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, wherein the plurality of shape-forming members include three or more shape-forming members.

4. The apparatus of claim 1, wherein the shape-forming members are angularly spaced around the main axis.

5. The apparatus of claim 1, wherein the shape-forming members are adhered to an external surface of the balloon member.

6. The apparatus of claim 1, wherein, in the first configuration, the shape-forming members are in contact with each other around the balloon member, and in the second configuration the shape-forming members are spaced apart from each other around the balloon member.

15. The apparatus of claim 1, wherein each of the shape-forming members forms a pie-shaped cross-sectional configuration with an external surface that defines a portion of the outer envelope and two generally radially oriented sides that contact the adjacent shape-forming members sides in the first configuration.

16. The apparatus of claim 1, wherein the outer envelope of the shape-forming members collectively define a trilobular shape.

17. The apparatus of claim 1, wherein the longitudinal profile has a first end, a second end radially smaller than the first end, and an intermediate portion with a diameter that is radially smaller than both the first and second ends.

18. The apparatus of claim 17, wherein the outer envelope of the shape-forming members collectively define a trilobular shape in the second configurations at the first end, and a substantially circular cross-section in the intermediate portion.

7. 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 comprises a balloon member and a plurality of rigid shape-forming members surrounding the balloon member to define the mounting surface,

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, wherein in the first configuration, the shape-forming members are in contact with each other, and in the second configuration the shape-forming members are spaced apart from each other and define on outer envelope that determines the expanded shape of the prosthetic device; and

wherein each of the shape-forming members has a longitudinal profile that varies along its axial length in both the first and second configurations, and wherein the longitudinal profile has one end radially larger than the other end.

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

9. The apparatus of claim 7, 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.

10. The apparatus of claim 9, wherein there are six shape-forming members.

11. The apparatus of claim 7, wherein each of the shape-forming members forms a pie-shaped cross-sectional configuration with an external surface that defines a portion of the outer envelope and two generally radially oriented sides that contact the adjacent shape-forming members sides in the first configuration.

12. The apparatus of claim 7, wherein the outer envelope of the shape-forming members collectively define a trilobular shape in both the first and second configurations.

13. The apparatus of claim 7, wherein the longitudinal profile has a first end, a second end radially smaller than the first end, and an intermediate portion with a diameter that is radially smaller than both the first and second ends.

14. The apparatus of claim 13, wherein the outer envelope of the shape-forming members collectively define a trilobular shape in the second configurations at the first end, and a substantially circular cross-section in the intermediate portion.