Conformal expansion of prosthetic devices to anatomical shapes

• US 9,314,334 B2
• Filed: 11/25/2013
• Issued: 04/19/2016
• 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 R., Pintor, Rafael
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US14/089,723
• Publication Number:
  US 20140081389A1
• Time in Patent Office: 876 Days
• US Class Current: 1/1
• 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. A mechanical 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 having a first configuration for mounting the prosthetic device in a crimped state thereon, the expansion device comprising a plurality of rigid, single piece shape-forming members angularly arranged around the main axis and each having a three-dimensional external surface, wherein the combination of the external surfaces collectively defines a longitudinal profile for the outer mounting surface that varies along its axial length in the first configuration, and

an axially moveable shaft configured to cam the shape-forming members radially outwards and convert the outer mounting surface from the first configuration to a larger second configuration, wherein the combination of the external surfaces collectively defines, perpendicular to a main axis of the expansion device when in the second configuration, a non-circular shape at a first axial location and a circular cross-section at a second axial location, and expand the prosthetic device to an expanded state having a longitudinal profile that varies along its axial length and conforms to the shape of the conduit or orifice.

2. The apparatus of claim 1, wherein in the expanded state a distal end of the prosthetic device is radially larger than a proximal end of the prosthetic device.

3. 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.

4. The apparatus of claim 3, wherein the external surfaces of the shape-forming members collectively define, at the first axial location, a trilobular shape in the second configuration at the first end, and, at the second axial location, a substantially circular cross-section in the intermediate portion.

5. The apparatus of claim 1, wherein the axially moveable shaft comprises concentric inner and outer shafts, and the expansion device comprises a distal wedge member to which the inner shaft connects and a proximal wedge member to which the outer shaft connects, wherein the wedge members are arranged to be axially displaced toward one another and cam outward the shape-forming members upon relative movement of the inner and outer shafts.

6. The apparatus of claim 5, wherein at least one of the inner and outer shafts has a threaded portion and is axially displaced by relative rotation of a mating threaded member.

7. The apparatus of claim 5, wherein each of the wedge members includes axial slots therethrough and the shape-forming members include projections formed on inner surfaces thereof which extend into the slots.

8. The apparatus of claim 1, wherein the axially moveable shaft comprises a plunger that extends distally in between the shape-forming members which are flexible and cam apart from imposition of the plunger therebetween.

9. The apparatus of claim 8, wherein the plunger has a threaded portion and is axially displaced by relative rotation within a mating threaded handle.

10. The apparatus of claim 1, wherein the expansion device comprises one or more hinged linkages connected to a distal end of the axially-movable shaft and to the shape-forming members.

11. 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 mounting surface and two generally radially oriented sides that contact the adjacent shape-forming members'"'"' sides in the first configuration.

12. A mechanical 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 having a first configuration for mounting the prosthetic device in a crimped state thereon, wherein the expansion device comprises a plurality of rigid, single piece shape-forming members angularly arranged around the main axis and each having an external surface, wherein the combination of the external surfaces defines the outer mounting surface and a longitudinal profile for the outer mounting surface that varies along its axial length in the first configuration, and

an axially moveable shaft configured to displace the shape-forming members radially outwards and convert the outer mounting surface from the first configuration to a larger second configuration and expand the prosthetic device to an expanded state having a longitudinal profile that varies along its axial length and conforms to the shape of the conduit or orifice, wherein in the first configuration, the shape-forming members at the outer mounting surface are in contact with each other along circumferentially-adjacent sides, and in the second configuration the circumferentially-adjacent sides of the shape-forming members at the outer mounting surface are spaced apart from each other and the plurality of external surfaces define a longitudinal profile that varies along its axial length.

13. The apparatus of claim 12, 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 mounting surface and two generally radially oriented sides that contact the circumferentially-adjacent sides of the adjacent shape-forming members in the first configuration.

14. The apparatus of claim 12, 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.

15. The apparatus of claim 12, wherein in the expanded state a distal end of the prosthetic device is radially larger than a proximal end of the prosthetic device.

16. The apparatus of claim 12, wherein the axially moveable shaft comprises concentric inner and outer shafts, and the expansion device comprises a distal wedge member to which the inner shaft connects and a proximal wedge member to which the outer shaft connects, wherein the wedge members are arranged to be axially displaced toward one another and force outward the shape-forming members upon relative movement of the inner and outer shafts.

17. The apparatus of claim 16, wherein at least one of the inner and outer shafts has a threaded portion and is axially displaced by relative rotation of a mating threaded member.

18. The apparatus of claim 16, wherein each of the wedge members includes axial slots therethrough and the shape-forming members include projections formed on inner surfaces thereof which extend into the slots.

19. The apparatus of claim 12, wherein the axially moveable shaft comprises a plunger that extends distally in between the shape-forming members which are flexible and cam apart from imposition of the plunger therebetween.

20. The apparatus of claim 12, wherein the expansion device comprises one or more hinged linkages connected to a distal end of the axially-movable shaft and to the shape-forming members.