Cylindrical implant and balloon

• US 10,314,703 B2
• Filed: 09/12/2016
• Issued: 06/11/2019
• Est. Priority Date: 09/21/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Maimon, David, Bialas, Michael R., Black, Mindy Lee Ann, Levi, Tamir S., Thai, Linda, Zhu, Yidong M.
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/263,204
• Publication Number:
  US 20170079793A1
• Time in Patent Office: 1,002 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped

Abstract

Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve'"'"'s tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Claims

1. A system comprising:

a prosthetic heart valve having a generally cylindrical stent frame with an axial opening and having an inflow end defining an inflow diameter, an outflow end defining an outflow diameter and a central region defining a central diameter, the central region between the inflow end and outflow end; and

a balloon extending through the axial opening and configured to expand and exert a radially directed force against the stent frame so that the outflow diameter and inflow diameter are smaller than the central diameter in an at least partially expanded condition;

wherein the stent frame in the at least partially expanded condition has a generally barrel shape such that the central diameter of the stent frame is larger than either the inflow or the outflow diameter of the stent frame by up to 6% in the at least partially expanded condition and at a pressure in the balloon of at least 4 atmospheres.

2. A system of claim 1, wherein the inflow diameter of the stent frame in the at least partially expanded condition is larger than the outflow diameter.

3. A system of claim 1, wherein the outflow diameter of the stent frame in the at least partially expanded condition is larger than the inflow diameter.

4. A system of claim 1, wherein the balloon is configured to exert the radially directed force through 4 to 6 atmospheres of pressure while the outflow and inflow diameters of the stent frame are smaller than the central diameter.

5. A system of claim 1, wherein the central diameter of the stent frame in the at least partially expanded condition is at most 2 mm larger than either the inflow or the outflow diameters.

6. A system of claim 5, wherein the pressure in the balloon is from 4 to 5 atmospheres.

7. A system of claim 1, wherein the central diameter of the stent frame in the at least partially expanded condition is at most 1.2 mm larger than either the inflow or outflow diameters.

8. A system of claim 1, wherein the central diameter of the stent frame in the at least partially expanded condition is at most 0.8 mm larger than either the inflow or the outflow diameters.

9. A system of claim 1, wherein the central diameter of the stent frame in the at least partially expanded condition is between 0% and 2% larger than the inflow diameter at the pressure in the balloon of at least 4 atmospheres.

10. A system of claim 9, wherein the inflow diameter of the stent frame in the at least partially expanded condition is larger than the outflow diameter.

11. A system of claim 1, wherein the balloon further includes enlarged ends configured to extend radially past the outflow end and the inflow end of the stent frame so as to retain the implant on the balloon.

12. A system of claim 1, wherein the balloon has a wall material with a stiffness adjacent the inflow end and outflow end of the stent frame that is greater than a stiffness of the wall material at the central region.

13. A system of claim 1, wherein the balloon is configured to expand to a larger diameter under the central region of the stent frame than under the inflow and outflow ends of the stent frame.

14. A system of claim 1, wherein the stent frame is configured to have regions of different stiffness.

15. A system of claim 14, wherein the stent frame has a lower stiffness at the central region than a stiffness adjacent the inflow and outflow ends.

16. A system of claim 14, wherein the stent frame has a lower stiffness adjacent the inflow and outflow ends than a stiffness at the central region.

17. A method comprising:

inflating a balloon, positioned in an axial opening of a generally cylindrical stent frame of a prosthetic heart valve, to a pressure of at least 4 atmospheres;

exerting a radial force against the cylindrical stent frame by the inflating the balloon; and

expanding the generally cylindrical stent frame to an at least partially expanded condition having a generally barrel shape by exerting the radial force so that an outflow diameter and an inflow diameter of the stent frame are smaller than a central diameter of the stent frame, the central diameter being larger than either the inflow or the outflow diameter by up to 6%.

18. The method of claim 17, wherein expanding the generally cylindrical stent frame includes expanding the generally cylindrical stent frame so that the central diameter is at most 2 mm larger than either the inflow or the outflow diameters in the at least partially expanded condition.

19. The method of claim 17, wherein expanding the generally cylindrical stent frame includes expanding the generally cylindrical stent frame so that the central diameter is at most 1.2 mm larger than either the inflow or the outflow diameters in the at least partially expanded condition.