Transcatheter prosthetic heart valve post-dilatation remodeling devices and methods

• US 10,449,045 B2
• Filed: 08/31/2016
• Issued: 10/22/2019
• Est. Priority Date: 04/26/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Yeung, Hubert, Krivoruchko, Mike, Deshmukh, Susheel
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/252,279
• Publication Number:
  US 20160374804A1
• Time in Patent Office: 1,147 Days
• Field of Search: 606108, 623 111, 623 112, 623 123, 623 211
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.

Claims

1. A method of remodeling a prosthetic heart valve of a patient, the method comprising:

percutaneously delivering a remodeling balloon in a deflated state to an implanted, fully expanded prosthetic heart valve, the balloon including a remodeling segment, the remodeling segment having a longitudinal length less than a longitudinal length of the implanted, fully expanded prosthetic heart valve;

arranging the remodeling segment within a region of the implanted, fully expanded prosthetic heart valve to be remodeled, the region to be remodeled having a longitudinal length less than the longitudinal length of the implanted, fully expanded prosthetic heart valve;

inflating the remodeling balloon such that the remodeling segment expands and contacts the implanted, fully expanded prosthetic heart valve in the region to be remodeled; and

expanding the region to be remodeled via continued inflation of the remodeling segment to alter a shape of the implanted, fully expanded prosthetic heart valve to a remodeled state;

wherein the step of expanding includes remodeling the implanted, fully expanded prosthetic heart valve primarily at the region to be remodeled as compared to other regions of the implanted, fully expanded heart valve.

2. The method of claim 1, further comprising:

evaluating the implanted, fully expanded prosthetic heart valve prior to the step of delivering the remodeling balloon.

3. The method of claim 1, wherein the implanted, fully expanded prosthetic heart valve includes a plurality of leaflets, and further wherein the step of expanding the region to be remodeled includes the remodeling segment not contacting the leaflets.

4. The method of claim 1, wherein the implanted, fully expanded prosthetic heart valve is a self-expandable prosthetic heart valve.

5. The method of claim 1, wherein the remodeling segment is configured such that in an expanded state, the remodeling segment has an obround shape in longitudinal cross-section.

6. The method of claim 1, wherein the remodeling balloon in an inflated state has a tri-lobed shape.

7. The method of claim 6, wherein the remodeling balloon in an inflated state has a first segment, a second segment, and a third segment, and further wherein the first segment and the third segment are on opposite sides of the second segment.

8. The method of claim 7, wherein a predetermined shape of the first segment upon inflation differs from a predetermined shape of the second segment upon inflation.

9. The method of claim 8, wherein a predetermined shape of the third segment upon inflation differs from the predetermined shape of the second segment upon inflation.

10. The method of claim 9, wherein the predetermined shape of the first segment upon inflation differs from the predetermined shape of the third segment upon inflation.

11. The method of claim 10, wherein the prosthetic heart valve includes leaflets that are arranged to establish an outflow region and an inflow region of the prosthetic heart valve, wherein the first segment upon inflation is configured to contact the inflow region and the third segment upon inflation is configured to contact the outflow region.

12. The method of claim 11, further comprising expanding the first segment to alter a shape of the inflow region.

13. The method of claim 11, further comprising expanding the third segment to alter a shape of the outflow region.

14. The method of claim 11, further comprising expanding the second segment to alter a shape of a region of the prosthetic heart valve between the inflow region and the outflow region.

15. The method of claim 1, wherein expanding the region to be remodeled via continued inflation of the remodeling segment to alter a shape of the implanted prosthetic heart valve to a remodeled state reduces paravalvular leakage.

16. The method of claim 1, further comprising evaluating a shape of the implanted, fully expanded prosthetic heart valve in the remodeled state.

17. A method of remodeling a prosthetic heart valve of a patient, the method comprising:

evaluating an arrangement of an implanted, fully expanded prosthetic heart valve;

percutaneously delivering a remodeling balloon in a deflated state to the implanted, fully expanded prosthetic heart valve, the balloon including a remodeling segment, the remodeling segment having a longitudinal length less than a longitudinal length of the implanted, fully expanded prosthetic heart valve;

arranging the remodeling segment within a region of the implanted, fully expanded prosthetic heart valve to be remodeled, the region to be remodeled having a longitudinal length less than the longitudinal length of the implanted, fully expanded prosthetic heart valve;

inflating the remodeling balloon such that the remodeling segment expands and contacts the implanted, fully expanded prosthetic heart valve in the region to be remodeled; and

expanding the region to be remodeled via continued inflation of the remodeling segment to alter a shape of the implanted, fully expanded prosthetic heart valve to a remodeled state;

wherein the step of expanding includes remodeling the implanted, fully expanded prosthetic heart valve primarily at the region to be remodeled as compared to other regions of the implanted, fully expanded heart valve.

18. The method of claim 17, wherein expanding the region to be remodeled via continued inflation of the remodeling segment to alter a shape of the implanted, fully expanded prosthetic heart valve to a remodeled state reduces paravalvular leakage.

19. The method of claim 17, wherein the implanted, fully expanded prosthetic heart valve is a self-expandable prosthetic heart valve.

20. A method of remodeling a prosthetic heart valve of a patient, the method comprising:

evaluating an arrangement of an implanted, fully expanded, self-expandable prosthetic heart valve;

percutaneously delivering a remodeling balloon in a deflated state to the prosthetic heart valve, the balloon including a remodeling segment, the remodeling segment having a longitudinal length less than the longitudinal length of the implanted prosthetic heart valve;

arranging the remodeling segment within a region of the prosthetic heart valve to be remodeled, the region to be remodeled having a longitudinal length less than the longitudinal length of the implanted prosthetic heart valve;

inflating the remodeling balloon such that the remodeling segment expands and contacts the prosthetic heart valve in the region to be remodeled; and

expanding the region to be remodeled via continued inflation of the remodeling segment to alter a shape of the prosthetic heart valve to a remodeled state to thereby reduce paravalvular leakage;

wherein the step of expanding includes remodeling the implanted, fully expand prosthetic heart valve primarily at the region to be remodeled as compared to other regions of the implanted, fully expanded heart valve.