Transcatheter Prosthetic Heart Valve Post-Dilatation Remodeling Devices and Methods

• US 20110264201A1
• Filed: 04/26/2011
• Published: 10/27/2011
• Est. Priority Date: 04/26/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Deshmukh, Susheel, Krivoruchko, Mike, Yeung, Hubert
• Granted Patent: US 8,568,474 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 restoring a defective heart valve of a patient, the method comprising:

manipulating a delivery device to percutaneously deliver a stented prosthetic heart valve in a compressed arrangement to an implantation site of the defective heart valve, the stented prosthetic heart valve having a stent frame to which a valve structure is attached, the stent frame being configured to radially self-expand from the compressed arrangement;

operating the delivery device to release the stented prosthetic heart valve, including permitting the stent frame to self-expand from the compressed arrangement toward a deployed arrangement in which the stented prosthetic heart valve is implanted within the defective heart valve in an initial state;

percutaneously delivering a post-dilatation balloon in a deflated state to the implantation site, the balloon including a compliant segment;

arranging the compliant segment within a region of the implanted prosthetic heart valve to be remodeled;

inflating the post-dilatation balloon such that the compliant segment expands and contacts the implanted prosthetic heart valve in the region to be remodeled; and

expanding the region to be remodeled via continued inflation of the compliant segment to alter a shape of the implanted prosthetic heart valve to a remodeled state.

2. The method of claim 1, further comprising:

removing the delivery device from the patient prior to the step of delivering the post-dilatation balloon.

3. The method of claim 1, further comprising:

evaluating an arrangement of the implanted prosthetic heart valve relative to the defective heart valve prior to the step of delivering the post-dilatation balloon.

4. The method of claim 1, wherein the implanted prosthetic heart valve defines a longitudinal length, and further wherein a longitudinal length of the compliant segment is less than the longitudinal length of the implanted prosthetic heart valve.

5. The method of claim 1, wherein the prosthetic heart valve terminates at an inflow end and an opposing outflow end, and further wherein the step of inflating the post-dilatation balloon includes the post-dilatation balloon imparting a maximum radial force on the implanted prosthetic heart valve between the inflow and outflow ends.

6. The method of claim 5, wherein the implanted prosthetic heart valve is located such that the inflow end is at an inflow side of a native annulus of the heart valve to be restored and the outflow end is at an outflow side of the native annulus, and further wherein the step of inflating the post-dilatation balloon includes applying the maximum radial force to the implanted prosthetic heart valve at a location along the outflow side, between the outflow end and the native annulus.

7. The method of claim 1, wherein the post-dilatation balloon further includes a first end segment immediately at a first side of the compliant segment and a second end segment immediately at a second side of the compliant segment opposite the first end segment, and further wherein the first and second end segments are less compliant than the compliant segment.

8. The method of claim 7, wherein the step of arranging the compliant segment within a region of the implanted prosthetic heart valve further includes at least one of the first and second end segments located within the implanted prosthetic heart valve simultaneously with the compliant segment.

9. The method of claim 8, wherein immediately prior to the step of inflating the post-dilatation balloon, each of the first and second end segments and the compliant segment are within the implanted prosthetic heart valve.

10. The method of claim 8, wherein the step of inflating the post-dilatation balloon further includes the first and second end segments expanding to a predetermined, fixed shape and size.

11. The method of claim 10, wherein following expansion, the post-dilatation balloon has an outer shape tapering in outer diameter at a transition from the first end segment to the compliant segment, and at a transition from the second end segment to the compliant segment.

12. The method of claim 10, wherein the step of inflating the post-dilatation balloon includes the first end segment contacting an outflow region of the implanted prosthetic heart valve and the second end segment contacting an inflow region of the implanted prosthetic heart valve, and further wherein a change in shape of the implanted prosthetic heart valve between the initial state and the remodeled state is increased at the region to be remodeled as compared to the outflow region and the inflow region.

13. The method of claim 10, wherein the step of inflating the post-dilatation balloon further includes:

inflating the post-dilatation balloon to a first pressure level, including the first end segment having a first maximum diameter, the second end segment having a second maximum diameter, and the compliant segment having a third maximum outer diameter;

evaluating a shape of the implanted prosthetic heart valve in the remodeled state; and

further inflating the post-dilatation balloon to a second pressure level greater than the first pressure level, wherein the compliant segment experiences an increase in the third maximum outer diameter that is greater than an increase in the first or second maximum diameters.

14. The method of claim 13, wherein the first and second maximum outer diameters do not change between the first and second pressure levels.

15. A system for percutaneously restoring a native heart valve of a patient, the system comprising:

a stented prosthetic heart valve having a stent frame to which a valve structure is attached, the stent frame configured to radially self-expand from a compressed arrangement;

a delivery device including a delivery sheath sized for percutaneously accessing a heart valve, the delivery device providing a delivery state in which the delivery sheath compressively maintains the stented prosthetic heart valve in the compressed arrangement, and a deployed state in which the delivery sheath is withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to self-expand from the compressed arrangement to a normal, expanded arrangement; and

a post-dilatation assembly including a catheter and a post-dilatation balloon fluidly attached to the catheter, the post-dilatation balloon sized for percutaneously accessing the stented prosthetic heart valve once implanted to the native heart valve;

wherein the post-dilatation balloon includes a compliant segment having a longitudinal length less than a longitudinal length of the prosthetic heart valve and further wherein with continuous inflation of the post-dilatation balloon, a maximum outer diameter of the compliant segment continuously expands.

16. The system of claim 15, wherein the post-dilatation balloon is configured such that in an inflated state, the compliant segment has an obround shape in longitudinal cross-section.

17. The system of claim 15, wherein the post-dilatation balloon further defines a first end segment immediately proximal the compliant segment and a second end segment immediately distal the compliant segment, and further wherein the first and second end segments expand upon inflation of the balloon and are less compliant than the compliant segment.

18. The system of claim 17, wherein the first segment tapers in outer diameter from a maximum diameter to a transition point with the compliant segment.

19. The system of claim 17, wherein in the inflated state, the post-dilatation balloon has a tri-lobed shape.

20. The system of claim 17, wherein a wall thickness of the post-dilatation balloon along the compliant segment is less than a wall thickness of the post-dilatation balloon along the first and second end segments.

21. The system of claim 17, wherein the post-dilatation assembly further includes an engagement feature along an exterior surface of at least one of the first and second end segments, the engagement feature configured to frictionally interface with the stent frame and selected from the group consisting of:

ridges, protrusions, surface roughness, and high friction material.

22. The system of claim 15, wherein the stented prosthetic heart valve and the delivery device are configured to percutaneously deploy and implant the stented prosthetic heart valve without inflation of the post-dilatation balloon.

23. The system of claim 22, wherein the post-dilatation balloon in configured for remodeling a region of the stented prosthetic heart valve following implantation.