Methods of implanting a heart valve at an aortic annulus

• US 9,931,207 B2
• Filed: 01/19/2016
• Issued: 04/03/2018
• Est. Priority Date: 03/31/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Oba, Travis, Pintor, Rafael, Campbell, Louis A.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US15/001,114
• Publication Number:
  US 20160128829A1
• Time in Patent Office: 805 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An exemplary two-stage prosthetic heart valve system has a radially expandable base stent implanted within a native valve annulus. The two-stage heart valve system also has a valve component that is delivered to and mounted within the base stent in a separate or sequential operation after the base stent has been anchored within the annulus. The valve component in certain embodiments comprises a hybrid valve component that includes a conventional, non-expandable surgical valve that is modified to include an expandable coupling stent that can be expanded to engage the inner surface of the base stent, thereby anchoring the valve component to the base stent. In its expanded configuration, the outflow end portion base stent has tri-lobular shape that closely conforms to the shape of the aortic root and a support ring of the prosthetic valve that is mounted within the base stent.

Claims

1. A method of implanting a prosthetic heart valve system at an aortic heart valve annulus, comprising:

advancing a base stent to an implant position adjacent an aortic heart valve annulus;

radially expanding the base stent so as to anchor the base stent to the aortic heart valve annulus, the expanded base stent having an outflow end portion and an inflow end portion, at least a portion of the outflow end portion having a three-lobed cross-sectional profile with three outwardly-projecting lobes intermediate three regions of lesser radial dimension;

providing a prosthetic valve having a support frame surrounding an orifice including a non-expandable, non-collapsible valve stent coupled to leaflets that coapt within the orifice and form the occluding surfaces of the prosthetic valve, the prosthetic valve further having a coupling stent connected to and extending from an inflow end of the valve stent;

advancing the prosthetic valve into the outflow end portion of the base stent; and

radially expanding the coupling stent to an expanded state so as to anchor the prosthetic valve to the base stent.

2. The method of claim 1, wherein the support frame has a diameter that is less than a diameter of the inflow end portion of the base stent.

3. The method of claim 1, wherein the prosthetic valve has a sewing ring with a three-lobed shape, and the step of anchoring the prosthetic valve comprises positioning the three lobes of the sewing ring within the three outward lobes of the outflow end portion of the base stent.

4. The method of claim 1, wherein the base stent is anchored to the aortic heart valve annulus such that the inflow end portion extends into the adjacent left ventricle and the three outward lobes of the outflow end portion extend into respective sinuses of Valsalva of the adjacent ascending aorta.

5. The heart valve system of claim 4, wherein the prosthetic valve has a sewing ring that seats against the portion of the base stent having the three-lobed cross-sectional profile at a location just above the aortic annulus, and wherein the step of anchoring the prosthetic valve comprises radially expanding the coupling stent to an expanded state extending into and engaging the inflow end portion of the base stent.

6. The method of claim 1, wherein the base stent is plastically expandable.

7. The method of claim 6, wherein prior to advancing the base stent to the implant position, the base stent is mounted in a radially compressed state on an outer mounting surface of an expansion device, and the step of expanding the base stent comprises expanding the expansion device to effect expansion of the base stent, wherein expansion of the expansion device causes at least a portion of the outflow end portion to assume the three-lobed cross-sectional profile.

8. The method of claim 7, wherein the expansion device comprises a plurality of shape-forming members having respective outer surfaces collectively defining the outer mounting surface, the shape-forming members being moveable radially outward from each other to expand the base stent when the expansion device is expanded to its expanded configuration.

9. The method of claim 8, wherein the expansion device further comprises an inflatable balloon on which the shape-forming members are mounted.

10. The method of claim 8, wherein the each shape-forming member is configured to contact adjacent shape-forming members on two adjacent sides to form the outer mounting surface of the expandable device, and when the shape-forming members move radially outward from each other the adjacent sides thereof separate.

11. A method of implanting a prosthetic heart valve system at an aortic heart valve annulus, comprising:

advancing a plastically expandable base stent on an outer mounting surface of an expansion device of a catheter to an implant position adjacent an aortic heart valve annulus;

radially expanding the expansion device to expand the base stent and anchor the base stent to the aortic heart valve annulus, the expanded base stent having an outflow end portion and an inflow end portion, wherein the step of expanding the expansion device causes the outer mounting surface to expand unevenly and force the plastically expandable outflow end portion of the base stent to assume a three-lobed cross-sectional profile with three outwardly-projecting lobes intermediate three regions of lesser radial dimension;

providing a prosthetic valve having a support frame surrounding an orifice including a non-expandable, non-collapsible valve stent coupled to leaflets that coapt within the orifice and form the occluding surfaces of the prosthetic valve, the prosthetic valve further having a plastically expandable coupling stent connected to and extending from an inflow end of the valve stent;

advancing the prosthetic valve such that the support frame is located within the outflow end portion of the base stent; and

radially expanding the coupling stent to an expanded state so as to anchor the prosthetic valve to the inflow end portion of the base stent.

12. The method of claim 11, wherein the support frame attaches to a peripheral sewing ring that has a diameter that is greater than a diameter of the inflow end portion of the base stent such that the support frame is prevented from advancing into the inflow end portion.

13. The method of claim 11, wherein the prosthetic valve has a sewing ring with a three-lobed shape which conforms to the three outward lobes of the outflow end portion of the base stent.

14. The method of claim 11, wherein the base stent is anchored to the aortic heart valve annulus such that the inflow end portion extends into the adjacent left ventricle and the three outward lobes of the outflow end portion extend into respective sinuses of Valsalva of the adjacent ascending aorta.

15. The heart valve system of claim 14, wherein the prosthetic valve has a sewing ring that seats against the portion of the base stent having the three-lobed cross-sectional profile at a location just above the aortic annulus.

16. The method of claim 11, wherein the expansion device comprises a plurality of shape-forming members having respective outer surfaces collectively defining the outer mounting surface, the shape-forming members being moveable radially outward from each other to expand the base stent when the expansion device is expanded to its expanded configuration.

17. The method of claim 16, wherein the expansion device further comprises an inflatable balloon on which the shape-forming members are mounted.

18. The method of claim 17, wherein there are three solid shape-forming members mounted on the balloon.

19. The method of claim 16, wherein the each shape-forming member is configured to contact adjacent shape-forming members on two adjacent sides to form the outer mounting surface of the expandable device, and when the shape-forming members move radially outward from each other the adjacent sides thereof separate.

20. The method of claim 11, wherein the step of advancing the prosthetic valve comprises advancing the prosthetic valve on a catheter with the coupling stent carried in a contracted state on a balloon of the catheter.