Methods of implanting minimally-invasive prosthetic heart valves

• US 8,709,077 B2
• Filed: 01/04/2013
• Issued: 04/29/2014
• Est. Priority Date: 04/06/2000
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US13/734,719
• Publication Number:
  US 20130131790A1
• Time in Patent Office: 480 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219, 623/900
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve. In one variation, flanges may be provided on the support stent for improving attachment of the support stent to the host tissue.

Claims

1. A method for replacing a damaged or diseased aortic valve, the method comprising:

minimally invasively advancing a delivery cannula into a patient, a self-expanding prosthetic heart valve in a radially compressed state loaded within the delivery cannula, the prosthetic valve comprising;

a collapsible, self-expanding support stent comprising a shape memory material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the three commissure posts being cantilevered from the base, each commissure post having a slot formed therein; and

a flexible tubular member attached to the support stent, the flexible tubular member comprising a fabric section connected to the base along the inflow end of the support stent and a leaflet section defining three leaflets connected to the commissure posts along the outflow end of the support stent, wherein portions of the leaflet section extend outward through the slots in the commissure posts for securing the leaflet section to the commissure posts;

wherein the leaflet section forms loops that pass through each of the commissure posts slots and the prosthetic heart valve further includes inserts disposed within the loops on an outside region of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots;

positioning the delivery cannula with the prosthetic heart valve within an annulus of a native aortic valve;

releasing the prosthetic heart valve from the delivery cannula within the annulus of the native aortic valve;

allowing the prosthetic heart valve to self-expand within the annulus of the native aortic valve such that the tubular base of the support stent of the prosthetic heart valve expands to engage the annulus and the three leaflets of the prosthetic heart valve are disposed downstream of the annulus; and

removing the delivery cannula from the patient.

2. The method of claim 1, wherein the support stent further comprises flanges for improved attachment to host tissue.

3. The method of claim 1, wherein the leaflet section is made of bovine pericardial tissue.

4. The method of claim 1, wherein the fabric section is sutured to the base.

5. The method of claim 1, wherein the fabric section is attached to the leaflet section by sutures along a seam.

6. The method of claim 5, wherein the seam is located substantially along an outflow portion of the base.

7. The method of claim 1, wherein the fabric section surrounds the base.

8. The method of claim 1, wherein the fabric section is made from a polyester material.

9. The method of claim 1, wherein the fabric section comprises polyethylene terephthalate.

10. The method of claim 1, wherein the stent further comprises an attachment mechanism configured for securing the valve within the annulus.

11. The method of claim 1, wherein minimally invasively advancing a delivery cannula into a patient comprises advancing the delivery cannula over a guidewire.

12. The method of claim 1, wherein minimally invasively advancing a delivery cannula into a patient comprises advancing the delivery cannula through an access port in a chest of the patient or advancing the delivery cannula percutaneously through a peripheral artery.

13. The method of claim 1, further comprising radially compressing the prosthetic heart valve;

and loading the radially compressed prosthetic heart valve into the delivery cannula.

14. The method of claim 1, wherein positioning the delivery cannula with the prosthetic heart valve within the annulus of the native aortic valve comprises at least one of fluoroscopy or ultrasonic imaging.

15. A method for replacing a damaged or diseased aortic valve, the method comprising:

advancing a delivery cannula over a guidewire into a patient through an access port in a chest of the patient, a self-expanding prosthetic heart valve in a radially compressed state loaded within the delivery cannula, the prosthetic valve comprising;

a collapsible, self-expanding support stent comprising nitinol, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the commissure posts being spaced in 120 degree intervals with gaps therebetween, the tubular base comprising a mesh or web;

a fabric section connected to the base along the inflow end of the support stent, the fabric section made from a polyester material; and

a leaflet section directly attached to the fabric section at a seam, the leaflet section defining three leaflets formed of bovine pericardium, the three leaflets attached to the commissure posts for opening and closing;

wherein each commissure post has a slot formed therein and wherein portions of the leaflet section pass through the slot in each of the commissure posts for securement to an outside thereof, and

wherein the portions of the leaflet section form loops and wherein inserts are disposed within the loops on the outside of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots;

positioning the delivery cannula with the prosthetic heart valve within an annulus of a native aortic valve;

releasing the prosthetic heart valve from the delivery cannula within the annulus of the native aortic valve;

allowing the prosthetic heart valve to self-expand within the annulus of the native aortic valve such that the tubular base of the support stent of the prosthetic heart valve expands to engage the annulus and the three leaflets of the prosthetic heart valve are disposed downstream of the annulus; and

removing the delivery cannula and guidewire from the patient.

16. The method of claim 15, wherein the base of the prosthetic heart valve expanding to engage the annulus comprises at least one attachment member on the base securing the base to host tissue.

17. The method of claim 16, wherein the at least one attachment member comprises at least one of staples or barbs.

18. The method of claim 15, further comprising radially compressing the prosthetic heart valve;

and loading the radially compressed prosthetic heart valve into the delivery cannula.

19. The method of claim 15, wherein positioning the delivery cannula with the prosthetic heart valve within an annulus of a native aortic valve comprises at least one of fluoroscopy or ultrasonic imaging.

20. The method of claim 15, wherein the polyester material of the fabric section is a woven polyester fabric.