Minimally-invasive prosthetic heart valve method

• US 9,504,567 B2
• Filed: 10/16/2012
• Issued: 11/29/2016
• Est. Priority Date: 03/18/2003
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Iobbi, Mario
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US13/653,201
• Publication Number:
  US 20130096674A1
• Time in Patent Office: 1,505 Days
• Field of Search: 623/2.11, 623/2.14, 623 217- 219, 623 124- 126
• US Class Current: 1/1
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and expanded. The prosthetic heart valve includes cusp positioners that engage sinus cavities above the valve annulus and rotationally orient the prosthetic valve. Preferred embodiments of the cusp positioners do not occlude the coronary arteries.

Claims

1. A method for implanting a collapsible prosthetic heart valve, the method comprising:

disposing a collapsed prosthetic heart valve into a distal end of a delivery tube, the prosthetic heart valve comprising a self-expanding tubular leaflet frame, three flexible leaflets, and three U-shaped cusp positioners, the leaflet frame and the cusp positioners being formed integrally as a single piece;

the leaflet frame comprising three cusp regions and three commissure regions at an outflow end thereof, the three cusp regions alternating with the three commissure regions, and the commissure regions are taller than the cusp positioners;

an outer edge of each leaflet attaches to the leaflet frame and when the heart valve expands the leaflets are arranged to coapt within the prosthetic heart valve to provide a one-way occlusion;

each cusp positioner rigidly fixed with respect to the leaflet frame, disposed intermediate two commissure regions, and extending radially farther outward than the commissure regions;

minimally invasively inserting the distal end of the delivery tube into a vasculature of a patient;

positioning the distal end of the delivery tube proximal of an aortic valve;

expelling the prosthetic heart valve from the delivery tube into an annulus of the aortic valve;

allowing the prosthetic heart valve to self-expand such that the cusp positioners come into contact with the sinus cavities of the aortic valve, rotationally orienting the prosthetic heart valve, the flexible leaflets expanding with the leaflet frame into a functional configuration; and

positioning the prosthetic valve with the cusp positioners located below the coronary artery ostia in the sinus cavities so as to stabilize and anchor the prosthetic valve in its implant position without occluding blood flow into coronary artery ostia.

2. The method of claim 1, wherein disposing the prosthetic heart valve comprising three flexible leaflets comprises disposing a prosthetic heart valve comprising three bovine pericardium leaflets.

3. The method of claim 1, wherein disposing the prosthetic heart valve comprising three flexible leaflets comprises disposing a prosthetic heart valve comprising a porcine valve.

4. The method of claim 1, wherein disposing the prosthetic heart valve comprising three flexible leaflets comprises disposing the prosthetic heart valve comprising three flexible leaflets, wherein each leaflet comprises a free edge and an outer edge, the free edges arranged to coapt within the prosthetic heart valve to provide the one-way occlusion and each outer edge is attached to the leaflet frame between two of the commissure regions and around one of the cusp regions.

5. The method of claim 1, wherein disposing the prosthetic heart valve comprising three cusp regions includes disposing the prosthetic heart comprising three U-shaped cusp regions.

6. The method of claim 1, wherein disposing the prosthetic heart valve comprising the self-expanding tubular leaflet frame comprises disposing the prosthetic heart valve comprising a self-expanding tubular leaflet frame formed from nitinol.

7. The method of claim 6, wherein disposing the prosthetic heart valve comprising the self-expanding tubular leaflet frame formed from nitinol comprises disposing a prosthetic heart valve comprising the self-expanding tubular leaflet frame formed from nitinol with a martensitic transition temperature of the leaflet frame less than room temperature and an austenitic transition temperature of the leaflet frame less than body temperature.

8. The method of claim 7, further comprising collapsing the leaflet frame at or below the martensitic transition temperature thereof.

9. The method of claim 7, further comprising balloon expanding the prosthetic heart valve.

10. The method of claim 9, further comprising loading the collapsed prosthetic heart valve on an expansion balloon.

11. The method of claim 1, wherein disposing the prosthetic heart valve comprising three U-shaped cusp positioners comprises disposing a prosthetic heart valve comprising three U-shaped cusp positioners, an apex of each cusp positioner pointed towards the outflow end of the prosthetic heart valve.

12. The method of claim 1, wherein disposing the prosthetic heart valve comprising three U-shaped cusp positioners comprises disposing a prosthetic heart valve comprising three U-shaped cusp positioners disposed at the outflow end of the prosthetic heart valve.

13. The method of claim 1, wherein minimally invasively inserting the distal end of the delivery tube comprises percutaneously inserting the distal end of the delivery tube.

14. The method of claim 1, wherein expelling the prosthetic heart valve into an annulus of the aortic valve comprises expelling the prosthetic heart valve into an annulus of the aortic valve in a position inferior of a final implant position;

and further comprising displacing the prosthetic heart valve in a superior direction, to the final implant position.

15. The method of claim 1, further comprising re-collapsing the prosthetic heart valve after allowing the prosthetic heart valve to self-expand.

16. The method of claim 1, further comprising compressing native aortic valve leaflets outwards against the sinus cavities of the aortic valve with the cusp positioners.

17. A method for implanting a collapsible prosthetic heart valve, the method comprising:

expanding a collapsed prosthetic heart valve in an annulus of a native aortic valve, the prosthetic heart valve having three outwardly flaring cusp positioners;

seating the prosthetic heart valve at the annulus including permitting the outwardly flaring cusp positioners to engage surrounding tissue, and wherein in the case of any rotational misalignment with the three aortic valve sinus cavities above the aortic valve annulus the cusp positioners rotationally orient the prosthetic heart valve so that the cusp positioners are channeled by and aligned with the sinus cavities; and

positioning the prosthetic valve with the cusp positioners in the sinus cavities of the aortic valve so as to stabilize and anchor the prosthetic valve in its implant position while permitting blood flow into coronary ostia.

18. The method of claim 17, wherein expanding the collapsed prosthetic heart valve comprises expanding a prosthetic heart valve further comprising a collapsible and expandable tubular leaflet frame and three flexible, biological leaflets;

the leaflet frame comprising three U-shaped cusp regions and three commissure regions at an outflow end thereof, the three U-shaped cusp regions alternating with the three commissure regions;

each leaflet comprising a free edge and an outer edge, the free edges arranged to coapt within the prosthetic heart valve to provide a one-way occlusion and each outer edge attached to the leaflet frame between two of the commissure regions and around one of the cusp regions.

19. The method of claim 18, wherein the flexible, biological leaflets are bovine pericardium or a porcine valve.

20. The method of claim 17, wherein the prosthetic heart valve comprises a self-expanding tubular leaflet frame, three flexible leaflets, and three cusp positioners, the leaflet frame and the cusp positioners being formed integrally as a single piece;

the leaflet frame comprising three cusp regions and three commissure regions at an outflow end thereof, the three cusp regions alternating with the three commissure regions, wherein the commissure regions are taller than the cusp positioners and the step of positioning results in the cusp positioners being located below the coronary artery ostia in the sinus cavities.