Method of positioning a minimally-invasive heart valve with cusp positioners

• US 9,675,455 B2
• Filed: 03/04/2016
• Issued: 06/13/2017
• 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:
  US15/061,895
• Publication Number:
  US 20160184094A1
• Time in Patent Office: 466 Days
• 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 prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures.

Claims

1. A method of positioning a prosthetic heart valve, comprising:

coupling a proximal end portion of a prosthetic heart valve to a distal end portion of an attachment mechanism of a delivery apparatus, wherein a distal end portion of the prosthetic heart valve extends distally beyond the attachment mechanism, the delivery apparatus includes a plurality of deflectable arms, and a plurality of releasable attachment structures extending through the deflectable arms and the prosthetic heart valve;

delivering the prosthetic heart valve through a patient'"'"'s vasculature to or adjacent the patient'"'"'s native aortic valve with the prosthetic heart valve retained in a first compressed configuration within a delivery tube of the delivery apparatus;

deploying the prosthetic heart valve from the delivery tube of the delivery apparatus;

allowing radial expansion of the prosthetic heart valve from the first compressed configuration to an expanded configuration at a first position in the patient'"'"'s body such that the prosthetic heart valve contacts the patient'"'"'s aortic valve; and

radially constricting the prosthetic heart valve from the expanded configuration to a second compressed configuration greater than the first compressed configuration to disengage the prosthetic heart valve from the patient'"'"'s aortic valve.

2. The method of claim 1, further comprising repositioning the prosthetic heart valve while in the second compressed configuration from the first position in the patient'"'"'s body to a second position in the patient'"'"'s body by axially moving the delivery apparatus relative to the patient'"'"'s body.

3. The method of claim 2, wherein the first position is inferior to the second position, and repositioning the prosthetic heart valve includes axially moving the delivery apparatus in a superior direction.

4. The method of claim 2, further comprising radially re-expanding the prosthetic heart valve to the expanded configuration after repositioning the prosthetic heart valve to the second position.

5. The method of claim 4, further comprising releasing the prosthetic heart valve from the delivery apparatus after re-expanding the prosthetic heart valve to the expanded configuration.

6. The method of claim 1, further comprising moving the delivery tube back over the prosthetic heart valve to cause the prosthetic heart valve to radially constrict from the second compressed configuration to the first compressed configuration.

7. The method of claim 1, further comprising positioning a plurality of cusp positioners of the prosthetic heart valve in the sinus cavities of the aortic valve.

8. The method of claim 7, wherein the act of positioning the cusp positioners results in the cusp positioners being located below the coronary artery in the sinus cavities.

9. The method of claim 1, at least some of the deflectable arms have distal ends positioned inside of a support frame of the prosthetic heart valve.

10. The method of claim 1, wherein the deflectable arms comprise nitinol.

11. The method of claim 1, wherein a support frame of the prosthetic heart valve comprises three commissures, the delivery apparatus comprises three deflectable arms, and the deflectable arms are circumferentially aligned with and releasably coupled to respective ones of the commissures.

12. The method of claim 11, wherein the delivery apparatus comprises more than three deflectable arms, with some of the deflectable arms releasably coupled to the proximal end portion of the prosthetic heart valve at locations between the commissures.

13. The method of claim 1, wherein a support frame of the prosthetic heart valve comprises three commissures, and wherein each deflectable arm of the delivery apparatus comprises an attachment aperture, and each attachment structure extends through a respective attachment aperture and commissure.

14. The method of claim 13, wherein the attachment structures comprise sutures.

23. The method of claim 1, wherein the deflectable arms comprise a sufficient degree of torsional strength to permit an operator to rotate the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

24. The method of claim 1, wherein the delivery apparatus comprises a shaft, and the deflectable arms extend from a distal end of the shaft and retain a proximal end portion of the prosthetic heart valve axially-spaced from the distal end of the shaft during the acts of delivering and deploying the prosthetic heart valve.

15. A method of positioning a prosthetic heart valve, comprising:

coupling a proximal end portion of a prosthetic heart valve to a distal end portion of a holder of a delivery apparatus, wherein the holder comprises a plurality of radially deflectable arms with apertures formed therein and that are circumferentially aligned with and coupled to respective commissures of a support frame of the prosthetic heart valve, and wherein releasable attachment structures extend through the commissures of the support frame and apertures in the deflectable arms;

delivering the prosthetic heart valve through a patient'"'"'s vasculature to or adjacent the patient'"'"'s native aortic valve with the prosthetic heart valve retained in a fully radially compressed configuration within a delivery tube of the delivery apparatus;

deploying the prosthetic heart valve from the delivery tube of the delivery apparatus;

allowing radial expansion of the prosthetic heart valve from the fully compressed configuration to an expanded configuration such that the prosthetic heart valve contacts the patient'"'"'s aortic valve; and

radially constricting the prosthetic heart valve from the expanded configuration to a partially compressed configuration greater than the fully compressed configuration.

16. The method of claim 15, further comprising:

retrieving the deployed prosthetic heart valve back into the delivery tube of the delivery apparatus; and

removing the prosthetic heart valve from the patient'"'"'s vasculature.

17. The method of claim 15, further comprising repositioning the prosthetic heart valve relative to the patient'"'"'s native aortic valve while the prosthetic heart is in the partially compressed configuration.

18. The method of claim 15, wherein radially constricting the prosthetic heart valve to the partially compressed configuration disengages the prosthetic heart valve from the patient'"'"'s aortic valve.

19. The method of claim 15, further comprising radially re-expanding the prosthetic heart valve to the expanded configuration after repositioning the prosthetic heart valve, and then releasing the prosthetic heart valve from the deflectable arms.

20. The method of claim 19, wherein releasing the prosthetic heart valve from the deflectable arms comprises removing the releasable attachment structures from the commissures and the deflectable arms, which allows the deflectable arms to be de-coupled from the support frame.

21. The method of claim 15, further comprising positioning a plurality of cusp positioners of the prosthetic heart valve in the sinus cavities of the aortic valve.

22. The method of claim 21, wherein the act of positioning the cusp positioners results in the cusp positioners being located below the coronary artery in the sinus cavities.

25. A method of positioning a prosthetic heart valve in a native aortic annulus, comprising:

coupling a proximal end portion of a prosthetic heart valve to a plurality of radially deflectable arms that are disposed at a distal end portion of a delivery apparatus;

delivering the prosthetic heart valve through a patient'"'"'s vasculature to or adjacent the patient'"'"'s native aortic valve with the prosthetic heart valve and the deflectable arms retained in a fully radially compressed configuration within a delivery tube of the delivery apparatus;

deploying the prosthetic heart valve and the deflectable arms from the delivery tube of the delivery apparatus; and

allowing radial expansion of the prosthetic heart valve and the deflectable arms from the fully compressed configuration to an expanded configuration, wherein the deflectable arms are configured to spring radially outwardly to facilitate the radial expansion of the prosthetic heart valve;

wherein the delivery apparatus comprises a shaft and a holder, and wherein the holder comprises the deflectable arms, extends from a distal end of the shaft, and retains a proximal end portion of the prosthetic heart valve axially-spaced from the distal end of the shaft during the acts of delivering and deploying the prosthetic heart valve.

26. A method of positioning a prosthetic heart valve in a native aortic annulus, comprising:

coupling a proximal end portion of a prosthetic heart valve to a distal end portion of a delivery apparatus, wherein the prosthetic heart valve includes a frame comprising nitinol, wherein the distal end portion of the delivery apparatus includes a plurality of radially deflectable arms comprising nitinol, and wherein the prosthetic heart valve and the deflectable arms are biased to an expanded configuration and are compressible to one or more compressed configurations;

radially compressing the prosthetic heart valve and the deflectable arms from the expanded configuration to a fully radially compressed configuration;

delivering the prosthetic heart valve through a patient'"'"'s vasculature to or adjacent the patient'"'"'s native aortic valve with the prosthetic heart valve and the deflectable arms retained in the fully radially compressed configuration within a delivery tube of the delivery apparatus;

deploying the prosthetic heart valve from the delivery tube of the delivery apparatus; and

allowing radial expansion of the prosthetic heart valve and the deflectable arms from the fully compressed configuration to an expanded configuration.

27. The method of claim 26, wherein the prosthetic heart valve comprises a plurality of leaflets, a support frame having a plurality of commissures, and a plurality of attachment flanges, and wherein pairs of the attachment flanges are coupled to the support frame adjacent the commissures, and each of the leaflets wraps around and is coupled to a respective attachment flange.

28. The method of claim 27, wherein the act of delivering the prosthetic heart valve comprises advancing the distal end portion of the delivery apparatus through an introducer that is inserted into the patient'"'"'s femoral artery.