Prosthetic heart valve and method

• US 9,132,006 B2
• Filed: 01/20/2014
• Issued: 09/15/2015
• Est. Priority Date: 10/11/2001
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Spenser, Benjamin, Benichou, Netanel, Bash, Assaf, Zakai, Avraham
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US14/159,327
• Publication Number:
  US 20140135911A1
• Time in Patent Office: 603 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A prosthetic heart valve comprises a radially crimpable and radially expandable, net-like, annular support frame and a valve assembly disposed therein, the valve assembly comprising a conduit tapering from an inlet towards an outlet thereof. Some embodiments or the support frame comprise a proximal portion and a distal portion, a diameter of the proximal portion smaller than a diameter of the distal portion. The proximal portion is dimensioned for deployment in an annulus of a native aortic valve and a distal portion for deployment in an ascending aorta. Some embodiments of the conduit comprise a support construction with a three-cusp, crown-shaped cut line, the support construction sutured to the support frame around a bottom portion thereof and around the cut line. A method for using the prosthetic heart valve to replace a defective native aortic valve uses a minimally invasive procedure.

Claims

1. A prosthetic aortic heart valve, comprising:

an annular support frame, the support frame comprising a nickel-titanium, shape memory alloy, the support frame radially crimpable to a narrow configuration and radially expandable, the support frame having an inlet end and an outlet end; and

a valve assembly comprising three pericardium leaflets defining three commissures and forming a tubular conduit having an inlet and an outlet, the conduit disposed within the annular support frame, the conduit tapering radially inward away from the support frame from the inlet towards the outlet such that there is a radial clearance distance between each leaflet and the outlet end of the support frame when the leaflets are in an open state and when the leaflets are in a closed state,

wherein the commissures are sutured to the support frame, and each leaflet comprises a curved inlet edge and a straight outlet edge.

2. The prosthetic aortic heart valve of claim 1, wherein the support frame is self-expanding.

3. A method for implanting the prosthetic aortic heart valve of claim 1 in a patient in need thereof, the method comprising:

radially crimping the prosthetic aortic heart valve;

mounting the crimped prosthetic aortic heart valve on a distal end portion of an elongate catheter;

advancing a guiding tool through a vasculature of a patient to a native aortic valve;

guiding the elongate catheter using the guiding tool to the native aortic valve;

positioning at least a portion of the support frame of the prosthetic aortic heart valve in an annulus of the native aortic valve; and

radially expanding the support frame of the prosthetic aortic heart valve, thereby implanting the prosthetic aortic heart valve.

4. The method of claim 3, further comprising removing the elongate catheter from the patient.

5. The method of claim 3, wherein advancing a guiding tool comprises advancing a guide wire.

6. The method of claim 3, wherein guiding the elongate catheter comprises guiding the elongate catheter in a retrograde approach.

7. The method of claim 3, wherein guiding the elongate catheter comprises guiding the elongate catheter in an antegrade approach.

8. The method of claim 3, wherein radially expanding the support frame of the prosthetic aortic heart valve comprises allowing the support frame to radially self-expand.

9. The method of claim 3, wherein radially expanding the support frame of the prosthetic aortic heart valve comprises radially expanding a balloon in the support frame.

10. A prosthetic heart valve, comprising:

an annular support frame, the support frame comprising a nickel-titanium, shape memory alloy, the support frame radially crimpable to a narrow configuration and radially expandable, the support frame having an inlet end and an outlet end; and

a valve assembly comprising three pericardium leaflets supported in the support frame in the form of a tubular conduit having an inlet and an outlet, the conduit tapering from the inlet towards the outlet such that the conduit comprises a radial clearance distance between three pericardium leaflets and the support frame at the outlet end when the leaflets are in an open state and when the leaflets are in a closed state.

11. The prosthetic heart valve of claim 10, wherein the prosthetic heart valve is a prosthetic aortic heart valve.

12. The prosthetic heart valve of claim 10, wherein the support frame comprises three longitudinally rigid support beams of fixed length, the valve assembly attached to the support beams.

13. The prosthetic heart valve of claim 12, wherein each support beam comprises a plurality of bores, the valve assembly sutured to the support beams through the bores.

14. The prosthetic heart valve of claim 10, wherein the three pericardium leaflets define three commissures, at least outlet ends of the commissures sutured to support beams of the support frame.

15. The prosthetic heart valve of claim 10, wherein the three pericardium leaflets each comprises opposing ends, each end being paired with an adjacent end of an adjacent leaflet to form commissures that are sutured to pairs of support beams located at the commissures, and each pair of adjacent ends of the leaflets extends radially between the support beams of a respective pair of support beams.

16. The prosthetic heart valve of claim 10, wherein each leaflet comprises a curved inlet edge and a straight outlet edge.

17. The prosthetic heart valve of claim 15, wherein each beam has openings and each leaflet is sutured to a respective beam.

18. The prosthetic heart valve of claim 15, wherein each leaflet is partially folded around a respective beam.

19. The prosthetic heart valve of claim 15, wherein each leaflet is partially folded around a respective beam in a first direction and an adjacent leaflet is folded around a respective beam in a second, opposite direction.

20. A prosthetic heart valve, comprising:

an annular support frame, the support frame comprising a nickel-titanium, shape memory alloy, the support frame radially crimpable to a narrow configuration and radially expandable, the support frame having an inlet end and an outlet end; and

a valve assembly comprising three pericardium leaflets disposed within the annular support frame, the leaflets defining three commissures and forming a tubular conduit having an inlet and an outlet, the conduit tapering from the inlet towards the outlet such that there is a clearance distance between each leaflet and the outlet end of the support frame when the leaflets are in an open state and when the leaflets are in a sealed state.

21. The prosthetic heart valve of claim 20, wherein the three commissures are sutured to three rigid support beams.

22. The prosthetic heart valve of claim 20, wherein each leaflet comprises a curved inlet edge and a straight outlet edge.