Prosthetic heart valve and method

• US 10,052,203 B2
• Filed: 03/23/2017
• Issued: 08/21/2018
• 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:
  US15/467,622
• Publication Number:
  US 20170189183A1
• Time in Patent Office: 516 Days
• 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 method of deploying a prosthetic heart valve at the natural aortic valve position in a patient, comprising:

advancing a guide wire into a femoral artery;

advancing a catheter over the guide wire, the catheter having a prosthetic heart valve disposed along a distal end portion thereof, the prosthetic heart valve comprising a radially collapsible and expandable annular support frame and three pairs of parallel support bars mounted radially inwardly of the support frame, each support bar provided with a plurality of preformed bores, the prosthetic heart valve further comprising a valve assembly anchored within the support frame at least in part by stitching that extends through the bores of the support bars and portions of the valve assembly;

radially expanding the prosthetic heart valve at the natural aortic valve position; and

withdrawing the catheter over the guide wire and removing the catheter and guide wire from the patient.

2. The method of claim 1, wherein the valve assembly comprises three pericardial leaflets.

3. The method of claim 2, wherein a gap is provided between each pair of parallel support bars through which a respective pair of adjacent end portions of the pericardial leaflets extend.

4. The method of claim 1, wherein a balloon is inflated for radially expanding the prosthetic heart valve.

5. The method of claim 1, wherein the annular support frame is made from a shape memory alloy.

6. The method of claim 5, wherein the shape memory alloy is nickel titanium.

7. The method of claim 1, wherein an inlet of the valve assembly is sutured to an inlet end of support frame.

8. The method of claim 1, wherein the support bars are not co-extensive with a height of the support frame.

9. The method of claim 8, wherein the support bars extend only along an outlet end portion of the support frame.

10. The method of claim 2, wherein each end portion of each pericardial leaflet wraps at least partially around one of the support bars.

11. A method for deploying a prosthetic heart valve at the natural aortic valve position at the entrance to the left ventricle of a myocardium of a patient, comprising:

radially collapsing an implantable prosthetic heart valve having a collapsible and expandable support frame and a plurality of longitudinal support bars coupled to the support frame, the prosthetic heart valve also having a collapsible and expandable valve assembly, wherein each support bar includes a plurality of preformed bores formed therein for allowing the valve assembly to be sutured to the support bars, wherein the plurality of support bars are arranged in three pairs of parallel support bars, wherein the valve assembly comprises three valve leaflets, each leaflet having opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form a commissure of the leaflet assembly, each commissure extending through a respective pair of parallel support bars, wherein at each pair of parallel support bars, the end portion of one leaflet is folded partially around and stitched to one of the support bars of the respective pair of parallel support bars and the end portion of the adjacent leaflet is folded partially around and stitched to the other support bar of the respective pair of parallel support bars;

advancing the prosthetic heart valve through the patient'"'"'s vasculature towards the natural aortic valve position via a catheterization technique;

positioning the prosthetic heart valve such that the support frame is located substantially within an annulus of a natural aortic valve; and

radially expanding the prosthetic heart valve such that the support frame engages leaflets of the natural aortic valve;

wherein, after implantation, the valve assembly allows blood to flow in a first direction and prevents blood from flowing in a second direction.

12. The method of claim 11, wherein the support frame is made from a shape memory, nickel titanium alloy.

13. The method of claim 11, wherein the pairs of parallel support bars are positioned along a top portion of the valve assembly.

14. The prosthetic heart valve assembly of claim 13, wherein a bottom portion of the valve assembly is stitched to an inlet end portion of the support frame along a circumference of the support frame inlet end portion.

15. The prosthetic heart valve assembly of claim 14, wherein the valve assembly comprises a middle slack portion between the top portion and the bottom portion, wherein the middle slack portion can collapse away from the support frame toward a center of the prosthetic heart valve assembly.