Prosthetic heart valve and method

• US 9,339,383 B2
• Filed: 10/09/2015
• Issued: 05/17/2016
• Est. Priority Date: 10/11/2001
• Status: Expired due to Term

• 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:
  US14/879,815
• Publication Number:
  US 20160030168A1
• Time in Patent Office: 221 Days
• 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 heart valve, comprising:

a radially collapsible and expandable annular support frame;

three pairs of parallel support bars, each pair of parallel support bars mounted radially inwardly of the support frame, each support bar provided with a plurality of preformed bores; and

a valve assembly comprising three pericardial leaflets, the valve assembly anchored within the support frame at least in part by stitching that extends through the pericardial leaflets and through the bores of the support bars;

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.

2. The prosthetic heart valve of claim 1, wherein each end portion of each pericardial leaflet wraps at least partially around one of the support bars.

3. The prosthetic heart valve of claim 2, wherein each pair of end portions of the pericardial leaflets is compressed between the support bars of a respective pair of support bars.

4. The prosthetic heart valve of claim 3, wherein each end portion of each pericardial leaflet extends circumferentially between an inner surface of the support frame and a respective support bar.

5. The prosthetic heart valve of claim 1, wherein each pair of support bars is connected to the support frame by a connecting member.

6. The prosthetic heart valve of claim 1, wherein each connecting member is located adjacent an outlet end of the support frame.

7. The prosthetic heart valve of claim 1, wherein the preformed bores extend through the support bars in a circumferential direction.

8. The prosthetic heart valve of claim 7, wherein the circumferentially extending bores in each pair of support bars are aligned.

9. The prosthetic heart valve of claim 1, wherein a clearance distance is provided between each pericardial leaflet and an outlet portion of the support frame for protecting the pericardial leaflets from abrasion against the support frame.

10. The prosthetic heart valve of claim 9, wherein an outlet of the valve assembly is tapered with respect to an inlet of the valve assembly.

11. The prosthetic heart valve of claim 1, wherein an inlet of the valve assembly is sutured to an inlet end of support frame.

12. The prosthetic heart valve of claim 1, wherein the support bars are not co-extensive with a height of the support frame.

13. The prosthetic heart valve of claim 12, wherein the support bars extend only along an outlet end portion of the support frame.

14. A prosthetic heart valve, comprising:

an annular support frame that is radially collapsible and radially expandable;

a plurality of longitudinal support bars of fixed length, each support bar mounted radially inwardly of the support frame, each support bar provided with a plurality of preformed bores along the length thereof, each of the preformed bores extending in a circumferential direction; and

a valve assembly comprising a tubular conduit having an inlet and an outlet, the conduit anchored within the annular support frame at least in part by stitching extending through the valve assembly and the bores of the support bars;

whereby, when flow is allowed to pass through the conduit from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as collapsible slack portions of the valve assembly between the support bars collapse inwardly providing blockage to the reverse flow.

15. The prosthetic heart valve of claim 14, wherein the conduit comprises a plurality of leaflets each comprising opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures that are secured to the support bars by the stitching.

16. The prosthetic heart valve of claim 15, wherein the support bars comprise three pairs of support bars located at the commissures, each pair of adjacent end portions of the leaflets extending between the support bars of a respective pair of support bars.

17. The prosthetic heart valve of claim 16, wherein for each pair of adjacent end portions of the leaflets, one end portion is folded at least partially around and stitched to one of the support bars of the respective pair of support bars and the other end portion is folded at least partially around and stitched to the other support bar of the respective pair of support bars.

18. The prosthetic heart valve of claim 17, wherein each commissure is secured to a respective pair of support bars by stitching that extends through a first layer of one end portion of a leaflet, through the openings of one of the support bars, through a second layer of the one end portion of the leaflet, through a first layer of the end portion of the other leaflet, through the openings of the other support bar, and through a second layer of the end portion of the other leaflet, in that order.

19. A prosthetic heart valve, comprising:

a collapsible and expandable annular support frame;

a plurality of circumferentially spaced, commissure connecting members coupled to the support frame, each commissure connecting member comprising a pair of longitudinal support bars, each support bar provided with a plurality of preformed bores along a length thereof, and each support bar positioned radially inwardly of the support frame; and

a valve assembly comprising pericardial tissue and forming three leaflets, each leaflet comprising opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures, each commissure extending radially between the support bars of a respective pair of support bars, each commissure secured to a respective pair of support bars by stitching that extends through the bores of the support bars and the end portions of the leaflets.

20. The prosthetic heart valve of claim 19, further comprising stitching securing each connecting member to the support frame.