Replacement prosthetic heart valves

• US 10,226,338 B1
• Filed: 11/20/2018
• Issued: 03/12/2019
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Wood, Larry L., Bourang, Henry, Bakis, George, Spenser, Benjamin, Benichou, Netanel, Bash, Assaf, Keidar, Yaron
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/197,280
• Publication Number:
  US 20190091017A1
• Time in Patent Office: 112 Days
• 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 2/2418 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

Claims

1. A prosthetic heart valve system comprising:

a prosthetic heart valve comprising;

an inflow end, an outflow end, and an axial axis;

an expandable valve member having three flexible, bioprosthetic leaflets arranged to permit blood flow from the inflow end to the outflow end of the prosthetic heart valve and to prevent blood flow from the outflow end to the inflow end thereof;

an expandable anchoring member including a nitinol stent having an inflow portion, an outflow portion, and, a tubular structure, the nitinol stent expandable from a delivery diameter to an implantation diameter;

a cover disposed on the stent; and

three latch assemblies, each latch assembly including a first member and a second member,

the first member having a first end and a second end, the first end coupled to the inflow portion of the stent and the second end extending towards the outflow end of the heart valve, the first member including a pair of parallel, spaced apart upstanding members, the second end of the first member including a pair of upstanding teeth, and

the second member disposed toward the outflow end of the heart valve and having an aperture through which the second end of the first member is extendable,

wherein each latch assembly has a locked configuration in which the first member and second member engage when the pair of upstanding teeth extends through the aperture; and

a plurality of guide filaments, each guide filament releasably coupled to the second end of the first member of each latch assembly and extending through a respective aperture of the second member, the plurality of guide filaments operable to axially guide the second end of each first member through the respective aperture,

wherein the heart valve has;

a delivery configuration with the nitinol stent in the delivery diameter and the latch assemblies are not in their locked configurations, and

an implanted configuration with the nitinol stent in the implantation diameter and each latch assembly in the locked configuration, thereby locking relative axial positions of the first end of the heart valve and the second end of the heart valve.

2. The prosthetic heart valve system of claim 1, wherein the nitinol stent is self-expanding.

3. The prosthetic heart valve system of claim 1, wherein an end of the nitinol stent is flared and the cover is disposed over the flared end.

4. A prosthetic heart valve system comprising:

a prosthetic heart valve comprising;

an inflow end, an outflow end, and an axial axis;

a valve member having three flexible, bioprosthetic leaflets arranged to permit blood flow from the inflow end to the outflow end of the prosthetic heart valve and to prevent blood flow from the outflow end to the inflow end thereof;

an expandable anchoring member including a nitinol stent having an inflow portion, an outflow portion, and, a tubular structure, the nitinol stent expandable from a delivery diameter to an implantation diameter; and

three locking assemblies, each locking assembly including a first member and a second member,

the first member having a first end and a second end, the first end coupled to the inflow portion of the stent and the second end extending towards the outflow end of the heart valve, the first member including a pair of parallel, spaced apart upstanding members, and

the second member disposed toward the outflow end of the heart valve and having an aperture through which the second end of the first member is extendable,

wherein each locking assembly has a locked configuration in which the first member and second member engage when the second end of the first member extends through the aperture; and

a plurality of guide filaments, each guide filament releasably coupled to the second end of the first member of the locking assembly and extending through a respective aperture of the second member, the plurality of guide filaments operable to axially guide the second end of each first member through the respective aperture,

wherein the heart valve has;

a delivery configuration with the nitinol stent in the delivery diameter and the latch assemblies are not in their locked configurations, and

an implanted configuration with the nitinol stent in the implantation diameter and each locking assembly in the locked configuration, thereby locking relative axial positions of the first end of the heart valve and the second end of the heart valve.

5. The prosthetic heart valve system of claim 4, wherein the valve member is expandable.

6. The prosthetic heart valve system of claim 4, wherein the nitinol stent is expandable.

7. The prosthetic heart valve system of claim 4, wherein an end of the nitinol stent is flared.

8. The prosthetic heart valve system of claim 4, further comprising a cover disposed over the nitinol stent.

9. The prosthetic heart valve system of claim 4, wherein each locking assembly comprises a latch.

10. The prosthetic heart valve system of claim 9, wherein each of the pair of parallel, spaced apart upstanding members further comprises an outwardly directed tooth.

11. The prosthetic heart valve system of claim 4, wherein the second members of the locking assemblies are circumferentially disposed on a coupling ring.