Prosthetic valve and upstream support therefor

• US 10,631,982 B2
• Filed: 01/16/2018
• Issued: 04/28/2020
• Est. Priority Date: 01/24/2013
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovale Limited
• Inventors: Hammer, Tal, Zipory, Yuval, Reich, Tal, Herman, Yaron, Hacohen, Gil, Miller, Eran, Neeman, Rotem, Kruglova, Natalia
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US15/872,501
• Publication Number:
  US 20180147059A1
• Time in Patent Office: 833 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 2/2418 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A prosthetic valve comprises a valve body, comprising a tubular frame and a plurality of leaflets; an upstream support, comprising a second frame; and a flexible sheet that couples the upstream support to the valve body. The prosthetic valve is compressible into a delivery tool such that the prosthetic valve is in a compressed state in which the second frame and the tubular frame are arranged in series within the tool, and the valve body has a compressed body-diameter. The prosthetic valve is deployable from the tool such that the prosthetic valve automatically expands into an expanded state. In the expanded state, the second frame defines an inner perimeter, the sheet extends inwardly from the inner perimeter to the valve body, and the prosthetic valve defines a conduit through the upstream support and the valve body. Other embodiments are also described.

Claims

1. Apparatus for use at a native valve of a heart of a subject, the apparatus comprising:

a prosthetic valve, comprising;

a valve body, comprising a tubular frame and a plurality of prosthetic leaflets arranged to facilitate upstream-to-downstream fluid flow through the prosthetic valve;

an upstream support, comprising a second frame that is distinct from the tubular frame; and

a flexible sheet that flexibly couples the upstream support to the valve body; and

a delivery tool comprising, at a distal portion of the delivery tool, a first housing and a second housing,

wherein;

in a delivery configuration of the apparatus, the distal portion of the delivery tool is configured for transluminal advancement to the heart, and the prosthetic valve is in a compressed state in which;

the second frame and the tubular frame are arranged in series within the delivery tool,

at least part of the tubular frame is compressed within the first housing, such that the valve body has a compressed body-diameter,

at least part of the second frame is compressed within the second housing,

at least part of the sheet extends between the tubular frame and the second frame and is exposed between the first housing and the second housing, thereby articulatably coupling the tubular frame to the second frame; and

the prosthetic valve is deployable from the delivery tool by moving the first housing and the second housing axially away from each other, such that the prosthetic valve automatically expands into an expanded state in which;

(1) the valve body;

has an expanded body-diameter that is greater than the compressed body-diameter, and

is shaped to fit within the native valve,

(2) the second frame;

is annular,

is shaped to be placed against an upstream surface of the native valve, and

defines an inner perimeter that is wider than the expanded body-diameter,

(3) the sheet extends inwardly from the inner perimeter to the valve body,

(4) the prosthetic valve defines a conduit through the upstream support and the valve body.

2. The apparatus according to claim 1, wherein:

the delivery tool has a proximal end and a distal end, and

in a delivery configuration of the apparatus, the prosthetic valve is in the compressed state within the delivery tool, and is oriented with the tubular frame closer than the second frame to the distal end.

3. The apparatus according to claim 1, wherein:

the delivery tool has a proximal end and a distal end, and

in a delivery configuration of the apparatus, the prosthetic valve is in the compressed state within the delivery tool, and is oriented with the second frame closer than the tubular frame to the distal end.

4. The apparatus according to claim 1, wherein, in the expanded state, the sheet is frustoconical.

5. The apparatus according to claim 1, wherein, in the compressed state of the prosthetic valve, the second frame is tubular.

6. The apparatus according to claim 1, wherein:

in the compressed state of the prosthetic valve, the second frame has a first end, and a second end that is closer to the tubular frame than is the first end, and

when the prosthetic valve automatically expands into the expanded state, the first end expands more than the second end.

7. The apparatus according to claim 1, wherein at least one side of the tubular frame and at least one side of the second frame are covered with a covering, and the sheet is defined by a portion of the covering that is disposed between the tubular frame and the second frame.

8. The apparatus according to claim 7, wherein the covering is disposed on a tissue-facing side of the second frame, the tissue-facing side being oriented to be placed against the upstream surface of the native valve.

9. The apparatus according to claim 8, wherein the covering lines an inner surface of the tubular frame.

10. The apparatus according to claim 1, wherein, in the compressed state, the valve body and the upstream support are longitudinally separated by a zone in which the sheet is disposed, but in which neither the tubular frame nor the second frame is disposed.

11. The apparatus according to claim 1, wherein the prosthetic valve is configured such that, upon deployment from the delivery tool, the second frame becomes annular by deflecting with respect to the valve body.