# US 2014/0207231 A1 · Anchoring of prosthetic valve supports

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- Number: US 2014/0207231 A1
- Document ID: US20140207231A1
- Status: Published application
- Kind: A1
- Application number: 14/161,921
- Filed: 2014-01-23
- Published: 2014-07-24
- Earliest claimed: 2013-01-24
- Assignees: Mitraltech Ltd.
- Applicants: Mitraltech Ltd.
- Inventors: Gili HACOHEN; Eran MILLER; Tal REICH; Yuval ZIPORY; Rotem NEEMAN; Natalia KRUGLOVA
- Web page: https://patentgrep.com/patent/US20140207231A1

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Apparatus is provided, including: (1) a delivery tube, transluminally advanceable to the heart of the subject; (2) a prosthetic valve support, configured to support a prosthetic valve at a native valve of the heart, and including an upstream support portion, the upstream support portion: (A) having a working configuration in which it is generally annular and (B) having a delivery configuration in which it defines a channel, and is configured to be disposed within the delivery tube; (3) a tissue anchor, slidable through the channel; and (4) an anchor driver. The anchor driver is slidable within the delivery tube and the channel, and configured to anchor the upstream support portion to tissue of the heart by driving the tissue anchor through the upstream support portion and into the tissue, while at least part of the upstream support portion is disposed within the delivery tube.

## Claims

### Claim 1

Apparatus for use with a prosthetic valve at a native valve of a heart of a subject, the apparatus comprising:
a delivery tube, transluminally advanceable to the heart of the subject;
a prosthetic valve support, configured to support the prosthetic valve at the native valve, and comprising an upstream support portion, the upstream support portion:
having a working configuration in which the upstream support portion is generally annular and has (1) a tissue-contacting side configured to be placed against an atrial surface of the native valve, and (2) an opposing side, and defines an opening therebetween, and
having a delivery configuration in which the upstream support portion defines a channel having a central longitudinal axis, and is configured to be disposed within the delivery tube;
a tissue anchor, configured to be disposed within the channel, and slidable through at least part of the channel; and
an anchor driver, slit able within the delivery tube and the channel, and configured to anchor the upstream support portion to tissue of the heart by driving the tissue anchor from the opposing side through the upstream support portion and into the tissue, while at least part of the upstream support portion is disposed within the delivery tube.

### Claim 2 (depends on 1)

The apparatus according to claim 1, wherein the tissue anchor comprises a helical tissue anchor, and is configured to be driven into the tissue by being rotated.

### Claim 3 (depends on 1)

The apparatus according to claim 1, wherein the upstream support portion is configured to be transitioned from the delivery configuration to the working configuration by being unrolled.

### Claim 4 (depends on 1)

The apparatus according to claim 1, wherein:
in the delivery configuration, the upstream support portion has a distal portion and a proximal portion, and the channel is defined between the distal portion and the proximal portion,
the anchor comprises a first anchor, and the anchor driver is configured to anchor the distal portion of the upstream support portion to the tissue by driving the first anchor through the distal portion of the upstream support portion, and
the apparatus is configured such that:
the proximal portion of the upstream support portion is configured to be at least partly exposed from the delivery tube subsequently to the anchoring of the distal portion, and the apparatus further comprises a second anchor, configured to be driven through the proximal portion of the upstream support portion and into the tissue subsequently to the exposing.

### Claim 5 (depends on 1)

The apparatus according to claim 1, wherein, in the delivery configuration, the upstream support portion has a distal portion and a proximal portion, and shapes the channel to be an uninterrupted lumen between the distal portion and the proximal portion.

### Claim 6 (depends on 1)

The apparatus according to claim 1, wherein the anchor driver is configured to slide the tissue anchor through at least most of the channel before driving the anchor through the upstream support portion.

### Claim 7 (depends on 1)

The apparatus according to claim 1, wherein the delivery tube is configured to be transluminally advanced while the upstream support portion is disposed within a distal portion of the delivery tube, and while the tissue anchor and a distal portion of the anchor driver are disposed within the channel.

### Claim 8 (depends on 1)

The apparatus according to claim 1, wherein the delivery tube is configured to retain the upstream support portion in the delivery configuration, and the upstream support portion is configured to automatically transition toward the working configuration upon becoming exposed from the delivery tube.

### Claim 9

The apparatus according to claim wherein, in the delivery configuration, at any given part of the upstream support portion, the opposing side of the upstream support portion is disposed closer to the central longitudinal axis than is the tissue-contacting side.

### Claim 10 (depends on 1)

The apparatus according to claim 1, wherein, while the upstream support portion is in the delivery configuration and disposed within the delivery tube, the channel shares a common central longitudinal axis with the delivery tube, and the anchor driver is configured to drive the tissue anchor through the upstream support portion by moving the tissue anchor along the common central longitudinal axis.

### Claim 11 (depends on 10)

The apparatus according to claim 10, wherein the delivery rube is configured to facilitate the driving of the tissue anchor through the upstream support portion by deflecting a portion of the prosthetic valve support to intersect with the common central longitudinal axis by pressing the portion of the prosthetic valve support against the tissue.

### Claim 12

A method for anchoring a prosthetic valve support to a native valve of a heart of a subject, the native valve having an annulus and a plurality of leaflets, the prosthetic valve support comprising an upstream support portion that is configured to be placed against an atrial surface of the annulus, the method comprising:
transluminally advancing, to the heart of the subject, the upstream support portion, while the upstream support portion (1) is in a delivery configuration thereof in which the upstream support portion has a distal portion and a proximal portion, and defines a channel therebetween, and (2) is disposed within a delivery tube;
advancing, out of a distal end of the delivery tube, the distal portion of the upstream support portion;
using an anchor driver at least a distal end of which is disposed within the channel, anchoring the distal portion of the upstream support portion to a site of the annulus by driving an anchor through the distal portion of the upstream support portion and into the site; and
subsequently, facilitating transition of the upstream support portion into a working configuration in which the upstream support portion is generally annular, and is disposed against the annulus.

### Claim 13 (depends on 12)

The method according to claim 12, wherein transluminally advancing the upstream support portion comprises transluminally advancing the delivery tube while the upstream support portion is disposed within a distal portion of the delivery tube, and while the tissue anchor and a distal portion of the anchor driver are disposed within the channel.

### Claim 14 (depends on 12)

The method according to claim 12, wherein facilitating transition of the upstream support portion into the working configuration comprises facilitating unrolling of the upstream support portion into the working configuration.

### Claim 15 (depends on 12)

The method according to claim 12, wherein facilitating transition of the upstream support portion into the working configuration comprises exposing the upstream support portion from the delivery tube such that the upstream support portion transitions automatically into the working configuration.

### Claim 16 (depends on 12)

The method according to claim 12, further comprising advancing the tissue anchor through at least most of the channel prior to anchoring the distal portion.

### Claim 17 (depends on 12)

The method according to claim 12, wherein:
the anchor includes a first anchor, and the site includes a first site, and
the method further comprises, subsequently to anchoring the distal portion, sliding the anchor driver proximally within the channel and subsequently anchoring, using a second anchor, a proximal portion of the upstream support portion to a second site of the annulus.

### Claim 18 (depends on 12)

The method according to claim 12, further comprising pressing the distal portion against the site such that a plane of the distal portion is disposed at greater than 45 degrees with respect to a longitudinal axis of the delivery tube.

### Claim 19 (depends on 12)

The method according to claim 12, wherein:
while the upstream support portion is in the delivery configuration and disposed within the delivery tube, the channel shares a common central longitudinal axis with the delivery tube, and
driving the anchor through the distal portion comprises driving the anchor through the distal wall by moving the tissue anchor along the common central longitudinal axis.

### Claim 20 (depends on 19)

The method according to claim 19, wherein:
the method further comprises pressing the distal portion against the site such that the distal portion deflects with respect to a central longitudinal axis of the channel, and
driving the tissue anchor through the distal portion comprises moving the anchor driver distally within the channel while the distal portion is pressed against the site.

### Claim 21

A method for anchoring a prosthetic valve support to a native valve of a heart of a subject, the native valve having an annulus and a plurality of leaflets, the prosthetic valve support comprising an upstream support portion that is configured to be placed against an atrial surface of the annulus, the method comprising:
transluminally advancing, to the heart of the subject, the upstream support portion, while the upstream support portion (1) is in a delivery configuration thereof in which the upstream support portion generally defines a tube that defines a channel, and
(2) is disposed within a delivery tube;
advancing, out of a distal end of the delivery tube, a distal portion of the upstream support portion in the delivery configuration thereof;
anchoring the distal portion to a first site of the annulus using an anchor that is reversibly coupled to an anchor driver, by moving the anchor driver distally within the channel of the tube defined by the upstream support portion; and
facilitating unrolling of the upstream support portion into a deployed configuration in which the upstream support portion is generally annular, and is disposed against the annulus.

### Claim 22 (depends on 21)

The method according to claim 21, wherein the anchor includes a first anchor, and wherein the method further comprises anchoring, using a second anchor, a proximal portion of the upstream support portion to a second site of the annulus.

### Claim 23 (depends on 21)

The method according to claim 21, wherein anchoring the distal portion of the upstream support portion to the first site comprises bending the distal portion by pressing the distal portion against the first site, such that moving the anchor driver distally within the channel of the tube defined by the upstream support portion moves the anchor through the distal portion.

### Claim 24 (depends on 21)

The method according to claim 21, further comprising pressing the distal portion against the first site such that a plane of the distal portion is disposed at greater than 45 degrees with respect to a longitudinal axis of the deliver, tube.

### Claim at position 25

25-66. (canceled)
