# US 2014/0155997 A1 · Collapsible-expandable prosthetic heart valves with structures for clamping native tissue

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- Number: US 2014/0155997 A1
- Document ID: US20140155997A1
- Status: Published application
- Kind: A1
- Application number: 11/906,133
- Filed: 2007-09-28
- Published: 2014-06-05
- Earliest claimed: 2007-09-28
- Assignees: St. Jude Medical, Inc.
- Inventors: Peter Nicholas Braido
- Web page: https://patentgrep.com/patent/US20140155997A1

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2433: {using balloon catheter}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2230/0078: hyperboloidal
- 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

A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

## Claims

### Claim 1

A prosthetic heart valve comprising:
an annular structure that is annularly continuous and that has an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient's native valve annulus and thereby implant the valve in the patient; and
a flexible leaflet structure attached to the annular structure; wherein the annular structure comprises an annular array of diamond-shaped cells, upstream apex portions of at least some of the cells being resiliently biased to deflect radially outwardly from at least some other portion of the annular structure forming a line circumscribing the annular structure, and downstream apex portions of at least some of the cells being resiliently biased to deflect radially outwardly from said at least some other portion of the annular structure forming the line circumscribing the annular structure; whereby, in use, tissue of the patient adjacent to the patient's native valve annulus is clamped between the upstream and downstream apex portions, with the upstream apex portions engaging tissue upstream from the annulus, and with the downstream apex portions engaging tissue downstream from the annulus.

### Claim 2 (depends on 1)

The valve defined in claim 1 wherein the annular perimeter is elastically changeable in length between the first relatively small length and the second relatively large length.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The valve defined in claim 1 wherein the resiliently biased, radially outward deflection of each of the upstream apex portions includes a downstream component of motion by that upstream apex portion; and
wherein the resiliently biased, radially outward deflection of each of the downstream apex portions includes and upstream component of motion by that downstream apex portion.

### Claim 5 (depends on 1)

The valve defined in claim 1 further comprising at least one site for attachment to the valve of material functioning as chordae tendonae.

### Claim 6 (depends on 5)

The valve defined in claim 5 wherein the located on the annular structure.

### Claim 7 (depends on 5)

The valve defined in claim 5 wherein the located on the flexible leaflet structure.

### Claim 8 (depends on 5)

The valve defined in claim 5 wherein the located on a commissure post member that is cantilevered from the annular structure.

### Claim 9 (depends on 1)

The valve defined in claim 1 further comprising a plurality of commissure post members that are cantilevered from the annular structure.

### Claim 10

A prosthetic aortic valve comprising:
an annular structure that is annularly continuous and that has an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient's native aortic valve annulus and also downstream from ostia of the patient's coronary arteries to thereby implant the valve in the patient, the annular structure including an annularly continuous annulus portion adapted for implanting adjacent the patient's native aortic valve annulus upstream from the ostia of the patient's coronary arteries, and an annularly continuous aortic portion adapted for
implanting in the patient's aorta downstream from the ostia of the patient's coronary arteries, the annulus portion and the aortic portion being connected to one another only by a plurality of linking structures that are disposed to pass through at least a portion of the patient's valsava sinus at locations that are spaced
from the ostia of the patient's coronary arteries in a direction that extends annularly around the valsalva sinus; and
a flexible leaflet structure attached to the annulus portion; wherein the annulus portion includes first and second tissue clamping structures that are spaced from one another along an axis that passes longitudinally through the valve, each of the clamping structures being resiliently biased to extend radially outwardly from the leaflet structure about a common pivot point, whereby, in use, tissue of the patient adjacent to the patient's native aortic valve annulus is clamped between the first and second clamping structures, with the first clamping structure engaging tissue upstream from the annulus, and with the second clamping structure engaging tissue downstream from the annulus.

### Claim 11 (depends on 10)

The valve defined in claim 10 wherein the annular perimeter is elastically changeable in length between the first relatively small length and the second relatively large length.

### Claim 12 (depends on 10)

The valve defined in claim 10 further comprising a plurality of commissure post members connected to the annulus portion.

### Claim 13 (depends on 12)

The valve defined in claim 12 wherein the linking structure consists essentially of a plurality of struts, each of which extends from a downstream end of a respective one of the commissure post members to the aortic portion.

### Claim 14 (depends on 13)

The valve defined in claim 13 wherein each of the struts connects to the aortic portion at a axially aligned with the commissure post member from which that strut extends.

### Claim 15 (depends on 12)

The valve defined in claim 12 wherein of the commissure post members includes a downstream end portion that is cantilevered from the annulus portion.

### Claim 16 (depends on 15)

The valve defined in claim 15 wherein the linking structure consists essentially of a respective pair of strut members associated with each of the commissure post members, the strut members in each pair extending along respective opposite sides of the associated commissure post members to the aortic portion.

### Claim 17 (depends on 16)

The valve defined in claim 16 wherein, at least at a transverse geometric plane across the valve at the ostia of the coronary arteries, circumferential spacing between the strut members in each pair is less than circumferential spacing between the pairs.

### Claim 18 (depends on 12)

The valve defined in claim 12 wherein the commissure post members are spaced circumferentially around the annulus portion so that they can be aligned with respective commissures of the patient's native aortic valve.

### Claim 19 (depends on 10)

The valve defined in claim 10 wherein the annulus portion comprises an annular array of diamond-shaped cells.

### Claim 20 (depends on 19)

The valve defined in claim 19 wherein the first clamping structure includes apex portions of at least some of the cells.

### Claim 21 (depends on 20)

The valve defined in claim 20 wherein the second clamping structure includes other apex portions of at least some of the cells.

### Claim 22

A prosthetic aortic valve comprising:
an annular structure that is annularly continuous and that has an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient's native aortic valve annulus and thereby implant the valve in the patient; and
a flexible leaflet structure attached to the annular structure; wherein, when implanted in the patient, any non-leaflet part of the valve that is at the level of the patient's native coronary artery ostia confined in a direction that is circumferential of the valve to areas that are adjacent to the patient's aortic valve commissures or downstream projections of those commissures, each of said areas having an extent in the circumferential direction that less than the distance in the circumferential direction between circumferentially adjacent ones of those areas; and wherein the annular structure includes first and second tissue clamping structures that are spaced from one another along an axis that passes longitudinally through the valve, each of the clamping structures being resiliently biased to extend radially outwardly from a common pivot point of the leaflet structure, whereby, in use, tissue of the patient adjacent to the patient's native aortic valve annulus is clamped between the first and second clamping structures, with the first clamping structure engaging tissue upstream from the annulus, and with the second clamping structure engaging tissue downstream from the annulus.

### Claim 23 (depends on 22)

The valve defined in claim 22 wherein the annular perimeter is elastically changeable in length between the first relatively small length and second relatively large length.

### Claim 24 (depends on 22)

The valve defined in claim 22 further comprising a plurality of commissure post members connected to the annular structure.

### Claim 25 (depends on 24)

The valve defined in claim 24 wherein each of the commissure posts members includes a downstream end portion that is cantilevered from the annular structure.

### Claim 26 (depends on 24)

The valve defined in claim 24 wherein the commissure post members are spaced circumentially around the annular structure so that they can be aligned with respective commissures of the patient's native aortic valve.

### Claim 27 (depends on 22)

The valve defined in claim 22 wherein the annular structure comprises an annular array of diamond-shaped cells.

### Claim 28 (depends on 27)

The valve defined in claim 27 wherein the first clamping structure includes apex portions of at least some of the cells.

### Claim 29 (depends on 28)

The valve defined in claim 28 wherein the second clamping structure includes other apex portions of at least some of the cells.
