# US 11,026,781 B2 · Valve anchor and installation method

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- Number: US 11,026,781 B2
- Document ID: US11026781B2
- Status: Granted
- Kind: B2
- Application number: 16/691,244
- Filed: 2019-11-21
- Published: 2020-03-19
- Granted: 2021-06-08
- Earliest claimed: 2017-05-22
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Dustin P. Armer; Sean Chow; Jenny Nguyen; Emil Karapetian; Tri D. Tran
- Web page: https://patentgrep.com/patent/US11026781B2

## CPC

- 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 2/2457: {Chordae tendineae prostheses}
- 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 2230/0056: W-shaped, e.g. M-shaped, sigma-shaped
- A61F 2250/001: for adjusting a diameter
- A61F 2250/0063: Nested prosthetic parts
- 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

Anchor devices and methods can be used to secure a prosthetic valve to a native valve annulus. The anchor device can be a separate expandable element from the prosthetic valve that is first advanced to the annulus and deployed, after which an expandable prosthetic valve is advanced to within the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets which holds the prosthetic valve in place. The anchor device can have a lower or ventricular portion and an upper or atrial portion. The anchor device can include one or more leaflet clamping portions. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.

## Claims

### Claim 1

A system for securing a prosthetic valve at a native valve, comprising:
an expandable/collapsible anchor device having a lower portion below an upper portion, the lower portion having an expandable tubular body about a vertical axis and comprising undulating struts, the tubular body defining at least two leaflet clamping portions each defined by at least one peak extending upward, wherein there are at least two downward valleys on the lower portion, one downward valley each on both sides of and adjacent the at least two leaflet clamping portions, the anchor device further including two and only two upstanding vertical posts each commencing at one of the at least two downward valleys and extending upward beyond a maximum height of the at least one peak of the leaflet clamping portion and terminating in the upper portion, wherein the lower portion further includes two or more integrally formed downwardly extending legs that extend downward below the valleys in buckles to facilitate manipulation and deployment of the anchor device.

### Claim 2 (depends on 1)

The system of claim 1, wherein the clamping portions each include at least two peaks and one valley therebetween.

### Claim 3 (depends on 1)

The system of claim 1, wherein each clamping portion is covered with fabric.

### Claim 4 (depends on 1)

The system of claim 1, wherein each undulating strut has an S-shape and terminates in an asymptotic manner at each end at a peak and a valley.

### Claim 5 (depends on 1)

The system of claim 1, wherein the upstanding vertical posts are located less than 180° from each other around a circumference of the anchor device.

### Claim 6 (depends on 1)

The system of claim 1, wherein at least one of the legs extends downward from the at least one peak of the leaflet clamping portion.

### Claim 7 (depends on 1)

The system of claim 1, wherein there are three of the downwardly extending legs and buckles.

### Claim 8 (depends on 1)

The system of claim 1, wherein the buckles form squares or rectangles with a hole therethrough.

### Claim 9 (depends on 1)

The system of claim 1, wherein the upper portion includes an annular ring of porous material attached to a top end of the vertical posts.

### Claim 10 (depends on 9)

The system of claim 9, wherein the annular ring of porous material is selected from the group consisting of polyester fabric, porous polymer material, ePTFE, and foam.

### Claim 11 (depends on 1)

The system of claim 1, wherein the upper portion includes a pair of Y-shaped struts at a terminal end of each vertical post.

### Claim 12 (depends on 11)

The system of claim 11, further including a fabric cover across each pair of Y-shaped struts.

### Claim 13 (depends on 1)

The system of claim 1, wherein the upper portion includes a wire ring at a terminal end of each vertical post.

### Claim 14 (depends on 13)

The system of claim 13, further including a fabric cover across the wire rings.

### Claim 15 (depends on 1)

The system of claim 1, further including an expandable prosthetic heart valve expanded within the anchor device.

### Claim 16 (depends on 6)

The system of claim 6, wherein the buckles form squares or rectangles with a hole therethrough.

### Claim 17 (depends on 7)

The system of claim 7, wherein the buckles form squares or rectangles with a hole therethrough.

### Claim 18 (depends on 1)

The system of claim 1, wherein the clamping portions are covered with fabric.

### Claim 19

A system for securing a prosthetic valve at a native valve, comprising:
an expandable/collapsible anchor device having a lower portion below an upper portion, the lower portion having an expandable tubular body about a vertical axis and including undulating struts and two vertical posts, the tubular body defining at least two leaflet clamping portions each defined by at least one peak extending upward, wherein the undulating struts define one downward valley each on both sides of and adjacent the at least two leaflet clamping portions, and the expandable tubular body has an axial dimension extending between the peaks and the valleys, the anchor device further including two and only two of the vertical posts each of which commences at a downward valley and extends upward beyond a maximum height of the at least two leaflet clamping portions and terminates in the upper portion.

### Claim 20 (depends on 19)

The system of claim 19, wherein the clamping portions each include at least two peaks and one valley therebetween.

### Claim 21 (depends on 19)

The system of claim 19, wherein the clamping portions are each covered with fabric.

### Claim 22 (depends on 19)

The system of claim 19, wherein each undulating strut has an S-shape and terminates in an asymptotic manner at each end at a peak and a valley.

### Claim 23 (depends on 19)

The system of claim 19, wherein the two vertical posts are located less than 180° from each other around a circumference of the anchor device.

### Claim 24 (depends on 19)

The system of claim 19, wherein the lower portion further includes at least two integrally formed downwardly extending legs that extend downward below the valleys in buckles to facilitate manipulation and deployment of the anchor device.

### Claim 25 (depends on 24)

The system of claim 24, wherein at least one of the legs extends downward from the at least one peak of one of the leaflet clamping portions.

### Claim 26 (depends on 24)

The system of claim 24, wherein the buckles form squares or rectangles with a hole therethrough.

### Claim 27 (depends on 19)

The system of claim 19, wherein the upper portion includes an annular ring of porous material attached to top ends of the vertical posts.

### Claim 28 (depends on 27)

The system of claim 27, wherein the annular ring of porous material is selected from the group consisting of polyester fabric, porous polymer material, ePTFE, and foam.

### Claim 29 (depends on 19)

The system of claim 19, wherein the upper portion includes a pair of Y-shaped struts at a terminal end of each vertical post.

### Claim 30 (depends on 29)

The system of claim 29, further including a fabric cover across each pair of Y-shaped struts.

### Claim 31 (depends on 19)

The system of claim 19, wherein the upper portion includes a wire ring at a terminal end of each vertical post.

### Claim 32 (depends on 31)

The system of claim 31, further including a fabric cover across the wire rings.

### Claim 33 (depends on 19)

The system of claim 19, further including an expandable prosthetic heart valve expanded within the anchor device.
