# US 2019/0167424 A1 · Delivery Systems And Methods For Transcatheter Prosthetic Valves

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- Number: US 2019/0167424 A1
- Document ID: US20190167424A1
- Status: Published application
- Kind: A1
- Application number: 16/269,692
- Filed: 2019-02-07
- Published: 2019-06-06
- Earliest claimed: 2012-07-30
- Assignees: Tendyne Holdings, Inc.
- Applicants: Tendyne Holdings, Inc.
- Inventors: Robert Vidlund; Kemal Schankereli
- Web page: https://patentgrep.com/patent/US20190167424A1

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2439: {Expansion controlled by filaments}
- 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: 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

This invention relates to a delivery apparatus and method for deployment of a mitral valve replacement.

## Claims

### Claim 1

(canceled)

### Claim 2

A method of implanting a prosthetic mitral valve in a mitral valve annulus of a heart of a patient, the method comprising:
loading the prosthetic mitral valve into a delivery device in a collapsed condition;
delivering the prosthetic mitral valve to a left atrium of the patient through an atrial septal wall separating the left atrium from a right atrium of the heart of the patient;
deploying the prosthetic mitral valve into the mitral valve annulus of the heart of the patient by allowing the prosthetic mitral valve to transition from the collapsed condition to an expanded condition within the mitral valve annulus; and
without piercing an exterior wall of the heart, anchoring the prosthetic mitral valve to a structure of the heart with an anchoring tether.

### Claim 3 (depends on 2)

The method of claim 2, wherein anchoring the prosthetic mitral valve to the structure of the heart includes attaching a first end of the anchoring tether to the prosthetic mitral valve, and attaching a second end of the anchoring tether to the structure of the heart.

### Claim 4 (depends on 3)

The method of claim 3, wherein the first end of the anchoring tether includes a plurality of stent tethers, each of the plurality of stent tether having a first end coupled to the prosthetic mitral valve and a second end coupled to a collar.

### Claim 5 (depends on 3)

The method of claim 3, wherein the structure of the heart is a papillary muscle of the heart.

### Claim 6 (depends on 3)

The method of claim 3, wherein the structure of the heart is a ventricular septum separating a left ventricle from a right ventricle of the heart of the patient.

### Claim 7 (depends on 6)

The method of claim 6, further comprising:
prior to anchoring the anchoring tether to the ventricular septum, inserting the delivery device through the mitral valve annulus, through the left ventricle and piercing the ventricular septum, the delivery device including a delivery sheath defining a lumen and the prosthetic mitral valve being disposed within the lumen of the delivery sheath while inserting the delivery device.

### Claim 8 (depends on 6)

The method of claim 6, wherein the second end of the anchoring tether is attached to the ventricular septum before allowing the prosthetic mitral valve to transition from the collapsed condition to the expanded condition within the mitral valve annulus.

### Claim 9 (depends on 6)

The method of claim 6, further comprising attaching an anchor device to the ventricular septum, the anchor device having a first portion abutting a first side wall of the ventricular septum, and a second portion abutting a second side wall of the ventricular septum.

### Claim 10 (depends on 9)

The method of claim 9, wherein the first and second portions of the anchor device are pledgets.

### Claim 11 (depends on 2)

The method of claim 2, wherein the prosthetic mitral valve includes a valve body, the anchoring tether has a first end attached to a ventricular end of the valve body, and anchoring the prosthetic mitral valve to the structure of the heart includes attaching a second end of the anchoring tether to the structure of the heart.

### Claim 12 (depends on 11)

The method of claim 11, wherein the prosthetic mitral valve includes an atrial cuff extending from an atrial end of the valve body.

### Claim 13 (depends on 12)

The method of claim 12, wherein allowing the prosthetic mitral valve to transition from the collapsed condition to an expanded condition within the mitral valve annulus includes engaging the atrial cuff to an atrial side of the mitral valve annulus.

### Claim 14 (depends on 13)

The method of claim 13, wherein allowing the prosthetic mitral valve to transition from the collapsed condition to an expanded condition includes removing a delivery sheath from the valve body.

### Claim 15 (depends on 2)

The method of claim 2, further comprising urging at least a portion of the prosthetic mitral valve body against the mitral valve annulus.

### Claim 16 (depends on 2)

The method of claim 2, further comprising:
after deploying the prosthetic mitral valve within the mitral valve annulus, adjusting a length of the anchoring tether between the prosthetic mitral valve and the structure of the heart.

### Claim 17 (depends on 2)

The method of claim 2, wherein the anchoring tether is bioabsorbable.

### Claim 18 (depends on 2)

The method of claim 2, wherein the anchoring tether is elastic.

### Claim 19 (depends on 2)

The method of claim 2, wherein the anchoring tether is inelastic.

### Claim 20 (depends on 2)

The method of claim 2, wherein the anchoring tether is a biocompatible polymer suture.

### Claim 21 (depends on 2)

The method of claim 2, wherein the anchoring tether is formed of a material selected from the group consisting of ultra-high molecular weight polyethylene, polytetrafluoroethylene, and polypropylene.
