# US 2014/0194977 A1 · Methods and apparatuses for deploying minimally-invasive heart valves

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- Number: US 2014/0194977 A1
- Document ID: US20140194977A1
- Status: Published application
- Kind: A1
- Application number: 14/203,258
- Filed: 2014-03-10
- Published: 2014-07-10
- Earliest claimed: 2001-09-13
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Jibin Yang; Scott H. Heneveld, SR.; Matthew L. Pease; Brandon G. Walsh
- Web page: https://patentgrep.com/patent/US20140194977A1

## CPC

- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- 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

Methods and systems for delivering and deploying a prosthetic heart valve include a deployment mechanism coupled to the prosthetic heart valve, the deployment mechanism comprising a longitudinal shaft that when rotated in a first direction, expands the prosthetic heart valve from a contracted state to an expanded state, and optionally, when rotated in a second direction opposite the first direction, re-contracts the prosthetic valve from the expanded state. Embodiments of the deployment mechanism comprise a pinion gear that engages a gear track on the prosthetic heart valve.

## Claims

### Claim 1

A method for deploying a prosthetic aortic heart valve in a patient in need thereof, the method comprising:
percutaneously advancing through a patient's vasculature a distal end portion of an elongate delivery system, a prosthetic aortic heart valve in a contracted configuration disposed on the distal end portion, the prosthetic valve comprising a radially contractible and expandable tubular stent and a plurality of leaflets secured to the stent, the stent coupled to a deployment mechanism disposed on the distal end portion, the deployment mechanism comprising a longitudinally extending shaft, the shaft rotatable about a longitudinal axis thereof;
positioning the prosthetic valve in an annulus of a heart valve; and
rotating the shaft of the deployment mechanism in a first direction, thereby expanding the prosthetic valve to a final expanded configuration within the annulus of the heart valve.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
before rotating the shaft of the deployment mechanism in the first direction, rotating the shaft in the first direction to expand the valve from the contracted configuration to an initial expanded configuration;
rotating the shaft in a second direction opposite the first direction, thereby re-contracting the prosthetic valve from the initial expanded configuration; and
repositioning the prosthetic valve.

### Claim 3 (depends on 1)

The method of claim 1, further comprising disengaging the delivery system from the prosthetic heart valve and removing the delivery system from the patient.

### Claim 4 (depends on 3)

The method of claim 3, wherein disengaging the delivery system further comprises disengaging at least a portion of the deployment mechanism.

### Claim 5 (depends on 1)

The method of claim 1, wherein percutaneously advancing the prosthetic heart valve comprises percutaneously advancing the prosthetic heart valve over a guide wire.

### Claim 6 (depends on 1)

The method of claim 1, wherein percutaneously advancing the prosthetic heart valve comprises percutaneously advancing a self-expandable prosthetic heart valve.

### Claim 7 (depends on 1)

The method of claim 1, wherein the deployment mechanism further comprises a distal component coupled to a distal portion of the stent and a proximal component coupled to a proximal portion of the stent, the shaft rotatably engaging the distal component and the proximal component.

### Claim 8 (depends on 1)

The method of claim 1, wherein the shaft further comprises a set of gear teeth and the stent comprises a gear track positioned to engage the gear teeth.

### Claim 9 (depends on 8)

The method of claim 8, wherein the shaft comprises a distal set of gear teeth and a proximal set of gear teeth, and the stent comprises a distal gear track and a proximal gear track, the distal set of gear teeth positioned to engage the distal gear track and the proximal set of gear teeth positioned to engage the proximal gear track.

### Claim 10

A system for repairing a defective aortic heart valve, the system comprising a prosthetic heart valve and a deployment mechanism,
the prosthetic heart valve comprising a radially contractible and expandable tubular stent; and a plurality of leaflets secured to the stent, the plurality of leaflets defining a one-way valve for fluid flow therethrough,
the deployment mechanism coupled to the stent, the deployment mechanism comprising a longitudinally extending shaft,
wherein the shaft is rotatable about a longitudinal axis in a first direction to radially expand the prosthetic heart valve from a contracted state.

### Claim 11 (depends on 10)

The system of claim 10, wherein the shaft is rotatable in a second direction opposite the first direction to radially contract the prosthetic heart valve from an expanded state.

### Claim 12 (depends on 10)

The system of claim 10, wherein the deployment mechanism further comprises a distal component coupled to a distal portion of the stent and a proximal component coupled to a proximal portion of the stent, the shaft rotatably engaging the distal component and the proximal component.

### Claim 13 (depends on 10)

The system of claim 10, wherein the shaft further comprises a set of gear teeth and the stent comprises a gear track positioned to engage the gear teeth.

### Claim 14 (depends on 13)

The system of claim 13, wherein the shaft comprises a distal set of gear teeth and a proximal set of gear teeth, and the stent comprises a distal gear track and a proximal gear track, the distal set of gear teeth positioned to engage the distal gear track and the proximal set of gear teeth positioned to engage the proximal gear track.

### Claim 15 (depends on 10)

The system of claim 10, wherein the shaft is disposed on an interior surface of the stent.

### Claim 16 (depends on 10)

The system of claim 10, wherein the stent comprises lockout features configured to lock the stent in a final expanded configuration.

### Claim 17 (depends on 10)

The system of claim 10, wherein the stent is a self-expandable stent.

### Claim 18 (depends on 10)

The system of claim 10, wherein at least a portion of the deployment mechanism is disengageable from the stent.

### Claim 19 (depends on 10)

The system of claim 10, further comprising an elongate delivery system, the stent releasably disposable on a distal end portion of the delivery system, a proximal end of the delivery system comprising a handle, the handle comprising a mechanism for generating rotational motion, the delivery system comprising a catheter shaft extending from the handle to the distal end portion of the delivery system, the catheter shaft configured for transmitting rotational motion generated in the handle to the deployment mechanism.

### Claim 20 (depends on 10)

The system of claim 10, wherein the leaflets are bovine pericardium.
