# US 11,439,505 B2 · Apparatus and methods for delivery of prosthetic heart valves

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- Number: US 11,439,505 B2
- Document ID: US11439505B2
- Status: Granted
- Kind: B2
- Application number: 16/935,655
- Filed: 2020-07-22
- Published: 2021-02-04
- Granted: 2022-09-13
- Earliest claimed: 2019-08-02
- Assignees: Tendyne Holdings, Inc.
- Applicants: Tendyne Holdings, Inc.
- Inventors: Zachary R. Vidlund
- Web page: https://patentgrep.com/patent/US11439505B2

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2439: {Expansion controlled by filaments}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2433: {using balloon catheter}
- A61M 25/09: Guide wires
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00358: {Snares for grasping}
- A61B 2017/0404: {Buttons}
- 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 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Apparatus and methods are described herein for use in in establishing an improved AV loop with the use of a pulley/snare device at the base of a ventricle of a heart. In some methods described herein, a pulley/snare device is established to create a path with inherent concentricity to the aortic and mitral valves, allowing the valves to function normally during an interventional procedure in the heart, without impeding the motion of any leaflets. The pulley/snare device described herein minimizes the forces that are applied on the valves or associated cardiac tissue to “make the turn” from the aortic valve to the mitral valve.

## Claims

### Claim 1

A method of establishing an arteriovenous loop in a heart of a patient for delivery of a transcatheter prosthetic valve, the method comprising:
inserting a first catheter into a first access point of the patient, the catheter having a leading end, a trailing end opposite the leading end and a lumen extending between the leading and trailing ends;
positioning the leading end of the first catheter in the left ventricle of the heart;
inserting a first snare device into the lumen of the first catheter, the first snare device having a loop at a leading end of the first snare device;
advancing the leading end of the first snare device through the leading end of the first catheter such that the loop of the first snare device is positioned in the left ventricle of the heart;
inserting a first guidewire into a second access point of the patient different than the first access point, the first guidewire having a leading end;
positioning the first guidewire into the left ventricle of the patient; and
ensnaring the guidewire in the loop of the first snare device to form an arteriovenous loop such that a first portion of the arteriovenous loop traversing the native aortic valve and a second portion of the arteriovenous loop traversing the native mitral valve are spaced from the native aortic valve annulus and the native mitral valve annulus.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first access point is the femoral vein, and the step of positioning the first catheter comprises routing the leading end of the first catheter from the femoral vein into the left atrium of the heart via a transseptal puncture, through the mitral valve, and into the left ventricle of the heart, and wherein the second access point is the femoral artery, and the step of positioning the first guidewire comprises routing the leading end of the first guidewire from the femoral artery through the aortic arch, the aortic valve and into the left ventricle of the heart.

### Claim 3 (depends on 1)

The method of claim 1, further comprising puncturing the left ventricle of the heart.

### Claim 4 (depends on 3)

The method of claim 3, further comprising:
inserting a leading end of a second guidewire through the puncture and into the left ventricle of the heart.

### Claim 5 (depends on 4)

The method of claim 4, wherein the puncture is created using a needle having a lumen and the leading end of the second guidewire is inserted into the left ventricle of the heart through the lumen of the needle.

### Claim 6 (depends on 5)

The method of claim 5, further comprising withdrawing the needle over the second guidewire after the leading end of the second guidewire has been inserted into the left ventricle of the heart.

### Claim 7 (depends on 4)

The method of claim 4, further comprising advancing the leading end of the second guidewire from the left ventricle of the heart, through the aortic valve, the aortic arch, the abdominal aorta, into a femoral artery and exteriorizing the leading end of the second guidewire through the second access point.

### Claim 8 (depends on 7)

The method of claim 7, further comprising:
advancing a second catheter over the second guidewire, the second catheter having a leading end, a trailing end opposite the leading end and a lumen extending between the leading and trailing ends.

### Claim 9 (depends on 8)

The method of claim 8, further comprising:
inserting a second snare device into the lumen of the second catheter, the second snare device having a leading end and a loop opposite the leading end; and
advancing the leading end of the second snare device through the second catheter to exteriorize the leading end of the second snare device from the left ventricle of the heart,
wherein the loop of the second snare device is positioned adjacent the access point and outside the lumen of the second catheter.

### Claim 10 (depends on 9)

The method of claim 9, wherein the first guidewire is routed through the loop of the second snare device, along an exterior sidewall of the second catheter and into the left ventricle of the heart.

### Claim 11 (depends on 10)

The method of claim 10, further comprising:
retracting the second catheter; and
retracting the loop of the second snare device over the first guidewire and into the left ventricle of the patient.

### Claim 12 (depends on 11)

The method of claim 11, further comprising:
pulling the second snare device to apply tension to the arteriovenous loop during delivery of a prosthetic valve to ensure that the first and second portions of the arteriovenous loop remain spaced from the native aortic valve annulus and the native mitral valve annulus.

### Claim 13 (depends on 12)

The method of claim 12, further comprising delivering a prosthetic heart valve over the atrioventricular loop.

### Claim 14 (depends on 13)

The method of claim 13, wherein the prosthetic heart valve is delivered to and implanted within the native mitral valve annulus.

### Claim 15 (depends on 11)

The method of claim 11, further comprising:
inserting a third catheter into the second access point of the patient and over the first guidewire, the third catheter having a leading end with a nosecone balloon and a trailing end opposite the leading end; and
advancing the nosecone balloon from the second access point, through the loop of the second snare device and into abutment with the leading end of the first catheter.

### Claim 16 (depends on 15)

The method of claim 15, further comprising:
clamping each of the first catheter and the third catheter to the first guidewire.

### Claim 17 (depends on 15)

The method of claim 15, further comprising:
exteriorizing the nosecone balloon through the first access point.

### Claim 18 (depends on 15)

The method of claim 15, further comprising:
inserting a tether of the prosthetic heart valve into the third catheter, the prosthetic heart valve comprising a collapsible and expandable stent and a plurality and plurality of leaflets disposed within the stent;
placing a leading end of a valve delivery catheter into abutment with the nosecone balloon;
advancing the valve delivery catheter and the nosecone balloon catheter into the right atrium of the heart;
inflating the nosecone balloon;
advancing the nosecone balloon and the valve delivery catheter through the transseptal puncture and into the left atrium; and
deflating the nosecone balloon and removing the nosecone balloon from the second access point of the patient.

### Claim 19 (depends on 18)

The method of claim 18, further comprising:
deploying the prosthetic heart valve from the valve delivery catheter;
pulling the tether of the prosthetic heart valve through the puncture in the left ventricle; and
attaching an anchoring device to the apex of the heart to anchor the prosthetic heart.

### Claim 20 (depends on 19)

The method of claim 19, further comprising retracting the loop of the second snare device through the puncture in the left ventricle to exteriorize the tether before deploying the prosthetic heart valve from the valve delivery catheter.