# US 11,432,884 B1 · Method for delivery of prosthetic aortic valve

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- Number: US 11,432,884 B1
- Document ID: US11432884B1
- Status: Granted
- Kind: B1
- Application number: 17/547,588
- Filed: 2021-12-10
- Published: 2022-09-29
- Granted: 2022-09-06
- Earliest claimed: 2016-08-03
- Assignees: HBX, Inc.
- Applicants: HBX, Inc.
- Inventors: Paul A. Spence
- Web page: https://patentgrep.com/patent/US11432884B1

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61F 2/86: Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F 2/89: the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3762: {using computed tomography systems [CT]}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2433: {using balloon catheter}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2002/0081: {directly machined on the prosthetic surface, e.g. holes, grooves (A61F2/30771 takes precedence)}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2230/0004: Rounded shapes, e.g. with rounded corners
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2230/0021: square
- A61F 2230/0045: Omega-shaped
- A61F 2230/0054: V-shaped
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0039: differing in diameter
- A61F 2250/0069: Sealing means
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- 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

Methods of delivering a prosthetic aortic heart valve are disclosed. The disclosed methods include loading a prosthetic aortic valve in a collapsed configuration into a delivery sheath so that a selected point on the prosthetic valve is rotationally aligned relative to a long axis of the delivery sheath with a selected radiopaque marker on the delivery sheath, while under fluoroscopic imaging, rotating the delivery sheath about its long axis to align a selected radiopaque marker on the delivery sheath with the selected point on the native aortic valve in a fluoroscopic imaging plane, thereby establishing a desired orientation of the prosthetic aortic valve with respect to the native aortic valve in which the prosthetic valve commissures are rotationally aligned with commissures of the native aortic valve, further advancing the delivery sheath along its long axis until the prosthetic aortic valve is disposed inside the native aortic valve, and deploying the prosthetic aortic valve into an implanted state inside the native aortic valve with the prosthetic aortic valve aligned in the desired orientation with respect to the native aortic valve.

## Claims

### Claim 1

A method of implanting a prosthetic aortic valve in a native aortic valve of patient with a delivery sheath, the prosthetic aortic valve including a stent frame having an interior and three prosthetic valve leaflets mounted within the interior and joined at three respective commissures to provide unidirectional flow of blood through the prosthetic aortic valve, the stent frame further including a portion at a lower edge thereof, the method comprising:
collapsing the prosthetic aortic valve into a collapsed configuration;
loading the prosthetic aortic valve in the collapsed configuration into the delivery sheath so that a selected point on the prosthetic valve is rotationally aligned relative to a long axis of the delivery sheath with a selected radiopaque marker on the delivery sheath;
introducing the delivery sheath along the long axis of the delivery sheath into a vasculature of the patient;
advancing the delivery sheath until a distal end of the delivery sheath is disposed in an ascending aorta of the patient with the entire prosthetic aortic valve in a position above the native aortic valve;
while the entire prosthetic aortic valve is in the position above the native aortic valve, fluoroscopically imaging the native aortic valve with a fluoroscopic camera;
setting a position of the fluoroscopic camera to establish an imaging plane in which a selected point on the native aortic valve appears on a central axis of the image of the native aortic valve;
after the advancing the delivery sheath, and while under the fluoroscopic imaging, and while the entire prosthetic aortic valve is in the position above the native aortic valve, rotating the delivery sheath about its long axis to align the selected radiopaque marker on the delivery sheath with the selected point on the native aortic valve in the imaging plane, thereby establishing a desired orientation of the prosthetic aortic valve with respect to the native aortic valve in which the prosthetic valve commissures are rotationally aligned with commissures of the native aortic valve;
after the rotating the delivery sheath, further advancing the delivery sheath along its long axis until the prosthetic aortic valve is disposed inside the native aortic valve; and
deploying the prosthetic aortic valve into an implanted state inside the native aortic valve with the prosthetic aortic valve aligned in the desired orientation with respect to the native aortic valve and with the portion of the stent frame disposed adjacent to the location of conduction tissue of the native aortic valve so that the frame does not damage the conduction tissue.

### Claim 2 (depends on 1)

The method of claim 1, wherein the rotating the delivery sheath is a second rotating, and further comprising, before the advancing the delivery sheath, initially rotating the delivery sheath towards the desired orientation to reduce the amount of rotation required during the second rotating.

### Claim 3 (depends on 1)

The method of claim 1, further comprising, before the introducing, placing the prosthetic aortic valve mounted in the delivery sheath into an introducer sheath with the long axis of the delivery sheath in a rotational orientation relative to the introducer sheath that ensures the prosthetic aortic valve will be at least substantially aligned in the desired rotational orientation after the advancing.

### Claim 4 (depends on 1)

The method of claim 1, wherein the prosthetic aortic valve includes a radiopaque marker.

### Claim 5 (depends on 4)

The method of claim 4, wherein the rotating the delivery sheath includes aligning the selected radiopaque marker on the delivery sheath and the radiopaque marker on the prosthetic aortic valve.

### Claim 6 (depends on 1)

The method of claim 1, wherein the selected point on the native aortic valve is one of a commissure, a cusp, a nadir of a cusp, or a coronary artery.

### Claim 7 (depends on 1)

The method of claim 1, wherein the setting the position of the fluoroscopic camera incudes referencing a CT scan of the native aortic valve on which the selected point on the native aortic valve can be identified.

### Claim 8 (depends on 1)

The method of claim 1, wherein the setting the position of the fluoroscopic camera incudes referencing a CT scan of the native aortic valve on which the selected point on the native aortic valve can be identified, identifying a fluoroscopic plane containing the selected point, and replicating the fluoroscopic plane for the fluoroscopic imaging.

### Claim 9 (depends on 1)

The method of claim 1, wherein the portion includes a cut-out, recess, or opening.

### Claim 10 (depends on 1)

The method of claim 1, further comprising, before the setting the position of the fluoroscopic camera:
predicting an initial position of the fluoroscopic camera that will establish the imaging plane based on a CT scan of the patient; and
setting the initial position of the fluoroscopic camera.

### Claim 11 (depends on 10)

The method of claim 10, further comprising, after the setting the initial position of the fluoroscopic camera and before the setting the position of the fluoroscopic camera, injecting a small puff of contrast dye into the native aortic valve.