# US 12,005,214 B2 · Device and method for regulating pressure in a heart chamber

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- Number: US 12,005,214 B2
- Document ID: US12005214B2
- Status: Granted
- Kind: B2
- Application number: 16/866,377
- Filed: 2020-05-04
- Published: 2020-08-20
- Granted: 2024-06-11
- Earliest claimed: 2009-05-04
- Assignees: V-Wave Ltd.
- Applicants: V-Wave Ltd.
- Inventors: Yaacov Nitzan; Boaz Harari; Ascher Shmulewitz; Tovy Sivan
- Web page: https://patentgrep.com/patent/US12005214B2

## CPC

- A61M 27/002: {Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61M 27/006: {Cerebrospinal drainage; Accessories therefor, e.g. valves}
- A61B 2017/00243: {cardiac}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61F 2002/249: {Device completely embedded in the heart wall}
- A61F 2220/0058: soldered or brazed or welded
- A61F 2220/0066: stapled
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2230/0078: hyperboloidal
- 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)}
- 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)

## Abstract

A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a loft heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.

## Claims

### Claim 1

A shunt for regulating blood pressure between a patient's left atrium and right atrium, the shunt comprising:
a shunt conduit configured to be implanted at an atrial septum of the patient to dilate an opening in the atrial septum, the shunt conduit having an outer surface along a length greater than a thickness of the atrial septum, the shunt conduit configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient's atrial septum such that the shunt conduit has a smallest diameter where the outer surface traverses the atrial septum and has a larger diameter at the outer surface where an end region of the shunt conduit extends into an atrium, wherein the shunt conduit has a diabolo shape and is configured to be collapsible after implantation.

### Claim 2 (depends on 1)

The shunt of claim 1, further comprising an anchor configured to anchor the shunt conduit to the atrial septum when deployed.

### Claim 3 (depends on 1)

The shunt of claim 1, wherein a flow rate capacity of the shunt conduit increases with an increase in pressure of the left atrium.

### Claim 4 (depends on 1)

The shunt of claim 1, wherein the shunt conduit is configured to be expanded to a predetermined diameter using a balloon catheter.

### Claim 5 (depends on 1)

The shunt of claim 1, wherein the diabolo shape of the shunt conduit is configured to prevent migration of the shunt conduit through the atrial septum when deployed.

### Claim 6 (depends on 1)

The shunt of claim 1, wherein the shunt conduit is coated with expanded-polytetrafluoroethylene (ePTFE).

### Claim 7 (depends on 1)

The shunt of claim 1, wherein the length of the shunt conduit is greater than twice the thickness of the atrial septum.

### Claim 8 (depends on 1)

The shunt of claim 1, wherein the shunt conduit comprises a plurality of sinusoidal rings interconnected by a plurality of struts.

### Claim 9 (depends on 8)

The shunt of claim 8, wherein the sinusoidal rings and struts further define a neck where the outer surface traverses the atrial septum between conical sections of the shunt conduit.

### Claim 10 (depends on 9)

The shunt of claim 9, wherein the neck is between 4 and 6 mm in diameter.

### Claim 11 (depends on 1)

The shunt of claim 1, wherein the shunt conduit is constructed from a nitinol frame.

### Claim 12 (depends on 1)

The shunt of claim 1, wherein the shunt conduit defines a neck where the outer surface traverses the atrial septum between conical sections.

### Claim 13 (depends on 12)

The shunt of claim 12, wherein the neck and the conical sections are collapsible.

### Claim 14 (depends on 12)

The shunt of claim 12, wherein the neck is between 4 and 6 mm in diameter.

### Claim 15

A method for regulating blood pressure between a patient's left atrium and right atrium, the method comprising:
implanting a shunt conduit at an atrial septum of the patient to dilate an opening in the atrial septum, the shunt conduit having an outer surface along a length greater than a thickness of the atrial septum, the shunt conduit configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient's atrial septum such that the shunt conduit has a smallest diameter where the outer surface traverses the atrial septum and has a larger diameter at the outer surface where an end region of the shunt conduit extends into an atrium, wherein the shunt conduit has a diabolo shape and is configured to be collapsible after implantation.

### Claim 16 (depends on 15)

The method of claim 15, further comprising expanding the shunt conduit to a predetermined diameter using a balloon catheter.

### Claim 17 (depends on 15)

The method of claim 15, wherein the shunt conduit defines a neck where the outer surface traverses the atrial septum between conical sections.

### Claim 18 (depends on 17)

The method of claim 17, wherein the neck and the conical sections are collapsible.

### Claim 19 (depends on 17)

The method of claim 17, wherein the neck is between 4 and 6 mm in diameter.

### Claim 20 (depends on 15)

The method of claim 15, further comprising shunting blood through the atrial septum via the shunt conduit to treat heart failure.

### Claim 21 (depends on 1)

The shunt of claim 1, wherein the end region of the shunt conduit, when implanted in the expanded state, is configured to be disposed in the atrium and to not contact the atrial septum.

### Claim 22 (depends on 21)

The shunt of claim 21, wherein the shunt conduit further comprises a second end region at an opposing end of the shunt conduit and having a larger diameter when deployed than the smallest diameter,
wherein the second end region of the shunt conduit, when implanted in the expanded state, is configured to be disposed in an opposing atrium and to not contact the atrial septum.

### Claim 23 (depends on 15)

The method of claim 15, wherein the end region of the shunt conduit, when implanted in the expanded state, is disposed in the atrium and does not contact the atrial septum.

### Claim 24 (depends on 23)

The method of claim 23, wherein the shunt conduit further comprises a second end region at an opposing end of the shunt conduit and having a larger diameter when deployed than the smallest diameter,
wherein the second end region of the shunt conduit, when implanted in the expanded state, is disposed in an opposing atrium and does not contact the atrial septum.