# US 11,298,117 B2 · Techniques for providing a replacement valve and transseptal communication

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- Number: US 11,298,117 B2
- Document ID: US11298117B2
- Status: Granted
- Kind: B2
- Application number: 16/738,516
- Filed: 2020-01-09
- Published: 2020-10-08
- Granted: 2022-04-12
- Earliest claimed: 2016-02-16
- Assignees: Cardiovalve Ltd.
- Applicants: Cardiovalve Ltd.
- Inventors: Ilia Hariton; Tal Reich; Paul Kaye
- Web page: https://patentgrep.com/patent/US11298117B2

## CPC

- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- 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)}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2002/249: {Device completely embedded in the heart wall}
- A61F 2210/0057: stretchable
- A61M 2210/125: Heart
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- 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

A method is provided, including (1) identifying the subject as having mitral valve regurgitation; (2) during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and (3) during the same medical procedure, implanting a therapeutic septal device at a septum of the heart. Other embodiments are also described.

## Claims

### Claim 1

A method for use with a heart of a subject, comprising:
identifying the subject as having mitral valve regurgitation;
during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and
during the same medical procedure, implanting a shunt including a check valve at a septum of the heart such that the check valve facilitates one-way blood flow from a chamber of a left side of the heart, via the shunt, to a chamber of a right side of the heart.

### Claim 2 (depends on 1)

The method according to claim 1, wherein implanting the prosthetic valve and implanting the shunt respectively comprise implanting the prosthetic valve and implanting the shunt in an absence of an identification of the subject as having heart failure.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the septum is an interatrial septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interatrial septum.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the septum is an interventricular septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interventricular septum.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the subject is an adult subject, and wherein the method is performed on the adult subject.

### Claim 6 (depends on 1)

The method according to claim 1, further comprising making a fenestration in the septum of the heart, and delivering the prosthetic valve transfemorally to the heart and through the fenestration to the mitral valve site, and wherein implanting the shunt comprises implanting the shunt in the fenestration.

### Claim 7 (depends on 6)

The method according to claim 6, further comprising transfemorally delivering the shunt to the septum.

### Claim 8 (depends on 6)

The method according to claim 6, wherein making the fenestration comprises making the fenestration transfemorally.

### Claim 9 (depends on 1)

The method according to claim 1, further comprising transapically making a fenestration in the septum of the heart, wherein implanting the shunt comprises implanting the shunt in the fenestration.

### Claim 10 (depends on 1)

The method according to claim 1, further comprising transapically delivering the prosthetic valve to the mitral valve site.

### Claim 11 (depends on 1)

The method according to claim 1, wherein implanting the shunt comprises implanting the shunt after implanting the prosthetic valve.

### Claim 12 (depends on 1)

The method according to claim 1, wherein implanting the shunt comprises implanting the shunt before implanting the prosthetic valve.

### Claim 13

A method for use with a heart of a subject, comprising:
identifying the subject as having mitral valve regurgitation;
during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and
during the same medical procedure, implanting a shunt at a septum of the heart, the shunt being shaped to define a lumen and including a membrane that regulates blood flow through the lumen, wherein:
the membrane:
has a closed position in which the membrane inhibits blood flow through the lumen, and an open position in which the inhibiting of the blood flow by the membrane is reduced,
resides in the closed position while a blood pressure difference across the membrane is lower than a threshold blood pressure difference,
moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference, and
is configured such that the threshold blood pressure difference is 4-6 mmHg, and
implanting the shunt that is shaped to define the lumen and includes the membrane comprises implanting the shunt that is shaped to define the lumen and includes the membrane that:
has the closed position and the open position,
resides in the closed position while the blood pressure difference across the membrane is lower than the threshold blood pressure difference,
moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference, and
is configured such that the threshold blood pressure difference is 4-6 mmHg.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the membrane is configured to move from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane, and wherein implanting the shunt that includes the membrane comprises implanting the shunt that includes the membrane that is configured to move from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane.

### Claim 15 (depends on 13)

The method according to claim 13, wherein the membrane is transected by intersecting slits, and wherein implanting the shunt comprises implanting the shunt that includes the membrane that is transected by intersecting slits.

### Claim 16 (depends on 13)

The method according to claim 13, wherein implanting the prosthetic valve and implanting the shunt respectively comprise implanting the prosthetic valve and implanting the shunt in an absence of an identification of the subject as having heart failure.

### Claim 17 (depends on 13)

The method according to claim 13, wherein the septum is an interatrial septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interatrial septum.

### Claim 18 (depends on 13)

The method according to claim 13, wherein the septum is an interventricular septum of the heart, and wherein implanting the shunt at the septum comprises implanting the shunt at the interventricular septum.

### Claim 19 (depends on 13)

The method according to claim 13, wherein the subject is an adult subject, and wherein the method is performed on the adult subject.

### Claim 20 (depends on 13)

The method according to claim 13, further comprising making a fenestration in the septum of the heart, and delivering the prosthetic valve transfemorally to the heart and through the fenestration to the mitral valve site, and wherein implanting the shunt comprises implanting the shunt in the fenestration.

### Claim 21 (depends on 20)

The method according to claim 20, further comprising transfemorally delivering the shunt to the septum.

### Claim 22 (depends on 20)

The method according to claim 20, wherein making the fenestration comprises making the fenestration transfemorally.

### Claim 23 (depends on 13)

The method according to claim 13, further comprising transapically making a fenestration in the septum of the heart, wherein implanting the shunt comprises implanting the shunt in the fenestration.

### Claim 24 (depends on 13)

The method according to claim 13, further comprising transapically delivering the prosthetic valve to the mitral valve site.

### Claim 25 (depends on 13)

The method according to claim 13, wherein implanting the shunt comprises implanting the shunt after implanting the prosthetic valve.

### Claim 26 (depends on 13)

The method according to claim 13, wherein implanting the shunt comprises implanting the shunt before implanting the prosthetic valve.
