# US 11,896,811 B2 · Implantable ventricular assist devices and methods

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- Number: US 11,896,811 B2
- Document ID: US11896811B2
- Status: Granted
- Kind: B2
- Application number: 16/577,565
- Filed: 2019-09-20
- Published: 2020-05-07
- Granted: 2024-02-13
- Earliest claimed: 2018-11-02
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Scott M. Bryson; Dustin C. Burkart; Zachary A. Crannell; Joshua D. Cross; Robert M. Depue; James L. Goepfrich; Paul D. Goodman; Brandon C. Hedberg; Jason D. Hemmer; Jeffrey Kennington; Elton R. Migliati; Bryan Reep; Edward E. Shaw; James D. Silverman; Richard D. Strones
- Web page: https://patentgrep.com/patent/US11896811B2

## CPC

- A61M 60/139: inside the aorta, e.g. intra-aortic balloon pumps
- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- A61M 60/135: inside a blood vessel, e.g. using grafting
- A61M 60/17: inside a ventricle, e.g. intraventricular balloon pumps
- A61M 60/178: drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
- A61M 60/232: Centrifugal pumps
- A61M 60/237: the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
- A61M 60/408: the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
- A61M 60/422: the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
- A61M 60/508: Electronic control means, e.g. for feedback regulation
- A61M 60/857: Implantable blood tubes
- A61M 60/861: Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
- A61M 60/894: Passive valves, i.e. valves actuated by the blood
- A61N 1/3962: {in combination with another heart therapy}
- A61B 5/0031: {Implanted circuitry}
- A61F 2/07: Stent-grafts
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- 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)}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- 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)

## Abstract

Various aspects of the present disclosure are directed toward implantable medical devices, systems, and methods for cardiac assistance.

## Claims

### Claim 1

An implantable medical device for cardiac assistance, the implantable medical device comprising:
a main body configured to be disposed within the aorta, the main body including a lumen operable to convey blood through the aorta;
an access site in a sidewall of the main body operable to provide access to the lumen of the main body; and
a branch member configured to be disposed within the access site to fluidly connect with the lumen of the main body, the branch member includes one or more anchor elements configured to interface with and secure a pump with the branch member.

### Claim 2 (depends on 1)

The implantable medical device of claim 1, wherein the branch member is configured to be disposed within an atrium or a ventricle of a patient.

### Claim 3 (depends on 2)

The implantable medical device of claim 2, wherein the pump is configured to convey blood into the aorta from the atrium or ventricle for cardiac assistance through the branch member and into the main body.

### Claim 4 (depends on 1)

The implantable medical device of claim 1, wherein the branch member includes a sealing element near a first end of the branch member, the sealing member configured to engage a tissue wall of a left atrium or a left ventricle.

### Claim 5 (depends on 4)

The implantable medical device of claim 4, wherein the sealing element includes a flange configured to engage the tissue wall.

### Claim 6 (depends on 1)

The implantable medical device of claim 1, wherein the access site in the main body includes a fenestration, wherein the branch member is configured to seal with the fenestration to fluidly connect the branch member and the main body.

### Claim 7 (depends on 1)

The implantable medical device of claim 1, further comprising a portal arranged within a main lumen that is aligned with the access site in the main body, and a first portion of the branch member is configured to be disposed within the portal to fluidly connect the branch member and the main body.

### Claim 8 (depends on 7)

The implantable medical device of claim 7, wherein a second portion of the branch member is configured to be disposed within the access site to fluidly connect with the lumen of the main body and a left atrial appendage of a heart.

### Claim 9 (depends on 8)

The implantable medical device of claim 8, further including a stent structure coupled to the branch member or the pump and configured to stabilize the branch member or the pump within the left atrial appendage.

### Claim 10 (depends on 9)

The implantable medical device of claim 9, wherein the branch member or the pump is arranged through an eyelet of the stent structure.

### Claim 11 (depends on 10)

The implantable medical device of claim 10, wherein the stent structure defines an acorn shape or a shape that tapers toward a distal end.

### Claim 12 (depends on 1)

The implantable medical device of claim 1, wherein the branch member is arranged about a patient's heart.

### Claim 13 (depends on 1)

The implantable medical device of claim 1, wherein the pump includes one or more pump anchor elements, wherein the one or more branch anchor elements are operable for cooperative engagement with the one or more pump anchor elements and configured to anchor the pump with the branch member.

### Claim 14 (depends on 1)

The implantable medical device of claim 1, wherein the one or more branch anchor elements are configured to frictionally engage the branch member and the pump to anchor the pump within the branch member.

### Claim 15

A system for implanting an implantable medical device for cardiac assistance, the system com prising:
a first catheter configured to deploy an implantable medical device within an aorta, the implantable medical device including a main body, the main body including a lumen operable to maintain fluid flow through the aorta, the main body including an access site in a sidewall of the main body providing access to the lumen of the main body; and
a second catheter configured to deploy a branch member within the access site to fluidly connect with the lumen of the main body and including a pump configured to convey blood through the branch member and into the lumen of the main body.

### Claim 16 (depends on 15)

The system of claim 15, wherein the second catheter is configured to deploy the branch member transapically.

### Claim 17 (depends on 15)

The system of claim 15, wherein the second catheter is configured to deploy the branch member transseptally.

### Claim 18 (depends on 15)

The system of claim 15, further comprising a puncture device configured to create an access site in the aorta and an access site in an atrium or ventricle, and wherein the second catheter is configured to deploy the branch member across the access site in the aorta and the access site in an atrium or ventricle.

### Claim 19 (depends on 18)

The system of claim 18, wherein the second catheter includes a sheath configured to deploy a flange arranged with a distal end of the branch member, the flange is configured to engage a tissue wall of the atrium or the ventricle in a fluid tight engagement.

### Claim 20

An implantable medical device for cardiac assistance, the implantable medical device comprising:
a stent-graft having a main body having a lumen operable to convey blood therethrough and a branch member fluidly connected with the lumen of the main body, the branch member including one or more anchor elements;
an access site in a sidewall of the main body operable to provide access to the lumen of the main body;
a pump configured to deploy within a pulmonary vein and configured to interface with and secure with the one or more anchor elements of the branch member, the pump including a lumen configured to maintain blood flow through the pulmonary vein and configured to convey blood through the lumen.

### Claim 21 (depends on 20)

The implantable medical device of claim 20, wherein the pump is configured to intake blood from the pulmonary vein and discharge the blood into the left atrium.

### Claim 22 (depends on 20)

The implantable medical device of claim 20, wherein the pump is configured to increase flow out of the pulmonary vein to increase cardiac output.

### Claim 23 (depends on 20)

The implantable medical device of claim 20, further comprising a driveline configured to power the pump, the driveline configured to extend out of the pulmonary vein into the left atrium and across a septum to exit a right side of the heart.

### Claim 24 (depends on 20)

The implantable medical device of claim 20, wherein the driveline is operable to exit a patient via an iliac vein.

### Claim 25

A method for cardiac assistance, the method com prising:
arranging an implantable medical device between an aorta and a heart chamber of a patient, the implantable medical device including a pump configured to convey blood from the heart chamber into the aorta; and
forming a conduit of native tissue about the pump and between the aorta and the heart cham ber.

### Claim 26 (depends on 25)

The method of claim 25, wherein forming the conduit of native tissue includes creating scarring or tissue ingrowth to farm a tissue layer between the aorta and the heart chamber.

### Claim 27 (depends on 25)

The method of claim 25, wherein the pump includes a material arranged about an outer surface of the pump configured to facilitate tissue ingrowth.

### Claim 28 (depends on 27)

The method of claim 27, wherein the material includes at least one of Dacron and ePTFE.

### Claim 29

A medical device for cardiac assistance, the medical device com prising:
a prosthetic valve comprising
a support frame,
a plurality of leaflets coupled to the support frame and configured to open to allow forward flow therethrough and to occlude the support frame to prevent retrograde flow, and
a pump arranged within the support frame and configured to convey blood through the support frame.

### Claim 30 (depends on 29)

The medical device of claim 29, wherein the plurality of leaflets are configured to coapt about the pump.

### Claim 31 (depends on 30)

The medical device of claim 30, wherein the pump is arranged centrally within the support frame.

### Claim 32 (depends on 29)

The medical device of claim 29, further comprising a filter arranged at an outflow end of the support frame.

### Claim 33 (depends on 32)

The medical device of claim 32, wherein the filter is arranged on an outflow end of the pump.

### Claim 34 (depends on 29)

The medical device of claim 29, wherein the prosthetic valve is configured to replace an aortic valve of a patient.

### Claim 35 (depends on 29)

The medical device of claim 29, wherein the prosthetic valve is configured to replace a mitral valve of a patient.

### Claim 36 (depends on 29)

The medical device of claim 29, wherein the prosthetic valve and the pump are configured for transcatheter delivery.

### Claim 37

An implantable medical device for cardiac assistance, the implantable medical device comprising:
a main body configured to deploy within an aorta, the main body including a lumen configured to maintain fluid flow through the aorta;
a branch member extending from the main body and configured to deploy within a chamber of a heart to fluidly connect the aorta and the chamber of the heart; and
a pump arranged within the branch member and configured to convey blood from the chamber of the heart through the branch member and into the lumen of the main body.

### Claim 38 (depends on 37)

The implantable medical device of claim 37, wherein the branch member is integral with the main body.

### Claim 39 (depends on 38)

The implantable medical device of claim 38, wherein the branch member is configured to telescope inwardly and outwardly relative to the main body.

### Claim 40

An implantable medical device for cardiac assistance, the implantable medical device comprising:
a main body defining a lumen; and
a stent-graft defining a branch member configured to deploy within a pulmonary vein and including a lumen configured to maintain fluid flow through the pulmonary vein and the lumen of the main body, the stent-graft configured to receive blood through the lumen; and
a pump arranged within the branch member a pump arranged within the branch member to convey blood through the branch member, wherein the pump includes one or more anchor elements and is secured to the branch member via the one or more anchor elements.

### Claim 41 (depends on 40)

The implantable medical device of claim 40, wherein the stent-graft is configured to interface with the pump, and the pump is configured to convey blood from the pulmonary vein to a left atrium.

### Claim 42 (depends on 40)

The implantable medical device of claim 40, wherein the branch member includes one or more anchor elements, wherein the one or more pump anchor elements are operable for cooperative engagement with the one or more branch anchor elements and configured to anchor the pump with the branch member.
