# US 2014/0194678 A1 · Supporting a heart

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- Number: US 2014/0194678 A1
- Document ID: US20140194678A1
- Status: Published application
- Kind: A1
- Application number: 13/839,455
- Filed: 2013-03-15
- Published: 2014-07-10
- Earliest claimed: 2013-01-08
- Assignees: AdjuCor GmbH
- Inventors: Stephen Manuel Wildhirt; Andreas Maier
- Web page: https://patentgrep.com/patent/US20140194678A1

## CPC

- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2/2481: {Devices outside the heart wall, e.g. bags, strips or bands}
- A61M 60/191: mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
- A61M 60/289: Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
- A61M 60/468: the force acting on the actuation means being hydraulic or pneumatic
- A61M 60/531: using blood pressure data, e.g. from blood pressure sensors
- A61M 60/839: of devices for mechanical circulatory actuation
- A61M 60/867: using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
- A61M 60/88: Percutaneous cables
- A61N 1/0597: {Surface area electrodes, e.g. cardiac harness}
- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- A61N 1/36514: {controlled by a physiological quantity other than heart potential, e.g. blood pressure (controlled by two or more physical parameters A61N1/36585)}
- A61F 2002/2484: {Delivery devices therefor}
- A61F 2250/0097: Visible markings, e.g. indicia
- 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)}
- 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)

## Abstract

A heart support system featuring a sleeve sized to fit about at least a portion of an adult human heart in a living body, the sleeve having an inner surface arranged to contact the heart in use and a sheath extending about and constraining the sleeve. At least one of the sheath and sleeve carry a discrete mark detectable from outside the body with the sheath and sleeve implanted within the body. The position of the support system about the heart can be determined with reference to the mark.

## Claims

### Claim 1

A heart support system comprising
a sleeve sized to fit about at least a portion of an adult human heart in a living body, the sleeve having an inner surface arranged to contact the heart in use; and
a sheath extending about and constraining the sleeve;
wherein at least one of the sheath and sleeve carry a discrete mark detectable from outside the body with the sheath and sleeve implanted within the body.

### Claim 2 (depends on 1)

The system of claim 1, wherein the mark is of a different color than a surface of the support system adjacent the mark.

### Claim 3 (depends on 1)

The system of claim 1, wherein the mark is formed of a more radiopaque material than a surface of the support system adjacent the mark.

### Claim 4 (depends on 1)

The system of claim 1, wherein the sheath has an edge extending about an open end of the sheath, and wherein at least a portion of the mark is disposed adjacent the edge.

### Claim 5 (depends on 4)

The system of claim 4, wherein the mark comprises a line extending away from the edge.

### Claim 6 (depends on 5)

The system of claim 5, wherein the line is substantially perpendicular to the edge.

### Claim 7 (depends on 1)

The system of claim 1, wherein the mark is in the form of at least one of the group consisting of a point, a circle, an oval, a polygon, and an alphanumeric character.

### Claim 8 (depends on 1)

The system of claim 1, wherein the mark comprises a discrete structural difference in a portion of the sheath.

### Claim 9 (depends on 1)

The system of claim 1, wherein the sleeve defines at least one internal chamber; the system further comprising a fluid conduit extending from the internal chamber of the sleeve to a source of pressurized fluid.

### Claim 10 (depends on 1)

The system of claim 1, wherein the mark is disposed on a surface of the sleeve.

### Claim 11 (depends on 1)

The system of claim 1, further comprising an implantation delivery device, and wherein the sheath is collapsible to fit within the implantation delivery device and sufficiently expandable to fit about at least a portion of an adult human heart in an expanded state.

### Claim 12 (depends on 11)

The system of claim 11, wherein the delivery device has a wall formed of a transparent material and through which the mark is visible with the sheath collapsed within the delivery device.

### Claim 13 (depends on 11)

The system of claim 11, wherein the delivery device comprises a catheter.

### Claim 14 (depends on 13)

The system of claim 13, wherein the catheter comprises a catheter mark on a portion of the catheter configured to be inserted into the body during implantation of the sheath and sleeve.

### Claim 15 (depends on 14)

The system of claim 14, wherein the catheter mark comprises at least one discrete line.

### Claim 16 (depends on 14)

The system of claim 14, wherein the catheter mark comprises a haptic feature of a surface of the catheter.

### Claim 17

A method of supporting a heart, the method comprising:
inserting a heart support system into a living body, the support system bearing a mark;
surrounding at least a portion of a heart within the body with the inserted heart support system; and
determining a positioning of the support system about the heart with reference to the mark.

### Claim 18 (depends on 17)

The method of claim 17, wherein the support system comprises an expandable sheath, and wherein inserting the heart support system comprises inserting the sheath into the body in a collapsed state and then expanding the sheath to fit about the heart portion once inside the body.

### Claim 19 (depends on 18)

The method of claim 18, wherein inserting the sheath first comprises:
inserting a catheter into the body and into the pericardium;
forming a sealed opening in the pericardium; and
inserting the expandable heart sheath into the body and into the pericardium via the catheter.

### Claim 20 (depends on 18)

The method of claim 18, wherein the support system further comprises a sleeve disposed within the sheath, and wherein surrounding the heart portion comprises surrounding the heart portion with the sheath with the sleeve disposed between the heart and the sheath.

### Claim 21 (depends on 20)

The method of claim 20, wherein the sleeve defines an internal chamber, the method further comprising connecting a fluid supply line to the sleeve and causing fluid to flow into the sleeve to alter a volume of the internal chamber after surrounding the heart portion with the heart support system.

### Claim 22 (depends on 21)

The method of claim 21, wherein altering the volume comprises pumping a fluid into the internal chamber of the sleeve, thereby increasing a pressure of the sleeve against the heart.
