# US 2014/0194670 A1 · Implanting cardiac devices

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- Number: US 2014/0194670 A1
- Document ID: US20140194670A1
- Status: Published application
- Kind: A1
- Application number: 13/838,831
- 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/US20140194670A1

## CPC

- A61F 2/2481: {Devices outside the heart wall, e.g. bags, strips or bands}
- A61B 17/3431: {being collapsible, e.g. made of thin flexible material (A61B17/3423 takes precedence)}
- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- 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 60/523: using blood flow data, e.g. from blood flow transducers
- A61M 60/531: using blood pressure data, e.g. from blood pressure sensors
- A61M 60/839: of devices for mechanical circulatory actuation
- A61M 60/861: Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
- A61M 60/867: using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61F 2002/2484: {Delivery devices therefor}
- A61M 2039/0273: {for introducing catheters into the body}
- A61M 2039/0297: {at least part of it being inflatable, e.g. for anchoring, sealing or removing}
- 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)}
- 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 method of implanting a cardiac device featuring the insertion of an inner seal member through an opening in a pericardium about a living human heart. The inner seal member has a first sealing lip disposed inside the pericardium and surrounding an aperture through the inner seal member. An outer seal member is aligned with the inner seal member. The outer seal member has a second sealing lip disposed outside the pericardium, surrounding an aperture through the outer seal member. The inner seal member is secured to the outer seal member. The firsts sealing lip is engaged against an inner surface of the pericardium. The second sealing lip is engaged against an outer surface of the pericardium. A cardiac device is inserted into the pericardium through the apertures of the inner and outer seal members.

## Claims

### Claim 1

A method of implanting a cardiac device, the method comprising
inserting an inner seal member through an opening in a pericardium about a living human heart, the inner seal member having a first sealing lip disposed inside the pericardium and surrounding an aperture through the inner seal member;
aligning an outer seal member with the inner seal member, the outer seal member having a second sealing lip disposed outside the pericardium and surrounding an aperture through the outer seal member;
securing the inner seal member to the outer seal member, with the firsts sealing lip engaged against an inner surface of the pericardium and the second sealing lip engaged against an outer surface of the pericardium; and
inserting a cardiac device into the pericardium through the apertures of the inner and outer seal members.

### Claim 2 (depends on 1)

The method of claim 1, wherein securing the inner seal member to the outer seal member comprises causing a relative rotation between the inner seal member and the outer seal member to engage a threaded connection between the inner seal member and the outer seal member.

### Claim 3 (depends on 1)

The method of claim 1, wherein the inner seal member is inserted in a collapsed condition, and expands within the pericardium to expose the first sealing lip.

### Claim 4 (depends on 1)

The method of claim 1, wherein inserting the inner seal member comprises first inserting a catheter through the pericardium opening, and then moving the inner seal member along the catheter.

### Claim 5 (depends on 4)

The method of claim 4, further comprising moving the outer seal member into position along the catheter.

### Claim 6 (depends on 1)

The method of claim 1, wherein each of the first and second sealing lips comprise a material selected from the group consisting of polyamide, polyurethane, polyetheretherketone, polyethylene, polypropylene, polycarbonate, polyethylene terephthalate and elastomers.

### Claim 7 (depends on 1)

The method of claim 1, wherein at least one of the first and second sealing lips is of a flexibility that increases with distance from a center of the aperture of the corresponding seal member.

### Claim 8 (depends on 1)

The method of claim 1, wherein at least one of the first and second sealing lips is reinforced with structural reinforcements.

### Claim 9 (depends on 1)

The method of claim 1, wherein at least one of the first and second sealing lips has surface gripping features, the method including engaging tissue of the pericardium with the surface gripping features.

### Claim 10 (depends on 1)

The method of claim 1, further comprising sealing the inserted cardiac device within at least one of the aperture through the outer seal member and the aperture through the inner seal member.

### Claim 11 (depends on 1)

The method of claim 1, wherein the cardiac device further comprises a cable extending through the inner and outer seal members following implantation of the cardiac device.

### Claim 12 (depends on 1)

The method of claim 1, wherein the cardiac device comprises a heart support sheath.

### Claim 13 (depends on 1)

The method of claim 1, wherein the cardiac device comprises a sensor responsive to the heart.

### Claim 14

A surgical cardiac device implantation system, comprising
an inner pericardium seal member defining an aperture and having a first sealing lip arranged to engage an inner surface of a pericardium surrounding a human heart;
an outer pericardium seal member defining an aperture and having a second sealing lip arranged to engage an inner surface of a pericardium when the inner and outer pericardium seal members are interconnected to sandwich a wall of the pericardium between the first and second sealing lips; and
an insertion tool configured to carry the inner pericardium seal member through an opening in the pericardium wall and to position the inner pericardium seal member while the inner and outer pericardium seal members are interconnected.

### Claim 15 (depends on 14)

The surgical cardiac device implantation system of claim 14, wherein the insertion tool comprises a catheter.

### Claim 16 (depends on 15)

The surgical cardiac device implantation system of claim 15, wherein the catheter defines an inner diameter of between about 10 and 50 mm.

### Claim 17 (depends on 15)

The surgical cardiac device implantation system of claim 15, wherein the catheter has a transparent wall.

### Claim 18 (depends on 15)

The surgical cardiac device implantation system of claim 15, wherein the catheter comprises a sensor.

### Claim 19 (depends on 18)

The surgical cardiac device implantation system of claim 18, wherein the sensor is responsive to at least one of temperature, pH-value, osmolarity and oxygen saturation.

### Claim 20 (depends on 15)

The surgical cardiac device implantation system of claim 15, wherein the catheter comprises a heating element.

### Claim 21 (depends on 15)

The surgical cardiac device implantation system of claim 15, wherein the catheter defines fluid circulation ducts for the circulation of thermal regulation fluids.

### Claim 22 (depends on 15)

The surgical cardiac device implantation system of claim 15, further comprising a heart support collapsible to fit within the catheter and expandable when ejected from the catheter.

### Claim 23 (depends on 14)

The surgical cardiac device implantation system of claim 14, wherein the tool comprises an inner portion configured to engage and position the inner pericardium seal member, and an outer portion movable with respect to the inner portion and configured to engage and position the outer pericardium seal member.

### Claim 24 (depends on 23)

The surgical cardiac device implantation system of claim 23, wherein the outer portion comprises a rotatable sleeve and wherein the inner and outer pericardium seal members comprise mating halves of a threaded coupling.

### Claim 25 (depends on 14)

The surgical cardiac device implantation system of claim 14, wherein the insertion tool comprises a guide wire.

### Claim 26 (depends on 25)

The surgical cardiac device implantation system of claim 25, wherein the insertion tool further comprises a dilator insertable along the guide wire.