IMPLANTING CARDIAC DEVICES

• US 20140194670A1
• Filed: 03/15/2013
• Published: 07/10/2014
• Est. Priority Date: 01/08/2013
• Status: Active Grant

• Current Assignee: Adjucor GmbH
• Original Assignee: Adjucor GmbH
• Inventors: Wildhirt, Stephen Manuel, Maier, Andreas
• Granted Patent: US 9,220,824 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0297 at least part of it being inflatable, e.g. for anchoring, sealing or removing
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: 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
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/839 of devices for mechanical circulatory actuation
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/867 using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

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

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.

2. 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.

3. 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.

4. 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.

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

6. 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.

7. 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.

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

9. 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.

10. 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.

11. 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.

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

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

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.

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

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

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

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

19. 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.

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

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

22. 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.

23. 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.

24. 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.

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

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