SUPPORTING A HEART

• US 20140194678A1
• 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 10,130,456 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• 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: A61F 2250/0097 Visible markings, e.g. indicia
• 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 60/531 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 60/867 using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
• CPC Class Codes: A61M 60/88 Percutaneous cables
• CPC Class Codes: A61N 1/0597 Surface area electrodes, e.g. cardiac harness
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: 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

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

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.

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

3. 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.

4. 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.

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

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

7. 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.

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

9. 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.

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

11. 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.

12. 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.

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

14. 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.

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

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

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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.