Supporting a heart

• US 10,130,456 B2
• Filed: 03/15/2013
• Issued: 11/20/2018
• Est. Priority Date: 01/08/2013
• Status: Active Grant

• Current Assignee: Adjucor GmbH
• Original Assignee: Adjucor GmbH
• Inventors: Wildhirt, Stephen Manuel, Maier, Andreas
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US13/839,455
• Publication Number:
  US 20140194678A1
• Time in Patent Office: 2,076 Days
• Field of Search: 600 37, 128897-899
• 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 heart shaped cup including;

a self-expanding sheath sized to fit about an apex and at least a portion of ventricles of a heart in a living body, wherein the self-expanding sheath comprises an internal contour that corresponds to a natural outer contour of the heart according to a scaling factor within a range of 1.01 to 1.2, wherein the outer contour of the heart is scaled by the scaling factor to obtain the inner contour of the self-expanding sheath,

a left expandable unit assembly configured to selectively apply pressure to a left ventricle of the heart via hydraulic or pneumatic actuation, and

a right expandable unit assembly configured to selectively apply pressure to a right ventricle of the heart via hydraulic or pneumatic actuation,

wherein the left and right expandable unit assemblies are arranged asymmetrically around the heart; and

a plurality of discrete markings arranged on the heart shaped cup, wherein

the plurality of discrete markings is detectable from outside the body with the sheath implanted within the body, and

the plurality of discrete markings is disposed in a spaced arrangement corresponding to predetermined anatomical points of reference configured to aid in proper positioning of the heart shaped cup.

2. The system of claim 1, wherein the plurality of discrete markings are each of a different color than a surface of the support system adjacent each marking.

3. The system of claim 1, wherein the plurality of discrete markings are each formed of a more radiopaque material than a surface of the support system adjacent each marking.

4. The system of claim 1, wherein the self-expanding sheath defines an upper edge parallel to and vertically offset from a valve plane of the heart, wherein at least one of the plurality of discrete markings is disposed adjacent the upper edge.

5. The system of claim 1, wherein at least one of the plurality of discrete markings has a unique form selected from the group consisting of an oval, a polygon, and an alphanumeric character.

6. The system of claim 1, wherein at least one of the plurality of discrete markings comprises a discrete structural difference in a portion of the sheath.

7. The system of claim 1, wherein:

each of the left and right expandable unit assemblies comprises a plurality of expandable chambers; and

the system further comprises a fluid conduit extending from at least one of the left and right expandable unit assemblies to a source of pressurized fluid.

8. The system of claim 1, wherein at least one of the plurality of discrete markings is disposed on a surface of the sheath.

9. The heart support system of claim 1, wherein the self-expanding sheath includes an active pharmaceutical agent.

10. The heart support system of claim 1, wherein the sheath includes an extra-cellular matrix protein.

11. The system of claim 1, wherein the self-expanding sheath is configured to hold itself in place about the heart without use of an adhesive.

12. A heart support system comprising:

a geometrically customized heart support apparatus, including;

a self-expanding sheath having a contour customized to a particular patient and sized to fit about an apex and at least a portion of ventricles of a heart in a living body, wherein

the self-expanding sheath-has an inner contour configured to correspond to a natural outer contour of the heart according to a scaling factor within a range of 1.01 to 1.2, wherein the outer contour of the heart is scaled by the scaling factor to obtain the inner contour of the self-expanding sheath,

a plurality of expandable units configured to selectively apply pressure to different regions of the heart via hydraulic or pneumatic actuation, wherein the expandable units are configured to be spaced apart about a periphery of the heart, and

a plurality of discrete markings applied to the self-expanding sheath for facilitating placement of the heart support system, wherein

each of the plurality of discrete markings is composed of a material detectable via an imaging technique while implanted in the living body, and

the plurality of discrete markings is disposed in a spaced arrangement corresponding to predetermined anatomical points of reference configured to facilitate correct placement of the heart support system; and

an implantation delivery device for implanting the heart support system in the living body in a minimally invasive procedure, wherein

the heart support system is collapsible to fit within a delivery lumen of the implantation delivery device.

13. The system of claim 12, wherein the delivery device has a wall formed of a transparent material and through which a first discrete marking of the plurality of discrete markings is visible with the heart support system collapsed within the delivery device.

14. The system of claim 12, wherein the delivery device comprises a catheter.

15. The system of claim 12, wherein the delivery device comprises a delivery marking disposed on a portion of the delivery device configured to be inserted into the body during implantation of the heart support system.

16. The system of claim 12, wherein, in producing the heart support system, a three-dimensional image of the particular patient'"'"'s heart is obtained, and the inner contour is geometrically customized to correspond to dimensions of the three-dimensional image.

17. The system of claim 12, wherein a first marking of the plurality of markings is disposed, after implantation of the geometrically customized heart support apparatus, adjacent an apex of the heart.

18. A heart support system comprising:

a heart support apparatus comprising;

a self-expanding sheath configured to fit about an apex and at least a portion of ventricles of a heart in a living body, the self-expanding sheath having an internal contour that corresponds to a natural contour of the heart according to a scaling factor within a range of 1.01 to 1.2, wherein the outer contour of the heart is scaled by the scaling factor to obtain the inner contour of the self-expanding sheath,

a plurality of expandable chambers independently configured to selectively apply pressure to different regions of the heart via hydraulic or pneumatic actuation, each expandable chamber being disposed at least in part on the self-expanding sheath, wherein the plurality of expandable chambers is configured to be spaced apart about a periphery of the heart,

a sensor configured to be positioned in electrical communication with the heart, wherein the sensor is electrically responsive to a heart parameter, and

a plurality of markings disposed in a spaced arrangement upon the heart support apparatus corresponding to predetermined anatomical points of reference, wherein

the plurality of markings are each configured for detection via an imaging technique during implantation of the heart support apparatus to support proper orientation of the heart support apparatus around the heart,

wherein the heart support apparatus is configured to be implanted in a minimally invasive procedure, wherein the heart support apparatus is collapsible and in a collapsed state for implanting;

at least one conduit in fluid communication with at least a first expandable chamber of the plurality of expandable chambers; and

a supply unit configured to control supply of the fluid to the plurality of expandable chambers, wherein the plurality of expandable chambers are configured to expand towards the heart in coordination with a natural pumping function of the heart to support heart function.

19. The heart support system of claim 18, wherein a portion of a first marking of the plurality of discrete markings is disposed on or adjacent to an upper edge of the self-expanding sheath.

20. The heart support system of claim 18, wherein the imaging technique is one of a CT scan and an Mill scan.

21. The heart support system of claim 18, wherein each of the plurality of markings is a fluorescent marking.

22. The heart support system of claim 18, wherein the heart support apparatus, in a collapsed state, is implanted using a delivery lumen.

23. The heart support system of claim 18, wherein the plurality of discrete markings are each applied to an exterior surface of the heart support apparatus.

24. The heart support system of claim 18, wherein a first marking of the plurality of discrete markings is in a first geometric form different than a second geometric form of a second marking of the plurality of discrete markings.

25. The heart support system of claim 18, wherein a first marking of the plurality of discrete markings is a visual marking.

26. The heart support system of claim 18, wherein the sheath is custom made according to a three-dimensional image of the heart.