Implanting cardiac devices

• US 10,123,875 B2
• Filed: 12/29/2015
• Issued: 11/13/2018
• 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): Hulbert, Amanda
• Application Number:
  US14/982,741
• Publication Number:
  US 20170007404A1
• Time in Patent Office: 1,050 Days
• 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 for implanting a self-expanding cardiac device, the method comprising:

providing the self-expanding cardiac device configured to fit about an apex and at least a portion of ventricles of a living heart such that an upper edge of the self-expanding cardiac device is parallel to and vertically offset from a valve plane of the living heart upon implanting, wherein

the vertical offset is between 1 mm and 30 mm, and

the self-expanding cardiac device comprises

a self-expanding sheath,

a plurality of expandable units each disposed at least in part on the self-expanding sheath,

at least one conduit in fluid communication with at least a first expandable unit of the plurality of expandable units, and

at least one sensor configured for positioning against the living heart, and

at least one lead or second conduit connected to at least one of the self-expanding sheath and the at least one sensor;

inserting, in a collapsed state, the self-expanding cardiac device through an aperture of a pericardium about the living heart of a patient using a minimally invasive procedure;

releasing the self-expanding cardiac device to cause the self-expanding cardiac device to automatically transform from the collapsed state to an expanded state; and

orienting the self-expanding cardiac device relative to the living heart;

wherein, upon orienting,

the self-expanding sheath has an internal contour that corresponds to an outer contour of the living heart such that a spacing between the outer contour and the inner contour is substantially constant, and

the self-expanding cardiac device is held in place surrounding the living heart absent an adhesive.

2. The method of claim 1, wherein:

the self-expanding cardiac device comprises at least one marking; and

orienting the self-expanding cardiac device comprises, after inserting the self-expanding cardiac device,

obtaining, through an imaging technique, one or more images of the self-expanding device within the pericardium, and

identifying, through imaging, the at least one marking.

3. The method of claim 1, further comprising connecting the at least one conduit and the at least one lead or second conduit to a supply unit configured to supply energy and fluid to the self-expanding cardiac device.

4. The method of claim 3, further comprising implanting the supply unit in one of a thoracic cavity and an abdominal cavity of the patient.

5. The method of claim 1, wherein a first sensor of the at least one sensor comprises an electrode.

6. The method of claim 1, wherein providing the self-expanding cardiac device comprises:

obtaining a three-dimensional model of a surface of the living heart, and

selecting the self-expanding cardiac device to be sized based on the three-dimensional model.

7. The method of claim 6, wherein:

obtaining the three-dimensional model comprises obtaining the three-dimensional model through medical imagery of the living heart; and

selecting the self-expanding cardiac device comprises

determining, from the three-dimensional model, a plurality of anatomical points of reference, and

using the plurality of anatomical points to size the self-expanding cardiac device.

8. The method of claim 7, wherein the self-expanding cardiac device is custom made for the living heart.

9. The method of claim 1, wherein providing the self-expanding cardiac device comprises providing the self-expanding cardiac device within a lumen of a catheter.

10. A method for implanting a self-expanding cardiac device, the method comprising:

providing a self-expanding cardiac device geometrically configured for a living heart of a patient, wherein

the self-expanding cardiac device comprises

a self-expanding sheath,

a plurality of expandable units each disposed at least in part on the self-expanding sheath,

at least one conduit in fluid communication with at least a first expandable unit of the plurality of expandable units,

at least one sensor configured for positioning against the living heart, and

at least one lead or second conduit connected to at least one of the self-expanding sheath and the at least one sensor,

the self-expanding cardiac device is formed to fit about an apex and a least a portion of ventricles of the living heart having, when in an expanded state, an internal contour that corresponds to an outer contour of the living heart such that a gap between the outer contour and the internal contour is at all points less than 8 mm;

inserting, in a collapsed state, the self-expanding cardiac device through an aperture of a pericardium about the living heart of the patient using a minimally invasive procedure;

releasing the self-expanding cardiac device to cause the self-expanding cardiac device to automatically transform from the collapsed state to an expanded state; and

orienting the self-expanding cardiac device relative to the living heart.

11. The method of claim 10, wherein, upon orienting the self-expanding cardiac device, the self-expanding cardiac device is held in place surrounding the living heart absent an adhesive.

12. The method of claim 10, wherein the at least one sensor is configured to detect at least one parameter of a) a heart functionality and b) an environmental condition.

13. The method of claim 10, wherein the at least one parameter comprises at least one of heart rate, ventricular pressure, systolic blood pressure, diastolic blood pressure, pressure applied to a surface of the living heart, fluid presence, acidity, electrical resistance, osmolarity, oxygen saturation and flow through a vessel.

14. The method of claim 10, further comprising providing the self-expanding cardiac device within a lumen of a catheter.

15. The method of claim 10, wherein the self-expanding sheath has an upper edge positioned between about 1 mm and 2 cm below a valve plane of the living heart, when implanted about the living heart.

16. The method of claim 10, wherein the at least one conduit is a pneumatic conduit.