Methods for intracardiac surgery and intracardiac delivery of therapies and devices

• US 9,950,168 B2
• Filed: 07/07/2014
• Issued: 04/24/2018
• Est. Priority Date: 07/05/2013
• Status: Active Grant

• Current Assignee: Emory University
• Original Assignee: Emory University
• Inventors: Puskas, John D.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US14/324,583
• Publication Number:
  US 20150012069A1
• Time in Patent Office: 1,387 Days
• Field of Search: 607 62, 607116, 604 96, 604272, 604507, 604508, 604523, 604532, 606194
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

A method of performing an intracardiac procedure using controlled intermittent diastolic arrest (CIDA) to expand the chambers of the heart to a volume between about 75 to 200% of their normal end-diastolic volume. In one embodiment, CIDA is conducted so that cardiac arrest with cardiac distention is achieved in about 5 to 15 seconds and diastolic arrest is maintained for a time between about 5 and 90 seconds. Intracardiac procedures that are facilitated with CIDA include heart valve repair or replacement. The method involves the use of CIDA and wherein the procedure is performed in or on the heart with the use of a catheter or catheter-delivered device, therapy, or agent. In one aspect, the heart is accessed during CIDA via a left ventricular apical access port or device. In one aspect CIDA is conducted via stimulation of the vagal nerve alone or in combination with one or more of an acetylcholinesterase inhibitor, a β-adrenergic receptor blocker, and/or a calcium channel blocker.

Claims

1. A method, comprising:

conducting controlled intermittent diastolic arrest (CIDA) comprising;

stimulating, by a stimulator, a vagal nerve for a first amount of time; and

applying, by an application device, at least one pharmacological agent, wherein the first amount of time and the at least one pharmacological agent are selected to achieve a diastolic distension volume of at least a portion of a heart for a second amount of time; and

restoring, by a restoring system, a heart beat of the heart after;

a third amount of time during which the at least a portion of the heart fills and expands to reach the diastolic distension volume; and

the second amount of time at which the least the portion of the heart is at the diastolic distension volume.

2. The method of claim 1, wherein the diastolic distension volume is 75 to 200% of a normal end-diastolic volume.

3. The method of claim 2, wherein the diastolic distension volume is 100 to 150% of the normal end-diastolic volume.

4. The method of claim 2, wherein the third amount of time is 5 to 15 seconds.

5. The method of claim 1, wherein the second amount of time is 5 to 90 seconds.

6. The method of claim 5, wherein the second amount of time is about 60 seconds.

7. The method of claim 1, further comprising performing, by a intracardiac procedure device while heart is at the diastolic distension volume for the second amount of time, an intracardiac procedure, wherein the intracardiac procedure includes a heart valve repair or replacement of at least one of a mitral valve, an aortic valve, a pulmonic valve, a tricuspid valve.

8. The method of claim 1, further comprising performing, by a intracardiac procedure device while heart is at the diastolic distension volume for the second amount of time, an intracardiac procedure, wherein the intracardiac procedure includes at least one of:

cardioscopy;

creation or closure of an apical access hole with sutures; and

insertion of an apical access port or device.

9. The method of claim 1, further comprising performing, by an intracardiac procedure device while the heart is at the diastolic distension volume for the second amount of time, an intracardiac procedure, wherein the intracardiac procedure is one that is performed at least one of:

in or on the heart is performed with the use of at least one of a catheter or catheter-delivered device, therapy, or agent; and

via a left ventricular apical access port or device, with an instrument, catheter, or device or therapy introduced into the left ventricle via a left ventricular apex of the heart.

10. The method of claim 1, further comprising performing, by an intracardiac procedure device while heart is at the diastolic distension volume for the second amount of time, an intracardiac procedure, wherein the intracardiac procedure is at least one of:

a diagnostic or therapeutic electrophysiology procedure to diagnose or treat a cardiac arrhythmia; and

the delivery of an active agent to the heart.

11. The method of claim 10, wherein the active agent is a medication, stem cell, gene therapy, growth factor, angiogenic factor, other factor to facilitate regeneration of part of the heart, or acellular matrix for tissue engineering of the heart.

12. The method of claim 1, wherein the pharmacological agent is at least one of an acetylcholinesterase inhibitor, a beta-adrenergic receptor blocker, and a calcium channel blocker.

13. A method, comprising:

conducting at least one trial controlled intermittent diastolic arrest (CIDA), comprising;

conducting, by a CIDA system comprising at least a stimulator device and a restoring system, the at least one trial CIDA for an amount of time; and

determining, by an imaging device, a degree of cardiac chamber distension during the at least one trial CIDA arrest;

associating, by the CIDA system, an optimal degree of cardiac chamber distention for performing an intracardiac procedure with the amount of time where the determined degree of cardiac chamber distention is the optimal degree of cardiac distension; and

performing, by the CIDA system, CIDA for an amount of time based on a selection of at least one of an optimal degree of cardiac chamber distention and the intracardiac procedure.

14. A system for conducting controlled intermittent diastolic arrest (CIDA), comprising:

a stimulator configured to stimulate a vagal nerve for a first amount of time; and

an application device configured to apply at least one pharmacological agent, wherein the first amount of time and the at least one pharmacological agent are selected based on achieving a diastolic distension volume of at least a portion of a heart for a second amount of time; and

a restoring system configured to restore a heartbeat of the heart after;

a third amount of time during which the at least a portion of the heart fills and expands to reach the diastolic distension volume; and

the second amount of time at which the least the portion of the heart is at the diastolic distension volume.

15. The system of claim 14, wherein the diastolic distension volume is 75 to 200% of a normal end-diastolic volume.

16. The system of claim 14, wherein the third amount of time is 5 to 15 seconds.

17. The system of claim 14, wherein the second amount of time is 5 to 90 seconds.

18. The system of claim 14, further comprising an intracardiac procedure device configured to perform, while heart is at the diastolic distension volume for the second amount of time, an intracardiac procedure, wherein the intracardiac procedure includes at least one of:

a heart valve repair or replacement of at least one of a mitral valve, an aortic valve, a pulmonic valve, a tricuspid valve;

cardioscopy;

creation or closure of an apical access hole with sutures; and

insertion of an apical access port or device;

a diagnostic or therapeutic electrophysiology procedure to diagnose or treat a cardiac arrhythmia; and

the delivery of an active agent to the heart;

or wherein the intracardiac procedure is one that is performed at least one of;

in or on the heart is performed with the use of at least one of a catheter or catheter-delivered device, therapy, or agent; and

via a left ventricular apical access port or device, with an instrument, catheter, or device or therapy introduced into the left ventricle via a left ventricular apex of the heart.

19. The system of claim 18, wherein the active agent is a medication, stem cell, gene therapy, growth factor, angiogenic factor, other factor to facilitate regeneration of part of the heart, or acellular matrix for tissue engineering of the heart.

20. The system of claim 14, wherein-the pharmacological agent is at least one of an acetylcholinesterase inhibitor, a beta-adrenergic receptor blocker, and a calcium channel blocker.