Methods for Intracardiac Surgery and Intracardiac Delivery of Therapies and Devices

• US 20150012069A1
• Filed: 07/07/2014
• Published: 01/08/2015
• Est. Priority Date: 07/05/2013
• Status: Active Grant

• Current Assignee: Emory University
• Original Assignee: Emory University
• Inventors: Puskas, John D.
• Granted Patent: US 9,950,168 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• 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 of performing an intracardiac procedure comprising the step of conducting controlled intermittent diastolic arrest (CIDA).

2. The method of claim 1, wherein CIDA is conducted to cause expansion of the chambers of the heart to a volume between about 75 to 200% of their normal end-diastolic volume.

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

4. The method of claim 2, wherein CIDA is conducted so that cardiac arrest with cardiac distention to such end-diastolic volume is achieved in about 5 to 15 seconds.

5. The method of claim 1, wherein CIDA is conducted so that diastolic arrest is maintained for a time between about 5 and 90 seconds.

6. The method of claim 5, wherein diastolic arrest is achieved for up to about 60 seconds.

7. The method of claim 1, wherein the intracardiac procedure is a heart valve repair or replacement.

8. The method of claim 7, wherein the procedure is mitral valve repair or replacement.

9. The method of claim 7, wherein the procedure is aortic valve repair or replacement.

10. The method of claim 7, wherein the procedure is pulmonic valve repair or replacement.

11. The method of claim 7, wherein the procedure is tricuspid valve repair or replacement.

12. The method of claim 1, wherein the procedure is, or includes, cardioscopy.

13. The method of claim 1 wherein the procedure is creation or closure of an apical access hole with sutures or insertion of an apical access port or device.

14. The method of claim 1, wherein the procedure performed in or on the heart is performed with the use of a catheter or catheter-delivered device, therapy, or agent.

15. The method of claim 1, wherein the procedure performed in or on the heart is performed via a left ventricular apical access port or device, with an instrument, catheter, or device or therapy introduced into the left ventricle via the left ventricular apex.

16. The method of claim 1, wherein the procedure performed in or on the heart is a diagnostic or therapeutic electrophysiology procedure to diagnose or treat a cardiac arrhythmia.

17. The method of claim 1, wherein the procedure is the delivery of an active agent to the heart.

18. The method of claim 17, 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.

19. The method of claim 1 wherein 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.

20. The method of claim 1, wherein CIDA is conducted to achieve a specific degree of distention of a cardiac chamber optimal to facilitate a specific intracardiac procedure by a series of one or more trial CIDA arrests that are timed and during which an imaging modality is used to select the optimal degree of cardiac chamber distention.

21. The method of claim 1, wherein CIDA is conducted to achieve a specific degree of distention of the left ventricle optimal to facilitate the visualization, localization and capture of the leaflets of the mitral valve for the purposes of mitral valve repair or modification by transcatheter or transapical insertion of a clip or other appliance that reduces mitral regurgitation.

22. The method of claim 1, wherein CIDA is conducted to achieve a specific degree of relaxation and distention of the left ventricle and left ventricular outflow tract optimal to facilitate balloon aortic valvuloplasty (balloon dilation of the aortic valve), optimal to facilitate accurate sizing of the aortic annulus, and optimal to facilitate transcatheter delivery of a prosthetic aortic valve.