Device and method to slow or stop the heart temporarily

• US 6,296,630 B1
• Filed: 02/25/1999
• Issued: 10/02/2001
• Est. Priority Date: 04/08/1998
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Altman, John D., Altman, Peter A.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): HAYES, MICHAEL J
• Application Number:
  US09/257,887
• Time in Patent Office: 950 Days
• Field of Search: 604/19, 604/20, 604/500, 604/503, 604/506, 604/508, 604/511, 604/246, 607/3, 607/4, 607/5, 607/120, 607/122
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

Implantable cardiac drug delivery systems. The systems are installed endocardially into a chamber in the heart, and are variously capable of delivering anti-arrhythmia agents into the heart wall, and into the epicardial space outside the heart, and into other chambers in the heart through the septa of the heart.

Claims

1. A method for controlling the motion of a heart of a patient, the heart having a heart wall and a myocardial conduction system, said method comprising the steps of:

inserting a catheter into the heart, the catheter having a distal end;

attaching the distal end of the catheter to the heart wall using a fixation structure;

injecting a block producing agent into a site in the myocardial conduction system through the catheter to produce a transient conduction block locally at the site in the myocardial conduction system to stop normal contraction of the heart; and

pacing the heart to induce contraction of the heart.

2. The method as in claim 1, wherein the block producing agent is cooled saline.

3. The method as in claim 1, wherein the injecting step is followed by performing a distal anastomosis during cardiac bypass surgery.

4. The method as in claim 1, wherein the patient is given systemic doses of agents to lower automaticity of cardiac myocyte contractions for the duration of the procedure.

5. The method as in claim 1, further comprising the step of ventillating the patient using a respirator, wherein the respirator is turned off at the same time that the pacing is slowed or stopped to provide for reduced muscle motion.

6. The method of claim 1 wherein the site within the heart wall is selected from the following group, the atrio-ventricular node, the infranodal structures, interventricular septum, sino-atrial node, Bachman'"'"'s bundle, and the HIS bundle.

7. The method of claim 1 wherein the fixation structure is a fixation helix.

8. A system for providing controlled asystole or bradycardia of a heart undergoing cardiac surgery, the heart having a heart wall, said system comprising:

a first catheter for local infusion of block producing agents into a site within the heart wall, the first catheter having a distal end, the distal end capable of being fixed to and penetrating within the heart wall;

a second catheter for electrical pacing of the heart; and

a controlling system that enables the combined control of the delivery of pacing energy and infusion of the block producing agents.

9. The system as in claim 8, further comprising a respirator, wherein the controlling system also controls the respirator in conjunction with the delivery of pacing energy.

10. The method of claim 8, wherein the block producing agent is cooled saline.

11. A system for controlling the motion of the heart of a patient upon demand of an operator, said system comprising:

an infusion system comprising a reservoir for holding a supply of a block producing agent and a catheter in fluid communication with the reservoir, said catheter having a distal tip capable of being attached to the heart and delivering the block producing agent to a depth within the heart;

a pacing system comprising a source of pacing energy and a pacing lead, said pacing lead having a distal tip adapted to contact the heart and deliver pacing signal to the heart;

a ventilator system adapted to provide air to the patient'"'"'s lungs;

a controller for controlling the infusion system, pacing system, and ventilator system, said controller being programmed to inject the block producing agent into the heart upon demand by the operator, said controller also being programmed to operate the pacing system to provide a slowed beating period in which the pacing system paces the heart in the range of 10-30 beats per minute upon injection of the block producing agent.

12. The system of claim 11 wherein:

the controller is further programmed to operate the pacing system to limit the duration of the slowed beating period to a predetermined length.

13. The system of claim 11 wherein:

the controller is further programmed to operate the ventilator to cease ventilation during the slowed beating period, and to resume ventilation after the slowed beating period.

14. The method of claim 11, wherein the block producing agent is cooled saline.

15. A system for controlling the motion of the heart of a patient upon demand of an operator, said system comprising:

an infusion system comprising a reservoir for holding a block producing agent and a catheter in fluid communication with the reservoir, said catheter having a distal tip capable of being attached to the heart and delivering the block producing agent to a depth within the heart;

a pacing system comprising a source of pacing energy and a pacing lead, said pacing lead having a distal tip adapted to contact the heart and deliver pacing signal to the heart;

a ventilator system adapted to provide air to the patient'"'"'s lungs;

a controller for controlling the infusion system, pacing system, and ventilator system, said controller being programmed to inject the block producing agent into the heart upon demand by the operator to stop the heart from beating, said controller also being programmed to operate the pacing system to pace the heart after a predetermined non-beating period in which the pacing system does not pace the heart.

16. The system of claim 15 wherein:

the controller is further programmed to operate the ventilator to cease ventilation during the non-beating period, and to resume ventilation after the non-beating period.

17. The method of claim 15, wherein the block producing agent is cooled saline.

18. A method for controlling the motion of a heart of a patient, the heart having a heart wall and a myocardial conduction system, said method comprising the steps of:

providing a catheter;

injecting cooled saline into the heart wall through the catheter to produce a transient conduction block locally at the site in the myocardial conduction system to stop normal contraction of the heart; and

pacing the heart to cause a contraction of the heart while injecting cooled saline.

19. A method for controlling the motion of a heart of a patient, the heart having a heart wall and a myocardial conduction system, said method comprising the steps of:

inserting a catheter into the heart, the catheter having a distal end;

attaching the distal end of the catheter to the heart wall using a fixation structure;

injecting cooled saline into a site within the heart wall through the catheter to produce a transient conduction block locally at the site in the myocardial conduction system to stop normal contraction of the heart; and

pacing the heart to cause a contraction of the heart.

20. The method of claim 19 wherein the site within the heart wall is selected from the following group, the atrio-ventricular node, the infranodal structures, interventricular septum, sino-atrial node, Bachman'"'"'s bundle, and the HIS bundle.