Method and apparatus using vagal stimulation for control of ventricular rate during atrial fibrillation

• US 5,916,239 A
• Filed: 11/24/1997
• Issued: 06/29/1999
• Est. Priority Date: 03/29/1996
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Purdue Research Foundation (Purdue University)
• Inventors: Elabbady, Tarek, Waninger, Matthew, Geddes, Leslie A., Schoenlein, William E., Bourland, Joe D.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/976,854
• Time in Patent Office: 582 Days
• Field of Search: 607/2, 607/4, 607/5, 607/9, 607/14, 607/44, 600/16, 600/17
• US Class Current: 607/14
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

A closed-loop, variable-frequency, vagal-stimulation apparatus for control of ventricular rate during atrial fibrillation. In one embodiment the apparatus includes a stimulator applied to the left vagus nerve and a controller programmed to automatically and continuously adjust the vagal stimulation frequency as a function of the difference between actual and desired ventricular excitation rates. In a second embodiment the apparatus includes a vagal nerve stimulator and a controller which automatically adjusts the vagal stimulation frequency as a function of the difference between ventricular excitation rate and arterial pulse rate in order to eliminate or minimize pulse deficit.

Claims

1. A closed-loop, variable-frequency, vagal-stimulation apparatus for control of ventricular rate during an ongoing atrial arrhythmia, comprising:

means for detecting an atrial arrhythmia;

means for sensing ventricular excitation rate;

means responsive to detection of said atrial arrhythmia for generating pulses for stimulation of the left vagus nerve at a stimulation frequency which is variable automatically as a function of the difference between actual and desired ventricular excitation rates, said adjusting means including means for changing said vagal stimulation frequency by a greater amount for one value of said ventricular rate difference than for a smaller value of said ventricular rate difference; and

means for delivering said pulses to said left vagus nerve.

2. The apparatus of claim 1, further comprising means for enabling generation of stimulating pulses by said generating means only in the presence of atrial fibrillation.

3. The apparatus of claim 2, wherein said means for sensing ventricular excitation rate senses QRS complexes and determines ventricular excitation rate therefrom.

4. The apparatus of claim 3, wherein said adjusting means includes means for changing said vagal stimulation frequency over a predetermined time interval by a greater amount for said one value than for said smaller value.

5. The apparatus of claim 4, wherein said adjusting means includes means for calculating a normalized deviation from said desired ventricular rate based on a predetermined tolerance value.

6. The apparatus of claim 5, wherein said adjusting means includes means for adding a value directly proportional to said normalized deviation to the vagal stimulation frequency to obtain a new vagal stimulation frequency.

7. The apparatus of claim 6, wherein said adjusting means includes means for adjusting said vagal stimulation frequency at intervals of approximately one second.

8. The apparatus of claim 1, wherein said adjusting means includes means for calculating a normalized deviation from said desired ventricular rate based on a predetermined tolerance value.

9. The apparatus of claim 1, wherein said adjusting means includes means for adding a value directly proportional to said ventricular rate difference to the vagal stimulation frequency to obtain a new vagal stimulation frequency.

10. A closed-loop, variable-frequency, vagal-stimulation method for control of ventricular rate during an ongoing atrial arrhythmia, comprising:

detecting an atrial arrhythmia;

sensing ventricular excitation rate;

automatically, upon detection of said atrial arrhythmia, determining a left vagal stimulation frequency and automatically adjusting said vagal stimulation frequency as a function of the difference between actual and desired ventricular excitation rates, said adjusting step including changing said vagal stimulation frequency by a greater amount for one value of said ventricular rate difference than for a smaller value of said ventricular rate difference;

generating pulses at said vagal stimulation frequency; and

delivering said pulses to a left vagus nerve.

11. The method of claim 10, further comprising the step of enabling generation of stimulating pulses only in the presence of atrial fibrillation.

12. The method of claim 11, wherein said sensing step includes sensing QRS complexes.

13. The method of claim 12, wherein said adjusting step includes changing said vagal stimulation frequency over a given time interval by a greater amount for said one value than for said smaller value.

14. The method of claim 13, wherein said adjusting step includes calculating a normalized deviation from said desired ventricular rate based on a predetermined tolerance value.

15. The method of claim 14, wherein said adjusting step includes adding a value directly proportional to said normalized deviation to the vagal stimulation frequency to obtain a new vagal stimulation frequency.

16. The method of claim 15, wherein said adjusting step includes adjusting said vagal stimulation frequency at intervals of approximately one second.

17. The method of claim 10, wherein said adjusting step includes calculating a normalized deviation from said desired ventricular rate based on a predetermined tolerance value.

18. The method of claim 10, wherein said adjusting step includes adding a value directly proportional to said ventricular rate difference to the vagal stimulation frequency to obtain a new vagal stimulation frequency.

19. A closed-loop, variable-frequency, vagal-stimulation method of controlling ventricular rate during atrial fibrillation without electrical stimulation of the heart, comprising:

detecting atrial fibrillation;

allowing said atrial fibrillation to persist;

sensing ventricular rate;

automatically, upon detection of said atrial fibrillation, determining a left vagal stimulation frequency in response to sensed ventricular rate relative to a desired value of ventricular rate, said determining step including increasing said vagal stimulation frequency by an amount directly proportional to a detected difference between sensed and desired ventricular excitation rates;

stimulating a left vagus nerve at said vagal stimulation frequency during said atrial fibrillation; and

terminating said vagal stimulation frequency upon cessation of said atrial fibrillation.