Treatment of the autonomic nervous system

• US 20060058851A1
• Filed: 07/06/2005
• Published: 03/16/2006
• Est. Priority Date: 07/07/2004
• Status: Active Grant

• Current Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Inventors: Cigaina, Valerio
• Granted Patent: US 7,664,551 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Systems and methods are provided for modulating the autonomic nervous system by the electrical stimulation of the neuro-muscular system of a patient, and include an implantable electrical system for gastrointestinal stimulation which incorporates a heart rate sensor to indicate the neurovegetative patient condition, to initiate and terminate stimulation at specific locations, and an algorithm to automatically control electrical stimulation frequency, interval, amplitude, or a combination of such parameters for adaptive treatment of obesity, anorexia, other eating disorders, diseases related with the so called “metabolic syndrome” (e.g., impaired glucose tolerance and diabetes type 2, GERD, systemic hypertension, early arterovascular degeneration, early senility, and the like), and disorders related to a pathologic inbalance of the autonomic nervous system.

Claims

1. An implantable non-cardiac neuromuscular electrostimulator comprising a pulse generator to provide electrostimulation;

one or more leads with electrodes; and

a controller which, based upon sensed heart rate parameters, stimulates or withholds electrostimulation from the pulse generation through the one or more leads.

2. The implantable non-cardiac neuromuscular electrostimulator of claim 1, further comprising a sensor to sense the heart rate parameters.

3. The implantable non-cardiac neuromuscular electrostimulator of claim 2, further comprising a metal housing wherein the metal housing functions as the sensor.

4. The implantable non-cardiac neuromuscular electrostimulator of claim 1, wherein the controller has imbedded algorithms for the purpose of analyzing heart rate variability.

5. The implantable non-cardiac neuromuscular electrostimulator of claim 2, wherein the controller has imbedded algorithms for the purpose of analyzing heart rate variability.

6. The implantable non-cardiac neuromuscular electrostimulator of claim 5, wherein the algorithms utilize time domain analysis.

7. The implantable non-cardiac neuromuscular electrostimulator of claim 5, wherein the algorithms utilize frequency domain analysis.

8. The implantable non-cardiac neuromuscular electrostimulator of claim 7, wherein the frequency domain analysis utilizes fast Fourier transformation methods.

9. The implantable non-cardiac neuromuscular electrostimulator of claim 7, wherein the frequency domain analysis utilizes auto regression type analysis.

10. A implantable gastrointestinal neuromuscular pulse generator system comprising:

a pulse generator to provide electrostimulation;

one or more leads with electrodes for attachment to gastrointestinal tissue; and

a controller which stimulates or withholds electrostimulation, based upon sensed heart rate parameters, to the gastrointestinal tissue through the one or more leads.

11. The implantable gastrointestinal neuromuscular pulse generator system of claim 10, wherein the sensed heart rate parameters include:

length between heart beat intervals (R to R);

length between intra-beat intervals (P-Q), (P-R), (R-T), (T-P), or any other combining lengths;

length of T wave;

or

combinations thereof.

12. The implantable gastro-intestinal neuromuscular pulse generator system of claim 11, wherein the sensed heart rate parameters is the length between heart beat intervals (R to R).

13. The implantable gastrointestinal neuromuscular pulse generator system of claim 11, wherein the sensed heart rate parameters are measured and compared prior to, and after, stimulation or withholding of electrostimulation.

14. A method of treating disorders of the body by gastro-intestinal electrical stimulation based upon regulation of the autonomic nervous system.

15. The method of claim 14, wherein an implantable non-cardiac neuromuscular electrostimulator is used to provide the gastro-intestinal electrical stimulation and wherein the implantable non-cardiac neuromuscular electrostimulator comprises a pulse generator to provide electrostimulation;

one or more leads with electrodes; and

a controller which, based upon sensed heart rate parameters, stimulates or withholds electrostimulation from the pulse generation through the one or more leads.

16. The method of claim 14, wherein the regulation of the autonomic nervous system includes a defined balance between parasympathetic and sympathetic nervous systems.

17. A method of treating disorders by gastrointestinal electrical stimulation based upon regulation of the autonomic nervous system using sensed variability of gastric or intestinal electrograms.

18. The method of claim 17, wherein an implantable non-cardiac neuromuscular electrostimulator is used to provide the gastrointestinal electrical stimulation and wherein the implantable non-cardiac neuromuscular electrostimulator comprises a pulse generator to provide electrostimulation;

one or more leads with electrodes; and

a controller which, based upon sensed heart rate parameters, stimulates or withholds electrostimulation from the pulse generation through the one or more leads.

19. The method of claim 17, wherein the regulation of the autonomic nervous system includes a defined balance between parasympathetic and sympathetic nervous systems.

20. A method of treating an autonomic nervous system related disorder using electrical stimulation of nerve tissue or muscle tissue by altering parasympathetic activity.

21. The method of claim 20, wherein the autonomic nervous system related disorder is obesity.

22. The method of claim 20, wherein the autonomic nervous system related disorder is a disorder of the autoimmune system.

23. The method of claim 20, wherein the muscle tissue is gastrointestinal tract tissue.

24. The method of claim 20, wherein the nerve tissue includes the vagus nerve system or splanchnic nerve system.

25. A method of treating obesity by gastro intestinal electrical stimulation based upon the relationship between sensed heart rate variability and sensed gastric rate variability.

26. A method of electrically stimulating the gastrointestinal tract during a body'"'"'s sleep mode based upon sensed variability of heart rate or gastric rate.

27. (canceled)