Treatment of the autonomic nervous system

• US 8,792,986 B2
• Filed: 02/16/2010
• Issued: 07/29/2014
• Est. Priority Date: 07/07/2004
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Cigaina, Valerio
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US12/706,608
• Publication Number:
  US 20100211130A1
• Time in Patent Office: 1,624 Days
• Field of Search: 607/40
• 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 electro stimulator comprising:

a pulse generator to provide electrostimulation;

one or more leads with electrodes;

a sensor to sense heart rate parameters; and

a controller which, based upon sensed heart rate variability where the heart rate variability is based upon the sensed heart rate parameters, stimulates or withholds electrostimulation form the pulse generator through the one or more leads, wherein the controller performs embedded algorithms for the purpose of analyzing the heart rate variability, wherein the algorithms utilize frequency domain analysis, and wherein the frequency domain analysis utilizes auto regression type analysis.

2. The implantable non-cardiac neuromuscular electrostimulator of claim 1, further comprising a metal housing wherein the metal housing functions as the sensor.

3. The implantable non-cardiac neuromuscular electrostimulator of claim 1, wherein the algorithms also utilize time domain analysis.

4. The implantable non-cardiac neuromuscular electrostimulator of claim 1, wherein the frequency domain analysis also utilizes fast Fourier transformation methods.

5. An implantable gastro-intestinal neuromuscular pulse generator system comprising:

a pulse generator to provide electrostimulation;

one or more leads with electrodes for attachment to gastro-intestinal tissue; and

a controller which stimulates or withholds electrostimulation, based upon sensed heart rate variability where the heart rate variability is based upon sensed heart rate parameters, to the gastro-intestinal tissue through the one or more leads.

6. The implantable gastro-intestinal neuromuscular pulse generator system of claim 5, wherein the sensed heart rate parameters include:

length between heart heat 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.

7. The implantable gastro-intestinal neuromuscular pulse generator system of claim 6, wherein the sensed heart rate parameters is the length between heart beat intervals (R to R).

8. The implantable gastro-intestinal neuromuscular pulse generator system of claim 6, wherein the sensed heart rate parameters are measured and compared prior to, and after, stimulation or withholding of electrostimulation.

9. A method of treating disorders of the body by gastro intestinal electrical stimulation comprising regulating the autonomic nervous system of a patient wherein regulating comprises sensing heart rate variability (HRV), computing an HRV ratio, and stimulating or withholding electrical stimulation based upon the ratio.

10. The method of claim 9, 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 the electrostimulation;

one or more leads with electrodes; and

a controller whereby the electrostimulation may be provided to the patient through the one or more leads.

11. The method of claim 9, wherein the regulation of the autonomic nervous system includes a defined balance between parasympathetic and sympathetic nervous systems.

12. A method of treating a disorder of the autoimmune system comprising regulating the autonomic nervous system of a patient wherein regulating comprises sensing gastric or intestinal rate variability and, based upon the sensed gastric or intestinal rate variability, providing or withholding gastro-intestinal electrical stimulation.

13. The method of claim 12, further comprising sensing heart rate variability of the patient;

wherein an implantable non-cardiac neuromuscular electrostimulator is used to provide the gastro-intestinal electrical stimulation;

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 the sensed heart rate variability and gastric rate variability, stimulates or withholds electrostimulation from the pulse generator through the one or more leads.

14. The method of claim 12, wherein the regulation of the autonomic nervous system includes a defined balance between parasympathetic and sympathetic nervous systems.

15. The method of claim 12, wherein providing or withholding gastro-intestinal electrical stimulation comprises providing or withholding electrical stimulation to gastro-intestinal tract tissue.

16. The method of claim 12, where providing or withholding gastro-intestinal electrical stimulation comprises providing or withholding electrical stimulation to a vagus nerve system or splanchnic nerve system.

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

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

19. A method for treatment of a functional disorder related to a the balance of the autonomic nervous system with functional prevalence of the sympathetic or the parasympathetic component in a patient, said method comprising:

implanting a first electrical stimulation device comprising one or more first electrical stimulation leads and a first electrical connector for attachment to a first pulse generator such that the one or more first electrical stimulation leads are attached to, or adjacent to, the patient'"'"'s stomach, whereby electrical stimulation can be provided to the stomach through the one or more first electrical stimulation leads;

implanting a second electrical stimulation device comprising one or more second electrical stimulation leads and a second electrical connector for attachment to the first or potentially a second pulse generator such that the one or more second electrical stimulation leads are attached to, or adjacent to, the patient'"'"'s small intestines, whereby electrical stimulation can be provided to the patient'"'"'s small intestines through the one or more second electrical stimulation leads; and

placing a sensing element on or in the patient'"'"'s body to monitor the patient heart rate variability (HRV) and compute the P1/P2 ratio, and wherein the sensing element activates at least one of the first or second electrical stimulation devices to supply programmable electrical stimulation of the patient'"'"'s GI tract;

wherein the sensing element resumes monitoring and computation of the HRV ratio and further adjusts the stimulation to achieve a desired ratio.

20. A method for treatment of a functional disorder related to a balance of the autonomic nervous system with functional prevalence of the sympathetic or the parasympathetic component in a patient, said method comprising:

implanting an electrical stimulation device comprising one or more electrical stimulation leads and an electrical connector for attachment to a pulse generator such that the one or more first electrical stimulation leads are attached to, or adjacent to, the patient'"'"'s stomach, whereby electrical stimulation can be provided to the stomach through the one or more electrical stimulation leads; and

placing a sensing element on or in the patient'"'"'s body to monitor the patient heart rate variability (HRV) and compute an HRV ratio, and wherein the sensing element activates the electrical stimulation device to supply programmable electrical stimulation of the patient'"'"'s stomach;

wherein the sensing element resumes monitoring and computation of the HRV ratio and further adjusts the stimulation to achieve a desired ratio.