Method and apparatus for neuromodulation and phsyiologic modulation for the treatment of metabolic and neuropsychiatric disease

• US 20030018367A1
• Filed: 07/19/2002
• Published: 01/23/2003
• Est. Priority Date: 07/23/2001
• Status: Active Grant

• Current Assignee: DiLorenzo Biomedical, LLC
• Original Assignee: DiLorenzo Biomedical, LLC
• Inventors: DiLorenzo, Daniel John
• Granted Patent: US 7,599,736 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 2/00 Magnetotherapy
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The present invention teaches a method and apparatus for physiological modulation, including neural and gastrointestinal modulation, for the purposes of treating several disorders, including obesity, depression, epilepsy, and diabetes. This includes chronically implanted neural and neuromuscular modulators, used to modulate the afferent neurons of the sympathetic nervous system to induce satiety. Furthermore, this includes neuromuscular stimulation of the stomach to effect baseline and intermittent smooth muscle contraction to increase gastric intraluminal pressure, which induces satiety, and stimulate sympathetic afferent fibers, including those in the sympathetic trunk, splanchnic nerves, and greater curvature of the stomach, to augment the perception of satiety.

Claims

1. An apparatus for use in treating disease whereby fibers of the autonomic nervous system are stimulated, comprising:

(A)a pulse generator; and

(B)a modulator.

2. An apparatus as recited in claim 1, further comprising

(A)an attachment fixture attached to said pulse generator;

and

(B)wherein said attachment fixture is adapted to fix said implantable pulse generator to an interior organ of a living body.

3. An apparatus for use in treating disease as recited in claim 1, wherein at least one of afferent fibers of the autonomic nervous system, afferent fibers of the sympathetic nervous system, efferent fibers of the sympathetic nervous system, afferent fibers of the vagus nerve are stimulated.

4. An apparatus for use in treating disease, as recited in claim 1, wherein said modulator further comprises a device selected from the group consisting of monopolar electrodes, bipolar electrodes, quadrapolar electrodes, multipolar electrodes, optical stimulation devices, electromagnetic stimulation devices, radiofrequency stimulation devices, electrostatic stimulation devices, magnetic stimulation coils, vibratory stimulation devices, mechanical stimulation devices, acoustic stimulation devices, drug delivery catheters, chemical stimulation devices, electrolytic stimulation devices, thermal stimulation devices, neural stimulation devices, and neural inhibition devices.

5. As apparatus as recited in claim 1, whereby said pulse generator provides stimulation using a technique selected form the group consisting of electrical energy, chemical agents, pharmacological agents, optical energy, magnetic energy, electromagnetic energy as a stimulator.

6. A device for treating disease comprising a modulator, adapted to be implanted in the sympathetic nervous system, said modulator further comprising:

(A)an electrode;

(B)a connecting wire electrically connected to said electrode; and

(C)a connecting cable formed from said connecting wire.

7. A device for treating disease, as recited in claim 6, wherein said electrode is adapted to be placed in contact along the inner surface of a nerve cuff.

8. A device for treating disease, as recited in claim 6, further comprising a plurality of electrodes.

9. A device for treating disease, as recited in claim 6, further comprising a nerve cuff end plate attached to the nerve cuff.

10. A device for treating disease, as recited in claim 6, further comprising a longitudinal electrode array electrically attached to said connecting wire adapted for penetration into a nerve.

11. A device for treating disease, as recited in claim 6, wherein said electrode array is mounted within a regeneration tube array, contained within the nerve cuff.

14. A device as recited in claim 13, wherein said modulator is adapted to communicate with a portion of the sympathetic nervous system.

15. A device as recited in claim 13, wherein said modulator is adapted to communicate selectively with afferent fibers of the parasympathetic nervous system.

16. A device as recited in claim 13, wherein said modulator is adapted to communicate selectively with afferent fibers of the vagus nerve.

17. A device as recited in claim 13, wherein said modulator further comprises a sympathetic trunk neuromodulatory interrface in communication with said implantable pulse generator via said connecting cable.

18. A device for treating disease, as recited in claim 13, wherein said modulator further comprises a thoracic splanchnic neuromodulatory interface connected to said implantable pulse generator via said connecting cable.

19. A device for treating disease, as recited in claim 13, wherein said modulator further comprises a vagus neuromdulatory interface connected to said implantable pulse generator via said connecting cable.

20. A device for treating disease, as recited in claim 13, wherein said modulator further comprises an abdominal splanchnic neuromodulatory interface connected to said implantable pulse generator via said connecting cable.

21. A device for treating disease, as recited in claim 13, wherein said neuromodulatory interface further comprises an device selected from the group consisting of monopolar electrodes, bipolar electrodes, quadrapolar electrodes, multipolar electrodes, drug delivery catherters, optical stimulation devices, magnetic stimulation coils, electromagnetic stimulation devices, thermal stimulation devices, mechanical stimulation devices, vibratory stimulation devices, acoustic stimulation devices, neural stimulation devices, and neural inhibition devices.

12. A device for treating disease, as recited in 6, wherein said regeneration tube array is electrically connected to said connecting cable by an element of a connecting wire array.

13. A device for treating disease, comprising:

(A)an implantable pulse generator;

(B)a connecting cable attached to said implantable pulse generator; and

(C)a modulator.

22. A method for treating disease comprising at least one of modulating sympathetic afferent neurons, modulating sympathetic efferent neurons, modulating selectively parasympathetic afferents, modulating selectively vagus nerve afferent fibers, modulating gastric circular muscle layer fibers, modulating locus ceruleus neurons, modulating intermediolateral nucleus neurons, modulating sympathetic trunk neurons, modulating splanchnic nerve neurons.

23. A method for treating diseaseas recited in claim 22, further comprising modulating gastric pylorus.

24. A method for treating odiseaseas recited in claim 22, further comprising modulating multiple modalities.

26. An apparatus as recited in claim 25, further comprising an attachment fixture attached to said implantable pulse generator;

and wherein said attachment fixture is adapted to fix said implantable pulse generator to an interior organ of a living body.

28. A device as recited in claim 27, wherein said pulse generator is capable of stimulating fibers of the circular muscle layer.

29. A device as recited in claim 27, wherein said pulse generator is capable of stimulating gastric muscle fibers to increase the intraluminal pressure.

30. A method for treating disease as recited in claim 22, wherein said modulating is applied for the treatment of disease selected from the group consisting of obesity, eating disorders, anorexia nervosa, bulimia, diabetes, neuropsychiatric, depression, epilepsy.

25. An apparatus for use in treating disease whereby fibers of the sympathetic nervous system are stimulated, comprising:

(A)an pulse generator; and

(B)a modulator.

27. A device for treating obesity by stimulation of muscle fibers of the stomach, comprising:

(A)pulse generator, wherein said pulse generator employs at least one of tonic stimulation or non-peristaltic time varying stimulation; and

(B)modulator.