Implantable medical device having multiple electrode/sensor capability and stimulation based on sensed intrinsic activity

• US 20060167497A1
• Filed: 01/27/2005
• Published: 07/27/2006
• Est. Priority Date: 01/27/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K., Armstrong, Scott A.
• Granted Patent: US 8,600,521 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

In one embodiment, an implantable neurostimulator comprises a pulse generator that generates an electrical pulse signal to stimulate a neural structure in a patient, a stimulation lead assembly coupled to the pulse generator for delivering the electrical pulse signal to the neural structure, a plurality of sensors coupled to the pulse generator, and sensor select logic. Each sensor is individually selectable and the sensor select logic selects any two or more of the plurality of sensors for sensing a voltage difference between the selected sensors. In other embodiments, two or more physiologic parameters are sensed. In yet another embodiment, a method comprises sensing intrinsic electrical activity on a person'"'"'s nerve and stimulating the nerve based on the sensed intrinsic electrical activity of the nerve.

Claims

7. An implantable neurostimulator, comprising:

a pulse generator that provides an electrical pulse signal to stimulate a cranial nerve in a patient;

a stimulation lead assembly coupled to said pulse generator for delivering said electrical pulse signal to said cranial nerve, said lead assembly having a proximal end coupled to said pulse generator and a distal end comprising a stimulation electrode assembly coupled to said cranial nerve; and

a plurality of sensor elements coupled to said pulse generator and that sense at least two physiological parameters selected from the group consisting of an action potential in a nerve tissue, a heart parameter, a temperature, a blood parameter, and brain wave activity.

8. The implantable neurostimulator of claim 7, wherein at least one of said plurality of sensor elements comprises an electrode and a second of said plurality of said sensor elements is selected from the group consisting of an electrode, a thermocouple, a pressure transducer, an acoustic transducer, and a photonic element.

9. The implantable neurostimulator of claim 7, wherein one of said plurality of sensor elements comprises a nerve electrode that senses an action potential in a nerve tissue.

10. The implantable neurostimulator of claim 9, wherein said nerve electrode is adapted to couple to a vagus nerve of the patient for sensing action potentials traveling along said vagus nerve.

11. The implantable neurostimulator of claim 10, wherein said nerve electrode does not comprise part of said stimulation electrode assembly.

12. The implantable neurostimulator of claim 7, further comprising:

a controller that receives and analyzes signals representative of said at least two physiological parameters; and

said pulse generator generates said electrical pulse stimulation signal in response to an analysis by said controller of said signals representative of said at least two physiological parameters.

13. An implantable neurostimulator, comprising:

a pulse generator that provides a therapeutic electrical pulse signal to a nerve in a patient;

a stimulation lead assembly coupled to said pulse generator for delivering said electrical pulse to said nerve, said lead assembly having a proximal end coupled to said pulse generator and a distal end comprising a stimulation electrode assembly coupled to said nerve;

a plurality of sensor elements coupled to said pulse generator for sensing at least two physiological parameters selected from the group consisting of an action potential in a nerve tissue, a heart parameter, a temperature, a blood parameter, and brain wave activity, each of said sensor elements adapted to provide a sensor signal representative of at least one physiological parameter; and

a controller that receives and analyzes sensor signals from at least two of said sensor elements;

wherein said pulse generator generates said therapeutic electrical pulse signal in response to said analysis by said controller.

14. The implantable neurostimulator of claim 13 wherein said pulse generator also delivers a therapeutic electrical pulse signal at predetermined intervals

15. A method of providing electrical neurostimulation therapy to a patient, comprising:

receiving sensor signals from at least two sensors in a patient;

performing an analysis based on said at least two sensor signals to determine whether electrical neurostimulation is needed; and

providing an electrical pulse to a nerve in the patient when it is determined that electrical neurostimulation is needed.

16. The method of claim 15 further comprising programming at least one register in an implantable neurostimulator to select said at least two sensors that are to be used for receiving sensor signals.

17. The method of claim 15 further comprising providing an electrical pulse to the nerve at programmable time intervals.

18. A method of providing electrical neurostimulation therapy to a patient, comprising:

sensing at least two physiological parameters selected from the group consisting of voltage fluctuations in a nerve tissue, a heart parameter, a temperature, a blood parameter, and brain wave activity;

performing an analysis based on said at least two sensed physiological parameters to determine whether electrical neurostimulation is needed; and

providing an electrical pulse to a nerve in the patient when it is determined that electrical neurostimulation is needed.

19. The method of claim 18 further comprising providing an electrical pulse to the nerve at programmable time intervals.

20. A method, comprising:

sensing intrinsic electrical activity on a cranial nerve of a patient; and

stimulating the cranial nerve based on the sensed intrinsic electrical activity.

1. An implantable neurostimulator, comprising:

a pulse generator that provides an electrical pulse signal to stimulate a neural structure in a patient;

a stimulation lead assembly coupled to said pulse generator for delivering said electrical pulse signal to said neural structure, said lead assembly having a proximal end coupled to said pulse generator and a distal end comprising a stimulation electrode assembly coupled to said neural structure;

a plurality of sensors coupled to said pulse generator, each said sensor being individually selectable; and

sensor select logic that selects any two or more of said plurality of sensors for sensing a voltage difference between the selected sensors.

2. The implantable neurostimulator of claim 1 wherein the neural structure comprises a cranial nerve.

3. The implantable neurostimulator of claim 1 wherein the neural structure comprises a vagus nerve.

4. The implantable neurostimulator of claim 1 further comprising a programmable register and wherein each sensor is selectable by writing a predetermined value to said register.

5. The implantable medical device of claim 1 wherein said pulse generator comprises a housing and at least one of said plurality of sensor electrodes is integral with said housing.

6. The implantable medical device of claim 1 wherein said pulse generator comprises an electrically conductive housing and wherein said at least one of said plurality of sensor electrodes comprises said housing.

21. The method of claim 20 wherein stimulating the nerve comprises blocking intrinsic electrical activity from reaching the person'"'"'s brain.

22. The method of claim 20 wherein the cranial nerve is a vagus nerve and stimulating the nerve increases the efficacy of vagus nerve stimulation.

23. An implantable neurostimulator, comprising:

a pulse generator that provides an electrical pulse signal to a cranial nerve in a patient, said pulse generator being programmable to define a plurality of stimulation parameters that characterize said signal;

a stimulation lead assembly coupled to said pulse generator for delivering said electrical pulse signal to said cranial nerve, said lead assembly having a proximal end coupled to said pulse generator and a distal end comprising a stimulation electrode assembly coupled to said cranial nerve;

a sensing electrode assembly coupled to said pulse generator and said cranial nerve that senses electrical activity on said cranial nerve; and

control logic that causes said cranial nerve to be stimulated based on said sensed intrinsic electrical activity on said cranial nerve.

24. The implantable neurostimulator of claim 22 wherein the control logic causes the nerve to be stimulated to increase the efficacy of vagus nerve stimulation.

23-1. The implantable neurostimulator of claim 22 wherein the control logic causes the nerve to be stimulated to block intrinsic electrical activity of said cranial nerve.