CLOSED-LOOP VAGUS NERVE STIMULATION

• US 20160067497A1
• Filed: 04/10/2014
• Published: 03/10/2016
• Est. Priority Date: 11/17/2009
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: FALTYS, Michael A., LEVINE, Jacob A.
• Granted Patent: US 11,051,744 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6877 Nerve
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the controller is configured to operate using closed-loop feedback.

Claims

1. A method of closed-loop modulation of the inflammatory reflex, the method comprising:

sensing bioelectric activity on a vagus nerve from a microstimulator implanted around a cervical portion of the vagus nerve;

controlling one or more characteristic of stimulation of the microstimluator based on the sensed activity, wherein the one or more characteristic of stimulation is selected from the group consisting of;

duration, intensity, frequency, on-time and off-time; and

stimulating the vagus nerve using the microstimulator to apply a low duty-cycle stimulation to the vagus nerve.

2. The method of claim 1, further comprising:

sensing electrical activity from the heart; and

comparing the sensed electrical activity form the heart with the sensed activity on the vagus nerve.

3. The method of claim 1, further comprising comparing the sensed activity on the vagus nerve to a baseline level of activity on the vagus nerve.

4. The method of claim 1, further comprising comparing the sensed activity on the vagus nerve to a level of activity on the vagus nerve indicative of an inflammatory state.

5. The method of claim 1, further comprising:

performing a spectral analysis of the sensed electrical activity; and

identifying changes in the power of the sensed electrical activity at one or more frequencies.

6. The method of claim 5, wherein the one or more frequencies are between 0 and 100 Hz.

7. The method of claim 1, wherein the step of sensing activity on a vagus nerve includes counting electrical spikes.

8. The method of claim 7, wherein the electrical spikes are counted with a spike counter in an ASIC in the microstimulator.

9. The method of claim 1, determining whether the sensed activity is indicative of an inflammatory state.

10. The method of claim 1, determining whether the sensed activity is indicative of vagus nerve stimulation accommodation.

11. A leadless, implantable microstimulator device for treating chronic inflammation, the device comprising:

a hermetically sealed capsule body;

at least two electrically conductive capsule regions, wherein each region electrically connects to an electrode for applying stimulation to a vagus nerve and sensing electrical activity from the vagus nerve;

a power source within the sealed capsule body; and

a controller within the capsule body configured to control the application of low duty-cycle stimulation of the vagus nerve using feedback from sensed vagus nerve activity in a closed-loop stimulation regime.

12. The device of claim 11, further comprising an ASIC within the capsule body having a spike counter for counting electrical spikes of the sensed electrical activity from the vagus nerve.

13. The device of claim 12, further comprising a memory in communication with the spike counter for storing the counts of the spike counter.

14. The device of claim 11, wherein the electrode is a tri-polar, or a pseudotripolar, or a tetrode electrode.

15. The device of claim 11, further comprising an ASIC within the capsule body having a variable amplifier.

16. A method of closed-loop modulation of an inflammatory reflex, the method comprising:

sensing electrical activity on a vagus nerve during a baseline period from a microstimulator implanted around a cervical portion of the vagus nerve;

sensing electrical activity on the vagus nerve during an inflammatory episode;

determining a neural signature for each of a plurality of inflammatory states based on the sensed electrical activity from the baseline and the sensed electrical activity from the inflammatory episode;

sensing electrical activity on the vagus nerve at a first time period;

determining an inflammatory state based on a comparison of the sensed electrical activity to a neural signature;

controlling one or more characteristic of stimulation of the microstimluator based on the determined inflammatory state, wherein the one or more characteristic of stimulation is selected from the group consisting of;

duration, intensity, frequency, on-time and off-time.

17. A system for closed-loop modulation of an inflammatory reflex, the system comprising:

an implantable microstimlulator adapted to be applied around a cervical portion of a vagus nerve;

a sensing electrode on the implantable microstimulator configured to detect activity on the vagus nerve;

a controller configured to control one or more characteristic of stimulation of the microstimluator based on the sensed activity, wherein the one or more characteristic of stimulation is selected from the group consisting of;

duration, intensity, frequency, on-time and off-time.