IP Library Granted Patent US 11,471,681
Granted Patent B2
US 11,471,681 · App. 16/356,906 · Granted Oct 18, 2022

Batteryless implantable microstimulators

Inventors: Ralph J. Zitnik (Santa Barbara, CA); Michael A. Faltys (Valencia, CA); Jacob A. Levine (West Hempstead, NY); Jesse M. Simon (Los Angeles, CA)
Assignee: SetPoint Medical Corporation
A61N1/36053A61N1/3756A61N1/37205A61B5/24A61N1/36167A61N1/378A61N1/37518
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,471,681
App. No.
16/356,906
Granted
Oct 18, 2022
Kind
B2
Abstract

Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be leadless and batteryless.

Claims (34)

1. A batteryless and leadless microregulator for nerve stimulation, the microregulator comprising:

a wireless power receiver configured to receive a power signal;

a microprocessor powered by the power signal received by the wireless power receiver;

at least one pair of electrodes configured to deliver electrical stimulation using the power signal received by the wireless power receiver; and

a cuff forming a nerve channel configured to hold a nerve within the nerve channel, wherein the cuff is configured to secure the at least one pair of electrodes against the nerve within the nerve channel,

wherein the microprocessor is configured to apply energy to the at least one pair of electrodes only when the power signal is being received by the wireless power receiver, further wherein the microprocessor and electrodes are not connected to a battery.

2. The microregulator of claim 1 , wherein the wireless power receiver, the microprocessor, and at least a portion of the at least one pair of electrodes are encapsulated by a liquid crystal polymer, wherein the liquid crystal polymer is encapsulated by the cuff.

3. The microregulator of claim 2 , wherein the liquid crystal polymer forms a plurality of conduction windows on the at least one pair of electrodes that are aligned with the plurality of conduction windows in the cuff.

4. The microregulator of claim 1 , further comprising a non-volatile memory in communication with the microprocessor, wherein the microprocessor is programmed to log dose compliance in the non-volatile memory.

5. The microregulator of claim 1 , further comprising a plurality of shape memory metal struts configured to bias the cuff into a closed configuration.

6. The microregulator of claim 1 , further comprising a thermal protection circuit with a thermistor in electrical communication with the wireless power coil receiver, the thermal protection circuit configured to provide an open circuit when the thermistor measures a temperature that equals or exceeds a predetermined or set temperature.

7. The microregulator of claim 6 , wherein the predetermined or set temperature is about 41.5 degrees Celsius.

8. The microregulator of claim 6 , wherein the thermistor is positioned proximate the wireless power receiver.

9. The microregulator of claim 6 , wherein the thermistor is positioned proximate one of the electrodes of the one or more electrodes.

10. The microregulator of claim 1 , wherein the wireless power receiver comprises a power receiving coil having a ferrite core within the power receiving coil.

11. The microregulator of claim 1 , wherein the at least one pair of electrodes are made at least in part of platinum or a platinum alloy.

12. The microregulator of claim 11 , wherein the at least one pair of electrodes are made at least in part of a platinum-iridium alloy.

13. The microregulator of claim 1 , wherein the at least one pair of electrodes are spring cut.

14. The microregulator of claim 3 , wherein the conduction windows are dispersed substantially around an entire circumference of the cuff.

15. A batteryless and leadless microregulator for nerve stimulation, the microregulator comprising:

a wireless power receiver configured to receive a power signal;

a microprocessor powered by the power signal received by the wireless power receiver;

a demodulator in electrical communication with the wireless power receiver and the microprocessor for receiving information from the power signal;

at least one pair of electrodes configured to deliver electrical stimulation using the power signal received by the wireless power receiver; and

a nerve cuff that encapsulates the wireless power receiver, the microprocessor, the demodulator, and at least a portion of the pair of electrodes, the nerve cuff having a nerve channel and a slit that provides access to the nerve channel, wherein the nerve cuff is configured to adopt an open configuration in which the slit is open to expose the at least one pair of electrodes within the nerve channel, and a closed configuration in which the slit is closed,

wherein the microprocessor is configured to apply energy to the at least one pair of electrodes only when the power signal is being received by the wireless power receiver, further wherein the microprocessor and electrodes are not connected to a battery.

16. A method for stimulating a nerve to treat inflammation and/or an inflammatory disorder, the method comprising:

externally and wirelessly applying energy to an implanted leadless and batteryless microregulator, the implanted leadless and batteryless microregulator having a nerve cuff including a nerve channel, the nerve cuff encircling the nerve and securing the nerve in electrical communication with a pair of electrodes disposed within the nerve channel; and

delivering an electrical stimulation to the nerve from the pair of electrodes while applying the energy to the implanted leadless and batteryless microregulator to treat the inflammation and/or the inflammatory disorder, wherein the implanted leadless and batteryless microregulator is configured to condition the electrical stimulation based at least in part on a signal transmitted with the applied energy.

17. The method of claim 16 , wherein the electrical stimulation has an amplitude of up to 3 mA and a duration of up to 30 seconds.

18. The method of claim 16 , wherein the electrical stimulation is delivered as a plurality of sub-bursts, each sub-burst having a duration of about 1-5 seconds.

19. The method of claim 16 , wherein the nerve is the vagus nerve in a cervical region of the neck.

20. The method of claim 16 , wherein the nerve is a sub-diaphragmatic potion of the vagus nerve.

21. The method of claim 16 , wherein the nerve is a peripheral nerve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 11, 2021
From: ZITNIK, RALPH J.; FALTYS, MICHAEL A.; LEVINE, JACOB A.; SIMON, JESSE M.
To: SETPOINT MEDICAL CORPORATION
Reel/Frame 058091/0380 →
Continuity (6)
Continuation In Part 15411936 · Jan 20, 2017
Provisional Application 62286945 · Jan 25, 2016
Provisional Application 62286943 · Jan 25, 2016
Provisional Application 62286940 · Jan 25, 2016
Provisional Application 62281029 · Jan 20, 2016
Related Publication 20190275328A1 · Sep 12, 2019
Cited By (6)
US 12,296,169 US 12,402,826 US 12,444,497 US 12,465,768 US 12,582,819 US 12,649,059