IP Library › Granted Patent US 12,296,169
Granted Patent B2
US 12,296,169 · App. 18/604,465 · Granted May 13, 2025

Batteryless implantable microstimulators

Inventors: Ralph J. Zitnik (Santa Barbara, CA); Michael A. Faltys (Valencia, CA); Jacob A. Levine (West Hempstead, NY); Jesse M. Simon (Koh Phangan, TH)
Assignee: SetPoint Medical Corporation
A61N1/36053A61N1/37205A61N1/3756A61B5/24A61N1/36167A61N1/37518A61N1/378
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Quick Facts
Patent No.
US 12,296,169
App. No.
18/604,465
Granted
May 13, 2025
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 (32)

1. A system for nerve stimulation, the system comprising:

a microregulator comprising:

a receiver module configured to wirelessly receive a power signal;

at least one pair of electrodes configured to deliver electrical stimulation to a nerve;

a microprocessor configured to be powered by electrical energy received by the receiver module, wherein the microprocessor is configured to cause the at least one pair of electrodes to deliver the electrical stimulation to the nerve only when the power signal is being received by the receiver module; and

a cuff configured to secure the at least one pair of electrodes against the nerve; and

a charger configured to charge the microregulator, the charger including a transmitter that is configured to generate the power signal receivable by the receiver module of the microregulator.

2. The system of claim 1 , wherein the microregulator is configured for implantation into a patient's body, and wherein the charger is configured to be external to the patient's body.

3. The system of claim 1 , wherein the cuff defines a nerve channel that is configured to hold the nerve within the nerve channel.

4. The system of claim 1 , wherein the cuff comprises one or more conduction windows arranged to expose at least a portion of the at least one pair of electrodes for delivery of the electrical stimulation to the nerve.

5. The system of claim 1 , wherein the microprocessor is configured to cause the at least one pair of electrodes to deliver the electrical stimulation for modulating chronic inflammation.

6. The system of claim 1 , wherein the receiver module includes a power receiving coil, and the charger includes a transmitter coil.

7. The system of claim 1 , wherein the charger is configured to be wearable by a patient.

8. The system of claim 1 , wherein the charger is part of a pillow.

9. The system of claim 1 , wherein the receiver module, 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.

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

11. The system of claim 1 , wherein the microregulator is batteryless.

12. The system of claim 1 , further comprising an external controller module that is configured to allow a patient to set one or more parameters stimulation parameters.

13. The system of claim 1 , further comprising tester configured to test operation of the microregulator implanted in a patient.

14. A system for nerve stimulation, the system comprising:

a microregulator configured for implantation into a patient's body, the microregulator comprising:

a receiver module configured to wirelessly receive a power signal;

at least one pair of electrodes configured to deliver electrical stimulation to a nerve;

a microprocessor configured to be powered by electrical energy received by the receiver module, wherein the microprocessor is configured to cause the at least one pair of electrodes to deliver the electrical stimulation to the nerve only when the power signal is being received by the receiver module, wherein the electrical stimulation is configured to treat inflammation and/or an inflammatory disorder; and

a cuff configured to secure the at least one pair of electrodes against the nerve; and

an external charger configured to charge the microregulator when the microregulator is implanted within the patient's body, the charger including a transmitter that is configured to generate the power signal receivable by the receiver module of the microregulator.

15. The system of claim 14 , wherein the electrical stimulation has an amplitude of up to 3 mA and a duration of up to 30 seconds.

16. The system of claim 14 , wherein the electrical stimulation is delivered as a plurality of sub-bursts, each sub-burst having a duration of about 1-5 seconds.

17. The system of claim 14 , wherein the nerve is the vagus nerve in a cervical region of the neck, a sub-diaphragmatic portion of the vagus nerve, or a peripheral nerve.

18. The system of claim 14 , wherein the cuff defines a nerve channel that is configured to hold the nerve within the nerve channel.

19. The system of claim 14 , wherein the cuff comprises one or more conduction windows arranged to expose at least a portion of the at least one pair of electrodes for delivery of the electrical stimulation to the nerve.

20. The system of claim 14 , wherein the charger is part of a pillow or is configured to be wearable by a patient.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2024
From: ZITNIK, RALPH J.; FALTYS, MICHAEL A.; LEVINE, JACOB A.; SIMON, JESSE M.
To: SETPOINT MEDICAL CORPORATION
Reel/Frame 067020/0922 →
Continuity (8)
Continuation 17875327 · Jul 27, 2022
Continuation 16356906 · Mar 18, 2019
Continuation In Part 15411936 · Jan 20, 2017
Provisional Application 62286945 · Jan 25, 2016
Provisional Application 62286940 · Jan 25, 2016
Provisional Application 62286943 · Jan 25, 2016
Provisional Application 62281029 · Jan 20, 2016
Related Publication 20240216688A1 · Jul 4, 2024
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