Neural stimulation devices and systems for treatment of chronic inflammation

• US 8,612,002 B2
• Filed: 12/23/2010
• Issued: 12/17/2013
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Faltys, Michael A., Simon, Jesse M., Liu, Yiming
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/978,250
• Publication Number:
  US 20110190849A1
• Time in Patent Office: 1,090 Days
• Field of Search: 607/33, 607/116, 607/118
• US Class Current: 607/33
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• 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

A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject'"'"'s neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.

Claims

1. 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;

a resonator within the sealed capsule body;

a battery within the sealed capsule body; and

an electronic assembly within the sealed capsule body, wherein the electronic assembly is connected to the capsule body by a suspension configured to absorb mechanical shock and make electrical contact;

wherein the electronic assembly comprises power management circuitry configured to receive power from the resonator to charge the battery, and a microcontroller configured to control stimulation of the vagus nerve from the conductive capsule regions.

2. The device of claim 1 wherein the capsule body comprises a ceramic body with hermetically sealed titanium alloy ends and integral platinum-iridium electrodes attached thereto.

3. The device of claim 1, further comprising an overtemperature control including a thermister that is configured to shut the device down if the operating temperature exceeds a 41°

C.

4. The device of claim 1, wherein the battery comprises a Lithium solid-state battery.

5. The device of claim 1, further comprising voltage limiters to limit the amount of power that can charge the battery from the resonator.

6. The device of claim 1, further comprising load stabilizers to reduce communication errors due to power load fluctuations.

7. The device of claim 1, wherein the at least two electrically conductive capsule regions comprise the ends of the capsule body.

8. The device of claim 1, wherein the at least two electrically conductive capsule regions are made from a resistive titanium alloy to reduce magnetic afield absorption.

9. The device of claim 1, wherein the suspension comprises clips or springs.

10. The device of claim 1, further comprising an H-bridge current source with capacitor isolation connecting each of the two electrically conductive capsule regions.

11. The device of claim 1, further comprising a temperature sensor configured to detune the resonator to prevent energy absorption if the temperature exceeds a predetermined value.

12. The device of claim 1, further comprising an overvoltage sensor configured to detune the resonator to prevent energy absorption.

13. The device of claim 1, further comprising a current limiter configured to limit current from the resonator to enable reliable powerup.

14. The device of claim 1, wherein the resonator comprises a coil and capacitor configured to resonate at about 131 KHz+/−

2%.

15. The device of claim 1, wherein the resonator comprises a ferrite coil wherein the ferromagnetic material is chosen to maximize permittivity in the operating range and minimize permittivity and energy absorption from higher frequency sources such as MRI and Diathermy devices.

16. The device of claim 1, wherein the electronic assembly comprises telemetry circuitry configured to detect and demodulate control information from the resonator and communicate the control information with the microcontroller.

18. The device of claim 1, wherein the capsule body has a hemi-cylindrical nerve channel.

19. The device of claim 18, wherein the electrically conductive capsule regions are configured to apply stimulation to the vagus nerve within the nerve channel.

17. A leadless, implantable microstimulator device for treating chronic inflammation by stimulation of a cervical region of a vagus nerve, the device comprising:

a hermetically sealed capsule body having two electrically conductive capsule end regions separated by a central non-conductive region, wherein the capsule body has a hemi-cylindrical nerve channel, further wherein each conductive region is configured to electrically connect to an electrode for applying stimulation to a vagus nerve within the nerve channel;

a resonator, battery and electronic assembly within the sealed capsule body; and

a spring suspension connecting the electronic assembly to the capsule body to absorb mechanical shock;

wherein the electronic assembly comprises power management circuitry configured to receive power from the resonator to charge the battery, and a microcontroller configured to control stimulation of the vagus nerve from the conductive capsule regions.