Neural stimulation devices and systems for treatment of chronic inflammation

• US 8,855,767 B2
• Filed: 11/15/2013
• Issued: 10/07/2014
• 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:
  US14/082,047
• Publication Number:
  US 20140074186A1
• Time in Patent Office: 326 Days
• Field of Search: 607/116, 607/33, 607/36
• 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 system for treating chronic inflammation in a patient, the system comprising:

an implantable microstimulator configured for implantation around a cervical portion of a vagus nerve to modulate inflammation by applying a low duty-cycle stimulation;

a charger configured to be worn around the patient'"'"'s neck and to charge the implantable microstimulator, the charger comprising an energizer coil configured to fit around the patient'"'"'s neck, the charger having an open configuration and a closed configuration, wherein in the open configuration the charger is configured to be placed around the patients neck and the energizer coil is an open circuit, wherein in the closed configuration the charger is configured to be secured around the patient'"'"'s neck and the energizer coil is a closed circuit that forms a solenoid loop around the patient'"'"'s neck; and

an external controller configured to set a dose amplitude and dose interval for the microstimulator.

2. The system of claim 1, further comprising a POD for securing the microstimulator within the patient.

3. The system of claim 1, wherein the system is configured to charge the implantable microstimulator for less than about 10 minutes per week.

4. The system of claim 1, wherein the charger comprises a belt-like loop that fastens around the patient'"'"'s neck so that power may be transmitted by the loop to the implant.

5. The system of claim 1, wherein the external controller comprises an electronic prescription pad.

6. The system of claim 1, wherein the implantable microstimulator comprises a hermetically sealed capsule body having at least two conductive regions, the capsule body surrounding a resonator, battery and an electronic assembly sealed within the capsule body, wherein the electronic assembly is connected to the capsule body by a suspension configured to absorb mechanical shock.

7. The system of claim 6, 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 regions of the capsule body.

8. A system for treating chronic inflammation in a patient, the system comprising:

an implantable microstimulator configured for implantation around a cervical portion of a vagus nerve to modulate inflammation by applying low duty-cycle stimulation to the vagus nerve;

a POD configured to hold the implantable microstimulator in contact with a patient'"'"'s vagus nerve;

a charger configured to be worn around the patient'"'"'s neck and to charge the implantable microstimulator implanted within the patient'"'"'s neck region, the charger comprising an energizer coil configured to fit around the patient'"'"'s neck, the charger having an open configuration and a closed configuration, wherein in the open configuration the charger is configured to be placed around the patients neck and the energizer coil is an open circuit, wherein in the closed configuration the charger is configured to be secured around the patient'"'"'s neck and the energizer coins a closed circuit a solenoid loop around the patient'"'"'s neck; and

an external controller configured to communicate with the microstimulator through the charger and to thereby set the dose amplitude and dose interval for the microstimulator,

wherein microstimulator is configured to continuously modulate inflammation while charging by the charger for less than 10 minutes per week.

9. The system of claim 8, wherein the system is configured to charge the implantable microstimulator for less than about 10 minutes per day.

10. The system of claim 8, wherein the charger comprises a belt-like loop that fastens around the patient'"'"'s neck so that power may be transmitted by the loop to the implant.

11. The system of claim 8, wherein the charger loop is magnetically fastened for quick release and electrical contact is made through one or more spring like contacts for each turn of the coil.

12. The system of claim 8, wherein the external controller comprises an electronic prescription pad.

13. The system of claim 8, wherein the implantable microstimulator comprises a hermetically sealed capsule body having at least two conductive regions, the capsule body surrounding a resonator, battery and an electronic assembly sealed within the capsule body, wherein the electronic assembly is connected to the capsule body by a suspension configured to absorb mechanical shock.

14. The system of claim 12, 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 regions of the capsule body.

15. A system for treating chronic inflammation in a patient, the system comprising:

an implantable, leadless microstimulator configured for implantation around a portion of a vagus nerve to modulate inflammation by applying low duty-cycle stimulation to the vagus nerve, the microstimulator comprising at least two electrically conductive contacts and a battery; and

a POD configured to removably hold the microstimulator in electrical communication with a patient'"'"'s vagus nerve, the POD comprising a shell and a channel, the shell defining a cavity configured to encapsulate the microstimulator, the channel extending longitudinally through POD and configured to removably receive the vagus nerve, wherein the cavity is also configured to encapsulate the electrically conductive contacts.

16. The system of claim 15, wherein the POD comprises at least two electrodes disposed around the channel that are configured to contact the vagus nerve when the vagus nerve is within the channel, wherein the at least two electrodes are in electrical communication with the at least two electrically conductive contacts.

17. The system of claim 15, wherein the POD comprises a slit that is configured to provide access to the cavity and channel in an open configuration and is configured to encapsulate the microstimulator within the cavity in a closed configuration.

18. The system of claim 15, further comprising an external controller configured to wirelessly communicate with the microstimulator and to thereby set a plurality of stimulator parameters for the microstimulator.

19. The system of claim 15, wherein the microstimulator comprises a capsule body enclosing the battery and an electronic assembly, wherein the two electrically conductive contacts are integrated into the capsule body.

20. The system of claim 19, wherein the microstimulator comprises spring contacts that electrically couple the electronic assembly with the two electrically conductive contacts.

21. The system of claim 15, further comprising a charger configured to generate an electromagnetic field that charges the battery.