Implantable microstimulators and inductive charging systems

• US 10,314,501 B2
• Filed: 01/20/2017
• Issued: 06/11/2019
• Est. Priority Date: 01/20/2016
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Zitnik, Ralph J., Faltys, Michael A., Levine, Jacob A., Simon, Jesse M.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/411,936
• Publication Number:
  US 20170202467A1
• Time in Patent Office: 872 Days
• Field of Search: 607 60
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6877 Nerve
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• 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 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• 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

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 inductively charged and/or communicated with using the external charger. The implant may include a receiving antenna wrapped around the battery and/or the housing of the microstimulator/microregulator and/or may include a high magnetic permeability material in order to serve as a magnetic core for the antenna coil. Wearable inductive chargers/communication devices for inductively communicating with (including charging) an implanted microstimulator are described herein, which may include magnetically conductive material to enhance communication with an implant, including sub-diaphragmatic implants. Also described herein are inductive chargers/communication devices, including belts, and pads (e.g., mattresses) able to recharge an implanted neurostimulation device.

Claims

1. A method of treating an inflammatory disease in a patient by sub-diaphragmatic stimulation of a vagus nerve, the method comprising:

applying electrical stimulation from a leadless microstimulator coupled at least partially around a sub-diaphragmatic vagus nerve;

repeating the application of electrical stimulation of the sub-diaphragmatic vagus nerve to inhibit inflammation; and

inductively communicating with the leadless microstimulator using an inductive coil positioned adjacent to an abdominal region of the patient.

2. The method of claim 1, wherein the leadless microstimulator comprises a batteryless microstimluator configured to apply electrical stimulation only when inductively communicating with the inductive coil.

3. The method of claim 1, further comprising implanting the leadless microstimulator by positioning a nerve cuff over the sub-diaphragmatic vagus nerve wherein the leadless microstimulator is inserted within the nerve cuff so that two or more electrical contacts on the microstimulator are in electrical contact with the sub-diaphragmatic vagus nerve.

4. The method of claim 1, further comprising implanting the leadless microstimulator by positioning the microstimulator within a nerve cuff in electrical contact with the sub-diaphragmatic vagus nerve.

5. The method of claim 1, wherein the leadless microstimulator is sealed within a nerve cuff around the sub-diaphragmatic vagus nerve.

6. The method of claim 1, wherein inductively communicating comprises inductively charging the microstimulator from a belt worn around the patient'"'"'s abdominal region.

7. The method of claim 1, wherein inductively communicating comprises inductively charging the microstimulator from a mattress on which the patient is laying.

8. The method of claim 1, wherein applying electrical stimulation comprises applying electrical stimulation of greater than 6.5 V.

9. The method of claim 1, wherein repeating the application of electrical stimulation comprises repeating the electrical stimulation at between every hour and every 12 hours.

10. The method of claim 1, wherein inductively communicating comprises emitting a positional signal from the leadless microstimulator to assist in orienting the inductive coil prior to inductively communicating.

11. The method of claim 1, wherein inductively communicating comprises receiving inductive signals using a tri-axial inductive link within the leadless microstimulator.

12. The method of claim 1, wherein inductively communicating comprises applying a radially cycling field from outside of the patient'"'"'s abdomen to communicate with the leadless microstimulator.

13. A method of treating an inflammatory disease in a patient by sub-diaphragmatic stimulation of a vagus nerve, the method comprising:

applying electrical stimulation from a leadless and batteryless microstimulator coupled at least partially around a sub-diaphragmatic vagus nerve; and

repeating the application of electrical stimulation of the sub-diaphragmatic vagus nerve to inhibit inflammation;

wherein the leadless and batteryless microstimluator applies electrical stimulation only when inductively communicating with an inductive coil positioned adjacent to an abdominal region of the patient.

14. A method of treating an inflammatory disease by sub-diaphragmatic stimulation of a vagus nerve, the method comprising:

positioning a nerve cuff over a sub-diaphragmatic vagus nerve of a patient by longitudinally introducing the nerve cuff on a posterior sub-diaphragmatic vagus nerve;

positioning a microstimulator within the nerve cuff in electrical contact with the sub-diaphragmatic vagus nerve; and

sealing the microstimulator within the nerve cuff; and

applying electrical stimulation from the microstimulator to the sub-diaphragmatic vagus nerve to inhibit inflammation; and

inductively charging the microstimulator from a belt worn around an abdominal region of the patient.