Implantable nerve stimulator having internal electronics without ASIC and methods of use

• US 10,850,104 B2
• Filed: 02/06/2018
• Issued: 12/01/2020
• Est. Priority Date: 07/10/2015
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Nassif, Rabih
• Primary Examiner(s): Malamud, Deborah L
• Application Number:
  US15/889,844
• Publication Number:
  US 20180333581A1
• Time in Patent Office: 1,029 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable pulse generator that includes a current source/sink generator is disclosed herein. The current source/sink generator includes a current drive differential amplifier. The current driver differential amplifier is configured to selectively source current to, or sink current from a target tissue. The current drive differential amplifier includes an inverting input and a non-inverting input. One of the inputs of the current drive differential amplifier is connected to a virtual ground, and the other is connected to a current command. A stimulation controller can supply a voltage to the other of the inputs of the current drive differential amplifier to select either current sourcing or current sinking.

Claims

1. A method of controlling circuitry of an implantable neurostimulator to selectively source or sink current to an implantable lead electrically coupled thereto comprising a plurality of electrodes positionable proximate to a target region within a patient'"'"'s body for delivering electrical stimulation to the target region, the method comprising:

identifying a desired operation of a first differential amplifier, wherein the first differential amplifier is located within a hermetically sealed internal volume of a bio-compatible housing of the implantable neurostimulator, and wherein the first differential amplifier is configured to selectively source current to a lead and to selectively sink current from the lead;

generating a first control signal configured to cause the first differential amplifier to source current to the lead, wherein the first control signal comprises a voltage greater than a voltage of a constant voltage supply, wherein the constant voltage supply is coupled to an inverting input of the first differential amplifier; and

providing the first control signal to a non-inverting input of the first differential amplifier with a first current command.

2. The method of claim 1, wherein the first differential amplifier comprises an inverting input connected to the constant voltage supply and a non-inverting input connected to the first current command, and wherein the first differential amplifier is configured to selectively source current to at least one of the plurality of electrodes sink current from at least one of the plurality of electrodes based on the voltage of the first control signal with respect to the constant voltage supply.

3. The method of claim 2, wherein generating the first control signal comprises determining whether to source current from the first differential amplifier or to selectively sink current to the first differential amplifier.

4. The method of claim 3, further comprising:

receiving a first stimulation command;

selecting a stimulation circuit, wherein the stimulation circuit comprises at least the first differential amplifier and a second differential amplifier, wherein the second differential amplifier is located within the hermetically sealed internal volume, wherein the second differential amplifier is configured to selectively source current to the lead and to selectively sink current from the lead, wherein the second differential amplifier comprises an inverting input connected to the constant voltage supply; and

configuring the second differential amplifier to at least one of;

source current to the lead;

or sink current from the lead.

5. The method of claim 4, wherein the first differential amplifier is configured to selectively source current to a first at least one of the plurality of electrodes of the lead, and wherein the second differential amplifier is configured to selectively sink current from a second at least one of the plurality of electrodes of the lead.

6. The method of claim 5, wherein the first at least one of the plurality of electrodes of the lead and the second at least one of the plurality of electrodes of the lead are selected to complete a circuit through the target region within the patient'"'"'s body, wherein the target region of the patient'"'"'s body comprises sacral tissue.

7. The method of claim 4, further comprising:

receiving a second stimulation command;

selecting a second stimulation circuit, wherein the second stimulation circuit comprises at least the first differential amplifier and the second differential amplifier;

generating a third control signal configured to cause the first differential amplifier to sink current from the lead, wherein the third control signal comprises a voltage less than the voltage of the constant voltage supply; and

providing the third control signal to the first differential amplifier.

8. The method of claim 7, further comprising:

generating a fourth control signal configured to cause the second differential amplifier to source current to the lead, wherein the fourth control signal comprises a voltage greater than the voltage of the constant voltage supply; and

providing the fourth control signal to the second differential amplifier.

9. The method of claim 4, further comprising determining that the stimulation circuit is complete, wherein determining that the stimulation circuit is complete comprises determining at least one of:

that a desired number of current sources have been selected; and

that a desired number of current sinks have been selected.

10. The method of claim 4, further comprising determining that the stimulation circuit is incomplete, wherein determining that the stimulation circuit is incomplete comprises determining that less than a desired number of current sources and/or a desired number of current sinks have been selected.

11. The method of claim 10, further comprising:

identifying a desired operation of an additional differential amplifier, wherein the additional differential amplifier is located within a hermetically sealed internal volume of a bio-compatible housing of the implantable neurostimulator, and wherein the additional differential amplifier is configured to selectively source current to a lead and to selectively sink current from the lead;

generating an additional control signal configured to cause the additional differential amplifier to perform a desired one of;

source current to the lead;

or sink current from the lead; and

providing the additional control signal to a non-inverting input of the additional differential amplifier.

12. The method of claim 4, further comprising receiving current feedback data indicating a measured current passing through the target region.

13. The method of claim 12, wherein the current feedback data is based on the output of at least one current sense differential amplifier.

14. The method of claim 13, wherein the at least one current sense differential amplifier generates a signal indicative of a voltage drop across at least one a sensing resistor.

15. The method of claim 14, wherein each of the first differential amplifier and the second differential amplifier can have unique current feedback data.

16. The method of claim 12, further comprising identifying a discrepancy between a desired current through the target region and the measured current through the target region.

17. The method of claim 16, further comprising adjusting the first control signal based on the identified discrepancy between the desired current and the measured current.

18. The method of claim 17, further comprising iteratively adjusting the first control signal until the discrepancy between the desired current and the measured current is eliminated.

19. The method of claim 4, wherein the first differential amplifier and the second differential amplifier are configured to source current or sink current to generate one or several electrical pulses.

20. The method of claim 19, wherein the one or several electrical pulses are generated according to a pulse program specifying a parameter of the one or several electrical pulses.

21. The method of claim 4, wherein the second differential amplifier comprises a non-inverting input connected to a second current command, and wherein configuring the second differential amplifier to at least one of:

source current to the lead;

or sink current from the lead comprises;

generating a second control signal configured to cause the second differential amplifier to sink current from the lead, wherein the second control signal comprises a voltage less than the voltage of the constant voltage supply; and

providing the second control signal to the second differential amplifier with the second current command.