External Trial Stimulator Useable in an Implantable Neurostimulator System

• US 20120123502A1
• Filed: 11/02/2011
• Published: 05/17/2012
• Est. Priority Date: 11/17/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Aghassian, Daniel, Lamont, Robert G., Stinauer, Robert J.
• Granted Patent: US 9,259,574 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

An improved external trial stimulator provides neurostimulation functionality for implanted medical electrodes prior to implantation of an implantable neurostimulator. The external trial stimulator is housed in a four-part housing that provides mechanical and electrostatic discharge protection for the electronics mounted in a central frame of the housing. Connectors attached to leads from the electrodes connect to contacts that are recessed in the housing through ports that are centered for easy access. Multiple indicators provide information to users of the external trial stimulator.

Claims

1. An external trial stimulator powered by one or more replaceable batteries, comprising:

a housing, comprising;

a first portion;

a second portion; and

a center portion, disposed between the first portion and the second portion, forming a central cavity;

a first circuit board, disposed in the cavity of the center portion, comprising neurostimulation logic programmable to generate neurostimulation pulses for electrodes implanted in a user of the external trial stimulator; and

at least one port in the center portion, wherein the at least one port is electrically connected to the first circuit board and adapted for connection to leads for the electrodes.

2. The external trial stimulator of claim 1, wherein the at least one port comprises a second circuit board.

3. The external trial stimulator of claim 2, wherein the second circuit board is connected to the first circuit board by a flexible member.

4. The external trial stimulator of claim 1, further comprising on the first circuit board:

a microcontroller, coupled with the neurostimulation logic; and

a memory, coupled with the neurostimulation logic and the microcontroller.

5. The external trial stimulator of claim 4, wherein the first circuit board further comprises a power backup circuit, adapted to provide operational power to complete a write to the memory if battery power is lost during a write.

6. The external trial stimulator of claim 4, wherein the microcontroller measures battery charge prior to performing a write to the memory.

7. The external trial stimulator of claim 1, wherein the first circuit board further comprises:

a first indicator, adapted to indicate a battery charge status, visible through the center portion of the housing; and

a second indicator, adapted to indicate a functional status of the external trial stimulator, visible through the center portion of the housing.

8. The external trial stimulator of claim 7, wherein the first indicator and the second indicator use color to indicate information to the user of the external trial stimulator.

9. The external trial stimulator of claim 7, wherein at least one of the first indicator and the second indicator transition gradually between a powered state and an unpowered state.

10. The external trial stimulator of claim 1, wherein the first circuit board further comprises battery contacts, supported by the first circuit board independent of the housing.

11. The external trial stimulator of claim 1, wherein an area of the center portion is recessed around a switch.

13. The external trial stimulator of claim 1, wherein the first circuit board, when disposed in the cavity of the center portion of the housing, is accessible for testing in the absence of either the first portion or the second portion of the housing.

14. The external trial stimulator of claim 1, wherein the first circuit board further comprises an antenna, configured for telemetry with an external device;

and

15. The external trial stimulator of claim 14, wherein the housing is marked with an indication to assist the user of the external trial stimulator in orienting the external device for telemetry with the external trial stimulator.

16. The external trial stimulator of claim 1, wherein the first circuit board further comprises a power conversion logic, adapted to convert a battery voltage to a predetermined voltage.

17. The external trial stimulator of claim 16, wherein the power conversion logic is configured to alternate between a first power-saving mode and a second full-power mode.

18. The external trial stimulator of claim 17, wherein the power conversion logic is placed in the second full-power mode during telemetry with an external device.

19. The external trial stimulator of claim 1, wherein the at least one port is centered between the first portion of the housing and the second portion of the housing.

20. The external trial stimulator of claim 1, wherein the first circuit board further comprises a discontinuous electrostatic discharge guard ring.

21. The external trial stimulator of claim 1, wherein the external trial stimulator comprises a first port and a second port, wherein the first port is adapted for connection to leads for a first plurality of electrodes, and wherein the second port is adapted for connection to leads for a second plurality of electrodes.

22. The external trial stimulator of claim 1, wherein the first portion comprises a battery compartment, and wherein the housing further comprises a battery cover for covering the battery compartment.

23. The external trial stimulator of claim 22, wherein the first circuit board comprises battery contacts, and wherein the battery contacts pass through the first portion to the battery compartment.

12. The external trial stimulator of claim 12, wherein the switch comprises a recessed surface.

24. A system for neurostimulation powered by one or more replaceable batteries, comprising:

a plurality of electrodes, adapted for delivering neurostimulation pulses when implanted in a human body;

at least one lead wire, connected to the plurality of electrodes;

an external trial stimulator, configured to couple to the plurality of electrodes via the lead wire, comprising;

a housing, comprising;

a first portion;

a second portion; and

a center portion, disposed between the first portion and the second portion, forming a central cavity;

a first circuit board, disposed in the cavity of the center portion, comprising neurostimulation logic programmable to generate neurostimulation pulses for electrodes implanted in a user of the external trial stimulator; and

at least one port in the center portion, wherein the at least one port is electrically connected to the first circuit board and adapted for connection to leads for the electrodes.

25. A method of assembling an external trial stimulator powered by one or more replaceable batteries, comprising:

disposing a first circuit board in a cavity of a central housing frame;

connecting a second circuit board to the first circuit board so that mechanical stress on the second circuit board is isolated from the first circuit board;

connecting a shielded housing to the second circuit board;

positioning the shielded housing within a port of the central housing frame; and

connecting the central housing frame between a first housing cover and a second housing cover.

26. The method of claim 25, further comprising closing a battery compartment in the first housing cover with a battery cover.

27. The method of claim 25, wherein the act of connecting the central housing frame between a first housing cover and a second housing cover comprises screwing the assembled housing to fix the first housing cover, central housing frame, and second housing cover together.

28. The method of claim 25, wherein the act of positioning the shielded housing within a port of the central housing frame comprises:

disposing the shielded housing around a plurality of contacts of the second circuit board, wherein the shielded housing is recessed into the port of the central housing frame.