External trial stimulator useable in an implantable neurostimulator system

• US 9,259,574 B2
• Filed: 11/02/2011
• Issued: 02/16/2016
• 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.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US13/287,775
• Publication Number:
  US 20120123502A1
• Time in Patent Office: 1,567 Days
• Field of Search: 607/59
• US Class Current: 1/1
• 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 batteries, comprising:

a housing, comprising;

a first cover comprising a battery compartment;

a second cover; and

a center frame, disposed between the first cover and the second cover, wherein the center frame forms a central cavity within the external trial stimulator and defines at least a portion of an exterior surface of the external trial stimulator;

wherein the first cover, second cover, and center frame comprise separate components fixed together;

a first circuit board, disposed in the cavity of the center frame, 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 frame, wherein each at least one port is electrically connected to the first circuit board and adapted for connection to a lead 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 frame of the housing; and

a second indicator, adapted to indicate a functional status of the external trial stimulator, visible through the center frame 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 frame is recessed around a switch.

12. The external trial stimulator of claim 11, wherein the switch comprises a recessed surface.

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

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 cover of the housing and the second cover 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 at least one port comprises a first port and a second port, wherein the first port is adapted for connection to a lead for a first plurality of electrodes, and wherein the second port is adapted for connection to a lead for a second plurality of electrodes.

22. The external trial stimulator of claim 1, 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 cover to the battery compartment.

24. A system for neurostimulation powered by one or more 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, comprising;

a housing, comprising;

a first cover comprising a battery compartment;

a second cover; and

a center frame, disposed between the first cover and the second cover, wherein the center frame forms a central cavity within the external trial stimulator and defines at least a portion of an exterior surface of the external trial stimulator;

wherein the first cover, second cover, and center frame comprise separate components fixed together;

a first circuit board, disposed in the cavity of the center frame, comprising neurostimulation logic programmable to generate neurostimulation pulses for the plurality of electrodes; and

at least one port in the center frame, wherein the at least one port is electrically connected to the first circuit board and to the at least one lead wire.