Threshold optimization for tissue stimulation therapy

• US 7,869,885 B2
• Filed: 04/28/2006
• Issued: 01/11/2011
• Est. Priority Date: 04/28/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Begnaud, Jason D., Dupont, Chris G., Kolafa, Jerry J., Nguyen, Huan D.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/414,393
• Publication Number:
  US 20070255351A1
• Time in Patent Office: 1,719 Days
• Field of Search: 607/45, 607/46, 607/118
• US Class Current: 607/118
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Methods and systems for determining an optimal therapeutic window of parameter settings for nerve stimulation therapy are described herein. The disclosed techniques generally utilize one or more parameter sweeps to determine upper and lower threshold settings. The determination of the optimal therapeutic window may be performed during or after implantation.

Claims

1. A method, comprising:

a) automatically delivering an electrical signal to a cranial nerve of a patient according to at least a first parameter and a second parameter;

b) automatically measuring an electrical response of the nerve to the electrical signal;

c) automatically adjusting the first parameter while keeping the second parameter at a first test setting;

d) automatically repeating operations a) through c) to acquire a first plurality of electrical responses;

e) determining a lower threshold for the first parameter with the second parameter at the first test setting and an upper threshold for the first parameter with the second parameter at the first test setting, based on the first plurality of electrical responses, wherein the upper threshold corresponds to an electrical signal level above which increasing the first parameter does not cause a significant increase in the electrical response;

automatically adjusting the second parameter to at least one different test setting and then automatically repeating operations (a) through (e) to determine lower and upper thresholds for the first parameter with the second parameter at the different test setting;

recording the determined lower and upper thresholds and the corresponding test settings for the first and second parameters;

determining customized treatment parameters for the patient, based on the recorded information; and

programming an implantable medical device (IMD) for the patient to treat the patient according to the customized treatment parameters.

2. The method of claim 1, wherein the lower threshold corresponds to a minimum electrical signal level necessary to evoke a compound action potential response on the nerve.

3. The method of claim 1, further comprising, prior to operation (a), defining an initial first and second parameter setting, wherein said initial first and second parameter setting defines an electrical signal that does not evoke a compound action potential response.

4. The method of claim 1, wherein said first parameter comprises a parameter selected from the group consisting of current amplitude, frequency, pulse width, on time, off time, and duty cycle.

5. The method of claim 1, further comprising:

implanting the IMD into the patient; and

wherein operations (a) through (d) are performed during implantation of the IMD into of the patient.

6. The method of claim 1, wherein (b) further comprises measuring an electrical response of said nerve to a trigger signal received from an electrical signal generator, said trigger signal indicating an occurrence of said electrical signal.

7. The method of claim 1, wherein operations (a) through (e) are performed after implantation of the IMD into the patient.

8. The method of claim 1, further comprising attaching a temporary electrode to said nerve to measure said electrical response.

9. A method according to claim 1, wherein:

the first parameter pertains to current amplitude and the second parameter pertains to pulse width.

10. The method of claim 9, further comprising defining a range of current amplitudes for the first parameter prior to operation (a).

11. The method of claim 9, wherein the operation of recording the determined lower and upper threshold and the corresponding test settings for the first and second parameters comprises storing measurements of the electrical responses and the corresponding current amplitudes and pulse widths on a tangible storage medium.

12. The method of claim 9, wherein the operation of determining a lower threshold comprises determining a current amplitude and a pulse width that corresponds to a minimum electrical signal level necessary to evoke a compound action potential.

13. The method of claim 9, wherein determining an upper threshold comprises determining a current amplitude and a pulse width corresponding to an electrical signal level where increasing the current amplitude does not cause a significant increase in the electrical response.

14. A method according to claim 1, further comprising:

using the recoded information to plot multiple operating curves, wherein each operating curve depicts measured behavior of the cranial nerve of the patient at a different setting for the second parameter.

15. A system, comprising:

a processor;

an amplifier and an analog-to-digital (A/D) converter coupled to the processor, the amplifier and A/D converter operable to convert data from a sensor electrode coupled to a cranial nerve of a patient into data for the processor;

a transceiver coupled to the processor, the transceiver operable to communicate with an implantable medical device (IMD);

a storage medium responsive to the processor; and

software stored in the storage medium and executable on the processor, wherein the software, when executed, causes the processor to perform operations comprising;

a) instructing the IMD to deliver a plurality of electrical signals to the cranial nerve according to at least first and second parameters, wherein the first parameter is iteratively adjusted automatically, while the second parameter remains fixed at a first test setting;

b) automatically detecting a first plurality of electrical responses of the nerve to the plurality of electrical signals;

c) automatically determining a lower threshold for the first parameter with the second parameter at the first test setting and an upper threshold for the first parameter with the second parameter at the first test setting, based on the first plurality of electrical responses, wherein the upper threshold corresponds to an electrical signal level above which increasing the first parameter does not cause a significant increase in the electrical response;

automatically executing one or more iterations of a process comprising;

i) adjusting the second parameter to a different test setting and then

ii) repeating operations (a) through (c) to determine a lower threshold and an upper threshold for the first parameter with the second parameter at the different test setting; and

automatically recording multiple sets of lower and upper thresholds and the corresponding test settings for the first and second parameters, with each set corresponding to a different setting for the second parameter;

determining customized treatment parameters for the patient, based on the recorded information; and

programming an implantable medical device (IMD) for the patient to treat the patient according to the customized treatment parameters.

16. The system of claim 15, wherein the system comprises a programming device coupled to a removable cuff assembly comprising at least one sensing electrode.

17. The system of claim 15, wherein the operations further comprise:

detecting a trigger signal received by the system directly from said IMD; and

automatically detecting the first plurality of electrical responses of the nerve to the plurality of electrical signals, in response to detecting the trigger signal.

18. A system according to claim 15, wherein the operations further comprise:

using the recoded information to plot multiple operating curves, wherein each operating curve depicts measured behavior of the cranial nerve of the patient at a different setting for the second parameter.