Method and system for generating a cochlear implant program using multi-electrode stimulation to elicit the electrically-evoked compound action potential

• US 7,206,640 B1
• Filed: 10/31/2003
• Issued: 04/17/2007
• Est. Priority Date: 11/08/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Overstreet, Edward H.
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): Gedeon; Brian T.
• Application Number:
  US10/698,098
• Time in Patent Office: 1,264 Days
• Field of Search: 607/57
• US Class Current: 607/57
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/36038 Cochlear stimulation
• CPC Class Codes: A61N 1/36039 fitting procedures
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A multichannel cochlear implant system spatially spreads the excitation pattern in the target neural tissue by either: (1) rapid sequential stimulation of a small group of electrodes, or (2) simultaneously stimulating a small group of electrodes. Such multi-electrode stimulation stimulates a greater number of neurons in a synchronous manner, thereby increasing the amplitude of the extra-cellular voltage fluctuation and facilitating its recording. The electrical stimuli are applied simultaneously (or sequentially at a rapid rate) on selected small groups of electrodes while monitoring the evoked compound action potential (ECAP) on a nearby electrode. The presence of an observable ECAP not only validates operation of the implant device at a time when the patient may be unconscious or otherwise unable to provide subjective feedback, but also provides a way for the magnitude of the observed ECAP to be recorded as a function of the amplitude of the applied stimulus. From this data, a safe, efficacious and comfortable threshold level can be obtained which may be used thereafter as the initial setting of the stimulation parameters of the neurostimulation device, or to guide the setting of the stimulation parameters of the neurostimulation device.

Claims

1. In a cochlear implant system having multiple electrode contacts through which electrical stimuli are adapted to be applied to a patient'"'"'s inner ear, a method of generating stimulation parameters for use by the cochlear implant system, comprising:

generating electrical stimuli with selectable degrees of amplitude intensity;

delivering the electrical stimuli to selected groups of electrode contacts while gradually adjusting the intensity of the electrical stimuli and while monitoring at least one electrode contact near the group of electrode contacts receiving the delivered electrical stimuli for the occurrence of an evoked compound action potential (ECAP);

determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts, the tNRI threshold level for all of the selected groups comprising tNRI threshold data;

processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact; and

using the contour of tNRI threshold levels to define stimulation parameters thereafter used by the cochlear implant system to control the intensity of the electrical stimuli applied through the electrode contacts,

wherein processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact comprises combining the tNRI threshold level data from each selected group of electrodes and smoothing discontinuities therein; and

wherein smoothing discontinuities in the tNRI threshold data comprises applying a three-point weighted average, with the first and last data points of a three-consecutive data points being weighted a first prescribed percentage, and with the middle data point being weighted a second prescribed percentage, where the second prescribed percentage is greater than the first prescribed percentage.

2. The method of claim 1 wherein the step for delivering the electrical stimuli to a selected group of electrode contacts comprises simultaneously delivering the electrical stimuli to each electrode contact within the selected group of electrode contacts.

3. The method of claim 1 wherein the step for delivering the electrical stimuli to a selected group of electrode contacts comprises sequentially delivering the electrical stimuli at a fast rate to the electrode contacts within the selected group of electrode contacts.

4. The method of claim 1 wherein the step for determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts comprises measuring the magnitude of the ECAP corresponding to a plurality of electrical-stimuli intensity levels, thereby creating a data set of ECAP magnitudes with corresponding electrical-stimuli intensity levels, and determining from the resulting data set an appropriate threshold level.

5. The method of claim 4 wherein determining an appropriate threshold level from the data set comprises making a plot of ECAP magnitude verses electrical-stimuli intensity levels, and interpolating the plot, as required, to determine an appropriate tNRI threshold level for the selected group of electrodes.

6. The method of claim 1 wherein smoothing discontinuities in the tNRI threshold data comprises applying a b-spleen interpolation technique to the data.

7. The method of claim 1 wherein smoothing discontinuities in the tNRI threshold data comprises applying a curve-smoothing algorithm to the tNRI threshold data.

8. A method for setting stimulation parameters used in a cochlear implant system, the cochlear implant system having a multiplicity of electrode contacts and means for delivering electrical stimuli to a selected electrode contact or a selected group of electrode contacts, the method comprising steps for:

(a) defining a first group of electrode contacts;

(b) defining an initial stimulation level;

(c) simultaneously applying electrical stimuli at the defined stimulation level to the defined group of electrode contacts;

(d) determining whether an evoked compound action potential (ECAP) is observed on an electrode contact near the defined group of electrode contacts, and if not, adjusting the defined stimulation level and repeating step (c);

(e) recording the magnitude of the ECAP and the corresponding stimulation level by measuring the peak-to-peak amplitude of the ECAP from ECAP peak N1 to ECAP peak P2;

(f) determining whether at least three ECAP measurements have been made for the selected croup of electrode contacts, each measurement being made at a different stimulation level, and if not, adjusting the defined stimulation level and repeating steps (c) through (e);

(g) determining an appropriate NRI threshold (tNRI) for the defined electrode group of electrode contacts;

(h) determining whether all desired groups of electrode contacts have been evaluated to determine a tNRI threshold, and if not, defining a next group of electrode contacts and repeating steps (b) through (g);

(I) processing the tNRI threshold for each group of electrode contacts to obtain tNRI thresholds for each individual electrode contact; and

(j) using the processed tNRI thresholds as a guide for setting stimulation parameters of the cochlear implant system.

9. The method of claim 8 wherein step (g) comprises plotting the at least three ECAP measurements as a function of stimulation level and extrapolating the plot to determine a desired stimulation level (tNRI) for the selected group of electrode contacts.

10. The method of claim 9 wherein step (I) comprises plotting the group tNRI threshold as a function of electrode group position and smoothing any discontinuities in the plotted tNRI thresholds, thereby creating a smoothed curve of tNRI data as a function of electrode position.

11. A cochlear implant system comprising:

multiple electrode contacts through which electrical stimuli are adapted to be applied to a patient'"'"'s inner ear;

means for generating electrical stimuli with selectable degrees of amplitude intensity;

means for delivering the electrical stimuli to selected groups of electrode contacts while gradually adjusting the intensity of the electrical stimuli and while monitoring at least one electrode contact near the group of electrode contacts receiving the delivered electrical stimuli for the occurrence of an evoked compound action potential (ECAP);

means for determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts, the tNRI threshold level for all of the selected groups comprising tNRI threshold data;

means for processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact; and

means for using the contour of tNRI threshold levels to define stimulation parameters thereafter used by the cochlear implant system to control the intensity of the electrical stimuli applied through the electrode contacts,

wherein the means for processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact comprises means for combining the tNRI threshold level data from each selected croup of electrodes and means for smoothing discontinuities therein; and

wherein the means for smoothing discontinuities in the tNRI threshold data comprises means for applying a three-point weighted average, with the first and last data points of a three-consecutive data points being weighted a first prescribed percentage, and with the middle data point being weighted a second prescribed percentage, where the second prescribed percentage is greater than the first prescribed percentage.

12. The system of claim 11 wherein the means for delivering the electrical stimuli to a selected group of electrode contacts comprises means for simultaneously delivering the electrical stimuli to each electrode contact within the selected group of electrode contacts.

13. The system of claim 11 wherein the means for delivering the electrical stimuli to a selected group of electrode contacts comprises means for sequentially delivering the electrical stimuli at a fast rate to the electrode contacts within the selected group of electrode contacts.

14. The system of claim 11 wherein the means for determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts comprises means for measuring the magnitude of the ECAP corresponding to a plurality of electrical-stimuli intensity levels, thereby creating a data set of ECAP magnitudes with corresponding electrical-stimuli intensity levels, and means for determining from the resulting data set an appropriate threshold level.

15. In a cochlear implant system having multiple electrode contacts through which electrical stimuli are adapted to be applied to a patient'"'"'s inner ear, a method of generating stimulation parameters for use by the cochlear implant system, comprising:

generating electrical stimuli with selectable degrees of amplitude intensity;

delivering the electrical stimuli to selected groups of electrode contacts, such that at least two of the selected groups of electrode contacts output an electrical current into the inner ear tissue, while gradually adjusting the intensity of the electrical stimuli and while monitoring for the occurrence of an evoked compound action potential (ECAP) with another separate electrode contact near the at least two of the selected group electrode contacts;

determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts, the tNRI threshold level for all of the selected groups comprising tNRI threshold data;

processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact; and

using the contour of tNRI threshold levels to define stimulation parameters thereafter used by the cochlear implant system to control the intensity of the electrical stimuli applied through the electrode contacts.

16. The method of claim 15 further comprising delivering the electrical stimuli to the patient while the patient is still under the influence of an anesthesia when the cochlear implant is first implanted.

17. The method of claim 15 wherein the step for delivering the electrical stimuli to a selected group of electrode contacts comprises simultaneously delivering the electrical stimuli to each electrode contact within the selected group of electrode contacts.

18. The method of claim 15 wherein the step for delivering the electrical stimuli to a selected group of electrode contacts comprises sequentially delivering the electrical stimuli at a fast rate to the electrode contacts within the selected group of electrode contacts.

19. The method of claim 15 wherein the step for determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts comprises measuring the magnitude of the ECAP corresponding to a plurality of electrical-stimuli intensity levels, thereby creating a data set of ECAP magnitudes with corresponding electrical-stimuli intensity levels, and determining from the resulting data set an appropriate threshold level.

20. The method of claim 19 wherein determining an appropriate threshold level from the data set comprises making a plot of ECAP magnitude verses electrical-stimuli intensity levels, and interpolating the plot, as required, to determine an appropriate tNRI threshold level for the selected group of electrodes.

21. A method for setting stimulation parameters used in a cochlear implant system, the cochlear implant system having a multiplicity of electrode contacts and means for delivering electrical stimuli to a patient'"'"'s inner ear with a selected electrode contact or a selected group of electrode contacts, the method comprising steps for:

(a) defining a first group of electrode contacts;

(b) defining an initial stimulation level;

(c) simultaneously applying electrical stimuli at the defined stimulation level to the defined group of electrode contacts, wherein at least two of the defined groups of electrode contacts output an electrical current into the inner ear tissue, while gradually adjusting the intensity of the electrical stimuli;

(d) determining whether an evoked compound action potential (ECAP) is observed with another electrode contact near the at least two of the defined group of electrode contacts, and if not, adjusting the defined stimulation level and repeating step (c);

(e) recording the magnitude of the ECAP and the corresponding stimulation level;

(f) determining whether sufficient ECAP data has been obtained, and if not, adjusting the defined stimulation level and repeating steps (c) through (e);

(g) determining an appropriate NRI threshold (tNRI) for the defined electrode group of electrode contacts;

(h) determining whether all desired groups of electrode contacts have been evaluated to determine a tNRI threshold, and if not, defining a next group of electrode contacts and repeating steps (b) through (g);

(I) processing the tNRI threshold for each group of electrode contacts to obtain tNRI thresholds for each individual electrode contact; and

(j) using the processed tNRI thresholds as a guide for setting stimulation parameters of the cochlear implant system.

22. The method of claim 21 wherein simultaneously applying electrical stimuli at the defined stimulation level further comprises delivering the electrical stimuli to the patient while the patient is still under the influence of an anesthesia when the cochlear implant is first implanted.

23. The method of claim 21 wherein step (e) comprises measuring the peak-to-peak amplitude of the ECAP from ECAP peak N1 to ECAP peak P2.

24. The method of claim 23 wherein step (f) comprises determining whether at least three ECAP measurements have been made for the selected group of electrode contacts, each measurement being made at a different stimulation level.

25. The method of claim 24 wherein step (g) comprises plotting the at least three ECAP measurements as a function of stimulation level and extrapolating the plot to determine a desired stimulation level (tNRI) for the selected group of electrode contacts.

26. The method of claim 25 wherein step (I) comprises plotting the group tNRI threshold as a function of electrode group position and smoothing any discontinuities in the plotted tNRI thresholds, thereby creating a smoothed curve of tNRI data as a function of electrode position.

27. A cochlear implant system comprising:

multiple electrode contacts through which electrical stimuli are adapted to be applied to a patient'"'"'s inner ear;

means for generating electrical stimuli with selectable degrees of amplitude intensity;

means for delivering the electrical stimuli to selected groups of electrode contacts, such that at least two of the selected groups of electrode contacts output an electrical current into the inner ear tissue, while gradually adjusting the intensity of the electrical stimuli and while monitoring for the occurrence of an evoked compound action potential (ECAP) with another separate electrode contact near the at least two of the selected groups of electrode contacts receiving the delivered electrical stimuli for the occurrence of an evoked compound action potential (ECAP);

means for determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts, the tNRI threshold level for all of the selected groups comprising tNRI threshold data;

means for processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact; and

means for using the contour of tNRI threshold levels to define stimulation parameters thereafter used by the cochlear implant system to control the intensity of the electrical stimuli applied through the electrode contacts.

28. The system of claim 27 wherein the means for delivering the electrical stimuli to a selected group of electrode contacts comprises means for simultaneously delivering the electrical stimuli to each electrode contact within the selected group of electrode contacts.

29. The system of claim 27 wherein the means for delivering the electrical stimuli to a selected group of electrode contacts comprises means for sequentially delivering the electrical stimuli at a fast rate to the electrode contacts within the selected group of electrode contacts.

30. The system of claim 27 wherein the means for determining an electrical-stimuli intensity threshold level (tNRI) associated with the occurrence of the ECAP for each selected group of electrode contacts comprises means for measuring the magnitude of the ECAP corresponding to a plurality of electrical-stimuli intensity levels, thereby creating a data set of ECAP magnitudes with corresponding electrical-stimuli intensity levels, and means for determining from the resulting data set an appropriate threshold level.

31. The system of claim 27 wherein the means for processing the tNRI threshold data to determine a contour of tNRI threshold levels that defines a tNRI threshold for each electrode contact comprises means for combining the tNRI threshold level data from each selected group of electrodes and means for smoothing discontinuities therein.

32. The system of claim 27 wherein the means for smoothing discontinuities in the tNRI threshold data comprises means for applying a three-point weighted average, with the first and last data points of a three-consecutive data points being weighted a first prescribed percentage, and with the middle data point being weighted a second prescribed percentage, where the second prescribed percentage is greater than the first prescribed percentage.