IP Library Granted Patent US 12,447,342
Granted Patent B2
US 12,447,342 · App. 17/620,027 · Granted Oct 21, 2025

Use of one or more evoked response signals to determine an insertion state of an electrode lead during an electrode lead insertion procedure

Inventors: Leonid M. Litvak (Los Angeles, CA); Kanthaiah Koka (Valencia, CA)
Assignee: Advanced Bionics AG
A61N1/36039A61N1/025A61N1/0541A61N1/08A61N1/36171
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Quick Facts
Patent No.
US 12,447,342
App. No.
17/620,027
Granted
Oct 21, 2025
Kind
B2
Abstract

An exemplary diagnostic system is configured to direct an acoustic stimulation generator to an acoustic stimulation generator to apply acoustic stimulation having a plurality of stimulus frequencies to a recipient of a cochlear implant during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient, direct the cochlear implant to use an electrode disposed on the electrode lead to record a plurality of evoked response signals during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulus frequency included in the plurality of stimulus frequencies, and determine, based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals, an insertion state of the electrode lead within the cochlea of the recipient.

Claims (47)

1. A system comprising:

a memory storing instructions; and

a processor communicatively coupled to the memory and configured to execute the instructions to:

direct an acoustic stimulation generator to apply acoustic stimulation having a plurality of stimulus frequencies to a recipient of a cochlear implant during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient, wherein stimulus frequencies included in the plurality of stimulus frequencies are concurrently applied to the recipient;

direct the cochlear implant to use an electrode disposed on the electrode lead to record a plurality of evoked response signals during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulus frequency included in the plurality of stimulus frequencies and representative of evoked responses that occur within the recipient in response to the acoustic stimulation applied to the recipient; and

determine, based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals, an insertion state of the electrode lead within the cochlea of the recipient.

2. The system of claim 1 , wherein the processor is further configured to execute the instructions to:

determine, within a predetermined time period, that both an amplitude of a particular evoked response signal included in the plurality of evoked response signals decreases by at least an amplitude threshold amount and a phase of the particular evoked response signal changes by at least a phase threshold amount;

wherein the determining of the insertion state comprises determining, based on the determining that the amplitude of the particular evoked response signal decreases by at least the amplitude threshold amount and the phase of the particular evoked response signal changes by at least the phase threshold amount, that the electrode passes a characteristic frequency location in the cochlea, the characteristic frequency location corresponding to a particular stimulus frequency that corresponds to the particular evoked response signal and that is included in the plurality of stimulus frequencies.

3. The system of claim 2 , wherein the determining that the electrode passes the characteristic frequency is further based on at least one of

an amplitude of an additional evoked response signal included in the plurality of evoked response signals not decreasing by at least the amplitude threshold amount; or

a phase of the additional evoked response signal not changing by at least the phase threshold amount.

4. The system of claim 2 , wherein the processor is further configured to execute the instructions to:

determine, within an additional predetermined time period, that both an amplitude of an additional particular evoked response signal included in the plurality of evoked response signals decreases by at least an amplitude threshold amount and a phase of the additional particular evoked response signal changes by at least a phase threshold amount;

wherein the determining of the insertion state further comprises determining, after the electrode passes the characteristic frequency location and based on the determining that the amplitude of the additional particular evoked response signal decreases by at least the amplitude threshold amount and the phase of the additional particular evoked response signal changes by at least the phase threshold amount, that the electrode passes an additional characteristic frequency location in the cochlea, the additional characteristic frequency location corresponding to an additional particular stimulation frequency that corresponds to the additional particular evoked response signal and that is included in the plurality of stimulus frequencies.

5. The system of claim 1 , wherein the processor is further configured to execute the instructions to:

determine, within a predetermined time period, that amplitudes of one or more evoked response signals included in the plurality of evoked response signals have decreased by at least an amplitude threshold amount and that phases of the one or more evoked response signals have not changed by at least a phase threshold amount;

wherein the determining of the insertion state comprises determining, based on the determining that the amplitudes of the one or more evoked response signals included in the plurality of evoked response signals have decreased by at least the amplitude threshold amount and that the phases of the one or more evoked response signals have not changed by at least the phase threshold amount, that the electrode passes a cluster of hair cells within the cochlea.

6. The system of claim 1 , wherein the processor is further configured to execute the instructions to:

determine, within a predetermined time period, that amplitudes of at least two of the evoked response signals included in the plurality of evoked response signals have decreased by at least an amplitude threshold amount and that phases of the at least two of the evoked response signals have changed by at least a phase threshold amount;

wherein the determining of the insertion state comprises determining, based on the determining that the amplitudes the at least two of the evoked response signals included in the plurality of evoked response signals have decreased by at least the amplitude threshold amount and the phases of the at least two of the evoked response signals have changed by at least the phase threshold amount, that the electrode lead is in contact with a structure of the cochlea.

7. The system of claim 6 , wherein the determining of the insertion state further comprises determining at least one of a location or an amount of contact with respect to the structure of the cochlea based on the amplitudes and the phases of the at least two evoked response signals.

8. The system of claim 6 , wherein the structure of the cochlea is a basilar membrane of the cochlea.

9. The system of claim 1 , wherein the processor is further configured to execute the instructions to:

determine, within a predetermined time period, that amplitudes of the evoked response signals included in the plurality of evoked response signals have decreased by at least an amplitude threshold amount and phases of the evoked response signals have changed by at least a phase threshold amount that is relatively larger than an additional phase threshold amount indicative of the electrode lead contacting a structure of the cochlea;

wherein the determining of the insertion state comprises determining, based on the determining that the amplitudes of the evoked response signals included in the plurality of evoked response signals have decreased by the at least the amplitude threshold amount and the phases of the evoked response signals have changed by at least the phase threshold amount, that the electrode lead has translocated the structure and caused trauma to the cochlea.

10. The system of claim 1 , wherein the processor is further configured to execute the instructions to provide a notification regarding the insertion state while the electrode lead is inserted into the cochlea of the recipient.

11. The system of claim 1 , wherein the processor is further configured to execute the instructions to direct a display device to display a graph of the evoked response signals in substantially real time as the insertion procedure is being performed by displaying the evoked response signals such that, at any given time, multiple evoked response signals included in the plurality of evoked response signals are concurrently displayed by the display device.

12. The system of claim 11 , wherein the directing of the display device to display the graph of the evoked response signals comprises directing the display device to display the amplitudes and the phases of the evoked response signals for display in a single graph.

13. The system of claim 11 , wherein the directing of the display device to display the graph of the evoked response signals comprises directing the display device to display:

a first graph representative of the amplitudes of the evoked response signals; and

a second graph representative of the phases of the evoked response signals.

14. The system of claim 1 , wherein the electrode is a distal-most electrode disposed on the electrode lead.

15. A method comprising:

directing, by a diagnostic system, an acoustic stimulation generator to apply acoustic stimulation having a plurality of stimulus frequencies to a recipient of a cochlear implant during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient, wherein stimulus frequencies included in the plurality of stimulus frequencies are concurrently applied to the recipient;

directing, by the diagnostic system, the cochlear implant to use an electrode disposed on the electrode lead to record a plurality of evoked response signals during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulus frequency included in the plurality of stimulus frequencies and representative of evoked responses that occur within the recipient in response to the acoustic stimulation applied to the recipient; and

determining, by the diagnostic system based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals, an insertion state of the electrode lead within the cochlea of the recipient.

16. The method of claim 15 , further comprising providing, by the diagnostic system, a notification regarding the insertion state while the cochlear implant is inserted into the cochlea of the recipient.

17. The method of claim 15 , further comprising directing, by the diagnostic system, a display device to display a graph of the evoked response signals in substantially real time as the insertion procedure is being performed by displaying the evoked response signals such that, at any given time, multiple evoked response signals included in the plurality of evoked response signals are concurrently displayed by the display device.

18. The method of claim 17 , wherein the directing of the display device to display the graph of the evoked response signals comprises directing the display device to display the amplitudes and the phases of the evoked response signals for display in a single graph.

19. The method of claim 17 , wherein the directing of the display device to display the graph of the evoked response signals comprises directing the display device to display:

a first graph representative of the amplitudes of the evoked response signals; and

a second graph representative of the phases of the evoked response signals.

20. A non-transitory computer readable storage medium storing instructions that, when executed, direct a processor to:

direct an acoustic stimulation generator to apply acoustic stimulation having a plurality of stimulus frequencies to a recipient of a cochlear implant during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient, wherein stimulus frequencies included in the plurality of stimulus frequencies are concurrently applied to the recipient;

direct the cochlear implant to use an electrode disposed on the electrode lead to record a plurality of evoked response signals during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulus frequency included in the plurality of stimulus frequencies and representative of evoked responses that occur within the recipient in response to the acoustic stimulation applied to the recipient; and

determine based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals, an insertion state of the electrode lead within the cochlea of the recipient.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: LITVAK, LEONID M.; KOKA, KANTHAIAH
To: ADVANCED BIONICS AG
Reel/Frame 058525/0940 →
Continuity (2)
Continuation In Part PCTUS2019041136 · Jul 10, 2019
Related Publication 20220233861A1 · Jul 28, 2022
References Cited (17)
US 20130006328A1 · Bouchataoui et al. · 2013 [cited by applicant]
US 20150320550A1 · Downing et al. · 2015 [cited by applicant]
US 20190030323A1 · Koka · 2019 [cited by applicant]
US 20190045680A1 · Kondo · 2019 [cited by applicant]
CN 107371113A · 2017 [cited by applicant]
CN 107847739A · 2018 [cited by applicant]
CN 108601937A · 2018 [cited by applicant]
WO 2017065809 · 2017 [cited by applicant]
WO 2019045680 · 2019 [cited by applicant]
WO 2019045747 · 2019 [cited by applicant]
“International Search Report and Written Opinion received in International Application No. PCT/US20/30834.” [cited by applicant]
“International Search Report and Written Opinion received in International Application No. PCT/US2019/041136.” [cited by applicant]
Greenwood, DD et al., “A cochlear frequency-position function for several species—29 years later”, Journal of the Acoustical Society of America, vol. 87 ,1990, 2592-2605. [cited by applicant]
Greenwood, et al., “Critical bandwidth and the frequency coordinates of the basilar membrane”, J. Acoust. Soc. Am. 33, 1344-1356, 1961. [cited by applicant]
Kohllöffel, et al., “Longitudinal Amplitude and Phase Distribution of the Cochlear Microphonic (Guinea Pig) and Spatial Filtering”, Journal of Sound and Vibration, vol. 11, Issue 3, Mar. 1970, pp. 325-334. [cited by applicant]
Riggs, et al., “Intra-Cochlear Electrocochleography During Cochear Implant Electrode Insertion Is Predictive of Final Scalar Location”, Otology & Neurotology, vol. 39, No. 8, 2018 (7), 654-659. [cited by applicant]
Stakhovskaya, et al., “Frequency map for the human cochlear spiral ganglion: Implications for cochlear implants”, JARO—Journal of the Association for Research in Otolaryngology, 8(2), 220-233. [cited by applicant]