CN-114423488-B - System and method for determining insertion status of electrode leads during insertion of electrode leads

Abstract

An exemplary diagnostic system is configured to direct an acoustic stimulation generator to apply acoustic stimulation having a plurality of stimulation 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 the recipient's cochlea, direct the cochlear implant to record a plurality of evoked response signals using electrodes disposed on the electrode lead during the insertion procedure, each of the plurality of evoked response signals corresponding to a different stimulation frequency included in the plurality of stimulation frequencies, and determine an insertion status of the electrode lead within the recipient's cochlea based on an amplitude and a phase of each of one or more of the plurality of evoked response signals.

Inventors

• L.M. Litwak
• K. KUKA

Assignees

• 领先仿生公司

Dates

Publication Date

20260505

Application Date

20200430

Priority Date

20190710

Claims (18)

1. 1. A system for determining an insertion status of an electrode lead during insertion of the electrode lead, comprising: A memory storing instructions, and A processor communicatively coupled to the memory and configured to execute instructions to: Directing an acoustic stimulation generator to apply acoustic stimulation to a recipient of the cochlear implant having a plurality of stimulation frequencies during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea, wherein each stimulation frequency included in the plurality of stimulation frequencies is concurrently applied to the recipient; Guiding a cochlear implant to record a plurality of evoked response signals using an electrode disposed on an electrode lead during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulation frequency included in the plurality of stimulation frequencies and representing an evoked response occurring in a subject in response to acoustic stimulation applied to the subject, and An insertion state of the electrode lead within a cochlea of the recipient is determined based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals.
2. 2. The system of claim 1, wherein determining a characteristic frequency location of the electrode passing through the cochlea is based on at least one of The amplitude of the further evoked response signals included in the plurality of evoked response signals is not reduced by at least an amplitude threshold amount, or The phase of the additional evoked response signal is unchanged by at least a phase threshold amount.
3. 3. The system of claim 1, wherein the processor is further configured to execute instructions to: determining that the amplitude of one or more evoked response signals included in the plurality of evoked response signals has been reduced by at least an amplitude threshold amount and that the phase of the one or more evoked response signals has not been changed by at least a phase threshold amount within a predetermined period of time; Wherein determining the insertion state includes determining that the electrode passes through a hair cell cluster within the cochlea based on determining that the amplitude of one or more evoked response signals included in the plurality of evoked response signals has been reduced by at least an amplitude threshold amount and that the phase of the one or more evoked response signals has not been changed by at least a phase threshold amount.
4. 4. The system of claim 1, wherein the processor is further configured to execute instructions to: Determining that the amplitudes of at least two evoked response signals included in the plurality of evoked response signals have been reduced by at least an amplitude threshold amount and that the phases of the at least two evoked response signals have been changed by at least a phase threshold amount within a predetermined period of time; Wherein determining the insertion state includes determining that the electrode lead is in contact with a structure of the cochlea based on determining that the amplitudes of at least two evoked response signals included in the plurality of evoked response signals have been reduced by at least an amplitude threshold amount and that the phases of the at least two evoked response signals have been changed by at least a phase threshold amount.
5. 5. The system of claim 4, wherein determining the insertion state further comprises determining at least one of a contact location or a contact amount with respect to a structure of the cochlea based on the amplitude and phase of the at least two evoked response signals.
6. 6. The system of claim 4, wherein the structure of the cochlea is a basal membrane of the cochlea.
7. 7. The system of claim 1, wherein the processor is further configured to execute instructions to: Determining that the amplitude of each evoked response signal included in the plurality of evoked response signals has decreased by at least an amplitude threshold amount and that the phase of each evoked response signal has changed by at least a phase threshold amount that is relatively greater than another phase threshold amount indicative of structure of the electrode lead contacting the cochlea, over a predetermined period of time; Wherein determining the insertion state includes determining that the electrode lead has translocated the structure and traumatized the cochlea based on determining that the amplitude of each evoked response signal included in the plurality of evoked response signals has been reduced by at least an amplitude threshold amount and that the phase of each evoked response signal has been changed by at least the phase threshold amount.
8. 8. The system of claim 1, wherein the processor is further configured to execute instructions to provide notification regarding the insertion status when an electrode lead is inserted into a cochlea of a recipient.
9. 9. The system of claim 1, wherein the processor is further configured to execute instructions to direct the display device to display a graph of evoked response signals in real time as the insertion procedure is being performed by displaying the evoked response signals such that, at any given time, a plurality of evoked response signals included in the plurality of evoked response signals are simultaneously displayed by the display device.
10. 10. The system of claim 9, wherein directing the display device to display the plot of the evoked response signal includes directing the display device to display the magnitude and phase of the evoked response signal for display in a single plot.
11. 11. The system of claim 9, wherein directing the display device to display the graph of evoked response signals comprises directing the display device to display: a first graph representing the amplitude of the evoked response signal, and A second graph representing the phase of the evoked response signal.
12. 12. The system of claim 1, wherein the electrode is a distal-most electrode disposed on the electrode lead.
13. 13. A computer program product comprising instructions that when executed by a processor cause the processor to: Directing an acoustic stimulation generator to apply acoustic stimulation to a recipient of the cochlear implant having a plurality of stimulation frequencies during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea, wherein each stimulation frequency included in the plurality of stimulation frequencies is concurrently applied to the recipient; Guiding a cochlear implant to record a plurality of evoked response signals using an electrode disposed on an electrode lead during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulation frequency included in the plurality of stimulation frequencies and representing an evoked response occurring in a subject in response to acoustic stimulation applied to the subject, and An insertion state of the electrode lead within a cochlea of the recipient is determined based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals.
14. 14. The computer program product of claim 13, further comprising instructions that when executed by the processor cause the processor to provide a notification regarding the insertion status when the cochlear implant is inserted into the cochlea of the recipient.
15. 15. The computer program product of claim 13, further comprising instructions that when executed by the processor cause the processor to direct the display device to display a plot of evoked response signals in real time as the insertion procedure is being performed by displaying the evoked response signals such that a plurality of evoked response signals included in the plurality of evoked response signals are simultaneously displayed by the display device at any given time.
16. 16. The computer program product of claim 15 wherein directing the display device to display the plot of the evoked response signal includes directing the display device to display the magnitude and phase of the evoked response signal for display in a single plot.
17. 17. The computer program product of claim 15, wherein directing the display device to display the plot of evoked response signals comprises directing the display device to display: a first graph representing the amplitude of the evoked response signal, and A second graph representing the phase of the evoked response signal.
18. 18. A non-transitory computer-readable storage medium storing instructions that, when executed, direct a processor to: Directing an acoustic stimulation generator to apply acoustic stimulation to a recipient of the cochlear implant having a plurality of stimulation frequencies during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea, wherein each stimulation frequency included in the plurality of stimulation frequencies is concurrently applied to the recipient; Guiding a cochlear implant to record a plurality of evoked response signals using an electrode disposed on an electrode lead during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulation frequency included in the plurality of stimulation frequencies and representing an evoked response occurring in a subject in response to acoustic stimulation applied to the subject, and An insertion state of the electrode lead within a cochlea of the recipient is determined based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals.

Description

System and method for determining insertion status of electrode leads during insertion of electrode leads RELATED APPLICATIONS The present application claims priority from PCT international application number PCT/US 2019/04136 filed on 7/10 of 2019, the entire contents of which are hereby incorporated by reference. Background information During the insertion process of installing the electrode lead within the cochlea, it may be desirable to ascertain (ascertain) the insertion status of the electrode lead. For example, it may be desirable to determine and communicate in real time to a surgeon performing an insertion procedure when an electrode on an electrode lead passes a particular characteristic frequency location within the cochlea, when an electrode on an electrode lead is near a hair cell cluster, and/or when an electrode lead may be traumatic to cochlear structures. Drawings The accompanying drawings illustrate various embodiments and are a part of the specification. The illustrated embodiments are merely examples and do not limit the scope of the disclosure. The same or similar reference numbers will be used throughout the drawings to refer to the same or like elements. Fig. 1 illustrates an exemplary cochlear implant system in accordance with principles described herein. Fig. 2 illustrates an exemplary configuration of the cochlear implant system of fig. 1. FIG. 3 illustrates an exemplary diagnostic system according to principles described herein. Fig. 4-5 illustrate an exemplary implementation of the diagnostic system of fig. 3 according to principles described herein. Fig. 6A-6F illustrate an exemplary insertion process of an electrode lead into the cochlea of a recipient (recipient) according to principles described herein. Fig. 7-11 illustrate graphs of evoked response signals that can be generated in accordance with the principles described herein. Fig. 12 illustrates an exemplary method according to principles described herein. Fig. 13 illustrates an exemplary computing device according to principles described herein. Detailed Description Systems and methods for determining an electrode lead insertion state during an electrode lead insertion process using one or more evoked response signals are described herein. For example, the diagnostic system may direct the acoustic stimulation generator to apply acoustic stimulation having multiple stimulation frequencies to a recipient of the cochlear implant during an insertion process in which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea. The diagnostic system may guide the cochlear implant to record multiple evoked response signals during the insertion procedure using electrodes provided on the electrode leads. Each evoked response signal included in the plurality of evoked response signals may correspond to a different stimulus frequency included in the plurality of stimulus frequencies and may represent an evoked response occurring in the subject in response to the acoustic stimulus applied to the subject. The evoked responses may each be cochlear electrogram ("ECoG") potentials (e.g., cochlear microphone potentials, action potentials, sum potentials, etc.), auditory nerve responses, brain stem responses, compound action potentials, stapedial reflex, and/or any other type of nerve or physiological response that may occur in a subject in response to the application of acoustic stimuli to the subject. The evoked response may originate from neural tissue, hair cells to nerve synapses, internal hair cells or external hair cells, or other sources. As will be described herein, the attribute associated with the evoked response signals recorded by the electrodes may indicate the insertion status of the electrode lead within the recipient cochlea. For example, the amplitude and/or phase of one or more evoked response signals may be indicative of a particular insertion state. As used herein, an "insertion state" may correspond to any of a number of different insertion states associated with insertion of an electrode lead into a recipient cochlea. For example, one or more insertion states may be associated with passing through a characteristic frequency location of the cochlea, passing through a hair cell or cluster of neurons, contacting a structure of the cochlea (e.g., the basilar membrane), causing trauma to the cochlea (e.g., through the basilar membrane), and so forth. Accordingly, the diagnostic system may determine the insertion status of the electrode lead within the recipient cochlea based on the amplitude and phase of each of the one or more evoked response signals included in the plurality of evoked response signals. By facilitating determination of an insertion state using acoustic stimuli having multiple stimulus frequencies, the systems and methods described herein may optimize determination of an insertion state and/or facilitate determination of additional or alternative insertion s