Granted Patent B2

US 12,290,685 · App. 17/634,066 · Granted May 6, 2025

Inventor: Patrick J. Boyle (Kent, GB)

Assignee: Advanced Bionics AG

A61N1/36038A61N1/08A61N1/37247

Abstract

Claims (56)

1. A system comprising:

a memory storing instructions; and

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

identify, prior to a commencement of a lead insertion procedure in which an electrode lead having a plurality of an electrodes is to be inserted into a cochlea of a recipient of a cochlear implant, one or more attributes of the lead insertion procedure;

dynamically select, based on the one or more attributes of the lead insertion procedure as identified prior to the commencement of the lead insertion procedure, a first subset of electrodes included in the plurality of electrodes for inclusion in a monitoring electrode set, the monitoring electrode set configured to have less electrodes than a total number of the plurality of electrodes;

monitor, during the lead insertion procedure, impedance values for electrodes included in the monitoring electrode set; and

determine, during the lead insertion procedure and based on the monitoring, a positioning state of the electrode lead.

2. The system of claim 1 , wherein the one or more attributes comprise one or more of a characteristic of the electrode lead, a characteristic of a tool being used to insert the electrode lead into the cochlea, a characteristic of an opening in the recipient through which the electrode lead is to be inserted, an identity of a user performing the lead insertion procedure, a surgical tendency of the user performing the lead insertion procedure, a preoperative assessment of a hearing profile of the recipient, a preoperative image of the cochlea of the recipient, a geometrical model of the cochlea of the recipient, or an intraoperative measurement performed during the lead insertion procedure.

3. The system of claim 1 , wherein:

the processor is further configured to execute the instructions to provide, as an input to a machine learning model, attribute data representative of the one or more attributes; and

the dynamically selecting of the first subset of electrodes is based on an output of the machine learning model that takes into account the attribute data.

4. The system of claim 3 , wherein the machine learning model is trained by applying historical attribute data representative of one or more attributes of a plurality of lead insertion procedures in which electrode leads are inserted into cochleas of a plurality of cochlear implant recipients.

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

perform, during the lead insertion procedure, one or more intraoperative measurements;

determine, based on the one or more intraoperative measurements, one or more additional attributes.

6. The system of claim 1 , wherein:

the monitoring comprises identifying an anomaly in the impedance values; and

the determining of the position state comprises determining, based on the anomaly, that a translocation event in which the electrode lead translocates from a first scala of the cochlea to a second scala of the cochlea is about to occur or has occurred during the lead insertion procedure.

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

detect a change in the one or more attributes during the lead insertion procedure; and

dynamically update, based on the change in the one or more attributes, the monitoring electrode set to have a second subset of the plurality of electrodes, the second subset having at least one electrode not included in the first subset.

8. The system of claim 5 , wherein:

the processor is further configured to execute the instructions to provide, as an input to a machine learning model, attribute data representative of the one or more attributes; and

the dynamically updating of the monitoring electrode set is based on an output of the machine learning model that takes into account the attribute data.

9. The system of claim 8 , wherein the identifying of the anomaly comprises determining that at least one of the impedance values varies from an expected impedance value by at least a threshold amount.

10. The system of claim 1 , wherein:

the monitoring comprises identifying an anomaly in the impedance values; and

the determining of the position state comprises determining, based on the anomaly, that a tip foldover event in which a distal tip of the electrode lead folds over within the cochlea is about to occur or has occurred during the lead insertion procedure.

11. The system of claim 10 , wherein the identifying of the anomaly comprises determining that a change in cross impedance between two electrodes included in the monitoring electrode set exceeds a threshold amount.

12. The system of claim 1 , wherein the determining of the position state comprises determining, based on the monitoring, that the electrode lead is correctly positioned within the cochlea during the lead insertion procedure.

13. The system of claim 1 , wherein:

the monitoring electrode set comprises at a first electrode and a second electrode; and

the monitoring of the impedance values comprises:

directing the cochlear implant to apply electrical stimulation by way of the first electrode;

detecting, in response to the applying of the electrical stimulation by way of the first electrode, a voltage between the first electrode and a reference;

directing, subsequent to the applying of the electrical stimulation by way of the first electrode, the cochlear implant to apply the electrical stimulation by way of the second electrode; and

detecting, in response to the applying of the electrical stimulation by way of the second electrode, a voltage between the second electrode and the reference.

14. The system of claim 1 , wherein:

the monitoring electrode set comprises at a first electrode and a second electrode; and

the monitoring of the impedance values comprises:

directing the cochlear implant to apply electrical stimulation by way of the first electrode, and

detecting, in response to the applying of the electrical stimulation by way of the first electrode, a voltage between the second electrode and a reference.

15. The system of claim 1 , wherein the monitoring electrode set includes no more than four electrodes.

16. The system of claim 1 , wherein the processor is further configured to execute the instructions to present a notification indicating the positioning state of the electrode lead.

17. A method comprising:

identifying, by an insertion management system prior to a commencement of a lead insertion procedure in which an electrode lead having a plurality of electrodes is inserted into a cochlea of a recipient of a cochlear implant, one or more attributes of the lead insertion procedure;

dynamically selecting, by the insertion management system based on the one or more attributes of the lead insertion procedure as identified prior to the commencement of the lead insertion procedure, a first subset of electrodes included in the plurality of electrodes for inclusion in a monitoring electrode set, the monitoring electrode set configured to have less electrodes than a total number of the plurality of electrodes;

monitoring, by the insertion management system during the lead insertion procedure, impedance values for electrodes included in the monitoring electrode set; and

determining, by the insertion management system during the lead insertion procedure and based on the monitoring, a positioning state of the electrode lead.

18. A non-transitory computer-readable medium storing instructions that, when executed, direct a processor of a computing device to:

identify prior to a commencement of a lead insertion procedure in which an electrode lead having a plurality of electrodes is inserted into a cochlea of a recipient of a cochlear implant, one or more attributes of the lead insertion procedure;

dynamically select, based on the one or more attributes of the lead insertion procedure as identified prior to the commencement of the lead insertion procedure, a first subset of electrodes included in the plurality of electrodes for inclusion in a monitoring electrode set, the monitoring electrode set configured to have less electrodes than a total number of the plurality of electrodes;

monitor, during the lead insertion procedure, impedance values for electrodes included in the monitoring electrode set; and

determine, during the lead insertion procedure and based on the monitoring, a positioning state of the electrode lead.

19. The system of claim 7 , wherein the dynamically selecting the first subset of electrodes is further based on the one or more additional attributes.

20. The system of claim 7 , wherein the one or more additional attributes comprises at least one of an insertion depth for the electrode lead, an insertion speed at which the electrode lead is inserted into the cochlea, an insertion angle at which the electrode lead is inserted into the cochlea, or an impedance value for one or more of the plurality of electrodes.

Assignments (1)

Continuity (2)

References Cited (19)