# US 10,500,392 B2 · Monitoring stimulating assembly insertion > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,392 B2 - Document ID: US10500392B2 - Status: Granted - Kind: B2 - Application number: 15/245,547 - Filed: 2016-08-24 - Published: 2018-03-01 - Granted: 2019-12-10 - Earliest claimed: 2016-08-24 - Assignees: Cochlear Limited - Applicants: Cochlear Limited - Inventors: John Michael Heasman; Peter Gibson; Stephen O'Leary; Luke Campbell - Web page: https://patentgrep.com/patent/US10500392B2 ## CPC - A61N 1/0541: {Cochlear electrodes} - A61B 5/125: {objective methods} - A61B 5/38: Acoustic or auditory stimuli - A61B 5/4851: {Prosthesis assessment or monitoring} - A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)} - A61N 1/08: Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)} - A61N 1/36036: {of the outer, middle or inner ear} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Presented herein are techniques for monitoring the insertion of an intra-cochlear stimulating assembly for the occurrence of one or more insertion stop conditions. The insertion stop conditions are detectable events indicating that movement of the stimulating assembly into a recipient's cochlea should be at least temporarily stopped. The insertion monitoring is based on objectively measured inner ear potentials, such as acoustically-evoked potentials. ## Claims ### Claim 1 A method, comprising: during insertion of a stimulating assembly into a cochlea of a recipient, monitoring, at an intra-operative system, acoustically-evoked inner ear potentials obtained from the cochlea of the recipient; at the intra-operative system, detecting, based on the acoustically-evoked inner ear potentials, a target stop condition associated with a predetermined target stop point, wherein the target stop condition comprises a relative change in the acoustically-evoked inner ear potentials indicating that one or more stimulating contacts of the stimulating assembly are located at a tonotopic position corresponding to a pre-operatively defined insertion stop frequency; and responsive to detection of the target stop condition, initiating, at the intra-operative system, a feedback mechanism indicating that the stimulating assembly has been inserted to a target insertion depth and to stop insertion of the stimulating assembly into the cochlea. ### Claim 2 (depends on 1) The method of claim 1, wherein initiating the feedback mechanism comprises at least one of: stopping automated insertion of the stimulating assembly, or generating a stop notification for a surgeon to stop insertion of the stimulating assembly. ### Claim 3 (depends on 1) The method of claim 1, further comprising: at the intra-operative system, detecting, based on the acoustically-evoked inner ear potentials, an insertion warning condition; and responsive to detection of an insertion warning condition, initiating a feedback mechanism to slow insertion of the stimulating assembly into the cochlea. ### Claim 4 (depends on 1) The method of claim 1, wherein detecting the target stop condition comprises: detecting a peak or near peak in an attribute of the acoustically-evoked inner ear potentials associated with the insertion stop frequency. ### Claim 5 (depends on 1) The method of claim 1, comprising: prior to insertion of the stimulating assembly, performing one or more pre-operative tests on the cochlea; and determining the insertion stop frequency based on the one or more pre-operative tests. ### Claim 6 (depends on 5) The method of claim 5, wherein performing one or more pre-operative tests on the cochlea comprises: performing an audiogram measurement of the cochlea to determine at least one of frequency or frequency range where residual hearing begins in the cochlea. ### Claim 7 (depends on 1) The method of claim 1, wherein the intra-operative system includes an external component of a cochlear implant. ### Claim 8 (depends on 1) The method of claim 1, comprising: generating, during insertion of the stimulating assembly, acoustic signals for acoustic stimulation of the cochlea, wherein the acoustic signal includes frequency components corresponding to a pre-operatively defined insertion stop frequency; and capturing the acoustically-evoked inner ear potentials in response to delivery of the acoustic signals to the cochlea. ### Claim 9 (depends on 1) The method of claim 1, wherein the acoustically-evoked inner ear potentials are obtained in response to one or more complex acoustic inputs having a plurality of frequencies each associated with a different tonotopic region of the cochlea. ### Claim 10 (depends on 1) The method of claim 1, wherein the acoustically-evoked inner ear potentials are obtained from a plurality of different contacts of the stimulating assembly. ### Claim 11 A system, comprising: a receiver configured to receive, from a cochlear implant during insertion of a stimulating assembly of the cochlear implant into a cochlea of a recipient, acoustically-evoked inner ear potentials, and a processor configured to detect from the acoustically-evoked inner ear potentials, an occurrence of an insertion stop condition, wherein the insertion stop condition is selected from a group comprising: an error stop condition comprising a change in the acoustically-evoked inner ear potentials indicative of a mechanical impedance change of a basilar membrane of the recipient, and a target stop condition comprising a relative change in the acoustically-evoked inner ear potentials indicating that one or more stimulating contacts of the stimulating assembly are located at a tonotopic position corresponding to a pre-operatively defined insertion stop frequency. ### Claim 12 (depends on 11) The system of claim 11, wherein in response to detection of the occurrence of an insertion stop condition, the processor is configured to generate a notification to a user indicating that movement of the stimulating assembly should be at least temporarily stopped. ### Claim 13 (depends on 11) The system of claim 11, wherein in response to detection of the occurrence of an insertion stop condition, the processor is configured to stop an automated insertion of the stimulating assembly. ### Claim 14 (depends on 11) The system of claim 11, further comprising an acoustic receiver configured to acoustically stimulate the cochlea of the recipient during insertion of the stimulating assembly so as to evoke inner ear potentials. ### Claim 15 (depends on 11) The system of claim 11, further comprising an external component of the cochlear implant, and wherein the receiver is part of the external component. ### Claim 16 (depends on 11) The system of claim 11, wherein to detect a target stop condition, the processor is configured to: detect a peak or near peak in an attribute of the acoustically-evoked inner ear potentials associated with the insertion stop frequency. ### Claim 17 A method, comprising: during insertion of a stimulating assembly into a cochlea of a recipient, monitoring, at an intra-operative system, acoustically-evoked inner ear potentials obtained from the cochlea of the recipient; at the intra-operative system, detecting, based on the acoustically-evoked inner ear potentials, an error stop condition associated with an error stop point, wherein the error stop condition comprises a change in the acoustically-evoked inner ear potentials indicative of a mechanical impedance change of a basilar membrane of the recipient; and responsive to detection of the error stop condition, initiating, at the intra-operative system, a feedback mechanism indicating that the stimulating assembly has interfered with a basilar membrane of the cochlea and to stop insertion of the stimulating assembly into the cochlea. ### Claim 18 (depends on 17) The method of claim 17, wherein initiating a feedback mechanism to stop insertion of the stimulating assembly comprises at least one of: stopping automated insertion of the stimulating assembly, or generating a stop notification for a surgeon to stop insertion of the stimulating assembly. ### Claim 19 (depends on 17) The method of claim 17, further comprising: at the intra-operative system, detecting, based on the acoustically-evoked inner ear potentials, an insertion warning condition; and responsive to detection of an insertion warning condition, initiating a feedback mechanism to slow insertion of the stimulating assembly into the cochlea. ### Claim 20 (depends on 17) The method of claim 17, wherein the intra-operative system includes an external component of a cochlear implant. ### Claim 21 (depends on 17) The method of claim 17, comprising: generating, during insertion of the stimulating assembly, acoustic signals for acoustic stimulation of the cochlea, wherein the acoustic signal includes frequency components corresponding to a pre-operatively defined insertion stop frequency; and capturing the acoustically-evoked inner ear potentials in response to delivery of the acoustic signals to the cochlea. ### Claim 22 (depends on 17) The method of claim 17, wherein the acoustically-evoked inner ear potentials are obtained in response to one or more complex acoustic inputs having a plurality of frequencies each associated with a different tonotopic region of the cochlea. ### Claim 23 (depends on 17) The method of claim 17, wherein the acoustically-evoked inner ear potentials are obtained from a plurality of different contacts of the stimulating assembly.