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EP-4013488-B1 - REAL-TIME ESTIMATION OF ELECTRODE ARRAY POSE DURING INTRACOCHLEAR INSERTION

EP4013488B1EP 4013488 B1EP4013488 B1EP 4013488B1EP-4013488-B1

Inventors

  • ZYGORODIMOS, Matthew

Dates

Publication Date
20260506
Application Date
20200810

Claims (15)

  1. A system (300) comprising: at least one data input interface (310) configured to receive data (312) from a plurality of transducers during implantation of a medical device on or in a recipient; at least one controller (330) in operative communication with the at least one data input interface (310), at least one output interface (340) in operative communication with the at least one controller (330), the at least one output interface (320) configured to provide information regarding the estimated pose of the medical device, characterised in that said controller (330) is configured to access a probabilistic model of a parameterized description of a pose of the medical device relative to a body portion and to generate an estimate of a current pose of the medical device in response at least in part to the data and the probabilistic model.
  2. The system (300) of claim 1, further comprising: at least one control output interface (320) in operative communication with the at least one controller (330), the at least one control output interface (320) configured to transmit control signals to the plurality of transducers, the plurality of transducers responsive to the control signals by generating the data.
  3. The system (300) of claim 1 or claim 2, wherein the at least one controller (330) comprises at least one processor (334) and at least one storage device (336) in operative communication with the at least one processor (334), and/or the at least one storage device (336) is configured to collect and store the data, and/or the medical device comprises a stimulation assembly (118) of a cochlear implant auditory prosthesis (100), and the body portion comprise a cochlea of the recipient, and/or the medical device comprises at least some of the plurality of transducers, and/or the at least one controller (330) is configured to transmit the control signals to the plurality of transducers automatically during the implantation of the medical device.
  4. The system (300) of any of claims 1 to 3, further comprising at least one user input interface (350) in operative communication with the at least one controller (330), the at least one controller (330) configured to receive triggering signals from the at least one user input interface (350) intermittently during the implantation of the medical device, wherein the at least one controller (330) is configured to respond to the triggering signals by transmitting the control signals to the plurality of transducers.
  5. The system of any of claims 1 to 4, wherein the at least one output interface (340) is configured to be in operative communication with at least one status communication device configured to respond to the information by communicating a status signal indicative of the pose of the medical device, and/or wherein the at least one user input interface (350) and the at least one output interface (340) are configured to be in operative communication with a computing device configured to be utilized by a medical professional, and/or wherein the at least one output interface (340) is configured to be in operative communication with an automated insertion system configured to respond automatically and in real-time to the information by manipulating the medical device.
  6. The system of one of the claims 1-5, wherein the at least one controller (330) is further configured for: receiving (410) first information regarding a pose of a structure in a first time period, the structure configured to be inserted into a body portion of a recipient, the first information comprising at least one of: a first estimate of the pose of the structure in the first time period; and a first measurement set comprising one or more first measurement values, at least some of the one or more first measurement values generated using a plurality of sensors distributed along the structure, the one or more first measurement values indicative of the pose of the structure in the first time period; and generating (420) a second estimate of the pose of the structure using at least the first information and the probabilistic model of the structure and/or the body portion.
  7. The system of claim 6, wherein the first information comprises the first estimate of the pose of the structure and the first measurement set, and said generating the second estimate of the pose of the structure comprises updating the first estimate of the pose in response to the first measurement set, and/or said generating the second estimate of the pose comprises: generating a first ensemble of potential poses of the structure, the first ensemble generated using the probabilistic model of the structure and/or the body portion; and selecting the second estimate of the pose from the first ensemble of potential poses, and/or said generating the first ensemble of potential poses further comprises generating expectations of measurement values corresponding to the potential poses of the first ensemble, the method further comprising: receiving a second measurement set comprising one or more second measurement values, at least some of the one or more second measurement values generated using the plurality of sensors, the one or more second measurement values indicative of the pose of the structure in a second time period; and comparing the second measurement set to the expectations of the measurement values corresponding to the potential poses of the first ensemble, wherein the second time period is after the first time period.
  8. The system of any of claim 7, further comprising: generating a second ensemble of potential poses of the structure in a third time period, the second ensemble generated using the probabilistic model; and selecting a third estimate of the pose from the second ensemble of potential poses, wherein the third time period is after the second time period.
  9. The system of any of claims 6 to 8, wherein the structure comprises an electrode array of a cochlear implant system, the plurality of sensors comprises the electrode array, and the body portion comprises a cochlea of the recipient.
  10. The system of any of claims 6 to 9, further comprising generating at least one status reporting signal, in response at least in part to the second estimate and during insertion of the structure into the body portion and/or retraction of the structure from the body portion, the at least one status reporting signal configured to be received by at least one of: a status communication device configured to respond to the at least one status reporting signal by communicating a status signal to a user of the status communication device, the status signal indicative of a status of the structure; and an automated actuator configured to respond to the at least one status reporting signal by manipulating the structure and/or communicating information regarding the second estimate to an operator of an insertion system being used to insert the structure into the body portion and/or retract the structure from the body portion.
  11. The system of any of claims 1 to 5, wherein the at least one controller is further configured for: Accessing (610) information characterizing states and transitions between states of a structure at least partially inserted into a body portion of a recipient; accessing (620) expectation measurement values or ranges of values expected to be generated by at least one sensor of the structure; obtaining (630) at least one first measurement value from the at least one sensor at a first time period; and determining (640), in response to a comparison of the at least one first measurement value to the expectation measurement values or ranges of values, a first state of the structure during the first time period.
  12. The system of claim 11, wherein said accessing expectation measurement values or ranges of values comprises calculating the expectation measurement values or ranges of values using a parameterized model of the structure and/or the body portion, and/or the at least one sensor is responsive to the states of the structure
  13. The system of any of claims 11 to 12, wherein the structure comprises an electrode array of a cochlear implant system, the at least one sensor comprises at least one electrode of the electrode array, and the body portion comprises a cochlea of the recipient, wherein the states of the structure comprise at least: a folded state in which an end portion of the stmcture within the cochlea is folded over; and an unfolded state in which the end portion of the structure within the cochlea is not folded over, wherein the states of the structure further comprise a bent state in which the end portion of the structure within the cochlea is bent by more than a predetermined amount.
  14. The system of claim 13, wherein the at least one first measurement value is selected from the group consisting of: a transimpedance measurement; an electrocochleography measurement; a voltage measurement; an impedance measurement; a four-point impedance measurement; an electrically evoked compound action potential (ECAP) measurement.
  15. The system of any of claims 11 to 14, further comprising: adjusting the expectation measurement values or ranges of values in response to the at least one first measurement value, and/or obtaining at least one second measurement value from the at least one sensor at a second time period after the first time period; and determining, in response to a comparison of the at least one second measurement value to the expectation measurement values or ranges of values, a second state of the structure during the second time period.

Description

BACKGROUND Field The present application relates generally to systems and methods for monitoring the implantation of medical devices within the body of a recipient, and more specifically, to facilitating positioning of stimulation elements of a cochlear-implanted auditory prosthesis during implantation. Description of the Related Art Hearing loss, which may be due to many different causes, is generally of two types, conductive and/or sensorineural. Conductive hearing loss occurs when the normal mechanical pathways of the outer and/or middle ear are impeded, for example, by damage to the ossicular chain or ear canal. Sensorineural hearing loss occurs when there is damage to the inner ear, or to the nerve pathways from the inner ear to the brain. Individuals who suffer from conductive hearing loss typically have some form of residual hearing because the hair cells in the cochlea are undamaged. As a result, individuals suffering from conductive hearing loss might receive an auditory prosthesis that generates mechanical motion of the cochlea fluid instead of a hearing aid based on the type of conductive loss, amount of hearing loss and customer preference. Such prostheses include, for example, bone conduction devices and direct acoustic stimulators. In many people who are profoundly deaf, however, the reason for their deafness is sensorineural hearing loss. Those suffering from some forms of sensorineural hearing loss are unable to derive suitable benefit from auditory prostheses that generate mechanical motion of the cochlea fluid. Such individuals can benefit from implantable auditory prostheses that stimulate nerve cells of the recipient's auditory system in other ways (e.g., electrical, optical, and the like). Cochlear implants are often proposed when the sensorineural hearing loss is due to the absence or destruction of the cochlea hair cells, which transduce acoustic signals into nerve impulses. Auditory brainstem stimulators might also be proposed when a recipient experiences sensorineural hearing loss due to damage to the auditory nerve. WO 2016/035027 A1 relates to intra-cochlear stimulating assembly insertion. This disclosure presented monitoring the angular insertion depth in real-time and advancement of the stimulating assembly is terminated when a selected angular insertion depth is achieved. SUMMARY OF THE INVENTION The invention is defined in claim 1. Any methods disclosed hereinafter do not form part of the scope of the invention, and are mentioned for illustrative purposes only. In one aspect disclosed herein, a method comprises receiving first information regarding a pose of a structure in a first time period. The structure is configured to be inserted into a body portion of a recipient. The first information comprises at least one of: a first estimate of the pose of the structure in the first time period, and a first measurement set comprising one or more first measurement values. At least some of the one or more first measurement values are generated using a plurality of sensors distributed along the structure. The one or more first measurement values are indicative of the pose of the structure in the first time period. The method further comprises generating a second estimate of the pose of the structure using at least the first information and a probabilistic model of the structure and/or the body portion. In another aspect disclosed herein, a method comprises accessing information characterizing states and transitions between states of a structure at least partially inserted into a body portion of a recipient. The method further comprises accessing expectation measurement values or ranges of values expected to be generated by at least one sensor of the structure. The method further comprises obtaining at least one first measurement value from the at least one sensor at a first time period. The method further comprises determining, in response to a comparison of the at least one first measurement value to the expectation measurement values or ranges of values, a first state of the structure during the first time period. In still another aspect disclosed herein, a system comprises at least one data input interface configured to receive data from a plurality of transducers during implantation of a medical device on or in a recipient. The system further comprises at least one controller in operative communication with the at least one data input interface. The at least one controller is configured to access a probabilistic model of a parameterized description of a pose of the medical device relative to the body portion and to generate an estimate of a current pose of the medical device in response at least in part to the data and the probabilistic model. The system further comprises at least one output interface in operative communication with the at least one controller. The at least one output interface is configured to provide information regarding the estimated pose of the medical device.