System and method for insertion of cochlear implant

Abstract

To provide a system and method for surgical implantation of cochlear implants that allow for the assessment of cochlear implant insertion progress during the surgical procedure through insertion planning, electrode selection, monitoring insertion progress, and confirming implant placement.SOLUTION: The present invention enables the determination of a desired insertion state and progress plan for the selected cochlear implant and subsequently enabling the monitoring of insertion progress. The provided system and methods allow for the use of imaging data, implant data, patient data, and electrophysiological data in determining the desired insertion state and progress plan and in selecting the implant, as well as for the use of various imaging and tracking methodologies in monitoring insertion progress and confirming that the implant has been properly placed. Through insertion planning, proper electrode selection, insertion monitoring, and confirmation of implant placement, ensured is high-quality cochlear implant insertion.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to the field of cochlear implantation (cochlear implant surgery). Specifically, the present invention relates to a system and method for surgical insertion of a cochlear implant that enables assessment of cochlear implant insertion progress during a surgical procedure through insertion planning, monitoring of insertion progress, and confirmation of implant placement. The system and method of the present invention enables determination of a desired insertion state and progression plan for a cochlear implant, selection of an optimal implant for a patient, and subsequent monitoring of insertion progress. Specifically, the system and method of the present invention enables the use of imaging data, implant data, patient data, and electrophysiological data in determining the desired insertion state and progression plan, as well as the use of various imaging and tracking methodologies in monitoring insertion progress and confirming proper implant placement. Most specifically, the system and method of the present invention relates to quality cochlear implant insertion through insertion planning, implant selection, insertion monitoring, and confirmation of implant placement. [Background technology]

[0002] Cochlear implant surgery ("CI") consists of three major steps. First, a mastoidectomy is performed, which opens the mastoid bone and provides access to the middle ear cavity. Next, the surgeon navigates the middle ear cavity, taking care to avoid critical structures such as the facial nerve and chorda tympani. Once inside the middle ear cavity, the surgeon creates an opening in either the round window membrane of the cochlea (round window approach) or the cochlear wall (cochleotomy). Finally, the electrode array is inserted into the cochlea. Each step of CI carries risks and challenges, including potential damage to nerves in the temporal bone, incorrect or incomplete insertion of the electrode array, damage to intracochlear structures, or suboptimal selection of a cochlear implant for an individual patient.

[0003] Some elements of robotic cochlear implantation, such as minimally invasive papillotomy, have been demonstrated using computer-assisted and template-based approaches (Labadie) or using robotic techniques (Weber et al., Science Robotics 2017). Additionally, automated / mechatronic cochlear access has been demonstrated (Peter Brett et al., 2014). Furthermore, the use of mechatronic approaches to deliver CI electrodes at prescribed insertion speeds has been investigated.

[0004] Computer-aided planning of CI procedures using medical images has been described to identify relevant anatomical structures (e.g., the cochlea) and plan the access path to the cochlea. Commercial tools such as OTOPLAN are now used to assist in optimal electrode selection (selecting the desired length of the CI electrode relative to the anatomy) with respect to the available imaging and hearing data for a given patient.

[0005] Specifically, this approach involves drilling a small hole directly on the mastoid surface to create a small-diameter tunnel (ranging from 1.5 to 2 mm in diameter) that provides direct access to the target site on the cochlea. This surgical approach traverses the facial recess; therefore, the resulting tunnel passes close to the facial nerve, chorda tympani, auditory canal, and ossicles. Therefore, the greatest challenge associated with performing the RCI approach to cochlear implantation is avoiding damage to those structures, particularly the facial nerve and chorda tympani. While current surgical practice accepts the sacrifice of the chorda tympani in a certain percentage of cases, it is highly undesirable, and in any case, facial nerve injury or physical disruption is an unacceptable consequence of CI surgery.

[0006] Due to the challenges associated with the RCI approach, various strategies to increase safety and reduce the incidence of damage to the facial nerve and other structures have been investigated by the present inventors and other groups. None of the known strategies alone provides the necessary safety margin for a successful RCI procedure. The goal of quality cochlear implant insertion, which can be defined as the ability to safely and accurately place a cochlear implant without damaging surrounding structures while achieving a placement that truly enhances the patient's hearing to a meaningful degree, has remained elusive in the art. In this regard, quality cochlear implantation involves planning both the surgical approach and optimal implant selection, monitoring the surgical process, and verifying that the desired surgical outcome has been achieved.

[0007] RCI has not achieved universal adoption due to factors such as cost, immaturity of the underlying technology, and the lack of a quality approach to robotic insertion. Therefore, current practice still involves manual, destructive surgical insertion. Inserting a cochlear implant practically exceeds the limits of human dexterity, and therefore, approximately 50% of cochlear implant patients do not achieve the desired hearing performance after surgery. This is because the insertion process is generally very harsh and destructive to the inner ear structures, often resulting in the destruction of any residual hearing the patient may have. Therefore, typical CI surgery is only available to hearing-impaired patients. Due to these factors and cost, the cochlear implant implementation rate is generally low at 5%. As a result, of the 15 million people worldwide with hearing problems that could be addressed by cochlear implants, perhaps only 70,000 actually receive an implant.

[0008] As a result, there is a strong need in the field for a safer, outcome-oriented approach to CI surgery, an approach that is likely to be achieved only through quality, minimally invasive placement of cochlear implants.

[0009] Various incomplete attempts to improve RCI have been previously disclosed. In WO 2019 / 157004, the inventors describe a tracking approach used to navigate / localize a cochlear implant using electromagnetic and / or potential tracking. U.S. Patent Application Publication No. 2018 / 0050196 describes remotely controlled arm insertion of a cochlear implant based at least in part on ECoG data. And U.S. Patent No. 8,594,799 provides limited disclosure of a robotic use case for a method of cochlear implant insertion that relies primarily on force sensing as a method of placement control.

[0010] While various safety measures are described in the available literature, a significant drawback is that none of the current approaches adequately combine planning and monitoring modalities to achieve a quality approach to cochlear implantation. For example, some known methods use tracking approaches to guide insertion and / or confirm placement, but do not successfully plan the implantation procedure in advance. Other approaches use electrophysiological data or force sensing to guide the mechanical insertion of the implant, but do not determine the desired insertion path in advance and select the cochlear implant accordingly. None of the known approaches combine surgical planning and / or monitoring with a process to select the optimal cochlear implant for a specific patient using a known database of preoperatively acquired patient and population data.

[0011] With these drawbacks in mind, the inventors recognized that an integrated approach including insertion planning, implant selection, monitoring of insertion progress, and confirmation of implant placement would result in high-quality, reliable, accurate, and safe cochlear implant placement in a manner not previously available. Summary of the Invention

[0012] These objectives and other advantages are achieved by a novel system and method for high-quality insertion of cochlear implants by minimally invasive or robotic means. The system and method of the present invention enable the use of available medical imaging, electrophysiological, genetic, audiological, and other clinical data to determine a desired insertion progression plan. Insertion progression can be monitored using intraoperative imaging data, electrophysiological data, tool position data, impedance data, implant characteristics, and implant interaction with various tissue types. Confirmation of desired implant placement can be achieved by imaging data, electrophysiological data, implant characteristics, implant interaction with tissue, and implant performance.

[0013] Thus, according to embodiments of the present invention, multiple diverse data points are combined to develop a desired cochlear implant insertion state and progression plan. This can include specific patient data, including physiological, audiological, imaging, genetic, and chemical data. Population-level data can also be incorporated to set general parameters for the shape and size of the cochlea and the tissue characteristics of various ear structures. Planning the desired insertion state and progression can also incorporate the use of electrophysiological data.

[0014] In embodiments, planning data is combined to determine insertion parameters such as depth, speed, direction, orientation, speed profile, and orientation profile. The data is also combined to determine a desired insertion progression. Thus, for example, the desired implant position, orientation, curvature, and shape are evaluated to arrive at a desired insertion state measured across positions and time points.

[0015] In an alternative embodiment, the planning data may be used in selecting the optimal cochlear implant for a particular patient based on patient data and its comparison with historical or average data.

[0016] According to an alternative embodiment, medical imaging data, data regarding tool position, electrophysiological data, and implant characteristics and their interaction with tissue type are used to monitor insertion progress and compare the measured insertion progress with the insertion plan. This comparison can be used to create a feedback loop that can modify insertion trajectory, speed, orientation, and other parameters to align the insertion progress with the insertion plan.

[0017] According to alternative embodiments, medical imaging data, electrophysiological data, implant characteristics, implant-cochlear tissue interaction, and implant performance can be used to confirm quality, accurate, and safe implant placement.

[0018] In an alternative embodiment, planning data, monitoring data, and confirmation of implant placement are combined in a system and method for quality insertion of cochlear implants.

[0019] In an alternative embodiment, medical imaging data, electrophysiological data, genetic data, hearing data, and other clinical data are input into an algorithm executed on a computer, which generates a desired insertion state and a desired insertion progression plan accordingly. The algorithm can optionally test implant-specific parameters against the desired insertion progression plan and desired insertion state, along with patient-specific data, to select the optimal cochlear implant for a particular patient. Similarly, the algorithm can operate iteratively to arrive at an optimized set of insertion state and progression parameters for a particular implant and patient.

[0020] The systems and methods of the present invention can be optimally used in minimally invasive approaches to cochlear implantation. Our combination of data sources and planning, monitoring, and confirmation of placement using minimally invasive techniques will yield the best quality outcomes for patients. Optionally, a minimally invasive approach to quality implant placement may include robotic cochlear implantation guided by the planning, monitoring, and confirmation approach taught by the inventors.

[0021] These and other embodiments of the systems and methods of the present invention are described in more detail below with reference to the accompanying drawings. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a schematic illustration of a method for inserting a cochlear implant, with pre-operative planning and intra-operative monitoring and confirmation, according to an embodiment of the present invention. [Figure 2] FIG. 2 is a schematic diagram of a method for electrode selection that involves applying patient and population data to a database of available electrodes and generating a resulting score, according to an embodiment of the present invention. [Figure 3] FIG. 3 provides an illustration of a system for the insertion of a cochlear implant incorporating a computerized planning tool and a robotic insertion tool, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] The present invention will now be described in detail in connection with its various embodiments with reference to the accompanying drawings.

[0024] In a first embodiment, a method is provided for inserting a cochlear implant electrode into a patient. Conventionally, a cochlear implant electrode includes multiple electrode portions. Generally, the cochlear implant electrode is implanted during a cochlear implantation procedure, which may be performed through any known surgical approach, but preferably a minimally invasive approach as is familiar to those skilled in the art.

[0025] Referring to FIG. 1 , a method for insertion of a cochlear implant electrode may include determining a desired insertion state and a desired insertion progress plan for the cochlear implant electrode, monitoring the insertion progress via available patient, cochlear implant electrode, and instrument data, and verifying that the cochlear implant electrode has reached the desired insertion state.

[0026] A desired insertion condition for a cochlear implant electrode is one in which the electrode reaches a desired position within the patient's cochlea without causing any damage to the cochlea or surrounding tissue, thereby positioning the electrode portion of the cochlear implant electrode to provide improved hearing performance for the patient.

[0027] Prior to the surgical procedure, the medical practitioner implanting the cochlear implant electrode can develop an insertion progression plan for the insertion of the cochlear implant electrode, which can include parameters for insertion speed, insertion angle, insertion depth, insertion direction, and insertion orientation, measured by conventional means known to those skilled in the art.

[0028] During the cochlear implant electrode implantation procedure, insertion progress can be monitored through available patient data, available cochlear implant electrode data, and available instrument data. This available information can be compared to a cochlear implant electrode insertion progress plan to continually assess whether the implantation procedure is progressing toward the desired insertion state. When the procedure data closely matches the desired insertion state, the cochlear implant electrode implantation procedure can be stopped. By setting the desired insertion state, developing an insertion progress plan, and comparing data obtained by the procedure with the insertion progress plan, implementing this method results in a safer implantation procedure for the patient and improved accuracy of cochlear implant electrode placement.

[0029]

[0013] With further reference to Figure 1, the determination of the desired insertion state and the desired insertion progression plan can be based on patient-specific data, cochlear implant electrode-specific data, and population-specific data. The insertion state and progression plan are optimally determined prior to the implantation procedure by reference to these available data sources. Those skilled in the art will understand that while reference to all available data sources will improve the planning of the desired insertion state and insertion progression plan, reference to less than all available data sources will still improve accuracy and safety compared to the state of the art, which does not involve relying on pre-operative planning, determining the desired outcome, and monitoring the progress of one implantation method.

[0030] The desired insertion state can be expressed in terms of any of the following: cochlear implant electrode entry position, cochlear implant electrode orientation, cochlear implant electrode curvature, cochlear implant electrode shape, and number of electrode portions inside the cochlea.

[0031] In various embodiments of the present invention, population-specific data, patient-specific data, and cochlear implant electrode-specific data can be used in developing a desired insertion state and a desired insertion progression plan. Population-specific data can include anatomical atlas data, statistical cochlear shape data, and genetic data. Patient-specific data can include medical imaging data, auditory data, electrophysiological data, and genetic data for a given patient. Cochlear implant electrode-specific data can include the physical dimensions, material properties, electrical properties, chemical properties, and tribological profile of a given cochlear implant electrode.

[0032] In an alternative embodiment of the present invention, determining a desired cochlear implant electrode insertion progression plan and a desired insertion state includes selecting an appropriate cochlear implant electrode for the patient. By way of example only, where the desired insertion state includes parameters of cochlear implant electrode entry location, cochlear implant electrode orientation, cochlear implant electrode curvature, cochlear implant electrode shape, and number of electrode portions within the cochlea, each of these parameters may vary based on patient and population-specific data.

[0033] Referring now to Figure 2, in one embodiment of the present invention, a computerized or automated iterative process is provided whereby patient- and population-specific data is input into a computer using associated software. Based on the provided data, the computer can select one or more choices of cochlear implant electrodes and generate a score for the electrode choice based on a desired correlation between the characteristics of the selected electrode and the input data. In the iterative method, a score can be calculated for each of the one or more cochlear implant electrode choices, and at the end of the selection process, the cochlear implant electrode with the highest score is selected for use in the implantation procedure because it is most likely to produce the desired insertion condition and conform to the desired insertion progression plan.

[0034] Thus, according to this embodiment of the present invention, the final selection of cochlear implant electrodes can be an automated iterative process employing a computerized planning tool that uses the calculated scores for each implant option and incorporates a database of patient and cochlear implant electrode data.

[0035] Those skilled in the art will appreciate that monitoring insertion progress has been described in the past, but never with as much consideration for the numerous different insertion parameters as the inventors have, and never in conjunction with pre-operative development of a desired insertion status and progression plan informed by an iterative selection process for the optimal cochlear implant electrode for a particular patient.

[0036] Thus, monitoring insertion progress can be performed using kinematic data of the instrument or insertion tool, intraoperative imaging, electrocochleography, tissue impedance measurements, stereotactic tracking of the cochlear implant electrode by tracking the cochlear implant electrode or the instrument or insertion tool, measuring insertion force as a function of position, and monitoring the shape of the cochlear implant electrode. Monitoring the shape of the cochlear implant electrode can be achieved by intraoperative imaging or by deriving the shape from available position and force data. The listed monitoring means are well known to those skilled in the art and can be achieved by known available methods.

[0037] Similarly, according to another embodiment of the present invention, confirmation that the cochlear implant electrode has reached the desired insertion state may be achieved through the use of any of the following: instrument or insertion tool kinematic data, intraoperative imaging, electrocochleography, tissue impedance measurements, stereotactic tracking of the cochlear implant electrode or instrument, insertion force measurements, and visualization or derivation of the shape of the cochlear implant electrode. As previously described herein, visualization of shape can be achieved by line of sight or by intraoperative imaging, and shape can also be derived from available position and force data.

[0038] According to an alternative embodiment of the present invention, a system for automated insertion of a cochlear implant electrode is provided. The system includes an insertion tool and an insertion progress monitoring device. In its most general sense, the system is configured to provide for insertion of the cochlear implant electrode by determining a desired insertion state and a desired insertion progress plan for the cochlear implant electrode, monitoring the insertion progress through available patient, cochlear implant electrode, and instrument data, and verifying that the cochlear implant electrode has reached the desired insertion state.

[0039] 3, the system can include a teleoperated device capable of performing kinematic movements in at least three degrees of freedom. Optionally, the teleoperated device can be a three-axis Cartesian robot or a full surgical robot or any other teleoperated device capable of performing the methods of the present invention. The system can further include a computer configured to receive insertion progress data, adjust insertion parameters based on the received insertion progress data, and determine when an end-of-insertion state has been reached.

[0040] According to a further embodiment of the present invention, and still referring to FIG. 3 , the system comprising the teleoperation device and the computer can further include a computerized planning tool associated with the computer, which can include a database of patient, population, and cochlear implant electrode data. The computerized planning tool is configured to receive patient-specific data for a particular cochlear implantation procedure and incorporate the population-specific data and implant-specific data to arrive at a desired insertion state and a desired insertion progression plan. The system comprising the teleoperation device, the computer, and the computerized planning tool can be configured to enable a feedback or control loop between the computerized planning tool, which enables monitoring of the implantation procedure by comparing the insertion state with the desired insertion progression plan and then adjusting surgical parameters to ensure that the insertion state conforms to the desired insertion progression plan.

[0041] As described herein with reference to previous embodiments, the population-specific data may include anatomical atlas data, statistical cochlear shape data, and genetic data; the patient-specific data may include medical imaging data, auditory data, electrophysiological data, and genetic data of a given patient; and the cochlear implant electrode-specific data may include the physical dimensions, material properties, electrical properties, chemical properties, and tribological profile of a given cochlear implant electrode.

[0042] According to this embodiment, a system comprising a remotely operated device and a computer configured to develop a desired insertion state and progression plan can also generate and receive treatment monitoring data and compare the resulting data to the desired insertion state and progression plan. Monitoring insertion progress can be performed using kinematic data of the instrument or insertion tool, intraoperative imaging, electrocochleography, tissue impedance measurements, stereotactic tracking of the cochlear implant electrode by tracking the cochlear implant electrode or the instrument or insertion tool, measuring insertion force as a function of position, and monitoring the shape of the cochlear implant electrode.

[0043] The system is configured to continuously monitor and receive insertion progress data, and comparison of the insertion progress data to a desired insertion state and progress plan creates a feedback loop that provides guidance for ongoing insertion parameters. Finally, once the desired insertion state is reached, the system stops the implantation procedure.

[0044] While the present invention has been shown and described with reference to specific embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. By way of example only, and not of limitation, those skilled in the art will readily appreciate that the methods / systems disclosed herein may be applied to other surgical fields.

Claims

1. 1. A method for inserting a cochlear implant electrode including multiple electrode portions during a cochlear implantation procedure in a patient, comprising: determining a desired insertion state and a desired insertion progression plan for the cochlear implant electrode; monitoring insertion progress via available patient, cochlear implant electrode, and instrument data; confirming that the cochlear implant electrode has reached the desired insertion state; A method comprising:

2. 2. The method of claim 1, wherein determining the desired insertion state and desired insertion progression plan is based on population-specific data, patient-specific data, and cochlear implant electrode-specific data, and wherein the desired insertion progression can be expressed in terms of any of insertion depth, speed, direction, orientation, speed profile, and orientation profile, and the desired insertion state can be expressed in terms of any of cochlear implant electrode entry position, cochlear implant electrode orientation, cochlear implant electrode curvature, cochlear implant electrode shape, and number of electrode portions inside the cochlea.

3. 3. The method of claim 2, wherein the population-specific data may include anatomical atlas data, statistical cochlear shape data, and genetic data; the patient-specific data may include medical imaging data, auditory data, electrophysiological data, and genetic data of a given patient; and the cochlear implant electrode-specific data may include physical dimensions, material properties, electrical properties, chemical properties, and tribological profile of a given cochlear implant electrode.

4. 4. The method of claim 1, wherein the step of determining a desired insertion state and insertion progression plan includes determining preferred cochlear implant electrode options by sequentially selecting different cochlear implant electrodes, a computer-generated score is calculated for each cochlear implant electrode option, and the cochlear implant electrode with the highest score is most likely to provide an optimal insertion state and insertion progression plan for the given patient.

5. 5. The method of claim 4, wherein the final selection of the cochlear implant electrode can be an automated iterative process employing a computerized planning tool that uses the scores calculated for each implant option and incorporates a database of patient and cochlear implant electrode data.

6. 10. The method of claim 1, wherein monitoring insertion progress is performed using kinematic data of an instrument or insertion tool, intraoperative imaging, electrocochleography, tissue impedance measurements, stereotactic tracking of the cochlear implant electrode by tracking the cochlear implant electrode or an instrument or insertion tool, measuring insertion force as a function of position, and monitoring the shape of the cochlear implant electrode.

7. 7. The method of claim 6, wherein monitoring the shape of the cochlear implant electrode can be performed by intraoperative imaging or by deriving shape from available position and force data.

8. 7. The method of claim 6, comprising the further step of comparing monitored insertion progress data with the desired insertion progress state and a desired insertion progress plan to assess whether the desired insertion state may have been reached.

9. 10. The method of claim 1, wherein the step of verifying that the cochlear implant electrode has reached the desired insertion state comprises the further step of comparing monitored insertion progress data with the desired insertion state.

10. 10. The method of claim 9, wherein verifying that the cochlear implant electrode has reached the desired insertion state can be achieved through the use of any of the following: instrument or insertion tool kinematic data, intraoperative imaging, electrocochleography, tissue impedance measurements, stereotactic tracking of the cochlear implant electrode or instrument, insertion force measurements, and visualization or derivation of the shape of the cochlear implant electrode.

11. 11. A system for automated insertion of a cochlear implant electrode, comprising an insertion tool configured to insert a cochlear implant electrode according to the method of any one of claims 1 to 10 and an insertion progress monitoring device.

12. 12. The system of claim 11, further comprising a computerized planning tool incorporating a database of patient and cochlear implant electrode data, and further capable of collecting insertion progress data and comparing said insertion progress data with a pre-operative plan.

13. The system of claim 12 , wherein the insertion tool is a teleoperated device capable of performing kinematic movements in at least three degrees of freedom.

14. 14. The system of claim 13, wherein the remote operation device comprises a computer configured to receive insertion progress data, adjust insertion parameters based on the received insertion progress data, and determine when an end-of-insertion state is reached.

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