Oct assisted cochlear implant electrode insertion

Abstract

Implant electrode insertion system (1) for inserting an implant electrode into the cochlea (99), comprising an oct device (2) comprising an oct probe (3) defining an optical axis (A) and configured to be held in a measurement position outside of the cochlea and configured to provide an orientation signal representative for an orientation of the oct probe with respect to a cochlea, measured using optical coherence tomography of light emitted from the probe in the measurement position along the optical axis (A); an implant electrode insertion module (4) connected to the oct device, and configured to be arranged in an insertion position on the basis of the orientation signal; and an alignment unit (5) configured to assist in positioning of the implant electrode insertion module (4) in the insertion position on the basis of the orientation signal; wherein the implant electrode insertion module (4) comprises an electrode guide that defines a guide axis (G), and is configured to, in the insertion position, guide a cochlear implant electrode along the guide axis towards the cochlea, wherein the guide axis (G) is coaxial with the optical axis (A) of the oct device.

Description

[0001] P37052PC00 / MBA

[0002] Title: OCT Assisted Cl Electrode Insertion

[0003] Field of the invention

[0004] The present invention relates to an implant electrode insertion system for inserting an implant electrode into the cochlea, to an implant electrode assembly, a method for guiding a cochlear implant electrode, a method for surgically implanting a cochlear implant electrode, and to a method for mapping electrode pads of a cochlear implant electrode to frequency bins on an auditory nerve.

[0005] Background of the invention

[0006] A cochlear implant (Cl) as known in the art is a surgically implantable medical device that directly stimulates the cochlear nerve by an electrode array in the cochlea. Their use in children with severe degree of hearing loss has brought substantial benefits to those implanted, and when accompanied by proper rehabilitation they lead to significant improvement in audiological status, overall functioning and speech perception skills. Children with cochlear implants have greater likelihood of acquiring oral language, integrating into regular schools and being able to experience sounds along with better speech skills.

[0007] Cochlear implants can also have a beneficial impact on learning and educational outcomes as well as the overall quality of life, though many factors other than implantation influence these results. In recent years, the scope of implantation has been expanded to adults with severe to profound sensorineural hearing loss, who show improved speech perception and health-related quality of life with their use.

[0008] A cochlear implant comprises both external and internal components. The external components generally comprise a microphone and a speech processor, which converts recorded sound into an electrical signal. The electric signal is transmitted to the internal components, usually comprising a decoder to generate electrical pulses and an electrode that is inserted into the spiral-shaped cochlea for stimulating the auditory nerve and bypassing the malfunctioning cochlea.

[0009] The electrode array is generally inserted in the scala tympani of the cochlea. This can be done by inserting it through the round window or through a drilled entrance to the scala tympani (cochleostomy). It has been found that the known procedures may lead to damage of internal ear structures such as the basilar membrane, the osseous spiral lamina or the spiral ligament in the cochlea, which can lead to an inflammation reaction and the formation of fibrotic tissue, potentially inducing necrosis and / or apoptosis, causing loss of the preserved auditory hair cells responsible for residual hearing and / or increasing the impedance and affecting residual hearing. It has been demonstrated that patients with preserved postoperative residual hearing have improved speech perception with electro-acoustic or electro-vibrational stimulation, especially in speech perception in noise and music perception.

[0010] Traditionally, an electrode is inserted using a mental representation of the cochlea, based on experience, a limited visual assessment and preoperative CT and / or MRI scans. However, it has been found that such scans have a relatively low resolution, do not visualize soft intraocular structures, and do not correlate to the orientation of the cochlea while inserting the implant electrode or to the actual position of the electrode inside the scala tympani. Further, such scans require relatively large and expensive machines and expose a patient to harmful radiation.

[0011] Further, during insertion of the electrode, only the entrance to the scala tympany may be seen and heavy reliance is placed on tactile feedback, and an insertion axis of the electrode can be changed when increased tactile resistance is experienced. However, as a result, tactile feedback can only be perceived after the electrode has already touched the cochlear wall and possibly traumatized it. This is especially important as it has been found that electrode insertion trauma is often not accompanied by an increased resistance or mechanical forces, making it currently an unreliable parameter for insertion monitoring.

[0012] US2012172893 WO2024226753 and WO2024159133 disclose sensing systems for implant surgery which allow imaging during insertion of the cochlear implant. Some of the disclosed systems allow for quantifying distance measurements between an end of the insertion device and anatomic surfaces to provide ‘parking sensor’ type of distance feedback.

[0013] However, it has been found that the ideal insertion angle of an implant electrode varies as much as 60 degrees among the subjects. Although measuring a distance may allow correct identification of insertion depth, it has been found to be relatively difficult to alter introduction angle when the cochlear implant is being inserted. As a result, Cl surgery poses a considerable risk for loss of residual hearing due to intraoperative trauma to the internal structures of the cochlea, occurring in up to 32% of implantations.

[0014] Object of the invention

[0015] It is therefore an object of the intention to provide an implant electrode insertion system that reduces the chances of trauma to the cochlea, that allows to visualize the position of the implant electrode relatively precisely, which correlates to the orientation of the cochlea while inserting the implant electrode or to the actual position of the electrode inside the scala tympani, or at least to provide an alternative implant electrode insertion system, for example an implant electrode insertion system that allows to visualize the position of the implant electrode, that allows to determine an optimal insertion angle before guiding the electrode into the cochlea, that allows for relative precise positioning of the electrode in the cochlea, at a higher resolution, that is better able to visualize soft structures, requires a smaller machine, and / or that exposes the patient to less harmful radiation.

[0016] Description of the invention

[0017] The present invention provides an implant electrode insertion system according to claim 1. The cochlear implant electrode insertion system comprises an oct device comprising an oct probe defining an optical axis. The oct device is configured to provide a cochlear orientation signal representative for an orientation of the oct probe with respect to a cochlea. The cochlear orientation signal is measured using optical coherence tomography of light emitted along the optical axis. The light may be emitted such that it can be reflected and / or backscattered by surfaces to be imaged, and can be received by the oct probe. The probe may be held in a measurement position outside of the cochlea and the orientation signal may be measured using light emitted from the probe in the measurement position.

[0018] The measurement position may correspond to a position in which the OCT probe is arranged outside of the cochlea, for example adjacent to or in front of the round window. The axis along which the probe emits light, e.g. the longitudinal axis of the probe may define the optical axis. The probe may comprise an integrated optical lens and / or scanning system configured to deliver the emitted light along the optical axis. The measurement position may be defined by a predetermined distance of the probe with respect to the cochlea. The measurement position may be a position that allows optical coherence tomography imaging of cochlear structures through the round window membrane or another external interface.

[0019] The light may be emitted from the distal end of the OCT probe, e.g. without passing through additional optical fibres, waveguides and / or other optical coupling media between the probe tip and the cochlea. The oct device may thus be arranged such that emitted light may travel along a free optical path between the probe and cochlear tissue to be imaged. A detector may be provided, configured to detect interference of the reflected and / or backscattered light with the emitted light to measure the cochlear orientation signal. The cochlear orientation signal may be representative for a distance and / or angle of the oct probe with respect to the cochlea.

[0020] The oct device may be configured to emit infrared laser light to image through the round window membrane in the cochlea. The oct device may be configured to visualize the orientation of the basilar membrane up to the basal turn. As such, an implant electrode may be guided into the cochlea relatively precise, with lower chances of touching the basilar membrane. The oct probe may be configured to be tilted manually in the correct position, e.g. such that the optimal insertion axis is aligned with the optical axis.

[0021] Optimal, as used herein, may refer to a desired insertion axis, for example an insertion axis along which the chances of damage to tissue due to contact between the implant electrode and the tissue are relatively low, e.g. the axis along which the chances of damage are lowest.

[0022] The oct device may be configured to measure the distance between the round window niche and the probe to determine an axial distance therebetween. The advantage is that oct may determine the distance at relatively high accuracy (microns).

[0023] The cochlear implant electrode insertion system comprises an implant electrode insertion module connected, e.g. rigidly, to the oct device, and configured to be arranged in an insertion position on the basis of the orientation signal.

[0024] The cochlear implant electrode insertion system further comprises an alignment unit configured to assist in positioning of the implant electrode insertion module in the insertion position on the basis of the orientation signal. The alignment unit may be configured to assist passively, e.g. by providing feedback on the orientation of the oct probe with respect to the cochlea, for example such that a surgeon may position the implant electrode insertion module manually with respect to the cochlea, and / or actively, e.g. by altering the orientation of the oct probe with respect to the cochlea, for example through a drive system.

[0025] The implant electrode insertion module comprises an electrode guide that defines a guide axis, and is configured to, in the insertion position, guide a cochlear implant electrode along the guide axis towards the cochlea. The guide axis may be the longitudinal axis of the electrode guide, in particular of the outer end thereof, and / or correspond to the longitudinal axis of an electrode arranged therein and protruding therefrom. The implant electrode insertion module may be connected to the oct device such that the orientation signal is representative for an orientation of the electrode guide. The electrode guide may be configured to guide the electrode such that a tip axis of a guided electrode matches the optical axis of the oct probe. The electrode guide may comprise a housing to protect the electrode array.

[0026] The guide axis is coaxial with the optical axis of the oct device. The guide axis and the optical axis may coincide. As such, the electrode may be guided and inserted into the cochlea along the precise axis that was measured with the oct probe.

[0027] It has been found that larger difference between an ideal or optimal insertion axis of the electrode, and actual insertion axis is associated with more damage to the intracochlear structures. The ideal insertion axis correlates with the centerline of the first nearly straight part of the cochlea extending from the round window to the basal turn (first turn) of the cochlea. The insertion angle is defined with respect to the basal turn of the cochlea as the electrode enters through the round window. This ideal insertion angle varies as much as 60 degrees among the subjects. From an intraoperative perspective, this variability involves pushing the electrodes “as near to the buttress” or “as near to the emergence of the corda tympani” as possible, depending on the case. Since the human cochlea is entirely surrounded by bone it is impossible for a surgeon to determine the pathway of the ideal insertion axis with respect to the position of the round window.

[0028] The oct probe allows to measure the optimal insertion axis very precisely, and due to the coaxial alignment of the guide axis with the optical axis of the oct probe, the electrode may be inserted while the oct probe is held in the same orientation, thereby reducing the chances of deviations.

[0029] As a result, the invention advantageously allows the electrode to be guided very precisely and the invention provides an implant electrode insertion system that reduces the chances of trauma to the cochlea, that, by using oct, allows to visualize the position of the implant electrode relatively precisely, which due to the coaxial alignment correlates to the orientation of the insertion module while inserting the implant electrode or to the actual position of the electrode inside the scala tympani. Therewith, the chances of preservation of residual hearing are increased, the postoperative outcomes may be improved and the surgeon may perform the cochlear implant insertion with increased confidence.

[0030] The combination of an oct probe and coaxial guide axis provides several advantages. Firstly, the oct probe may provide visualization of the cochlea at a relatively high resolution and that is relatively well able to visualize soft structures, compared to the prior art. In particular, pre-operative CT does not visualize soft intraocular structures and does not correlate to the orientation of the cochlea while inserting the implant electrode or to the actual position of the electrode inside the scala tympani. The same disadvantages apply to MRI which cannot be used intraoperatively, i.e. during insertion of the implant electrode. Further, due to the use of oct , less exposure of the patient harmful radiation may be achieved compared to CT or MRI imaging. Finally, the use of oct enables to use machines with a smaller foodprint compared to CT or MRI imaging.

[0031] Secondly, oct may enable measurement of speeds, for example via the doppler effect. As the guide axis is coaxial with the optical axis, the light emitted by the oct device may be backscattered and / or reflected by the implant electrode. As such, an insertion speed of the implant electrode during insertion of the implant electrode via the implant electrode insertion module may be measured, e.g. with respect to the oct probe. It has been found that magnitude and variation in electrode insertion speed correlate with trauma, especially when the electrode is inserted manually. By enabling measurement of insertion speed due to the advantageous combination of oct and coaxial alignment of the insertion axis and the guide axis, feedback on the speed and speed variation of the cochlear implant electrode may be provided to reduce the chances of trauma.

[0032] Thirdly, the oct device may allow visualization of the scala tympani up to the basal turn to identify the ideal axis of an electrode array, during surgery, e.g. in real time. Therewith, due to the connection of the implant electrode insertion module to the oct probe, it may be guaranteed that the guide axis remains coaxial with the optical device of the oct device.

[0033] Existing methodologies do not provide that, and scientific publications present devices do not demonstrate that.

[0034] Finally, the use of an oct probe allows relatively convenient control of the area imaged and represented in the orientation signal, compared to a relative large CT and / or MRI machine. As such, the oct probe may allow control of more degrees of freedom of the guide axis than was possible in the prior art.

[0035] The implant electrode insertion system may comprise a camera configured to receive light, e.g. parallel to the optical axis, wherein the cochlear implant insertion system is configured to provide the cochlear orientation signal in further dependence of camera footage. This way, the orientation signal may be representative for a relatively large number of degrees of freedom. The camera may be a full colour camera. The camera may be attached to, e.g. mounted on, the oct probe.

[0036] The camera may be configured to capture at least two degrees of freedom (e.g. x, horizontal; y, vertical) of the orientation of the cochlea, e.g. of the round window, whereas the oct probe may be configured to capture an additional three degrees of freedom (e,g, z, axial distance; Rx, rotation over x; Ry rotation over y) using optical coherence tomography. This way, in comparison to the prior art, more degrees of freedom (Rx, Ry) may be represented in the orientation signal that what would be possible in the prior art.

[0037] When the oct probe is positioned in front of the ear, e.g. in front of the round window of the cochlea, a surgeon’s view on the ear may be obstructed. By having a camera positioned on the oct probe, improved view on the ear may be provided to the surgeon via camera footage. As a result, positioning and safety of the device may be increased.

[0038] The camera may be configured to capture footage representative for lateral movement, e.g. movement in a direction transverse to the guide axis and / or transverse to the optical axis. It has been found that lateral shifts, e.g. shifts in the plane of the circular window, may be detected relatively well with a camera.

[0039] The alignment unit may be configured to assist in positioning of the implant electrode insertion module in further dependence of the footage captured with the camera. In particular, a feedback device may be configured to provide feedback in dependence of the orientation signal and captured camera footage. The feedback may be provided to assist in alignment of the oct probe with respect to the ear, e.g. to the round window.

[0040] In an embodiment, the alignment unit comprises a feedback device configured to provide feedback, e.g. visual, auditive and / or haptic feedback, in dependence the orientation signal. By providing feedback, an operator or surgeon may be assisted in manually positioning the electrode insertion system with respect to the ear, such that compared to the prior art, relatively less reliance is necessary on manual positioning, skill and blind eye view of the operator or surgeon.

[0041] In an embodiment, the cochlear implant insertion system comprises a processing unit configured to determine, e.g. calculate, an optimal insertion axis for the implant electrode on the basis of the cochlear orientation signal, wherein the alignment unit is configured to assist in alignment of the implant electrode insertion module with respect to the determined optimal insertion axis. The processing unit may be configured to determine the optimal insertion axis on the basis of a determined ideal insertion axis. The ideal insertion axis may be determined by the centerline of the first nearly straight part of the cochlea extending from the round window to the basal turn of the cochlea.

[0042] The processing unit may be configured to determine one or more dimensions, e.g. a length, a width and / or a volume of the first part of the cochlea. The ideal insertion axis may be determined by computing a longitudinal center line through the first part of the cochlea using the one or more dimensions.

[0043] The processing unit may be configured to determine a location of one or more obstructions, e.g. a location of the facial nerve and / or the chorda tympani nerve. The optimal insertion axis may be determined by adjusting the ideal insertion axis for the one or more obstructions, e.g. by selecting an optimal insertion axis having an angle with respect to the basal turn of the cochlea that is as close as possible to the angle of the ideal insertion axis, but wherein the optimal insertion axis does not intersect with the one or more obstructions.

[0044] In an embodiment, the processing unit is configured to determine the optimal insertion axis on the basis of the orientation signal before the implant electrode is guided into the cochlea with the implant electrode insertion module. This way, the optimal insertion axis may be calculated pre-insertion, allowing the electrode to be guided along an orientation that has been determined and verified prior to mechanical interaction with the cochlea. By determining the optimal axis in advance, intra-operative adjustments based on tactile feedback may be reduced, thereby lowering the risk of trauma to intracochlear structures. The predetermination step may also allow automatic or semi-automatic positioning of the insertion module, potentially resulting in faster surgical workflow and improved reproducibility between patients.

[0045] The term before may refer to any time preceding the start of mechanical insertion of the electrode, e.g. immediately prior to insertion or during an initial positioning stage. The processing unit may comprise one or more processors configured to execute algorithms that analyse the cochlear orientation signal and optionally pre-operative imaging data to estimate the orientation of the round window membrane or basal turn. The orientation signal may I this embodiment include information representative for angular alignment, distance, and surface curvature of the cochlear structures. The processing unit may thus determine the optimal insertion axis by identifying the geometric pathway through the round window that minimizes deviation from the cochlear centerline, i.e. the longitudinal axis of a first part of the cochlea, or from a defined structural element. The optimal insertion axis may be stored or displayed for verification and may optionally be used to automatically align a robotic actuator or alignment unit prior to electrode insertion.

[0046] In an embodiment, the optimal insertion axis is represented by an insertion angle with respect to a longitudinal axis of the cochlea into which the cochlear implant is guided. The optimal insertion axis may be expressed as a single measurable parameter that can be easily visualized, stored, or compared across patients. Representing the axis by an angle may allow simplified control algorithms and user interfaces for surgical planning or robotic alignment. The insertion angle may correspond to the angular deviation between the determined optimal insertion axis and a reference longitudinal axis of the cochlea, such as the central axis of the basal turn or an anatomical model-derived cochlear centerline. By defining the optimal axis as an angular relation rather than an absolute position, the system may compensate for individual cochlear variations and anatomical asymmetry, allowing patient-specific optimization of insertion trajectory. The term longitudinal axis of the cochlea may for example refer to an axis extending through the round window toward the modiolus. The insertion angle may be determined geometrically or computationally on the basis of imaging data derived from the orientation signal. The processing unit may be configured to determine the insertion angle in one or more planes, e.g. a sagittal plane or transverse plane relative to the cochlear orientation. The processing unit may further be configured to visualize the insertion angle in a display or to generate feedback to the alignment unit, which may adjust the electrode guide until the measured angle matches the desired optimal insertion angle.

[0047] In an embodiment, the processing unit comprises an object recognition module configured to recognize a structural element of the ear on the basis of the orientation signal and pre-provided recognition data representative for at least one property of the structural element, wherein the processing unit is configured to determine the optimal insertion axis in dependency of the recognized structural element. This embodiment may provide the advantage that the determination of the optimal insertion axis can take into account actual anatomical features that differ between patients. By recognizing specific structural elements, such as a part of the cochlea, the round window, the basal turn, the facial nerve, and / or the chorda tympani, the system may adapt the computed insertion axis to the real geometry of the individual cochlea. The object recognition module may allow automatic segmentation or identification of relevant ear structures from the OCT-based orientation signal. The recognition data may include reference orientation signals, reference shapes, reflectivity profiles, or depth-dependent patterns. The recognition data may be provided manually, preprovided from an external source, and / or pre-programmed. The recognition data may e.g. be obtained from stored anatomical datasets.

[0048] The term structural element may refer to any anatomical or artificial structure visible in the OCT data, e.g. including bony landmarks or soft-tissue interfaces. The object recognition module may comprise one or more processors configured to execute pattern-matching or machine-learning algorithms trained to detect such structures. The processing unit may use the recognized element to establish a spatial reference frame from which the optimal insertion axis may be calculated, for example by determining the tangent line through the round window membrane and / or by orienting the axis relative to the basal turn curvature. In some embodiments, the recognized structural element may be displayed to the operator or used to provide feedback to the alignment unit. This way, the electrode guide may be even better aligned in accordance with the patient-specific anatomy.

[0049] In an embodiment, the processing unit comprises an orientation recognition module configured to determine an orientation of the recognized structural element with respect to the OCT probe, wherein the processing unit is configured to determine the optimal insertion axis in dependency of the determined orientation of the structural element. This way, the optimal insertion axis may e.g. be calculated not only based on the position but also on the spatial orientation of relevant anatomical structures. By determining the angular relationship between the OCT probe and, for example, the round window membrane or the basal turn of the cochlea, the system may more precisely align the electrode guide with the natural curvature of the cochlea. As a result, insertion can be performed along a trajectory that minimizes contact forces and reduces the likelihood of trauma to intracochlear tissue. The orientation recognition module may thereby enable dynamic adaptation of the insertion axis based on real-time or pre-acquired orientation data.

[0050] The term orientation may refer to one or more angular parameters, such as pitch, roll, or yaw. The orientation may describe the inclination of a structural surface relative to the optical axis of the OCT probe. The orientation recognition module may comprise a computational unit, e.g. configured to evaluate gradients, contour directions, or vector fields derived from the orientation signal. The processing unit may use the determined orientation to adjust the calculated optimal insertion axis, e.g. so that it remains substantially perpendicular to the round window membrane or tangential to the basal turn, depending on the detected geometry. The orientation data may be visualized for the operator or transmitted to a robotic alignment system to automatically correct the probe position before insertion.

[0051] In an embodiment, the processing unit comprises an obstruction detection module configured to determine presence of one or more obstructions, e.g. a location of the facial nerve and / or the chorda tympani nerve, on the basis of the orientation signal when the OCT probe is arranged in the measurement position, wherein the processing unit is configured to adjust the determined optimal insertion axis for the detected one or more obstructions. This may provide the advantage that the insertion path can be optimized to avoid sensitive anatomical structures, thereby reducing the risk of nerve injury or other surgical complications, e.g. so that the electrode follows a safe trajectory that remains as close as possible to the ideal axis while avoiding intersecting tissue regions identified as potential obstructions. The obstruction detection module may enable automated safety verification before mechanical insertion is initiated, enhancing overall surgical precision and patient safety.

[0052] The term obstruction may refer to any anatomical structure or material region detected in the OCT-based orientation signal that could interfere with or be damaged by electrode insertion. The obstruction detection module may comprise image-processing or signalanalysis algorithms configured to identify discontinuities, high-reflectivity areas, or characteristic patterns corresponding to nerves or bone structures. The adjustment of the optimal insertion axis may involve recalculating an alternative trajectory having a minimal angular deviation from the previously determined axis or selecting an offset path that bypasses the obstruction within defined geometric constraints. The processing unit may optionally generate visual or haptic feedback to indicate the detected obstruction and the corresponding adjustment of the insertion axis to the operator or to a robotic control system.

[0053] In an embodiment, the alignment unit comprises a feedback device configured to provide feedback, e.g. visual, auditive and / or haptic feedback, in dependence of a difference between the optical axis and the determined optimal insertion axis. This way, the feedback device may assist an operator and / or surgeon in finding the optimal insertion axis and / or positioning the implant electrode insertion system even more effectively. The feedback device may provide feedback in dependence between deviation of the orientation of the OCT probe and / or the guide axis with respect to the determined optimal insertion axis.

[0054] In an embodiment, the oct device is configured to, during insertion of an implant electrode via the implant electrode insertion module, provide an insertion speed signal representative for an insertion speed of the implant electrode, e.g. with respect to the oct probe; further comprising an insertion monitoring unit configured to, on the basis of the insertion speed signal, determine the insertion speed of the cochlear implant electrode during insertion, e.g. using the doppler effect.

[0055] In an embodiment, the feedback device is a visual device configured to visualise the determined optimal insertion axis and to provide visual feedback in dependence of the difference between the optical axis and the determined optimal insertion axis. It has been found that by visually displaying the determine optimal insertion axis, positioning the implant electrode insertion system may be performed even more effectively.

[0056] In an embodiment, the electrode guide is releasably attachable to the OCT probe, e.g. via a bracket. This embodiment may provide the advantage that the electrode guide can be easily attached to or detached from the OCT probe, allowing flexible use of the OCT device for both imaging and insertion. A releasable connection may facilitate sterilization, maintenance, and interchangeability of electrode guides with different geometries or dimensions, depending on patient anatomy or electrode type. It may also allow the OCT probe to be used independently for diagnostic imaging or preoperative planning before connecting the insertion module. As a result, a single OCT probe may serve multiple roles within the surgical workflow, improving cost efficiency and usability.

[0057] The term releasably attachable may refer to any mechanical or magnetic coupling that allows repeated engagement and disengagement without damage or misalignment. The bracket may comprise a clip, latch, or sliding mechanism configured to hold the electrode guide in a fixed position relative to the OCT probe during operation. The bracket may further include alignment features, such as keyed surfaces or pins, ensuring that the guide axis remains coaxial with the optical axis of the OCT probe when attached. In some embodiments, the bracket may be made of sterilizable material, such as stainless steel or biocompatible polymer, and may optionally comprise damping or locking elements to minimize vibration or drift during electrode insertion.

[0058] In an embodiment, the electrode guide extends at least partially cylindrical along the guide axis and delimits a hollow interior through which the implant electrode can pass. The hollow interior may have a substantially circular cross section. The inner dimensions of the hollow interior, e.g. a diameter thereof, may be substantially equal to the outer dimensions of an implant electrode.

[0059] In an embodiment, the electrode guide comprises a detachment device for detachment of the implant electrode from the electrode guide. The detachment device may comprise a wiring opening for releasing electrode wiring from the electrode guide. The wiring opening may extend substantially parallel to the guide axis. It has been found that by using a wiring opening, detachment of the electrode from the electrode guide may be facilitated and / or electrode wiring may remain connected to the electrode during insertion.

[0060] In an additional and / or alternative embodiment, the detachment device may be releasably couplable with the cochlear implant electrode.

[0061] In an embodiment, the electrode guide comprises a feed part that is not aligned coaxially with the optical axis and a guide part having at least one bend section that guides the implant electrode towards the optical axis. The feed part may for example extend a longitudinal axis, e.g. substantially parallel to the guide axis. The at least one bend section may be configured to locally bend the implant electrode to change the direction thereof. This way, the implant electrode may be provided away from the optical axis, e.g. to limit obstruction of the field of view for an operator or surgeon.

[0062] In an embodiment, the guide part comprises a first bend section arranged on a first side of the optical axis, and a second bend section arranged on an opposite second side of the optical axis. The first bend section may be configured to direct the cochlear implant electrode from the feed part towards a first direction not coaxial with the optical axis and the second bend section may be configured to direct the cochlear implant electrode from the first direction towards the guide axis. The first bend section and the second bend section may be shaped oppositely to each other, e.g. be mirror symmetrical to each other. The at least one bend section may be provided such that the optical axis is unobstructed.

[0063] In an embodiment, the first bend section and the second bend section are arranged separately and at a distance from each other. For example, the first bend section may be provided on a first side of the oct probe, e.g. on a top side thereof, and the second bend section may be provided on an opposite side of the oct probe, e.g. on a bottom side thereof. The camera may for example be provided on the oct probe, e.g. on a surface between the top side and the bottom side.

[0064] In an embodiment, the electrode guide extends between the first bend section and the second bend section, wherein electrode guide comprises an oct opening aligned with the optical axis to allow light emitted along an optical axis to reach the cochlea. As such, additional guidance may be provided to the implant electrode between the first bend section and the second bend section. In an embodiment, the electrode guide comprises a fixed part that defines the guide axis and a movable part that is movable with respect to the fixed part, wherein the fixed part and the movable part together delimit the hollow interior. This may provide the advantage that the electrode guide can change shape or length during insertion, thereby enabling controlled release or repositioning of the implant electrode within the cochlea. The movable part may allow the electrode to be gradually advanced or exposed while maintaining precise guidance along the defined guide axis. This configuration may also facilitate use with precurved electrodes, which may be held in a straight configuration by the movable part and released progressively during insertion to follow the natural curvature of the cochlea.

[0065] The term movable part may refer to a segment of the electrode guide that is translatable, slidable, or pivotable relative to the fixed part. The movement may be linear, rotational, or telescopic, and may be driven manually or by an actuator coupled to the insertion module. The fixed and movable parts may jointly define a continuous hollow interior through which the electrode passes. The movable part may comprise a longitudinal slot or flexible coupling configured to maintain alignment with the fixed part while allowing smooth relative displacement. Optionally, the movable part may include locking features or position sensors to monitor and control its displacement, e.g. enhancing insertion accuracy and repeatability.

[0066] In an embodiment, the movable part comprises a longitudinal opening that slidingly engages the fixed part. This embodiment may provide that the movable part can smoothly translate along the fixed part while maintaining precise alignment of the hollow interior through which the implant electrode is guided. The longitudinal opening may act as a sliding interface, e.g. enabling controlled motion of the movable part relative to the fixed part, for example without introducing rotational misalignment or play. This structure may allow gradual advancement or retraction of the movable part after insertion of the pre-curved electrode .

[0067] The term longitudinal opening may refer to an elongated slot, groove, or channel extending substantially parallel to the guide axis. The opening may be configured to receive a projection, rib, or rail provided on the fixed part, thereby forming a linear sliding connection. The opening may have a circular, rectangular, or dovetail-shaped cross section, depending on the desired mechanical stability.

[0068] In an embodiment, the electrode insertion module comprises a manipulation recess configured to receive a forceps for moving a cochlear implant electrode along the optical axis e.g. by pushing the cochlear implant electrode. The manipulation recess may be formed by the wiring opening and / or vice versa. The manipulation recess may comprise one or multiple slits that extend longitudinally along the electrode guide, e.g. parallel to the optical axis. The manipulation recess may be shaped such that the interior of the electrode guide may be reached from outside with a forceps. The skilled person will understand that forceps as used herein is meant to include similar and suitable tools for moving the implant electrode.

[0069] In an embodiment, the implant electrode insertion system further comprises a forceps.

[0070] In an embodiment, the electrode insertion module comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises an input device for receiving a driving movement from an operator; and a transmission device configured to reduce and / or smoothen the movement received by the input device and to transmit the reduced and / or smoothened movement to the cochlear implant electrode for moving the cochlear implant electrode along the optical axis.

[0071] The input device may comprise an input element, e.g. a handle, movable pin and / or rotatable wheel and a moving surface configured to engage the implant electrode. The transmission device may be provided with a transmission ratio to reduce and / or smoothen the movement.

[0072] In an embodiment, the electrode insertion module comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises an actuator configured to, upon activation, provide a driving movement for moving the cochlear implant electrode along the optical axis. The actuator may for example comprise an electric motor or linear actuator, pneumatic and / or hydraulic actuator. It has been found that this way, a relatively controlled, e.g. constant, insertion of the implant electrode may be achieved.

[0073] The movement mechanism may comprise a controller configured to control the movement of the implant electrode through the electrode guide. For example, a movement sensor may be provided wherein the controller is configured to control movement on the basis of the sensor signal.

[0074] In an embodiment, the implant electrode insertion system comprises a support arm connected to the implant electrode insertion module for supporting the electrode guide in the insertion position. It has been found that the support arm may enhance stable holding of the implant electrode insertion system and may thereby further lower the chances of cochlear damage.

[0075] The invention further relates to a robotic implant electrode insertion system, comprising the implant electrode insertion system according to any of the embodiments as disclosed herein.

[0076] It has been found that robotic systems of the prior art have disadvantages that are similar to manual surgery methods, such that the chances of trauma are still significant. In particular, the insertion axis needs to be determined manually on the basis of preoperative CT scans and limited visibility. If an insertion axis would be determined automatically, such CT scans miss information about the soft tissues in the cochlea, such that a calculated ideal insertion axis on the basis of CT scans is not necessarily correct. Further, if haptic feedback is present, the disadvantage is similar as described herein for manual procedures.

[0077] The cochlear implant insertion system according to the present invention may be provided on a robotic arm. In particular, the electrode may be moved into the cochlea upon determining the optimal insertion axis and arranging the implant insertion module in the insertion position.

[0078] The invention further relates to a cochlear implant electrode assembly, comprising a cochlear implant electrode and an implant electrode insertion system and / or a robotic implant electrode insertion system according to any of the preceding claims, wherein the cochlear implant electrode is arranged in the electrode guide.

[0079] In an embodiment, a flexibility of the cochlear implant electrode is larger than a flexibility of the movable part, such that the movable part is configured to hold the implant electrode, e.g. a pre-curved electrode, in a straight configuration in the cochlea.

[0080] This embodiment may provide the advantage that the movable part of the electrode guide can temporarily constrain a pre-curved or flexible implant electrode in a straightened state during insertion, thereby enabling smooth advancement into the cochlea without buckling or undesired contact with cochlear walls. Once released, the electrode may return to its pre-curved shape and conform to the spiral geometry of the cochlea, improving positioning accuracy and reducing the risk of trauma. By designing the movable part to be stiffer than the electrode itself, a balance may be achieved between sufficient structural support and controlled flexibility, when retracting the movable part over the fixed part of the electrode guide.

[0081] The term flexibility may refer to a mechanical property such as bending stiffness or elastic modulus, measured for example as the ratio of applied force to deflection. The movable part may for example be made of a polymer or metal material with a higher stiffness than the electrode body. The electrode may for comprise a relatively soft silicone carrier with embedded conductive wires.

[0082] The movable part may extend along the length of the electrode guide and may include a release mechanism configured to gradually disengage the electrode once it has reached the desired depth. In some embodiments, the movable part may retract linearly or pivot outward, allowing the pre-curved electrode to resume its natural curvature inside the scala tympani, e.g. while maintaining alignment with the previously determined optimal insertion axis. The invention further relates to a method for implanting a cochlear implant electrode, e.g. using a cochlear implant insertion system according to any of the preceding claims, comprising the steps of: providing an orientation signal with an oct device using optical coherence tomography of light emitted along an optical axis; aligning a cochlear insertion module connected to the oct probe in an insertion position on the basis of the orientation signal; and while the cochlear insertion module is arranged in the insertion position, guiding a cochlear implant electrode with an electrode guide of the cochlear insertion module along a guide axis towards the cochlea.

[0083] In an embodiment, the method further comprises the step of determining an optimal insertion axis on the basis of the cochlear orientation signal, wherein the step of aligning the cochlear insertion module comprises aligning the electrode guide with respect to the determined optimal insertion axis.

[0084] In an embodiment, the method further comprises the step of determining, e.g. calculating, during insertion of an implant electrode via the implant electrode insertion module, an insertion speed of the cochlear implant electrode, for example using the doppler effect using optical coherence tomography of light emitted along the optical axis.

[0085] The invention further relates to a method for mapping electrode pads of a cochlear implant electrode to frequency bins on an auditory nerve, e.g. the cochlear implant electrode guided according to the method of any of the embodiments as disclosed herein, comprising the steps of: providing an orientation signal with the oct device using optical coherence tomography of light emitted along an optical axis; determining a position of at least one electrode pad of the implant electrode with respect to the cochlea on the basis of the orientation signal; and comparing the determined position with predetermined frequency data of the auditory nerve representative for the positions of respective frequency bins to map the at least one electrode pad to at least one corresponding frequency bin.

[0086] The robotic implant electrode insertion system, the implant electrode assembly, the method for guiding a cochlear implant electrode, the method for surgically implanting a cochlear implant electrode, and the method for mapping electrode pads of a cochlear implant electrode to frequency bins on an auditory nerve may be provided in or performed with different embodiments as disclosed herein for the implant electrode insertion system and similar advantages may be achieved as described for the respective embodiment of the implant electrode insertion system. Further, all embodiments as disclosed herein may be beneficial in an implant electrode insertion system not according to the invention, e.g. an implant electrode insertion system according to the invention, but in which the oct device wherein the guide axis is not coaxial with the optical axis of the oct device. Such embodiments may be subject of divisional patent applications.

[0087] Brief description of drawings

[0088] Further characteristics of the invention will be explained below, with reference to embodiments, which are displayed in the appended drawings, in which:

[0089] Figure 1A schematically depicts an implant electrode insertion system according to an embodiment of the invention, in perspective;

[0090] Figure 1B schematically depicts a top view of the insertion system of Fig. 1A;

[0091] Figure 1C schematically depicts a detailed partial view of the electrode guide of Fig. 1B; Figure 2A schematically depicts an electrode guide according to an embodiment;

[0092] Figure 2B schematically depicts the electrode guide of Fig. 2A, provided with an implant electrode;

[0093] Figure 3A schematically depicts an electrode guide according to an embodiment;

[0094] Figure 3B schematically depicts the electrode guide of Fig. 3A, provided with an implant electrode;

[0095] Figure 4A schematically depicts the electrode guide of Figs. 2A-2B; and

[0096] Figure 4B schematically depicts the electrode guide of Figs. 3A-3B.

[0097] Figure 5A schematically depicts the optimal and ideal insertion axis in an ear;

[0098] Figure 5B schematically depicts the optimal and ideal insertion axis in another ear;

[0099] Figure 6A schematically depicts an ear of a patient;

[0100] Figure 6B schematically depicts another ear of a patient;

[0101] Figure 7 schematically depicts an implant electrode insertion system according to an embodiment, arranged in the insertion position;

[0102] Figure 8A schematically depicts another embodiment of an implant electrode insertion system;

[0103] Figure 8B schematically depicts the embodiment of Fig. 8A in the measurement position; Figure 8C schematically depicts the embodiment of Fig. 8A in an insertion position;

[0104] Figure 8D schematically depicts a partial cross section of the electrode guide and the implant electrode along line D-D of Fig. 8A;

[0105] Figure 8E schematically depicts insertion of the cochlear implant electrode through the electrode guide of Fig. 8C;

[0106] Figure 8F schematically depicts the embodiment of Fig. 8E, wherein the movable part of the electrode guide is retracted along the fixed part;

[0107] Figure 8G schematically depicts the embodiment of Fig. 8F, wherein the movable part is retracted further; and Figure 8H schematically depicts the embodiment of Fig. 8G, wherein the movable part is detached from the implant electrode and from the fixed part of the electrode guide.

[0108] Throughout the figures, the same reference numerals are used to refer to corresponding components or to components that have a corresponding function.

[0109] Detailed description of embodiments

[0110] Figure 1A schematically depicts an implant electrode insertion system 1 for inserting an implant electrode into the cochlea, comprising an oct device 2 comprising an oct probe 3 defining an optical axis A and configured to provide an orientation signal representative for an orientation of the oct probe 3 with respect to a cochlea 99, measured using optical coherence tomography of light emitted along the optical axis A.

[0111] The system 1 comprises an implant electrode insertion module 4 connected to the oct device 2, and configured to be arranged in an insertion position on the basis of the orientation signal; and an alignment unit 5 configured to assist in positioning of the implant electrode insertion module in the insertion position on the basis of the orientation signal.

[0112] The implant electrode insertion module 4 comprises an electrode guide that defines a guide axis G, and is configured to, in the insertion position, guide a cochlear implant electrode 98 along the guide axis towards the cochlea 99. The guide axis G is coaxial with the optical axis A of the oct device 2. In use, the light is emitted along the optical axis A such that it can be reflected and / or backscattered by surfaces to be imaged, and can be received by the oct probe 3.

[0113] A detector is provided, configured to detect interference of the reflected and / or backscattered light with the emitted light to measure the cochlear orientation signal. The cochlear orientation signal is for a distance and / or angle of the oct probe 3 with respect to the cochlea 99.

[0114] The oct device 2 is configured to emit infrared laser light to image through the round window membrane in the cochlea. The oct device 1 is configured to visualize the orientation of the basilar membrane up to the basal turn. In the shown embodiment, the oct probe 3 is configured to be tilted manually to align the insertion module 4 in the insertion position, e.g. such that the optimal insertion axis O for the specific cochlea 99 of the patient is aligned with the optical axis A. The oct device 2, e.g. via the processing unit, is configured to measure the distance between the round window niche and the probe 3 to determine an axial distance therebetween.

[0115] The processing unit is configured to determine the optimal insertion axis O on the basis of the orientation signal before the implant electrode is guided into the cochlea with the implant electrode insertion module. The optimal insertion axis is represented by an insertion angle with respect to a longitudinal axis of the cochlea into which the cochlear implant is guided. The processing unit comprises an object recognition module configured to recognize a structural element of the ear on the basis of the orientation signal and pre-provided recognition data representative for at least one property of the structural element. The processing unit is configured to determine the optimal insertion axis in dependency of the recognized structural element.

[0116] The processing unit comprises an orientation recognition module configured to determine an orientation of the recognized structural element with respect to the oct probe, wherein the processing unit is configured to determine the optimal insertion axis in dependency of the determined orientation of the structural element.

[0117] Further, the processing unit comprises an obstruction detection module configured to determine presence of one or more obstructions, e.g. a location of the facial nerve and / or the chorda tympani nerve, on the basis of the orientation signal when the oct probe is arranged in the measurement position. The processing unit is configured to adjust the determined optimal insertion axis for the detected one or more obstructions.

[0118] The cochlear implant electrode insertion system comprises an implant electrode insertion module 4 rigidly connected to the oct device 2 and configured to be arranged in an insertion position on the basis of the orientation signal.

[0119] The cochlear implant electrode insertion system 1 further comprises an alignment unit 5 configured to assist in positioning of the implant electrode insertion module in the insertion position on the basis of the orientation signal. The alignment unit 5 may be configured to assist passively and / or actively.

[0120] The implant electrode insertion module 4 comprises an electrode guide that defines a guide axis G, and is configured to, in the insertion position, guide a cochlear implant electrode 98 along the guide axis G towards the cochlea 99. The guide axis G is formed by the longitudinal axis of the electrode guide, in particular of the outer end thereof, and corresponds to the longitudinal axis L of an electrode 98 arranged therein. The implant electrode insertion module 4 is connected to the oct device 2 such that the orientation signal is representative for an orientation of the electrode guide. The electrode guide comprises a housing and is configured to guide the electrode 98 such that a tip axis of a guided electrode matches the optical axis A of the oct probe 3. The electrode guide may comprise a housing to protect the electrode array.

[0121] The implant electrode insertion system 1 comprises a full colour camera (not shown) mounted on the oct probe 3 and configured to receive light parallel to the optical axis A and the cochlear orientation signal is provided in further dependence of camera footage.

[0122] The camera is configured to capture at least two degrees of freedom (i.e. x, horizontal; y, vertical) of the orientation of the cochlea, e.g. of the round window, whereas the oct probe 3 is configured to capture an additional three degrees of freedom (i.e. , z, axial distance; Rx, rotation over x; Ry rotation over y) using optical coherence tomography. The camera is configured to capture footage representative for lateral movement, e.g. movement in a direction transverse to the guide axis G and / or transverse to the optical axis A. The alignment unit 5 is configured to assist in positioning of the implant electrode insertion module in further dependence of the footage captured with the camera.

[0123] The cochlear implant insertion system 1 comprises a processing unit configured to determine, e.g. calculate, an optimal insertion axis O for the implant electrode on the basis of a determined ideal insertion axis I determined, e.g. calculated, on the basis of the cochlear orientation signal. The alignment unit 5 is configured to assist in alignment of the implant electrode insertion module with respect to the determined optimal insertion axis O. The ideal insertion axis, as shown in Figs. 5A-5B, may be determined by the centerline of the first nearly straight part of the cochlea extending from the round window to the basal turn of the cochlea 99. The processing unit is configured to determine one or more dimensions, e.g. a length, a width and / or a volume of the first part of the cochlea 99 and the ideal insertion axis I is determined by computing a longitudinal center line through the first part of the cochlea 99 using the one or more dimensions.

[0124] The processing unit is configured to determine a location of one or more obstructions, e.g. a location of the facial nerve 97 and / or the chorda tympani 96 nerve. The optimal insertion axis O may be determined by adjusting the ideal insertion axis I for the one or more obstructions 96, 97, e.g. by selecting an optimal insertion axis having an angle with respect to the basal turn of the cochlea that is as close as possible to the angle of the ideal insertion axis, but wherein the optimal insertion axis does not intersect with the one or more obstructions.

[0125] The alignment unit 5 comprises a feedback device configured to provide feedback, in particular visual, auditive and / or haptic feedback, in dependence the orientation signal and captured camera footage, in dependence of a difference between the optical axis A and the determined optimal insertion axis O, and as the optical axis is coaxial with the guide axis, on the basis of deviation between the guide axis and the determined optimal insertion axis A The oct device 2 is configured to, during insertion of an implant electrode 98 via the implant electrode insertion module 4, provide an insertion speed signal representative for an insertion speed of the implant electrode, e.g. with respect to the oct probe. The system 1 further comprises an insertion monitoring unit configured to, on the basis of the insertion speed signal, determine the insertion speed of the cochlear implant electrode 98 during insertion, e.g. using the doppler effect.

[0126] The feedback device 5 is a visual device configured to visualise the determined optimal insertion axis O and to provide visual feedback in dependence of the difference between the optical axis A and the determined optimal insertion axis O, e.g. by showing diagrams according to Figs. 5A-7 in the display.

[0127] The electrode guide 4 extends at least partially cylindrical along the guide axis G and delimits a hollow interior 40 having a substantially circular cross section, through which the implant electrode 98 can pass. The inner dimensions of the hollow interior 40, e.g. a diameter thereof, are substantially equal to the outer dimensions of an implant electrode 98.

[0128] The electrode guide 4 comprises a detachment device 41 for detachment of the implant electrode 98 from the electrode guide 4, formed by a wiring opening for releasing electrode wiring from the electrode guide 4, which extends substantially parallel to the guide axis G. In an additional and / or alternative embodiment, the detachment device may be releasably couplable with the cochlear implant electrode.

[0129] The electrode guide 4 may be provided in various embodiments, as illustrated in Figs.

[0130] 2A-4B. In an embodiment, the electrode guide 4 comprises a feed part 42 extending along a longitudinal axis parallel to the guide axis G, that is not aligned coaxially with the optical axis A and a guide part 43 having at least one bend 44 section that guides the implant electrode 98 and changes its direction towards the optical axis A.

[0131] The guide part comprises a first bend 44 section arranged on a first side of the optical axis A, and a second bend section 45 arranged on an opposite second side of the optical axis A. The first bend section 44 is configured to direct the cochlear implant electrode 98 from the feed part 42 towards a first direction not coaxial with the optical axis and the oppositely shaped second bend section 43 is configured to direct the cochlear implant electrode 98 from the first direction towards the guide axis G. In an embodiment, the first bend section and the second bend section may be mirror symmetrical to each other.

[0132] In Figs. 2A-4B, the first bend section 44 and the second bend section 45 are arranged separately and at a distance from each other. The first bend section 44 is provided on a first top side of the oct probe 3, and the second bend section 45 is provided on an opposite bottom side of the oct probe 3.

[0133] In Figs 1A-1C and Fig. 7, the electrode guide 4 extends between the first bend section 44 and the second bend section 45. The electrode guide comprises an oct opening 46 aligned with the optical axis A to allow light emitted along an optical axis to reach the cochlea.

[0134] In Figs. 1A-2B, the electrode insertion module 4 comprises a manipulation recess 41 formed by the wiring opening and configured to receive a forceps for moving a cochlear implant electrode along the optical axis A e.g. by pushing the cochlear implant electrode 98. Alternatively, the manipulation recess may comprise one or multiple slits that extend longitudinally along the electrode guide, e.g. parallel to the optical axis A.

[0135] In the embodiment of Figs. 1A-1C, the electrode insertion module 4 comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises an input device 47 for receiving a driving movement from an operator. The movement mechanism comprises a transmission device configured to reduce and / or smoothen the movement received by the input device 47 and to transmit the reduced and / or smoothened movement to the cochlear implant electrode 98 and / or an actuator configured to, upon activation by pressing input device 47, provide a driving movement for moving the cochlear implant electrode along the optical axis. The actuator may for example comprise an electric motor or linear actuator, pneumatic and / or hydraulic actuator. The movement mechanism may comprise a controller configured to control the movement of the implant electrode through the electrode guide. For example, a movement sensor may be provided wherein the controller is configured to control movement on the basis of the sensor signal.

[0136] The implant electrode insertion system 1 may comprise a support arm connected to the implant electrode insertion module for supporting the electrode guide in the insertion position, and / or may be provided on a robotic implant electrode insertion system.

[0137] Figures 5A-5B schematically depict an ideal insertion axis I. Unfortunately, the ideal insertion axis can often not be reached due to blockage of the facial nerve 97 and chorda tympani nerve 96. Therefore, herein a differentiation is made between the ideal insertion axis I and the optimal insertion axis O, wherein the optimal insertion axis O is defined as the axis closest to the ideal insertion axis I that extends through the surgical opening and can be used for inserting the implant electrode. The ideal insertion axis I correlates with the centerline of the first nearly straight part of the cochlea 99 extending from the round window 95 to the basal turn (first turn) of the cochlea 99. The insertion angle of the insertion axis is defined with respect to the basal turn of the cochlea as the electrode enters through the round window 95. This ideal insertion angle I varies as much as 60 degrees among subjects, due to varying ear geometry as for example depicted in Figs. 6A-6B. Since the human cochlea is entirely surrounded by bone, it was impossible for a skilled person to determine the pathway of the ideal insertion axis I with respect to the position of the round window 95 using the prior art. In Fig. 8A, the electrode guide including all parts and sections, in particular fixed part 48 as well as movable part 49, 49’ is releasably attachable from the oct probe via bracket 51.

[0138] Furthermore, this electrode guide 4 comprises a fixed part 48 that defines the guide axis and a movable part 49, 49’ that is movable with respect to the fixed part, wherein the fixed part and the movable part together delimit the hollow interior 40. The movable part 49, 49’ comprises a longitudinal opening 50 along which the movable part 49 can move over the fixed part 48. Further, movable part 49’ is provided with slits in the guide part 43 to enhance flexibility when retracting the movable part from the fixed part upon guiding the pre-curved electrode into the cochlea 99 as shown in Figs. 8B-8H. A flexibility of the cochlear implant electrode 98 is larger than a flexibility of the movable part 49’. CLAUSES

[0139] Additional and / or alternative embodiments of the invention may be described as follows:

[0140] 1. Implant electrode insertion system (1) for inserting an implant electrode into the cochlea (99), comprising:

[0141] - an oct device (2) comprising an oct probe (3) defining an optical axis (A) and configured to provide an orientation signal representative for an orientation of the oct probe with respect to a cochlea, measured using optical coherence tomography of light emitted along the optical axis (A);

[0142] - an implant electrode insertion module (4) connected to the oct device, and configured to be arranged in an insertion position on the basis of the orientation signal; and

[0143] - an alignment unit (5) configured to assist in positioning of the implant electrode insertion module (4) in the insertion position on the basis of the orientation signal; and

[0144] wherein the implant electrode insertion module (4) comprises an electrode guide that defines a guide axis (G), and is configured to, in the insertion position, guide a cochlear implant electrode along the guide axis towards the cochlea,

[0145] wherein the guide axis (G) is coaxial with the optical axis (A) of the oct device.

[0146] 2. Implant electrode insertion system according to the preceding embodiment, wherein the alignment unit (5) comprises a feedback device configured to provide feedback, e.g. visual, auditive and / or haptic feedback, in dependence of the orientation signal.

[0147] 3. Implant electrode insertion system according to embodiment 1 or 2, further comprising a processing unit configured to determine, e.g. calculate, an optimal insertion axis (O) for the implant electrode on the basis of the cochlear orientation signal;

[0148] wherein the alignment unit is configured to assist in alignment of the implant electrode insertion module (4) with respect to the determined optimal insertion axis.

[0149] 4. Implant electrode insertion system according to the preceding embodiment, wherein the feedback device is a visual device configured to visualise the determined optimal insertion axis and to provide visual feedback in dependence of the difference between the optical axis and the determined optimal insertion axis. Implant electrode insertion system according to any of the preceding embodiments, wherein the oct device (2) is configured to, during insertion of an implant electrode via the implant electrode insertion module (4), provide an insertion speed signal representative for an insertion speed of the implant electrode, e.g. with respect to the oct probe (3); further comprising an insertion monitoring unit configured to, on the basis of the insertion speed signal, determine the insertion speed of the cochlear implant electrode during insertion, e.g. using the doppler effect.

[0150] Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode guide extends at least partially cylindrical along the guide axis (G) and delimits a hollow interior (40) through which the implant electrode can pass.

[0151] Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode guide comprises a detachment device for detachment of the implant electrode from the electrode guide, e.g. wherein the detachment device comprises a wiring opening (41) that extends substantially parallel to the guide axis.

[0152] Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode guide comprises a feed part (42) that is not aligned coaxially with the optical axis (A) and a guide part (43) having at least one bend section (44) that guides the implant electrode towards the optical axis.

[0153] Implant electrode insertion system according to the preceding embodiment, wherein the guide part (43) comprises a first bend section (44) arranged on a first side of the optical axis, and a second bend section (45) arranged on an opposite second side of the optical axis.

[0154] Implant electrode insertion system according to the preceding embodiment, wherein the first bend section (44) and the second bend section (45) are arranged separately and at a distance from each other.

[0155] Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode guide (4) extends between the first bend section (44) and the second bend section (45), wherein electrode guide comprises an oct opening (46) aligned with the optical axis to allow light emitted along an optical axis by the oct device (2) to reach the cochlea. 12. Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode insertion module (4) comprises a manipulation recess configured to receive a forceps for moving a cochlear implant electrode along the optical axis e.g. by pushing the cochlear implant electrode.

[0156] 13. Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode insertion module (4) comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises:

[0157] - an input device (47) for receiving a driving movement from an operator; and - a transmission device configured to reduce and / or smoothen the movement received by the input device and to transmit the reduced and / or smoothened movement to the cochlear implant electrode for moving the cochlear implant electrode along the optical axis.

[0158] 14. Implant electrode insertion system according to any of the preceding embodiments, wherein the electrode insertion module comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises an actuator configured to, upon activation, provide a driving movement for moving the cochlear implant electrode along the optical axis.

[0159] 15. Implant electrode insertion system according to any of the preceding embodiments, further comprising a support arm connected to the implant electrode insertion module for supporting the electrode guide in the insertion position.

[0160] 16. Robotic implant electrode insertion system, comprising the implant electrode insertion system according to any of the preceding embodiments.

[0161] 17. Implant electrode assembly, comprising:

[0162] - a cochlear implant electrode; and

[0163] - an implant electrode insertion system and / or a robotic implant electrode insertion system according to any of the preceding embodiments;

[0164] wherein the cochlear implant electrode is arranged in the electrode guide.

[0165] 18. Method for guiding a cochlear implant electrode, e.g. using a cochlear implant electrode insertion system according to any of the preceding embodiments, comprising the steps of: - providing an orientation signal with an oct device (2) using optical coherence tomography of light emitted along an optical axis;

[0166] - aligning a cochlear implant electrode insertion module (4) connected to the oct device (2) in an insertion position on the basis of the orientation signal; and - while the cochlear implant electrode insertion module is arranged in the insertion position, guiding a cochlear implant electrode with an electrode guide of the cochlear implant electrode insertion module (4) along a guide axis towards the cochlea (99).

[0167] 19. Method for guiding a cochlear implant electrode according to the preceding embodiment, further comprising the step of determining an optimal insertion axis (O) on the basis of the cochlear orientation signal,

[0168] wherein the step of aligning the cochlear implant electrode insertion module (4) comprises aligning the electrode guide with respect to the determined optimal insertion axis (O).

[0169] 20. Method for surgically implanting a cochlear implant electrode, comprising the steps of:

[0170] - exposing an access to the cochlea (99); and

[0171] - performing the method according to embodiment 18 or 19;

[0172] wherein the step of guiding the cochlear implant electrode is performed such that the cochlear implant electrode is guided along the guide axis (G), through the access and into the cochlea.

[0173] 21. Method for mapping electrode pads of a cochlear implant electrode to frequency bins on an auditory nerve, e.g. the cochlear implant electrode guided according to the method of any of the embodiments 18-20, comprising the steps of:

[0174] - providing an orientation signal with the oct device (2) using optical coherence tomography of light emitted along an optical axis (A);

[0175] - determining a position of at least one electrode pad of the implant electrode (98) with respect to the cochlea (99) on the basis of the orientation signal; and - comparing the determined position with predetermined frequency data of the auditory nerve representative for the positions of respective frequency bins to map the at least one electrode pad to at least one corresponding frequency bin.

Claims

27CLAIMS1. Implant electrode insertion system (1) for inserting an implant electrode into the cochlea (99), comprising:- an oct device (2) comprising an oct probe (3) defining an optical axis (A) and configured to be held in a measurement position outside of the cochlea and configured to provide an orientation signal representative for an orientation of the oct probe with respect to a cochlea, measured using optical coherence tomography of light emitted from the probe in the measurement position along the optical axis (A);- an implant electrode insertion module (4) connected to the oct device, and configured to be arranged in an insertion position on the basis of the orientation signal; and- an alignment unit (5) configured to assist in positioning of the implant electrode insertion module (4) in the insertion position on the basis of the orientation signal; andwherein the implant electrode insertion module (4) comprises an electrode guide that defines a guide axis (G), and is configured to, in the insertion position, guide a cochlear implant electrode along the guide axis towards the cochlea,wherein the guide axis (G) is coaxial with the optical axis (A) of the oct device.

2. Implant electrode insertion system according to the preceding claim, further comprising a processing unit configured to determine an optimal insertion axis (O) for the implant electrode on the basis of the cochlear orientation signal; wherein the alignment unit is configured to assist in alignment of the guide axis of the implant electrode insertion module (4) with respect to the determined optimal insertion axis.

3. Implant electrode insertion system according to claim 1 or 2, wherein the processing unit is configured to determine the optimal insertion axis (O) on the basis of the orientation signal before the implant electrode is guided into the cochlea with the implant electrode insertion module.

4. Implant electrode insertion system according to any of the preceding claims, wherein the optimal insertion axis is represented by an insertion angle with respect to a longitudinal axis of the cochlea into which the cochlear implant is guided.

5. Implant electrode insertion system according to any of the preceding claims, wherein the processing unit comprises an object recognition module configured to recognize a structural element of the ear on the basis of the orientation signal and pre-provided recognition data representative for at least one property of the structural element, wherein the processing unit is configured to determine the optimal insertion axis in dependency of the recognized structural element.

6. Implant electrode insertion system according to the preceding claim, wherein the processing unit comprises an orientation recognition module configured to determine an orientation of the recognized structural element with respect to the oct probe, wherein the processing unit is configured to determine the optimal insertion axis in dependency of the determined orientation of the structural element.

7. Implant electrode insertion system according to any of the preceding claims, wherein the processing unit comprises an obstruction detection module configured to determine presence of one or more obstructions, e.g. a location of the facial nerve and / or the chorda tympani nerve, on the basis of the orientation signal when the oct probe is arranged in the measurement position,wherein the processing unit is configured to adjust the determined optimal insertion axis for the detected one or more obstructions.

8. Implant electrode insertion system according to any of the preceding claims, wherein the alignment unit (5) comprises a feedback device configured to provide feedback, e.g. visual, auditive and / or haptic feedback, in dependence of a deviation between the guide axis and the determined optimal insertion axis represented in the orientation signal.

9. Implant electrode insertion system according to the preceding claim, wherein the feedback device is a visual device configured to visualise the determined optimal insertion axis and to provide visual feedback in dependence of the difference between the optical axis and the determined optimal insertion axis.

10. Implant electrode insertion system according to any of the preceding claims, wherein the oct device (2) is configured to, during insertion of an implant electrode via the implant electrode insertion module (4), provide an insertion speed signal representative for an insertion speed of the implant electrode, e.g. with respect to the oct probe (3); further comprising an insertion monitoring unit configured to, on the basis of the insertion speed signal, determine the insertion speed of the cochlear implant electrode during insertion, e.g. using the doppler effect.

11. Implant electrode insertion system according to any of the preceding claims, wherein the electrode guide is releasably attachable to the oct probe, e.g. via a bracket (51).

12. Implant electrode insertion system according to any of the preceding claims, wherein the electrode guide extends at least partially cylindrical along the guide axis (G) and delimits a hollow interior (40) through which the implant electrode can pass.

13. Implant electrode insertion system according to any of the preceding claims, wherein the electrode guide comprises a detachment device for detachment of the implant electrode from the electrode guide, e.g. wherein the detachment device comprises a wiring opening (41) that extends substantially parallel to the guide axis.

14. Implant electrode insertion system according to any of the preceding claims, wherein the electrode guide comprises a feed part (42) that is not aligned coaxially with the optical axis (A) and a guide part (43) having at least one bend section (44) that guides the implant electrode towards the optical axis.

15. Implant electrode insertion system according to the preceding claim, wherein the guide part (43) comprises a first bend section (44) arranged on a first side of the optical axis, and a second bend section (45) arranged on an opposite second side of the optical axis.

16. Implant electrode insertion system according to the preceding claim, wherein the first bend section (44) and the second bend section (45) are arranged separately and at a distance from each other.

17. Implant electrode insertion system according to any of the preceding claims, wherein the electrode guide (4) extends between the first bend section (44) and the second bend section (45), wherein electrode guide comprises an oct opening (46) aligned with the optical axis to allow light emitted along an optical axis by the oct device (2) to reach the cochlea.

18. Implant electrode insertion system according to any of the preceding claims, wherein the electrode guide (4) comprises a fixed part (48) that defines the guideaxis and a movable part (49, 49’) that is movable with respect to the fixed part, wherein the fixed part and the movable part together delimit the hollow interior (40).

19. Implant electrode insertion systema according to the preceding claim, wherein the movable part (49, 49’) comprises a longitudinal opening (50) that slidingly engages the fixed part (48).

20. Implant electrode insertion system according to any of the preceding claims, wherein the electrode insertion module (4) comprises a manipulation recess configured to receive a forceps for moving a cochlear implant electrode along the optical axis e.g. by pushing the cochlear implant electrode.

21. Implant electrode insertion system according to any of the preceding claims, wherein the electrode insertion module (4) comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises:- an input device (47) for receiving a driving movement from an operator; and - a transmission device configured to reduce and / or smoothen the movement received by the input device and to transmit the reduced and / or smoothened movement to the cochlear implant electrode for moving the cochlear implant electrode along the optical axis.

22. Implant electrode insertion system according to any of the preceding claims, wherein the electrode insertion module comprises a movement mechanism for moving the implant along the guide axis, wherein the movement mechanism comprises an actuator configured to, upon activation, provide a driving movement for moving the cochlear implant electrode along the optical axis.

23. Implant electrode insertion system according to any of the preceding claims, further comprising a support arm connected to the implant electrode insertion module for supporting the electrode guide in the insertion position.

24. Robotic implant electrode insertion system, comprising the implant electrode insertion system according to any of the preceding claims.

25. Implant electrode assembly, comprising:- a cochlear implant electrode; and31- an implant electrode insertion system and / or a robotic implant electrode insertion system according to any of the preceding claims;wherein the cochlear implant electrode is arranged in the electrode guide.

26. Implant electrode assembly according to the preceding claim, comprising the implant electrode according to claim 18 or 19, wherein a flexibility of the cochlear implant electrode is larger than a flexibility of the movable part, such that the movable part (49, 49’) is configured to hold the implant electrode, e.g. a pre-curved electrode, in a straight configuration in the cochlea.

27. Method for aligning a cochlear implant electrode with respect to the cochlea (99), e.g. before guiding the implant electrode into the cochlea, e.g. using a cochlear implant electrode insertion system according to any of the preceding claims, comprising the steps of:- providing an orientation signal with an oct device (2) comprising an oct probe (3) using optical coherence tomography of light emitted along an optical axis by emitting the light from the oct probe (3) in a measurement position;- determining an optimal insertion axis (O) for the implant electrode on the basis of the orientation signal,- arranging a cochlear implant electrode insertion module (4) connected to the oct device (2) in an insertion position on the basis of the orientation signal, comprising aligning an a guide axis (G) of an electrode guide, that is coaxial with the optical axis (A) of the oct device (2), with respect to the determined optimal insertion axis (O).

28. Method for aligning a cochlear implant electrode according to the preceding claim, wherein the step of providing the orientation signal is performed using the oct probe (3) emitting light outside of the cochlea.

29. Method for surgically implanting a cochlear implant electrode, comprising the method according to claim 27 or 28, further comprising the step of, while the cochlear implant electrode insertion module is arranged in the insertion position, guiding a cochlear implant electrode with the electrode guide along the guide axis towards the cochlea (99).

30. Method for mapping electrode pads of a cochlear implant electrode to frequency bins on an auditory nerve, e.g. the cochlear implant electrode guided according to the method of any of the claims 27-29, comprising the steps of:- providing an orientation signal with the oct device (2) using optical coherence tomography of light emitted along an optical axis (A);- determining a position of at least one electrode pad of the implant electrode (98) with respect to the cochlea (99) on the basis of the orientation signal; and - comparing the determined position with predetermined frequency data of the auditory nerve representative for the positions of respective frequency bins to map the at least one electrode pad to at least one corresponding frequency bin.

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