Real-time estimation of electrode array posture during cochlear implant insertion

Abstract

A method is provided that includes receiving first information about a pose of a structure over a first time period. The structure is configured to be inserted into a body part of a recipient. The first information includes at least one of a first estimate of a pose of the structure over the first time period and a first set of measurements including one or more first measurement values. At least some of the one or more first measurement values are generated using a plurality of sensors distributed along the structure. The one or more first measurement values are indicative of a pose of the structure over the first time period. The method further includes generating a second estimate of a pose of the structure using at least the first information and a probabilistic model of the structure and / or the body part.

Description

background Technical Field

[0002] This application generally relates to systems and methods for monitoring the implantation of a medical device in a recipient's body, and more specifically to facilitating the localization of the stimulating element of a cochlear implanted auditory prosthesis during implantation. Background Technology

[0004] Hearing loss can be caused by many different reasons, and is generally classified into two types: conductive and / or sensorineural. Conductive hearing loss occurs when, for example, damage to the ossicular chain or ear canal obstructs the normal mechanical pathways of the outer and / or middle ear. Sensorineural hearing loss occurs when there is damage to the inner ear or the neural pathways from the inner ear to the brain.

[0005] Individuals with conductive hearing loss may often retain some form of residual hearing because the hair cells in the cochlea may not be damaged. Therefore, individuals with conductive hearing loss may receive auditory prostheses rather than hearing aids, which generate mechanical movement of the cochlear fluid, based on the type and amount of conductive loss and customer preference. Such prostheses include, for example, bone conduction devices and direct acoustic stimulators.

[0006] However, in many people with total deafness, the cause of hearing loss is sensorineural hearing loss. Individuals with some forms of sensorineural hearing loss do not adequately benefit from hearing prostheses that generate mechanical movement of the cochlear fluid. Such individuals can benefit from implantable hearing prostheses that stimulate the nerve cells of the recipient's auditory system in other ways (e.g., electrical, optical, etc.). Cochlear implants are generally recommended when sensorineural hearing loss is due to the absence or destruction of the cochlear hair cells that convert sound signals into nerve impulses. Auditory brainstem stimulators can also be recommended when the recipient experiences sensorineural hearing loss due to damage to the auditory nerve. Summary of the Invention

[0007] In one aspect disclosed herein, a method includes receiving first information about the pose of a structure during a first time period. The structure is configured to be inserted into a body part of a receiver. The first information includes at least one of the following: a first estimate of the pose of the structure during the first time period; and a first set of measurements comprising one or more first measurements. At least some of the one or more first measurements are generated using a plurality of sensors distributed along the structure. The one or more first measurements indicate the pose of the structure during the first time period. The method further includes generating a second estimate of the pose of the structure using at least the first information and a probabilistic model of the structure and / or the body part.

[0008] In another aspect disclosed herein, a method includes accessing information characterizing the state and transitions between states of a structure at least partially inserted into a body part of a recipient. The method also includes accessing a range of desired measurements or values ​​expected to be generated by at least one sensor of the structure. The method further includes obtaining at least one first measurement from the at least one sensor during a first time period. The method also includes determining a first state of the structure during the first time period in response to a comparison of the at least one first measurement with the range of the desired measurement or values.

[0009] In another aspect disclosed herein, a system includes at least one data input interface configured to receive data from a plurality of transducers during implantation of a medical device on or in a recipient. The system also includes at least one controller operatively communicating with the at least one data input interface. The at least one controller is configured to access a probabilistic model of a parameterized description of the posture of the medical device relative to the body portion, and to generate, at least in part, an estimate of the current posture of the medical device in response to the data and the probabilistic model. The system further includes at least one output interface operatively communicating with the at least one controller. The at least one output interface is configured to provide information about the estimated posture of the medical device.

[0010] In another aspect disclosed herein, a non-transitory computer-readable storage medium is provided thereon having a computer program that instructs a computer system to provide real-time information about the structure when the structure is inserted into and / or retracted from the region. The computer system provides the real-time information by at least: receiving information about the structure when the structure is inserted into the region; accessing a parameterized description of the structure and / or the region; and using at least one processor to generate an estimated pose of the structure relative to the region based on the information and the parameterized description. Attached Figure Description

[0011] Embodiments are described herein in conjunction with the accompanying drawings, wherein:

[0012] Figure 1 This is a perspective view of an exemplary auditory prosthesis implanted in a recipient according to certain embodiments described herein, wherein a stimulating component is inserted into the cochlea;

[0013] Figure 2 This is a cross-sectional view of the cochlea according to certain embodiments described herein, illustrating a stimulation component partially implanted in the cochlea;

[0014] Figure 3An exemplary system according to certain embodiments described herein is illustrated schematically;

[0015] Figure 4 This is a flowchart of an exemplary method according to certain embodiments described herein;

[0016] Figures 5A-5C An exemplary voltage measurement can be fabricated using an electrode array of a stimulating component according to certain embodiments described herein;

[0017] Figure 6A Exemplary regularization models of structures and / or body parts according to certain embodiments described herein are schematically illustrated;

[0018] Figure 6B Exemplary graphs illustrating observations based on certain embodiments described herein are shown schematically;

[0019] Figure 6C Some embodiments according to the description herein are illustrated schematically. Figure 6A An exemplary regularized model of the structure and / or body parts, in which instances of other physical factors are shown;

[0020] Figure 6D The illustration schematically shows certain embodiments according to the description herein from Figure 6C The array measurement is based on D electrode-apex An exemplary graph of the impedance;

[0021] Figure 6E A first set of observed impedance values ​​(e.g., unaffected by certain embodiments described herein) for a first orientation of the array are schematically illustrated. Figure 6C A graph comparing the effects of physical factors (as shown) with a set of predicted impedance values;

[0022] Figure 6F The second pose of the array is schematically illustrated according to certain embodiments described herein. Figure 6E A graph comparing the first set of observed impedance values ​​with a set of predicted impedance values;

[0023] Figure 6G A second set of observed impedance values ​​(e.g., subjected to) is schematically shown according to certain embodiments described herein. Figure 6C The influence of the physical factors shown) and Figure 6E A graph comparing the same set of predicted impedance values;

[0024] Figure 6H Some embodiments according to the description herein are illustrated schematically. Figure 6G The second set of observed impedance values ​​and Figure 6FA graph comparing the same set of predicted impedance values;

[0025] Figure 6I and 6J Two examples of calculated likelihoods for possible pose ranges according to certain embodiments described herein are illustrated schematically;

[0026] Figures 7A-7C Another exemplary use of a regularized model of a structure and / or body portion according to certain embodiments described herein is illustrated schematically;

[0027] Figure 8 This is a flowchart of an exemplary method according to certain embodiments described herein, which compares measurements with a set of possible poses generated using a probabilistic model of the structure;

[0028] Figure 9 An exemplary evaluation of the posture evolution of an array orally inserted into the cochlea according to certain embodiments described herein is schematically illustrated; and

[0029] Figure 10 This is a flowchart of an exemplary method according to certain embodiments described herein. Detailed Implementation

[0030] Certain embodiments described herein provide a system and method for providing medical personnel (e.g., surgeons) with real-time information (e.g., feedback) on the orientation of a structure (e.g., an electrode array of a cochlear implantation system) as it is implanted into a recipient's body part (e.g., the cochlea). Such real-time information can be advantageously used to avoid suboptimal implantation structures, provide better and more consistent outcomes for the recipient, and / or improve the surgical technique of the medical personnel.

[0031] Some embodiments described herein utilize measurements taken during implantation, along with probabilistic models of the structure and / or body parts, to estimate the orientation of the structure relative to the body parts. For example, the systems and methods may provide a mapping of the progress of the electrode array as it is being inserted into the cochlea by: taking measurements related to the orientation of the array relative to the cochlea during insertion; using the resulting measurements and probabilistic models to estimate the orientation or changes in orientation of the electrode array in the cochlea; and providing real-time feedback to the operator regarding the estimates (e.g., via a hearing prosthesis system or assistive device). Measurements of the electrode array's orientation (e.g., angular depth; folding span; insertion speed; distance from the basilar membrane; deflection within the ear canal) can be continuously reported to the operator. Events related to the insertion of the electrode array (e.g., hooking of the electrode, initiation of folding; scala dislocation) can be detected and used to trigger explicit alerts to the operator.

[0032] Figure 1This is a perspective view of an exemplary hearing prosthesis 100 (e.g., a cochlear implant) implanted in a recipient according to certain embodiments described herein, wherein a stimulation component 118 is inserted into a cochlea 140. Figure 1 As shown, the recipient has an outer ear 101, a middle ear 105, and an inner ear 107. In a fully functional ear, the outer ear 101 includes an auricle 110 and an ear canal 102. Sound pressure, or sound wave 103, is collected by the auricle 110 and enters through the channel and passes through the ear canal 102. A tympanic membrane 104, which vibrates in response to the sound wave 103, is located at the distal end of the ear canal 102. This vibration is connected to an elliptical or oval window 112 by three bones in the middle ear 105, collectively referred to as ossicles 106, including the malleus 108, incus 109, and stapes 111. The bones 108, 109, and 111 of the middle ear 105 filter and amplify the sound wave 103, thereby causing the elliptical window 112 to hinge or vibrate in response to the vibration of the tympanic membrane 104. This vibration establishes a fluid motion wave of perilymph within the cochlea 140. This fluid motion then activates tiny hair cells (not shown) inside the cochlea 140. The activation of the hair cells enables the generation of appropriate neural impulses, which are transmitted to the brain (also not shown) via spiral ganglion cells (not shown) and the auditory nerve 114, where they are perceived as sound.

[0033] like Figure 1 As shown, the exemplary hearing prosthesis 100 includes one or more components that are temporarily or permanently implanted in a recipient. The exemplary hearing prosthesis 100 in... Figure 1 The diagram shows an external component 142 that is directly or indirectly attached to the recipient's body, and an internal component 144 that is temporarily or permanently implanted in the recipient (e.g., positioned in a recess of the temporal bone adjacent to the recipient's auricle 110). The external component 142 typically includes one or more sound input elements for sound detection (e.g., an external microphone 124), a sound processing unit 126 (e.g., disposed in a behind-the-ear unit), a power supply (not shown), and an external transmitter unit 128. Figure 1 In the illustrated embodiment, the external transmitter unit 128 includes an external coil 130 (e.g., a multi-turn wire antenna coil comprising electrically insulated single or multiple strands of platinum or gold wire), and preferably includes a magnet (not shown) directly or indirectly attached to the external coil 130. The external coil 130 of the external transmitter unit 128 is part of an inductive radio frequency (RF) communication link with the internal component 144. The sound processing unit 126 processes the output of a microphone 124, which in the depicted embodiment is positioned outside the receiver's body by the receiver's auricle 110. The sound processing unit 126 generates an encoded signal, sometimes referred to herein as an encoded data signal, which is provided to the external transmitter unit 128 (e.g., via a cable).

[0034] The power source of the external component 142 is configured to supply power to the hearing prosthesis 100, which includes a battery (e.g., located in the internal component 144 or disposed at a separate implantation site), said battery being recharged by power supplied from the external component 142 (e.g., via a percutaneous power delivery link). The percutaneous power delivery link is used to transfer power and / or data to the internal component 144 of the hearing prosthesis 100. Various types of power delivery, such as infrared (IR), electromagnetic, capacitive, and inductive delivery, can be used to transfer power and / or data from the external component 142 to the internal component 144. During operation of the hearing prosthesis 100, the power stored by the rechargeable battery is distributed as needed to various other implanted components.

[0035] Internal component 144 includes an internal receiver unit 132, a stimulator unit 120, and an elongated stimulation assembly 118. In some embodiments, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing, sometimes collectively referred to as the stimulator / receiver unit. The internal receiver unit 132 includes an internal coil 136 (e.g., a multi-turn wire antenna coil comprising electrically insulated single or multiple strands of platinum or gold wire), and preferably includes a magnet (also not shown) fixed relative to the internal coil 136. The internal coil 136 receives electrical and / or data signals from the external coil 130 via a transcutaneous power delivery link (e.g., an inductive RF link). The stimulator unit 120 generates an electrical stimulation signal based on the data signal, and the stimulation signal is delivered to the recipient via the elongated stimulation assembly 118.

[0036] An elongated stimulation component 118 has a proximal end connected to the stimulator unit 120 and a distal end implanted in the cochlea 140. The stimulation component 118 extends from the stimulator unit 120 through the mastoid bone 119 to reach the cochlea 140. In some embodiments, the stimulation component 118 may be implanted in at least the basal region 116, and sometimes deeper. For example, the stimulation component 118 may extend toward the apex of the cochlea 140, referred to as the cochlear apex 134. In some cases, the stimulation component 118 may be inserted into the cochlea 140 through a cochlear fenestration 122. In other cases, the cochlear fenestration 122 may be formed through a circular window 121, an oval window 112, a promontory 123, or through the apical gyrus 147 of the cochlea 140.

[0037] The elongated stimulation assembly 118 includes a longitudinally aligned and distally extending array 146 (e.g., an electrode array; a contact array) of stimulation elements 148 (e.g., electrodes; electrical contacts; light emitters; optical contacts). The stimulation elements 148 are longitudinally spaced apart from each other along the length of the elongated body of the stimulation assembly 118. For example, the stimulation assembly 118 may include an array 146 comprising twenty-two (22) stimulation elements 148 configured to deliver stimulation to the cochlea 140. Although the array 146 of stimulation elements 148 may be disposed on the stimulation assembly 118, in most practical applications, the array 146 is integrated into the stimulation assembly 118 (e.g., the stimulation elements 148 of the array 146 are disposed within the stimulation assembly 118). As noted, the stimulator unit 120 generates a stimulation signal (e.g., an electrical signal; an optical signal) which is applied to the cochlea 140 by the stimulation elements 148, thereby stimulating the auditory nerve 114.

[0038] Various types of intracochlear stimulation components 118 are compatible with some embodiments described herein, including but not limited to: short, straight, and perimodiolar. Perimodiolar stimulation components 118 are configured to adopt a curved configuration during and / or after implantation into the cochlea 140. To achieve this, in some embodiments, the perimodiolar stimulation component 118 is pre-bent to approximately the same curvature as the cochlea 140. This instance of the stimulation component 118 can be kept straight by, for example, a reinforcing pin (not shown) or sheath removed during implantation, or alternatively, a varying combination of materials or the use of shape memory materials, allowing the stimulation component 118 to adopt its curved configuration in the cochlea 140. Other implantation methods and other stimulation components 118 employing curved configurations can be used. Stimulation components 118 in some other embodiments include non-perimodiolar stimulation components 118. For example, stimulation components 118 may include a straight stimulation component 118 or a mid-scala component, which is in a mid-scala position during or after implantation. Alternatively, the stimulation component 118 may include a short electrode implanted in at least the basal region of the cochlea 140.

[0039] Figure 2 This is a cross-sectional view of a cochlea 140 according to certain embodiments described herein, illustrating a stimulation component 118 partially implanted in the cochlea. Figure 2Only a subset of the stimulating elements 148 of the stimulating assembly 118 is shown. The cochlea 140 is a conical spiral structure comprising three parallel, fluid-filled tubes or ducts, collectively referred to herein as tubes 236. Tubes 236 include the tympanic canal 237 (also known as the scala tympani 237), the vestibular canal 238 (also known as the scala vestibulum 238), and the middle auditory canal 239 (also known as the scala media 239). The cochlea 140 includes a cochlear axis 240, which is a conical central region around which the cochlear tubes 236 coil. The cochlear axis 240 is composed of cancellous bone, within which cochlear neurons, sometimes referred to herein as spiral ganglion cells, are located. The cochlear tubes 236 rotate approximately 2.5 times around the cochlear axis 240.

[0040] With normal hearing, the auricle 110 (see example) enters the auricle. Figure 1 The sound causes a pressure change in the cochlea 140, which then travels through the fluid-filled tympanic canal 237 and vestibular canal 238. The organ of Corti 242, located on the basilar membrane 244 in the scala 239, contains several rows of hair cells (not shown) projecting from its surface. Above the hair cells is a tectoral membrane 245, which moves in response to pressure changes in the fluid-filled tympanic canal 237 and vestibular canal 238. Small relative movements of the layers of the tectoral membrane 245 are sufficient to move the hair cells, resulting in the generation of voltage impulses or action potentials, which propagate along the associated nerve fibers connecting the hair cells to the auditory nerve 114. The auditory nerve 114 relays the impulses to the auditory region of the brain (not shown) for processing.

[0041] Typically, in cochlear implant recipients, a portion of the cochlea 140 (e.g., hair cells) is damaged, preventing the cochlea 140 from converting pressure changes into nerve impulses to relay to the brain. Therefore, the stimulating element 148 of the stimulating assembly 118 is used to directly stimulate the cells to generate nerve impulses, thereby enabling the perception of received sound (e.g., to induce auditory perception).

[0042] In order to insert the intracochlear stimulation component 118 into the cochlea 140, through the recipient's mastoid bone 119 (see example...). Figure 1 ) to form an opening (facial recess) to approach the recipient's middle ear cavity 106 (see example) Figure 1 Then, for example, an opening is formed from the middle ear 106 into the cochlea 140 through the circular window 121, the elliptical window 112, the promontory 123, etc. of the cochlea 140. The stimulating component 118 is then gently advanced (e.g., pushed) into the cochlea 140 until the stimulating component 118 reaches the implantation position. Figure 1 and Figure 2 As shown, the stimulation component 118 follows the spiral shape of the cochlea 140. That is, the stimulation component 118 spirals around the cochlear axis 240.

[0043] The effectiveness of stimulation by the stimulating element 118 depends at least in part on its location along the basilar membrane 244 where the stimulation is delivered. That is, the cochlea 140 is characteristically referred to as “tonotopically mapped” because regions of the cochlea 140 facing the basal end respond more to high-frequency signals, while regions of the cochlea 140 facing the apex respond more to low-frequency signals. These tonotopically mapped characteristics of the cochlea 140 are utilized in cochlear implants by delivering stimulation within a predetermined frequency range to the region of the cochlea 140 most sensitive to that particular frequency range. However, this stimulation depends on the final implantation location of the specific stimulating element 148 being adjacent to the corresponding tonotopically mapped region of the cochlea 140 (e.g., the region of the cochlea 140 sensitive to the frequency of the sound represented by the stimulating element 148).

[0044] To achieve the selected final implantation location, the tip (e.g., distal / tip) portion 250 of array 146 is positioned at a selected angular location (e.g., angular insertion depth). As used herein, angular location or angular insertion depth refers to the angle at which the tip portion 250 of array 146 is rotated from the inner ear opening 122 (e.g., circular window 121) through which the stimulation component 118 enters the cochlea 140. Thus, angular location / angular insertion depth can be expressed in terms of how much the tip portion 250 has traveled within the cochlea 140 relative to the inner ear opening 122. For example, an angular insertion depth of 180 degrees indicates that the tip portion 250 has traveled to approximately half (1 / 2) of the first turn of the cochlea 140. An angular insertion depth of 360 degrees indicates that the tip portion 250 has traveled completely around the first turn of the cochlea 140.

[0045] In some embodiments, when the stimulation component 118 is implanted (e.g., during a surgical procedure performed by an operator, such as a medical professional, surgeon, and / or automated or robotic surgical system), as the array 146 is advanced and placed in the appropriate position within the cochlea 140, the position and / or orientation of the array 146 relative to the cochlea 140 (e.g., collectively referred to as the orientation of the array 146) is adjusted. The goal of implantation is for the fully implanted array 146 to have an optimal orientation, wherein the array 146 is positioned such that the stimulation element 148 is adjacent to the corresponding phoneme distribution area of ​​the cochlea 140. To achieve the optimal orientation, the array 146 is expected to follow a trajectory within the cochlea 140 such that (i) the stimulation element 148 is linearly distributed along the axis of the cochlear duct 239, (ii) the array 146 does not contact the basilar membrane 244, and (iii) the stimulation element 148 is either close to the cochlear axis wall (e.g., if the array 146 is pre-bent) or distant from the cochlear axis wall (e.g., if the array 146 is not pre-bent).

[0046] However, one or more of these expectations may be violated during the insertion of array 146. For example, the top portion 250 of array 146 may snag on the wall of cochlear duct 239, array 146 may become stuck, folded, and / or over-inserted, and / or portions of cochlea 140 (e.g., scala tympani 237; scala vestibulae 238; cochlear duct 239; organ of Corti 242; basilar membrane 244) may dislocate, resulting in suboptimal placement of array 146. It is desirable to provide the operator with information about the orientation and / or status of array 146 during the implantation procedure (e.g., providing real-time feedback). For example, during the implantation process, measures related to the orientation of array 146 (e.g., angular depth; span of fold; insertion speed; distance from basement membrane 244; deflection within tube 236) can be reported continuously, at predetermined intervals and / or in response to operator requests, and alerts regarding events related to insertion (e.g., electrode snagging; scala misalignment; other suboptimal conditions) can be provided to the operator so that the operator can take corrective action.

[0047] Figure 3 An exemplary system 300 according to certain embodiments described herein is schematically illustrated. System 300 includes at least one data input interface 310 configured to receive data 312 from a plurality of transducers during insertion of a medical device onto or into a recipient's body part. System 300 also includes at least one control output interface 320 configured to transmit control signals 322 to the plurality of transducers. The plurality of transducers respond to the control signals 322 by generating data 312. System 300 also includes at least one controller 330 operatively communicating with at least one data input interface 310 and at least one control output interface 320. At least one controller 330 is configured to access a probabilistic model of a parameterized description of the medical device's posture relative to the body part. At least one controller 330 is also configured to generate an estimate of the current posture of the medical device, at least partially in response to the received data 312 and the probabilistic model. System 300 also includes at least one output interface 340 operatively communicating with at least one controller 330 and configured to provide information 342 regarding the estimated posture of the medical device. In some embodiments, system 300 further includes at least one user input interface 350, which operatively communicates with at least one controller 330 and is configured to provide user input 352 to at least one controller 330.

[0048] In some embodiments, system 300 includes at least one computing device configured to communicate operationally with a plurality of transducers (e.g., via at least one data input interface 310 and at least one control output interface 320) and with an operator (e.g., a medical professional; a surgeon; an automated or robotic surgical system) (e.g., via at least one output interface 340 and at least one user input interface 350). The at least one computing device may include, but is not limited to: a desktop computer, a laptop computer, a mobile computing device or accessory; a smartphone; a smart tablet. The at least one computing device may communicate with another computing device used by the operator (e.g., an external device used by a medical professional or surgeon; a component of an automated or robotic surgical system) (e.g., via at least one output interface 340 and / or at least one user input interface 350). In some embodiments, at least one computing device is external to the implantable medical device, while in some other embodiments, at least one computing device is incorporated into the implantable medical device.

[0049] At least one data input interface 310, at least one control output interface 320, at least one output interface 340, and / or at least one user input interface 350 may include any combination of wired and / or wireless ports, including but not limited to: a Universal Serial Bus (USB) port; an IEEE 1394 port; a PS / 2 port; a network port; an Ethernet port; a Bluetooth port; and a wireless network interface. In some embodiments, at least one data input interface 310 and at least one control output interface 320 are integral to each other (e.g., including the same ports), while in some other embodiments, at least one data input interface 310 and at least one control output interface 320 are separate from each other. In some embodiments, at least one data input interface 310 and at least one control output interface 320 communicate with the same transducer operation, while in some other embodiments, at least one data input interface 310 and at least one control output interface 320 communicate with different transducer operations.

[0050] In some embodiments, at least one output interface 340 is configured to communicate operationally with at least one communication device (e.g., a display device; a screen; a status indicator; an audio device; a speaker; a vibration motor), which is configured to transmit information to an operator during implantation of the medical device. For example, the at least one communication device may provide the operator with information, warnings, and / or alarms regarding the posture of the medical device and / or the operational status of the system 300. At least one user input interface 350 may be configured to communicate operationally with one or more keyboards, computer mice, touchscreens, switches, buttons, or other devices through which a human operator (e.g., a medical professional; a surgeon) can provide commands or data to the system 300.

[0051] In some embodiments, at least one controller 330 is configured to automatically transmit control signals 322 to multiple transducers (e.g., at a predetermined constant repetition rate; at times determined by the internal logic of the controller 330) during implantation of the medical device. For example, multiple transducers may be activated or triggered to automatically perform data acquisition when the system 300 is connected to multiple transducers of the medical device (e.g., when the surgical sound processing unit 126 is connected to the cochlear implantation system 100 during implantation). In some other embodiments, at least one controller 330 is configured to intermittently receive trigger signals from at least one user input interface 350 during implantation of the medical device. At least one controller 330 may be configured to respond to the trigger signals by transmitting control signals 322 to multiple transducers. In this way, multiple transducers may be selectively activated by a human operator (e.g., by pressing a button on an external device that communicates with at least one user input interface 350) and / or by an automated or robotic surgical system. In some other embodiments, the controller 300 does not send control signals 322 to the multiple transducers, and the system 300 does not include a control output interface 320.

[0052] In some embodiments, at least one controller 330 includes at least one processor 334 and at least one storage device 336 operatively communicative with at least one processor 334. At least one storage device 336 may be configured to collect and store data 312 received from a plurality of transducers, and at least one processor 334 may be configured to generate an estimate of the attitude of the medical device, at least in part, in response to the stored data. At least one processor 334 may include a microprocessor or microcontroller configured to receive data 312 via at least one data input interface 310 and transmit the received data 312 to at least one storage device 336. At least one processor 334 may also be configured to access data 312 (e.g., stored on at least one storage device 336), access a probabilistic model of a parameterized description of the attitude of the medical device (e.g., stored on at least one storage device 336), execute instructions (e.g., stored on at least one storage device 336), generate information (e.g., an estimated attitude of the medical device), and provide it to at least one output interface 340 and / or at least one storage device 336 for storage and later retrieval.

[0053] In some embodiments, at least one processor 334 is configured to filter data 312 received from multiple transducers. For example, at least one processor 334 may filter (e.g., in the time domain; using a median filter; using an exponentially weighted moving average filter) data 312 generated from multiple measurements. In another instance, at least one processor 334 may apply more weight to more recently generated data 312 (e.g., to selectively apply more weight to data 312 that may be affected by the presence of electrodes 148 in the cochlea 140). In some embodiments, at least one processor 334 is configured to aggregate data 312 generated by the transducers (e.g., aggregating the 10 most recent measurements taken by the transducers). In some embodiments, at least one processor 334 is configured to aggregate data 312 generated by multiple transducers (e.g., aggregating the 10 most recent measurements taken by the transducers when each transducer is at a predetermined location relative to the body part of the medical device being implanted, e.g., 5 mm from the circular window 121 of the cochlea 140).

[0054] In some embodiments, at least one processor 334 is configured to associate data 312 with a specific transducer (e.g., electrode contact; microphone) based on prior knowledge of the configuration of the transducers used for measurement acquisition (e.g., electrode montage). For example, prior estimates of the orientation of electrode array 146 can be used to associate data 312 with the location of electrodes 148 in cochlea 140. In some embodiments, at least one processor 334 is configured to extrapolate data 312 to a nearby location using interpolation (e.g., inverse distance weighting; piecewise linear interpolation).

[0055] At least one storage device 336 may include at least one tangible (e.g., non-transitory) computer-readable storage medium, examples of which include, but are not limited to: read-only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory. At least one storage device 336 may be encoded with software (e.g., a computer program downloaded as an application) including computer-executable instructions for instructing a computer system (e.g., measurement logic and / or evaluation logic to be executed by at least one processor 334). For example, measurement logic may be executed by at least one processor 334 to generate control signals 322 to activate and / or otherwise control a plurality of transducers. In another example, evaluation logic may be executed by at least one processor 334 to evaluate data 312 received from a plurality of transducers, generate an estimate of the posture of the medical device using a probabilistic model, and provide information 342 regarding the estimated posture of the medical device.

[0056] In some embodiments, implanting a medical device includes inserting at least a portion of the medical device into a body part of a recipient. For example, the medical device may include a stimulation component 118 of a cochlear implant auditory prosthesis 100, and the body part may include the recipient's cochlea 140.

[0057] In some embodiments, at least some transducers are configured to function as stimulators to initiate biophysical phenomena based on the current orientation of the medical device, and at least some transducers are configured to function as sensors to generate data 312 indicative of the biophysical phenomena. In some such embodiments, at least some transducers are configured to function as both stimulators and sensors.

[0058] In some embodiments, the medical device includes at least some of a plurality of transducers. For example, the plurality of transducers may include stimulation elements 148 (e.g., electrodes) of the electrode array 146 of the stimulation component 118 of the cochlear implant auditory prosthesis 100 (e.g., to generate transimpedance data, wherein the electrode 148 is configured to function as both a stimulator and a sensor). In some other embodiments, the plurality of transducers includes at least one transducer that is not part of the medical device. For example, to provide cochlear electrogram (e.g., cochlear microphone) data, the plurality of transducers may include electrodes 148 of the electrode array 146 (which are part of the stimulation component 118 and configured to function as a sensor) and one or more actuators that are not part of the stimulation component 118 (and configured to function as a stimulator). The one or more actuators may be implanted or external (e.g., in the ear canal 102) and may include, but are not limited to, acoustic receivers, bone conduction devices, or middle ear / staped / circular window oscillators that are implanted or external (e.g., in the ear canal 102). In another example, to provide stapedius reflex data, multiple transducers may include electrodes 148 of electrode array 146 (which are part of stimulation component 118 and configured to function as stimulators) and one or more microphones that are not part of stimulation component 118 (and configured to function as sensors). In yet another example, to provide cochlear electrogram calibration or quality assurance data, multiple transducers may include one or more actuators that are not part of stimulation component 118 (and configured to function as stimulators) and one or more microphones that are not part of stimulation component 118 (and configured to function as sensors).

[0059] Figure 4This is a flowchart of an exemplary method 400 according to certain embodiments described herein. In operation block 410, method 400 includes receiving first information about the pose of a structure during a first time period. The structure is configured to be inserted into a body part of a receiver. The first information includes a first estimate of the pose of the structure during the first time period and at least one of a first set of measurements including one or more first measurements. At least some of the one or more first measurements are generated using a plurality of sensors distributed along the structure. The one or more first measurements indicate the pose of the structure during the first time period. In operation block 420, method 400 further includes generating a second estimate of the pose of the structure using at least the first information and a probabilistic model of the structure and / or body part.

[0060] In some embodiments, the second estimate corresponds to the pose of the structure within a second time period. For example, the second time period may be the same as the first time period, such that the second estimate includes a refinement compared to a first estimate of the structure's pose within the first time period (e.g., a closer approximation of the structure's pose within the first time period). In another instance, the second time period may be after the first time period, such that the second estimate includes a new estimate of the structure's pose within the second time period.

[0061] In some embodiments, the structure includes a medical device configured to be implanted on or inside at least a portion of a recipient's body. For example, the structure may include an array 146 of stimulation components 118 of a cochlear implantation system 100 (e.g., an electrode array), and the structure is configured to be inserted into a body portion comprising the recipient's cochlea 140. In some such embodiments, the orientation of the structure includes the position and / or orientation of the array 146 of stimulation components 118 relative to the cochlea 140 (e.g., relative to the cochlear axis 240; relative to the canal 236; relative to the phoneme distribution area of ​​the cochlea 140).

[0062] In some embodiments, multiple sensors include components of the medical device used after implantation is completed and during operation of the medical device. For example, multiple sensors may include stimulation elements 148 (e.g., electrodes) of an array 146 of stimulation components 118. In some other embodiments, multiple sensors include one or more sensors (e.g., voltage and / or current sensors; optical sensors; vibration sensors) dedicated to use during the implantation procedure and not used during operation of the medical device after implantation is completed.

[0063] Figures 5A-5CExemplary voltage measurements performed using an array 146 of electrodes 148 of stimulation component 118 according to certain embodiments described herein are schematically illustrated to generate a measurement set including one or more measurements. Voltage (e.g., potential difference) measurements can be performed between electrodes 148, inside and / or outside the cochlea 140, before, during, and / or after electrical stimulation of the cochlea 140 by electrodes 148 (e.g., generating current between electrodes 148). In some embodiments, the voltage measurements are sensitive to the cochlear axis proximity of electrodes 148 and / or to the linear distance between electrodes 148 within the cochlea 140.

[0064] like Figure 5A As schematically illustrated, a four-point impedance measurement can be performed by stimulating the cochlear tissue using a first pair of stimulating electrodes and measuring the voltage between a second pair of measuring electrodes. Such measurements are sensitive to the proximity of electrode 148 to the cochlear axis (e.g., the distance D between electrode 148 and cochlear axis 240). When this distance D decreases, the voltage V increases (e.g., see, U.S. Patent No. 9,173,585, entitled “Real-time measurement of electrode impedance during intracortical electrode insertion”, Laryngoscope, vol. 123(4), pp. 1028-1032 (2013), by CTtan et al.).

[0065] like Figure 5B As schematically illustrated, excitation propagation can be measured by stimulating cochlear tissue with a stimulating electrode and measuring the evoked compound action potential (ECAP) response with a measuring electrode spaced L from the stimulating electrode. A larger value of L results in a reduction in the number of stimulating neurons 142 that respond to the ECAP response detected by the measuring electrode (in...). Figure 5BThe signal amplitude is contributed by the electrode 148 (shown in the overlapping shaded area), thus contributing to attenuation in the signal amplitude. Such measurements are sensitive to the proximity of the electrode 148 to the cochlear axis (e.g., the distance D between the electrode 148 and the cochlear axis 240). When the electrode 148 is closer to the cochlear axis 240 (e.g., D is smaller), the signal amplitude attenuates more quickly, and the full width at half maximum (FWHM) of the ECAP response is smaller; conversely, when the electrode 148 is farther from the cochlear axis 240 (e.g., D is larger), the signal amplitude attenuates more slowly, and the FWHM of the ECAP response is larger. See, for example, D. Degen's article "Effect of electrode position on electrophysiological and psychophysical parameters in CI patients with lateral and perimodiolarelectrode arrays" in CI 2017 Pediatrics 15. th A presentation at the Pediatric Cochlear Implantation Symposium (July 26-29, 2017).

[0066] like Figure 5C As schematically illustrated, the voltage measurement varies with the proximity of the measuring electrode to the stimulating electrode, and this voltage measurement can be used to generate a transimpedance matrix (TIM). As the distance L increases, the voltage V detected by the measuring electrode decreases, and therefore, the corresponding value of the TIM decreases. For example, the TIM measurement can be used to classify electrode posture (e.g., whether the electrode is folded; the fold position on the electrode portion) (see, for example, U.S. Patent Application Publication No. 2018 / 0140829). Additionally, the voltage recordings acquired during electrical stimulation using one or more electrodes 148 in the cochlea 140 vary with the degree of immersion of the electrodes 148 in the cochlear duct 239 due to the ability of current to flow from the electrodes 148 (see, for example, U.S. Patent No. 9,987,490).

[0067] exist Figures 5A-5C In the exemplary measurements, the electrodes 148 of the stimulation component 118 serve as transducers to generate stimulation and measure the response (e.g., voltage; potential difference). In some other embodiments, other types of measurements may be used to acquire one or more measurements of a measurement set, utilizing other types of transducers (e.g., at least one actuator configured to generate stimulation) separate from the stimulation component 118 of the cochlear implant system 100. The measurement set of some embodiments includes measurements acquired using a combination of stimulation and / or measurement transducers disclosed herein.

[0068] In some embodiments, at least one acoustic actuator may be configured to generate acoustic stimulation, and voltage measurements (e.g., using electrodes 148 of stimulation assembly 118) may be performed before, during, and / or after acoustic stimulation by at least one acoustic actuator (e.g., electrocochleography measurement). At least one acoustic actuator may be implanted or external (e.g., in ear canal 102), and examples of such acoustic actuators include, but are not limited to: acoustic receivers; bone conduction devices; and middle ear (e.g., stapes or round window) oscillators. For example, voltage measurements performed using at least one electrode 148 in cochlea 140 before, during, and / or after acoustic stimulation, due to hair cell responses induced by mechanical stimulation, vary with the mechanical degrees of freedom of the basilar membrane 244, thus such measurements may indicate that stimulation assembly 118 impinges on the basilar membrane 244. For example, see the article “Cochlear response telemetry: intracochlear electrocochleography via cochlear implant neural response telemetry pilot study results” by L. Campbell et al., Otol. Neurotol. Vol. 36(3), pp. 399-405 (2015).

[0069] In some embodiments, an implanted or external microphone (e.g., in the ear canal 102) may be used to perform acoustic or vibration measurements (e.g., stapedius reflex measurements) before, during, and / or after electrical stimulation (e.g., current between electrodes 148 inside and / or outside the cochlea 140). In some embodiments, an implanted or external microphone (e.g., in the ear canal 102) may be used to perform acoustic or vibration measurements before, during, and / or after acoustic stimulation (e.g., calibration / quality assurance measurements for electrocochleography measurements). Acoustic actuators may be implanted or external (e.g., in the ear canal 102), examples of which include, but are not limited to: acoustic receivers; bone conduction devices; and middle ear (e.g., stapes or round window) oscillators.

[0070] In some embodiments, the measurement set indicates symmetrical changes in the structure's orientation during insertion and / or retraction relative to a body part (e.g., the changes at every point of the structure are the same). In other embodiments, the measurement set indicates asymmetrical changes in the structure's orientation during insertion and / or retraction relative to a body part (e.g., the changes at two or more points of the structure are different from each other). For example, asymmetrical changes may occur during insertion and / or retraction when the bottom of the electrode array moves while the top of the electrode array does not move.

[0071] Exemplary use of probabilistic models

[0072] In some embodiments, method 400 provides a maximum likelihood estimate of the structure's attitude. The first information received in operation block 410 may include a first set of measurements without a prior first estimate of the structure's attitude, and the generation of a second estimate of the attitude in operation block 420 may include determining the estimated attitude of the structure (e.g., the most likely attitude) without prior knowledge of the previous estimate of the structure's attitude. For example, for a plurality of electrodes 148 of an electrode array, a probabilistic model (e.g., a canonical model) can be used based on a set of acquired measurements of the electrode-to-ground impedance, without prior knowledge, to determine the estimated attitude of the electrode array 146. In some embodiments, maximum likelihood estimation may use various mathematical techniques (e.g., Monte Carlo; particle filter; Kalman filter; recursive Bayesian estimation) to produce an estimated attitude of the structure. The attitude estimate may be generated based on a probabilistic model. For example, the probability distributions of various possible attitudes may be analyzed to derive an estimate of the attitude corresponding to the mean, median, mode, and / or center of mass (e.g., standard deviation; interquartile range) of the probability distribution and / or uncertainty.

[0073] Figure 6A-6J An exemplary use of regularized models of structures and / or body parts according to certain embodiments described herein is illustrated. Figure 6A A canonical model (e.g., a probabilistic model) according to certain embodiments described herein is schematically illustrated, wherein an elongated array 146 of stimulating elements 148 (e.g., an electrode array of electrodes) is inserted into the cochlea 140 through the middle ear 105. In some embodiments, the cochlea 140 is modeled as a tube containing a conductive fluid, and the middle ear 105 is modeled as a cavity containing an insulating gas. The electrodes 148 are distributed along the length of the array 146 and can be determined by a distance D from the apex 150 of the array 146. electrode-apex Characterization. The orientation of array 146 can be determined by the distance D between the apex 150 of array 146 and the opening 152 (e.g., through a circular window 121, an elliptical window 112, a promontory 123, or an inner ear opening 122 formed by the apical gyrus 147 of cochlea 140). apex-opening The array 146 enters the cochlea 140 through the opening. The impedance between each electrode 148 and a remote ground potential can be predicted based on the orientation of the array 146. It can be predicted that the electrodes 148 inside the cochlea 140 are connected to the remote ground potential through a conductive path corresponding to the predicted low impedance, and that the electrodes 148 outside the cochlea 140 correspond to the predicted high impedance.

[0074] In some embodiments, the predicted impedance measurement is derived from an anatomical diagram of a body part (e.g., the cochlear duct 239). For example, it can be derived from the distance D between the apex 150 of array 146 and the opening 152 of cochlea 140. apex-openingDescribe the orientation of array 146 within cochlear duct 239. This can be based on the distance D between electrode 148 and the tip 150 of array 146. electrode-apex The position of each electrode 148 within the cochlear duct 239 is calculated. The impedance between the electrode 148 and the remote ground potential can be predicted (e.g., by locating the electrode 148 in a predicted impedance diagram of the remote ground potential).

[0075] In some embodiments, the impedance between each electrode 148 and the remote ground potential is observed (e.g., measured). Figure 6B Exemplary graphs illustrating such observations according to certain embodiments described herein (e.g., according to D) are shown schematically. electrode-apex (Measured impedance). Measured from multiple electrodes 148. Figure 6B The impedance appears to conform to Figure 6A The expected value of the probability model, wherein the boundary between the electrodes 148 outside the cochlea 140 and the electrodes 148 inside the cochlea 140 lies between the sixth and seventh electrodes 148 starting from the apex 150 (e.g., the first to sixth electrodes 148 are located inside the cochlea 140, and the seventh to "n-1"th electrodes 148 are outside the cochlea 140). These observations can be compared to the predictions using various metrics, including but not limited to: root mean square of the difference, arithmetic mean, and maximum absolute difference. In some embodiments, the predicted and observed values ​​are transformed before such comparisons are made. For example, impedance can be determined by falling within a predetermined threshold impedance Z. threshold The following are encoded as 0, otherwise they are encoded as 1.

[0076] However, other physical factors may affect the grounding impedance measurement of electrode 148 and the estimated orientation of array 146. Figure 6C Some embodiments according to the description herein are illustrated schematically. Figure 6A A regularized model of the structure (e.g., a probabilistic model) that illustrates instances of such physical factors. For example, such as Figure 6C As shown, the electrode 148 outside the cochlea 140 can be short-circuited to ground potential (e.g., via the fluid bead 154 or via a surgical instrument, such as forceps, for inserting the array 146 into the cochlea 140). For another example, as... Figure 6C As shown, the electrode 148 inside the cochlea 140 can be open-circuited from ground potential (e.g., due to a bubble 156 between the electrode 148 and the surrounding structures of the cochlear tube 239, or due to wire damage between the electrode 148 and the internal component 144 of the hearing prosthesis 100), thereby providing a high grounding impedance measurement. Figure 6CAs shown, the array 146 has six electrodes 148 inside the cochlea 140, with a bubble 156 on the second electrode 148 starting from the top 150, and four electrodes 148 outside the cochlea 140, with a fluid bead 154 on the ninth electrode 148 starting from the top 150.

[0077] Figure 6D The illustration schematically shows certain embodiments according to the description herein from Figure 6C The array 146 measurements are based on D electrode-apex An exemplary graph of the impedance. Due to the... Figure 6C The schematic illustration shows distortions caused by physical factors (e.g., artifacts), resulting in non-compliance of the measured impedances of at least some electrodes 148. Figure 6A The expectation of a probability model. For example, in Figure 6D In this configuration, the measuring impedance of the second electrode 148, starting from the top 150, is affected by the bubble 156, and the measuring impedance of the ninth electrode 148, also starting from the top 150, is affected by the liquid bead 154. Due to the potential influence of such physical factors, examining only the measuring impedance may not reveal the orientation of the array 146 (e.g., the boundary between the electrodes 148 outside and inside the cochlea 140). For example, in Figure 6D In this context, given the presence of distortion (e.g., artifacts), simply checking the measured impedance is insufficient to determine the attitude (e.g., the location of the boundary) with the required level of accuracy (e.g., more accurate than at a certain point within multiple attitude ranges, such as the boundary being within the range of the sixth electrode 148 to the tenth electrode 148).

[0078] Figure 6E A first set of observed impedance values ​​for the orientation of array 146 according to certain embodiments described herein (e.g., unaffected by...) is schematically shown. Figure 6C The graph shows the effect of physical factors (as shown) compared to a set of predicted impedance values, where the eighth electrode 148 is inside the cochlea 140 and the ninth electrode 148 is outside the cochlea 140 (e.g., opening 152 is between the eighth and ninth electrodes 148). Figure 6F The pose of array 146 according to certain embodiments described herein is schematically illustrated. Figure 6E A graph comparing the first set of observed impedance values ​​with a set of predicted impedance values, wherein the sixth electrode 148 is inside the cochlea 140 and the seventh electrode 148 is outside the cochlea 140 (e.g., opening 152 is between the sixth and seventh electrodes 148).

[0079] Figure 6E and 6FThese are two instances of predicted impedance values ​​for array 146 in different orientations during insertion into cochlea 140, based on a regularized model. Array 146 is considered as one of n states, depending on how many of the n-1 electrodes 148 of array 146 are within cochlea 140. For example, the first state corresponds to no electrodes 148 within cochlea 140, the second state corresponds to only one electrode 148 closest to the tip 150 within cochlea 140, the third state corresponds to two electrodes 148 closest to the tip 150 within cochlea 140, ..., the nth state corresponds to all n-1 electrodes 148 within cochlea 140. Each state corresponds to a set of ground impedance measurements Z1...Z1 expected to be obtained from the multiple electrodes 148. n-1 For example, for each state, the electrode 148 inside the cochlea 140 is expected to provide a common value Z. in The measured grounding impedance value (e.g., less than a first predetermined grounding impedance threshold Z) threshold-1 The electrodes 148 located outside the cochlea 140 are expected to provide a common value Z. out The measured grounding impedance value (e.g., greater than the second predetermined grounding impedance threshold Z) threshold-2 In some embodiments, the first predetermined ground impedance threshold Z threshold-1 The first and second predetermined grounding impedance thresholds are equal to each other, while in some other embodiments, the first and second predetermined grounding impedance thresholds are different from each other.

[0080] Figure 6G The second set of observed impedance values ​​is schematically shown (e.g., subjected to...). Figure 6C The influence of the physical factors shown) and Figure 6E A graph comparing the same set of predicted impedance values. Figure 6H schematically shown Figure 6G The second set of observed impedance values ​​and Figure 6F A graph comparing the same set of predicted impedance values.

[0081] In some embodiments, a set of possible poses is used to generate predictions of possible measurements, and each set of predictions is compared to a set of possible measurements. For example, the error metric generated by each comparison can be used to estimate the likelihood of the pose (e.g., by direct computation). In some embodiments, the likelihood and the error metric have an inverse relationship (e.g., the likelihood estimate is...). or e -error ).

[0082] Figure 6I and 6J Two examples of calculated likelihood of possible pose ranges according to certain embodiments described herein are illustrated schematically. Figure 6I Corresponding to various poses for array 146 (e.g., ... Figure 6E and6F (as shown) Figure 6E and 6F The first set of observed impedance values ​​(e.g., unaffected by) Figure 6C The influence of physical factors shown in the figure is compared with the predicted impedance values ​​of each group. Figure 6I A distinct peak in the likelihood is shown for the orientation of placing the sixth electrode 148 inside the cochlea 140 and placing the seventh electrode 148 outside the cochlea 140 (e.g., the opening 152 between the sixth and seventh electrodes 148), where the likelihood monotonically decreases as the depth moves out of this range.

[0083] Figure 6J Corresponding to various poses for array 146 (e.g., ... Figure 6G and 6H (as shown) Figure 6G and 6H The second set of observed impedance values ​​(e.g., subjected to) Figure 6C The influence of physical factors shown in the figure is compared with the predicted impedance values ​​of each group. Figure 6J The diagram shows that for positions where the sixth electrode 148 is placed inside the cochlea 140 and the seventh electrode 148 is placed outside the cochlea 140, peaks still exist, but are less pronounced, and small likelihood peaks are present near the second and ninth electrodes 148, both of which are affected by... Figure 6C The artifact effect. Since if the second electrode 148 is outside the cochlea 140, there must be four low-impedance electrodes 148 outside the cochlea 140, and the peak value near the second electrode 148 is significantly lower than the peak value near the ninth electrode 148.

[0084] In some embodiments, the estimated pose can be calculated based on the calculated likelihood array 146. For example, the pose with the highest likelihood can be selected (e.g., maximum likelihood estimation can be used), or poses with numerical metrics (e.g., depth in millimeters) can be combined to produce an estimate (e.g., calculating the average or median pose).

[0085] In some embodiments, the calculated likelihood of the pose of array 146 is combined with previously calculated probabilities of the pose of array 146 to calculate the posterior probability of the pose of array 146. For example, at initialization, all poses of array 146, or a subset of all poses, may be considered equally likely. Based on the calculated posterior probabilities, an estimated pose of array 146 can be calculated. For example, poses with the highest likelihood (e.g., maximum posterior estimate) or poses with numerical metrics (e.g., depth in millimeters) can be selected and combined to produce an estimate (e.g., a calculated average or median pose).

[0086] In some embodiments, method 400 provides a maximum a posteriori estimate of the structure's attitude. First information received in operation block 410 may include a first estimate of the structure's attitude and a first set of measurements over a first time period, and generating a second estimate of the structure's attitude in operation block 420 may include updating the first estimate in response to the first set of measurements. For example, for a plurality of electrodes 148 of an electrode array, an estimated attitude (e.g., most likely attitude) of the electrode array 146 may be determined based on a set of acquired measurements of the electrode-to-ground impedance, using a probabilistic model (e.g., a canonical model) and at least one previously estimated attitude of the electrode array 146. The probability of each possible state may be scaled proportionally to the distance D between its boundary position and the boundary position of the previously estimated attitude (e.g., the probability may be multiplied by a factor of 1 / (1+D), where D is the distance in millimeters from the boundary position immediately preceding the previously estimated attitude). In some such embodiments, the maximum a posteriori estimate may use various mathematical techniques (e.g., Monte Carlo; particle filter; Kalman filter; recursive Bayesian estimation) to generate a second estimate of the structure's attitude.

[0087] In some embodiments, the probabilistic model can be adjusted based on additional information generated during the implantation process (e.g., different states are weighted differently relative to each other). For example, the probabilistic model may be adjusted at least in part based on measurements generated by at least one sensor in response to the structure's posture. Examples of such sensors include, but are not limited to, accelerometers mechanically coupled to the structure, sheaths or pins mechanically coupled to the structure, tools for manipulating the structure (e.g., forceps), and / or virtual reality systems used by medical personnel.

[0088] In another example, the probabilistic model may be adjusted at least in part based on manipulation control signals known to have been sent to an implanted actuator (e.g., a surgical robot) that directly or indirectly manipulates the electrode array 146. For example, for a manipulation control signal corresponding to the electrode array 146 advancing into the cochlea 140, the probability of a forward-advancing state having occurred would be considered more likely than the probability of a backward-moving state. In some embodiments, the probabilistic model may include a likelihood that device malfunctions (e.g., an open or short-circuited electrode 148).

[0089] In some embodiments, cumulative estimations of posture and / or collected measurements can be used to map the anatomy of body parts (e.g., the cochlear duct) and / or refine (e.g., update) existing maps. This map can be initialized based on preoperative images (e.g., from magnetic resonance imaging). For example, based on the estimated posture, measurements (e.g., observed remote grounding impedance) can be combined with (e.g., added to) the map of the anatomy. In some embodiments, cumulative estimations of posture and / or collected measurements are used to refine the logic applied during posture likelihood calculations. For example, if the estimated values ​​of all electrodes 148 within the cochlea 140 are greater than Z... threshold-1 The impedance of +dZ, then the threshold Z threshold-1 A fixed step size dZ can be added.

[0090] Figures 7A-7C Another exemplary use of regularized models of structures and / or body parts according to certain embodiments described herein is illustrated schematically. Figures 7A-7C The example is applicable to detecting the folded state of the top portion 250 of the electrode array 146. Figure 7A An exemplary state diagram is shown for two states of the electrode array 146 (e.g., pre-bent electrode array 146) inserted into the cochlea 140. The "unfolded" state (e.g., alternatively referred to as "proximal to the cochlear axis" or "close to the cochlear axis") is shown. Figure 7B (Schematively shown), the electrode array 146 extends along the tube 236 in a single direction (e.g., optimally positioned relative to the electrode bottom or the worm shaft 240). Figure 7C In the schematically illustrated "folded" state, at least a portion of the electrode array 146 extends away from the bottom of the electrodes, and the top portion 250 extends toward the worm shaft 240, with an acute angle (e.g., a bend; a knot) between the two portions. In some other embodiments, the regularization pattern may include a third state of the electrode array 146 between the "unfolded" and "folded" states, wherein a portion of the electrode array 146 extends away from the bottom of the electrodes, and the top portion 250 extends toward the worm shaft 240, with an obtuse angle (e.g., a bend; a knot) between the two portions (e.g., referred to as the "hooked" state).

[0091] like Figure 7A As shown, the orientation of the electrode array 146 can transition between states in a regularized model during insertion into the cochlea 140 (e.g., from time t1 to time t2>t1) (e.g., advancing the tip of the electrode array 146 into the cochlea 140 and / or withdrawing the bottom of the electrode array 146 from the cochlea 140). For example, for Figure 7AIn the two-state regularized model, from the "unfolded" state, electrode array 146 can remain in the "unfolded" state (e.g., inserted more deeply into cochlea 140) or transition to the "folded" state. From the "folded" state, electrode array 146 can remain in the "folded" state or transition to the "unfolded" state. For the regularized model that includes a "hooked" state between the "unfolded" and "folded" states, electrode array 146 in the "unfolded" state can remain in the "unfolded" state or transition to the "hooked" state; electrode array 146 in the "hooked" state can remain in the "hooked" state and transition to the "folded" state or transition to the "unfolded" state; electrode array 146 in the "folded" state can remain in the "folded" state or transition to the "hooked" state.

[0092] In some embodiments, each state of the regularized model describes a set of attitudes of the electrode array 146 that affect the measured values ​​(e.g., from electrode 148). Measurements indicating the distance between electrodes include, but are not limited to, transresistance measurements. For example, referencing... Figure 7B The "unfolded" state describes the distance D between electrode 18 and electrode 22. 18-22 Greater than the distance D between electrode 18 and electrode 21 18-21 The set of attitudes, the transresistance Z between electrode 18 and electrode 22 18-22 The expected transresistance Z between electrode 18 and electrode 21 18-21 Small. Conversely, reference. Figure 7C The "unfolded" state describes the distance D between electrode 18 and electrode 21. 18-21 Greater than the distance D between electrode 18 and electrode 22 18-22 The set of attitudes, the transresistance Z between electrode 18 and electrode 22 18-22 The expected transresistance Z between electrode 18 and electrode 21 18-21 big.

[0093] The probability of each of these states can be estimated by comparing the expected value of the regularized model with the measurement value generated by electrode 148. By comparing the poses, each with its own expected measurement value, with the probabilities of other possible poses, the pose of electrode array 146 can be estimated or partially estimated based on the most probable pose.

[0094] Figure 8 This is a flowchart of an exemplary method 500 according to certain embodiments described herein, which compares measurements with a set of possible poses generated using a probabilistic model of the structure. Figure 9 An exemplary evaluation of the posture evolution of an array 146 inserted into a cochlea 140 according to certain embodiments described herein is illustrated. Figure 9The posture evolution corresponds to the evolution from a first state (e.g., a previous state; a state in a first time period ≤ t1) to a second state (e.g., a new state; a state in a second time period > t1) according to certain embodiments described herein.

[0095] In operation block 510, method 500 includes receiving first information about the posture of the structure relative to a body part of the receiver during a first time period (e.g., posture at times ≤t1). The first information includes at least one of a first estimate of the structure's posture during the first time period and a first set of measurements (e.g., measurements generated by multiple sensors distributed along the structure during the first time period). Figure 9 As schematically shown, the first state is represented by a black cross, which corresponds to a measurement derived from TIM, four-point impedance, and / or cochlear electrogram measurements during the first time period.

[0096] In operation block 520, method 500 further includes generating a second estimate of the structure's pose (e.g., pose at times >t1) within a second time period. For example, generating the second estimate may include, in operation block 522, generating a first set of possible poses of the structure within the second time period using a probabilistic (e.g., regularized) model of the structure and / or body parts. Figure 9 In the example schematically shown, the first state of array 146 is an "unfolded" (e.g., "proximal cochlear axis") state, and corresponds to a specific observation (e.g., a measurement value) of one or more measurements (e.g., TIM measurements, examples of which include TIM gradient measurements; voltage measurements; impedance measurements; four-point impedance measurements; electrocochleography measurements) generated during a first time period (e.g., at a time ≤t1). Figures 7A-7C The first set of possible poses generated by the probabilistic (e.g., regularized) model may include: (i) possible poses in which array 146 remains in an "expanded" state and translates forward (e.g., further into) cochlea 140; (ii) possible poses in which array 146 remains in an "expanded" state and translates backward (e.g., further out) cochlea 140; and (iii) possible poses in which array 146 transitions to a "folded" state. In some embodiments, the first set may also include possible poses in which array 146 remains stationary (e.g., still in the first state). In some embodiments, generating the first set of possible poses further includes generating (e.g., calculating) expected measurements (in the first set) of possible poses. Figure 9 (Represented by a black circle).

[0097] In some embodiments, generating the second estimate in operation block 520 may further include selecting a second estimate of the pose from the first set of possible poses in operation block 530. For example, as Figure 8As shown, selecting a second estimate in operation block 530 may include receiving a second set of measurements including one or more second measurements in operation block 532. At least some of the one or more second measurements are generated using multiple sensors, and at least some of the one or more second measurements indicate the attitude of the structure within a second time period (e.g., a time >t1) following the first time period. Selecting a second estimate in operation block 530 may further include comparing the second set of measurements with expected measurements of possible attitudes corresponding to a first set in operation block 534, and in operation block 536, selecting a possible attitude of the first set as the second estimated attitude based on the comparison.

[0098] For example, in Figure 9 The white cross indicates that the new observation (e.g., measurement) generated at time t2>t1 corresponds to a new state of array 146 and can be compared with the expected measurements for various poses of the first possible pose set. (Reference) Figure 9 The new observations can be compared with: (i) the expected measurements of the array 146 while it is still in the "deployed" state during forward translation into the cochlea 140; (ii) the expected measurements of the electrode array 146 while it is still in the "deployed" state after backward translation out of the cochlea 140; and (iii) the expected measurements of the electrode array 146 transitioning to the "deployed" state. In some embodiments, the new observations can also be compared with the expected measurements when the array 146 is not moved (e.g., still in the first state). Figure 9 In the example, the new observation is closer to the expected measurement of array 146 transitioning to the "folded" state, so the second state can be regarded as the "folded" state.

[0099] In some embodiments, a second estimate of the pose is then used as the pose (e.g., as shown in the image). Figure 8 The first estimate (indicated by arrow 540) is used for subsequent attitude estimation (e.g., to continuously estimate the attitude of the structure during the implantation process). For example, method 500 may include generating a second set of possible attitudes of the structure in a third time period after the second time period, the second set being generated using a probabilistic model, and selecting a third estimate of the attitude from the second set of possible attitudes (e.g., by comparing a third set of measurements indicating the attitude in the third time period with expected measurements of possible attitudes corresponding to the second set, and selecting a possible attitude as the third estimate of the attitude).

[0100] In some embodiments, pose estimates generated from measurement sets produced during and / or retraction of the structure from the body portion are used to facilitate implantation and / or retraction. This can be achieved by... Figure 3System 300 uses attitude estimation to generate at least one status report signal (e.g., information 342 about the estimated attitude, symmetrical changes in attitude, and / or asymmetrical changes in attitude). In some embodiments, during the insertion and / or retraction of the structure into and / or from the body part, the state of the structure (e.g., attitude; attitude change) is transmitted to the operator of the insertion system (e.g., a manual insertion system; an automated or robotic insertion system) (e.g., a medical professional; a surgeon), enabling the operator to take appropriate action (e.g., continue implantation; take corrective actions to avoid suboptimal attitude). For example, at least one status report signal may be configured to be received by a status communication device (e.g., a display device; a screen; a status indicator; an audio device; a speaker; a vibration motor) operating in communication with at least one output interface 340, the status communication device being configured to respond to at least one status report signal by transmitting a status signal (e.g., an alarm; a warning; a message; information about attitude and / or attitude change) indicating the state of the structure (e.g., attitude; attitude change) to the operator of system 300. In some embodiments, at least one status reporting signal is configured to be inserted by an automated insertion system (e.g., with...). Figure 3 The system 300 receives at least one output interface 340 of the automated or robotic insertion system (which is configured to respond automatically and in real time to at least one status report signal via a manipulation structure, such as continuing implantation or taking corrective actions to avoid suboptimal posture). In some such embodiments, the at least one status report signal includes at least one manipulation control signal.

[0101] Figure 10 This is a flowchart of an exemplary method 600 according to certain embodiments described herein. In operation block 610, method 600 includes accessing information representing the state of a structure at least partially inserted into a body part of a recipient and information about the transitions between states. In some embodiments, accessing a range of desired measurements or values ​​includes calculating the range of desired measurements or values ​​using a parameterized model of the structure and / or body part (e.g., a parameterized probabilistic model or a regularized model).

[0102] Figures 7A-7C Examples of states and transitions between states are shown for the structure of the electrode array 146 of the cochlear implant system 100 and the body portion of the cochlea 140 including the recipient. Figures 7A-7CAs shown, the states of array 146 include at least the following: (i) a folded state, wherein the end portion of array 146 within cochlea 140 is folded; and (ii) an unfolded (e.g., proximal to the cochlear axis) state, wherein the end portion 250 of array 146 within cochlea 140 is not folded (e.g., not bent). In some embodiments, the states of array 146 also include a “bent” state (e.g., between the “folded” and “unfolded” states, wherein the end portion 250 of array 146 within cochlea 140 is bent (e.g., beyond a predetermined amount)).

[0103] In operation block 620, method 600 further includes accessing a range of desired measurements or values ​​expected to be generated by at least one sensor of the structure. For example, the at least one sensor may include at least one electrode 148 of electrode array 146 that responds to a state (e.g., orientation) of array 146, and the range of desired measurements or values ​​may correspond to measurements expected to be generated when electrode array 146 is in each state (e.g., ...). Figures 7A to 7C As shown). Figure 9 As illustrated schematically, the desired measurements may include those expected to be generated by at least one electrode 148 when array 146 is in each state.

[0104] In operation block 630, method 600 further includes obtaining at least one first measurement value from at least one sensor during a corresponding time period. The at least one first measurement value may be selected from: transresistance measurement (e.g., transresistance gradient measurement); voltage measurement; impedance measurement; four-point impedance measurement; electrocochleography measurement; electrically evoked compound action potential (ECAP) measurement.

[0105] In operation block 640, method 600 further includes determining a first state of the structure during a first time period in response to a comparison of at least one first measurement with a desired measurement or a range of values. For example, refer to Figure 9 At least one first measurement (represented by a white cross labeled "new observation") can be compared with a desired measurement (represented by a black circle). The state corresponding to the desired measurement that most closely matches at least one first measurement can be considered as the state of the structure during that time period.

[0106] In some embodiments, method 600 further includes adjusting a desired measurement value or range of values ​​in response to at least one first measurement value. For example, if a desired measurement (e.g., four-point impedance) provides a first desired value of 4 in the unfolded state and a second desired value of 1 in the folded state, and the first measurement value is 3, then array 146 is considered to be in the unfolded state, and the desired measurement values ​​in the unfolded and folded states can be adjusted to lower values ​​(e.g., 3.6 and 0.9 respectively) based on predefined logic, such that the desired measurement values ​​more closely reflect the actual measurement values ​​generated by electrode 148. In this way, some embodiments can be used to estimate and correct deviations in the measurement values ​​provided by electrode 148.

[0107] In some embodiments, method 600 can be used to monitor the state (e.g., posture) in real time during the implantation procedure. For example, method 600 may further include obtaining at least one second measurement from the at least one sensor during a second time period following a first time period, and determining a second state of the structure during the second time period in response to a comparison of the at least one second measurement with a desired measurement or a range of values. Measurements can be obtained continuously from the at least one sensor during the implantation procedure, at predetermined intervals, and / or in response to an operator's request, and comparisons with desired measurement values ​​or a range of values ​​can be performed at a sufficient speed to provide real-time feedback to the operator.

[0108] It should be understood that the embodiments disclosed herein are not mutually exclusive and can be combined with each other in various arrangements. Furthermore, although the disclosed methods and apparatus are largely described in the context of conventional cochlear implants, the various embodiments described herein can be incorporated into a variety of other suitable devices, methods, and environments, including but not limited to fully implantable cochlear implants (“TICI”) and / or substantially implantable cochlear implants (“MICI”). For example, a TICI may utilize a battery and a microphone, both implanted in the body of a recipient (e.g., as part of an overall system or as a collection of interconnected modules), capable of operation at least for a period of time without external devices and without any percutaneous signal transmission. As another example, a MICI may utilize a battery implanted within the recipient's body, with all or some sound processing performed by the implant, and a small (or very small) external processor may include a microphone and the ability to wirelessly transmit information to the implant via RF signals (as in current cochlear implant systems) or any other wireless data and / or audio transmission scheme.

[0109] More generally, as you will understand, while certain embodiments are described herein with reference to illustrative medical devices, namely cochlear implant systems, certain other embodiments may be applicable to a variety of other situations. For example, some embodiments described herein may be used with other implantable medical devices that can benefit from improved device positioning while providing a wide range of therapeutic benefits to recipients, patients, or other users. For example, the systems and methods described herein may be used in other hearing prostheses, vision prostheses, sensors, stents and / or electrode stents inserted into arteries, pacemaker leads inserted into the chambers of the heart, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, or other monitoring situations to provide real-time feedback on unseen cavities in procedures involving surgical interventions involving elongated structures. Other non-medical contexts may include, but are not limited to: underwater or other harsh conditions (e.g., via automated or robotic systems), and drilling in exploration excavation (e.g., to map mineral deposits).

[0110] The invention described and claimed herein is not limited in scope to the specific exemplary embodiments disclosed herein, because these embodiments are intended to be illustrative rather than limiting several aspects of the invention. Any equivalent embodiments are intended to be within the scope of the invention. In fact, various modifications in form and detail of the invention will become apparent to those skilled in the art based on the foregoing description, in addition to those shown and described herein. These modifications are also intended to fall within the scope of the claims. The breadth and scope of the invention should not be limited to any of the exemplary embodiments disclosed herein, but should be defined only by the claims and their equivalents.

Claims

1. A system for estimating the attitude of a structure, comprising: At least one processor is configured to: Receive first information about the posture of the structure, which is configured to be inserted into a body part of a receiver, during a first time period. The first information includes at least one of the following: The first estimate of the structure's attitude during the first time period; and A first measurement set, comprising one or more first measurement values, at least some of which are generated using a plurality of sensors distributed along the structure, the one or more first measurement values ​​indicating the orientation of the structure during the first time period; as well as A second estimate of the structure's pose is generated using at least the first information and a probabilistic model that parametrically describes the structure's pose relative to the body part.

2. The system according to claim 1, wherein, The first information includes a first estimate of the structure's pose and a first set of measurements, and the second estimate of generating the structure's pose includes updating the first estimate of the pose in response to the first set of measurements.

3. The system according to claim 1 or claim 2, wherein, The second estimate for generating the pose includes: Generate a first set of possible poses for the structure, the first set being generated using the probabilistic model; and The second estimate of the pose is selected from the first set of possible poses.

4. The system according to claim 3, wherein, The first set of possible poses further includes generating expected measurements corresponding to the possible poses of the first set, and the at least one processor is further configured to: Receive a second set of measurements including one or more second measurements, at least some of which are generated using the plurality of sensors, the one or more second measurements indicating the orientation of the structure during a second time period; as well as The second set of measurements is compared with the desired measurements of possible poses corresponding to the first set.

5. The system according to claim 4, wherein, The second time period is after the first time period.

6. The system according to any one of claims 4 to 5, wherein the at least one processor is further configured to: During the third time period, a second set of possible poses of the structure is generated, the second set being generated using the probability model; and A third estimate of the pose is selected from the second set of possible poses.

7. The system according to claim 6, wherein, The third time period is after the second time period.

8. The system according to any one of claims 1, 2, 4 and 5, wherein, The structure includes an electrode array for a cochlear implantation system, the plurality of sensors include the electrode array, and the body portion includes the recipient's cochlea.

9. The system according to any one of claims 1, 2, 4, and 5, further comprising generating at least one status reporting signal at least in response to the second estimation and during the insertion of the structure into the body portion and / or the retraction of the structure from the body portion, the at least one status reporting signal being configured to be received by at least one of the following: A status communication device configured to respond to the at least one status report signal, the status signal indicating the state of the structure, by transmitting a status signal to a user of the status communication device; and An automatic actuator configured to respond to the at least one status report signal by manipulating the structure.

10. The system according to any one of claims 1, 2, 4 and 5, further comprising transmitting information about the second estimate to an operator of an insertion system for inserting the structure into the body portion and / or retracting the structure from the body portion.

11. A system for estimating the state of a structure, comprising: At least one processor is configured to: Access information representing the state of the structure, at least partially inserted into the body parts of the recipient, and the transitions between states; Access to a range of expected measurements or values ​​generated by at least one sensor of the structure, wherein the range of expected measurements or values ​​is calculated using a probabilistic model of a parameterized description of the structure relative to the body part; At least one first measurement value is obtained from the at least one sensor during a first time period; as well as In response to a comparison of the at least one first measurement value with the desired measurement value or a range of values, a first state of the structure is determined during the first time period.

12. The system according to claim 11, wherein, The at least one sensor responds to the state of the structure.

13. The system according to any one of claims 11 and 12, wherein, The structure includes an electrode array for a cochlear implantation system, the at least one sensor includes at least one electrode of the electrode array, and the body portion includes the recipient's cochlea.

14. The system according to claim 13, wherein, The state of the structure includes at least the following: In a folded state, the end portion of the structure within the cochlea is folded; and In the unfolded state, the end portion of the structure within the cochlea does not fold.

15. The system according to claim 14, wherein, The structure also includes a bent state in which the end portion of the structure within the cochlea bends beyond a predetermined amount.

16. The system according to any one of claims 14 and 15, wherein, The at least one first measurement value is selected from: transimpedance measurement; electrocochleography measurement; voltage measurement; impedance measurement; four-point impedance measurement; electrically evoked compound action potential (ECAP) measurement.

17. The system according to any one of claims 11, 12, 14 and 15, wherein the at least one processor is further configured to: adjust the desired measurement value or range of values ​​in response to the at least one first measurement value.

18. The system according to any one of claims 11, 12, 14, and 15, wherein the at least one processor is further configured to: At least one second measurement value is obtained from the at least one sensor during a second time period following the first time period; and In response to a comparison of the at least one second measurement with the desired measurement or a range of values, a second state of the structure is determined during the second time period.

19. A system for estimating the orientation of a medical device, comprising: At least one data input interface, the at least one data input interface being configured to receive data from a plurality of transducers during the implantation of the medical device on or in a recipient’s body part; At least one controller, the at least one controller being operatively communicated with the at least one data input interface, the at least one controller being configured to access a probabilistic model of a parameterized description of the posture of the medical device relative to the body part, and at least in part in response to the data and the probabilistic model generating a current estimated posture of the medical device, wherein generating the estimated posture includes calculating a probability distribution of various possible postures using a parameterized description of the structure relative to the body part, and using the probability distribution to derive the estimated posture; as well as At least one output interface, which communicates with the at least one controller, and is configured to provide information about the estimated attitude of the medical device.

20. The system of claim 19, further comprising at least one control output interface, the at least one control output interface being operatively communicated with the at least one controller, the at least one control output interface being configured to transmit control signals to the plurality of transducers, the plurality of transducers responding to the control signals by generating data.

21. The system according to claim 19 or claim 20, wherein, The at least one controller includes at least one processor and at least one storage device, the at least one storage device being operationally communicative with the at least one processor.

22. The system according to claim 21, wherein, The at least one storage device is configured to collect and store the data.

23. The system according to any one of claims 19, 20, and 22, wherein, The medical device includes a stimulation component for a cochlear implant auditory prosthesis, and the body portion includes the recipient's cochlea.

24. The system according to any one of claims 19, 20, and 22, wherein, The medical device includes at least some of the plurality of transducers.

25. The system according to any one of claims 19, 20, and 22, wherein, The at least one controller is configured to automatically transmit the control signal to the plurality of transducers during implantation of the medical device.

26. The system of any one of claims 19, 20, and 22, further comprising at least one user input interface operably communicating with the at least one controller, the at least one controller being configured to intermittently receive a trigger signal from the at least one user input interface during implantation of the medical device, wherein the at least one controller is configured to respond to the trigger signal by transmitting the control signal to the plurality of transducers.

27. The system according to any one of claims 19, 20, and 22, wherein, The at least one output interface is configured to communicate with at least one status communication device, which is configured to respond to the information by transmitting a status signal indicating the attitude of the medical device.

28. The system according to claim 26, wherein, The at least one user input interface and the at least one output interface are configured to communicate with a computing device configured for use by medical personnel.

29. The system according to any one of claims 19, 20, 22 and 28, wherein, The at least one output interface is configured to communicate with an automated insertion system, which is configured to respond automatically and in real time to the information by manipulating the medical device.

30. A non-transitory computer-readable storage medium having a computer program thereon, the computer program instructing a computer system to provide real-time information about the structure by at least the following: Information about the structure is received when the structure is inserted into the region and / or retracted from the region; Access the parameterized description of the structure relative to the region; as well as At least one processor is used to generate an estimated pose of the structure relative to the region based on the information and the parameterized description; The generation of the estimated pose includes calculating the probability distribution of various possible poses using the parameterized description of the structure relative to the region, and using the probability distribution to derive the estimated pose.

31. The non-transitory computer-readable storage medium according to claim 30, wherein, The structure includes multiple sensors, and the information is generated by the multiple sensors.

32. The non-transitory computer-readable storage medium according to claim 31, wherein, The structure includes a stimulation component of a cochlear implantation system, the plurality of sensors include an electrode array of the stimulation component, and the region includes the cochlea of ​​the recipient.

33. The non-transitory computer-readable storage medium according to claim 32, wherein, It is also configured to instruct the computer system to generate a state signal indicating an estimated posture to the medical personnel and the at least one of the automated insertion system when the stimulation component is inserted into and / or retracted from the cochlea by at least one of the medical personnel and the automated insertion system.

34. The non-transitory computer-readable storage medium according to claim 33, wherein, The status signal includes at least one of the following: alarm; warning; message; information about the estimated attitude.

35. The non-transitory computer-readable storage medium according to claim 30, wherein, The estimated attitude corresponds to at least one of the following: the mean of the probability distribution, the median of the probability distribution, the pattern of the probability distribution, the center of mass of the probability distribution, the standard deviation of the probability distribution, and the interquartile range of the probability distribution.

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