Interface and manipulation concepts related to robotic insertion of perimodiolar electrode arrays

Abstract

The disclosure relates to systems, devices, and methods for robotically assisted implantation of an elongate implant, such as a perimodiolar electrode array for cochlear implants. The system includes an actuator assembly with independently movable sheath and electrode actuators housed within an actuator housing. The actuators engage the sheath and electrode of the implant, respectively, and are driven by a remote drive unit via flexible drive cables. The drive unit provides precise linear movement to the actuators, enabling accurate and controlled implantation. The system can be positioned relative to a patient using an adjustable arm, and sensors monitor the position of the sheath and electrode during implantation. The method includes steps for engaging and manipulating the sheath and electrode independently to implant the elongate implant into a target site within the patient, enhancing surgical precision and reducing the risk of trauma to delicate structures.

Description

INTERFACE AND MANIPULATION CONCEPTS RELATED TO ROBOTIC INSERTION OF PERIMODIOLAR ELECTRODE ARRAYSCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority to U.S. Provisional Application Serial No. 63 / 612,802, filed December 20, 2023, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] This document relates generally to medical systems and more particularly to systems, devices, and methods for robotic control of an electrode assembly during implantation of a perimodiolar cochlear electrode array (“electrode”).BACKGROUND

[0003] The cochlea is the auditory portion of the inner ear. It comprises a spiraled, hollow, conical chamber of bone in which sound waves propagate from the base to the apex of the cochlea. The sound waves vibrate the perilymph that moves hair cells in the organ of Corti, converting the vibrations to electrical signals that are sent to the cochlear nerve. The hair cells and nerves in the basal or outer region of the spiraled cochlea are more sensitive to higher frequencies of sound and are frequently the first part of the cochlea to lose sensitivity. The apical or inner region of the spiraled cochlea is more sensitive to lower frequencies.

[0004] Moderate to profound hearing loss affects a large amount of people worldwide and may have a significant impact on a patient's physical and mental health, education, employment, and overall quality of life. Hearing loss may be caused by partial damage to the cochlea. Many patients with various degrees of hearing loss have partial damage to the cochlea in the high-frequency regions (basal cochlea) from common causes such as noise exposure, drugs, genetic mutations, or aging, but may retain adequate low-frequency hearing.

[0005] Cochlear implants have been used to treat patients with hearing loss. A cochlear implant is a medical device that comprises an external soundprocessor, a subcutaneously implantable stimulator, and an electrode assembly sized and shaped for cochlear insertion. The sound processor can convert sound signals into electrical signals and transmit the electrical signals to the implantable stimulator. Based on the physical properties (e.g., frequencies) of the received electrical signals, the stimulator can generate electrical impulses to stimulate specific regions in the cochlea via an array of electrode contacts on the electrode assembly surgically inserted into the cochlea. The region for stimulation may be determined based on the frequencies of the received electrical signals. For example, higher frequencies may result in stimulation at the outer or basal cochlear region, and lower frequencies may result in stimulation at the inner or apical cochlear region.

[0006] For patients who have lost high-frequency hearing and consequently have significant difficulty with word understanding but who have substantial residual, low-frequency hearing function in apical cochlea, a short electrode assembly may be indicated to electrically stimulate the basal or outer cochlea to restore high-frequency hearing. A cochlear implant surgery may be performed by a surgeon to manually insert the electrode assembly into the damaged portion of a patient cochlea (e.g., basal cochlea), while avoiding or minimizing any trauma to the undamaged cochlear regions to preserve the low-frequency hearing function. The cochlear implant may be used together with a hearing aid that acoustically stimulates the undamaged low-frequency sensitive apical cochlea.

[0007] The electrode placement in cochlear implant surgery is a crucial step that plays a significant role in the success of the procedure. The following outlines a few key aspects of electrode placement, such as insertion technique, insertion depth, number of electrode contacts, preservation of residual hearing, intraoperative testing, and imaging and surgical guidance. The surgeon carefully inserts the electrode array into the cochlea, which is the part of the inner ear responsible for converting sound into electrical signals that can be transmitted to the brain. The array is designed to be gently threaded through the cochlea to ensure that the electrode contacts come into close contact with the auditory nerve fibers. The depth to which the electrode array is inserted into the cochlea is an essential consideration. The surgeon aims to achieve a balance between maximizing the coverage of the cochlea and avoiding damage to delicate structures. The exactinsertion depth depends on factors such as the individual's anatomy, the size and shape of their cochlea, and the surgeon's expertise. The electrode assembly may also include markers on it proximal to the electrode array to help guide the surgeon insert to a particular depth. Cochlear implant electrode arrays consist of multiple electrode contacts that are designed to stimulate different regions of the cochlea. The number of contacts can vary depending on the specific device being used. The goal is to place a sufficient number of electrode contacts to cover the frequency range of speech and other important sounds. In some cases, individuals undergoing cochlear implant surgery may have some residual hearing in low-frequency regions of the cochlea. Whenever possible, the surgeon may try to preserve this residual hearing by avoiding damage to those areas during electrode insertion. This can be achieved through techniques such as electrode arrays with thin, flexible designs or by using specialized surgical approaches. During the surgery, intraoperative testing is often performed to assess the neural responses to electrical stimulation. These tests help the surgical team determine the optimal placement and functioning of the electrode array. Intraoperative testing may involve measures such as impedance testing, electrically evoked auditory brainstem response (EABR), or neural response telemetry (NRT). In recent years, advances in imaging techniques and surgical navigation technology have improved the accuracy of electrode placement. Preoperative imaging, such as high-resolution computed tomography (CT) scans or magnetic resonance imaging (MRI), can provide detailed information about the patient's cochlear anatomy. Surgical navigation systems may assist the surgeon in precisely positioning the electrode array based on this preoperative imaging. Ultimately, the goal of electrode placement in cochlear implant surgery is to achieve optimal contact between the electrode contacts and the auditory nerve fibers, ensuring effective electrical stimulation and subsequent transmission of sound signals to the brain. The expertise and experience of the surgical team, along with technological advancements, contribute to improving the accuracy and outcomes of electrode placement.

[0008] As noted above, one potential complication during electrode insertion is intracochlear trauma. Intracochlear trauma can occur from large pressure spikes generated during the insertion of cochlear implant electrodes. Cochlear implant surgery can also involve insertion of a guide sheath or tube nearor partially into the cochlea. Insertion of any solid or flexible bodies, tubes, or sheaths into the cochlea could elicit similar fluid and force spikes. These pressures spikes may be of sufficient intensity to cause trauma similar to that of an acoustic blast injury and are one likely source for postoperative loss of residual hearing. Similar to the insertion trauma caused by electrode insertion, the manual insertion of a sheath or other solid body / tube manually into the cochlea may cause intracochlear fluid pressure spikes and result in intracochlear damage.SUMMARY

[0009] A hearing-preservation cochlear implant surgery involves implanting an electrode assembly (commonly referred to simply as an electrode) into the damaged cochlear region, while avoiding any trauma to the undamaged cochlear region to preserve any normal residual hearing. In current cochlear implant surgery, a surgeon manually inserts the electrode into a patient’s cochlea. However, a complete manual maneuvering of the electrode may cause undesirable outcome in some patients. For example, manual insertion of electrode may lack precision in implant position and motion control, such as the control of insertion rate, distance, depth, or forces applied to the implant for advancing the electrode to the target cochlear region. This may cause damage to fragile cochlear structures such as local trauma to cochlea wall and hair cells and result in residual hearing loss.

[0010] Complete manual maneuvering of the electrode may also be subject to high inter-operator variability among surgeons. The inter-operator variability is demonstrated in dramatic differences in patient outcomes between institutions and surgeons of differing skill levels. Some patients undergoing hearing-preservation cochlear implant surgery may experience additional hearing decline weeks to years after surgery. Such a continual decline in hearing function may be attributed to an inflammatory response to the trauma inflicted during an initial cochlear implant surgery. Some clinical studies show that techniques aimed at reducing electrodeinsertion forces during surgery have improved patient hearing preservation outcomes. For at least these reasons, the present inventors have recognized that there remains a need to improve patient outcome following a hearing-preservation cochlear implant surgery, particularly systems, apparatus, and methods thatenhance surgical precision in implant delivery and positioning as well as reducing the risk of perioperative trauma to undamaged cochlea region.

[0011] This document discusses, among other things, systems, devices, and methods for robotically assisted implantation of an implant in a patient, such as for delivering and positioning a cochlear implant (e.g., electrode) for treating hearing loss in a hearing-preservation cochlear implant surgery. The systems and devices discussed are specifically designed and adapted for robotically controlling insertion of a perimodiolar electrode array. The modular system discussed herein includes an external positioning unit reversibly interfacing with and securely engaging an implant such as a cochlear implant having an elongate member, and a computerized control unit for robotically controlling the external positioning unit to regulate the motion of the implant. The computerized control unit may have a user interface that enables a user (e.g., a surgeon) to program various motion control parameters or to select an implantation protocol. The system may include sensors providing feedback on the position or the motion of the implant, or the force or friction applied to the implant during the implantation procedure. The sensors can include navigation markers to enable optical or electromagnetic navigation of the electrode and / or sheath. The computerized control unit may regulate the motion of the implant based on user input and sensor feedback. The control systems may also interface with external systems providing electrophysiological measurements to enable closed loop feedback on electrode positioning in real-time during implantation.

[0012] The systems, devices, and methods discussed in this document may improve the technological field of robotic surgery, particularly robotically assisted implantation of an implant or prosthesis. For example, when the systems or methods discussed herein are used in hearing-preservation cochlear implant surgery, the robotic motion control of the insertion or manipulation cochlear implant (specifically a perimodiolar electrode array) may reduce the mechanical forces imposed on the delicate cochlear structure such as basilar membrane and organ of Corti, thereby minimizing the risk of trauma on the undamaged structure such as at the apical cochlea. This may ultimately better preserve patient residual natural hearing. Compared to manual insertion and steering of a cochlear implant,the robotically assisted cochlear implantation may allow more people with disabling hearing loss to hear better over their lifetimes.

[0013] The devices and systems discussed herein provide a comprehensive solution to the problems identified in the prior art by introducing a robotically assisted system for the precise and controlled insertion of perimodiolar electrode arrays during cochlear implant surgeries. Aspects of the solution include the following components.

[0014] Actuator Assembly: In an example, an actuator assembly can include a sheath actuator and an electrode actuator, both optionally housed within an actuator housing. These actuators are designed to move independently, allowing for precise manipulation of both the sheath and the electrode. The actuators in the actuator assembly can be robotically controlled. The independent movement of the sheath and electrode actuators ensures that each component can be positioned and advanced with high precision, reducing the risk of trauma to delicate cochlear structures and improving the accuracy of implant placement.

[0015] Drive Unit: In certain examples, the actuators can be driven by a drive unit via flexible drive cables. The drive unit provides linear movement to the actuators, enabling controlled and precise insertion of the electrode array. The use of flexible drive cables allows the drive unit to be positioned away from the surgical site, reducing the system's footprint and providing greater freedom of movement. This setup also isolates the delicate surgical area from potential mechanical vibrations and movements of the drive unit. Additionally, in certain examples, the drive unit can allow for easier reusability of expensive components of the system and delivery of patient interfacing components in a single-use configuration.

[0016] The drive unit can be designed as a modular system with a base unit and a removable cartridge. The cartridge includes control wires that extend to the sheath and electrode actuators. The modular design allows for easy replacement and sterilization of the cartridge, improving the system's usability and maintenance. The magnetic coupling between the base unit and the drive bearings in the cartridge ensures reliable and precise transmission of movement to the actuators.

[0017] Adjustable Arm for Positioning: The actuator assembly can be mounted on an adjustable arm, which can be positioned relative to the patient. This arm allows for precise alignment and stabilization of the actuator assembly during the surgical procedure. The adjustable arm provides a stable and adjustable platform for the actuator assembly, ensuring that the implant can be inserted along the desired trajectory with minimal deviation. This stability is advantageous for achieving optimal electrode positioning and minimizing the risk of intracochlear trauma. This arm may be mounted rigidly to the patient using screws or clamps or may be mounted on a frame to which the patient is expected to be stable, such as the rail-mount on an operative table or on a heavy base adjacent to the operating table.

[0018] By automating the insertion process and providing precise control over the movement of the sheath and electrode, the system can significantly reduce inter-operator variability and enhances the overall precision of the procedure. The robotic assistance ensures consistent and repeatable outcomes, regardless of the surgeon's skill level. This consistency is crucial for improving patient outcomes and preserving residual hearing.

[0019] In summary, the invention addresses the deficiencies in the prior art by providing a robotically assisted system that enhances the precision, control, and safety of cochlear implant surgeries. The functional interrelationships between the independently movable actuators, flexible drive cables, adjustable arm, sensors, and modular drive unit create a cohesive and innovative solution that significantly improves the accuracy and outcomes of the implantation process.

[0020] Although the discussion in this document focuses on a perimodiolar electrode array implant, this is meant only by way of example and not limitation. It is within the contemplation of the present inventors, and within the scope of this document, that the systems, devices, and methods discussed herein may be configured for robotically delivering, steering, positioning, or extracting various types of implants or prosthesis. By way of non-limiting examples, the implants may include leads, catheter, guidewire, or other mechanical or electrical devices. In particular, perimodiolar cochlear implants may come equipped with, or be designed to be later equipped with a stiffener accessory, such as a stylet or holly sheath, in order to help enable insertion. The implants may be designed fortemporary or permanent implantation. The implants may be used for medical diagnosis of a disease or other conditions such as diagnostic catheters, or for therapeutic purposes of cure, mitigation, treatment, or prevention of disease, such as implantable electrodes for stimulating cardiac, neural, muscular, or other tissues. In addition to new implantation, the systems, devices, and methods discussed herein may also be used to surgically reposition or replace an existing implant.

[0021] This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. The detailed description is included to provide further information about the present patent application. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIGS. 1A-1D are various views illustrating an electrode assembly in accordance with at least one example of the disclosure.

[0023] FIGS. 2A-2B are various views illustrating a robotic implant manipulation platform in accordance with at least one example of the disclosure.

[0024] FIG. 3 is a sideview illustration of a robotic implant manipulation platform in accordance with at least one example of the disclosure.

[0025] FIGS. 4A-4C illustrate various views of an adjustable actuator assembly mount for use with a robotic implant manipulation platform in accordance with at least one example of the disclosure.

[0026] FIGS. 5A-5F illustrate various views of an actuator assembly for use with a robotic implant manipulation platform in accordance with at least one example of the disclosure.

[0027] FIGS. 6A-6N illustrate various views of an actuator assembly including sheath and electrode actuators for use within the robotic implant manipulation platforms discussed herein.

[0028] FIGS. 7A-7F illustrate various views of an alligator clip sheathelectrode interface assembly for use within the robotic implant manipulation platforms discussed herein.

[0029] FIGS. 8A-8F illustrate various views of an actuator assembly for use with a robotic implant manipulation platform in accordance with at least one example of the disclosure.

[0030] FIGS. 9A-9B illustrate various views of an electrode pusher assembly for use within the robotic implant manipulation platforms discussed herein.

[0031] FIGS. 10A-10F illustrate various views of a modular drive unit with a replaceable cartridge in accordance with at least one example of the present disclosure.

[0032] FIG. 11 is a flowchart illustrating a technique for detecting tip fold over in accordance with at least one example of the disclosure.

[0033] FIG. 12 is a flowchart illustrating a technique for detecting tip fold over in accordance with at least one example of the disclosure.

[0034] FIG. 13 is a block diagram of a computing device operable as part of a robotic implant manipulation platform and capable of performing the techniques discussed within the disclosure.DETAILED DESCRIPTION

[0035] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced.These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized, and that structural, logical, and electrical changes may be made without departing from the spirit and scope of the present invention. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description provides examples, and the scope of the present invention is defined by the appended claims and their legal equivalents.

[0036] Disclosed herein are systems, devices, and methods for robotically assisted implantation of an implant in a patient. More specifically, disclosed are various embodiments of a robotically assisted device for implantation of aperimodiolar electrode array (also referred to as a cochlear electrode or simply “electrode”) as well as various related interface devices and control techniques. One focus of the disclosure is various examples of actuator assemblies designed for robotic manipulation of perimodiolar electrode arrays. Examples of other types of implants that the discussed concept can interface with include leads, catheters, guidewires, guide sheaths, or other mechanical or electrical devices. The implants may be designed for temporary or permanent implantation. The implants may additionally be used for medical diagnosis of a disease or other conditions such as diagnostic catheters, or for therapeutic purposes of cure, mitigation, treatment, or prevention of disease, such as implantable electrodes for stimulating cardiac, neural, muscular, or other tissues. As noted above, the present inventions are discussed in view of manipulation of a cochlear electrode and associated delivery sheath. The present system may be implemented using a combination of hardware and software designed to provide precise control of implant movement, such as insertion of a cochlear implant during a hearing-preservation cochlear implant surgery.

[0037] An example system includes an implant-positioning unit, and a control console communicatively coupled to the implant-positioning unit. The implant-positioning unit includes a drive head containing one or more actuators configured to engage an elongate member of the implant and robotically deliver and position the implant into a target implantation site. The control console may have a user interface that enables a user to input motion control instructions. The control console may generate a motion control signal, according to a specific motion control instruction, to control the external positioning unit to propel the implant into a target implant site.

[0038] The concepts discussed below have been developed to enable and / or improve robotic implantation of a cochlear electrode, and more specifically a perimodiolar cochlear electrode. FIGS. 1A-1D are various views illustrating an electrode assembly in accordance with at least one example of the disclosure. The illustrated electrode assembly is a typical perimodiolar cochlear electrode. The figures and related discussion introduce the terminology used throughout the rest of the specification to discuss the cochlear electrode array (“electrode”) and related structures, such as the delivery sheath. While the concepts discussed herein arefocused on implantation of a cochlear electrode, the concepts are applicable to other similar implants.

[0039] FIG. 1A illustrates a perimodi olar cochlear electrode assembly 100 (also referred to herein as an electrode assembly 100) that includes a cochlear electrode 105 loaded into a sheath 110. For the purposes of this document, the cochlear electrode 105 is referred to as simply an electrode 105. The sheath 110 is a delivery mechanism to assist in positioning and inserting the electrode 105 into the patient’s cochlea. The electrode 105 and sheath 110 together are discussed as a perimodi olar electrode assembly 100 or simply “electrode assembly 100.” As illustrated below, the electrode 105 includes various components including an active portion 115 (see FIG. IB) containing an array of individual electrode contacts that is intended to be implanted within a patient’s cochlea. The active portion 115 is an elongated flexible member designed to hold the array of individual electrodes and connecting wires. The active portion 115 of the electrode 105 is adapted to conform to the spiral shape of the cochlea upon extension out of the sheath (as shown below in FIG. IB).

[0040] FIG. 1C illustrates just the perimodiolar cochlear electrode 105 (e.g., “ the electrode”) after it has been detached from the sheath 110. As noted above, the electrode includes an active portion 115 adapted for implantation into a patient’s cochlea. The active portion 115 is coupled to a central body portion 120 that transitions into a stimulator connection 125 that routes the electrical connections from the array of individual electrode contacts back to the stimulator / receiver electronics that control the electrode in use. The central body 120 includes an offset portion 130 that can operate as an electrode interface to enable manipulation while the electrode is within the sheath. The offset / interface portion 130 includes a radial protrusion that can take the form of a white ring in some examples of the electrode.

[0041] FIG. ID illustrates the sheath 110 portion of the perimodiolar cochlear electrode assembly 100 (electrode assembly). As illustrated, the sheath 110 can include a wing (tab) 140 to assist in gripping the sheath 110 with a forceps or a robotic manipulator during implantation of the electrode. The sheath 110 also includes a cap 145 on the proximal end and a stopper 150 in the shape of a white ring near the distal end to visualize the location of the sheath 110 relative to theelectrode 105 and to create an interference fit when advancing the sheath 110 into the cochlea. In practice, the stopper 150 of the sheath 110 prevents the sheath 110 from advancing into the patient’s cochlea during implantation. The cap 145 is typically used to protect the proximal end of the sheath 110, as discussed below some of the embodiments discussed remove the cap 145 to access the proximal end of lumen running the length of the sheath 110. The electrode assembly 100 starts with the electrode 105 disposed within the lumen of the sheath 110.

[0042] The devices and systems discussed below include various embodiments of a robotically assisted implantation system optimized for use with perimodiolar electrode assembly (e.g., electrode and sheath). The designs discussed herein include innovations related to the systems, devices, and techniques discussed in co-pending U.S. Patent Application Serial Number 18 / 336,448, titled “SYSTEMS AND METHODS FOR MANIPULATION OF PERIMODIOLAR ELECTRODE ARRAYS”, the contents of which are hereby incorporated by reference in their entirety. This patent application may be referenced herein as “the ‘448 application.”

[0043] FIGS. 2A-2B are illustrations of a robotic implant manipulation platform 200 that includes a separable motor unit 210 and an articulating arm 220 coupling to an adjustable actuator assembly mount 400 (also referred to herein as an assembly mount 400) to enable initial positioning of the actuator assembly 500 for driving implantation of the electrode assembly 100.

[0044] In this example, the robotic implant manipulation system 200 includes a motor housing 210, an articulating arm 220, and an assembly mount 400 to interface with the actuator assembly 500 for manipulation of the electrode assembly 100. The motor housing 210 can include push-pull actuators or similar mechanisms (e.g., linear actuators) to affect linear movement of the sheath and electrode actuators discussed below. In at least some of the examples, the motor housing 210 is coupled to the actuator assembly 500 by flexible drive cables (not illustrated). The flexible drive cables can be nitinol wires encased in a flexible housing for example. A more detailed example of a motor housing 210 is discussed below in reference to FIGS. 10A-10F.

[0045] In this example, the articulating arm 220 is formed from a plurality of segments that fit together with one another and incorporate a tensioning cablerunning through their center. When the cable is loose, the arm can be manipulated in any direction or orientation by the user. When the cable is pulled in tension, the arm becomes rigid and remains in the desired shape. In this example, tensioning knob 250A is illustrated as the mechanisms to tension the articulating arm 220. The tensioning knob 250A extends from the motor housing 210 to enable locking of the articulating arm. In this example, the arm locking mechanism includes an elongate shaft 255 that can be pushed through the plurality of segments to lock the arm in a straight position. Various additional designs of articulating arms are discussed in co-pending PCT Application Serial Number PCT / US2024 / 061470, titled “ ADJUSTABLE HOLDER FOR IMPLANT INSERTION TOOL ARM”, filed December 20, 2024, the contents of which is hereby incorporated by reference in its entirety.

[0046] One feature of the articulating arm 220, which connects to the assembly mount 400 and can be manipulated to achieve multiple trajectories, is the stiffness can be set by the user. This allows the user more freedom while manipulating the arm (while it is loose) with the option to make the assembly rigid (stiff or tight) when the desired trajectory is achieved. The user may also choose a variable stiffness based on their preference throughout the procedure. An example embodiment of this approach is shown in FIGS. 2A-2B there is a tensioning knob 250A extending from the motor unit 210. This design makes use of the cable running through the arm segments connected at the distal most end adjacent the assembly mount 400 and terminated on a proximal end within the knob 250A. As the knob 250A is turned, the effective length of the cable becomes shorter, and the segments of the arm are pulled together, making the connections tight. Cable tensioning can also be achieved with a spring-loaded button. When the button is pressed, and held in place, the cable will be loose, and the arm can be easily manipulated. When the button is released, the spring biases the position of the button, pulling the cable tight. In this scenario, the default position of the button, and therefore the arm, is in a locked position. Other tensioning mechanisms can include structures such as a cam lock or other mechanical structures capable of shortening a cable. Tensioning knob 250B, in FIG. 3, can operate in a similar manner.

[0047] FIG. 3 is a sideview illustration of a robotic implant manipulation system 300 in accordance with at least one example of the disclosure. In this example, the system 300 includes drive unit 310, manipulator base 320, articulating arm 220, assembly mount 400, and actuator assembly 500. In this example, the drive unit 310 is coupled to the actuator assembly 500 via flexible drive cable 305. In an example, the flexible drive cable 305 can include two (or more) drive wires coupled to linear actuators within the drive unit 310. The linear actuators can push or pull each drive wire to activate individual actuators within the actuator assembly 500 as discussed below.

[0048] The drive unit 310 , in this example, is separable from the manipulator base 320 and can be located at a distance from the patient’s head where the manipulator base 320 can be mounted. In this case, the manipulator base 230 remains mounted to the skull in the same manner as earlier entire systems, but control of the implant is accomplished by translating movement with the flexible drive cable 305 routed through the assembly mount 400 and interfacing with the actuator assembly 500 that moves the implant (e.g., electrode assembly 100). The flexible drive cable can therefore span from the interface to the implant, back to the drive unit 310 that can be resting on the patient’s torso or mounted to the side of the bed. This flexible drive cable can provide a push-pull motion, to linearly drive the actuator directly in a linear direction. This flexible drive cable could alternatively be driven rotationally by a rotary motor, as to import rotation to a lead screw or other similar component to transform the rotary cable motion to the actuators. A remote motor assembly configuration is illustrated in FIG. 3 as well as in FIGS. 10A-10F. An alternative embodiment of the motor assembly may further separate the motors from components that drive cables or other force transmitting elements, with the intention of separating sterile from nonsterile components by a thin sterile drape or bag. Separating components in this manner can also separate reusable components, such as the motor assembly, from disposable components, such as the sheath holder.

[0049] The designs discussed above provide benefits including an increased freedom of movement and range of motion of the actuator assembly. Further benefits are that the motor control can be accomplished separate from the actuator assembly, and that it can be at a distance. Mounting to the patient (bonemounted) can reduce the system footprint and directly couples the device to the patient.

[0050] FIGS. 4A-4C illustrate various views of an adjustable actuator assembly mount 400 for use with a robotic implant manipulation platform in accordance with at least one example of the disclosure. The adjustable assembly mount 400 includes an actuator assembly housing 430 with a male dovetail slide 420 captured within a mount arm 410 with a corresponding female dovetail interface 414. The vertical adjustment provided by the female dovetail interface 414 sliding over the dovetail extension 420 can be locked in place with the threaded screw and knob locking mechanism (e.g., lock screw 440). Other mechanisms for retaining or releasing friction from the dovetail, such as a spring- loaded pin, could replace the lock screw 440 to provide a different mode of interaction to lock or unlock the slide along the dovetail slide 420. The adjustable assembly mount 400 allows for vertical movement along the dovetail slide 420 as well as rotation about the end of the arm (e.g., adjustable arm interface 412) independent of the joints of the positioning arm (articulating arm 220), and whether or not the arm is locked Adjusting this vertical motion with the arm locked may prove preferable for a manual “advancement” of the distal tip of the electrode assembly if the preferred trajectory of the arm is otherwise set.

[0051] FIGS. 5A-5F illustrate various views of an actuator assembly 500 for use with a robotic implant manipulation platform in accordance with at least one example of the disclosure. FIGS. 5A-5B illustrate an optional assembly mount 540 adapted to assist in positioning an electrode actuator 505 and a sheath actuator 510. FIG. 5 A illustrates how the assembly mount 540 can integrate with an articulating arm via mounter interface 544. FIG. 5B illustrates the sheath actuator 510 and electrode actuator 505 in different positions during operation. FIGS. 5C- 5F illustrate the sheath actuator 510 and the electrode actuator 505 subassemblies and how they interface with the sheath 110 and electrode 105. The sheath actuator 510 and the electrode actuator 505 are the key components of the actuator assembly 500, as the assembly mount 540 is optional and could be replaced with another mount such as assembly mount 400.

[0052] The actuator assembly 500 is designed to accept the electrode assembly 100 (electrode 105 and sheath 110) and interface with eachindependently. As shown in FIG. 5C the sheath actuator 510 includes a wing interface 515 that accepts the sheath wing 140 (white portion of sheath extending radially out of the sheath actuator window). A slot 520 (also referenced as electrode slot 520) opposite of the wing interface 515 provides clearance for the radial protrusion (e.g., offset / interface 130) and stimulator connection 125 of the electrode 105. The sheath actuator 510 operates through inaction between the wing interface 515 and the wing 140 of the sheath 110. When the sheath actuator 510 is activated to move linearly the sheath 110 is move along with the actuator 1510. FIGS. 5E-5F illustrate how the electrode actuator 505 operates to move the electrode 105. The electrode actuator 505 includes a wing slot 530 that allows the electrode actuator 505 to move linearly over the sheath actuator 510 without interfering with the sheath 110 or the sheath actuator 510. FIG. 5F illustrates the interface between the electrode actuator 505 and the electrode 105. The electrode actuator 505 includes an electrode interface 535. The base of the electrode interface 535 provides the contact surface that pushes on the electrode 105 during electrode advancement. The width of the slot of the electrode interface can be slightly narrower than the diameter of the electrode offset / interface 130, as to allow for the electrode 105 to “snap into” the electrode actuator 505 to maintain attachment. The electrode slot 520 operates to maintain concentricity and alignment between the sheath 110, sheath actuator 510, and the electrode 105. In this example, the electrode actuator 505 is concentric, and runs outside of sheath actuator 510.

[0053] FIGS. 6A-6N illustrate various views of an actuator assembly 600 including sheath and electrode actuators for use within the robotic implant manipulation platforms discussed herein. FIG. 6A illustrates the actuator assembly 600 within the context of additional optional components of the system, such as the articulating arm 10, magnetic stage 20, and actuator assembly holder 30. The actuator assembly 600 can be used without an articulating arm , magnetic stage, or assembly holder as illustrated herein. In this example, the articulating arm 10 and magnetic stage 20 provide an adjustable platform affixed to the patient adjacent the surgical site to allow the actuator assembly 600 to be properly positioned for implant insertion.

[0054] FIG. 6B is a perspective view of the actuator assembly 600 mounted in the actuator assembly holder 30. In this example, the actuator assembly 600 is clipped into a c-clip style assembly interface 34. The assembly interface 34 allows for linear movement of the actuator assembly 600 along a longitudinal axis running through the assembly interface 34 along the length of the actuator housing 620. The actuator assembly holder 30 also includes an articulating arm interface 36 coupled to the assembly interface 34 via a holder arm 32. In this example, the holder arm 32 includes enlarged corner structures that provide additional rigidity as well as operating as grasping points for the surgeon to manipulate the assembly.

[0055] In this example, the actuator assembly 600 can include the actuator housing 620 that contains the sheath actuator 610 and the electrode actuator 630 nested coaxially within the actuator housing 620. Entering through a proximal end of the actuator housing 620 is the electrode drive cable (wire) 622 and the sheath drive cable (wire) 624. The drive cables (wires) can connect back to a drive unit that generates linear movement of the respective drive wires to affect movement of the actuators (sheath actuator 610 and electrode actuator 630). In an example, the drive wires are nitinol wires encased in a flexible protective sheath and the drive unit couples the proximal end of the drive wires to linear actuators as discussed in further detail below in reference to FIGS. 10A-10F, which illustrate an example drive unit 1000.

[0056] FIGS. 6C and 6D illustrate different views of the actuator assembly holder 30. In FIG. 6C, additional details of the assembly interface 34 are evidence, such as the c-clip 35. In this example, the c-clip 35 includes intersecting circular sections that provide for sufficient elasticity to move the actuator assembly as need while still maintain a firm grip on the actuator housing 620. FIG. 6D illustrates additional details of the articulating arm interface 36 that includes an annular interface 37 with a spherical annular surface to interface with spheres of an articulating arm.

[0057] FIG. 6E illustrates the actuator housing 620 coupled to the actuator assembly holder 30 via the assembly interface 34. In this example, the actuator housing 620 includes a holder stop 621, a guide slot 623, a housing tab 626, and a proximal end 628. The holder stop 621 limits proximal movement of the actuator housing 620 within the assembly interface 34 of the actuator assembly holder 30.The housing tab 626 provides angular orientation indication and manipulation as well as operating to limit distal movement of the actuator housing 620 relative to the assembly interface 34. The housing tab 626 aligns with the guide slot 623 which controls the rotational orientation of the sheath actuator 610 and electrode actuator 630.

[0058] FIG. 6F and 6G illustrate additional details of the sheath actuator 610 and electrode actuator 630. In this example, the sheath actuator 610 includes a tab interface 612 that engages the wing (tab) 140 of the sheath 110. The tab interface 612 is a slot in the sheath actuator 610 that aligns with and sized to fit around the wing (tab) 140 of the sheath 110. The tab interface 612 is the primary feature of the sheath actuator 610 that enables movement of the sheath 110 and maintains rotational alignment of the sheath 110 within the actuator assembly 600. The sheath actuator 610 is the inner most cylindrical actuator within the actuator assembly with the electrode actuator 630 positioned between the actuator housing 620 and the sheath actuator 610. FIGS 6H-6J provide additional illustrations of the sheath actuator 610. FIG. 6H is a perspective view of the sheath actuator 610 in isolation. FIG. 61 is a perspective view of the sheath actuator 610 with the electrode assembly 100 in place. In FIGS. 6H and 61 the housing recess 616 is illustrated. The housing recess 616 is a slot running distally from the proximal end of the sheath actuator 610. The housing recess 616 allows the sheath actuator 610 to move freely around the housing tab 626. The electrode recess 614 is illustrated in FIG. 61. The electrode recess 614 is a slot running proximally from the distal end of the sheath actuator 610. The electrode recess 614 allows the electrode 105 to be moved distally relative to the sheath actuator 610. FIG. 6J is another perspective view of the sheath actuator 610 with the electrode assembly 100 in place and give another view of the wing (tab) 140 extending through the tab interface 612.

[0059] FIGS. 6K-6N are various illustrations focused on the electrode actuator 630. In this example, the electrode actuator 630 includes an electrode clip 632 and an electrode fork 636 having a fork slot 638. The electrode clip 632 is positioned to receive a distal portion of the stimulator connection 125. The electrode fork 636 engages with the offset / interface 130 of the electrode 105 to transmit linear movement from the electrode actuator 630 to the electrode 105. Asshown in FIG. 6L, the electrode actuator 630 includes a tab slot 634 that allows for movement of the wing (tab) 140 of the sheath 110 relative to the electrode actuator 630.

[0060] FIGS. 7A-7E illustrate various views of an alligator clip-based actuator assembly 700 for use within the robotic implant manipulation platforms discussed herein. In this example, biased alligator clips are used to secure the sheath 110 and the electrode 105 for independent robotic manipulation. In this example, a sheath alligator clip 714 interfaces with the sheath wing 140 and an electrode alligator clip 734 connects to the electrode shaft just above the offset / interface 130. During the procedure, the user would pinch the proximal portion of the sheath alligator clip 714 to open the jaws to grab the sheath 110 at the wing 140. Once the sheath 110 is secured, the user would pinch open the electrode alligator clip 734 to grab the electrode 105 at a position between the offset / interface 130 and the stimulator connection 125. The electrode alligator clip 734 is designed to interface with the offset / interface portion 130 of the electrode 105 (illustrated best in FIG. 7B).

[0061] FIG. 7A illustrates a complete view of the clip-based actuator assembly 700 that utilizes clips to interface with the sheath 110 and electrode 105 of the electrode assembly 100. In this example, the actuator assembly 700 can include a sheath actuator 710, an electrode actuator 730, and an actuator assembly mount 720. Like other mounts discussed herein, the actuator assembly mount 720 can interface with an adjustable arm or similar mechanism to position the actuator assembly 700. In this example, each actuator includes an elongated cylindrical body that can include exterior tracks (sheath actuator track 712 and electrode actuator track 732) for linearly moving each actuator related to the actuator assembly mount 720. The clip-based interface illustrated in this example can be adapted to be robotically translated in other manners, such as telescoping actuators driven by drive wires similar to those discussed above.

[0062] FIG. 7B illustrates how the actuator clips engage the electrode assembly 100. In this example, the sheath clip 714 engages with the wing 140 of the sheath. The electrode clip 734 engages with the electrode 105 just above the distal end of the offset / interface 130. The sheath clip 714 opens via clip hinge 716and the electrode clip 734 opens via clip hinge 736. FIGS. 7C and 7D provide additional illustrations of engagement with the sheath 110 and electrode 105.

[0063] FIG. 7E illustrates certain internal mechanisms of the clip-based actuators. In this example, the sheath actuator 710 is illustrated at least partially transparent to show internal structures, such as the release button 740, clip spring 742 and clip tension cable(s) 744. In this example, the clips (sheath clip 714 and electrode clip 734) are biased by clip spring 742 via clip tension cable(s) 744 coupling to the hinge tension interface 754 (illustrated in FIG. 7F). The release button 740 can be manually depressed to release the tension on the clips.

[0064] FIG. 7F is a magnified illustration of an example structure of the clip hinges. In this example, each clip includes a fixed jaw 760 opposing a movable jaw 750. The movable jaw includes a movable hinge 752. The movable hinge 752 interacts with the fixed hinge 762 to allow the movable jaw 750 to pivot relative to the fixed jaw 760. Note, the illustration in FIG. 7F is illustrating the fixed portion of the electrode actuator 730 and the movable portion of the sheath actuator 710 solely for ease of illustration.

[0065] FIGS. 8A-8F illustrate various views of an actuator assembly 800 for use with a robotic implant manipulation platform in accordance with at least one example of the disclosure. In this example, the actuator assembly 800 is designed to actuate the electrode through an internal electrode actuator 830 that runs through the central lumen of the actuator assembly 800. In this example, the sheath 110 does not include a wing (tab) 140 feature and the sheath actuator 810 can be press fit over a proximal end of the sheath 110.

[0066] FIG. 8A is a perspective view of the actuator assembly 800 mounted in an actuator assembly mount 840. The actuator assembly mount 840 can be attached to an articulating arm or other fixation device to position the actuator assembly 800 relative to the patient. In this example, the actuator assembly 800 includes a sheath actuator 810, an actuator housing 820, and an electrode actuator 830 internal to the actuator housing 820 and sheath actuator 810. The actuators are actuated via a sheath actuator drive 814 and an electrode actuator drive 834. These actuator drives can be nitinol wires within a flexible sheath to deliver linear actuation from a remotely located drive unit.

[0067] In FIG. 8B the electrode actuator 830, electrode actuator rod 832, and sheath actuator rod 812 are illustrated through a slot running proximally from a distal end of the actuator housing 820. The electrode actuator rod 832 engages with the electrode actuator 830 to transmit linear movement from the electrode actuator drive 834. Similarly, the sheath actuator rod 812 engages the sheath actuator 810 to transmit linear movement from the sheath actuator drive 814.

[0068] FIGS. 8C and 8D remove the sheath actuator 810 to better illustrate the electrode actuator 830 and related structures. As shown in FIG. 8C, the electrode actuator 830 extends through a proximal end of the sheath 110 to engage with a proximal end 836 of the electrode 105.

[0069] FIGS. 8E and 8F include the sheath actuator 810 and the electrode actuator 830 with the electrode assembly 100. As illustrated in FIG. 8E, the sheath actuator rod 812 is coupled to a proximal end of the sheath actuator 810. As noted above, the sheath actuator rod 812 transfers linear movement from the sheath actuator drive 814. FIG. 8F illustrates the sheath interface 816 on the distal end of the sheath actuator 810. The sheath interface 816 is where the sheath actuator 810 engages with the sheath 110. In this example, the sheath 110 is press fit into the sheath interface 816 to engage transferring movement between the sheath actuator 810 and the sheath 110.

[0070] FIGS. 9A-9B illustrate various views of an electrode pusher assembly 900 for use within the robotic implant manipulation platforms discussed herein. The previous examples describe various means of attaching the robotic assembly to a commercially available perimodiolar implant. The actuator assembly 900 uses an alternative approach, similar to that discussed above in reference to actuator assembly 800, that involves modifying the sheath 110 to facilitate connection to the robotic actuator assembly and enable an alternative approach to manipulating the electrode and sheath independently. In this example, the system can still accommodate an industry standard electrode 105, but the sheath 110 is modified from the industry standard including removing the proximal cap 145 and optionally the wing (tab) 140. FIGS. 9A and 9B illustrate a concept in which the proximal portion of the sheath 110 is open (e.g., cap 145 is removed) and allows for an electrode pusher to pass through the lumen and interface directly with the electrode 105. In this embodiment, the proximal end of the sheath 110 is flared(see flared sheath interface 912), and the electrode pusher 930 is sized to fit within the inner lumen of the sheath 110 and contact the proximal most portion of the electrode 105. This allows the electrode pusher 930 to advance the electrode 105 the desired distance forward during the procedure. The modified sheath is controlled by the sheath actuator 910 that interfaces with the flared portion of the proximal end of the sheath at the flared sheath interface 912. In this example, the sheath actuator 910 is sized to create a friction fit with the inner diameter of the flared portion of the proximal end of the sheath (best illustrated in FIG. 9B). The electrode pusher 930 is feed concentrically through the sheath actuator 910 to control the electrode positioning. In another example, the end of the sheath actuator can be flared to fit over a standard (e.g., not flared) proximal end of the sheath (similar to sheath actuator 810 and sheath interface 816), while still retaining the concentric (or co-axial) arrangement with the electrode pusher. In this alternative arrangement, the sheath is only modified by removal of the cap 145 on the proximal end to allow the electrode pusher 930 to access the sheath lumen and contact the electrode 105. In both examples, connection between the sheath actuator 910 and proximal end of the sheath can include annular press fit (friction fit), threaded connection, or a magnetic connection, among others.

[0071] FIGS. 10A-10F illustrate various views of a modular drive unit 1000 with a replaceable cartridge in accordance with at least one example of the present disclosure. As introduced above in reference to FIG. 3, in certain examples the robotic implant manipulation platforms discussed herein can utilize a remote drive unit coupled to an actuator assembly via a flexible drive cable containing one or more drive wires. In this example, the remote drive unit is a modular drive unit 1000 that includes a base unit 1010 and a removable (disposable) cartridge 1020. The modular arrangement can allow for the cartridge and actuator assemblies to be delivered as a disposable single use package, while allowing for reuse of the base unit 1010 that contains more expensive components, such as linear actuators.

[0072] FIG. 10A illustrates the base unit 1010 and the drive cartridge 1020 of the drive unit 1000 separated. The drive cartridge 1020 includes control wires 1022, 1024 extending from the end opposite the engagement with the base unit 1010. The base unit 1010 includes a cartridge port 1012 for receiving the drive cartridge 1020. FIG. 10B illustrates the drive cartridge 1020 inserted into thecartridge port 1012 of the base unit 1010. In this configuration, the linear actuators within the base unit 1010 can impart linear movement through the control wires 1022, 1024 to an actuator assembly (such as those discussed above).

[0073] FIG. 10C is a cross-sectional view of the base unit 1010 and the drive cartridge 1020 that illustrates the basic internal components of each portion of the drive unit 1000. In this example, the base unit 1010 can include linear actuators 1042, 1040 with magnetic couplers 1044, 1046 affixed to movable shafts of the linear actuators. The linear actuators 1042, 1040 can be linear electric motors or stepper / servo motors with lead screws or other similar linear actuation devices. In this example, the magnetic couplers 1044, 1046 of the base unit 1010 are designed to magnetically couple to the drive bearings 1030, 1032 within the drive cartridge 1020. In this example, the control wires 1022, 1024 couple directly to the back side of the drive bearings 1030, 1032 and run through guide tubes 1034, 1036 before exiting the drive cartridge through the control wire guide 1052. In some examples, the control wire guide 1052 can direct the control wires 1022, 1024 into a multi-lumen flexible cable to run to the actuator assemblies. As shown in FIG. 10D, the drive bearings 1030, 1032 slide in a bearing race 1050. FIGS. 10E and 10F are cross-sectional views that illustrate the drive cartridge 1020 and base unit 1010 separated (FIG. 10E) and coupled (FIG. 10F). In these cross-sectional views, structures such as the linear actuator 1040 are further illustrated including the linear actuator rod 1048 that couples to the magnetic coupler 1044.

[0074] In the previous examples, where sheath actuators and / or electrode actuators interface in a known and repeatable way with the electrode or sheath, tracking sensors may be deployed on the sheath actuator or electrode actuator so that a tracking system may track the positions of those sensors during surgery. These positions, in combination with calibration data or routines that provide information about where the sensors are deployed relative to the electrode or sheath geometries, can provide to those skilled in the art of surgical navigation, a means to track the position or insertion trajectories of the implant during insertion. Furthermore, the displacement of the electrode actuator and sheath actuators can provide information about how far the electrode is deployed beyond the sheath. This in combination with a model of the implant’s curvature at different distances of exposure, can further inform a likely position and shape of the geometry of theimplant relative to other surgical navigation data, e.g., the location of the cochlea and the orientation of the patient’s basal canal.

[0075] In some examples, the sheath-electrode assemblies (sheath holders) are configured to be detachable from the rest of the robotic system to ease loading. One interface point between the sheath-electrode assemblies and the robotic system can be the free end of the articulating arm. All of the actuator assembly mounts discussed herein can allow for the actuator assemblies to be detached from the robotic system and / or the articulating arms without necessarily impacting the positioning provided by the assembly mounts. For example, as illustrated in FIGS. 6A-6E, the actuator assembly holder 30 includes an assembly interface 34 in the form of a c-clip that allows for easy detachability of the actuator assembly 600 as needed to load an electrode assembly 100.

[0076] In some examples, the sheath-electrode assemblies can incorporate various techniques to confirm properly loading. In an example, as the sheath is loaded into the distal end of the assembly, it interfaces with a tube that is pushed out the back (proximal end). The user can visualize this tube coming out of the end, and it could include visual markers or colors to reinforce distance and if the action is complete. Tactile feedback can also be incorporated to allow a user to “feel” confirmation of loading via a bump or ridge. Auditory feedback can also be incorporated in addition to or instead of tactile and visual. The sheath-electrode assemblies can also incorporate a sensor or switch to electronically recognize the location of the sheath and / or electrode to notify the user. In certain examples, the sensor is part of a position feedback circuit to monitor the relative position of the sheath and electrode during insertion. The system can be configured to allow for a “zero-point” to be set when the electrode is starting to advance out of the sheath.

[0077] The approach described above, in which the articulating arm is maneuvered to the desired location prior to advancement of the implant along a specific trajectory, leverages a straight sheath. In another example, the sheath can be pre-curved or can be deflected in a specific curved shape during the procedure. A curved or curvable sheath would allow for the trajectory of the sheath to better match the curve of the patient’s anatomy. Current practice is to advance a straight, rigid, sheath into an entry portion of the spiral shaped cochlea. When the electrode is advanced out of the sheath, it can immediately hit the side wall of the cochlea,potentially leading to misalignment and damage. A curved or curvable sheath would assist in avoiding immediate contact between the electrode and the side wall of the cochlea.

[0078] In some examples, the surgeon can hold the actuator assemblies in their hand during the insertion. Although there may be more motion of the actuators (and thereby the implant) during insertion as compared to insertions that employ a bone-mounted articulating arm, the handheld technique benefits potentially from greater dexterity and freedom of positioning by utilizing the surgeon’s skill and training. Furthermore, using a handheld actuator may allow the surgeon to employ secondary controllers to influence the insertion, such as a foot pedal that sends inputs directly or indirectly to the motor assembly. In this scenario, the surgeon can focus on remaining still and can plant their hands on the patient providing a stable base, while the insertion motion is smoother than humanly possible without robotic assistance.With the handheld approach, the actuator assemblies may be reversibly into a handle to provide ergonomic benefit to the surgeon. A mechanical “clip” feature may be designed into the handle to allow for the handle to use as an optional component, perhaps packaged separately to take advantage of certain distribution, sterilization, or packaging benefits. A similarly compatible clip feature may be designed into an articulating arm to allow for an insertion system that provides the benefit described herein, where a surgeon may choose during surgery to employ a bone-mounted articulating or a handheld approach during surgery. In this case, the same actuation assembly can be provided for the surgery, thereby gaining advantages for inventory management at the hospital or vendor company. This also allows for the surgical approach (bone-mounted vs handheld) to be switched during surgery in case the surgeon deems a change to be advantageous based on the surgical situation. For example, if during surgery, the quality of the patient’s bone proves insufficient for secure mounting, they may revert to a handheld technique by detaching the actuator assembly from the articulating arm and attaching it to a handle assembly, or simply hold the actuator assembly by hand.

[0079] A problem seen during insertion of cochlear implants involves the tip of the electrode folding over. In an example, the robotic system can include a technique for detection of tip fold over during sheath-based insertion. Onemechanism currently used to guide electrode insertion involves trans-impedance measurement (TIM), as described in US Patent Application US 18 / 022,472, included here by reference in its entirety, but tip fold over cannot easily be detected during insertion using TIM due to limited information from electrode contacts not exposed beyond the sheath. Available TIM foldover-detection models are based on an electrode array fully deployed from the sheath. The newly developed technique utilizes a series of TIM models specifically formulated at different electrode exposure distances. Accordingly, a plurality of models are developed to detect tip fold over with each model defined for a particular amount of electrode exposure. During robotic insertion, the exposure level of the electrode can be tracked and then the system can utilize the appropriate TIM model based on the level of current exposure to test for tip fold over. In this example, the system includes a mechanism for monitoring proper insertion. The mechanism works from a base reference frame including a zero point for electrode exposure. The sheath drive mechanism is configured to extend the sheath along an axis relative to the base reference frame. The implant (electrode) drive system is configured to extend the implant independently of the sheath along the axis relative to the base reference frame. The system includes mechanisms to determine positions of the sheath drive mechanism and the implant drive mechanism relative to the zero point. A transfer function is utilized to determine the location of the electrode tip relative to the sheath. Impedance measurements are taken during insertion and evaluated with a model selected based on the current extension of the implant. Classifier to determine a Preferred Electrical impedance model based on output the Transfer Function as applied to positions of the Sheath Drive and the Implant Drive relative to the zero point. Various embodiments are illustrated in the figures above. One or more features from one or more of these embodiments may be combined to form other embodiments.

[0080] FIG. 11 is a flowchart illustrating a technique for detecting tip fold over in accordance with at least one example of the disclosure. In this example, a method for detecting foldover using combined data from robotic insertion and transimpedance matrix (TIM) analysis is defined. Prior to insertion, a series of experiments are used to determine qualities of a sampled TIM matrix for a range of electrode exposure amounts within a cochlea. These experiments result in a seriesof transfer functions TIM(e) that classify TIM data at an exposure distance “e” as representing either an electrode that is folded over, or an electrode that is not folded over.

[0081] During the surgery, either manually or through robotic control, the user configures the insertion device so that the actuator and electrode assemblies position the electrode and the sheath such that the tip electrode contact is at the tip of the sheath (i.e. a “zero position”). In this example, the technique 1100 can begin at 1102 with the synchronization of the robotic insertion system. At operation 1102, the system can be calibrated to synchronize positional encoders and / or internal memory variables to allow the system to determine the amount of exposure of the electrode contacts. In this example, the technique 1100 continues with the user beginning insertion by controlling the actuator assembly at 1104. At 1106, the technique 1100 can continue with the drive electronics and computer continually calculating the electrode array exposure beyond the sheath based on reading positional encoders. Alternatively, at 1106, the technique 1100 can utilize dead -reckoning to calculate a predicted exposure amount. At 1108, the technique 11000 continues with each sample point using the electrode exposure to select a TIM transfer function, TIM(preferred), that is closest to the exposure originally used to sample the TIM data that determined the transfer function. At 1110, the technique continues with TIM(preferred) being applied to the sampled TIM data, and then at 1112 the technique 1100 uses the classifier to determine if the data is likely to represent a foldover or a non-foldover. The system may react to an expected foldover by showing an error to the user or halting the robotic insertion at operation 1116. In the event of no foldover being determined at 1112, the system may continue at 1114 by resuming insertion, and the system may repeat this iterated analysis until the user chooses to stop insertion.

[0082] FIG. 12 is a flowchart illustrating a technique 1200 for detecting tip fold over in accordance with at least one example of the disclosure. In FIG 12, a method for detecting foldover using combined data from robotic insertion and transimpedance matrix (TIM) analysis is defined. Prior to insertion, a series of experiments are used to determine qualities of a sampled TIM matrix for a range of electrode exposure amounts within a cochlea. These experiments inform the creation of a single transfer function that takes both TIM data and an exposuredistance. The single transfer function is an improvement over already established foldover detection functions, which do not take external information about the physical exposure of the electrode contacts within the cochlea. Generation of the transfer functions only needs to be done once, and can be reused for additional implant surgeries. In some examples, the series of experiments can be performed on multiple different people to develop transfer functions applicable across a wide range of anatomical variation.

[0083] During the surgery, either manually or through robotic control, the user configures the insertion device so that the actuator and electrode assemblies position the electrode and the sheath such that the tip electrode contact is at the tip of the sheath (i.e. a “zero position”). In this example, the technique 1200 can begin at 1202 with calibration of the system to synchronize positional encoders and / or internal memory variables to allow the system to determine the amount of exposure of the electrode contacts. At 1204, the technique 1200 continues with the user beginning insertion by controlling the actuator assembly (such as actuator assembly 600). The technique 1200 continues with the system continually calculating the electrode array exposure beyond the sheath at 1206 and at 1208 with the system sampling the TIM data. In some examples, operations 1206 and 1208 occur concurrently. At 1210, the technique 1200 continues with the transfer function being passed both the electrode exposure and the TIM data, and the classifier determines if the data is likely to represent a foldover or a non-foldover. At 1212, the technique 1200 continues with the system evaluating the results of application of the transfer function to determine whether foldover has occurred. If foldover is detected, the technique 1200 can conclude at 1216 with the system can display an error to the user or halting the robotic insertion. In the event of no foldover being determined, the technique 1200 can continue at 1214 with the system continuing insertion. Operations 1206, 1208, 1210, 1212, and 1214 are repeated to iterated the foldover analysis until the user chooses to stop insertion.

[0084] FIG. 13 is a block diagram of a computing device operable as part of a robotic implant manipulation platform and capable of performing the techniques discussed within the disclosure. In alternative embodiments, the machine 1300 may operate as a standalone device and / or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1300 mayoperate in the capacity of a server machine, a client machine, or both in serverclient network environments. In an example, the machine 1300 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1300 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term "machine" shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations. The machine 1300 may also be integrated into any of the components of the robotic insertion platforms discussed herein. For example, the machine 1300 may be integrated into the drive unit 1000 to process inputs to control insertion of the electrode assembly 100 using one of the actuator assemblies, such as actuator assembly 600.

[0085] Machine (e.g., computer system) 1300 may include a hardware processor 1302 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1304 and a static memory 1306, some or all of which may communicate with each other via an interlink (e.g., bus) 1308. The machine 1300 may further include a display unit 1310, an alphanumeric input device 1312 (e.g., a keyboard), and a user interface (UI) navigation device 1314 (e.g., a mouse). In an example, the display unit 1310, input device 1312 and UI navigation device 1314 may be a touch screen display. The machine 1300 may additionally include a storage device (e.g., drive unit) 1316, a signal generation device 1318 (e.g., a speaker), a network interface device 1320, and one or more sensors 1321, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 1300 may include an output controller 1328, such as a serial (e.g., Universal Serial Bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate and / or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0086] The storage device 1316 may include a machine readable medium 1322 on which is stored one or more sets of data structures or instructions 1324 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 1324 may also reside, completely or at least partially, within the main memory 1304, within static memory 1306, or within the hardware processor 1302 during execution thereof by the machine 1300. In an example, one or any combination of the hardware processor 1302, the main memory 1304, the static memory 1306, or the storage device 1316 may constitute machine readable media.

[0087] While the machine readable medium 1322 is illustrated as a single medium, the term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store the one or more instructions 1324. The term "machine readable medium" may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1300 and that cause the machine 1300 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding, or carrying data structures used by or associated with such instructions. Non-limiting machine- readable medium examples may include solid-state memories, and optical and magnetic media.

[0088] The instructions 1324 may further be transmitted or received over a communications network 1326 using a transmission medium via the network interface device 1320 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 1320 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) orone or more antennas to connect to the communications network 1326. In an example, the network interface device 1320 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1300, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.

[0089] Technique (method) examples described herein may be machine or computer-implemented at least in part. Some examples may include a computer- readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code may be tangibly stored on one or more volatile, non- transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.EXAMPLES

[0090] The following are non-limiting examples of the devices and techniques discussed herein. The example expansion mechanisms can be used alone or in combination with other disclosed expansion mechanisms. The methods or techniques discussed can be performed using any of the disclosed expansion mechanisms, unless the example involves utilizing a particular aspect of a particular expansion mechanism.

[0091] Example 1 comprises an actuator assembly designed for robotically assisted manipulation of an elongate implant. It includes a first actuator thatengages a sheath of the elongate implant, a second actuator that engages an electrode of the elongate implant, and an actuator housing that contains the sheath actuator and the electrode actuator, wherein the sheath actuator and the electrode actuator are configured to move independently within the actuator housing to manipulate the sheath and the electrode independently.

[0092] In Example 2, the subject matter of Example 1 can optionally include a sheath actuator with a tab interface configured to engage a wing of the sheath.

[0093] In Example 3, the subject matter of any one of Examples 1 or 2 can optionally include an electrode actuator with an electrode interface configured to engage an offset portion of the electrode.

[0094] In Example 4, the subject matter of any one of Examples 1 to 3 can optionally include a drive unit coupled to the sheath actuator and the electrode actuator via flexible drive cables, wherein the drive unit is configured to provide linear movement to the sheath actuator and the electrode actuator.

[0095] In Example 5, the subject matter of any one of Examples 1 to 4 can optionally include an actuator housing with a guide slot configured to control the rotational orientation of the sheath actuator and the electrode actuator.

[0096] In Example 6, the subject matter of any one of Examples 1 to 5 can optionally include a sheath actuator with a housing recess to allow movement around a housing tab of the actuator housing.

[0097] In Example 7, the subject matter of any one of Examples 1 to 6 can optionally include an electrode actuator with an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

[0098] In Example 8, the subject matter of any one of Examples 1 to 7 can optionally include an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

[0099] In Example 9, the subject matter of any one of Examples 1 to 8 can optionally include sheath and electrode actuators configured to be driven by nitinol wires encased in a flexible protective sheath.

[0100] In Example 10, the subject matter of any one of Examples 1 to 9 can optionally include an actuator housing with a holder stop to limit proximalmovement of the actuator housing within an assembly interface of an actuator assembly holder.

[0101] Example 11 comprises a system designed for robotically assisted manipulation of an elongate implant. It includes an actuator assembly with a sheath actuator that engages a sheath of the elongate implant, an electrode actuator that engages an electrode of the elongate implant, and an actuator housing that contains the sheath actuator and the electrode actuator, wherein the sheath actuator and the electrode actuator are configured to move independently within the actuator housing to manipulate the sheath and the electrode independently; and a drive unit coupled to the sheath actuator and the electrode actuator via a flexible drive wire, wherein the drive unit is configured to provide actuation movement to the sheath actuator and the electrode actuator.

[0102] In Example 12, the subject matter of Example 11 can optionally include a drive unit with linear actuators configured to impart linear movement through the flexible drive wire to the sheath actuator and the electrode actuator.

[0103] In Example 13, the subject matter of any one of Examples 11 or 12 can optionally include an actuator assembly with an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

[0104] In Example 14, the subject matter of any one of Examples 11 to 13 can optionally include a sheath actuator with a tab interface configured to engage a wing of the sheath, and an electrode actuator with an electrode interface configured to engage an offset portion of the electrode.

[0105] In Example 15, the subject matter of any one of Examples 11 to 14 can optionally include an actuator housing with a guide slot configured to control the rotational orientation of the sheath actuator and the electrode actuator.

[0106] In Example 16, the subject matter of any one of Examples 11 to 15 can optionally include a drive unit that is a modular drive unit with a base unit and a removable cartridge, the removable cartridge including control wires extending to the sheath actuator and the electrode actuator.

[0107] In Example 17, the subject matter of Example 16 can optionally include a base unit with linear actuators with magnetic couplers configured tomagnetically couple to drive bearings within the removable cartridge to impart linear movement to the control wires.

[0108] In Example 18, the subject matter of any one of Examples 11 to 17 can optionally include a sheath actuator with a housing recess to allow movement around a housing tab of the actuator housing, and an electrode actuator with an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

[0109] In Example 19, the subject matter of any one of Examples 11 to 18 can optionally include flexible drive wires that are nitinol wires encased in a flexible protective sheath.

[0110] In Example 20, the subject matter of any one of Examples 11 to 19 can optionally include an actuator housing with a holder stop to limit proximal movement of the actuator housing within an assembly interface of an actuator assembly holder.

[0111] Example 21 comprises a method for robotically assisted implantation of an elongate implant. The method includes the following steps: providing an actuator assembly with a sheath actuator that engages a sheath of the elongate implant, an electrode actuator that engages an electrode of the elongate implant, and an actuator housing containing the sheath actuator and the electrode actuator, wherein the sheath actuator and the electrode actuator are configured to move independently within the actuator housing; coupling the actuator assembly to a drive unit to provide independent movement to the sheath actuator and the electrode actuator; positioning the actuator assembly relative to a patient using an adjustable arm; engaging the sheath of the elongate implant with the sheath actuator; engaging the electrode of the elongate implant with the electrode actuator; and independently manipulating the sheath and the electrode using the drive unit to implant the elongate implant into a target site within the patient.

[0112] In Example 22, the subject matter of Example 21 can optionally include controlling the rotational orientation of the sheath actuator and the electrode actuator within the actuator housing using a guide slot.

[0113] In Example 23, the subject matter of Example 21 or 22 can optionally include providing linear movement to the sheath actuator and the electrode actuator using linear actuators within the drive unit.

[0114] In Example 24, the subject matter of any one of Examples 21 to 23 can optionally include monitoring the position of the sheath and the electrode during implantation using sensors coupled to the sheath actuator and the electrode actuator.

[0115] In Example 25, the subject matter of any one of Examples 21 to 24 can optionally include providing feedback to the drive unit based on the monitored position of the sheath and the electrode to adjust the linear movement of the sheath actuator and the electrode actuator.

[0116] In Example 26, the subject matter of any one of Examples 21 to 25 can optionally include configuring the drive unit as a modular drive unit with a base unit and a removable cartridge, the removable cartridge including control wires extending to the sheath actuator and the electrode actuator.

[0117] In Example 27, the subject matter of Example 26 can optionally include magnetically coupling linear actuators within the base unit to drive bearings within the removable cartridge to impart linear movement to the control wires.

[0118] In Example 28, the subject matter of any one of Examples 21 to 27 can optionally include limiting proximal movement of the actuator housing within an assembly interface of an actuator assembly holder using a holder stop.

[0119] In Example 29, the subject matter of any one of Examples 21 to 28 can optionally include driving the sheath actuator and the electrode actuator using nitinol wires encased in a flexible protective sheath.

[0120] In Example 30, the subject matter of any one of Examples 21 to 29 can optionally include setting a zero point for electrode exposure, determining the electrode exposure during electrode insertion, selecting a transfer function based on the determined electrode exposure, and utilizing a transfer function to determine the location of the electrode tip relative to the sheath during implantation.

[0121] In Example 31, the subject matter of any one of Examples 21 to 29 can optionally include setting a zero point for electrode exposure, determining the electrode exposure during electrode insertion, measuring transimpedance values from a variety of electrode contacts on the inserted electrode, and utilizing the electrode exposure and the transimpedance values in a transfer function to detect fold-over.

[0122] Example 32 comprises an actuator assembly designed for robotically assisted manipulation of an elongate implant. It includes a sheath actuator with a sheath clip configured to engage a sheath of the elongate implant, an electrode actuator with an electrode clip configured to engage an electrode of the elongate implant, and an actuator assembly mount configured to position the sheath actuator and the electrode actuator relative to a patient, wherein the sheath clip and the electrode clip are configured to move independently to manipulate the sheath and the electrode independently.

[0123] In Example 33, the subject matter of Example 32 can optionally include a sheath clip configured to engage a wing of the sheath.

[0124] In Example 34, the subject matter of any one of Examples 32 or 33 can optionally include an electrode clip configured to engage an offset portion of the electrode.

[0125] In Example 35, the subject matter of any one of Examples 32 to 34 can optionally include a sheath clip with a movable jaw and a fixed jaw, the movable jaw being pivotally connected to the fixed jaw via a clip hinge.

[0126] In Example 36, the subject matter of any one of Examples 32 to 35 can optionally include an electrode clip with a movable jaw and a fixed jaw, the movable jaw being pivotally connected to the fixed jaw via a clip hinge.

[0127] In Example 37, the subject matter of any one of Examples 32 to 36 can optionally include a release button configured to release the sheath clip and the electrode clip from engagement with the sheath and the electrode, respectively.

[0128] In Example 38, the subject matter of any one of Examples 32 to 37 can optionally include sheath and electrode actuators configured to be driven by flexible drive cables, and an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

[0129] In Example 39, the subject matter of any one of Examples 32 to 38 can optionally include sheath and electrode clips biased by a clip spring to maintain engagement with the sheath and the electrode, respectively.

[0130] In Example 40, the subject matter of any one of Examples 32 to 39 can optionally include sheath and electrode actuators with actuator tracks for linearly moving the sheath clip and the electrode clip relative to the actuator assembly mount.

[0131] Example 41 comprises an actuator assembly designed for robotically assisted manipulation of an elongate implant. It includes a first actuator configured to engage a sheath of the elongate implant, a second actuator configured to engage an electrode of the elongate implant, and a mounting mechanism configured to position the first actuator and the second actuator relative to a patient, wherein the first actuator and the second actuator are configured to move independently to manipulate the sheath and the electrode independently.

[0132] In Example 42, the subject matter of Example 41 can optionally include a first actuator with an engagement mechanism configured to engage a feature of the sheath.

[0133] In Example 43, the subject matter of any one of Examples 41 or 42 can optionally include a second actuator with an engagement mechanism configured to engage a feature of the electrode.

[0134] In Example 44, the subject matter of any one of Examples 41 to 43 can optionally include a release mechanism configured to disengage the first actuator from the sheath and the second actuator from the electrode.

[0135] In Example 45, the subject matter of any one of Examples 41 to 44 can optionally include the first and second actuators driven by a remote drive mechanism.

[0136] In Example 46, the subject matter of any one of Examples 41 to 45 can optionally include a mounting mechanism that interfaces with a positioning system to position the actuator assembly relative to a patient.

[0137] In Example 47, the subject matter of any one of Examples 41 to 46 can optionally include engagement mechanisms of the first and second actuators that are biased to maintain engagement with the sheath and the electrode, respectively.

[0138] In Example 48, the subject matter of any one of Examples 41 to 47 can optionally include linear movement mechanisms for the first and second actuators to move the engagement mechanisms relative to the mounting mechanism.

[0139] In Example 49, the subject matter of any one of Examples 41 to 48 can optionally include sensors configured to monitor the position of the sheath andthe electrode during implantation and provide real-time feedback to a remote drive mechanism.

[0140] In Example 50, the subject matter of any one of Examples 41 to 49 can optionally include a remote drive mechanism including flexible drive cables configured to transmit linear movement to the first actuator and the second actuator.

[0141] In Example 51, the subject matter of any one of Examples 41 to 50 can optionally include a first actuator with a movable engagement mechanism configured to securely engage the sheath.

[0142] In Example 52, the subject matter of any one of Examples 41 to 51 can optionally include a second actuator with a movable engagement mechanism configured to securely engage the electrode.

[0143] In Example 53, the subject matter of any one of Examples 41 to 52 can optionally include a first actuator with a housing recess to allow movement around a housing tab of an actuator housing.

[0144] In Example 54, the subject matter of any one of Examples 41 to 53 can optionally include a second actuator with an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

[0145] In Example 55, the subject matter of any one of Examples 41 to 54 can optionally include an actuator housing configured to retain the first actuator nested inside the second actuator.

[0146] In Example 56, the subject matter of Example 55 can optionally include an actuator housing with at least one of: a guide slot configured to control rotational orientation of the first actuator and the second actuator; and a holder stop to limit proximal movement of the actuator housing within an assembly interface of an actuator assembly holder.

[0147] Example 57 comprises a system for robotically assisted manipulation of an elongate implant. It includes a first actuator configured to engage a sheath of the elongate implant; a second actuator configured to engage an electrode of the elongate implant, wherein the first actuator and the second actuator are configured to move independently to manipulate the sheath and the electrode independently; a mounting mechanism configured to position the first actuator and the second actuator relative to a patient; and a drive unit coupled to the firstactuator and the second actuator, wherein the drive unit is configured to provide independent movement to the first actuator and the second actuator.

[0148] In Example 58, the subject matter of Example 57 can optionally include a drive unit with linear actuators configured to impart linear movement through flexible drive cables to the first actuator and the second actuator.

[0149] In Example 59, the subject matter of Example 57 can optionally include an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

[0150] In Example 60, the subject matter of Example 57 can optionally include a first actuator with an engagement mechanism configured to engage a feature of the sheath, and a second actuator with an engagement mechanism configured to engage a feature of the electrode.

[0151] In Example 61, the subject matter of Example 57 can optionally include an actuator housing containing the first actuator and the second actuator.

[0152] In Example 62, the subject matter of Example 61 can optionally include an actuator housing with a guide slot configured to control rotational orientation of the first actuator and the second actuator.

[0153] In Example 63, the subject matter of Example 61 can optionally include a first actuator with a housing recess to allow movement around a housing tab of the actuator housing.

[0154] In Example 64, the subject matter of Example 61 can optionally include an actuator housing with a holder stop to limit proximal movement of the actuator housing within an assembly interface of the mounting mechanism.

[0155] In Example 65, the subject matter of Example 57 can optionally include a second actuator with an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

[0156] In Example 66, the subject matter of Example 57 can optionally include a drive unit that is a modular drive unit with a base unit and a removable cartridge, the removable cartridge including control wires extending to the first actuator and the second actuator.

[0157] In Example 67, the subject matter of Example 66 can optionally include a base unit with linear actuators with magnetic couplers configured tomagnetically couple to drive bearings within the removable cartridge to impart linear movement to the control wires.

[0158] In Example 68, the subject matter of Example 66 can optionally include control wires that are nitinol wires encased in a flexible protective sheath.

[0159] In Example 69, the subject matter of Example 57 can optionally include sensors configured to monitor the position of the sheath and the electrode during implantation and provide real-time feedback to the drive unit.

[0160] In Example 70, the subject matter of Example 57 can optionally include a mounting mechanism that interfaces with a positioning system to position an actuator assembly including the first actuator and the second actuator relative to a patient.

[0161] In Example 71, the subject matter of Example 57 can optionally include linear movement mechanisms for moving the engagement mechanisms relative to the mounting mechanism.

[0162] In Example 72, the subject matter of Example 57 can optionally include a first actuator with a movable engagement mechanism configured to securely engage the sheath.

[0163] In Example 73, the subject matter of Example 57 can optionally include a second actuator with a movable engagement mechanism configured to securely engage the electrode.

[0164] These examples can be combined in any permutation or combination. This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.

[0165] The detailed description above is intended to be illustrative, and not restrictive. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSWhat is claimed is:

1. An actuator assembly for robotically assisted manipulation of an elongate implant, comprising: a sheath actuator configured to engage a sheath of the elongate implant; an electrode actuator configured to engage an electrode of the elongate implant; and an actuator housing containing the sheath actuator and the electrode actuator, wherein the sheath actuator and the electrode actuator are configured to move independently within the actuator housing to manipulate the sheath and the electrode independently.

2. The actuator assembly of claim 1, wherein the sheath actuator includes a tab interface configured to engage a wing of the sheath.

3. The actuator assembly of claim 1, wherein the electrode actuator includes an electrode interface configured to engage an offset portion of the electrode.

4. The actuator assembly of claim 1, further comprising: a drive unit coupled to the sheath actuator and the electrode actuator via flexible drive cables, wherein the drive unit is configured to provide linear movement to the sheath actuator and the electrode actuator.

5. The actuator assembly of claim 1, wherein the actuator housing includes a guide slot configured to control rotational orientation of the sheath actuator and the electrode actuator.

6. The actuator assembly of claim 1, wherein the sheath actuator includes a housing recess to allow movement around a housing tab of the actuator housing.

7. The actuator assembly of claim 1, wherein the electrode actuator includes an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

8. The actuator assembly of claim 1, further comprising: an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

9. The actuator assembly of claim 1, wherein the sheath actuator and the electrode actuator are configured to be driven by nitinol wires encased in a flexible protective sheath.

10. The actuator assembly of claim 1, wherein the actuator housing includes a holder stop to limit proximal movement of the actuator housing within an assembly interface of an actuator assembly holder.

11. A system for robotically assisted manipulation of an elongate implant, comprising: an actuator assembly including a sheath actuator configured to engage a sheath of the elongate implant, an electrode actuator configured to engage an electrode of the elongate implant, and an actuator housing containing the sheath actuator and the electrode actuator, wherein the sheath actuator and the electrode actuator are configured to move independently within the actuator housing to manipulate the sheath and the electrode independently; and a drive unit coupled to the sheath actuator and the electrode actuator via a flexible drive wire, wherein the drive unit is configured to provide actuation movement to the sheath actuator and the electrode actuator.

12. The system of claim 11, wherein the drive unit includes linear actuators configured to impart linear movement through the flexible drive wire to the sheath actuator and the electrode actuator.

13. The system of claim 11, wherein the actuator assembly further comprises an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

14. The system of claim 11, wherein the sheath actuator includes a tab interface configured to engage a wing of the sheath, and the electrode actuator includes an electrode interface configured to engage an offset portion of the electrode.

15. The system of claim 11, wherein the actuator housing includes a guide slot configured to control rotational orientation of the sheath actuator and the electrode actuator.

16. The system of claim 11, wherein the drive unit comprises a modular drive unit with a base unit and a removable cartridge, the removable cartridge including control wires extending to the sheath actuator and the electrode actuator.

17. The system of claim 16, wherein the base unit includes linear actuators with magnetic couplers configured to magnetically couple to drive bearings within the removable cartridge to impart linear movement to the control wires.

18. The system of claim 11, wherein the sheath actuator includes a housing recess to allow movement around a housing tab of the actuator housing, and the electrode actuator includes an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

19. The system of claim 11, wherein the flexible drive wire includes one or more nitinol wires encased in a flexible protective sheath.

20. The system of claim 11, wherein the actuator housing includes a holder stop to limit proximal movement of the actuator housing within an assembly interface of an actuator assembly holder.

21. A method for robotically assisted implantation of an elongate implant, comprising: providing an actuator assembly including a sheath actuator configured to engage a sheath of the elongate implant, an electrode actuator configured to engage an electrode of the elongate implant, and an actuator housing containing the sheathactuator and the electrode actuator, wherein the sheath actuator and the electrode actuator are configured to move independently within the actuator housing; coupling the actuator assembly to a drive unit to provide independent movement to the sheath actuator and the electrode actuator; positioning the actuator assembly relative to a patient using an adjustable arm; engaging the sheath of the elongate implant with the sheath actuator; engaging the electrode of the elongate implant with the electrode actuator; and independently manipulating the sheath and the electrode using the drive unit to implant the elongate implant into a target site within the patient.

22. The method of claim 21, further comprising controlling rotational orientation of the sheath actuator and the electrode actuator within the actuator housing using a guide slot.

23. The method of claim 21, further comprising providing linear movement to the sheath actuator and the electrode actuator using linear actuators within the drive unit.

24. The method of claim 21, further comprising monitoring position of the sheath and the electrode during implantation using sensors coupled to the sheath actuator and the electrode actuator.

25. The method of claim 21, further comprising providing feedback to the drive unit based on the monitored position of the sheath and the electrode to adjust the linear movement of the sheath actuator and the electrode actuator.

26. The method of claim 21, further comprising configuring the drive unit as a modular drive unit with a base unit and a removable cartridge, the removable cartridge including control wires extending to the sheath actuator and the electrode actuator.

27. The method of claim 26, further comprising magnetically coupling linear actuators within the base unit to drive bearings within the removable cartridge to impart linear movement to the control wires.

28. The method of claim 21, further comprising limiting proximal movement of the actuator housing within an assembly interface of an actuator assembly holder using a holder stop.

29. The method of claim 21, further comprising driving the sheath actuator and the electrode actuator using nitinol wires encased in a flexible protective sheath.

30. The method of claim 21, further comprising: setting a zero point for electrode exposure; determining the electrode exposure during electrode insertion; selecting a transfer function based on the determined electrode exposure; measuring transimpedance values from a variety of electrode contacts on the inserted electrode; and utilizing the selected transfer function to detect fold-over from impedance information.

31. The method of claim 21, further comprising: setting a zero point for electrode exposure; determining the electrode exposure during electrode insertion; measuring transimpedance values from a variety of electrode contacts on the inserted electrode; and utilizing the electrode exposure and the transimpedance values in a transfer function to detect fold-over.

32. An actuator assembly for robotically assisted manipulation of an elongate implant, comprising: a sheath actuator including a sheath clip configured to engage a sheath of the elongate implant;an electrode actuator including an electrode clip configured to engage an electrode of the elongate implant; and an actuator assembly mount configured to position the sheath actuator and the electrode actuator relative to a patient, wherein the sheath clip and the electrode clip are configured to move independently to manipulate the sheath and the electrode independently.

33. The actuator assembly of claim 32, wherein the sheath clip is configured to engage a wing of the sheath.

34. The actuator assembly of claim 32, wherein the electrode clip is configured to engage an offset portion of the electrode.

35. The actuator assembly of claim 32, wherein the sheath clip includes a movable jaw and a fixed jaw, the movable jaw being pivotally connected to the fixed jaw via a clip hinge.

36. The actuator assembly of claim 32, wherein the electrode clip includes a movable jaw and a fixed jaw, the movable jaw being pivotally connected to the fixed jaw via a clip hinge.

37. The actuator assembly of claim 32, further comprising a release button configured to release the sheath clip and the electrode clip from engagement with the sheath and the electrode, respectively.

38. The actuator assembly of claim 32, wherein the sheath actuator and the electrode actuator are configured to be driven by flexible drive cables; and wherein the actuator assembly mount is configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

39. The actuator assembly of claim 32, wherein the sheath clip and the electrode clip are biased by a clip spring to maintain engagement with the sheath and the electrode, respectively.

40. The actuator assembly of claim 32, wherein the sheath actuator and the electrode actuator include actuator tracks for linearly moving the sheath clip and the electrode clip relative to the actuator assembly mount.

41. An actuator assembly for robotically assisted manipulation of an elongate implant, comprising: a first actuator configured to engage a sheath of the elongate implant; a second actuator configured to engage an electrode of the elongate implant; and a mounting mechanism configured to position the first actuator and the second actuator relative to a patient, wherein the first actuator and the second actuator are configured to move independently to manipulate the sheath and the electrode independently.

42. The actuator assembly of claim 41, wherein the first actuator includes an engagement mechanism configured to engage a feature of the sheath.

43. The actuator assembly of claim 41, wherein the second actuator includes an engagement mechanism configured to engage a feature of the electrode.

44. The actuator assembly of claim 41, further comprising a release mechanism configured to disengage the first actuator from the sheath and the second actuator from the electrode.

45. The actuator assembly of claim 41, wherein the first actuator and the second actuator are configured to be driven by a remote drive mechanism.

46. The actuator assembly of claim 41, wherein the mounting mechanism is configured to interface with a positioning system to position the actuator assembly relative to a patient.

47. The actuator assembly of claim 41, wherein the engagement mechanisms of the first actuator and the second actuator are biased to maintain engagement with the sheath and the electrode, respectively.

48. The actuator assembly of claim 41, wherein the first actuator and the second actuator include linear movement mechanisms for moving the engagement mechanisms relative to the mounting mechanism.

49. The actuator assembly of claim 41, further comprising sensors configured to monitor the position of the sheath and the electrode during implantation and provide real-time feedback to a remote drive mechanism.

50. The actuator assembly of claim 41, further comprising a remote drive mechanism including flexible drive cables configured to transmit linear movement to the first actuator and the second actuator.

51. The actuator assembly of claim 41, wherein the first actuator includes a movable engagement mechanism configured to securely engage the sheath.

52. The actuator assembly of claim 41, wherein the second actuator includes a movable engagement mechanism configured to securely engage the electrode.

53. The actuator assembly of claim 41, wherein the first actuator includes a housing recess to allow movement around a housing tab of an actuator housing.

54. The actuator assembly of claim 41, wherein the second actuator includes an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

55. The actuator assembly of claim 41, further comprising an actuator housing configured to retain the first actuator nested inside the second actuator.

56. The actuator assembly of claim 55, wherein the actuator housing includes at least one of: a guide slot configured to control rotational orientation of the first actuator and the second actuator; and a holder stop to limit proximal movement of the actuator housing within an assembly interface of an actuator assembly holder.

57. A system for robotically assisted manipulation of an elongate implant, comprising: a first actuator configured to engage a sheath of the elongate implant; a second actuator configured to engage an electrode of the elongate implant, wherein the first actuator and the second actuator are configured to move independently to manipulate the sheath and the electrode independently; a mounting mechanism configured to position the first actuator and the second actuator relative to a patient; and a drive unit coupled to the first actuator and the second actuator, wherein the drive unit is configured to provide independent movement to the first actuator and the second actuator.

58. The system of claim 57, wherein the drive unit includes linear actuators configured to impart linear movement through flexible drive cables to the first actuator and the second actuator.

59. The system of claim 57, further comprising an actuator assembly mount configured to interface with an adjustable arm to position the actuator assembly relative to a patient.

60. The system of claim 57, wherein the first actuator includes an engagement mechanism configured to engage a feature of the sheath, and the second actuator includes an engagement mechanism configured to engage a feature of the electrode.

61. The system of claim 57, further comprising an actuator housing containing the first actuator and the second actuator.

62. The system of claim 61, wherein the actuator housing includes a guide slot configured to control rotational orientation of the first actuator and the second actuator.

63. The system of claim 61, wherein the first actuator includes a housing recess to allow movement around a housing tab of the actuator housing.

64. The system of claim 61, wherein the actuator housing includes a holder stop to limit proximal movement of the actuator housing within an assembly interface of mounting mechanism.

65. The system of claim 57, wherein the second actuator includes an electrode clip configured to receive a distal portion of a stimulator connection of the electrode.

66. The system of claim 57, wherein the drive unit comprises a modular drive unit with a base unit and a removable cartridge, the removable cartridge including control wires extending to the first actuator and the second actuator.

67. The system of claim 66, wherein the base unit includes linear actuators with magnetic couplers configured to magnetically couple to drive bearings within the removable cartridge to impart linear movement to the control wires.

68. The system of claim 66, wherein the control wires are nitinol wires encased in a flexible protective sheath.

69. The system of claim 57, further comprising sensors configured to monitor the position of the sheath and the electrode during implantation and provide realtime feedback to the drive unit.

70. The system of claim 57, wherein the mounting mechanism is configured to interface with a positioning system to position an actuator assembly including the first actuator and the second actuator relative to a patient.

71. The system of claim 57, wherein the first actuator and the second actuator include linear movement mechanisms for moving the engagement mechanisms relative to the mounting mechanism.

72. The system of claim 57, wherein the first actuator includes a movable engagement mechanism configured to securely engage the sheath.

73. The system of claim 57, wherein the second actuator includes a movable engagement mechanism configured to securely engage the electrode.

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