Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/30—Surgical robots
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00477—Coupling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/30—Surgical robots
  • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/06—Measuring instruments not otherwise provided for
  • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0526—Head electrodes
  • A61N1/0541—Cochlear electrodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
  • A61N1/36038—Cochlear stimulation

Definitions

• This document relates generally to medical systems and more particularly to systems, devices, and methods for robotic control of delivery, positioning, and manipulation of a perimodi olar electrode array.
• 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.
• a cochlear implant is a medical device that comprises an external sound processor, 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.
• the 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 electrodes 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.
• 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.
• 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 electrodes, 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 electrodes 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.
• Cochlear implant electrode arrays consist of multiple electrodes that are designed to stimulate different regions of the cochlea. The number of electrodes can vary depending on the specific device being used. The goal is to place a sufficient number of electrodes 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.
• 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).
• EABR electrically evoked auditory brainstem response
• NRT neural response telemetry
• 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.
• the goal of electrode placement in cochlear implant surgery is to achieve optimal contact between the electrodes 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.
• 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 near or 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 cause 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.
• a hearing-preservation cochlear implant surgery involves implanting an electrode assembly into the damaged cochlear region, while avoiding any trauma to the undamaged cochlear region to preserve any normal residual hearing.
• a surgeon manually inserts an electrode assembly into patient cochlea.
• a complete manual maneuvering of the electrode assembly may cause undesirable outcome in some patients.
• manual insertion of electrode assembly may lack precision in implant position and motion control, such as the control of insertion rate, distance, or forces applied to the implant for advancing the electrode assembly 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.
• 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 that enhance surgical precision in implant delivery and positioning as well as reducing the risk of perioperative trauma to undamaged cochlea region.
• 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 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 external positioning unit is a non-implanted external device. Compared to a partially or completely implantable insertion device, the external positioning unit discussed herein may substantially reduce the risk of complications associated with surgical implantation, extraction, or replacement of otherwise partially or completely implantable insertion device.
• the external positioning unit also has the advantage of easy troubleshooting, maintenance, and replacement, thereby reducing cost of the system and the procedure.
• the external positioning unit may have a small size with limited mechanical and electrical parts, thus making it flexible for external fixation to a patient.
• the external position unit can be affixed to the patient, affixed to an adjacent piece of equipment, or be handheld, among other affixation options considered within the scope of this disclosure.
• 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.
• the implants may include leads, catheter, guidewire, or other mechanical or electrical devices.
• the implants may be designed for temporary 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.
• FIGS. 1 A-1E illustrate, by way of example and not limitation, a robotically assisted implantation system and portions of an environment in which the robotically assisted implantation system may operate for manipulation of a perimodi olar electrode array.
• FIGS. 2A-2B illustrate, by way of example and not limitation, different views of another embodiment of an implant positioning unit including a mounting base and adjustable arm.
• FIGS. 3A-3E illustrate, by way of example and not limitation, different views of another embodiment of an implant-positioning unit for engaging and manipulating a perimodi olar electrode array.
• FIGS. 4A-4D are diagrams illustrating, by way of example and not limitation, different views of a sheath embodiment for manipulation of a perimodiolar electrode array.
• FIGS. 5A-5H are multiple views illustrating, by way of example and not limitation, the functioning of yet another embodiment of a portion of a robotically assisted implantation system designed to manipulate a perimodiolar electrode array.
• FIGS. 6A-6G are multiple views illustrating, by way of example and not limitation, an alternative actuator embodiment for manipulation of a perimodiolar electrode array including a sheath and electrode for use within one of the systems described herein.
• FIGS. 7A-7C are multiple views illustrating, by way of example and not limitation, another actuator embodiment for manipulation of a perimodiolar electrode array including an electrode and a sheath for use within one of the systems described herein.
• a robotically assisted device for implantation of a perimodiolar electrode array examples include leads, catheter, guidewire, guide sheath, 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.
• 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 or positioning or manipulation of a cochlear implant in a thyroplasty surgery.
• the system includes an implant-positioning unit a control console communicatively coupled to the implant-positioning unit.
• the implant-positioning unit includes a drive head 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.
• the included figures depict various embodiments of a robotically assisted implantation system optimized for use with perimodiolar electrode arrays.
• the robotically assisted implantation system consists of an enclosure housing, two or more motor assemblies providing torque independent of one another, two or more lead screws rotated by each motor, and two or more carriages actuated linearly by turning of the screws.
• Another example includes two or more motors coupled to a co-axial drive cable to transmit rotational movement to a drive head with multiple drive wheels.
• Yet another example can utilize linear actuators to, directly or in-directly, manipulate the electrode and sheath independently.
• the robotically assisted implantation system also utilizes a flexible portion of the outside sheath positioning cable as well as a flexible portion of the inside electrode positioning cable.
• the positioning cable is a coaxial cable with the outside sheath positioning cable surrounding the inside electrode positioning cable to deliver either linear actuation to the electrode and/or sheath or torque from the motors to a drive head (see alternative embodiments discussed further below).
• the housing includes an exit port for the positioning cables to travel concentrically out of the enclosure, through a flexible gooseneck tubing or adjustable semi-rigid arm, to the electrode/sheath assembly. More generally, the positioning cables or similar structures can extend out of a housing through an adjustable drive transmission conduit between the housing and a drive head.
• Gooseneck is used within the specification to describe an adjustable drive transmission conduit or similar structure.
• the outside sheath positioning cable can include a flexible wound cable with a hollow lumen and rigid end, capable of transmitting rotation, pushing, and pulling through a flexible gooseneck or an adjustable semi-rigid arm.
• the outside sheath positioning cable can also be attached with a revolute joint on one end to a carriage and on the other end rigidly to the sheath. When linearly actuated by the carriage either forward or backward the outside sheath positioning cable can transmit linear movement advancing or retracting the sheath or other instrumentation independent of the other movement.
• a third motor and gear may rotate the outside sheath positioning cable within the enclosure controlling the orientation of the sheath and therefore the orientation of the pre curved electrode insertion.
• a third motor and friction wheel assembly can be incorporated to enable rotational control over the electrode during insertion.
• the inside electrode positioning cable can include a flexible wound cable with a rigid end, capable of transmitting rotation, pushing, and pulling through a flexible gooseneck or an adjustable semi-rigid arm and outside sheath positioning cable.
• the inside electrode positioning cable can be attached with a revolute joint on one end to a carriage and on the other end can push an electrode array or other instrumentation. When linearly actuated by the carriage either forward or backwards the inside electrode positioning cable can transmit linear movement advancing or retracting the electrode independent of the sheath movement.
• the attachment between the outside sheath positioning cable and the sheath may be a friction-based press fit as depicted or may be an annular snap joint, or a cantilever snap joint, or graspers, or magnetic coupling.
• the sheath may be integrated into the rigid portion of the outside sheath positioning cable as once continuous piece eliminating the attachment to a 3rd party sheath.
• the attachment between the inside electrode positioning cable and the electrode may be a friction-based press fit as depicted or may be an annular snap joint, or a cantilever snap joint, or graspers, or magnetic coupling.
• the device is capable of advancing both the electrode and sheath together to or through the round window, into the cochlea, to the first turn. Then only the pre curved electrode is advanced forward out of the sheath around the turns of the cochlea while keeping the sheath stationary. And finally, the sheath is retracted while keeping the electrode stationary until the sheath and electrode disengage and the entire device is removed.
• the device is securely mounted in a stage/base that is attached to the patient using bone screws, sutures, adhesives, or straps.
• the stage/based of the system can be mounted or secured to a bed or any rigid structure within the adjacent surgical field.
• the stage/base is adapted to be handheld.
• the device e.g., external positioning device
• the stage, device, and sheath may have fiduciary markers for 3D (three dimensional) position tracking feedback.
• the motors may have rotary encoders for position tracking feedback while the carriages may have linear encoders for position tracking feedback.
• the motors used within the robotically assisted implantation system can be electro-magnetic motors, piezo-electric motors, or may be replaced with knobs/wheels turned manually by hand.
• each motor may be controlled using one or more foot pedals, console controller, or other controller.
• Each motor may be integrated into a closed loop positioning feedback system using one or more of rotary encoders, linear encoders, pressure sensors, torque sensors, or physiological feedback.
• the motors and additional mechanical mechanisms can be replaced with linear electric motors or linear actuators.
• the semi-rigid support arm used within the robotically assisted implantation system can be made of segmented balls and cylinders with a tension cable running down the center lumen. In an example, to move the arm tension is released and when in position, tension is reapplied making the entire arm rigid.
• Tension control can be controlled through lever actuation, button actuation, wheel actuation, or motor actuation.
• FIGS. 1A-1E illustrate a robotically assisted implantation system 100 for manipulation of a perimodiolar electrode array electrode 130.
• One of the key aspects of the system 100 is the ability to robotically manipulate both an electrode (such as electrode electrode 130) and an associated sheath sheath 140.
• the sheath sheath 140 is used to assist in implantation of the electrode electrode 130, such as by straightening a length of a naturally curved electrode, among other things.
• the systems discussed herein can also be utilized to manipulate other components such as sensing electrodes, stimulating electrodes, lights, lasers, cameras, or irrigation tools, among other things.
• the system 100 can include components such as device enclosure 105, stage base 110, and gooseneck 120.
• the stage base 110 can include mounting screws 112 (mounting screw 112A and mounting screw 112B, collectively referenced as mounting screws 112) to assist in securing the stage base 110 to the patient temporary for the procedure.
• the gooseneck 120 provides a semi-rigid conduit for transmission of linear actuation from the drive assembly within the device enclosure 105.
• the gooseneck 120 is adjustable to accommodate different orientations between the device enclosure 105/stage base 110 and the patient.
• the gooseneck 120 is an example of an adjustable drive transmission conduit.
• the stage base 110 can be adapted for fixation via a clamp to a bed (or other equipment within the surgical field), a microscope, surgical instruments such as a retractor, or a bone or other part of the patient.
• the stage base 110 can also be adapted to be handheld during a procedure.
• navigation system can be used to assist in determining and/or maintaining an optimal insertion trajectory of the electrode 130.
• the system 100 includes multiple fiducial markers 150 (in the drawings, the references 150 point to example locations for fiducial markers, the fiducial markers are not specifically illustrated) that can be used by a navigation system to coordinate determining and/or maintaining a trajectory for the electrode 130.
• the fiducial markers 150 could be optical or electromagnetic markers, among other well-known options for surgical navigation.
• FIG. IB and 1C illustrate the inner workings of the system 100 in various views.
• the system 100 includes actuation components dedicated to either electrode actuation (movement) or sheath actuation.
• the system 100 includes an electrode actuator and a sheath actuator, where each actuator includes components such as a motor, gears, a lead screw, a carriage, and control cables to deliver actuation through a flexible elongate body (gooseneck or adjustable drive transmission conduit) to a drive head.
• the actuators discussed in this embodiment can be alternatively implemented with linear electric motors or linear actuators of various types.
• the sheath 140 is manipulated by a combination of a sheath motor 210 coupled to a sheath lead screw 214 through a sheath motor gear 212 and a sheath lead screw gear 213. Rotation of the sheath lead screw 214 moves a sheath carriage 216 which in turn moves a sheath position control cable 218 that runs through the gooseneck 120 to a drive head 250 where the sheath position control cable 218 couples to the sheath 140.
• the electrode 130 is manipulated through a combination of an electrode motor 220 coupled to an electrode lead screw 224 through an electrode motor gear 222 and an electrode lead screw gear 223.
• the control cable is a coaxial cable that includes the electrode positioning control cable 228 running through the middle of the sheath position control cable 218.
• coaxial is utilized in describing the physical structure of the positioning control cable that, in this example, contains an outer cylindrical cable with an inner cable. In this example, the inner and outer cables can move independently or together.
• FIG. 6D illustrates a drive head 850 adapted to accept the actuator 805 discussed above.
• the drive head 850 includes sheath drive gear 851 and electrode drive gear 852. Extending above and below (proximal and distal of) the drive gears (851, 852), the drive head 850 includes a sheath actuator slot 853 and an electrode actuator slot 854 that are adapted to guide the sheath actuator 820 and electrode actuator 810 respectively.
• the drive head 850 also includes a latch door 858 that pivots over the drive head 850 to capture the actuator 805 once the electrode actuator 810 and the sheath actuator 820 are in position within the drive head 850 (see FIG. 6F where the latch door 858 is closed).
• FIG. 6E illustrates the drive head 850 with the latch door 858 open and the actuator 805 inserted into the sheath actuator slot 853 and the electrode actuator slot 854.
• FIG. 6G is a cross-section view of the drive head 850 and additional components of an implant positioning system 800.
• the system 800 can include flexible arm 860, electrode motor 870, and sheath motor 880.
• the electrode motor 870 couples to the electrode drive gear 852 via inside drive cable 864, which extends through the outer drive cable 862 within the flexible arm 860.
• the system 800 allows for independent manipulation of the electrode 130 and the sheath 140 within the limits of the electrode actuator 810 and the sheath actuator 820.
• the system 800 maintains small footprint drive head 850 that operates the actuator 805 with only two internal gears (851, 852).
• the system 800 enables manipulation of the sheath 140 and electrode 130 including the ability to extend the electrode 130 out of the distal end 142 of the sheath 140.
• FIGS. 7A-7C are multiple views illustrating an actuator 900 for manipulation of a perimodiolar electrode array including an electrode and a sheath for use within one of the systems described above.
• the actuator 900 includes an electrode actuator 910 and a sheath actuator 920.
• the electrode actuator 910 includes a split shaft 912 and distal fingers 914.
• the distal fingers 914 are adapted to receive a proximal portion of the electrode 130.
• the distal fingers 914 include enough proximal space to allow the proximal section 132 of the electrode 130 to extend outward.
• the sheath actuator 920 includes a distal end 922 with a sheath grasping slot 924. As shown in FIG.
• the sheath grasping slot 924 is adapted to receive the forceps flange 144 of the sheath 140.
• the method examples described herein can 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 or system 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 can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.
• Example 1 can include a system for robotically assisted manipulation of an elongate implant.
• the system can include a main enclosure coupled to a drive head.
• the main enclosure can include a first actuator to control linear movement of a sheath and second actuator to control linear movement of the elongate implant.
• the drive head can include a first drive structure to transmit actuation generated by the first actuator to the sheath and a second drive structure to transmit actuation generated by the second actuator to the elongate implant.
• Example 2 the subject matter of Example 1 can optionally include each of the first actuator and the second actuator having a motor rotationally coupled to a lead screw and a carriage coupled to the lead screw to translate rotation generated by the motor into linear movement.
• Example 3 the subject matter of Example 2 can optionally include each of the first actuator and the second actuator including a control cable coupled to the carriage to transmit linear movement of the carriage to the drive head.
• Example 4 the subject matter of Example 3 can optionally include the first drive structure coupling to the control cable from the first actuator to transmit linear movement to the sheath.
• Example 5 the subject matter of any one of Examples 3 and 4 can optionally include the second drive structure coupling to the control cable from the second actuator to transmit linear movement to the elongate implant.
• Example 6 the subject matter of any one of Examples 1 to 5 can optionally include the first drive structure including a rigid tube coupled to the sheath.
• Example 7 the subject matter of any one of Examples 1 to 6 can optionally include the second drive structure including a rigid tube to interface with the elongate implant.
• Example 8 the subject matter of any one of Examples 1 to 7 can optionally include the first actuator having a motor coupled to a transmission mechanism to transmit rotation to the first drive structure in the drive head.
• Example 9 the subject matter of Example 8 can optionally include the first drive structure being a friction wheel configured to transition the rotation delivered by the transmission mechanism into linear movement of the sheath.
• the first drive structure being a friction wheel configured to transition the rotation delivered by the transmission mechanism into linear movement of the sheath.
• Example 10 the subject matter of Example 9 can optionally include the transmission mechanism including a set of gears and a torque cable.
• the subject matter of Example 10 can optionally include the torque cable extending through a flexible gooseneck structure to the drive head.
• Example 12 the subject matter of any one of Examples 1 to 11 can optionally include the second actuator including a second motor coupled to a second transmission mechanism to transmit rotation to the second drive structure in the drive head.
• Example 13 the subject matter of Example 12 can optionally include the second drive structure being a friction wheel configured to transition the rotation delivered by the second transmission mechanism into linear movement of the elongate implant.
• the second drive structure being a friction wheel configured to transition the rotation delivered by the second transmission mechanism into linear movement of the elongate implant.
• Example 14 the subject matter of Example 13 can optionally include the second transmission mechanism including a central drive cable within a coaxial drive cable.
• Example 15 the subject matter of Example 14 can optionally include the coaxial drive cable including an outer drive cable coupled to the first actuator.
• Example 16 the subject matter of any one of Examples 1 to 15 can optionally include the first drive structure including a drive wheel to transmit rotation to a sheath actuator.
• Example 17 the subject matter of Example 16 can optionally include the sheath actuator including a cylindrical tube with a proximal half cylinder section and a distal end couplable to the sheath.
• the sheath actuator including a cylindrical tube with a proximal half cylinder section and a distal end couplable to the sheath.
• Example 18 the subject matter of any one of Examples 1 to 17 can optionally include the second drive structure including a drive wheel to transmit rotation to an elongate implant actuator.
• Example 19 the subject matter of Example 18 can optionally include the elongate implant actuator being a cylindrical structure that extends through an open side wall of a cylindrical sheath actuator.
• Example 20 the subject matter of any one of Examples 1 to 19 can optionally include each of the first actuator and the second actuator including a linear electric motor or a linear actuator to generate the linear movement.
• Example 21 the subject matter of any one of Examples 1 to 20 can optionally include a gooseneck extending out of the enclosure to transmit actuation generated by the first actuator and the second actuator to the sheath and the elongate implant via the drive head.
• Example 22 is a system including a first motor, a second motor, a first transmission mechanism, a second transmission mechanism, a first actuation mechanism, and a second actuator mechanism.
• the first transmission mechanism is coupled to the first motor
• the second transmission mechanism is coupled to the second motor.
• the first actuation mechanism is coupled to the first transmission mechanism to transmit movement generated by the first motor to a sheath actuator.
• the second actuation mechanism is coupled to the second transmission mechanism to transmit movement generated by the second motor to an electrode actuator.
• Example 23 the subject matter of Example 22 can optionally include the first actuation mechanism having a first drive wheel driven by one or more gears, the one or more gears driven by a torque cable coupled to the first motor.
• Example 24 the subject matter of Example 23 can optionally include the drive wheel including a pinion gear configured to engage a sheath rack portion of the sheath actuator.
• Example 25 the subject matter of any one of Examples 22 to 24 can optionally include the second actuation mechanism includes a second drive wheel driven by a torque cable coupled to the second motor.
• Example 26 the subject matter of Example 25 can optionally include the second drive wheel including a pinion gear configured to engage an electrode rack portion of the electrode actuator.
• Example 27 the subject matter of any one of Examples 22 to
• the first actuation mechanism having a sheath gear including gear teeth adapted to engage a gear section of the sheath actuator.
• Example 28 the subject matter of any one of Examples 22 to
• the second actuation mechanism including an electrode gear including gear teeth adapted to engage a gear section of the electrode actuator.
• Example 29 the subject matter of any one of Examples 22 to
• the electrode actuator 28 can optionally include the electrode actuator including a dovetail groove extending from a proximal end to a distal position adjacent a distal end of the electrode actuator.
• Example 30 the subject matter of Example 29 can optionally include the sheath actuator including a lateral extension arm including a dovetail shaped lateral end, the dovetailed shaped lateral end received within the dovetail groove.
• Example 31 the subject matter of Example 30 can optionally include the dovetail groove and the dovetailed shaped lateral end operable to enable restrained relative linear movement between the electrode actuator and the sheath actuator while maintaining parallel orientation between the electrode actuator and the sheath actuator.
• Example 32 the subject matter of any one of Examples 22 to
• the sheath actuator including an offset distal section extending into a distal end including a forceps flange slot adapted to receive a portion of the sheath.
• Example 33 the subject matter of any one of Examples 22 to
• Example 32 can optionally include the electrode actuator including distal fingers to engage an electrode.
• Example 34 the subject matter of Example 33 can optionally include the sheath actuator extending from a split shaft portion of the electrode actuator and includes a forceps flange slot on a distal end.

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