Adjustable holder for implant insertion tool arm

The magnetically coupled positioning apparatus addresses the challenge of varying cochlear orientations by enabling precise and stable tool positioning during cochlear implantation, reducing the risk of implant or structural damage through controlled, patient-specific insertion trajectories.

WO2025137578A1PCT designated stage expired Publication Date: 2025-06-26IOTAMOTION INC +5

Patent Information

Application Number
PCT/US2024/061470
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-12-20
Filing Date
2024-12-20
Publication Date
2025-06-26

AI Technical Summary

Technical Problem

Cochlear implantation procedures face challenges in achieving precise, patient-specific tool positioning due to the variability in cochlear orientation among patients, which can lead to incorrect insertion trajectories and potential damage to the implant or delicate cochlear structures.

Method used

A magnetically coupled positioning apparatus is used, comprising a plate mounted to the patient's head and a base that magnetically couples with the plate, allowing for precise translation and articulation of an implant insertion tool through an articulating arm with magnetically coupled ball-and-socket joints, enabling controlled movement and optimal insertion angles.

Benefits of technology

The apparatus allows for precise and stable positioning of surgical tools, reducing the risk of damage to the implant and cochlear structures by enabling controlled, patient-specific insertion trajectories, thus enhancing the accuracy and safety of cochlear implantation procedures.

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Abstract

A third hand apparatus to aid cochlear implantation can include a plate with a mounting feature for securing to a patient's head and a base configured to magnetically couple with the plate. The base can translate in at least one dimension along a plane defined by the plate during magnetic coupling. An articulating arm can include a first joint, capable of maintaining an orientation of an implant insertion tool, held at a distal end of the arm, at a specified angle relative to the patient's head. The apparatus can facilitate precise tool positioning and stable holding during delicate cochlear procedures while eliminating the need for tension cables or mechanical tensioning mechanisms. The magnetic coupling approach can provide adjustable resistance to movement, allowing preferential articulation of certain joints while maintaining overall stability.
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Description

ADJUSTABLE HOLDER FOR IMPLANT INSERTION TOOL ARMCLAIM 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.BACKGROUND

[0002] Cochlear implantation is a surgical procedure performed under microscopic visualization to restore hearing function in patients with severe hearing loss. The procedure can involve the precise placement of an electrode array into the cochlea, which is a spiralshaped cavity within the inner ear. Such a procedure can involve maintaining precise control of the inserted device while simultaneously managing multiple instruments, such as implant and auxiliary tools, which can present a challenge to human dexterity.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0004] FIG. 1 A depicts an example of an apparatus to aid a cochlear implantation procedure in a human patient.

[0005] FIG. IB depicts an example of an apparatus to aid a cochlear implantation procedure in a human patient.

[0006] FIG. 2A is a cross section of an example of an apparatus to aid a cochlear implantation procedure in a human patient.

[0007] FIG. 2B is a side view of an example of an apparatus to aid a cochlear implantation procedure in a human patient.

[0008] FIG. 2C is a top view of an example of an apparatus to aid a cochlear implantation procedure in a human patient.

[0009] FIG. 2D is a bottom, perspective view of an apparatus to aid a cochlear implantation procedure in a human patient.

[0010] FIG. 3A is a perspective view of a plate coupled with an example of a base portion of an apparatus to aid a cochlear implantation procedure in a human patient.

[0011] FIG. 3B is a top view of a plate coupled with an example of a base portion of an apparatus to aid a cochlear implantation procedure in a human patient.

[0012] FIG. 4A is a side view of a plate coupled with an example of a base portion of a modular apparatus to aid a cochlear implantation procedure in a human patient.

[0013] FIG. 4B is a side view of a plate coupled with an example of a base portion of a modular apparatus to aid a cochlear implantation procedure in a human patient.

[0014] FIG. 5 A is a side view of an example of a patient -wearable apparatus to aid a cochlear implantation procedure in a human patient.

[0015] FIG. 5B is a perspective view of an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient.

[0016] FIG. 5C is a perspective view of an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient.

[0017] FIG. 6A is a perspective view of an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient.

[0018] FIG. 6B is a perspective view of an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient.

[0019] FIG. 6C is a perspective view of an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient.

[0020] FIG. 7A is a perspective view of an example of an apparatus to aid a cochlear implantation procedure, including a mounting plate including a clip for securing a portion of the base under patient tissue.

[0021] FIG. 7B is a perspective view of an example of an apparatus to aid a cochlear implantation procedure, including a mounting plate including a clip for securing a portion of the base under patient tissue.

[0022] FIG. 7C is a perspective view of an example of a mounting plate, including a clip for securing a portion of the base under patient tissue.

[0023] FIG. 7D is a perspective view of an example of a mounting plate, including a clip for securing a portion of the base under patient tissue.

[0024] FIG. 8A is a perspective view of an example of an apparatus to aid a cochlear implantation procedure, including a locking portion.

[0025] FIG. 8B is a perspective view of an example of an apparatus to aid a cochlear implantation procedure, including a locking portion.

[0026] FIG. 9 is a flowchart describing a process for cochlear implantation in a human patient.DETAILED DESCRIPTION

[0027] Cochlear implantation is a surgical procedure performed under microscopic visualization to restore hearing function in patients with severe hearing loss. A cochlear implant is composed of two main components: an external device worn behind the ear, and an internal device surgically placed under the skin behind the ear. Generally, the external device captures sound and transmits it to the internal device, which then stimulates the auditory nerve and sends electrical impulses to the brain, allowing the patient to perceive sound. During cochlear implantation procedure, a small incision is made behind the ear to access the mastoid bone, which is then drilled to create a small opening into the middle ear. The surgeon then carefully inserts an electrode array into the cochlea, making sure it is placed in the right position and that the delicate structures of the inner ear are not damaged. Once the electrode array is in place, the internal device is secured under the skin behind the ear. The orientation and trajectory of surgical tools during implantation can be important, such as to avoid possible damage either the implant or patient anatomy. The implant itself can, e.g., contain delicate internal wires that deliver sound stimulus to the cochlea, and insertion at an incorrect trajectory during insertion can cause the implant to bend, kink, or break these internal wires. Additionally, certain application of extremely misaligned insertion forces could possibly even damage sensitive structures within the cochlea, such as contributing to a poor hearing outcome.

[0028] A challenge in cochlear implantation is that the orientation of the cochlea varies considerably between patients, making it difficult for surgeons to determine the optimal insertion trajectory using standard anatomical reference points. This variability necessitates the ability to achieve precise, patient-specific tool positioning during the procedure. Certain surgical approaches rely primarily on the surgeon's manual dexterity and visual guidance, such as involving the surgeon working under microscopic visualization while coordinating multiple instruments. In an example, the procedure can be performed with the patient awake,which can involve specialized surgical tools and positioning systems that can accommodate patient movement while maintaining precise alignment.

[0029] One particular approach to aid tool positioning during cochlear implantation involves a bone-mounted plate with single degree of freedom linear stages, often referred to as "sleds," that allow sliding movement in one direction (e.g., movement in the "X" direction, while restricting movement in the “Y” direction and the “Z” direction). Such devices can present challenges in achieving a desired insertion angle of the implant. Another approach to aid tool positioning during cochlear implantation involves a “gooseneck”-style articulating arm (e.g., mounted to a patient head or on a surgical cart or table) that exhibits shape memory and tension in attempt to maintain a specified 3D position and angular orientation. However, certain gooseneck mechanisms often require variable and unpredictable forces to manipulate, can spring back from desired positions, and provide limited range of motion requiring screw removal for certain adjustments.

[0030] The present inventors have recognized the benefits of systems and methods for aiding in cochlear implantation procedures through the use of magnetically coupled positioning apparatus. This document describes an apparatus including a plate that mounts to or is otherwise fastened to a patient's head and a base that magnetically couples with the plate. The base can translate along the plane defined by the plate while maintaining magnetic coupling. This magnetic coupling approach can reduce, mitigate, or eliminate a need for tension cables or other mechanical tensioning mechanisms. An articulating arm can extend from the base and includes one or more ball-and-socket joints. The ball and socket joints can include magnetic couplings, or alternative can be non-magnetic and can be sized and shaped to hold a particular joint at a specified position via friction forces only. In an example, the apparatus can include multiple joints each having different magnetic coupling strengths from one another, allowing preferential movement of certain joints before others when manipulated. For example, a first joint closer to the base may resist articulation at forces that cause a second joint further from the base to move. This can provide a benefit to the end user, such as to provide a specified level of movement freedom, such as to suit a preference of the end user. Specific force ranges can be established (e.g., via end user-selection of magnetic strength in each respective joint), such as 0.1-0.8 newtons for joint articulation and less than 4 newtons for base-plate movement. The magnetic coupling strengths can be adjusted through various means, including adjustable spacing between magnetic components and surface treatments affecting friction, which can facilitate calibrating the device for desired movement characteristics corresponding with differing surgical scenarios. In an example, the magneticcouplings can be modular such as to facilitate quick attachment and detachment of different arm configurations.

[0031] In an example, the mounting plate can be secured to the patient's head by way of one or more mounting features, such as via bone screws through dedicated screw holes, clips that extend between the skin and skull, or including adjustable leveling features that buttress against the head. For example, clips extending between the skin and skull are described below in greater detail with respect to FIG. 7A, FIG. 7B, FIG. 7C, and FIG. 7D. The plate mounting approach can provide stability while following patient movement, which can be particularly important during procedures where the patient may be awake. The apparatus enables precise positioning and stable holding of surgical tools, particularly for cochlear implant insertion, where optimal trajectory is critical for preventing damage to both the implant and delicate cochlear structures. For example, the apparatus can facilitate that the articulating arm maintains tool orientation at specified angles relative to the patient's head without requiring constant manual support. This can free the surgeon's hands for other aspects of the procedure while working under microscopic visualization.

[0032]

[0033] FIG. 1A and FIG. IB each depict an example of an apparatus to aid positioning of a cochlear implant electrode array during an implantation procedure in a human patient. A third hand apparatus 102 can facilitate precise control and stability during cochlear implantation procedures through an innovative magnetic coupling system. In an example, the third hand apparatus 102 can be mounted to a patient head (e.g., at or near the skull) such that the third hand apparatus 102 orients an implant insertion tool 104 toward a target body location 106 on the patient. In another example, the third hand apparatus 102 is mounted to an operating table, a surgical chair, or stand nearby a patient, or another suitable location. In yet another example, the third hand apparatus 102 can be mounted to or otherwise include a band (e.g., 502 as depicted in FIG. 5 A) or other wearable garment for fastening the apparatus with respect to the patient head.

[0034] In an example, the third hand apparatus 102, the implant insertion tool 104, or both can include an attachment mechanism that can facilitate reliable, sturdy, and / or repeatable connections to the third hand apparatus 102. For instance, the third hand apparatus 102 can include a slot, subplate, quick-release, clamp, or another such mechanism adapted to align and secure the implant insertion tool 104 in a desired one or more of translation, rotation, tilt, or other degrees-of-freedom with the third hand apparatus 102. The attachment mechanism can also facilitate aligning aspects of the implant insertion tool 104 with a particular internalobject during implantation such as us er- adjustable motors, actuators, sensors, or object manipulators. In an example, the third hand apparatus 102 can include one or more coupling features (e.g., slots, grooves, magnetic elements, etc.) which can slidably interact to couple corresponding a coupling feature of the implant insertion tool 104. In an example, the attachment mechanism can facilitate quick-release or removal of the implant insertion tool 104 from the third hand apparatus 102, such as to allow for optional (e.g., temporary) handheld manipulation as desired by a user during a surgical procedure, such as to reorient or reload an implant into the implant insertion tool 104.

[0035] FIG. 2A is a cross section of an example of an apparatus to aid cochlear during an implantation procedure in a human patient. FIG. 2B, FIG. 2C, and FIG. 2D are side, top, and perspective view, respectively, of an apparatus to aid cochlear during an implantation procedure in a human patient. In an example, the third hand apparatus 102 can include a plate 202 sized and shaped for securing to the patient's head and a base 204 magnetically coupled to the plate 202, such that the base 204 is selectively repositionable on a surface 203 of the plate 202. The third hand apparatus 102 can also include an articulating arm 214 extending from the base 204, and the articulating arm 214 can hold and orient the implant insertion tool 104 at a desired 3 dimensional (3D) location and angular position with respect to patient anatomy, such as the target body location 106 as depicted in FIG. 1 A and FIG. IB.

[0036] As shown in FIG. 2A (as well as FIG. 1 A and FIG. IB), the third hand apparatus 102 and the implant insertion tool 104 can be coupled to establish a system to aid cochlear implantation at a target site of a patient. In operation and use, the articulating arm 214 can maintain an orientation of the implant insertion tool 104, held at a distal end 212 of the articulating arm 214, at a specified angle relative to the head of the patient. The specified angle can be an angle for forming a directed, gradual insertion of a target body location 106 of the patient, for example to a specified scala of the cochlea. For example, the specified angle can be between about 45-90 degrees relative to the surface 203, such as having an angular range capable of providing a near-horizontal (e.g., ±10%) trajectory for insertion of cochlear electrode array. In an example, the specified angle can be determined based on specific patient anatomical factors such as head shape (e.g. circumference of the head), head curvature shape and angle, and thickness of skin above the scala tympani. The design of the articulating arm, as described further below, provides several benefits for its use in surgery. Notably, the articulating arm 214 can be manipulated to hold the implant insertion tool 104 at the specified angle to substantially maintain the specified angle (e.g., within ± 5% of the specified angle) during the surgical procedure unless the articulating arm 214 is reoriented by a substantial(e.g., greater than about 1 Newton (N)) force. Likewise, the articulating arm 214 can articulate in a manner substantially free of “shape memory” or other retraction after positioning and can maintain position to hold the weight of the implant insertion tool 104 without “drooping” or similar movement during the surgical procedure.

[0037] In an example, the articulating arm 214 can include a plurality of magnetically coupled ball-and-socket (or spheroid) joints (e.g., first joint 206 and a second joint 210). For example, the first joint 206 and the second joint 210 can be joined by a connecting portion 208, which can act as the receiving feature or “socket” for one or both of the first joint 206 and the second joint 210. In an example, one or both of the “ball” or the “socket” portion of the first joint 206 or the second joint 210 can be magnetized. For example, the connecting portion 208, a receiving feature of the base 204, a receiving feature of the distal end 212, or a spherical ball of the first joint 206 or the second joint 210 can be magnetized. Alternatively or additionally, only the respective receiving portions (e.g., the connecting portion 208, a receiving feature of the base 204, a receiving feature of the distal end 212) or only the spherical balls of the first joint 206 or the second joint 210 can be magnetized, such as magnetized balls with non-magnetized sockets and vice versa. As described further below with respect to FIG. 4A and FIG. 4B, the "ball" portions and the “socket” portions can be removably couplable in a modular fashion, such as to allow an end user to construct and articulating arm 214 with desired characteristics for a procedure. As described herein, the terms “ball-and-socket” or "spheroid" need not relate to objects that are perfectly spherical and can similarly relate to similar round complementary shapes (e.g., oblate spheroid, ellipsoid, etc.). Also, such round complementary shapes need not be exactly complementary, such as differing slightly in shape from each other yet still “fitting” to form a functional joint.

[0038] In an example, the first joint 206 and the second joint 210 can be configured such as to have a hierarchical “strength” with respect to each other. This hierarchical arrangement enables preferential movement patterns, with the first joint resisting articulation when subject to forces between 0.1-0.8 newtons that would articulate the second joint, while the base-plate interface resists movement at forces below 4 newtons that would articulate both joints. Such a graduated resistance system can mimic a biomechanical joint relationship found in nature, such as similar to how human shoulder joints exhibit greater strength than elbow joints, which in turn are stronger than finger joints. The magnetic coupling strengths can be precisely enduser-adjusted. In an example, the first joint 206 or the second joint 210 can include screw threads for receiving mountable magnets, such as to facilitate fine-tuning of separation distances between magnetic components. Other features, such as insertable spacers, screws,sliceable parts, washers, interconnecting magnets, shims, spring biased elements, and the like that can be included such as to provide end-user adjusting of a magnetic strength of the articulating ball-and-socket joints. In an example, the interface surfaces between magnetic components can be modified with various treatments, including rough surfaces, lubricated surfaces, or tacky plastic surfaces, to achieve desired frictional characteristics.

[0039] FIG. 3 A and FIG. 3B are a perspective and top views, respectively of a plate coupled with an example of a base portion of an apparatus to aid during a cochlear implantation procedure in a human patient. As shown by the arrows a, b, c, and d, the base 204 can be slidably (and optionally, removably) coupled to the plate 202 in a plurality of directions (e.g., in one direction a-c or b-d, or in at least two directions, a-c and b-d). In an example, the base 204 can be magnetically coupled to the plate 202, permitting manipulation of the base in every direction along a plane defined by the interfacing surface of the plate 202. The sliding action of the base 204 with respect to the plate 202 can be performed independent of the articulating action of the articulating arm 214 (as depicted in and described with respect to FIG. 2 A, FIG. 2B, FIG. 2C, and FIG. 2D). For example, it is possible that the base 204 be slidably manipulated without significantly altering an angular orientation of an implant insertion tool 104 by the implant insertion tool 104 (as depicted in FIG. 1A and FIG. IB). In an example, a magnetic resistance provided by the interface between the plate 202 and the base 204 can be selected such as to be “stronger” (e.g., resist movement more than) the magnetic interface of one or more of the joints (e.g., the first joint 206 or the second joint 210) of the articulating arm 214. As such, the sliding and articulating actions of the third hand apparatus 102 can be manipulated in concert, with relatively fine movements available toward the distal end 212 of the third hand apparatus 102 and relatively “crude” movements available toward the plate 202 (as depicted in FIG. 2A).

[0040] In an example, a mounting interface between the plate 202 and the target body location 106 (e.g., an incision on a head of a human patient) can utilize various attachment mechanisms, such as screws, clips that engage with soft tissue, or other friction-based systems, providing flexibility in securing the device while maintaining stable positioning. For example, the plate 202 can be fastened to the patient head via screw holes 302 of the plate 202. Alternatively or additionally, the plate 202 can include or be fastened to a clip that can be inserted into the incision underneath patient skin or muscle, such as to secure the third hand apparatus 102 to the patient head without a need to drill into the skull.

[0041] In an example, the plate 202 can be formed of a material to resist undesired flexing during placement, particularly when mounted on curved surfaces, ensuring stable positioningduring surgical manipulation. For example, the base plate can be formed of a rigid polycarbonate polymer, a latex-free PVC polymer of a biocompatible grade, or another similarly biocompatible polymer that can be strengthened with internal metal or carbon fiber members (e.g. reinforced plastic). In an example, the plate 202 is designed to provide a stable planar surface on which the base 204 can be positioned relative to the insertion location for implantation of a cochlear implant using the insertion tool 104.

[0042] FIG. 4A and FIG. 4B each depict a side view of a plate coupled with an example of a base portion a modular apparatus to aid during a cochlear implantation procedure in a human patient.

[0043] In an example, the third hand apparatus 102 can include components having a modular magnetic design, such as to facilitate swapping of different kinematic structures and to construct a third hand apparatus 102 having a specified arm lengths (e.g., having a specified number of joints) to suit a given surgical scenario. Alternatively or additionally, the third hand apparatus 102 can include components having a modular design that is non-magnetic, such that the ball and socket joints are configured to hold a specified orientation based on friction or via a tensioning cable running therethrough. The modular design can facilitate customization of coupling strengths through adjustable spacing, interchangeable friction surfaces, and fine-tuning mechanisms. Such a modular technique can help simplify maintenance of the third hand apparatus 102 by providing component separation and enables optimization of joint behavior by adjusting individual characteristics to create preferential movement patterns, such as to mimic a natural hierarchy of human joint strengths. Such a modular adaptability can extend to a configuration of the base 204 with respect to the plate 202, such that an interface between the two can be modified from a rectangular shape to another base plate 202 shape, such as a triangular tripod layout, a circular shape, a polygon, etc. For example, as shown in FIG. 4B, additional joints to those described above with respect to FIG. 2A, FIG. 2B, FIG. 2C, and FIG. 2D can be optionally added by an end-user, such as to establish a third joint 404 involving a second connecting feature 402. The various joints created by the modular configuration of joints can establish an articulating arm, which can be end-user positionable to direct a surgical instrumentation at a desired orientation and hold the desired orientation despite a payload of the surgical instrument. Various elements of such an articulating arm can also be used in a robotic implant manipulation system, such as in various devices and systems described in PCT Application No. PCT / US2024 / XXXXXX and entitled, “INTERFACE AND MANIPULATION CONCEPTS RELATED TO ROBOTICINSERTION OF PERIMODIOLAR ELECTRODE ARRAYS” (Attorney Docket No. 4700.008W01).

[0044] In an example, the first joint 206 can be specified such as to resist articulation when subject to forces that would otherwise move the second joint 210, creating a hierarchical movement system. In another example, the first joint 206 and the second joint 210 can be substantially “matched” in terms of their magnetic resistance. While FIG. 4A and FIG. 4B each depict the first joint 206, second joint 210 and the third joint 404 as being relatively equal in size or having a substantially same ball diameter, the joints 206, 210, and 404 can instead be varied in relative sizing such as to be progressively larger or progressively smaller from the base 204 toward the distal end 212 of the articulating arm 214. For example, any combination of selected ball sizes and respective strengths thereof can be selected to construct a third hand apparatus 102 with a desired articulating action and horizontal movement action, such as to suit a particular surgeon's preferences or to help optimize the third hand apparatus 102 for a particular procedure (e.g., a pediatric implantation procedure vs. an adult implantation procedure).

[0045] Table 1, below, shows an example of a selection of holding forces and sliding / rolling forces, respectively, to move each of the base 204, the first joint 206 and the second joint 210. Similar AN can be progressively applied for further joints (e.g., in the event that a third joint 404 or n joint is added) such as to provide progressively finer movement toward a distal end 212 of the third hand apparatus 102 (as depicted in FIG. 2A). Herein, “holding force” refers to an applied force required to initially move the joint or interface from rest and “sliding / rolling force” refers to an applied force required to continually move the joint or interface once it has been set in motion.

[0046] Table 1 :

[0047] FIG. 5 A is a side view of an example of a patient -wearable apparatus to aid a cochlear implantation procedure in a human patient. FIG. 5B and FIG. 5C are each perspective viewsof an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient. In an example, the apparatus to aid cochlear implantation can be patient-wearable, such as on a band, strap, cap, or other garment for securing a base 504 of the apparatus at a fixed location on the patient. For example, as depicted in FIG. 5 A, the apparatus can include or use a headband 502 for fastening around a patient head, such that the base 504 of the apparatus is fixed with respect to the target body location 106. In an example, the base 504 can include the plate 202 (as depicted in FIG. 2B), which can be attachable directly to the headband 502.

[0048] Alternatively, the base 504 can include a linear track for receiving a follower 506 of the apparatus. Herein, the term “linear track” need not be limited to a strictly straight pathway, and instead can include any track having a planar path, such as tracks that are curved or include a bend. The follower 506 can be slidably coupled to the linear track and can move along the linear track such as to adjust the position of an instrument holder 510 extending from an arm 508 of the apparatus. In an example, the follower 506 can define an axis perpendicular to the linear track (i.e., in the upward direction as depicted in FIG. 5B). As shown in FIG. 5B and FIG. 5C, the arm 508 can be attached to the follower and can rotate around an axis perpendicular to the axis defined by the follower 506. A combined range of motion provided by the mechanism can include the movement of the follower 506 along the linear track, a rotation of the follower along the axis defined by the follower, the rotation of the arm 508 along the axis perpendicular to the axis defined by the follower 506, or optionally a rotation of the instrument holder 510 toward the target body location 106 (as shown in the movement of the instrument holder 510 between FIG. 5B and FIG. 5C). Each rotational and linear movement of the combined range of motion provided by the mechanism can be set by a user and can retain an orientation once manually placed by the user in a desired configuration.

[0049] FIG. 6A, FIG. 6B, and FIG. 6C are each perspective views of an example of a mechanism for a patient-wearable apparatus to aid a cochlear implantation procedure in a human patient. In an example, the apparatus can include one of several types of mechanisms, each comprised of at least the instrument holder 510 and the arm 508 (and optionally, the base 504) to provide various types of ranges of motion. For example, each respective mechanism depicted in FIG. 6A, FIG. 6B, and FIG 6C can be implemented on the headband 502 of FIG. 5 A. Also for example, the respective mechanisms depicted in FIG. 6A and FIG. 6B can each be attached to or otherwise include the follower 506 and the base 504 including the linear track, as depicted in FIG. 5B and FIG. 5C. As shown in FIG. 6A, the arm 508 can form a fullcontinuous “U” shape and provide a rigid arc to enable the instrument holder 510 to travel along the arm over a range of approximately 180 degrees. Such a configuration can help facilitate precise fine-tuning of an orientation of an axis of a surgical instrument with respect to the target body location 106. By manipulating the instrument holder 510 to different locations along the arm 508, allows the flexibility to choose the trajectory of the instrument holder 510 to a location based on the anatomy while reducing any impairment to the users visualization of the surgical field. As shown in FIG. 6B, the arm 508 can be relatively straight and the instrument holder 510 can travel in a straight line along the length of the arm 508. Here, the arm 508 can extend from a pivot (e.g., the follower 506 as depicted in FIG. 5C) and can rotate about the pivot to provide a relatively broad range of motion for the instrument holder 510. As shown in FIG. 6C, such a “straight” arm 508 can be slidably coupled to a base 504, such as providing a linear track and the arm 508 can slide (rather than pivot, as shown in FIG. 6B) to provide the relatively broad range of motion for the instrument holder 510.

[0050] FIG. 7A, FIG. 7B, FIG. 7C, and FIG. 7D each depict a mounting plate including a clip for securing a portion of the base under patient tissue, for use as a part of an apparatus to aid a cochlear implantation procedure. The mounting plate 714 can be similar in many respects to the mounting plate 202 as described in FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 3A, FIG. 3B, etc., and can be used similarly with corresponding elements to form the apparatus 702.

[0051] In an example, the apparatus 702 can include the mounting plate 714 having a “clip” feature 716, e.g., sized and shaped to provide a substantially flat surface that can be used as a support for the mounting plate 714. In operation and use, after an incision for the cochlear implantation access is made, a surgeon can detach soft tissues (e.g., muscle or connective tissue) from the skull surface in the region of skull superior to the mastoid region. The clip feature 716 can be sit against the bone, held by the tissue tensions and weight of the muscle and skin above such as to secure the mounting plate 714 to the patient head. In an example, the clip feature 716 includes a protrusion at or near an interface with the mounting plate 714, e.g., configured to suspend the mounting plate above the clip feature, an elevated over the soft tissue. Such a protrusion can help mitigate or prevent undesired flexing of the mounting plate 714 relative to the bone. The friction of the soft tissue and bone surface on the clip can help mitigate or prevent substantial movement of the mounting plate 714 during the surgery.

[0052] FIG. 8A is and FIG. 8B each depict an example of an apparatus to aid a cochlear implantation procedure, including a locking portion. The apparatus 802 depicted in FIG. 8A and FIG 8B can be similar in many respects to the apparatus 102 and the apparatus 702depicted in FIGs. 2A and 7A, respectively. As such, like components of the apparatus 802 can be used in a similar fashion to that previously described with respect to apparatus 102 and apparatus 702.

[0053] Apparatus 802 can include the mounting plate 202, a base portion 808, and one or more locking joints 812. In an example, at least one of the locking joints 812 can include a lever 810 configured to provide clamping force and to secure a locking joint 812 in a locked position. In an example, the base portion 808 can provide relatively limited rotational movement via a ball and socket joint (e.g., less than about 45 degrees of maximum angular movement across any plane) such that relatively large adjustments in the orientation of the apparatus can be performed via the one or more locking joints 812 and relatively fine adjustments can be performed via the base portion 808 or sliding of the base portion 808 along a surface of the mounting plate 202.

[0054] FIG. 9 is a flowchart describing a process for cochlear implantation in a human patient. For example, the process 900 can be performed using the third hand apparatus 102 as described depicted in and described with respect to FIG. 1 A, FIG. IB, FIG 2A, FIG. 2B, FIG 2C, FIG. 2D, FIG. 4A, FIG. 4B, FIG. 5A, FIG. 5B, FIG. 5C, FIG. 6A, FIG. 6B, FIG. 6C, FIG. 7 A, FIG. 7B, FIG. 7C, FIG. 7D, FIG 8 A, or FIG. 8B.

[0055] At 902, the process can include securing a plate to the patient's head using a mounting feature. For example, the mounting feature may utilize various attachment mechanisms, including screw holes for direct bone attachment through which screws are inserted to secure the plate, clips specifically sized and shaped to extend between the skin and skull, or an adjustable leveling feature that can be established or adjusted to buttress the plate against the patient's head.

[0056] At 904, the process can include translating a magnetically coupled base along the plate surface. For example, the base can be configured to move in at least one dimension along a plane defined by the plate while maintaining magnetic coupling. Such translation capability can facilitate precise positioning of the subsequent articulating components, with the baseplate interface magnetized to resist movement when subject to forces that would articulate the joints.

[0057] At 906, the process con include controlling an implant insertion tool's orientation through an articulating arm that includes first and second magnetically removable ball-and- socket joints. In an example, the first joint can be arranged between the second joint and the base, and a magnetic resistance of the joints can be selected between the first and secondjoints such as to establish a hierarchical structure, where the first joint resists articulation at forces between 0.1-0.8 newtons that would otherwise move the second joint. In an example, an interface at the base and the plate can maintain a stability against forces less than 4 newtons that would articulate the first and the second joint.

[0058] In an example, the process can further include adjusting coupling strengths through various mechanisms, such as by modification of magnetic separation distances and surface treatments, to optimize the system's performance for specific surgical requirements. Such a modular selection and coupling of various parts (e.g., as described with respect to FIG. 4 A and FIG. 4B) can be performed to provide rapid reconfiguration of arm lengths and joint arrangements.

[0059] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0060] Example l is a third hand apparatus to aid cochlear implantation in a human patient, the apparatus comprising: a plate including a mounting feature for securing the plate to a head the patient and a superior surface creating a substantially planar mounting surface; a base including a substantially flat inferior surface magnetically couplable to the planar mounting surface, wherein the flat inferior surface is configured to be translatable in two dimensions along a plane defined by the plate during magnetic coupling with the plate; and an articulating arm including a first joint, wherein the arm configured to maintain an orientation of an implant insertion tool, held at a distal end of the arm, at a specified angle relative to the head of the patient.

[0061] In Example 2, the subject matter of Example 1 includes, wherein the first joint includes a magnetically, removably couplable ball-and-socket joint.

[0062] In Example 3, the subject matter of Example 2 includes, wherein the arm includes a second joint including a magnetically, removably couplable ball-and-socket joint.

[0063] In Example 4, the subject matter of Example 3 includes, wherein the first joint and the second joint are respectively magnetized such that the first joint resists articulation when subject to a first specified force that articulates the second joint.

[0064] In Example 5, the subject matter of Example 4 includes, wherein the first joint is arranged between the second joint and the base.

[0065] In Example 6, the subject matter of Examples 4-5 includes, wherein the first specified force is within a range of zero point one newtons (N) and zero point eight N.

[0066] In Example 7, the subject matter of Examples 4-6 includes, wherein a base-plate interface is magnetized such that the base resists movement with respect to the plate when subject to a second specified force that articulates each of the first joint and the second joint.

[0067] In Example 8, the subject matter of Example 7 includes, wherein the second specified force is less than four newtons (N).

[0068] In Example 9, the subject matter of Examples 1-8 includes, wherein the arm configured to substantially maintain a user-manipulated configuration, upon release of external user-manipulation, without further articulation of the arm.

[0069] In Example 10, the subject matter of Examples 1-9 includes, wherein the mounting feature includes screw holes for screwing the plate to the head of the patient.

[0070] In Example 11, the subject matter of Examples 1-10 includes, wherein the mounting feature includes a clip configured to extend between skin of the head of the patient and a patient skull to secure the plate with respect to the head of the patient.

[0071] In Example 12, the subject matter of Examples 1-11 includes, wherein the mounting feature includes a leveling feature adjustable to buttress the plate against the head of a patient.

[0072] Example 13 is a system to aid cochlear implantation in a human patient, the system comprising: an elongate implant insertion tool; a plate including a mounting feature for securing the plate to a head the patient; a base configured to magnetically couple with the plate, wherein the base is configured to translate in at least one dimension along a plane defined by the plate during magnetic coupling with the plate; and an articulating arm including a first joint, wherein the arm configured to maintain an orientation of the elongate implant insertion tool, held at a distal end of the arm, at a specified angle relative to the head of the patient.

[0073] In Example 14, the subject matter of Example 13 includes, wherein the first joint includes a magnetically, removably couplable ball and socket joint.

[0074] In Example 15, the subject matter of Example 14 includes, wherein the arm includes a second joint including a magnetically, removably couplable ball and socket joint.

[0075] In Example 16, the subject matter of Example 15 includes, wherein the first joint and the second joint are respectively magnetized such that the first joint resists articulation when subject to a first specified force that articulates the second joint.

[0076] Example 17 is a method for cochlear implantation in a human patient, the method comprising: securing a plate including a mounting feature, a head the patient; translating a base, magnetically coupled with the plate, in at least one dimension along a plane defined bythe plate during magnetic coupling with the plate; and controlling, via an articulating arm including at least one joint, an orientation of an implant insertion tool held at a distal end of the arm, to orient the insertion tool at a specified angle relative to the head of the patient.

[0077] In Example 18, the subject matter of Example 17 includes, wherein: the at least one joint includes first and second magnetically, removably couplable ball-and-socket joints; the first joint is arranged between the second joint and the base; and a base-plate interface is magnetized such that the base resists movement with respect to the plate when subject to a second specified force that articulates each of the first joint and the second joint.

[0078] In Example 19, the subject matter of Example 18 includes, establishing or adjusting the first specified force to be within a range of zero point one newtons (N) and zero point eight N.

[0079] In Example 20, the subject matter of Examples 18-19 includes, establishing or adjusting the second specified force to be less than four newtons (N).

[0080] In Example 21, the subject matter of Examples 17-20 includes, wherein the arm configured to substantially maintain a user-manipulated configuration, upon release of external user-manipulation, without further articulation of the arm.

[0081] In Example 22, the subject matter of Examples 17-21 includes, securing the plate to the head of the patient via screws inserted through screw holes included in the mounting feature.

[0082] In Example 23, the subject matter of Examples 17-22 includes, securing the plate to the head of the patient via a clip included in the mounting feature, the clip sized and shaped to extend between skin of the head of the patient and a patient skull.

[0083] In Example 24, the subject matter of Examples 17-23 includes, establishing or adjusting a position of a leveling feature, included in the mounting feature, to buttress the plate against the head of a patient.

[0084] Example 25 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1-24.

[0085] Example 26 is an apparatus comprising means to implement of any of Examples 1- 24.

[0086] Example 27 is a system to implement of any of Examples 1-24.

[0087] Example 28 is a method to implement of any of Examples 1-24.

[0088] The above Detailed Description can include references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0089] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that can include elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.

[0090] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” can include “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain- English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that can include elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0091] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the aboveDetailed Description, various features can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should 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. A third hand apparatus to aid cochlear implantation in a human patient, the apparatus comprising: a plate including a mounting feature for securing the plate to the head of a patient and a superior surface creating a substantially planar mounting surface; a base including a substantially flat inferior surface magnetically couplable to the planar mounting surface, wherein the flat inferior surface is configured to be translatable in two dimensions along a plane defined by the plate during magnetic coupling with the plate; and an articulating arm including a first joint, wherein the arm is configured to maintain an orientation of an implant insertion tool, held at a distal end of the arm, at a specified angle relative to the head of the patient.

2. The apparatus of claim 1, wherein the first joint includes a magnetically, removably couplable ball-and-socket joint.

3. The apparatus of claim 2, wherein the arm includes a second joint including a magnetically, removably couplable ball-and-socket joint.

4. The apparatus of claim 3, wherein the first joint and the second joint are respectively magnetized such that the first joint resists articulation when subject to a first specified force that articulates the second joint.

5. The apparatus of claim 4, wherein the first joint is arranged between the second joint and the base.

6. The apparatus of claim 4, wherein the first specified force is within a range of 0.1 newtons (N) and 0.8 N.

7. The apparatus of claim 4, wherein a base-plate interface is magnetized such that the base resists movement with respect to the plate when subject to a second specified force that articulates each of the first joint and the second joint.

8. The apparatus of claim 7, wherein the second specified force is less than 4 newtons (N).

9. The apparatus of claim 1, wherein the arm configured to substantially maintain a user- manipulated configuration, upon release of external user-manipulation, without further articulation of the arm.

10. The apparatus of claim 1, wherein the mounting feature includes screw holes for screwing the plate to the head of the patient.

11. The apparatus of claim 1, wherein the mounting feature includes a clip configured to extend between skin of the head of the patient and a patient skull to secure the plate with respect to the head of the patient.

12. The apparatus of claim 1, wherein the mounting feature includes a leveling feature adjustable to buttress the plate against the head of a patient.

13. A system to aid cochlear implantation in a human patient, the system comprising: an elongate implant insertion tool; a plate including a mounting feature for securing the plate to a head the patient; a base configured to magnetically couple with the plate, wherein the base is configured to translate in at least one dimension along a plane defined by the plate during magnetic coupling with the plate; and an articulating arm including a first joint, wherein the arm configured to maintain an orientation of the elongate implant insertion tool, held at a distal end of the arm, at a specified angle relative to the head of the patient.

14. The system of claim 13, wherein the first joint includes a magnetically, removably couplable ball and socket joint.

15. The system of claim 14, wherein the arm includes a second joint including a magnetically, removably couplable ball and socket joint.

16. The system of claim 15, wherein the first joint and the second joint are respectively magnetized such that the first joint resists articulation when subject to a first specified force that articulates the second joint.

17. A method for cochlear implantation in a human patient, the method comprising: securing a plate including a mounting feature, a head the patient; translating a base, magnetically coupled with the plate, in at least two dimensions along a plane defined by the plate during magnetic coupling with the plate; andcontrolling, via an articulating arm including at least one joint, an orientation of an implant insertion tool held at a distal end of the arm, to orient the insertion tool at a specified angle relative to the head of the patient.

18. The method of claim 17, wherein: the at least one joint includes first and second magnetically, removably couplable ball-and-socket j oints; the first joint is arranged between the second joint and the base; and a base-plate interface is magnetized such that the base resists movement with respect to the plate when subject to a second specified force that articulates each of the first joint and the second joint.

19. The method of claim 18, comprising establishing or adjusting the first specified force to be within a range of 0.1 newtons (N) and 0.8 N.

20. The method of claim 18, comprising establishing or adjusting the second specified force to be less than 4 newtons (N).

21. The method of claim 17, wherein the arm configured to substantially maintain a user- manipulated configuration, upon release of external user-manipulation, without further articulation of the arm.

22. The method of claim 17, comprising securing the plate to the head of the patient via screws inserted through screw holes included in the mounting feature.

23. The method of claim 17, comprising securing the plate to the head of the patient via a clip included in the mounting feature, the clip sized and shaped to extend between skin of the head of the patient and a patient skull.

24. The method of claim 17, comprising establishing or adjusting a position of a leveling feature, included in the mounting feature, to buttress the plate against the head of a patient.

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