Conveying motion equipment

Abstract

A system for transferring motion from a non-sterilizable component to a sterilizable component is provided. The motion is transmitted by coupling a ferromagnetic source in the non-sterilizable component to a ferromagnetic sink attached to the sterilizable component. The ferromagnetic sinks may be configured as adapters that may be further coupled to tools for advancing or manipulating objects in the sterile field. A system for a surgical implantable medical device including an insertion tool is also provided. The insertion tool may be configured for holding and precise placement of a cochlear implant during surgery. The system of the present invention allows safe and accurate placement of cochlear implants in a patient in the context where the procedure is manually performed beyond the limits of human dexterity without the device of the present invention. An insertion tool for placing a cochlear implant may include a non-sterile handpiece incorporating electrical and mechanical components, an element for coupling the handpiece to a fine adjustment device, a sterile adapter, and a clip portion for holding the cochlear implant. Thus, a system of the invention is provided that ensures high quality cochlear implant insertion by safely and accurately placing the cochlear implant in a manner beyond the limits of dexterity of ordinary persons.

Description

Technical Field

[0001] The present invention relates to a system for moving objects in a sterile environment by transmitting motion generated in a non-sterile environment and transmitted through a sterile barrier and toward a sterile environment. In certain embodiments, the system may include a sterilizable component equipped with an adapter, the adapter being used to hold a tool mounted on the non-sterile component, wherein the movement of a magnetic source inside the non-sterile component transmits motion to the adapter acting as a ferromagnetic sink. In particular, the adapter may be equipped with a tool that can be used to move objects that need to be precisely placed or manipulated. In various embodiments, the present invention relates to objects (tools or implants) that must be moved during a surgical procedure. In particular, the present invention relates to the movement of objects in situations where movement with precise speed and acceleration is required. In certain embodiments, the movement of the object of the present invention may be in a precise and predefined spatial position and / or orientation, for which a fine adjustment device may be required, which may also be optionally coupled to a surgical positioning arm, which may or may not be a robotic arm. More particularly, the present invention relates to the movement of surgical tools used in a procedure, wherein the precision of the spatial and temporal aspects of the movement is necessary for success. Most particularly, the present invention relates to surgical instruments for placement of cochlear implants during cochlear implant surgery. The insertion tool of the present invention can optionally be used with a fine adjustment mechanism for even greater control of insertion and can also be coupled to a surgical positioning arm, which can optionally be a robotic arm. Furthermore, various embodiments of the present invention relate to surgical insertion tools having a sterilizable or disposable component and a non-disposable component connected by a coupling device, which can be magnetic. Background Art

[0002] In all surgical applications, there is a need to precisely move or place sterile devices within a sterile field. This requirement also finds application in various clinical and / or industrial fields such as tissue manipulation, precision manufacturing, and the medical and / or surgical fields. In each of these applications, a cost-effective method may be needed to precisely move and / or place devices or tools.

[0003] In many surgical scenarios (e.g., laparoscopic or robotic surgery), the motion generated by an electric motor must be transmitted to move surgical tools. The surgical tools that contact the patient must remain sterile throughout the surgical procedure. Sterilizing the electric motor or the housing containing the electric motor is often not technically feasible or cost-effective. As a result, the motion from the electrical / motor components of the surgical system must be transmitted through a sterile barrier.

[0004] The prior art describes many solutions in which a laparoscopic or robotic instrument (to be used sterile) can be attached to an additional non-sterile motor or set of motors. The movement of the motor(s) then generates subsequent movement of independent degrees of freedom in the laparoscopic or robotic instrument. The interface is typically formed across a soft / flexible sterile barrier (such as a sterile drape).

[0005] Soft sterile barriers, such as sterile drapes, have several disadvantages. In general, they are non-reproducible, making precise actuation of movement across them impossible. Actuation across soft barriers results in inconsistent translational motion, either in speed or position. Stick-slip behavior and undesirable slack or play can also occur.

[0006] As a result, there is an unmet need in the art for a device that can be operated without the need for a soft sterile barrier, and one such solution has been provided by the inventors in the context of the present disclosure.

[0007] U.S. Patent Application 2018 / 0161111 to Overmyer et al. provides an example of motion transfer from a motor in a robotic arm across a flexible sterile barrier to a corresponding component in a robotic surgical tool. Overmyer discloses the use of magnets across the sterile barrier, but the magnets are used to produce the mating of the corresponding components across the sterile barrier, rather than transferring motion. As discussed in detail herein, the applicant's invention does not require a sterile barrier at all - instead, the sterile components arranged around the non-sterile components are driven by magnetic forces rather than by motors.

[0008] One problem that may be encountered in each of these applications is that the machinery or equipment required for precise and consistent axial movement (i.e., minimal variation in the speed of movement) may be quite complex in its technical implementation and therefore not cost-effective to dispose of after each use cycle. Therefore, a non-disposable but also non-sterile embodiment is needed. Therefore, a solution approach may be to assemble a non-sterile component containing a precise and expensive moving actuator with a rather uncomplicated but "transfer" component that is durable and therefore reprocessable, and / or even simple and therefore cost-effective, that can be discarded after each use. In this approach, a solution for transmitting precise motion between the non-sterile component and the sterilizable component may be needed. Applicants are not aware of any such solution currently available, and they provide a cost-effective and precise solution herein.

[0009] While solutions for transferring precise motion from a non-sterile part of a device to a sterilizable part have broad applicability in science, manufacturing, and medicine, specific applications are evident in the surgical field. Many surgical applications require precise manipulation of surgical tools and / or precise placement of medical devices. This provides a clear example of situations where high precision is required, and therefore, machines that provide precise motion are potentially expensive and may not be sterilizable. Therefore, transferring precise motion from a non-sterile part to a sterilizable part would be highly desirable. Otology is an important example - the structures being manipulated are very small, and there are low tolerances for error. Cochlear implant surgery is an example of an otology surgical procedure that could benefit from such an approach.

[0010] Cochlear implant surgery ("CI") consists of three main steps. First, a mastoidectomy is performed, thereby opening the mastoid bone, providing access to the middle ear space. Next, the surgeon navigates the middle ear space, taking care to avoid critical structures such as the facial nerve and the chorda tympani. Once in the middle ear space, the surgeon creates an opening into the round window membrane of the cochlea (round window approach) or into the cochlear wall (cochleostomy). Finally, the electrode array is inserted into the cochlea. Each step of CI carries risks and challenges, including damage to the nerves located in the lateral skull base, incorrect or incomplete insertion of the electrode array, damage to structures within the cochlea, or the possibility of a suboptimal choice of cochlear implant for an individual patient.

[0011] Computer-assisted planning of CI procedures has been described using medical images to identify relevant anatomical structures (e.g., the cochlea) to plan access routes into the cochlea. To date, commercial tools such as OTOPLAN have been used to assist in optimal electrode selection (selecting the desired length of the CI electrode in conjunction with the anatomical structure) based on available imaging and audiological data for a given patient.

[0012] Every aspect and step of the cochlear implant procedure involves risks to the patient, including drilling, proper electrode selection, and the crucial step of actually inserting the selected electrode into the cochlea. Due to factors such as cost, the relative immaturity of the underlying technology, and the lack of high-quality methods for robotic insertion, robotic cochlear implant insertion (RCI) has not yet achieved near-universal adoption. Consequently, current practice still involves manual surgical insertion of the implant electrodes, which is inherently disruptive. Inserting a cochlear implant is practically beyond the limits of human dexterity, and as a result, approximately 50% of cochlear implant patients do not have the hearing performance they desire after surgery. This is largely because the insertion process is so rough and disruptive to the inner ear structures, which often results in the destruction of any residual hearing the patient may have. Consequently, conventional CI surgery is only approved for deaf patients. Due to this dynamic nature and cost issues, the overall implementation rate of cochlear implants is as low as 5%. As a result, of the 15 million people worldwide with hearing problems that could be addressed by cochlear implants, perhaps only 70,000 actually receive an implant.

[0013] The goal of high-quality cochlear implant insertion, which can be defined as the ability to safely and accurately place the cochlear implant - without damaging surrounding structures, while achieving a placement that actually enhances the patient's hearing to a valuable degree - has not yet been achieved in the field. High-quality cochlear implantation involves planning the surgical approach and patient-specific implant selection (using dedicated software-based decision support systems such as OTOPLAN), monitoring the progress of insertion (using fluoroscopy or electrocochleography - impedance measurement across different electrodes), and, critically, the actual insertion process that minimizes variations in insertion speed to avoid damaging delicate structures of the inner ear.

[0014] It has been stated that cochlear implantation is well beyond human dexterity and therefore there is a strong need in the clinical field for an insertion tool and methodology that can provide precise, safe insertion of the implant with the highest level of consistency of insertion (ie, minimal variation in insertion speed).

[0015] Manual insertion of cochlear implants involves the use of surgical tools such as forceps or probes. However, these surgical tools are currently moved manually, and as discussed herein, it will be appreciated that achieving consistency in movement is certainly beyond the limits of human mechanical dexterity, and therefore damage to the cochlear structures must be anticipated. Additionally, as is well known to surgeons and others skilled in the art, insertion of cochlear implants is additionally challenging due to the limited space provided by the surgical approaches (mastoidectomy, posterior tympanotomy), and consequently, access to manually manipulated surgical instruments is extremely limited.

[0016] The difficulty of electrode array insertion is often exacerbated by existing anatomical variations in the structures involved between patients (size of the cochlea, location and orientation of the round window), which means that different challenges are faced during each surgical procedure. For example, the round window opening of the cochlea is not always well exposed through the facial nerve recess in all patients, forcing the surgeon to navigate in a limited space without good visibility to place a small electrode array with imperfect instruments.

[0017] Therefore, there is a strong need in the art for an insertion tool and system that provides precise control over the placement of a cochlear implant during a CI procedure. There is also a need for an insertion tool and system that provides a disposable or sterilizable, relatively inexpensive insertion component designed for use in the sterile field that can be coupled with non-disposable, relatively expensive mechanical and electrical components that ultimately provide the required precision in movement of the disposable / sterilizable component.

[0018] Various strategies and tools have been proposed to improve the accuracy and safety of cochlear implant insertion. For example, the present assignee in WO2022 / 024090 proposed a method involving surgical planning, electrode selection, and monitoring the progress of insertion. In US8473075, Advanced Bionics disclosed an insertion system that includes a reinforcement element that provides for inserting an electrode array without buckling. In US7894916, Cochlear disclosed an insertion device involving a shape memory material that helps to adapt the electrode array to the shape of the patient's cochlea. And in US10994128, MedEl disclosed an insertion device that includes a retraction limiter and a plunger that is coupled to the implant to help ensure proper placement of the electrode array.

[0019] However, none of these known methods and devices provide an insertion tool that can be coupled to a platform that provides for efficient movement of the tool in selected spatial degrees of freedom. Such a platform can optionally take the form of a fine adjustment device and optionally take the form of a surgical arm that, in turn, allows for insertion of a cochlear implant with spatial and temporal precision that exceeds human dexterity. In this regard, it should be understood that known methods can improve implant placement, but only a system like the present invention (which truly takes the efficient movement of the implant out of the surgeon's hands during the insertion process) can provide the required precision to minimize structural damage to the cochlea.

[0020] In view of these shortcomings, the present inventors have recognized that a need exists for high-quality, safe CI procedures that involve a multifunctional insertion tool that includes disposable / sterilizable components coupled with non-disposable elements that can be configured to hold and precisely place a cochlear implant during surgery.

[0021] Of course, those skilled in the art will recognize that the same needs are felt in any surgical field requiring precise motion control and / or precise placement of medical devices. More broadly, scientific or manufacturing fields requiring precise motion control but also requiring the cost-effective use of sterile components will also benefit. Summary of the Invention

[0022] These objects and other advantages are achieved by a novel system for transmitting motion from a non-sterilizable component to a sterilizable component. In various embodiments, motion is transmitted from a ferromagnetic source within the sterilizable component to a ferromagnetic sink attached to the sterilizable component. In various specific embodiments, the ferromagnetic sink can be used as an adapter, which can be further equipped with a tool that can propel and / or manipulate objects within the sterile field.

[0023] In some embodiments, the system is configured such that the sterilizable component can be reproducibly and rigidly attached and detached from the non-sterile component, and such that movement of the moving element of the non-sterile component is transmitted to the moving element of the sterilizable component via magnetic coupling of a ferromagnetic source and a ferromagnetic sink.

[0024] In other embodiments, the magnetic coupling between the magnetic source and the magnetic sink can be selectively engaged and disengaged. Selective disengagement can occur at a predetermined load and can be implemented for safety reasons in certain applications. Selective engagement or disengagement can also be controlled by modulating the current flowing through a non-sterilizable component near the ferromagnetic source.

[0025] In some embodiments, these objects and other advantages are also achieved by a new system for high-quality insertion of cochlear implants by surgical means, which may include open, minimally invasive or robotic. The system of the present invention is an insertion tool that may include a handpiece, a sterile adapter, an electrode clamp, a piezoelectric motor box and a foot pedal that combine electrical and mechanical components. Those skilled in the art will understand that not all of these components will be necessary for an insertion tool for precise placement of a cochlear implant or other medical device. Therefore, elements may be omitted or modified, and the clamp may be configured to hold and place medical devices other than the electrode array. Nevertheless, the insertion device is optimally configured for precise placement of a cochlear implant or other medical device that requires precise placement.

[0026] Therefore, those skilled in the art will appreciate that the insertion device of the present invention can be used to insert other medical devices besides cochlear implants. Any surgical scenario in which a medical device must be inserted with extreme care and precision would be suitable for use with the present insertion device. The examples presented herein involving cochlear implant insertion are representative in nature, but not exclusive.

[0027] Thus, according to an embodiment of the present invention, a system for precise and secure placement of a medical device is provided. The system of the present invention may include: a non-sterile handpiece having a proximal end and a distal end; a coupling element for coupling a portion of the handpiece adjacent to its distal end to a device for fine adjustment of the position of the system; a sterile adapter portion removably attached to the distal end of the handpiece, the sterile adapter portion comprising a tube having a proximal end and a distal end and a rotating sleeve coupled to the proximal end of the tube, wherein the rotating sleeve is removably attachable to the distal end of the handpiece; and a clamp portion slidably engaged around the tube of the sterile adapter portion. The system is optimally configured to advance a medical device held by the clamp into position within a patient's body.

[0028] In an embodiment, the system is an insertion tool for a cochlear implant, the medical device is a cochlear implant, and the patient is a patient suffering from hearing loss suitable for treatment with a properly selected and placed cochlear implant.

[0029] In an embodiment, an inner circumferential portion of the rotating sleeve of the sterile adapter portion includes teeth that are engageable with corresponding teeth on an outer circumferential portion of the distal end of the handpiece to provide a secure, removable fixation of the sterile adapter to the handpiece.

[0030] In another embodiment, the tube of the sterile adapter portion includes a magnet slidably disposed within the interior lumen of the tube, and wherein the clamp portion is constructed of a magnetic material such that the position of the clamp portion on the tube can be controlled by engagement with the magnet.

[0031] In another embodiment, the rotational position of the clip portion can be adjusted by selectively engaging and rotating the teeth of the rotation sleeve about the teeth of the distal end of the handpiece.

[0032] In another embodiment, an apparatus for fine adjustment of the position of the system comprises an attachment element for selective engagement to the coupling element, and wherein the apparatus provides for adjusting the position of a medical device held by the clip in at least 3 vectors.

[0033] The inventive system of the present invention is optimally used in surgical approaches to cochlear implantation, which can be open, minimally invasive, or robotic. Once access to the patient's cochlea has been established, all surgical approaches to cochlear implantation would benefit from the precision of cochlear implant placement provided by current insertion tools. All surgical approaches require an insertion system that can precisely place the cochlear implant without damaging inner ear structures, which is understood to be beyond the limits of human dexterity. Therefore, an insertion tool that includes piezoelectric motor components and a fine adjustment modality such as the modality of the present invention would be beneficial, and indeed necessary, for reliable and atraumatic placement and positioning of cochlear implants.

[0034] Optionally, the insertion tool of the present invention can be combined with surgical planning, anatomically correct electrode placement, and intraoperative monitoring to achieve the goal of high-quality cochlear implant placement. However, even when deployed alone, the insertion tool of the present invention will improve the quality of CI procedures because it will provide for implant placement and positioning with precision beyond human dexterity, thereby reducing trauma and improving surgical outcomes. While this level of precision may eventually be achieved through the adoption of RCI procedures, providing insertion tools for precise implant placement in minimally invasive or open procedures is crucial given the low adoption rate of RCI.

[0035] These and other embodiments of the present systems and methods are described in more detail below with reference to the accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] - Figure 1 、 Figure 1 a and Figure 1 b shows a side cross-sectional view of a system for transferring motion from a non-sterile portion to a sterilizable portion according to various embodiments of the present invention.

[0037] - Figure 2 、 Figure 2 a and Figure 2 b shows a perspective cutaway view of a system for transferring two-dimensional motion from a non-sterile portion to a sterilizable portion according to various embodiments of the present invention.

[0038] - Figure 3 is a side view of an insertion device including sterile and non-sterile components according to an embodiment of the present invention.

[0039] - Figure 4 A close-up side view of an electrode clip and its components according to an embodiment of an insertion tool of the present invention is provided.

[0040] - Figure 5 A close-up view of a sterile adapter and its components of an embodiment of an insertion tool according to the present invention is provided.

[0041] - Figure 6 A close-up side view of a handpiece and components thereof is shown according to an embodiment of an insertion tool of the present invention.

[0042] - Figure 7 Components for coupling a handpiece to a fine adjustment device according to an embodiment of an insertion tool of the present invention are presented.

[0043] - Figure 8 A fine adjustment device for coupling to a handpiece of an embodiment of an insertion tool according to the present invention is shown.

[0044] - Figure 9 Shown is a perspective side view of a representative surgical scenario for using an insertion tool, according to an embodiment of the present invention. DETAILED DESCRIPTION

[0045] The present invention will now be described in detail in conjunction with various embodiments of the invention and with reference to the accompanying drawings.

[0046] In an embodiment, a system for transmitting motion from a non-sterile component to a sterilizable component is provided. The system may include: a non-sterile component including a moving element comprising a passive or active ferromagnetic source; a sterilizable component including a moving element comprising a passive ferromagnetic sink; and an adapter attached to the moving element of the sterilizable component to which an object, such as a surgical instrument, implant, etc., may be temporarily attached. The system may be configured such that the sterilizable component can be reproducibly and rigidly attached and detached from the non-sterile component, and such that motion of the moving element of the non-sterile component is transmitted to the moving element of the sterilizable component via magnetic coupling of the ferromagnetic source and the ferromagnetic sink.

[0047] In some embodiments, the motion of the transfer causes motion of the mobile element of the sterilizable component and, therefore, of the attached object within the sterile field. The motion may be translational or rotational.

[0048] In some embodiments, the magnetic coupling between the ferromagnetic source and the ferromagnetic sink can be selectively engaged and disengaged. Selective disengagement can occur when a predetermined load is reached, such as when movement in a sterile field is undesirable.

[0049] Now refer to Figure 1 , a system for transmitting motion may include a non-sterile part 101 and a sterilizable part 102. A ferromagnetic source 103 may be placed inside the non-sterile part 101. An actuator 104 may be provided that may be used to move the ferromagnetic source 103. A ferromagnetic sink 105 may be mounted to the sterilizable part 102. The ferromagnetic sink 105 may be used as an adapter for connecting to a tool 106. Figure 1In the embodiment of FIG, the movement of the actuator 104 causes the movement of the ferromagnetic source 103. Therefore, the movement of the ferromagnetic sink 105 or adapter also occurs, thereby further causing the movement of the tool 106. Figure 1 In embodiments of the present invention, sterilizable components, adapters, and tools can be sterilized and thus deployed in a sterile field, while non-sterile components can provide precise control of motion without the need for sterilization.

[0050] Figure 1 a and Figure 1 b shows components of an embodiment of the system of the present invention in different positions based on the movement of the actuator forwards and backwards in the horizontal direction.

[0051] Now refer to Figure 2 , a ferromagnetic source 201 can be placed inside a non-sterilizable component 202 and can be used to transmit two-dimensional motion to a ferromagnetic sink 203 attached to a sterilizable component 204. Figure 1 In an embodiment, the ferromagnetic sink can be used as an adapter for further coupling to a tool (not shown). Thus, precise movement of the tool in two dimensions in a sterile field can be provided.

[0052] Figure 2 a and Figure 2 b shows components of an embodiment of the system of the invention in different positions based on the movement of the ferromagnetic source along two dimensions of motion.

[0053] In another specific embodiment, a system for precise and secure placement of a medical device is provided. The system of the present invention is an insertion tool that may include a handpiece incorporating electrical and mechanical components, a sterile adapter, an electrode clamp, a piezoelectric motor box, and a foot pedal. The system of the present invention may include: a non-sterile handpiece having a proximal end and a distal end; a coupling element for coupling a portion of the handpiece adjacent to its distal end to a device for fine adjustment of the system's position; a sterile adapter portion that is removably attached to the distal end of the handpiece, the sterile adapter portion comprising a tube having proximal and distal ends and a rotating sleeve coupled to the proximal end of the tube, wherein the rotating sleeve is removably attachable to the distal end of the handpiece; and a clamp portion that slidably engages around the tube of the sterile adapter portion. The system is optimally configured to advance a medical device held by the clamp into position within a patient's body. The medical device may be a cochlear implant, and the clamp may be a pair of forceps or other suitable surgical tool for holding a cochlear implant.

[0054] A piezoelectric motor box may be incorporated into or coupled to a handpiece to allow a clamp or forceps to be advanced forward or retracted back into the surgical field. For example, a piezoelectric motor box may be incorporated into or coupled to a handpiece of an insertion tool used to insert a cochlear implant during a CI procedure. Thus, it may provide controlled advancement of a pair of forceps for holding a cochlear implant into a patient's inner ear, or retraction of forceps for holding a cochlear implant. Those skilled in the art will appreciate that elements other than the piezoelectric motor box may provide such advancement and / or retraction functionality, but that elements for controlled, precise advancement and retraction need to be provided to meet the goal of safe and precise placement of the cochlear implant. In various embodiments, a foot pedal may allow the operator to control the piezoelectric motor box, but those skilled in the art will appreciate that any similar functional element that can start and stop the advancement or retraction of the clamp or forceps that can be used in the operating room would be acceptable.

[0055] Now refer to Figure 3 , shows a side view of an insertion device comprising sterile and non-sterile components according to an embodiment of the present invention. The insertion device includes a clamp element 301, which can be configured to hold an electrode array for a cochlear implant or any other medical device requiring precise handling and / or insertion. Clamp element 301 can take the form of a pair of forceps or any other suitable holding device. Clamp element 301 can be formed from one or more interlocking sliding sleeve elements that fit together and circumferentially fit around a sterile adapter 302. Sterile adapter 302 and clamp element 301 are designed to be disposable or sterilizable and can therefore be deployed in a sterile field during surgery. Sterile adapter 302 is configured to attach to a handpiece 303, which can be held and manipulated by the surgeon during the surgical procedure. Handpiece 303 is not necessarily sterile and is not necessarily designed to be disposable or reusable. Handpiece 303 may contain electrical or mechanical components used to operate the insertion device.

[0056] Still refer to Figure 3 The handpiece 303 may also be coupled to a coupling element 304 that may be configured to couple the handpiece to a piezoelectric motor box (not shown) or other device for controlling movement of the insertion device. Those skilled in the art will appreciate that all elements of the insertion device may be constructed of materials known to be suitable for the construction and operation of similar devices and also suitable for use in an operating room setting.

[0057] Now refer to Figure 4 , provides a close-up side view of an electrode clip and its components according to an embodiment of an insertion tool of the present invention. Figure 3As disclosed, the clip element 301 can be formed from one or more interlocking sliding sleeve elements that fit together while also fitting circumferentially around the sterile adapter 302. Figure 4 , a close-up view of these elements of the clip element 401 is shown. Specifically, two interlocking sliding sleeve elements 401a and 401b are shown. These elements are configured to interlock together and circumferentially fit around the sterile adapter portion of the insertion device. Sliding sleeve elements 401a and 401b are exemplary in nature. Many variations are possible, the basic requirement being that the elements can interlock together, can together form a surgical tool suitable for holding or advancing a medical device in the surgical field, and can be circumferentially fitted around a sterile adapter or other similar component of an insertion tool according to the teachings of the present invention. Sliding sleeve elements 401a and 401b can have circumferential grooves to allow for appropriate manual fixation to the sterile adapter portion.

[0058] Now refer to Figure 5 , provides a close-up view of a sterile adapter 501 and its components according to an embodiment of an insertion tool of the present invention. The sterile adapter can be composed of three or more key components. First, portion 501a can be a polygonal sterile tube. Second, a rotating sleeve 502 can be assembled around the sterile tube 501a. The rotating sleeve 502 can present a snap-in spring 501b or other suitable element for securing to the clip element. The rotating sleeve 502 can also present an additional snap-in spring 501c (or other suitable element) on the inner edge for securing to the handpiece. Through this design, the sterile adapter provides for reliable fixation to the clip element and to the handpiece, ultimately providing for a stable sterile connection between the handpiece and the clip element.

[0059] Now refer to Figure 6 , provides a close-up side view of a handpiece and its components according to an embodiment of an insertion tool of the present invention. Handpiece 601 provides a circumferential groove 601a for securing the rotating sleeve of the sterile adapter. The body of handpiece 601b is preferably rotationally symmetrical and constructed of stainless steel. Handpiece 601 may also provide a snap-in groove 601c for attaching to a mounting component that can be used to secure the handpiece to a piezoelectric motor cartridge or other motorized element used for movement and / or advancement of the insertion tool within the surgical field.

[0060] Now refer to Figure 7 , shows components for coupling a handpiece to a fine adjustment device according to an embodiment of an insertion tool of the present invention. Coupling element 704 may incorporate a spring-loaded snap-fit ​​coupling. Figure 6, the spring-loaded snap coupling can be configured to engage the snap recess 601c of the handpiece 601. The coupling element 704 can be released from the handpiece of the insertion tool using a release button 705. The coupling element 704 can also incorporate means for securing to the fine adjustment mechanism via screws (not shown).

[0061] Now refer to Figure 8 , shows a fine adjustment device 800 for coupling to a handpiece according to an embodiment of an insertion tool of the present invention. The fine adjustment mechanism incorporates an interface coupling 801 that allows the fine adjustment mechanism to be adjusted by, for example, Figure 7 The coupling element shown in FIG is coupled to the handpiece. Figure 7 The coupling element 704 includes a screw or other suitable fixing element for fixing to a Figure 9 The device of the fine adjustment mechanism shown in . Figure 8 The fine adjustment device may further include linear z adjustment 802, vertical horizontal adjustment 803, and linear x / y adjustment 804. All elements 802, 803, and 804 allow for very precise and fine adjustment of the movement of the fine adjustment device, which in turn allows for very precise, fine, and controllable movement of, for example, an insertion tool to which the fine adjustment device may be coupled. The fine adjustment device may further include an additional coupling mechanism 805 that can be used to couple the fine adjustment device to a device such as, by way of example only, a manual or robotic surgical arm.

[0062] Those skilled in the art will now appreciate that the invention disclosed herein is an insertion tool for use in surgical scenarios requiring precise control of the insertion of a medical device. In the various embodiments presented, a handpiece of the insertion tool is coupled to or integrated with motorized and / or mechanical and / or electrical components that allow controlled movement of a clip portion or other retainer for a medical device, such as an electrode array for a cochlear implant. A fine adjustment mechanism may also be integrated that provides for even finer control of movement in surgical applications where such control is required to achieve a desired result.

[0063] Insertion device also solves key demand by having sterile parts and non-sterile parts.In an exemplary embodiment, insertion device has clip element, and this clip element can be disposable or sterilizable, and is configured to be assembled around the sterile adapter part, and this sterile adapter part also can be disposable or sterilizable.At the same time, the sterile adapter part can be assembled to handpiece, and this handpiece contains or is connected to all equipment parts that contain electrical or mechanical or motor components.Handpiece and other elements that contain electrical or mechanical or motor components that are connected with it are not configured to be disposable or sterilizable.Therefore, the more expensive elements of insertion device remain outside the sterile field, and can be constructed of suitable materials and do not need to be processed again, which means that they can have a much longer lifespan before needing to be replaced.This strategy keeps the total cost of insertion device and its components at a minimum.

[0064] Now refer to Figure 9 , shows a representative surgical scenario for using the insertion tool of the present invention. In this exemplary embodiment, the surgical scenario is prepared for inserting a cochlear implant into a patient's inner ear. Insertion tool 901 is shown coupled to fine adjustment device 902, which in turn is further coupled to surgical arm 903. The illustrated surgical scenario provides for precise control of the movement of insertion tool 901 during surgery, and therefore provides for accurate and controllable placement of the electrode array for the cochlear implant within the patient's body.

[0065] While the present invention has been shown and described with reference to particular embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. By way of example only and not limitation, those skilled in the art will readily appreciate that the methods / systems disclosed herein may be applied to other surgical fields.

[0066] In the following description paragraphs, further aspects of the present invention and its embodiments are listed as items. However, these items can also be precisely expressed as claims of the present application:

[0067] Item 1: A system for moving an object by conveying motion across a sterile barrier, comprising:

[0068] - a non-sterilizable component comprising a moving element containing a passive or active ferromagnetic source;

[0069] - a sterilizable component comprising a moving element comprising a passive ferromagnetic sink; and

[0070] an adapter, which is attached to the mobile element of the sterilizable member, to which an object such as a surgical instrument, an implant, etc. can be temporarily attached,

[0071] The system is configured such that the sterilizable component can be reproducibly and rigidly attached and detached from the non-sterile component, and such that the movement of the moving element of the non-sterile component is transmitted to the moving element of the sterilizable component via magnetic coupling of a ferromagnetic source and a ferromagnetic sink.

[0072] Item 2: The system of item 1, wherein the conveyed motion causes motion of the moving element of the sterilizable component and, thereby, the attached object within the sterile field.

[0073] Item 3: The system of Item 2, wherein the effective motion of the attached object is translational or rotational or both translational and rotational.

[0074] Item 4: The system of any of the preceding items, wherein the system allows motion in more than one degree of freedom.

[0075] Item 5: The system of Item 4, wherein effective motion of the object is enabled while all other degrees of freedom of motion are blocked.

[0076] Item 6: The system of item 1, wherein the source of the ferromagnetic field is static.

[0077] Item 7: The system of Item 6, wherein the source of the ferromagnetic field is a permanent magnet.

[0078] Item 8: The system of Item 1, wherein the source of the ferromagnetic field is dynamic.

[0079] Item 9: The system of Item 8, wherein the source of the ferromagnetic field is dynamically controlled.

[0080] Item 10: The system of Item 1, wherein the magnetic coupling between the ferromagnetic source and the ferromagnetic sink is selectively engageable and disengageable.

[0081] Item 11. The system of Item 10, wherein the magnetic coupling selectively disengages under a predetermined load.

[0082] Item 12: The system of Item 11, wherein the magnetic coupling is selectively disengaged when movement of the sterilizable component in the sterile field is undesirable.

[0083] Item 13: The system of Item 12, wherein the motion is undesirable because the moving object attached to the actuator encounters an obstacle or because the motion is restricted due to increased physical resistance.

[0084] Item 14: The system of any one of items 10 to 13, wherein the selective disconnection of the interaction is controlled by modulation of the field strength of the ferromagnetic source.

[0085] Item 15: The system of Item 14, wherein modulation of the source of the ferromagnetic field is achieved by dynamic control of the current flowing through the coil in the non-sterile component.

[0086] Item 16: The system of Item 15, wherein the adapter is configured to position / place the implantable medical device within the patient, wherein the implantable medical device is selectively grasped by forceps or clamps or other grasping instruments.

[0087] Item 17: The system of Item 16, wherein the implantable medical device is a cochlear implant.

[0088] Item 18: The system of any one of items 1 to 17, wherein the sterilizable member is configured to position the syringe within the patient.

[0089] Item 19: The system of any of the preceding items, wherein the sterilizable component is a sleeve assembled over the sterile barrier and the non-sterile component.

[0090] Item 20: The system of any preceding item, wherein the sterilizable component is configured for single use only.

[0091] Item 21: The system of any preceding item, wherein the sterilizable component is configured for multiple uses.

[0092] Item 22: A system for precise and safe placement of a medical device, comprising: a non-sterile handpiece having a proximal end and a distal end;

[0093] a coupling element for coupling a portion of the handpiece adjacent to its distal end to a device for fine adjustment of the position of the system;

[0094] a sterile adapter portion that is removably attached to the distal end of the handpiece, the sterile adapter portion comprising:

[0095] a tube having a proximal end and a distal end; and

[0096] a rotation sleeve coupled to the proximal end of the tube, wherein the rotation sleeve is removably attachable to the distal end of the handpiece; and

[0097] a clamp portion that slidably engages about the tubing of the sterile adapter portion;

[0098] Therein, the system is configured to advance a medical device held by a clip to a location within a patient's body.

[0099] Item 23: The system of Item 22, wherein the inner circumferential portion of the rotating sleeve includes teeth that are engageable with corresponding teeth on the outer circumferential portion of the distal end of the handpiece to provide a secure, removable fixation of the sterile adapter to the handpiece.

[0100] Item 24: A system according to Item 23, wherein the tube includes a magnet slidably disposed in the interior lumen of the tube, and wherein the clamp portion is constructed of a magnetic material so that the position of the clamp portion on the tube can be controlled by engaging with the magnet.

[0101] Item 25: The system of Item 23, wherein the rotational position of the clip is adjustable by selectively engaging and rotating the teeth of the rotating sleeve about the teeth of the distal end of the handpiece.

[0102] Item 26: A system according to Item 22, wherein the device for fine adjustment of the position of the system includes an attachment element for selectively engaging the coupling element, and wherein the device provides for adjusting the position of the medical device held by the clip in at least 3 vectors.

Claims

1. A system for moving an object by conveying motion through a sterile barrier, comprising: - a non-sterilizable component comprising a moving element containing a passive or active ferromagnetic source; - a sterilizable component comprising a moving element comprising a passive ferromagnetic sink; as well as an adapter attached to the mobile element of the sterilizable member, to which adapter an object such as a surgical instrument, an implant, etc. can be temporarily attached, The system is configured such that the sterilizable component can be reproducibly and rigidly attached and detached from the non-sterile component, and such that the movement of the moving element of the non-sterile component is transmitted to the moving element of the sterilizable component via the magnetic coupling of the ferromagnetic source and the ferromagnetic sink.

2. The system according to claim 1, wherein: The transmitted movement causes movement of the moving element of the sterilizable component and thus of the attached object in the sterile field.

3. The system according to claim 2, wherein: The effective motion of the attached object is translational or rotational or both translational and rotational.

4. A system according to any one of the preceding claims, wherein: The system allows motion in more than one degree of freedom.

5. The system according to claim 4, wherein: The effective motion of the object is enabled in one degree of freedom, while all other degrees of freedom are blocked.

6. The system according to claim 1, wherein: A static ferromagnetic field is generated by the ferromagnetic source.

7. The system according to claim 6, wherein: The ferromagnetic source is a permanent magnet.

8. The system according to claim 6, wherein: The strength of the ferromagnetic field is dynamic.

9. The system according to claim 8, wherein: The strength of the ferromagnetic field in the corresponding degree of freedom is dynamically controlled.

10. The system according to claim 1, wherein: The magnetic coupling between the ferromagnetic source and the ferromagnetic sink can be selectively engaged and disengaged by varying the strength of the magnetic field or by user control.

11. The system according to claim 10, wherein: The magnetic coupling is selectively disengaged under a predetermined load, wherein, in particular, the magnetic coupling is selectively disengaged when a movement of the sterilizable component in the sterile field is undesirable.

12. The system according to claim 11, wherein Movement may be undesirable because the moving object attached to the actuator encounters an obstacle or because movement is restricted due to increased physical resistance.

13. The system according to any one of claims 10 to 12, wherein: The selective disconnection of the interaction is controlled by the modulation of the field strength of the ferromagnetic source, wherein, in particular, the modulation of the source of the ferromagnetic field is achieved by dynamic control of the current flowing through the coil in the non-sterile component, and wherein, in particular, the adapter is configured to position / place an implantable medical device in the patient's body, wherein the implantable medical device is selectively grasped by forceps or a clamp or other grasping instrument.

14. The system according to claim 13, wherein: The implantable medical device is a cochlear implant.

15. A system according to any one of the preceding claims, wherein The sterilizable component is a sleeve that fits over the sterile barrier and the non-sterile component.

16. A system according to any one of the preceding claims, wherein: The sterilizable component is configured for single use only.

17. The system according to any one of claims 1 to 15, wherein: The sterilizable component is configured for multiple uses.

18. A system for accurate and safe placement of a medical device, comprising: a non-sterile handpiece having a proximal end and a distal end; a coupling element for coupling a portion of the handpiece adjacent to its distal end to a device for fine adjustment of the position of the system; a sterile adapter portion removably attachable to the distal end of the handpiece, the sterile adapter portion comprising: a tube having a proximal end and a distal end; a rotation sleeve coupled to the proximal end of the tube, wherein the rotation sleeve is removably attachable to the distal end of the handpiece; and a clamp portion slidably engaged about the tube of the sterile adapter portion; Therein, the system is configured to advance a medical device held by the clip to a location within a patient's body.

19. The system according to claim 18, wherein: An inner circumferential portion of the rotating sleeve includes teeth that are engageable with corresponding teeth on an outer circumferential portion of the distal end of the handpiece to provide secure, removable fixation of the sterile adapter to the handpiece.

20. The system of claim 19, wherein: The tube includes a magnet slidably disposed within an interior lumen of the tube, and wherein the clamp portion is constructed of a magnetic material such that a position of the clamp portion on the tube can be controlled by engagement with the magnet.

21. The system of claim 19, wherein: The rotational position of the clip is adjustable by selectively engaging and rotating the teeth of the rotation sleeve about the teeth of the distal end of the handpiece.

22. The system of claim 18, wherein: The apparatus for fine adjustment of the position of the system comprises an attachment element for selective engagement to the coupling element, and wherein the apparatus provides for adjusting the position of the medical device held by the clip in at least three vectors.

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