Transport and movement device

Abstract

A system for transmitting motion from a non-sterilizable component to a sterilizable component is provided. The motion is transmitted via coupling of a ferromagnetic source within the non-sterilizable component to a ferromagnetic sink attached to the sterilizable component. The ferromagnetic sink may be configured as an adapter that can further couple with a tool for propelling or manipulating an object within a sterile field. A system for a surgical implant medical device is also provided, which includes an insertion tool. The insertion tool may be configured for holding and accurately placing a cochlear implant during surgery. The system of the present invention allows for safe and accurate placement of a cochlear implant within a patient in situations where manually performing the procedure without the device of the present invention exceeds the limits of human dexterity. The insertion tool for cochlear implant placement 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. This provides a system of the present invention that ensures high-quality cochlear implant insertion through safe and accurate placement of the cochlear implant in a manner that exceeds the limits of normal human dexterity.

Description

[Technical Field]

[0001] The present invention relates to a conveying and moving device. FIELD OF THE INVENTION The present invention relates to a system for moving objects within a sterile environment by transmitting motion generated in the nonsterile environment and transmitted through a sterile barrier to the sterile environment. In certain embodiments, the system may include a sterilizable member fitted with an adapter for holding a tool that fits over the non-sterilizable member, where movement of a magnetic source within the non-sterilizable member transmits motion to the adapter, which functions as a ferromagnetic sink. In particular, the adapter may be fitted with a tool that can function to move objects requiring precise positioning or manipulation. 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 moving objects in situations requiring movement with precise speed and acceleration. In certain embodiments, the movement of the objects of the present invention can be performed at precise and predefined spatial locations and / or orientations that may require a fine adjustment apparatus that may optionally be further combined with a surgical positioning arm, which may or may not be a robotic arm. More specifically, the present invention relates to the movement of surgical tools for use in procedures where precision in the spatial and temporal aspects of the movement is required for success.More specifically, the present invention relates to surgical instruments for use in the placement of cochlear implants during cochlear implant surgery. The insertion tools of the present invention may optionally be used with a fine adjustment mechanism for further improved control of insertion and may optionally be coupled to a surgical positioning arm, which may be a robotic arm. Additionally, various embodiments of the present invention relate to surgical insertion tools with sterilizable or disposable components and non-disposable components connected by a coupling means, which may be magnetic. Background of the Invention

[0002] All surgical applications require precise movement or placement of sterile devices within a sterile field. This requirement may also find application in a variety of clinical and / or industrial fields, such as tissue manipulation, precision manufacturing, and medical and / or surgical fields. Each application may require a cost-effective approach for precise movement and / or placement of devices or tools.

[0003] In many surgical settings (e.g., laparoscopic or robotic surgical settings), motion generated by electric motors must be transmitted to move surgical tools. Surgical tools that come into contact with the patient must remain sterile throughout the procedure. Sterilizing electric motors or the enclosures that house them is generally technically difficult or cost-ineffective. As a result, motion from the electrical / motor components of the surgical system must be transmitted through a sterile barrier.

[0004] The state of the art describes numerous solutions in which a laparoscopic or robotic (to be used sterile) instrument can be attached to an otherwise non-sterile motor or set of motors. Movement of the motor then generates subsequent movement of an independent degree of freedom in the laparoscopic or robotic instrument. The interface is often created across a soft / flexible sterile barrier such as a sterile drape.

[0005] Soft sterile barriers, such as sterile drapes, have several drawbacks. In a general sense, they have a non-reproducible nature, making precise actuation of movements across them impossible. Movements across soft barriers can result in inconsistencies in the speed or position of the translated motion. Also, stick-slip behavior and undesirable slack or play can occur.

[0006] As a result, there is an unmet need in the field for instruments that can be operated without the requirement for a soft sterile barrier, with one of the solutions proposed by the present invention in the context of the current disclosure.

[0007] U.S. Patent Application Publication No. 2018 / 0161111 to Overmyer et al. proposes an example of transmission of motion from a motor in a robotic arm to a corresponding component in a robotic surgical tool across a flexible sterile barrier. While Overmyer's disclosure shows the use of magnets across the sterile barrier, the magnets are used to create a mating of corresponding components across the sterile barrier rather than to transmit motion. As discussed in detail herein, Applicant's invention does not require a sterile barrier at all; rather, a sterile component positioned around a non-sterile component is driven by magnetic force rather than by a motor.

[0008] One problem that may be encountered in each of these applications is that machines or devices requiring precise and consistent axial movement (i.e., minimal variation in the speed of movement) may be quite complex in their technical implementation and therefore may not be cost-effective to discard after each use cycle. Thus, a non-disposable, yet non-sterilizable, implementation is required. One solution approach may therefore be to fit non-sterilizable components containing precise and expensive movement actuators with less complex components that act as "transmission" components and are robust and therefore re-processable, and / or simple and therefore cost-effective to discard after each use. This approach may require a solution to transmit precise motion between non-sterilizable and sterilizable components. Applicant is not aware of any solutions of this type currently available, and provides a cost-effective and precise solution herein.

[0009] Solutions for transferring precise motion from non-sterilizable to sterilizable parts of a device have broad applicability in science, manufacturing, and medicine, with obvious specific applications 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 an instance where high precision is required, and thus, machines providing precise motion may be expensive and non-sterilizable. Therefore, transferring precise motion from a non-sterilizable portion to a sterilizable portion is highly desirable. Otological surgery is a key example—the structures being manipulated are very small, with a low margin for error. Cochlear implant surgery is one example of an otological surgical procedure that could benefit from such an approach.

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

[0011] Computer-assisted planning of CI surgery is described using medical images to identify relevant anatomy (e.g., the inner ear) and plan the access pathway to the inner ear. Current commercial tools, such as OTOPLAN, are used to assist in optimal electrode selection (determining the desired length of the CI electrode relative to the anatomy) given the available image and audiological data for a given patient.

[0012] Various aspects and steps of the cochlear implant procedure involve risks to the patient, including drilling, appropriate electrode selection, and, most importantly, the actual insertion of the selected electrode into the inner ear. Robotic cochlear implant insertion (RCI) has not achieved widespread adoption due to factors such as cost, the relative immaturity of the underlying technology, and the lack of a high-quality approach to robotic insertion. Therefore, current practice still involves manual surgical insertion of the implant electrode, which is inherently destructive. Because inserting a cochlear implant currently exceeds the limits of human dexterity, approximately 50% of cochlear implant patients do not achieve their required hearing function after surgery. This is generally because the insertion process is very rough and destructive to the inner ear structures, often resulting in the destruction of any residual hearing the patient may have. Therefore, conventional CI surgery is limited to deaf patients. Because of this trend, coupled with cost issues, cochlear implant adoption rates are generally low at 5%. As a result, of the 15 million people worldwide with hearing problems that could be addressed by cochlear implants, perhaps only 70,000 currently receive implants.

[0013] The goal of high-quality cochlear implant insertion remains elusive in the field, and can be defined as the ability to safely and accurately place a cochlear implant—one that truly enhances the patient's hearing to a meaningful degree, while avoiding damage to surrounding structures. High-quality cochlear implantation involves planning the surgical approach and selecting a patient-specific implant (using a dedicated software-based decision support system, such as OTOPLAN), monitoring the insertion progress (using fluoroscopy or electro-cochleography—using impedance measurements between different electrodes), and, especially importantly, the actual insertion process, minimizing variability in insertion speed to avoid damage to the delicate structures of the inner ear.

[0014] It is argued that cochlear implants literally exceed the limits of human dexterity, and therefore there is a strong clinical need for insertion tools and methodologies that can provide accurate and safe insertion of the implant through insertion with the highest level of consistency, i.e., minimal variability in insertion speed.

[0015] Manual insertion of cochlear implants involves the use of surgical tools such as forceps and stylets. However, these surgical tools are currently moved manually, and as discussed herein, it is understood that achieving consistency in movement clearly exceeds the limits of human mechanical dexterity, and therefore, damage to the cochlear structures is anticipated. Furthermore, as is well known to surgeons and others skilled in the art, insertion of cochlear implants is further complicated by the limited space provided by surgical approaches (mastoidectomy, posterior tympanotomy), which results in severely limited access for manually operated surgical instruments.

[0016] The difficulty of inserting an electrode array is often compounded by existing anatomical variations in the involved structures (cochlear size, round window location and orientation) between patients, and different challenges can be faced in each procedure. For example, the cochlear round window opening is not adequately exposed through the facial recess in all patients, thus forcing the surgeon to proceed with imperfect instruments and without good visibility in the limited space for placing the small electrode array.

[0017] Thus, there is a strong need in the field for insertion tools and systems that provide precise control of cochlear implant placement during CI surgery, and that provide relatively inexpensive disposable or sterilizable insertion components designed for use in the sterile field that can be combined with non-disposable, relatively expensive mechanical and electrical components that ultimately provide the desired precision of movement of the disposable / sterilizable components.

[0018] Various strategies and tools have been proposed to improve the accuracy and safety of cochlear implant insertion. For example, in WO 2022 / 024090, the present applicant proposes an approach involving surgical planning, electrode selection, and monitoring of insertion progress. In US 8,473,075, Advanced Bionics discloses an insertion system including a stiffening element that provides for buckling-free insertion of the electrode array. In US 7,894,916, Cochlear discloses an insertion device involving a shape memory material that helps adapt the electrode array to the shape of the patient's cochlea. Also, in US 1,099,4128, Med El discloses an insertion device including a retraction limiter and plunger coupled to the implant to help ensure proper placement of the electrode array.

[0019] However, none of these known approaches and devices provide an insertion tool that can be coupled to a stage capable of providing efficient movement of the tool in selected spatial degrees of freedom. Such a stage takes the form of a fine adjustment device and, concomitantly, a surgical arm that therefore permits insertion of the cochlear implant with spatial and temporal precision that exceeds that of human dexterity. In this regard, it will be appreciated that known approaches can improve implant placement; however, only a system such as the present invention, which literally employs efficient movement of the implant during the insertion process without the surgeon's hands, can provide the precision necessary to minimize structural damage to the cochlea.

[0020] With these drawbacks in mind, the inventors recognized that a high quality and safe CI procedure requires a multifaceted insertion tool involving disposable / sterilizable parts coupled with a non-disposable element that can be configured to hold and precisely position a cochlear implant during surgery.

[0021] Those skilled in the art will, of course, recognize that the same need is felt in any surgical field requiring precise movement control and / or precise placement of a medical device. More broadly, any scientific or manufacturing field requiring not only precise movement control but also cost-effective use of sterile components would also be beneficial. Summary of the Invention

[0022] These objects and other advantages are achieved by a novel system for transferring motion from a non-sterilizable component to a sterilizable component. In various embodiments, motion is transferred from a ferromagnetic source within the sterilizable component to a ferromagnetic sink fitted to the sterilizable component. In various specific embodiments, the ferromagnetic sink can function as an adapter that can be advanced in the sterile field and / or further fitted to a tool that manipulates objects in the sterile field.

[0023] In some embodiments, the system is configured so that the sterilizable member is rigidly attached and reproducibly detachable onto the non-sterilizable member, and so that motion of a moving element of the non-sterilizable member is transmitted to the moving element of the sterilizable member via magnetic coupling of a ferromagnetic source with a ferromagnetic sink.

[0024] In further embodiments, the magnetic coupling between the magnetic source and magnetic sink can be selectively engaged and disengaged. Selective disengagement can occur at a predetermined load and may be implemented for safety reasons in certain applications. Selective engagement or disengagement can be controlled via modulation of current through non-sterilizable components in the vicinity of the ferromagnetic source.

[0025] In some embodiments, these objects and other advantages are also achieved by a novel system for high-quality insertion of cochlear implants by surgical means, which may include open, minimally invasive, or robotic. The inventive system is an insertion tool that may include a handpiece incorporating electrical and mechanical components, a sterile adapter, an electrode clip, a piezo-motor box, and a foot pedal. Those skilled in the art will appreciate that not all of these components are required for an insertion tool to function for precise placement of a cochlear implant or other medical device. Accordingly, elements may be omitted or modified, and the clip may be configured to hold and position medical devices other than an electrode array. The insertion device is nevertheless optimally configured for precise placement of a cochlear implant or other medical device requiring precise placement.

[0026] Those skilled in the art will therefore understand that the inventive insertion device can also be used for the insertion of other medical devices alongside cochlear implants. Any surgical situation in which a medical device must be inserted with great care given to precision and placement will be suitable for use with the present insertion device. The examples given herein relating to the insertion of cochlear implants are representative and not limiting in nature.

[0027] Thus, according to one embodiment of the present invention, there is provided a system for accurate and safe placement of a medical device. The inventive system may include a non-sterile handpiece with proximal and distal ends, a coupling element for coupling a portion adjacent the distal end of the handpiece to a device for fine-tuning the position of the system, a sterile adapter portion removably secured to the distal end of the handpiece and including a tube with proximal and distal ends and a rotation sleeve engaged with the proximal end of the tube, the rotation sleeve being removably secured to the distal end of the handpiece, and a clip portion slidably engaged around the tube of the sterile adapter portion. The system is optimally configured to advance the medical device retained by the clip to a position in a patient.

[0028] In one 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 a hearing loss suitable for treatment with an appropriately selected and placed cochlear implant.

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

[0030] In a further embodiment, the tube of the sterile adapter portion comprises a magnet slidably disposed in the inner lumen of the tube, and the clip portion is constructed from a magnetic material, such that the position of the clip portion on the tube is controllable by engagement with the magnet.

[0031] In a further embodiment, the rotational position of the clip portion is adjustable by selectively engaging and rotating teeth on a rotating sleeve around teeth on the distal end of the handpiece.

[0032] In a further embodiment, the device for fine-tuning the position of the system comprises an attachment element for selective engagement with the coupling element, and the device provides for adjustment in at least 3 vectors of the position of the medical device held by the clip.

[0033] The inventive system of the present invention can be optimally used in any surgical approach to cochlear implantation, whether open, minimally invasive, or robotic. All surgical approaches to cochlear implantation can benefit from the precision of cochlear implant placement provided by current insertion tools once access to the patient's cochlea is established. It is understood that all surgical approaches require an insertion system capable of precisely placing the cochlear implant without damaging inner ear structures, which exceeds the limits of human dexterity. Therefore, an insertion tool equipped with piezo-motorized components with a fine adjustment modality, such as that of the present invention, can be beneficial and, indeed, desired for reliably injury-free cochlear implant placement and positioning.

[0034] Additionally, the insertion tool of the present invention can be combined with surgical planning, anatomically correct electrode placement, and intra-operative monitoring to achieve the goal of high-quality cochlear implant placement. Deployed by itself, however, the inventive insertion tool can improve quality in CI surgery because it provides implant placement and positioning with precision that exceeds human dexterity, thereby reducing trauma and improving surgical outcomes. While this level of precision may ultimately be possible with the adoption of RCI surgery, in settings where RCI adoption is low, an insertion tool for accurate implant placement in minimally invasive or open surgery is critical.

[0035] These and other embodiments of the inventive systems and methods are described in detail below with reference to the accompanying drawings. [Brief explanation of the drawings]

[0036] 1, 1a and 1b show side cross-sectional views of a system for transmitting motion from a non-sterilizable part to a sterilizable part according to various embodiments of the present invention. - Figures 2, 2a and 2b show perspective cut-away views of systems for transmitting motion in two dimensions from a non-sterilizable part to a sterilizable part according to various embodiments of the present invention. FIG. 3 is a side view of an insertion device with sterile and non-sterile parts according to one embodiment of the present invention. FIG. 4 provides an enlarged side view of an electrode clip and its parts according to one embodiment of the insertion tool of the invention. - Figure 5 provides an enlarged side view of a sterile adapter and its parts according to one embodiment of the insertion tool of the present invention. FIG. 6 shows an enlarged side view of the handpiece and its parts according to one embodiment of the insertion tool of the invention. FIG. 7 depicts the components for coupling the handpiece to the micro-adjustment device according to one embodiment of the insertion tool of the invention. FIG. 8 shows a micro-adjustment device for coupling to a handpiece according to one embodiment of the insertion tool of the invention. FIG. 9 shows an enlarged side view of a typical surgical setup for use of an insertion tool according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0037] The present invention will now be described in detail with reference to various embodiments thereof and with reference to the accompanying drawings.

[0038] In one embodiment, a system for transferring motion from a non-sterilizable component to a sterilizable component is provided. The system may include a non-sterilizable component with a moving element containing a passive or active ferromagnetic source, a sterilizable component with a moving element containing 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, or the like, can be temporarily attached. The system may be configured such that the sterilizable component is rigidly attached to and reproducibly detached from the non-sterilizable component, and such that motion of the moving element of the non-sterilizable component is transferred to the moving element of the sterilizable component via magnetic coupling of the ferromagnetic source with the ferromagnetic sink.

[0039] In some embodiments, the transmitted motion causes motion of a moving element of the sterilizable member, which consequently causes motion of the attached object within the sterile field. The motion can be translational or rotational.

[0040] In some embodiments, the magnetic coupling between the ferromagnetic source and the ferromagnetic sink can be selectively engaged and disengaged. The selective disengagement can occur when a predetermined load is reached, for example, when movement in the sterile field is undesirable.

[0041] Referring now to FIG. 1 , a system for transmitting motion may include a non-sterilizable component 101 and a sterilizable component 102. A ferromagnetic source 103 may be disposed within the non-sterilizable component 101. An actuator 104 may be provided and may function to move the ferromagnetic source 103. A ferromagnetic sink 105 may be fitted to the sterilizable component 102. The ferromagnetic sink 105 may function as an adapter for connection with a tool 106. In the embodiment of FIG. 1 , movement of the actuator 104 causes movement of the ferromagnetic source 103. Consequently, movement of the ferromagnetic sink 105 or adapter, in turn, causes movement of the tool 106. In the embodiment of FIG. 1 , the sterilizable component, adapter, and tool may be sterilized and thereby deployed in a sterile field, while the non-sterilizable component may provide precise control of motion without the need for sterilization.

[0042] 1a and 1b show components of an embodiment of the inventive system in different positions based on the actuator forward and backward movement in the horizontal direction.

[0043] Referring now to Figure 2, a ferromagnetic source 201 may be disposed within a non-sterilizable component 202 and may be used to transmit motion in two dimensions to a ferromagnetic sink 203 attached to a sterilizable component 204. As in the embodiment of Figure 1, the ferromagnetic sink may serve as an adapter for further coupling to a tool (not shown). Thus, precise movement of the tool in two dimensions in the sterile field may be provided.

[0044] 2a and 2b show components of an embodiment of the inventive system in different positions based on the movement of a ferromagnetic source along two dimensions of motion.

[0045] In a more specific embodiment, a system for accurate and safe placement of a medical device is provided. The inventive system is an insertion tool that may include a handpiece incorporating electrical and mechanical components, a sterile adapter, an electrode clip, a piezo motor box, and a foot pedal. The inventive system may include a non-sterile handpiece with proximal and distal ends, a coupling element for coupling a portion adjacent the distal end of the handpiece to a device for fine-tuning the position of the system, a sterile adapter portion removably secured to the distal end of the handpiece and including a tube with proximal and distal ends and a rotating sleeve engaged with the proximal end of the tube, the rotating sleeve being removably secured to the distal end of the handpiece, and a clip portion slidably engaged around the tube of the sterile adapter portion. The system is optimally configured to advance the medical device, held by the clip, into position within a patient. The medical device may be a cochlear implant, and the clip may be a pair of forceps or other suitable surgical tool for holding a cochlear implant.

[0046] The piezo motor box can be incorporated into or coupled to a handpiece to allow for advancement and withdrawal of a clip or forceps forward or backward into the surgical field. For example, the piezo motor box can be incorporated into or coupled to a handpiece of an insertion tool for inserting a cochlear implant during CI surgery. This can then provide for controlled advancement of a pair of forceps holding a cochlear implant into a patient's inner ear, or for retraction of the forceps holding the cochlear implant. Those skilled in the art will understand that elements other than a piezo motor box can provide this advancement and / or retraction function; however, an element providing controlled and precise advancement and retraction is required to meet the goal of safe and accurate placement of a cochlear implant. In various embodiments, a foot pedal can provide operator control for the piezo motor box, but those skilled in the art will understand that a similarly functional element available in an operating room that can start and stop the advancement or retraction of a clip or forceps is acceptable.

[0047] Referring now to FIG. 3 , a side view of an insertion device including sterile and non-sterile components is shown in accordance with one embodiment of the present invention. The insertion device includes a clip element 301 that can be configured to hold an electrode array of a cochlear implant or other medical device requiring precise handling and / or insertion. The clip element 301 can be in the form of a pair of forceps or other suitable holding device. The clip element 301 can be comprised of one or more interlocking sliding sleeve elements that fit together and circumferentially around a sterile adapter 302. The sterile adapter 302 and clip element 301 are designed to be disposable or sterilizable, and thus can be deployed in a sterile field during surgery. The sterile adapter 302 is configured to be attachable to a handpiece 303 that can be held and operated by a physician during surgery. The handpiece 303 need not be sterile and need not be disposable or reprocessable. The handpiece 303 can contain electrical or mechanical components for operation of the insertion device.

[0048] 3, handpiece 303 can be configured to couple to coupling element 304, which can be configured to couple the handpiece to a piezo 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 can be constructed of materials known to be suitable for the construction and operation of similar devices and for use in an operating room setting.

[0049] Referring now to FIG. 4, an enlarged side view of an electrode clip and its components is provided in accordance with one embodiment of an insertion tool of the present invention. As disclosed with reference to FIG. 3, clip element 301 can be formed from one or more interlocking sliding sleeve elements that fit together and circumferentially around a sterile adapter 302. In FIG. 4, an enlarged view of these elements of 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 around the sterile adapter portion of the insertion device. Sliding sleeve elements 401a and 401b are exemplary in nature. Many variations are possible with the basic requirements that the elements be capable of interlocking together, forming with a surgical tool suitable for holding or advancing a medical device in a surgical field, and fitting circumferentially around a sterile adapter or other similar component of an insertion tool in accordance with the teachings of the present invention. The sliding sleeve elements 401a and 401b may have a circumferential groove to allow for proper manual fixation to the sterile adapter portion.

[0050] Referring now to FIG. 5, a close-up view of a sterile adapter 501 and its components is provided in accordance with one embodiment of the insertion tool of the present invention. The sterile adapter may be composed of three or more key elements. First, portion 501a may be a polygonal sterile tube. Second, rotating sleeve 502 may fit around sterile tube 501a. Rotating sleeve 502 may present snap-in spring 501b or other suitable element for fastening to a clip element. Rotating sleeve 502 may also present an additional snap-in spring 501c on its inner edge (or other suitable element) for fastening to a handpiece. With this design, the sterile adapter provides reliable fastening to the clip element and to the handpiece, ultimately providing a stable sterile connection between the handpiece and clip element.

[0051] Referring now to Figure 6, an enlarged side view of a handpiece and its components is provided in accordance with one embodiment of the tool insert of the present invention. The handpiece 601 provides a circumferential groove 601a for fastening a rotating sleeve of a sterilization adapter. The body 601b of the handpiece is optimally rotationally symmetrical and constructed of stainless steel. The handpiece 601 may also provide a snap-in groove 601c for attachment of a mounting component, which may provide for securing the handpiece to a piezo motor box or other motor-driven element for movement and / or advancement of the tool insert in the surgical field.

[0052] Referring now to Figure 7, an element for coupling a handpiece to a micro-adjustment mechanism according to one embodiment of the tool insertion of the present invention is shown. Coupling element 704 may incorporate a spring-loaded snap coupling, which may be configured to fit with snap-in groove 601c of handpiece 601, referring back to Figure 6. Coupling element 704 may be released from the handpiece of the tool insertion with release button 705. Coupling element 704 may also incorporate means for fastening to the micro-adjustment mechanism via a screw (not shown).

[0053] Referring now to FIG. 8, a micro-adjustment device 800 for coupling to a handpiece in accordance with one embodiment of a tool insert of the present invention is shown. The micro-adjustment mechanism incorporates an interface coupling 801, allowing it to be coupled to a handpiece via a coupling element, such as that shown in FIG. 7 for the micro-adjustment mechanism. Referring specifically back to FIG. 7, coupling element 704 includes means for fastening to the micro-adjustment mechanism via a screw or other suitable fastening element, such as that shown in FIG. 9. The micro-adjustment device of FIG. 8 may also include a linear z adjustment 802, a vertical horizontal adjustment 803, and a linear x / y adjustment 804. All of elements 802, 803, and 804 allow for very precise and fine adjustment of the movement of the micro-adjustment device, which in turn allows for very precise, fine, and controllable movement of, for example, a tool insert that may be coupled to the micro-adjustment device. The microadjustment device may also comprise a further coupling mechanism 805 which may provide, solely by way of example, for coupling the microadjustment device to a device such as a manual or robotic surgical arm.

[0054] Those skilled in the art will now appreciate that the invention disclosed herein is an insertion tool for use in surgical settings where precise control of the insertion of a medical device is desired. In various embodiments presented, the 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 holder for a medical device, such as the electrode array of a cochlear implant. Fine adjustment mechanisms can also be integrated, providing even finer movement control in surgical applications where such control is required to achieve a desired result.

[0055] The insertion device also addresses an important need by having both sterile and non-sterile components. In an exemplary embodiment, the insertion device has a clip element, which may be disposable or sterilizable, configured to fit around a sterile adapter portion, which may also be disposable or sterilizable. The sterile adapter portion, in turn, can fit onto a handpiece containing or coupled to the entire device portion, including electrical, mechanical, or motorized components. The handpiece and other components coupled to it, including electrical, mechanical, or motorized components, are not configured to be disposable or sterilizable. Thus, the more expensive components of the insertion device can be kept outside the sterile field, can be constructed of appropriate materials, do not require reprocessing, and can have a much longer lifetime before needing replacement. This strategy keeps the overall cost of the insertion device and its components to a minimum.

[0056] Referring now to Figure 9, a representative surgical setup for use of the inventive insertion tool is shown. In this exemplary embodiment, the surgical setup is prepared for the insertion of a cochlear implant into a patient's inner ear. An insertion tool 901 is shown coupled to a micro-adjustment device 902, which in turn is further coupled to a surgical arm 903. The presented surgical setup provides for precise control of the movement of the insertion tool 901 during surgery, and thus precise and controllable placement of the electrode array of the cochlear implant within the patient.

[0057] While the present invention has been shown and described with reference to specific embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the claims. By way of example only, and not by way of limitation, those skilled in the art will readily appreciate that the methods / systems disclosed herein are applicable to other surgical fields.

[0058] In the following description paragraphs, further aspects of the invention and its embodiments are listed as clauses. These clauses may, however, also be written as claims of the invention: Item 1: A system for moving an object by transmitting motion through a sterile barrier, comprising: a non-sterilizable member comprising a moving element containing a passive or active ferromagnetic source; a sterilizable member comprising a moving element containing a passive ferromagnetic sink; an adapter attached to the moving element of the sterilizable member, to which an object such as a surgical instrument, an implant or the like can be temporarily attached, The system is configured so that the sterilizable member is rigidly attached to and reproducibly detached from the non-sterilizable member, and so that motion of a moving element of the non-sterilizable member is transmitted to the moving element of the sterilizable member via magnetic coupling of a ferromagnetic source with a ferromagnetic sink. Item 2: The system of item 1, wherein the transmitted motion causes motion of a moving element of the sterilizable member, and consequently motion of the attached object within the sterile field. Item 3: The system of item 2, wherein the effective motion of the attached object is translational or rotational, or both translational and rotational. Item 4: A system of any of the preceding items, wherein the system allows for the generation of motion in more than one degree of freedom. Item 5: The system of item 4, where the effective movement of the object is allowed and all other degrees of freedom of movement are blocked. Item 6: The system of item 1, wherein the source of the strong magnetic field is static. Item 7: The system of item 6, wherein the source of the strong magnetic field is a permanent magnet. Item 8: The system of item 1, wherein the source of the strong magnetic field is dynamic. Item 9: The system of item 8, wherein the source of the strong magnetic field is dynamically controlled. Item 10: The system of item 1, wherein the magnetic coupling between the ferromagnetic source and the ferromagnetic sink is selectively engageable and disengageable. Item 11: The system of item 10, wherein the magnetic coupling is selectively disengaged at a predetermined load. Item 12: The system of item 11, wherein the magnetic coupling is selectively disengaged when movement of the sterilizable item within the sterile field is undesirable. Item 13: The system of item 12, where movement is undesirable because the moving object attached to the actuator encounters an obstacle or because movement is restricted due to increased physical resistance. Item 14: The system of any of items 10 to 13, wherein the selective decoupling of the interaction is controlled by modulation of the field strength of the ferromagnetic source. Item 15: The system of item 14, wherein modulation of the source of the strong magnetic field is achieved via dynamic control of current through a coil within the non-sterilizable member. Item 16: The system of item 15, wherein the adapter is configured to position / locate an implantable medical device within a patient, the implantable medical device being selectively grasped by forceps or a clamp or other grasping instrument. Item 17: The system of item 16, wherein the implantable medical device is a cochlear implant. Item 18: The system of any of items 1 to 17, wherein the sterilizable member is configured to place an injector within a patient. Item 19: The system of any of the preceding items, wherein the sterilizable member is a sleeve that fits over the sterile barrier and the non-sterilizable member. Item 20: A system of any of the preceding items, wherein the sterilizable member is configured for single use. Item 21: A system according to any of the preceding items, wherein the sterilizable member is configured for multiple use. Item 22: A system for accurate and safe placement of a medical device, comprising: a non-sterile handpiece with a proximal and a distal end; a coupling element for coupling a portion of the handpiece adjacent the distal end to a device for fine adjustment of the position of the system; a sterile adapter portion removably secured to the distal end of the handpiece, a tube with proximal and distal ends; a rotating sleeve engaged with the proximal end of the tube, the rotating sleeve being removably secured to the distal end of the handpiece; a clip portion slidably engageable around the tube of the sterile adapter portion; Equipped with The system is configured to propel a medical device held by the clip into a position within the patient. Item 23: The system of item 22, wherein the inner periphery of the rotating sleeve is provided with teeth engageable with corresponding teeth on the outer periphery of the distal end of the handpiece to provide secure and removable fixation of the sterile adapter portion to the handpiece. Item 24: The system of item 23, wherein the tube comprises a magnet slidably disposed in the lumen of the tube, the clip portion is made of a magnetic material, and the position of the clip portion on the tube is controllable by engagement with the magnet. Item 25: The system of item 23, wherein the rotational position of the clip portion is adjustable by selectively engaging and rotating teeth on the rotating sleeve around teeth on the distal end of the handpiece. Item 26: The system of item 22, wherein the device for fine-tuning the position of the system comprises an attachment element for selective engagement with the coupling element, the device providing for adjustment of the position of the medical device held by the clip portion in at least three vectors.

Claims

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

2. 10. The system of claim 1, The transmitted motion causes motion of the moving element of the sterilizable member, which in turn causes motion of the attached object within a sterile field. system.

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

4. The system according to any one of claims 1 to 3, The system allows for the generation of motion in more than two degrees of freedom. system.

5. 5. The system of claim 4, The object's effective motion is possible in one degree of freedom, with all other degrees of freedom blocked system.

6. 10. The system of claim 1, The ferromagnetic source generates a strong static magnetic field. system.

7. 7. The system of claim 6, The ferromagnetic source is a permanent magnet system.

8. 7. The system of claim 6, The strength of the strong magnetic field is dynamic. system.

9. 9. The system of claim 8, The strength of the strong magnetic field in each degree of freedom is dynamically controlled system.

10. 10. The system of claim 1, 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. system.

11. The system of claim 10, The magnetic coupling is selectively disengaged at a predetermined load, particularly when movement of the sterilizable member within a sterile field is undesirable. system.

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

13. 13. The system according to any one of claims 10 to 12, the selective decoupling of the interaction is controlled by modulation of the field strength of the ferromagnetic source; In particular, modulation of the source of the strong magnetic field is achieved via dynamic control of a current through a coil within the non-sterilizable member; In particular, the adapter is configured to position / locate an implantable medical device within a patient; The implantable medical device is selectively grasped with forceps or a clamp or other grasping instrument. system.

14. 14. The system of claim 13, The implantable medical device is a cochlear implant system.

15. 10. The system of claim 1, The sterilizable member is a sleeve that fits over the sterile barrier and the non-sterilizable member. system.

16. 10. The system of claim 1, The sterilizable member is configured for single use. system.

17. 10. The system of claim 1, The sterilizable member is configured for multiple use. system.

18. 1. 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 the distal end to a device for fine adjustment of the position of the system; a sterile adapter portion removably secured to the distal end of the handpiece, a tube with a proximal end and a distal end; a rotating sleeve engaged with the proximal end of the tube, the rotating sleeve being removably secured to the distal end of the handpiece; a clip portion slidably engageable around the tube of the sterile adapter portion; Equipped with The system is configured to propel a medical device held by the clip into a location within a patient. system.

19. 20. The system of claim 18, The inner periphery of the rotating sleeve includes teeth engageable with corresponding teeth on the outer periphery of the distal end of the handpiece to provide secure and removable fixation of the sterile adapter portion to the handpiece. system.

20. 20. The system of claim 19, the tube includes a magnet slidably disposed within the lumen of the tube; The clip portion is made of a magnetic material, and the position of the clip portion on the tube is controllable by engagement with the magnet. system.

21. 20. The system of claim 19, The rotational position of the clip portion is adjustable by selectively engaging and rotating teeth on the rotating sleeve around teeth on the distal end of the handpiece. system.

22. 20. The system of claim 18, the device for fine-tuning the position of the system comprises a mounting element for selective engagement with the coupling element; The apparatus provides for adjustment of the position of the medical device held by the clip portion in at least three vectors. system.

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