Method for conducting a guided intracranial surgical procedure

Description

[0001] METHOD FOR CONDUCTING A GUIDED INTRACRANIAL SURGICAL PROCEDURE

[0002] BACKGROUND OF THE DISCLOSURE

[0003] Field of the Disclosure

[0004] The present disclosure relates to intracranial surgical procedures and, more particularly, to methods and systems for a conducting guided intracranial surgical procedures, such as a cochlear implant procedure or a trans-nasal intracranial surgical procedure.

[0005] Description of Related Art

[0006] For an intracranial surgical procedure such as, for example, a cochlear implant procedure, it is critical to access the inner ear (e.g., the cochlea within the inner ear) precisely through the skull and around intervening intracranial anatomical structures in order to place or implant an electronic lead for the cochlear implant within the inner ear. Such a procedure typically requires multiple stages of manual drilling and surgery in order to provide a suitable bore or passageway for the electronic lead insertion into the inner ear. However, such a manual procedure often lacks the steadiness and precision to provide the level of accuracy needed for the procedure and to minimize the risk of damage to the intracranial anatomical structures.

[0007] An alternate procedure, Direct Cochlear Access (DCA), involves a straight-line approach from the skull surface / cranium to the cochlea. However, such a straight-line approach risks damage to the critical intervening intracranial anatomical structures, particularly if done manually.

[0008] Certain rigid patient-specific templates have been developed to constrain the surgical tool orientation and / or guide the surgical tool along a planned pathway to the inner ear in a cochlear implant procedure. However, although this approach could possibly achieve adequate accuracy, the latency involved in production and delivery of the template is problematic and such patient-specific templates do not readily accommodate changes in the surgical plan.

[0009] In some instances, industrial robots have also been investigated for use in creating a DCA procedure according to a preoperative plan. However, although such industrial robot systems may come close to the required accuracy, the size and weight of such systems render them difficult and cumbersome for integration into the operating room environment. In addition, such industrial robots often lack an adequate and convenient arrangement for tracking the patient during the procedure. That is, the industrial robot approach often requires rigid head fixation (see, e.g., FIGS. 3 A-3C) by way of locating pins and fasteners that are invasively attached to the patient’s skull in a separate surgical procedure generally requiring anesthesia.

[0010] Another example of an intracranial surgical procedure involves accessing the region about the base of the skull for performing ear, nose, or throat (ENT) and / or neurological procedures (e.g., for tumor removal / biopsy or other surgical issue). In such instances, however, necessary access to the relevant intracranial anatomical structures through the exterior of the skull often requires the brain to be retracted in order to provide access to the region about the base of the skull. Thus, there exists a need for a method for providing improved intracranial surgical procedures such as, for example, a cochlear implant procedure or surgical procedure targeted to the region about the base of the skull, that address the noted shortcomings of current procedures, and facilitates, for example, effective pre-procedure planning and convenient and proactive guidance during the intracranial surgical procedure.

[0011] BRIEF SUMMARY OF THE DISCLOSURE

[0012] The above and other needs are met by the present disclosure which, in one aspect, provides a method of conducting an intracranial procedure, wherein such a procedure comprises engaging a fiducial device with maxillofacial anatomy of a patient, with the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and with the tracking arm being arranged in communication with a robot arm having a procedure-conducting device engaged with a distal end thereof. A virtual procedure plan is formed for forming a bore through a skull and into an intracranial region of the patient, and for accessing intracranial anatomy at issue through the bore to conduct the intracranial procedure, in registration with and relative to the fiducial marker. Movement of the procedureconducting device is physically regulated via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue. Tactile feedback is provided, via the procedure-conducting device, if the physical manipulation of the procedure-conducting device deviates from the virtual procedure plan.

[0013] Another example embodiment provides a method of conducting a cochlear implant procedure, wherein such a procedure comprises engaging a fiducial device with maxillofacial anatomy of a patient, with the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and wherein the tracking arm is arranged in communication with a robot arm having a boreforming and implantation device engaged with a distal end thereof. A virtual cochlear implant plan is formed for forming a bore through a skull and into a middle ear of the patient, and for implanting a cochlear implant in the middle ear through the bore, in registration with and relative to the fiducial marker. Movement of the bore-forming and implantation device is physically regulated via the robot arm, and relative to the fiducial marker, in accordance with the virtual cochlear implant plan and commensurately with physical manipulation of the bore-forming and implantation device during forming the bore and during implanting the cochlear implant. Tactile feedback is provided, via the bore-forming and implantation device, if the physical manipulation of the bore-forming and implantation device deviates from the virtual cochlear implant plan.

[0014] Yet another example aspect provides a method of conducting an intracranial procedure in a region about a base of a skull, wherein such a procedure comprises engaging a fiducial device with maxillofacial anatomy of a patient, with the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and with the tracking arm being arranged in communication with a robot arm having a procedure-conducting device engaged with a distal end thereof. A virtual procedure plan is formed for trans-nasally forming the bore through the skull and into the region about the base of the skull of the patient, and for accessing the intracranial anatomy at issue through the bore, in registration with and relative to the fiducial marker. Movement of the procedure-conducting device is physically regulated via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue. Tactile feedback is provided, via the procedure-conducting device, if the physical manipulation of the procedure-conducting device deviates from the virtual procedure plan.

[0015] Various other aspects of the present disclosure are directed to a system for facilitating the disclosed methods of conducting an intracranial procedure, such as a cochlear implant procedure or an intracranial procedure in a region about the base of the skull via the nasal structure.

[0016] The present disclosure thus includes, without limitation, the following example embodiments:

[0017] Example Embodiment 1 : A method of conducting an intracranial procedure, comprising engaging a fiducial device with maxillofacial anatomy of a patient, the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and the tracking arm being arranged in communication with a robot arm having a procedure-conducting device engaged with a distal end thereof; forming a virtual procedure plan for forming a bore through a skull and into an intracranial region of the patient, and for accessing intracranial anatomy at issue through the bore to conduct the intracranial procedure, in registration with and relative to the fiducial marker; physically regulating movement of the procedure-conducting device via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue; and providing tactile feedback, via the procedure-conducting device, if the physical manipulation of the procedure-conducting device deviates from the virtual procedure plan.

[0018] Example Embodiment 2: The method of any preceding example embodiment, or combinations thereof, comprising imaging the intracranial anatomy at issue, the maxillofacial anatomy, and the fiducial marker engaged with the fiducial device to facilitate registration of the virtual procedure plan with the fiducial marker.

[0019] Example Embodiment 3: The method of any preceding example embodiment, or combinations thereof, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging the fiducial device with an upper jaw or with one or more teeth of the upper jaw of the patient.

[0020] Example Embodiment 4: The method of any preceding example embodiment, or combinations thereof, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging a splint device with an upper jaw or with one or more teeth of the upper jaw of the patient.

[0021] Example Embodiment 5: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises allowing movement of the procedure- conducting device in accordance with the virtual procedure plan, and physically preventing movement of the procedure-conducting device deviating from the virtual procedure plan.

[0022] Example Embodiment 6: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises allowing movement of the procedureconducting device along a route to the intracranial anatomy at issue defined by the virtual procedure plan, and physically preventing movement of the procedure-conducting device deviating from the route defined by the virtual procedure plan.

[0023] Example Embodiment 7 : The method of any preceding example embodiment, or combinations thereof, wherein forming a virtual procedure plan comprises defining virtual boundaries about anatomical structures to be avoided by the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue, and wherein providing tactile feedback further comprises providing tactile feedback via the procedure-conducting device if the procedure-conducting device contacts any of the virtual boundaries during forming the bore or during accessing the intracranial anatomy at issue.

[0024] Example Embodiment 8: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises vibrating the procedure-conducting device if movement of the procedure-conducting device deviates from the virtual procedure plan.

[0025] Example Embodiment 9: The method of any preceding example embodiment, or combinations thereof, wherein physically regulating movement of the procedure-conducting device comprises physically regulating movement of the procedure-conducting device via the robot arm physically engaged with the procedure-conducting device and the fiducial device via the tracking arm, the robot arm being responsive to a controller to physically regulate the physical manipulation of the procedure-conducting device according to the virtual procedure plan.

[0026] Example Embodiment 10: The method of any preceding example embodiment, or combinations thereof, wherein the robot arm comprises a plurality of arm segments serially engaged via respective joints, and wherein physically regulating movement of the procedure-conducting device comprises physically regulating movement of the procedure-conducting device by regulating one or more degrees of freedom of at least one of the joints of the robot arm.

[0027] Example Embodiment 11: The method of any preceding example embodiment, or combinations thereof, comprising mounting the tracking arm and the robot arm to a common base such that the tracking arm is in physical communication with the robot arm.

[0028] Example Embodiment 12: The method of any preceding example embodiment, or combinations thereof, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in physical communication with the fiducial marker via the fiducial device.

[0029] Example Embodiment 13: The method of any preceding example embodiment, or combinations thereof, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in nonphysical communication with the fiducial marker. Example Embodiment 14: The method of any preceding example embodiment, or combinations thereof, wherein engaging the tracking arm with the fiducial device comprises engaging the tracking arm with the fiducial device via a wireless communication arrangement, a WiFi communication arrangement, an electrical communication arrangement, an electromechanical communication arrangement, an optical communication arrangement, a magnetic communication arrangement, an electromagnetic communication arrangement, or an infrared communication arrangement, such that the tracking arm is in non-physical communication with the fiducial marker.

[0030] Example Embodiment 15: The method of any preceding example embodiment, or combinations thereof, wherein the procedure-conducting device includes and is arranged to interchangeably receive a first end effector configured to form the bore and a second end effector configured to access the intracranial anatomy at issue.

[0031] Example Embodiment 16: The method of any preceding example embodiment, or combinations thereof, wherein the intracranial procedure comprises a cochlear implant procedure, and the procedureconducting device comprises a bore-forming and implantation device, and wherein forming a virtual procedure plan comprises forming a virtual cochlear implant plan for forming the bore through the skull and into a middle ear of the patient, and for implanting a cochlear implant in the middle ear through the bore, in registration with and relative to the fiducial marker.

[0032] Example Embodiment 17: The method of any preceding example embodiment, or combinations thereof, wherein physically regulating movement of the procedure-conducting device comprises physically regulating movement of the bore-forming and implantation device via the robot arm, and relative to the fiducial marker, in accordance with the virtual cochlear implant plan and commensurately with physical manipulation of the bore-forming and implantation device during forming the bore and during implanting the cochlear implant.

[0033] Example Embodiment 18: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback comprises providing tactile feedback, via the bore-forming and implantation device, if the physical manipulation of the bore-forming and implantation device deviates from the virtual cochlear implant plan.

[0034] Example Embodiment 19: The method of any preceding example embodiment, or combinations thereof, comprising imaging the inner ear, the maxillofacial anatomy, and the fiducial marker engaged with the fiducial device to facilitate registration of the virtual cochlear implant plan with the fiducial marker.

[0035] Example Embodiment 20: The method of any preceding example embodiment, or combinations thereof, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging the fiducial device with an upper jaw or with one or more teeth of the upper jaw of the patient.

[0036] Example Embodiment 21: The method of any preceding example embodiment, or combinations thereof, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging a splint device with an upper jaw or with one or more teeth of the upper jaw of the patient. Example Embodiment 22: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises allowing movement of the bore-forming and implantation device in accordance with the virtual cochlear implant plan, and physically preventing movement of the bore-forming and implantation device deviating from the virtual cochlear implant plan.

[0037] Example Embodiment 23: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises allowing movement of the bore-forming and implantation device along a route to the inner ear defined by the virtual cochlear implant plan, and physically preventing movement of the bore-forming and implantation device deviating from the route defined by the virtual cochlear implant plan.

[0038] Example Embodiment 24: The method of any preceding example embodiment, or combinations thereof, wherein forming a virtual cochlear implant plan comprises defining virtual boundaries about anatomical stmctures to be avoided by the bore-forming and implantation device during forming the bore and during implanting the cochlear implant, and wherein providing tactile feedback further comprises providing tactile feedback via the bore-forming and implantation device if the bore-forming and implantation device contacts any of the virtual boundaries during forming the bore or during implanting the cochlear implant.

[0039] Example Embodiment 25: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises vibrating the bore-forming and implantation device if movement of the bore-forming and implantation device deviates from the virtual cochlear implant plan.

[0040] Example Embodiment 26: The method of any preceding example embodiment, or combinations thereof, wherein physically regulating movement of the bore-forming and implantation device comprises physically regulating movement of the bore-forming and implantation device via the robot arm physically engaged with the bore-forming and implantation device and the fiducial device via the tracking arm, the robot arm being responsive to a controller to physically regulate the physical manipulation of the boreforming and implantation device according to the virtual cochlear implant plan.

[0041] Example Embodiment 27: The method of any preceding example embodiment, or combinations thereof, wherein the robot arm comprises a plurality of arm segments serially engaged via respective joints, and wherein physically regulating movement of the bore-forming and implantation device comprises physically regulating movement of the bore-forming and implantation device by regulating one or more degrees of freedom of at least one of the joints of the robot arm.

[0042] Example Embodiment 28: The method of any preceding example embodiment, or combinations thereof, comprising mounting the tracking arm and the robot arm to a common base such that the tracking arm is in physical communication with the robot arm.

[0043] Example Embodiment 29: The method of any preceding example embodiment, or combinations thereof, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in physical communication with the fiducial marker via the fiducial device. Example Embodiment 30: The method of any preceding example embodiment, or combinations thereof, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in nonphysical communication with the fiducial marker.

[0044] Example Embodiment 31: The method of any preceding example embodiment, or combinations thereof, wherein engaging the tracking arm with the fiducial device comprises engaging the tracking arm with the fiducial device via a wireless communication arrangement, a WiFi communication arrangement, an electrical communication arrangement, an electromechanical communication arrangement, an optical communication arrangement, a magnetic communication arrangement, an electromagnetic communication arrangement, or an infrared communication arrangement, such that the tracking arm is in non-physical communication with the fiducial marker.

[0045] Example Embodiment 32: The method of any preceding example embodiment, or combinations thereof, wherein the bore-forming and implantation device includes and is arranged to interchangeably receive a first end effector configured to form the bore and a second end effector configured to implant the cochlear implant within the bore.

[0046] Example Embodiment 33: The method of any preceding example embodiment, or combinations thereof, wherein the intracranial procedure comprises an intracranial procedure in a region about a base of the skull, and wherein forming the virtual procedure plan comprises forming the virtual procedure plan for trans-nasally forming the bore through the skull and into the region about the base of the skull of the patient, and for accessing the intracranial anatomy at issue through the bore, in registration with and relative to the fiducial marker.

[0047] Example Embodiment 34: The method of any preceding example embodiment, or combinations thereof, wherein forming the virtual procedure plan comprises forming the virtual procedure plan including defining a virtual intra-nasal boundary about intra-nasal anatomical structures to be avoided by the procedure-conducting device during forming the bore.

[0048] Example Embodiment 35: The method of any preceding example embodiment, or combinations thereof, wherein physically regulating movement of the procedure-conducting device comprises physically regulating movement of the procedure-conducting device via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue such that movement of the procedure-conducting device is constrained within the virtual intra-nasal boundary.

[0049] Example Embodiment 36: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises providing tactile feedback via the procedureconducting device if the procedure-conducting device contacts the virtual intra-nasal boundary during forming the bore or during accessing the intracranial anatomy at issue.

[0050] Example Embodiment 37: The method of any preceding example embodiment, or combinations thereof, wherein the procedure-conducting device includes and is arranged to receive at least a first end effector configured to form the bore, and wherein forming the virtual procedure plan comprises forming the virtual procedure plan including defining a virtual intra-nasal boundary configured as a conical frustrum having a major diameter end and an opposing minor diameter end, the conical frustrum being configured and arranged to avoid intra-nasal anatomical structures, with the minor diameter end being disposed about an intra-nasal site for forming the bore through the skull.

[0051] Example Embodiment 38: The method of any preceding example embodiment, or combinations thereof, wherein physically regulating movement of the procedure-conducting device comprises physically regulating movement of the procedure-conducting device and the first end effector via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device and the first end effector during forming the bore and during accessing the intracranial anatomy at issue such that movement of the procedure-conducting device and the first end effector are constrained within the virtual intra-nasal boundary.

[0052] Example Embodiment 39: The method of any preceding example embodiment, or combinations thereof, wherein providing tactile feedback further comprises providing tactile feedback via the procedureconducting device if the procedure-conducting device of the first end effector contacts the virtual intra-nasal boundary during forming the bore or during accessing the intracranial anatomy at issue.

[0053] These and other features, aspects, and advantages of the present disclosure will be apparent from a reading of the following detailed description together with the accompanying drawings, which are briefly described below. The present disclosure includes any combination of two, three, four, or more features or elements set forth in this disclosure, regardless of whether such features or elements are expressly combined or otherwise recited in a specific embodiment description herein. This disclosure is intended to be read holistically such that any separable features or elements of the disclosure, in any of its aspects and embodiments, should be viewed as intended, namely to be combinable, unless the context of the disclosure clearly dictates otherwise.

[0054] It will be appreciated that the summary herein is provided merely for purposes of summarizing some example aspects so as to provide a basic understanding of the disclosure. As such, it will be appreciated that the above described example aspects are merely examples and should not be constmed to narrow the scope or spirit of the disclosure in any way. It will be appreciated that the scope of the disclosure encompasses many potential aspects, some of which will be further described below, in addition to those herein summarized. Further, other aspects and advantages of such aspects disclosed herein will become apparent from the following detailed description taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the described aspects.

[0055] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0056] Having thus described the disclosure in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

[0057] FIG. 1A schematically illustrates anatomical aspects of a human ear; FIG. IB schematically illustrates anatomical aspects of the inner ear portion of FIG. 1A;

[0058] FIGS. 2A and 2B schematically illustrate a cochlear implant system in example implementations with respect to the human ear;

[0059] FIGS. 3A-3C schematically illustrate prior art provisions for invasively fixing a patient’s head to conduct a cochlear implant procedure;

[0060] FIG. 4A schematically illustrates a flow of a method for conducting an intracranial procedure, according to one aspect of the present disclosure;

[0061] FIG. 4B schematically illustrates a flow of a method for conducting a cochlear implant procedure, according to one aspect of the present disclosure;

[0062] FIG. 4C schematically illustrates a flow of a method for conducting an intracranial procedure in a region about a base of a skull via the nasal structure, according to one aspect of the present disclosure;

[0063] FIG. 5 schematically illustrates a system for conducting a cochlear implant procedure, according to one aspect of the present disclosure;

[0064] FIGS. 6 and 7 schematically illustrate a system for conducting a cochlear implant procedure, according to an alternate aspect of the present disclosure;

[0065] FIG. 8 schematically illustrates a system for conducting a cochlear implant procedure, according to yet an alternate aspect of the present disclosure;

[0066] FIG. 9 schematically illustrate a trans-nasal or trans-sinus approach for conducting an intracranial surgical procedure in a region about the base of the skull, according to one aspect of the present disclosure; and

[0067] FIG. 10 schematically illustrate a trans-nasal or trans-sinus approach for conducting an intracranial surgical procedure in a region about the base of the skull, according to another aspect of the present disclosure.

[0068] DETAILED DESCRIPTION OF THE DISCLOSURE

[0069] The present disclosure now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the disclosures are shown. Indeed, these disclosures may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

[0070] Aspects of the present disclosure are generally directed to methods of conducting an intracranial procedure, such as a cochlear implant or cochlear implant procedure or an intracranial procedure in a region about a base of a skull via the nasal structure, while minimizing or eliminating risk of damage to critical anatomical structures between the cranium or the skull and the inner ear or intracranial anatomy at issue in the region about the base of the skull of the patient.

[0071] FIG. 1 A schematically illustrates a cross-section of the anatomical structures of a human ear system 5, as one example of an intracranial anatomical structure on which to conduct an intracranial procedure according to aspects of the present disclosure, while FIG. IB schematically illustrates a cross-section of the anatomical structures of the middle ear 10 portion of the human ear system 5. In general, should the patient have lost hearing and be a candidate for a cochlear implant system 15 to restore hearing, such a cochlear implantation system 15 (see, e.g., FIGS. 2A and 2B) requires at least the subcutaneous implantation of a receiver / stimulator 20 having an electronic lead / electrode array 25 extending therefrom, through the skull 30, and into the cochlea 35 within the middle ear 10. Other typical components of a cochlear implant system 15 include, for example, a transmitter 40, a speech processor 45, and a microphone 50, which are generally implemented externally to the skull 30.

[0072] In this regard, aspects of the present disclosure are directed to and address a method of conducting a cochlear implant procedure, as one example of an intracranial anatomical structure on which to conduct an intracranial procedure according to aspects of the present disclosure, which addresses the limitations noted herein in regard to prior art methods and systems for conducting the cochlear implant procedure. More particularly, aspects of the present disclosure implement pre-procedure virtual cochlear implant planning in conjunction with physically guided robotic assistance in the bore-forming and electronic lead implantation portions of a cochlear implant procedure, and haptic or tactile feedback to the user via bore-forming and implantation device physically engaged with and guided by the robotic assistance, all in relation to a non- invasive fiducial device / fiducial marker, and without physically constraining the patient (e.g., physically constraining the patient as shown, for example, in FIG. 3).

[0073] Accordingly, aspects of the present disclosure, as shown, for example, in FIG. 4A, generally address an intracranial procedure comprising a method 60 A of conducting an intracranial procedure. Such a procedure comprises engaging a fiducial device with maxillofacial anatomy of a patient, with the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and with the tracking arm being arranged in communication with a robot arm having a procedureconducting device engaged with a distal end thereof (block 65 A). A virtual procedure plan (e.g., a virtual cochlear implant plan) is formed for forming a bore through a skull and into an intracranial region of the patient, and for accessing intracranial anatomy at issue through the bore to conduct the intracranial procedure, in registration with and relative to the fiducial marker (block 70A). Movement of the procedureconducting device is physically regulated via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue (block 75A). Tactile feedback is provided, via the procedure-conducting device, if the physical manipulation of the procedure-conducting device deviates from the virtual procedure plan (block 80 A).

[0074] More particular aspects of the present disclosure, as shown, for example, in FIG. 4B, comprise a method 60B of conducting a cochlear implant procedure (also referred to herein as a “cochlear implant procedure”) as a particular example of an intracranial procedure according to the present disclosure. Such a procedure may comprise, for example, engaging a fiducial device with maxillofacial anatomy of a patient, wherein the fiducial device has a fiducial marker engaged therewith and is arranged in communication with a tracking arm, and wherein the tracking arm is arranged in communication with a robot arm having a boreforming and implantation device engaged with a distal end thereof (block 65B), and forming a virtual cochlear implant plan for forming a bore through a skull and into a middle ear of the patient, and for implanting a cochlear implant in the middle ear through the bore, in registration with and relative to the fiducial marker (block 70B). Movement of the bore-forming and implantation device is physically regulated via the robot arm, and relative to the fiducial marker, in accordance with the virtual cochlear implant plan and commensurately with physical manipulation of the bore-forming and implantation device during forming the bore and during implanting the cochlear implant (block 75B). Tactile feedback is provided, via the bore-forming and implantation device, if the physical manipulation of the bore-forming and implantation device deviates from the virtual cochlear implant plan (block 80B).

[0075] FIGS. 5-8 illustrate example systems which may facilitate pre-procedure virtual cochlear implant planning in conjunction with physically guided robotic assistance in the bore-forming and electronic lead implantation portions of a cochlear implant procedure, according to the present disclosure, the example systems being generally indicated by the numeral 100. Such systems 100 may be similar to dental implantation systems as disclosed, for example, in U.S. Patent Nos. US 8,808,000 and US 10,918,459, both assigned to Neocis Inc., also the assignee of the present application. US 8,808,000 and US 10,918,459 are thus incorporated herein by reference in their entirety.

[0076] As previously disclosed, one aspect of the cochlear implant procedure disclosed herein may generally involve a pre-procedure imaging step, wherein CT, MRI, X-ray, or other appropriate imaging of the patient’s skull and inner ear structure is obtained. From the imaging step, any anomalies can be diagnosed and / or particular locations of intervening intracranial anatomical structures can be determined. In such instances where a cochlear implant procedure may be prescribed by or associated with the preprocedure imaging for conducting a guided robotic procedure, a fiducial device 250 is engaged with maxillofacial anatomy of the patient. For example, the fiducial device 250 can comprise or otherwise be associated with a splint device engaged with an upper jaw or with one or more teeth of the upper jaw of the patient. The splint device is preferably configured to engage the patient’s upper jaw / teeth in a “firm” or secure interaction (i.e., the splint device is engaged with the patient’s teeth or upper jaw and does not move with respect to the teeth or upper jaw), as shown in FIGS. 5 and 6. In one aspect, the exact positioning of the splint device with respect to the patient’s teeth / upper jaw may not be critical or important, as long as the splint device remains securely in place. A suitable and appropriate splint device is disclosed, for example, in U.S. Patent Nos. US 10,016,242 and US 10,639,128; U.S. Patent Application Publication No. US 2022 / 0233248; and U.S. Patent Application Serial Nos. 17 / 915,861; 17 / 915,863; 17 / 916,438; and 18 / 040,261, all assigned to Neocis Inc., also the assignee of the present application, and which are all incorporated herein by reference in their entirety.

[0077] In particular aspects, the fiducial device 250 has a fiducial marker engaged therewith. Such a fiducial marker is configured to have a geometry or other characteristic or feature that uniquely defines the fiducial marker in a three-dimensional space (i.e., such that the fiducial marker is readily identified in images of the patient’s jaw structure). In such instances, the fiducial marker is attached to, integrated with, or otherwise defined by the fiducial device 250. In some aspects, the fiducial marker may be comprised of, for example, a radiopaque material that can be clearly defined in the image (e.g., CT, MRI, X-ray). In some instances, for example, where the splint device includes a kinematic mount associated therewith, the fiducial marker may be configured / arranged to be mounted to the kinematic mount for the pre-procedure imaging process.

[0078] With the fiducial marker established with respect to the fiducial device 250 and the teeth or upper jaw of the patient, the pre-procedure imaging can include imaging the inner ear, the maxillofacial anatomy, and the fiducial marker engaged with the fiducial device 250 to facilitate registration of the virtual cochlear implant plan with the fiducial marker. That is, by imaging the inner ear and the maxillofacial anatomy with the fiducial marker, the cochlear implant plan can thus be formed in registration with and with respect to the fiducial marker. In addition, intracranial anatomical structures between the skull and the inner ear can be identified and located with respect to the fiducial marker. Since the intracranial anatomical structures are thus located and known relative to the fiducial marker (and / or the kinematic mount engaged with the splint device), the virtual cochlear implant plan can thus be formed to include a pathway or route between the skull / cranium and the inner ear (and particularly the cochlea) for forming the bore or the insertion channel for inserting the electronic lead of the cochlear implant. The imaging procedure may provide additional data for the virtual cochlear implant plan with respect to, for example, the orientation(s), direction(s), dimension(s), depth(s) and / or order of the required bore(s). Accordingly, relevant parameters may be included in the virtual cochlear implant plan, and determined relative to the fiducial marker.

[0079] The virtual cochlear implant plan can then be integrated or otherwise associated with an appropriate robotic assistance system, such as system 100, having an appropriate bore-forming and implantation device 150 (e.g., a procedure-conducting device) operably engaged therewith. The robotic assistance system 100 may include, for instance, a guidance system 200 in communication with and between the fiducial device 250 / fiducial marker and the bore-forming and implantation device 150. The guidance system 200, in some aspects, comprises an articulating arm member or robot arm 350 having the bore-forming and implantation device 150 engaged with a distal end of the robot arm 350, wherein the robot arm 350 determines a range of motion of the bore-forming and implantation device 150. The guidance system 200 can also include a tracking arm 400 in communication between the fiducial device 250 and the bore-forming and implantation device 150 and / or the robot arm 350.

[0080] For example, the tracking arm 400 can comprise a mechanical linkage connecting the splint device to the distal end of the tracking arm 400 (e.g., by the distal end of the tracking arm 400 physically engaging the kinematic mount of the splint device (fiducial device 250)). As such, with the fiducial device 250 and / or the fiducial marker being a coordinate frame reference (e.g., from the pre-procedure imaging step), and with a tracking arm 400 of a known configuration physically engaged with the fiducial device 250, the tracking arm 400 (e.g., the proximal and distal ends of the tracking arm 400) can thus be located within the coordinate space defined with respect to the fiducial marker and upon which the virtual cochlear implant plan is based. Further, with the tracking arm 400 being in communication with the robot arm 350 (e.g., mounted to a common base), and the robot arm 350 being or a known configuration, the robot arm 350 (e.g., the proximal and distal ends of the robot arm 350) as well as the bore-forming and implantation device 150 engaged with the distal end of the robot arm 350 can also be located within the coordinate space defined with respect to the fiducial marker and upon which the virtual cochlear implant plan is based. In some instances, the tracking arm 400 and the robot arm 350 can be configured to be tracked, for example, by appropriate positioning sensors operably engaged with articulating joints connecting the segments of the tracking arm 400 and the robot arm 350 and / or mounting the tracking arm 400 and the robot arm 350 to the common base.

[0081] In some instances, as shown in FIGS. 5-7, the tracking arm 400 may be physically attached to the fiducial device 250 (rigidly, securely, and in a known, repeatable manner) via an attachment mechanism configured to interface with the kinematic mount engaged with the fiducial device 250. Attached to the patient in this manner via the fiducial device 250, the tracking arm 400 provides data (whether constantly, selectively, or otherwise as necessary) about the position of the patient with respect to the fiduciary marker, and planning and executing the virtual cochlear implant plan is communicated to the bore-forming and implantation device 150 / robot arm 350, in registration with and also relative to the fiducial marker. Accordingly, once the coordinate system is established in regard to the fiducial marker / kinematic mount (e.g., the position of the kinematic mount relative to the fiduciary marker in the coordinate system is also known or determined), the fiduciary marker is not necessarily required to be engaged with the fiducial device 250 during execution of the virtual cochlear implant plan. In addition, since the execution of the virtual cochlear implant plan is relative to the coordinate system established and tracked via the fiducial device 250, accurate guidance of the robot arm 350 / bore-forming and implantation device 150 in the event that the patient moves during execution of the virtual cochlear implant plan. In various aspects, the fiducial marker may be in communication with the tracking arm 400, for example, via a wireless transceiver, a hardwire connection, an optical communication system, or any other suitable mechanism, whether electrical, mechanical, electromechanical, or optical in nature.

[0082] Further, one skilled in the art will appreciate that, given the disclosed arrangement, the fiducial device 250 and / or the fiducial marker associated therewith may be in communication with the tracking arm 400 or the bore-forming and implantation device 150 / robot arm 350 in many different manners. For example, as shown in FIG. 8, the tracking arm 400 can be arranged in non-physical communication with the fiducial device 250 / fiducial marker. More particularly, the tracking arm 400 can be in communication with the fiducial device 250 / fiducial marker via a wireless communication arrangement, a WiFi communication arrangement, an electrical communication arrangement, an electromechanical communication arrangement, an optical communication arrangement, a magnetic communication arrangement, an electromagnetic communication arrangement, or an infrared communication arrangement. One skilled in the art will appreciate that such non-physical communication arrangement may be accomplished, for example, by an emitter-detector arrangement (e.g., a detector engaged with the tracking arm 400 and an emitter engaged with the fiducial device 250 / fiducial marker), a receiver-emitter arrangement, a transceiver arrangement (e.g., a transceiver engaged with the tracking arm 400 emits a signal that is reflected from the fiducial device 250 / fiducial marker and the reflected signal detected by the transceiver engaged with the tracking arm), or any other suitable arrangement whereby the position of the tracking arm 400 can be determined relative to the position of the fiducial device 250 / fiducial marker.

[0083] In some aspects, the guidance system 200 may be further configured to include a controller device 450 (e.g., a computer device as shown in FIGS. 6-8) for registering the fiducial marker and determining the coordinate system from the imaging of the inner ear, the maxillofacial anatomy, and the fiducial marker engaged with the fiducial device, and for appropriately executing the virtual cochlear implant plan with respect to the fiducial marker and / or otherwise communicating the fiducial marker to the bore-forming and implantation device 150 / robot arm 350, and physically regulating movement of the bore-forming and implantation device 150 / robot arm 350 in accordance with the virtual cochlear implant plan.

[0084] In one aspect, the controller device 450 may be configured to receive the imaging of the patient’s inner ear and maxillofacial anatomy, including the fiducial marker engaged with the fiducial device, and to register the anatomical structures with the fiducial marker and allow the formation of the virtual cochlear implant plan / procedure. In some instances, the controller device 450 may be further configured to be capable of executing or facilitating execution of the virtual cochlear implant plan. As such, the computer device 450 may comprise software, hardware, or a combination thereof. The virtual cochlear implant plan / procedure may allow the user to create, for example, the virtual cochlear implant plan based on the captured image(s), whether in two dimensions or three dimensions, and to manipulate the image(s) of the patient’s anatomical structures, between and including the skull and the inner ear, in conjunction with a “virtual procedure” in order to develop the virtual cochlear implant plan for creating the bore / passage through the skull and into the inner ear, as well as implanting the electronic lead for the cochlear implant into the inner ear, in conjunction with a computerized model based on the image(s). In some aspects, the cochlear implant routine / process and / or virtual cochlear implant plan may be created, for example, in relation to a coordinate system (relative or absolute) based on the fiducial marker, as will be appreciated by one skilled in the art, for associating the cochlear implant parameters and requirements with the fiducial marker. In other aspects, the controller device 450 may include a peripheral device (i.e., a trackball or joystick in conjunction with, for example, 3D goggles, all not shown) to assist with or otherwise permit virtual manipulation of the pertinent anatomical structure(s) with respect to the image(s) in order to, for example, determine an appropriate route for accessing the inner ear relative to the upper jaw / maxilla structure. The controller device 450 may be further configured to perform such manipulation manually, automatically, or semi-automatically, as necessary or desired.

[0085] In aspects where the fiducial device 250 / fiducial marker approach is used, the teeth / upper jaw of the patient is automatically registered with the system 100 once the tracking arm 400 is attached to the fiducial device 250 via the kinematic mount, or otherwise established in communication with the fiducial marker. That is, the fiducial marker is automatically determined from the image(s) of the patient’s teeth / upper jaw structure and inner ear, and the alignment and location thereof in physical space (or coordinate system relative to the fiducial marker) is known due to the kinematic mount connecting the tracking arm 400 to the fiducial device 250 or otherwise the communication therebetween. The communication between the tracking arm 400 and the robot arm 350 / bore-forming and implantation device 150 thus allows the boreforming and implantation device 150 to be registered with respect to the fiducial marker (or other reference with respect to the patient) via the robot arm 350, the tracking arm 400, and the fiducial device 250 / kinematic mount.

[0086] In one aspect, the system 100 thus disclosed herein may be configured to form a physical or nonphysical communication between the fiducial marker (i.e., by way of a physical or non-physical engagement with the fiducial device having the fiducial marker associated therewith) and an end effector 500 associated with the bore-forming and implantation device 150 engaged with the robot arm 350. In this manner, the virtual cochlear implant process / plan, formed via the controller device 450, may be accomplished in relation to and in registration with the fiducial marker (or other reference with respect to the patient) and thus translated or otherwise communicated to the system 100 for physically regulating the movement of the boreforming and implantation device 150. In some instances, the bore-forming and implantation device 150 includes and is arranged to interchangeably receive different end effectors 500, including a first end effector configured to form the bore and a second end effector configured to implant the cochlear implant (or the electronic lead thereof) within the bore.

[0087] The bore-forming and implantation device 150 thus has the end effector 500 engaged therewith or forming a portion thereof, wherein the bore-forming and implantation device 150, in turn, is engaged with the distal end of the robot arm 350. The robot arm 350 may be configured, for example, to provide six degrees of freedom to the bore-forming and implantation device 150, and can also be configured to restrict or otherwise control the movement of the bore-forming and implantation device 150. For example, the robot arm 350 may be configured to include any number of mechanisms, arrangements, or provisions (e.g., controllable articulating joints connecting segments of the robot arm 350 and / or mounting the proximal end of the robot arm 350 such as to the common base), that may restrict or regulate the freedom of motion of the robot arm 350 in a particular direction, while freely or unrestrictedly allowing freedom of motion of the robot arm 350 in other particular directions (i.e., restricted freedom of motion when the motion of the boreforming and implantation device 150 deviates from the virtual cochlear implant plan, but unrestricted freedom of motion when the motion of the bore-forming and implantation device 150 is moved in accordance with the virtual cochlear implant plan). The robot 350 may have a miniature parallel structure (or function as having a parallel structure) to which the bore-forming and implantation device 150 is secured to a distal end thereof and allowed to have full freedom of movement when not in bore-forming or implantation mode.

[0088] Since the bore-forming and implantation device 150 includes the end effector 500, the end effector 500 (see, e.g., FIGS. 5, 7, and 8) must be in a known position (i.e., known to the system 100) relative to the robot arm 350. In some aspects, in order to calibrate the end effector 500 of the bore-forming and implantation device 150 with respect to the fiducial marker, a calibration element may be engaged with the fiducial device 250 (i.e., rigidly mounted thereto in a known, repeatable manner) or otherwise comprising an element or integral feature of the fiducial device 250. In other instances, calibration element may be interchangeable with other end effectors in the bore-forming and implantation device 150. In such instances, one skilled in the art will thus appreciate that the end effector 500 in the form of the calibration element can then be calibrated with the coordinate system via various tip calibrating methods (i.e., invariant point, etc.). Once calibrated, the calibration element is replaced with the first end effector configured to form the bore or the second end effector configured to implant the cochlear implant (or the electronic lead thereof) within the bore, in the bore-forming and implantation device 150, in a known and repeatable manner, so that the calibration parameters (i.e., the position of the distal-most point and axis of bore-forming) associated with the respective end effectors 500 are maintained as calibrated.

[0089] With the registration, alignment, and / or orientation with respect to the patient established and known by the system 100, and the virtual cochlear implant plan developed through the controller device 450, the cochlear implant procedure can then be initiated by the practitioner physically engaging (i.e., grasping) and moving the bore-forming and implantation device 150 toward the skull (with the fiducial device 250 engaged with the teeth / upper jaw and the tracking arm in communication with the fiducial marker). In such instances, the controller device 450 is configured to control or regulate the movement of the boreforming and implantation device 150 via the robot arm 350 such that the manipulation thereof by the practitioner only allows the end effector 500 to be moved to the appropriate starting position for the cochlear implant procedure (e.g., adjacent to the patient’s skull adjacent to the initiation point for the bore), with respect to the fiducial marker associated with the patient’s teeth / upper jaw, as determined by the controller device 450 and dictated by the virtual cochlear implant plan. For example, the controller device 450 executing or following the virtual cochlear implant plan may regulate or control movement of the boreforming and implantation device 150 by providing unrestricted movement of the bore-forming and implantation device 150 by the practitioner along a route and in an orientation for forming the bore in the skull, but may prevent motion of the bore-forming and implantation device 150 in a direction that would otherwise create a risk of damaging critical anatomical structures (i.e., by locking or restricting movement of a joint between segments of the robot arm 350 or otherwise providing resistance to moving the bore-forming and implantation device in a direction or into an orientation that deviates from the route established and planned in the virtual cochlear implant plan). That is, the robot arm 350 can comprise a plurality of arm segments serially engaged via respective articulating joints, wherein physically regulating movement of the bore-forming and implantation device 150 can be accomplished by regulating one or more degrees of freedom of at least one of the joints of the robot arm 350.

[0090] In some instances, such regulation or control of the movement of the bore-forming and implantation device 150 via the robot arm 350 may be physically sensed by the practitioner (e.g., as tactile or haptic feedback through the grasp of the bore-forming and implantation device 150). That is, in some instances, tactile feedback can be provided by allowing movement of the bore-forming and implantation device 150 in accordance with the virtual cochlear implant plan, and physically preventing movement of the bore-forming and implantation device 150 deviating from the virtual cochlear implant plan. More particularly, such tactile feedback can be established relative to movement of the bore-forming and implantation device along a route to the inner ear defined by the virtual cochlear implant plan.

[0091] In some aspects, forming the virtual cochlear implant plan can include defining virtual boundaries about anatomical structures to be avoided by the bore-forming and implantation device 150 during forming the bore and during implanting the cochlear implant. In such instances, tactile / haptic feedback can be provided via the bore-forming and implantation device 150, if the bore-forming and implantation device 150 contacts any of the virtual boundaries during forming the bore or during implanting the cochlear implant. In yet other instances, in addition to or instead of restricting movement of the bore-forming and implantation device 150 via the robot arm 350, tactile feedback can be provided by vibrating the bore-forming and implantation device 150, if movement of the bore-forming and implantation device 150 deviates from the virtual cochlear implant plan. In still other instances, the bore-forming and implantation device 150 / end effector 500 may not function if a deviation from the virtual cochlear implant plan is detected. In still other instances, an audible tone or tactile vibration may be emitted from a device separate from the bore-forming and implantation device 150 (i.e., the system 100 may otherwise include an audible alarm or a vibrating warning component). As such, one skilled in the art will appreciate that the system 100 may be further configured to provide other manners of feedback (tactile, haptic, or otherwise) to the practitioner such as, for example, via a deviation warning indicia or other indicator, or any other suitable audio and / or visual mechanism.

[0092] Once the end effector 500 is in the starting / initiating position dictated by the controller device 450 and the virtual cochlear implant plan, the invasive (bore forming) portion of the cochlear implant procedure can then be initiated, wherein the controller device 450 may further dictate other parameters of the boreforming and implantation device 150 such as, for example, the orientation of the path / route of the first end effector configured to form the bore and / or the direction / distance / depth from the bore origin, also according to the virtual cochlear implant plan. One skilled in the art will appreciate that the bore-forming and implantation device 150 may be guided according to the virtual cochlear implant plan to form the bore, for example, in a Direct Cochlear Access (DCA) procedure. However, in other instances, the bore-forming and implantation device 150 may be guided so as to form the bore in two or more stages that vary, for example, in direction, orientation, etc. Once the bore is formed, the end effectors may be exchanged in the bore-forming and implantation device 150 to the second end effector configured to implant the cochlear implant (or the electronic lead thereof) within the bore, wherein the second end effector may be in the form of a cannula or other suitable device configured to facilitate insertion of the electronic lead through the bore and into the inner ear (cochlea).

[0093] Therefore, the system 100 includes provisions for actually implementing the virtual cochlear implant plan, physically regulating movement of the bore-forming and implantation device 150, and providing tactile / haptic feedback to the practitioner via the bore-forming and implantation device 150, and thus facilitates an improved cochlear implant procedure, rather than merely warning the practitioner if any procedural parameters may be inaccurate or requiring the practitioner to manually follow a pathway or navigate anatomical structures displayed on a screen. One skilled in the art will also appreciate, however, that, in some instances, the system 100 may be further configured to autonomously accomplish the virtual cochlear implant plan, without the manipulation of the practitioner, through automatic manipulation of the robot arm 350 / bore-forming and implantation device 150 via the controller device 450. In other aspects of the present disclosure, the structure and function of the system 100, in regard to conducting a cochlear implant procedure, are similarly applicable to the aforementioned more general aspect of conducting / performing an intracranial procedure disclosed herein. Accordingly, the method steps involved with the disclosed and claimed cochlear implant procedure are similarly involved with the more general intracranial procedure, particularly when implemented using the system 100 also disclosed herein.

[0094] One skilled in the art will thus further appreciate that aspects of the system 100 disclosed herein may also be implemented to perform other intracranial procedures, and that the involvement of the system 100 may provide advantages and benefits in those other procedures, in addition to those advantages and benefits disclosed herein. In another example of an intracranial procedure, FIG. 4C schematically illustrates a method 60C of conducting an intracranial procedure in a region 600 about a base of a skull (e.g., involving the pituitary gland (see, e.g., element 610 in FIG. 9) or intracranial anatomy within the region of the pituitary gland), as shown in FIGS. 9 and 10. Such a procedure comprises engaging a fiducial device with maxillofacial anatomy (e.g., the upper teeth / upper jaw 620) of a patient, with the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and with the tracking arm being arranged in communication with a robot arm having a procedure-conducting device engaged with a distal end thereof (block 65C). A virtual procedure plan is formed for trans-nasally (e.g., through the nasal passages / sinuses 630) forming the bore through the skull 640 and into the region 600 about the base of the skull of the patient, and for accessing the intracranial anatomy at issue through the bore, in registration with and relative to the fiducial marker (block 70C). Movement of the procedureconducting device is physically regulated via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue (block 75C). Tactile feedback is provided, via the procedure-conducting device, if the physical manipulation of the procedure-conducting device deviates from the virtual procedure plan (block 80C).

[0095] In some instances, the step of forming the virtual procedure plan includes defining a virtual intranasal boundary about intra-nasal anatomical structures (e.g., the anatomical structure 635, including hard tissue and soft tissue, defining the nasal passages / sinuses 630) to be avoided by the procedure-conducting device during forming the bore through the skull 640, as shown, for example, in FIG. 9. In such aspects, physically regulating movement of the procedure-conducting device comprises physically regulating movement of the procedure-conducting device via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue such that movement of the procedure-conducting device is constrained within the virtual intra-nasal boundary. Moreover, in such aspects, providing tactile feedback further comprises providing tactile feedback via the procedure-conducting device, if the procedure-conducting device contacts the virtual intra- nasal boundary during forming the bore or during accessing the intracranial anatomy at issue. Such aspects thus implement the anatomical structure 635, including hard tissue and soft tissue, defining the nasal passages / sinuses 630 as the boundary within which movement of the procedure-conducting device is not constrained. Constraint of movement of the procedure-conducting device and / or other tactile feedback via the procedure-conducting device is implemented when the procedure-conducting device approaches or contacts the boundary, so as to prevent damage or injury to the anatomical structure.

[0096] In other aspects, the procedure-conducting device includes and is arranged to receive at least a first end effector configured to form the bore. In such aspects, forming the virtual procedure plan includes defining a virtual intra-nasal boundary 650 (see, e.g., FIG. 10) configured as a conical frustrum having a major diameter end 665 and an opposing minor diameter end 660. The conical frustrum is configured and arranged to avoid intra-nasal anatomical structures 635, with and upon the minor diameter end 660 being disposed about an intra-nasal site for forming the bore through the skull. In such aspects, physically regulating movement of the procedure-conducting device comprises physically regulating movement of the procedure-conducting device and the first end effector via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device and the first end effector during forming the bore and during accessing the intracranial anatomy at issue (e.g., the intra-nasal site) such that movement of the procedure-conducting device and the first end effector are constrained within the virtual intra-nasal boundary 650 (e.g., within the conical frustrum). Moreover, in such aspects, providing tactile feedback further comprises providing tactile feedback via the procedure-conducting device if the procedure-conducting device of the first end effector contacts the virtual intra-nasal boundary 650 (e.g., within the conical frustrum) during forming the bore or during accessing the intracranial anatomy at issue (e.g., the intra-nasal site). Such aspects thus implement the virtual intra-nasal boundary 650 (e.g., the conical frustrum) as the boundary within which movement of the procedure-conducting device and the first end effector are not constrained. Constraint of movement of the procedure-conducting device and the first end effector and / or other tactile feedback via the procedureconducting device is implemented when the procedure-conducting device and / or the first end effector approaches or contacts the boundary (e.g., the conical frustrum), so as to prevent damage or injury to the anatomical structure 635, including hard tissue and soft tissue, defining the nasal passages / sinuses 630.

[0097] In other aspects of the present disclosure, the structure and function of the system 100, in regard to conducting a cochlear implant procedure, are similarly applicable to the aforementioned method of conducting / performing an intracranial procedure in a region about a base of a skull, as disclosed herein, based on both procedures being particular examples of the more general method of conducting an intracranial procedure. Accordingly, the method steps involved with the disclosed and claimed cochlear implant procedure are similarly involved with the disclosed and claimed method of conducting / performing an intracranial procedure in a region about a base of a skull, as well as the more general intracranial procedure, particularly when such procedures are implemented using the system 100 also disclosed herein.

[0098] Many modifications and other embodiments of the disclosures set forth herein will come to mind to one skilled in the art to which these disclosures pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the disclosures are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

THAT WHICH IS CLAIMED:

1. A method of conducting an intracranial procedure, comprising: engaging a fiducial device with maxillofacial anatomy of a patient, the fiducial device having a fiducial marker engaged therewith and being arranged in communication with a tracking arm, and the tracking arm being arranged in communication with a robot arm having a procedure-conducting device engaged with a distal end thereof; forming a virtual procedure plan for forming a bore through a skull and into an intracranial region of the patient, and for accessing intracranial anatomy at issue through the bore to conduct the intracranial procedure, in registration with and relative to the fiducial marker; physically regulating movement of the procedure-conducting device via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue; and providing tactile feedback, via the procedure-conducting device, if the physical manipulation of the procedure-conducting device deviates from the virtual procedure plan.

2. The method of Claim 1, comprising imaging the intracranial anatomy at issue, the maxillofacial anatomy, and the fiducial marker engaged with the fiducial device to facilitate registration of the virtual procedure plan with the fiducial marker.

3. The method of Claim 1, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging the fiducial device with an upper jaw or with one or more teeth of the upper jaw of the patient.

4. The method of Claim 1, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging a splint device with an upper jaw or with one or more teeth of the upper jaw of the patient.

5. The method of Claim 1, wherein providing tactile feedback further comprises allowing movement of the procedure-conducting device in accordance with the virtual procedure plan, and physically preventing movement of the procedure-conducting device deviating from the virtual procedure plan.

6. The method of Claim 1, wherein providing tactile feedback further comprises allowing movement of the procedure-conducting device along a route to the intracranial anatomy at issue defined by the virtual procedure plan, and physically preventing movement of the procedure-conducting device deviating from the route defined by the virtual procedure plan.

7. The method of Claim 1, wherein forming a virtual procedure plan comprises defining virtual boundaries about anatomical stmctures to be avoided by the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue, and wherein providing tactile feedback further comprises providing tactile feedback via the procedure-conducting device if the procedureconducting device contacts any of the virtual boundaries during forming the bore or during accessing the intracranial anatomy at issue.

8. The method of Claim 1, wherein providing tactile feedback further comprises vibrating the procedure-conducting device if movement of the procedure-conducting device deviates from the virtual procedure plan.

9. The method of Claim 1, wherein physically regulating movement of the procedureconducting device comprises physically regulating movement of the procedure-conducting device via the robot arm physically engaged with the procedure-conducting device and the fiducial device via the tracking arm, the robot arm being responsive to a controller to physically regulate the physical manipulation of the procedure-conducting device according to the virtual procedure plan.

10. The method of Claim 1, wherein the robot arm comprises a plurality of arm segments serially engaged via respective joints, and wherein physically regulating movement of the procedureconducting device comprises physically regulating movement of the procedure-conducting device by regulating one or more degrees of freedom of at least one of the joints of the robot arm.

11. The method of Claim 1, comprising mounting the tracking arm and the robot arm to a common base such that the tracking arm is in physical communication with the robot arm.

12. The method of Claim 1, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in physical communication with the fiducial marker via the fiducial device.

13. The method of Claim 1, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in non-physical communication with the fiducial marker.

14. The method of Claim 13, wherein engaging the tracking arm with the fiducial device comprises engaging the tracking arm with the fiducial device via a wireless communication arrangement, a WiFi communication arrangement, an electrical communication arrangement, an electromechanical communication arrangement, an optical communication arrangement, a magnetic communicationarrangement, an electromagnetic communication arrangement, or an infrared communication arrangement, such that the tracking arm is in non-physical communication with the fiducial marker.

15. The method of Claim 1, wherein the procedure-conducting device includes and is arranged to interchangeably receive a first end effector configured to form the bore and a second end effector configured to access the intracranial anatomy at issue.

16. The method of Claim 1, wherein the intracranial procedure comprises a cochlear implant procedure, and the procedure-conducting device comprises a bore-forming and implantation device, and wherein forming a virtual procedure plan comprises forming a virtual cochlear implant plan for forming the bore through the skull and into a middle ear of the patient, and for implanting a cochlear implant in the middle ear through the bore, in registration with and relative to the fiducial marker.

17. The method of Claim 16, wherein physically regulating movement of the procedureconducting device comprises physically regulating movement of the bore-forming and implantation device via the robot arm, and relative to the fiducial marker, in accordance with the virtual cochlear implant plan and commensurately with physical manipulation of the bore-forming and implantation device during forming the bore and during implanting the cochlear implant.

18. The method of Claim 17, wherein providing tactile feedback comprises providing tactile feedback, via the bore-forming and implantation device, if the physical manipulation of the bore-forming and implantation device deviates from the virtual cochlear implant plan.

19. The method of Claim 18, comprising imaging the inner ear, the maxillofacial anatomy, and the fiducial marker engaged with the fiducial device to facilitate registration of the virtual cochlear implant plan with the fiducial marker.

20. The method of Claim 18, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging the fiducial device with an upper jaw or with one or more teeth of the upper jaw of the patient.

21. The method of Claim 18, wherein engaging the fiducial device with the maxillofacial anatomy of the patient, comprises engaging a splint device with an upper jaw or with one or more teeth of the upper jaw of the patient.

22. The method of Claim 18, wherein providing tactile feedback further comprises allowing movement of the bore-forming and implantation device in accordance with the virtual cochlear implant plan,and physically preventing movement of the bore-forming and implantation device deviating from the virtual cochlear implant plan.

23. The method of Claim 18, wherein providing tactile feedback further comprises allowing movement of the bore-forming and implantation device along a route to the inner ear defined by the virtual cochlear implant plan, and physically preventing movement of the bore-forming and implantation device deviating from the route defined by the virtual cochlear implant plan.

24. The method of Claim 18, wherein forming a virtual cochlear implant plan comprises defining virtual boundaries about anatomical structures to be avoided by the bore-forming and implantation device during forming the bore and during implanting the cochlear implant, and wherein providing tactile feedback further comprises providing tactile feedback via the bore-forming and implantation device if the bore-forming and implantation device contacts any of the virtual boundaries during forming the bore or during implanting the cochlear implant.

25. The method of Claim 18, wherein providing tactile feedback further comprises vibrating the bore-forming and implantation device if movement of the bore-forming and implantation device deviates from the virtual cochlear implant plan.

26. The method of Claim 18, wherein physically regulating movement of the bore-forming and implantation device comprises physically regulating movement of the bore-forming and implantation device via the robot arm physically engaged with the bore-forming and implantation device and the fiducial device via the tracking arm, the robot arm being responsive to a controller to physically regulate the physical manipulation of the bore-forming and implantation device according to the virtual cochlear implant plan.

27. The method of Claim 18, wherein the robot arm comprises a plurality of arm segments serially engaged via respective joints, and wherein physically regulating movement of the bore-forming and implantation device comprises physically regulating movement of the bore-forming and implantation device by regulating one or more degrees of freedom of at least one of the joints of the robot arm.

28. The method of Claim 18, comprising mounting the tracking arm and the robot arm to a common base such that the tracking arm is in physical communication with the robot arm.

29. The method of Claim 18, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in physical communication with the fiducial marker via the fiducial device.

30. The method of Claim 18, comprising engaging the tracking arm with the fiducial device, such that the tracking arm is in non-physical communication with the fiducial marker.

31. The method of Claim 30, wherein engaging the tracking arm with the fiducial device comprises engaging the tracking arm with the fiducial device via a wireless communication arrangement, a WiFi communication arrangement, an electrical communication arrangement, an electromechanical communication arrangement, an optical communication arrangement, a magnetic communication arrangement, an electromagnetic communication arrangement, or an infrared communication arrangement, such that the tracking arm is in non-physical communication with the fiducial marker.

32. The method of Claim 18, wherein the bore-forming and implantation device includes and is arranged to interchangeably receive a first end effector configured to form the bore and a second end effector configured to implant the cochlear implant within the bore.

33. The method of Claim 1, wherein the intracranial procedure comprises an intracranial procedure in a region about a base of the skull, and wherein forming the virtual procedure plan comprises forming the virtual procedure plan for trans-nasally forming the bore through the skull and into the region about the base of the skull of the patient, and for accessing the intracranial anatomy at issue through the bore, in registration with and relative to the fiducial marker.

34. The method of Claim 33, wherein forming the virtual procedure plan comprises forming the virtual procedure plan including defining a virtual intra-nasal boundary about intra-nasal anatomical structures to be avoided by the procedure-conducting device during forming the bore.

35. The method of Claim 34, wherein physically regulating movement of the procedureconducting device comprises physically regulating movement of the procedure-conducting device via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device during forming the bore and during accessing the intracranial anatomy at issue such that movement of the procedure-conducting device is constrained within the virtual intra-nasal boundary.

36. The method of Claim 34, wherein providing tactile feedback further comprises providing tactile feedback via the procedure-conducting device if the procedure-conducting device contacts the virtual intra-nasal boundary during forming the bore or during accessing the intracranial anatomy at issue.

37. The method of Claim 33, wherein the procedure-conducting device includes and is arranged to receive at least a first end effector configured to form the bore, and wherein forming the virtual procedureplan comprises forming the virtual procedure plan including defining a virtual intra-nasal boundary configured as a conical frustrum having a major diameter end and an opposing minor diameter end, the conical frustrum being configured and arranged to avoid intra-nasal anatomical structures, with the minor diameter end being disposed about an intra-nasal site for forming the bore through the skull.

38. The method of Claim 37, wherein physically regulating movement of the procedureconducting device comprises physically regulating movement of the procedure-conducting device and the first end effector via the robot arm, and relative to the fiducial marker, in accordance with the virtual procedure plan and commensurately with physical manipulation of the procedure-conducting device and the first end effector during forming the bore and during accessing the intracranial anatomy at issue such that movement of the procedure-conducting device and the first end effector are constrained within the virtual intra-nasal boundary.

39. The method of Claim 37, wherein providing tactile feedback further comprises providing tactile feedback via the procedure-conducting device if the procedure-conducting device of the first end effector contacts the virtual intra-nasal boundary during forming the bore or during accessing the intracranial anatomy at issue.

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