Methods for performing guided intracranial surgical procedures

Abstract

The intracranial procedure involves engaging a fiducial device having a fiducial marker with the maxillofacial anatomical structure of a patient, wherein the fiducial device is positioned in communication with a tracking arm, which is positioned in communication with the robotic arm and has a procedure execution device engaged with the distal end of the robotic arm. A virtual procedure plan is prepared to penetrate the skull and form a bore entering the intracranial region, and to access the target intracranial anatomical structure by penetrating the bore and aligning with and relative to the fiducial marker. The movement of the procedure execution device is physically adjusted via the robotic arm and relative to the fiducial marker according to the virtual procedure plan and in accordance with the physical manipulation of the procedure execution device during bore formation and access to the target intracranial anatomical structure. Tactile feedback is provided via the procedure execution device if the physical manipulation of the procedure execution device deviates from the virtual procedure plan.

Description

Technical Field

[0001] The present disclosure relates to intracranial surgical procedures, and more particularly, to methods and systems for performing guided intracranial surgical procedures such as cochlear implant procedures or transnasal intracranial surgical procedures.

Background Art

[0002] For example, in the case of intracranial surgical procedures such as cochlear implant procedures, it is critical to penetrate the skull and accurately access the inner ear (e.g., the cochlea within the inner ear) around the intervening intracranial anatomical structures in order to place or implant an electronic lead for a cochlear implant within the inner ear. Such procedures typically require multiple stages of manual drilling and surgery to provide an appropriate bore or passage for insertion of the electronic lead into the inner ear. However, such manual procedures often lack stability and accuracy in order to provide the level of precision required for the procedure and to minimize the risk of damage to intracranial anatomical structures.

[0003] An alternative procedure, direct cochlear access (DCA), involves a straight-line approach from the skull surface / skull to the cochlea. However, such a straight-line approach has a risk of damage to critical intracranial anatomical structures, especially when performed manually.

[0004] Certain rigid patient-specific templates have been developed to limit the orientation of surgical tools and / or to guide surgical tools along a planned path to the inner ear in cochlear implant procedures. However, while this approach may potentially achieve appropriate accuracy, delays associated with the production and incorporation of the templates are a problem, and such patient-specific templates cannot easily accommodate changes to the surgical plan.

[0005] In some cases, industrial robots have also been investigated for use in creating DCA procedures according to preoperative plans. However, while such industrial robot systems may come close to the required precision, their size and weight make integration into the operating room environment difficult and cumbersome. Furthermore, such robotic systems often lack suitable and convenient positional configurations for tracking the patient during the procedure. That is, robotic approaches often require rigid head fixation with positioning pins and fasteners that are invasively attached to the patient's skull in a separate surgical procedure that generally requires anesthesia (see, for example, Figures 3A-3C).

[0006] Another example of intracranial surgical procedures involves accessing the area around the base of the skull to perform ear, nose, or throat (ENT) and / or neurological procedures (e.g., for tumor removal / biopsy or other surgical procedures). In such cases, however, the necessary access to the relevant intracranial anatomical structures that penetrate the outside of the skull often requires the brain to be retracted in order to provide access to the area around the base of the skull. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent No. 8,808,000 [Patent Document 2] U.S. Patent No. 10,918,459 [Patent Document 3] U.S. Patent No. 10,016,242 [Patent Document 4] U.S. Patent No. 10,639,128 [Patent Document 5] U.S. Patent Application Publication No. 2022 / 0233248 [Patent Document 6] U.S. Patent Application No. 17 / 915,861 [Patent Document 7] U.S. Patent Application No. 17 / 915,863 [Patent Document 8] U.S. Patent Application No. 17 / 916,438 [Patent Document 9] U.S. Patent Application No. 18 / 040,261 [Overview of the project] [Problems that the invention aims to solve]

[0008] Therefore, there is a need for methods to provide improved intracranial surgical procedures, such as cochlear implantation or surgical procedures, that target the area around the base of the skull, thereby addressing the stated shortcomings of current procedures and facilitating, for example, effective pre-procedure planning and favorable, proactive guidance during intracranial surgical procedures. [Means for solving the problem]

[0009] The above and other needs are satisfied by the present disclosure, which in one embodiment provides a method for performing an intracranial procedure, such procedure comprising engaging a fiducial device with the maxillofacial anatomical structure of a patient, the fiducial device having a fiducial marker engaged with the fiducial device, and positioned in communication with a tracking arm, the tracking arm having a procedure execution device engaged with the distal end of a robotic arm, and positioned in communication with a robotic arm. A virtual procedure plan is formed to penetrate the patient's skull and form a bore into an intracranial region, and to penetrate the bore, access the target intracranial anatomical structure, and perform the intracranial procedure in registration with and relative to the fiducial marker. The movement of the procedure execution device is physically coordinated via the robotic arm and with respect to the fiducial marker, in accordance with the virtual procedure plan and in correspondence with the physical manipulation of the procedure execution device while forming the bore and accessing the target intracranial anatomical structure. Haptic feedback is provided via the treatment device when the physical operation of the treatment device deviates from the virtual treatment plan.

[0010] Another exemplary embodiment provides a method for performing a cochlear implant procedure, the procedure comprising engaging a fiducial device with the maxillofacial anatomical structure of a patient, the fiducial device having a fiducial marker engaged with the fiducial device, and positioned in communication with a tracking arm, the tracking arm having a boreforming and implantation device engaged with the distal end of a robotic arm, and positioned in communication with a robotic arm. A virtual cochlear implant plan is formed to form a bore that penetrates the patient's skull and enters the middle ear, and to implant a cochlear implant through the bore into the middle ear, aligned with and relative to the fiducial marker. The movement of the boreforming and implantation device is physically controlled via the robotic arm and relative to the fiducial marker, according to the virtual cochlear implant plan and in accordance with the physical manipulation of the boreforming and implantation device during bore formation and implantation of the cochlear implant. Tactile feedback is provided via the boreforming and implantation devices when the physical manipulation of the boreforming and implantation devices deviates from the virtual cochlear implant plan.

[0011] Another exemplary embodiment provides a method for performing an intracranial procedure in a region around the base of the skull, such procedure comprising engaging a fiducial device with the maxillofacial anatomical structure of a patient, the fiducial device having a fiducial marker engaged with the fiducial device, and positioned in communication with a tracking arm, the tracking arm having a procedure execution device engaged with the distal end of a robotic arm, and positioned in communication with a robotic arm. A virtual procedure plan is formed to transnasally form a bore that penetrates the patient's skull and enters the region around the base of the skull, and to access the target intracranial anatomical structure by penetrating the bore and relative to the fiducial marker, while aligned with and relative to the fiducial marker. The movement of the procedure execution device is physically adjusted via the robotic arm and relative to the fiducial marker according to the virtual procedure plan and in accordance with the physical manipulation of the procedure execution device during bore formation and access to the target intracranial anatomical structure. Tactile feedback is provided via the procedure execution device if the physical manipulation of the procedure execution device deviates from the virtual procedure plan.

[0012] Various other aspects of this disclosure relate to systems for facilitating the disclosed method of performing intracranial procedures, such as cochlear implantation or intracranial procedures, in a region around the base of the skull via the nasal structure.

[0013] Therefore, this disclosure includes, without limitation, the following exemplary embodiments: Exemplary Embodiment 1: A method for performing an intracranial procedure, comprising engaging a fiducial device with the maxillofacial anatomical structure of a patient, wherein the fiducial device has a fiducial marker engaged with the fiducial device and is positioned in communication with a tracking arm, the tracking arm has a procedure execution device engaged with the distal end of a robotic arm and is positioned in communication with the robotic arm; forming a virtual procedure plan for penetrating the patient's skull and entering an intracranial region, and penetrating the bore to access the target intracranial anatomical structure, and performing an intracranial procedure aligned with and relative to the fiducial marker; physically adjusting the movement of the procedure execution device via the robotic arm and relative to the fiducial marker in accordance with the virtual procedure plan and in correspondence with the physical manipulation of the procedure execution device while forming the bore and while accessing the target intracranial anatomical structure; and providing tactile feedback via the procedure execution device if the physical manipulation of the procedure execution device deviates from the virtual procedure plan.

[0014] Exemplary Embodiment 2: The method or a combination thereof according to Exemplary Embodiment 1, comprising imaging the target intracranial anatomical structure, maxillofacial anatomical structure, and fiducial markers engaged with a fiducial device to facilitate alignment with fiducial markers in a virtual treatment plan.

[0015] Exemplary Embodiment 3: The method according to any one or a combination of Exemplary Embodiments 1 to 2, wherein engaging the fiducial device with the maxillofacial anatomical structure of a patient includes engaging the fiducial device with the maxilla of a patient or with one or more teeth of the maxilla.

[0016] Exemplary Embodiment 4: Engaging a fiducial device with a patient's craniofacial anatomical structure is a method according to any one or combination of Exemplary Embodiments 1 to 3, including engaging a splint device with the patient's upper jaw or one or more teeth of the upper jaw.

[0017] Exemplary Embodiment 5: Providing haptic feedback further includes enabling movement of a treatment implementation device according to a virtual treatment plan and physically preventing movement of the treatment implementation device that deviates from the virtual treatment plan, which is a method according to any one or combination of Exemplary Embodiments 1 to 4.

[0018] Exemplary Embodiment 6: Providing haptic feedback further includes enabling movement of a treatment implementation device along a route to a target intracranial anatomical structure defined by a virtual treatment plan and physically preventing movement of the treatment implementation device that deviates from the route defined by the virtual treatment plan, which is a method according to any one or combination of Exemplary Embodiments 1 to 5.

[0019] Exemplary Embodiment 7: Forming a virtual treatment plan includes defining a virtual boundary around an anatomical structure avoided by a treatment implementation device during bore formation and accessing a target intracranial anatomical structure. Providing haptic feedback further includes providing haptic feedback via the treatment implementation device when the treatment implementation device contacts any of the virtual boundaries during bore formation or accessing the target intracranial anatomical structure, which is a method according to any one or combination of Exemplary Embodiments 1 to 6.

[0020] Exemplary Embodiment 8: Providing haptic feedback further includes vibrating the treatment implementation device when the movement of the treatment implementation device deviates from the virtual treatment plan, which is a method according to any one or combination of Exemplary Embodiments 1 to 7.

[0021] Exemplary Embodiment 9: Physically adjusting the movement of the treatment device includes physically adjusting the movement of the treatment device via a robotic arm physically engaged with the treatment device, and physically adjusting the movement of the fiducial device via a tracking arm, where the robotic arm responds to a controller to physically adjust the physical operation of the treatment device according to a virtual treatment plan, the method according to any one or a combination thereof of Exemplary Embodiments 1 to 8.

[0022] Exemplary Embodiment 10: The robotic arm includes a plurality of arm segments serially engaged via respective joints, and physically adjusting the movement of the treatment device includes physically adjusting the movement of the treatment device by adjusting one or more degrees of freedom of at least one of the joints of the robotic arm, the method according to any one or a combination thereof of Exemplary Embodiments 1 to 9.

[0023] Exemplary Embodiment 11: Mounting the tracking arm and the robotic arm on a common base such that the tracking arm is in a physical communication state with the robotic arm, the method according to any one or a combination thereof of Exemplary Embodiments 1 to 10.

[0024] Exemplary Embodiment 12: Engaging the tracking arm with the fiducial device such that the tracking arm is in a physical communication state with the fiducial marker via the fiducial device, the method according to any one or a combination thereof of Exemplary Embodiments 1 to 11.

[0025] Exemplary Embodiment 13: Engaging the tracking arm with the fiducial device such that the tracking arm is not in a physical communication state with the fiducial marker, the method according to any one or a combination thereof of Exemplary Embodiments 1 to 12.

[0026] Exemplary Embodiment 14: The method of any one or a combination of Exemplary Embodiments 1 to 13, wherein engaging a tracking arm with a fiducial device involves engaging the tracking arm with a fiducial device via a wireless communication configuration, WiFi communication configuration, telecommunication configuration, electromechanical communication configuration, optical communication configuration, magnetic communication configuration, electromagnetic communication configuration, or infrared communication configuration, such that the tracking arm is in a non-physical state of communication with a fiducial marker.

[0027] Exemplary Embodiment 15: The method according to any one of the exemplary embodiments 1 to 14 or a combination thereof, wherein the procedure execution device includes a first end effector configured to form a bore and a second end effector configured to access the target intracranial anatomical structure, and is arranged to receive the first and second end effectors interchangeably.

[0028] Exemplary Embodiment 16: The method of any one of the Exemplary Embodiments 1 to 15 or a combination thereof, wherein the intracranial procedure includes a cochlear implant procedure, the procedure implementation device comprises a bore formation and implantation device, and forming a virtual procedure plan includes forming a bore that penetrates the patient's skull and enters the middle ear, and forming a virtual cochlear implant plan for implanting a cochlear implant into the middle ear, aligned with and relative to a fiducial marker, through the bore.

[0029] Exemplary Embodiment 17: A method by any one of the exemplary embodiments 1 to 16 or a combination thereof, comprising physically adjusting the movement of the procedure execution device via a robotic arm and with respect to a fiducial marker, in accordance with a virtual cochlear implant plan and in accordance with the physical manipulation of the boreforming and implantation device during bore formation and implantation of the cochlear implant.

[0030] Exemplary Embodiment 18: The method of any one of the exemplary embodiments 1 to 17 or a combination thereof, wherein providing tactile feedback includes providing tactile feedback via the boreforming and implantation device when the physical manipulation of the boreforming and implantation device deviates from the virtual cochlear implant plan.

[0031] Exemplary Embodiment 19: The method of any one of the exemplary embodiments 1 to 18 or a combination thereof, comprising imaging the inner ear, maxillofacial anatomical structures, and fiducial markers engaged with fiducial devices to facilitate alignment with fiducial markers of a virtual cochlear implant.

[0032] Exemplary Embodiment 20: The method according to any one of the exemplary embodiments 1 to 19 or a combination thereof, wherein engaging the fiducial device with the maxillofacial anatomical structure of a patient includes engaging the fiducial device with the maxilla of a patient or with one or more teeth of the maxilla.

[0033] Exemplary Embodiment 21: The method according to any one of the exemplary embodiments 1 to 20 or a combination thereof, wherein engaging the fiducial device with the maxillofacial anatomical structure of a patient includes engaging the splint device with the maxilla of a patient or with one or more teeth of the maxilla.

[0034] Exemplary Embodiment 22: The method of any one of the exemplary embodiments 1 to 21 or a combination thereof, further comprising providing tactile feedback, enabling the movement of the boreforming and implantation device in accordance with a virtual cochlear implantation plan, and physically preventing the movement of the boreforming and implantation device from deviating from the virtual cochlear implantation plan.

[0035] Exemplary Embodiment 23: The method of any one of the exemplary embodiments 1 to 22 or a combination thereof, further comprising providing tactile feedback by enabling bore formation and movement of the implantation device along a route to the inner ear as defined by a virtual cochlear implant plan, and physically preventing bore formation and movement of the implantation device from deviating from the route defined by the virtual cochlear implant plan.

[0036] Exemplary Embodiment 24: The method of any one of the exemplary embodiments 1 to 23 or a combination thereof, wherein forming a virtual cochlear implant plan comprises defining virtual boundaries around anatomical structures to be avoided by the boreforming and implantation device during bore formation and cochlear implantation, and providing tactile feedback further comprises providing tactile feedback via the boreforming and implantation device when the boreforming and implantation device comes into contact with any of the virtual boundaries during bore formation or cochlear implantation.

[0037] Exemplary Embodiment 25: The method of any one of the exemplary embodiments 1 to 24 or a combination thereof, further comprising providing tactile feedback by vibrating the boreforming and implantation device when the movement of the boreforming and implantation device deviates from the virtual cochlear implantation plan.

[0038] Exemplary Embodiment 26: The method of any one of the exemplary embodiments 1 to 25 or a combination thereof, wherein physically regulating the motion of the boreforming and implantation device includes physically regulating the motion of the boreforming and implantation device via a robotic arm physically engaged with the boreforming and implantation device and the motion of a fiducial device via a tracking arm, the robotic arm responding to a controller to physically regulate the physical operation of the boreforming and implantation device according to a virtual cochlear implantation plan.

[0039] Exemplary Embodiment 27: The method of any one of the exemplary embodiments 1 to 26 or a combination thereof, wherein the robot arm comprises a plurality of arm segments engaged in serially via their respective joints, and the motion of the boreforming and implantation device is physically regulated by adjusting one or more degrees of freedom of at least one joint of the robot arm joints.

[0040] Exemplary Embodiment 28: A method of any one of the exemplary embodiments 1 to 27 or a combination thereof, comprising mounting the tracking arm and the robot arm on a common base such that the tracking arm is in physical communication with the robot arm.

[0041] Exemplary Embodiment 29: A method according to any one of the exemplary embodiments 1 to 28 or a combination thereof, comprising engaging a tracking arm with a fiducial device such that the tracking arm is in a state of physical communication with a fiducial marker via the fiducial device.

[0042] Exemplary Embodiment 30: A method according to any one of the exemplary embodiments 1 to 29 or a combination thereof, comprising engaging a tracking arm with a fiducial device such that the tracking arm is in a state of non-physical communication with a fiducial marker.

[0043] Exemplary Embodiment 31: The method of any one or a combination of Exemplary Embodiments 1 to 30, wherein engaging the tracking arm with the fiducial device is performed by engaging the tracking arm with the fiducial device via a wireless communication configuration, WiFi communication configuration, telecommunication configuration, electromechanical communication configuration, optical communication configuration, magnetic communication configuration, electromagnetic communication configuration, or infrared communication configuration, such that the tracking arm is in a non-physical communication state with the fiducial marker.

[0044] Exemplary Embodiment 32: The method according to any one of the exemplary embodiments 1 to 31 or a combination thereof, wherein the bore forming and implantation device comprises a first end effector configured to form a bore and a second end effector configured to implant a cochlear implant within the bore, and the first end effector and the second end effector are arranged to receive interchangeably.

[0045] Exemplary Embodiment 33: The method of any one of the Exemplary Embodiments 1 to 32 or a combination thereof, wherein the intracranial procedure includes an intracranial procedure in a region around the base of the skull, and forming a virtual procedure plan includes forming a virtual procedure plan for transnasally forming a bore that penetrates the patient's skull and enters the region around the base of the skull, and for accessing the target intracranial anatomical structure by penetrating the bore in alignment with and relative to a fiducial marker.

[0046] Exemplary Embodiment 34: The method of any one of the exemplary embodiments 1 to 33 or a combination thereof, wherein forming a virtual treatment plan includes defining a virtual intranasal boundary around intranasal anatomical structures to be avoided by the treatment device while forming a bore.

[0047] Exemplary Embodiment 35: The method of any one of the exemplary embodiments 1 to 34 or a combination thereof, comprising physically adjusting the movement of the procedure execution device via a robotic arm and with respect to a fiducial marker, in accordance with a virtual procedure plan and in accordance with the physical manipulation of the procedure execution device during the formation of a bore and access to the target intracranial anatomical structure, such that the movement of the procedure execution device is constrained within a virtual intranasal cavity boundary.

[0048] Exemplary Embodiment 36: The method of any one of the exemplary embodiments 1 to 35 or a combination thereof, further comprising providing tactile feedback when the procedure device comes into contact with a virtual intranasal cavity boundary while forming a bore or accessing a target intracranial anatomical structure.

[0049] Exemplary Embodiment 37: The method of any one of the Exemplary Embodiments 1 to 36 or a combination thereof, wherein the procedure execution device includes at least a first end effector configured to form a bore, and is positioned to receive at least the first end effector, and the formation of a virtual procedure plan includes defining a virtual intranasal boundary configured as a frustum having a large diameter end and an opposing small diameter end, wherein the frustum is configured and positioned to avoid intranasal anatomical structures, the small diameter end being positioned around an internal nasal location to form a bore penetrating the skull.

[0050] Exemplary Embodiment 38: The method of any one of the exemplary embodiments 1 to 37 or a combination thereof, comprising physically adjusting the motion of the procedure device via a robotic arm and to a fiducial marker, in accordance with a virtual procedure plan and in correspondence with the physical manipulation of the procedure device and the first end effector while forming a bore and accessing the target intracranial anatomical structure, such that the motion of the procedure device and the first end effector is constrained within a virtual intranasal cavity boundary.

[0051] Exemplary Embodiment 39: The method of any one of the exemplary embodiments 1 to 38 or a combination thereof, further comprising providing tactile feedback via the procedure execution device when the procedure execution device of the first end effector comes into contact with the virtual intranasal cavity boundary while forming a bore or accessing the target intracranial anatomical structure.

[0052] These and other features, aspects, and advantages of the Disclosure will become apparent from reading the following detailed description together with the accompanying drawings, which are briefly described below. The Disclosure includes any combination of two, three, four, or more features or elements described herein, whether such features or elements are expressly combined or otherwise mentioned in the description of specific embodiments herein. Any separable feature or element of the Disclosure should be considered to be intended to be combined in any aspect or embodiment, unless the context of the Disclosure expressly indicates otherwise.

[0053] It will be recognized that this abstract is provided merely to summarize several exemplary embodiments in order to provide a basic understanding of the disclosure. Therefore, it will be recognized that the exemplary embodiments described above are merely examples and should not be construed as narrowing the scope or intent of the disclosure in any way. It will be recognized that the scope of the disclosure encompasses many possible embodiments, some of which are described further below in addition to those summarized herein. Furthermore, other embodiments disclosed herein and the advantages of such embodiments will become apparent from the following detailed description, which will refer to the principles of the embodiments described in conjunction with the accompanying drawings provided as examples.

[0054] Thus, the present disclosure is explained in general terms, and references are made here to the attached drawings, which are not necessarily drawn according to a fixed proportional scale. [Brief explanation of the drawing]

[0055] [Figure 1A] This is a schematic diagram showing the anatomical features of the human ear. [Figure 1B] This figure schematically shows the anatomical features of the inner ear region shown in Figure 1A. [Figure 2A] This diagram schematically illustrates a cochlear implant system in an exemplary implementation for the human ear. [Figure 2B] This diagram schematically illustrates a cochlear implant system in an exemplary implementation for the human ear. [Figure 3A] This diagram schematically illustrates conventional equipment for invasively fixing a patient's head in order to perform a cochlear implant procedure. [Figure 3B] This diagram schematically illustrates conventional equipment for invasively fixing a patient's head in order to perform a cochlear implant procedure. [Figure 3C] This diagram schematically illustrates conventional equipment for invasively fixing a patient's head in order to perform a cochlear implant procedure. [Figure 4A] This diagram schematically illustrates a flow chart of a method for performing an intracranial procedure according to one aspect of the present disclosure. [Figure 4B] This diagram schematically illustrates a flow chart of a method for performing a cochlear implant procedure according to one aspect of the present disclosure. [Figure 4C] This figure schematically illustrates a flow of a method for performing an intracranial procedure in a region around the base of the skull via the nasal structure, according to one aspect of the present disclosure. [Figure 5] This figure schematically illustrates a system for performing cochlear implantation according to one aspect of the present disclosure. [Figure 6] This figure schematically illustrates a system for performing cochlear implantation procedures according to an alternative embodiment of the present disclosure. [Figure 7] This figure schematically illustrates a system for performing cochlear implantation procedures according to an alternative embodiment of the present disclosure. [Figure 8] This figure schematically illustrates a system for performing cochlear implantation procedures according to an alternative aspect of this disclosure. [Figure 9] This figure schematically illustrates a transnasal or transvenous sinus approach for performing intracranial surgical procedures in the region around the base of the skull, according to one aspect of the present disclosure. [Figure 10] This figure schematically illustrates a transnasal or transvenous sinus approach for performing intracranial surgical procedures in the region around the base of the skull, according to another aspect of the present disclosure. [Modes for carrying out the invention]

[0056] Herein, this disclosure will be described more fully with reference to the accompanying drawings, in which some, though not all, of the disclosure are shown. In practice, these disclosures may be embodied in many different forms and should not be construed as being limited to the embodiments described herein, but rather these embodiments are provided to satisfy the legal requirements in which this disclosure is applicable. Similar figures refer to similar elements throughout.

[0057] Aspects of this disclosure generally relate to methods for performing intracranial procedures, such as cochlear implantation or cochlear implantation procedures or intracranial procedures, in a region around the base of the skull of a patient, while minimizing or eliminating the risk of damage to the skull or critical anatomical structures between the skull and the inner ear or intracranial anatomical structures, via the nasal structures.

[0058] Figure 1A schematically shows a cross-section of the anatomical structure of the human ear system 5 as an example of an intracranial anatomical structure on which an intracranial procedure is performed according to an aspect of this disclosure, while Figure 1B schematically shows a cross-section of the anatomical structure of the middle ear 10 portion of the human ear system 5. Generally, when a patient has lost hearing and a cochlear implantation system 15 is a candidate for hearing restoration, such a cochlear implantation system 15 (see, for example, Figures 2A and 2B) requires at least a subcutaneous implantation of a receiver / stimulator 20 having an electronic lead / electrode array 25 extending from the receiver / stimulator 20 that penetrates the skull 30 and enters the cochlea 35 within the middle ear 10. Other typical components of the cochlear implantation system 15 include, for example, a transmitter 40, a speech processor 45, and a microphone 50, which are generally mounted externally to the skull 30.

[0059] In this regard, aspects of the present disclosure relate to and address methods for performing cochlear implantation, as an example of an intracranial anatomical structure on which the intracranial procedure according to aspects of the present disclosure is performed, addressing the limitations set forth herein with respect to prior art methods and systems for performing cochlear implantation. More specifically, aspects of the present disclosure implement physically guided robotic assistance in the bore formation and electronic lead implantation portions of cochlear implantation, all relating to non-invasive fiducial devices / fiducial markers and without physically restraining the patient (for example, without physically restraining the patient as shown in Figure 3), and pre-procedure virtual cochlear implantation planning in conjunction with haptic or tactile feedback to the user via bore formation and implantation devices physically engaged with and guided by the robotic assistance.

[0060] Accordingly, aspects of the present disclosure generally address intracranial procedures, including a method 60A for performing an intracranial procedure, as illustrated, for example, in Figure 4A. Such a procedure involves engaging a fiducial device with the maxillofacial anatomical structure of a patient, the fiducial device having a fiducial marker engaged with the fiducial device, and being positioned in communication with a tracking arm, the tracking arm having a procedure execution device engaged with the distal end of a robotic arm, and being positioned in communication with the robotic arm (block 65A). A virtual procedure plan (e.g., a virtual cochlear implant plan) is formed to penetrate the patient's skull and enter an intracranial region, and to penetrate the bore to access the target intracranial anatomical structure and perform the intracranial procedure in alignment with and relative to the fiducial marker (block 70A). The movement of the treatment device is physically adjusted via the robotic arm and to the fiducial marker in accordance with the virtual treatment plan and in accordance with the physical manipulation of the treatment device while forming a bore and accessing the target intracranial anatomical structure (block 75A). Tactile feedback is provided via the treatment device if the physical manipulation of the treatment device deviates from the virtual treatment plan (block 80A).

[0061] More detailed aspects of the present disclosure include, for example, a method 60B for performing a cochlear implant procedure (also referred to herein as a “cochlear implant procedure”) as a specific example of an intracranial procedure according to the present disclosure, as illustrated in Figure 4A. Such a procedure may include, for example, engaging a fiducial device with the maxillofacial anatomical structure of a patient, wherein the fiducial device has a fiducial marker engaged with the fiducial device and is positioned in communication with a tracking arm, the tracking arm is positioned in communication with a robotic arm having a bore-forming and implantation device engaged with the distal end of a robotic arm (block 65B), and forming a virtual cochlear implant plan for penetrating the patient’s skull and entering the middle ear, and for penetrating the bore and implanting a cochlear implant into the middle ear in alignment with and relative to the fiducial marker (block 70B). The movement of the boreforming and implantation device is physically adjusted via a robotic arm and to a fiducial marker in accordance with the virtual cochlear implant plan and in accordance with the physical manipulation of the boreforming and implantation device during bore formation and cochlear implantation (block 75). Tactile feedback is provided via the boreforming and implantation device if the physical manipulation of the boreforming and implantation device deviates from the virtual cochlear implant plan (block 80B).

[0062] Figures 5 to 8 illustrate exemplary systems that may facilitate pre-procedure virtual cochlear implant planning in conjunction with physically guided robotic assistance in the bore formation and electronic lead implantation portions of cochlear implantation procedures, as described herein, and the exemplary systems are generally indicated by the number 100. Such systems 100 may be similar to, for example, the dental implantation systems described in U.S. Patent No. 8,808,000 and No. 10,918,459, both of which have been jointly assigned to Neocis Inc., the assignee of this application. U.S. Patents 8,808,000 and No. 10,918,459 are incorporated herein by reference in their entirety.

[0063] As disclosed above, one embodiment of the cochlear implantation procedure disclosed herein may generally involve a pre-procedure imaging step, in which CT, MRI, X-ray, or other suitable imaging of the patient's skull and inner ear structures is obtained. From the imaging step, any abnormalities can be diagnosed, and / or the specific location of the intervening intracranial anatomical structure can be determined. In such cases where the cochlear implantation procedure may be prescribed or associated with pre-procedure imaging for an guided robotic procedure, the fiducial device 250 is engaged with the patient's maxillofacial anatomical structure. For example, the fiducial device 250 may comprise or otherwise be associated with a split device engaged with the patient's maxilla or one or more teeth of the maxilla. The split device is preferably configured to engage with the patient's maxilla / teeth in a “firm” or secure interaction, as shown in Figures 5 and 6 (i.e., the split device engages with the patient's teeth or maxilla and does not move relative to the teeth or maxilla). In one embodiment, the precise positioning of the split device relative to the patient's teeth / maxilla may be critical or irrelevant, as long as the split device is securely in place. Convenient and suitable split devices are disclosed, for example, in U.S. Patent Nos. 10,016,242 and 10,639,128, U.S. Patent Application Publication No. 2022 / 0233248, and U.S. Patent Applications Nos. 17 / 915,861, 17 / 915,863, 17 / 916,438, and 18 / 040,261, all of which are assigned in their entirety to Neocis Inc., the assignee of this application, and are incorporated herein by reference in their entirety.

[0064] In certain embodiments, the fiducial device 250 has a fiducial marker engaged with the fiducial device 250. Such a fiducial marker is configured to have a geometric shape or other properties or features that uniquely define the fiducial marker in three-dimensional space (i.e., the fiducial marker is easily identifiable in an image of the patient's jaw structure). In such cases, the fiducial marker is attached to and integrated with the fiducial device 250, or otherwise defined by it. In some embodiments, the fiducial marker may be composed of a radiopaque material that can be clearly defined in an image (e.g., CT, MRI, X-ray). In some cases, for example, if the split device includes a kinematic mount associated with the split device, the fiducial marker may be configured / positioned to be mounted on the kinematic mount for a pre-procedural imaging process.

[0065] With the fiducial marker established on the fiducial device 250 and the patient's teeth or maxilla, pre-procedure imaging may include imaging the inner ear, maxillofacial anatomical structures, and the fiducial marker engaged with the fiducial device 250 to facilitate alignment of the virtual cochlear implant plan with the fiducial marker. That is, by imaging the inner ear and maxillofacial anatomical structures together with the fiducial marker, the cochlear implant plan can be aligned with and thus formed relative to the fiducial marker. Furthermore, intracranial anatomical structures between the skull and the inner ear can be identified and located relative to the fiducial marker. Since intracranial anatomical structures are thus located and known relative to fiducial markers (and / or kinematic mounts engaged with the splint device), the virtual cochlear implant plan can thus be formed to include pathways or routes between the skull / cranium and the inner ear (and, in particular, the cochlea) to form bores or insertion channels for inserting the electronic leads of the cochlear implant. The imaging procedure may provide further data on the virtual cochlear implant plan, for example, regarding the orientation, direction, dimensions, depth, and / or sequence of the required bores(s). Thus, relevant parameters may be included in the virtual cochlear implant plan and determined relative to the fiducial markers.

[0066] The virtual cochlear implant plan may then be integrated with or otherwise associated with a suitable robotic assistance system, such as the system 100, which has a suitable boreforming and implantation device 150 (e.g., a procedure execution device) operably engaged with the system 100. The robotic assistance system 100 may include, for example, a guidance system 200 that is in communication with and between a fiducial device 250 / fiducial marker and the boreforming and implantation device 150. In some embodiments, the guidance system 200 comprises an articulated arm member or robotic arm 350 having a boreforming and implantation device 150 engaged with the distal end of the robotic arm 350, the robotic arm 350 determining the range of motion of the boreforming and implantation device 150. The guidance system 200 may also include a tracking arm 400 that is in communication with the fiducial device 250 and the boreforming and implantation device 150 and / or the robotic arm 350.

[0067] For example, the tracking arm 400 may be equipped with a mechanical linkage mechanism to connect the splint device to the distal end of the tracking arm 400 (for example, by the distal end of the tracking arm 400 physically engaging with the kinematic mount of the splint device (fiducial device 250)). Thus, with the fiducial device 250 and / or fiducial marker as the reference of the coordinate system (e.g., from the imaging step before the procedure), and with the tracking arm 400 in 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 be positioned in a coordinate space defined with respect to the fiducial marker, and the virtual cochlear implant plan is based on that coordinate space. Furthermore, when the tracking arm 400 is in communication with the robot arm 350 (e.g., mounted on a common base), and the robot arm 350 is in a known configuration, the robot arm 350 (e.g., the proximal and distal ends of the robot arm 350) and the boreforming and implantation device 150 engaged with the distal end of the robot arm 350 can also be positioned in a coordinate space defined with respect to the fiducial marker, and the virtual cochlear implantation plan is based on that coordinate space. In some cases, the tracking arm 400 and the robot arm 350 may be configured to be tracked by appropriate positioning sensors operably engaged with articulation joints that connect segments of the tracking arm 400 and the robot arm 350 and / or mount the tracking arm 400 and the robot arm 350 on a common base.

[0068] In some cases, as shown in Figures 5 to 7, the tracking arm 400 may be physically attached to the fiducial device 250 (in a robust, secure, and known reproducible manner) via a mounting mechanism configured to interface with a kinematic mount engaged with the fiducial device 250. Thus attached to the patient via the fiducial device 250, the tracking arm 400 provides data on the patient's position relative to the fiducial marker (always, selectively, or otherwise as needed) and communicates with the boreforming and implantation device 150 / robot arm 350, aligned with and similarly to the fiducial marker, to plan and execute a virtual cochlear implantation plan. Therefore, once a coordinate system is established with respect to the fiducial marker / kinematic mount (for example, the position of the kinematic mount relative to the fiducial marker in the coordinate system is also known or determined), it is not necessarily required that the fiducial marker be engaged with the fiducial device 250 during the execution of the virtual cochlear implant plan. Furthermore, since the execution of the virtual cochlear implant plan is with respect to a coordinate system established and tracked via the fiducial device 250, precise guidance of the robotic arm 350 / boreforming and implantation device 150 is required if the patient moves during the execution of the virtual cochlear implant plan. In various embodiments, the fiducial marker may be able to communicate with the tracking arm 400 via, for example, a wireless transceiver, a hardwired connection, an optical communication system, or any other suitable mechanism, whether of an electrical, mechanical, electromechanical, or optical nature.

[0069] Furthermore, in consideration of the disclosed configurations, those skilled in the art will recognize that the fiducial device 250 and / or associated fiducial marker may be in a state of communication with the tracking arm 400 or the boreforming and implantation device 150 / robot arm 350 in many different ways. For example, as shown in Figure 8, the tracking arm 400 may be in a state of non-physical communication with the fiducial device 250 / fiducial marker. More specifically, the tracking arm 400 may be in a state of communication with the fiducial device 250 / fiducial marker via a wireless communication configuration, a WiFi communication configuration, a telecommunications configuration, an electromechanical communication configuration, an optical communication configuration, a magnetic communication configuration, an electromagnetic communication configuration, or an infrared communication configuration. Those skilled in the art will recognize that such non-physical communication configurations may be achieved by, for example, an emitter-detector configuration (e.g., a detector engaged with the tracking arm 400 and an emitter engaged with the fiducial device 250 / fiducial marker), a receiver-emitter configuration, a transceiver configuration (e.g., a transceiver engaged with the tracking arm 400 emits a signal reflected from the fiducial device 250 / fiducial marker, and the reflected signal is detected by a transceiver engaged with the tracking arm), or any other suitable configuration in which the position of the tracking arm 400 can be determined relative to the position of the fiducial device 250 / fiducial marker.

[0070] In some embodiments, the guidance system 200 may further be configured to include a controller device 450 (e.g., a computer device shown in Figures 6 to 8) for aligning the fiducial marker, determining a coordinate system from images of the inner ear, maxillofacial anatomical structures, and the fiducial marker engaged with the fiducial device, and for appropriately executing a virtual cochlear implantation plan relative to the fiducial marker, and / or for communicating the fiducial marker with the boreforming and implantation device 150 / robot arm 350 in other ways, and for physically adjusting the movement of the boreforming and implantation device 150 / robot arm 350 according to the virtual cochlear implantation plan.

[0071] In one embodiment, the controller device 450 may be configured to receive images of the patient's inner ear and maxillofacial anatomical structures, including a fiducial marker engaged with a fiducial device, to align the anatomical structures with the fiducial marker, and to enable the formation of a virtual cochlear implant plan / procedure. In some cases, the controller device 450 may be further configured to enable the execution of or facilitate the execution of the virtual cochlear implant plan. Accordingly, the computer device 450 may include software, hardware, or a combination thereof. A virtual cochlear implant plan / procedure may enable the user to create a bore / passage that penetrates the skull and enters the inner ear, and to develop a virtual cochlear implant plan for implanting an electronic lead for a cochlear implant into the inner ear, in conjunction with a computerized model based on image(s). For example, the virtual cochlear implant plan may be created based on captured images(s) (whether 2D or 3D), and in conjunction with a "virtual procedure," it may be possible to manipulate images(s) of the patient's anatomical structure between and including the skull and the inner ear. In some embodiments, the cochlear implant routine / process and / or virtual cochlear implant plan may be created in relation to a (relative or absolute) coordinate system based on fiducial markers, for example, to associate cochlear implant parameters and requirements with fiducial markers, as recognized by those skilled in the art. In other embodiments, the controller device 450 may include peripheral devices (i.e., a trackball or joystick in conjunction with 3D goggles, neither shown) to assist or otherwise enable virtual manipulation of the relevant anatomical structure(s) with respect to an image(s), for example, to determine a suitable route for accessing the inner ear with respect to the maxillary / maxillary structure. The controller device 450 may be further configured to perform such operations manually, automatically, or semi-automatically, as needed or desired.

[0072] In embodiments where the fiducial device 250 / fiducial marker approach is used, the patient's teeth / maxilla are automatically aligned to the system 100 once the tracking arm 400 is attached to the fiducial device 250 via a kinematic mount or otherwise established in communication with the fiducial marker. That is, the fiducial marker is automatically determined from images(s) of the patient's teeth / maxilla structure and inner ear, and its alignment and location (or coordinate system relative to the fiducial marker) in physical space is known by the kinematic mount connecting the tracking arm 400 to the fiducial device 250 or otherwise by communication between the two. Thus, communication between the tracking arm 400 and the robotic arm 350 / boreforming and implantation device 150 allows the boreforming and implantation device 150 to be aligned to the fiducial marker (or other criteria relating to the patient) via the robotic arm 350, the tracking arm 400, and the fiducial device 250 / kinematic mount.

[0073] In one embodiment, the system 100 thus disclosed herein may be configured to form physical or non-physical communication between a fiducial marker (i.e., by physical or non-physical engagement with a fiducial device having a fiducial marker associated with a fiducial device) and an end effector 500 associated with a boreforming and implantation device 150 engaged with a robotic arm 350. Thus, a virtual cochlear implantation process / plan formed via the controller device 450 is achieved in a state aligned with the fiducial marker (or other criteria relating to the patient) and may therefore be translated or otherwise communicated to the system 100 in order to physically regulate the movement of the boreforming and implantation device 150. In some cases, the boreforming and implantation device 150 includes different end effectors 500, including a first end effector configured to form a bore and a second end effector configured to implant a cochlear implant (or its electronic lead) into the bore, and is arranged to accept them interchangeably.

[0074] The boreforming and implantation device 150 thus has an end effector 500 that engages with or forms part of the boreforming and implantation device 150, which is then 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 boreforming and implantation device 150, or to limit or otherwise control the motion of the boreforming and implantation device 150. For example, the robot arm 350 may be configured to include any number of mechanisms, arrangements, or equipment (e.g., controllable articulated joints connecting segments of the robot arm 350 and / or mounting the proximal end of the robot arm 350 on a common base, etc.). The robot 350 may have (or function as) a miniature parallel structure, in which case the boreforming and implantation device 150 is fixed to its distal end and allowed to have full freedom of motion when not in boreforming and implantation mode.

[0075] Since the boreforming and implantation device 150 includes an end effector 500, the end effector 500 (see, for example, Figures 5, 7, and 8) must be in a known position relative to the robot arm 350 (i.e., a position recognized by the system 100). In some embodiments, to calibrate the end effector 500 of the boreforming and implantation device 150 relative to a fiducial marker, a calibration element may be engaged with the fiducial device 250 (i.e., firmly mounted on the fiducial device 250 in a known and repeatable manner), or otherwise comprise an element or integrated feature of the fiducial device 250. In other cases, the calibration element may be interchangeable with other end effectors within the boreforming and implantation device 150. In such cases, those skilled in the art will recognize that the end effector 500 as a calibration element can then be calibrated using a coordinate system by various tip calibration methods (i.e., invariant points, etc.). Once calibrated, the calibration elements are replaced in a known and reproducible manner with a first end effector configured to form a bore in the bore-forming and implantation device 150, or a second end effector configured to implant a cochlear implant (or its electronic lead) into the bore, thereby maintaining the calibration parameters associated with each end effector 500 (i.e., the position of the most distal point and the bore-forming axis) in a calibrated state.

[0076] Based on the patient positioning, alignment, and / or orientation established and known by System 100, as well as a virtual cochlear implant plan developed through the controller device 450, the cochlear implant procedure can then be initiated by a practitioner who physically engages (i.e., grasps) the boreforming and implantation device 150 and moves it toward the skull (with the fiducial device 250 engaged with the teeth / maxilla and the tracking arm in communication with the fiducial marker). In such a case, the controller device 450 is configured to control or regulate the movement of the boreforming and implantation device 150 via the robotic arm 350, thereby allowing the practitioner's operation to move the end effector 500 to an appropriate starting position for the cochlear implant procedure (e.g., adjacent to the patient's skull adjacent to the starting point for the bore) relative to the fiducial marker associated with the patient's teeth / maxilla, as determined by the controller device 450 and commanded by the virtual cochlear implant plan. For example, a controller device 450 that executes or follows a virtual cochlear implantation plan may regulate or control the movement of the boreforming and implantation device 150 by providing unrestricted movement of the boreforming and implantation device 150 by the operator along and in orientation for forming a bore within the skull, but may prevent movement of the boreforming and implantation device 150 in directions that would otherwise create a risk of damaging critical anatomical structures (i.e., by locking or restricting the movement of joints between segments of the robotic arm 350, or otherwise providing resistance to moving the boreforming and implantation device in a direction or orientation that deviates from the route established and planned in the virtual cochlear implantation plan).In other words, the robot arm 350 may comprise multiple arm segments that are serially engaged via their respective joints, and the physical adjustment of the motion of the boreforming and implantation device 150 can be achieved by adjusting one or more degrees of freedom of at least one joint of the robot arm 350's joints.

[0077] In some cases, such adjustment or control to the movement of the boreforming and implantation device 150 via the robotic arm 350 may be physically detected by the practitioner (e.g., as tactile or haptic feedback through grasping the boreforming and implantation device 150). That is, in some cases, tactile feedback may be provided by enabling the movement of the boreforming and implantation device 150 in accordance with the virtual cochlear implantation plan, thereby physically preventing the movement of the boreforming and implantation device 150 from deviating from the virtual cochlear implantation plan. More specifically, such tactile feedback may be established for the movement of the boreforming and implantation device along the route to the inner ear defined by the virtual cochlear implantation plan.

[0078] In some embodiments, forming a virtual cochlear implant plan may include defining virtual boundaries around anatomical structures to be avoided by the boreforming and implantation device 150 during bore formation and cochlear implantation. In such cases, tactile / haptic feedback may be provided via the boreforming and implantation device 150 when the device comes into contact with any of the virtual boundaries during bore formation or cochlear implantation. In yet other cases, in addition to or instead of restricting the movement of the boreforming and implantation device 150 via a robotic arm 350, tactile feedback may be provided by vibrating the boreforming and implantation device 150 when its movement deviates from the virtual cochlear implant plan. In yet other cases, the boreforming and implantation device 150 / end effector 500 may not function if a deviation from the virtual cochlear implant plan is detected. In other cases, an audible tone or tactile vibration may be emitted from a device separate from the boreforming and implantation device 150 (i.e., the system 100 may otherwise include an audible alarm or vibration warning component). A person skilled in the art will therefore recognize that the system 100 may be further configured to provide the practitioner with feedback in other ways (tactile, haptic, or otherwise), for example, through deviation warning displays or other indicators, or any other suitable audio and / or visual mechanism.

[0079] Once the end effector 500 is placed in the start / start position as commanded by the controller device 450 and the virtual cochlear implant plan, the invasive (bore-forming) portion of the cochlear implant procedure may then be initiated, and the controller device 450 may also further command other parameters of the bore-forming and implantation device 150, such as the orientation of the path / route of the first end effector configured to form a bore, and / or the direction / distance / depth from the bore origin, in accordance with the virtual cochlear implant plan. Those skilled in the art will recognize that the bore-forming and implantation device 150 may be guided, for example, in a direct cochlear access (DCA) procedure to form a bore according to the virtual cochlear implant plan. However, in other cases, the bore-forming and implantation device 150 may be guided to form a bore in two or more stages, for example, with varying directions, orientations, etc. Once the bore is formed, the end effector may be replaced in the bore forming and implantation device 150 with a second end effector configured to embed a cochlear implant (or its electronic lead) into the bore, the second end effector may be in the form of a cannula or other suitable device configured to facilitate the insertion of the electronic lead through the bore into the inner ear (cochlea).

[0080] Accordingly, System 100 includes equipment for actually implementing a virtual cochlear implant plan that physically modulates the movement of the boreforming and implantation device 150 and provides tactile / haptic feedback to the practitioner via the boreforming and implantation device 150, thereby facilitating an improved cochlear implantation procedure rather than merely warning the practitioner if any procedure parameter is inaccurate or requires the practitioner to navigate anatomical structures displayed on a screen or to manually follow a path. In some cases, however, those skilled in the art will recognize that System 100 may be further configured to autonomously achieve the virtual cochlear implant plan through the automatic operation of the robotic arm 350 / boreforming and implantation device 150 via a controller device 450 without practitioner intervention. In other embodiments of this disclosure, the structure and function of System 100 are similarly applicable to the more general embodiments described above for performing / implementing the intracranial procedures disclosed herein with respect to performing cochlear implantation procedures. Accordingly, the method steps involved in cochlear implantation procedures disclosed and claimed are also involved in more general intracranial procedures, in particular when implemented using System 100, also disclosed herein.

[0081] Those skilled in the art will thus further recognize that embodiments of System 100 disclosed herein may be similarly implemented to perform other intracranial procedures, and that the involvement of System 100 may provide advantages and benefits in those other procedures in addition to the advantages and benefits disclosed herein. In another example of an intracranial procedure, Figure 4C schematically illustrates a method 60C of performing an intracranial procedure in a region 600 around the base of the skull (e.g., including the pituitary gland (see, e.g., element 610 in Figure 9) or intracranial anatomical structures within the region of the pituitary gland), as shown in Figures 9 and 10. Such a procedure involves engaging a fiducial device with the maxillofacial anatomical structure of the patient (e.g., maxilla / maxilla 620), the fiducial device having a fiducial marker engaged with the fiducial device and positioned in communication with a tracking arm, the tracking arm having a procedure-performing device engaged with the distal end of a robotic arm and positioned in communication with the robotic arm (block 65C). A virtual procedure plan is formed to transnasally (e.g., through the nasal / paranasal sinuses 630) to penetrate the patient's skull 640 and enter the region 600 around the base of the skull, and to access the target intracranial anatomical structure by penetrating the bore while aligned with and relative to the fiducial marker (block 70C). The movement of the procedure device is physically adjusted via the robotic arm and relative to the fiducial marker in accordance with the virtual procedure plan and in correspondence with the physical manipulation of the procedure device while forming the bore and accessing the target intracranial anatomical structure (block 75C). Tactile feedback is provided via the procedure device if the physical manipulation of the procedure device deviates from the virtual procedure plan (block 80C).

[0082] In some cases, the step of forming a virtual procedure plan includes defining a virtual intranasal boundary around an intranasal anatomical structure (e.g., an anatomical structure 635 including hard and soft tissues that defines the nasal cavity / paranasal sinuses 630) that is to be avoided by the procedure device while forming a bore through the skull, as shown in Figure 9. In such embodiments, physically regulating the movement of the procedure device includes physically regulating the movement of the procedure device via a robotic arm and to a fiducial marker in accordance with the virtual procedure plan and in correspondence with the physical manipulation of the procedure device while forming the bore and accessing the target intracranial anatomical structure. Further in such embodiments, providing tactile feedback further includes providing tactile feedback via the procedure device when the procedure device comes into contact with the virtual intranasal boundary while forming the bore or accessing the target intracranial anatomical structure. Such an embodiment implements an anatomical structure 635, including hard and soft tissues, that defines the nasal cavity / paranasal sinuses 630, as a boundary within which the movement of the treatment device is not constrained. When the treatment device approaches or contacts the boundary, constraints on the movement of the treatment device and / or other tactile feedback via the treatment device are implemented to prevent damage or injury to the anatomical structure.

[0083] In other embodiments, the procedure device includes at least a first end effector configured to form a bore and positioned to receive at least the first end effector. In such embodiments, forming a virtual procedure plan involves defining a virtual intranasal boundary 650 (see, for example, Figure 10) configured as a frustum having a large diameter end 665 and an opposing small diameter end 660. The frustum is configured and positioned to avoid intranasal anatomical structures, with the small diameter end 660 positioned around an internal nasal cavity to form a bore penetrating the skull. In such embodiments, physically regulating the movement of the treatment device includes physically regulating the movement of the treatment device and the first end effector via a robotic arm and to a fiducial marker in accordance with a virtual treatment plan and in correspondence with the physical manipulation of the treatment device and the first end effector during bore formation and access to the target intracranial anatomical structure (e.g., internal nasal cavity location), so that the movement of the treatment device and the first end effector remains within the virtual intranasal cavity boundary 650 (e.g., within the frustum of the cone). Furthermore, in such embodiments, providing tactile feedback further includes providing tactile feedback via the treatment device when the treatment device of the first end effector comes into contact with the virtual intranasal cavity boundary 650 (e.g., within the frustum of the cone) during bore formation or access to the target intracranial anatomical structure (e.g., internal nasal cavity location). Therefore, in such an embodiment, a virtual intranasal cavity boundary 650 (e.g., a frustum of a cone) is implemented as a boundary within which the movement of the treatment device and the first end effector is not constrained. Constraints on the movement of the treatment device and the first end effector, as well as other tactile feedback via the treatment device, are implemented to prevent damage or injury to anatomical structures 635 defining the nasal cavity / intranasal cavity 630, including hard and soft tissues, when the treatment device and / or the first end effector approaches or contacts the boundary (e.g., a frustum of a cone).

[0084] In other aspects of this disclosure, the structure and function of System 100 are similarly applicable to the above methods of performing / implementing intracranial procedures in the region around the base of the skull, as disclosed herein, with respect to performing cochlear implantation procedures, based on the fact that both procedures are specific examples of the more general method of performing intracranial procedures. Accordingly, the method steps involved in the disclosed and claimed cochlear implantation procedure are similarly involved in the disclosed and claimed methods and more general intracranial procedures, in particular, when such procedures are implemented using System 100, as also disclosed herein.

[0085] Many modifications and other embodiments of the disclosures described herein will be readily conceivable to those skilled in the art relating to these disclosures, who are of interest in the teachings presented in the above description and the accompanying drawings. It is therefore understood that this disclosure is not limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the appended claims. Certain terms are used herein, but they are used merely in a general and descriptive sense and not to limit the scope.

Claims

1. A method for performing intracranial procedures, The fiducial device is engaged with the maxillofacial anatomical structure of a patient, wherein the fiducial device has a fiducial marker engaged with the fiducial device and is positioned in communication with a tracking arm, and the tracking arm has a procedure execution device engaged with the distal end of a robotic arm and is positioned in communication with the robotic arm. To form a virtual treatment plan for creating a bore that penetrates the patient's skull and enters the intracranial region, and for penetrating the bore to access the target intracranial anatomical structure, aligning with the fiducial marker, and performing an intracranial procedure on the fiducial marker, In accordance with the virtual procedure plan, and in accordance with the physical manipulation of the procedure device during bore formation and access to the target intracranial anatomical structure, the movement of the procedure device is physically adjusted via the robotic arm and relative to the fiducial marker. A method comprising providing haptic feedback via a treatment device when the physical operation of the treatment device deviates from a virtual treatment plan.

2. The method according to claim 1, comprising imaging the target intracranial anatomical structure, maxillofacial anatomical structure, and fiducial marker engaged with a fiducial device to facilitate alignment with fiducial markers of a virtual treatment plan.

3. The method according to claim 1, wherein engaging the fiducial device with the maxillofacial anatomical structure of a patient includes engaging the fiducial device with the maxilla of a patient or with one or more teeth of the maxilla.

4. The method according to claim 1, wherein engaging a fiducial device with the maxillofacial anatomical structure of a patient includes engaging a splint device with the maxilla or with one or more teeth of the maxilla of a patient.

5. The method according to claim 1, further comprising providing haptic feedback to enable the movement of a treatment device in accordance with a virtual treatment plan and to physically prevent the movement of the treatment device from deviating from the virtual treatment plan.

6. The method according to claim 1, further comprising providing tactile feedback to enable the movement of the treatment device along a route to a target intracranial anatomical structure as defined by a virtual treatment plan, and to physically prevent the movement of the treatment device from deviating from the route defined by the virtual treatment plan.

7. The method according to claim 1, further comprising: forming a virtual procedure plan, which includes defining virtual boundaries around anatomical structures to be avoided by the procedure device while forming a bore and while accessing the target intracranial anatomical structure; and providing tactile feedback, which further includes providing tactile feedback via the procedure device when the procedure device comes into contact with any of the virtual boundaries while forming a bore or while accessing the target intracranial anatomical structure.

8. The method according to claim 1, further comprising providing haptic feedback by vibrating the treatment device if the movement of the treatment device deviates from a virtual treatment plan.

9. The method according to claim 1, wherein physically adjusting the motion of a treatment device includes physically adjusting the motion of a treatment device via a robotic arm physically engaged with the treatment device, and physically adjusting the motion of a fiducial device via a tracking arm, the robotic arm responding to a controller to physically adjust the physical operation of the treatment device according to a virtual treatment plan.

10. The method according to claim 1, wherein the robotic arm comprises a plurality of arm segments engaged in serially via their respective joints, and the motion of the treatment device is physically controlled by adjusting one or more degrees of freedom of at least one joint of the robotic arm joints.

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

12. The method according to claim 1, comprising engaging the tracking arm with a fiducial device such that the tracking arm is in a state of physical communication with a fiducial marker via the fiducial device.

13. The method according to claim 1, comprising engaging the tracking arm with a fiducial device such that the tracking arm is not in physical communication with the fiducial marker.

14. The method according to claim 13, wherein engaging the tracking arm with the fiducial device includes engaging the tracking arm with the fiducial device via a wireless communication configuration, Wi-Fi communication configuration, telecommunication configuration, electromechanical communication configuration, optical communication configuration, magnetic communication configuration, electromagnetic communication configuration, or infrared communication configuration, such that the tracking arm is in a non-physical state of communication with the fiducial marker.

15. The method according to claim 1, wherein the procedure-performing device includes a first end-effector configured to form a bore and a second end-effector configured to access a target intracranial anatomical structure, and is arranged to interchangeably receive the first and second end-effectors.

16. The method according to claim 1, wherein the intracranial procedure includes a cochlear implant procedure, the procedure device comprises a bore formation and implantation device, and forming a virtual procedure plan includes forming a virtual cochlear implant plan for forming a bore that penetrates the patient's skull and enters the middle ear, and for implanting a cochlear implant in the middle ear, aligned with and relative to a fiducial marker, through the bore.

17. The method according to claim 16, wherein the movement of the procedure device is to be physically controlled via a robotic arm and with respect to a fiducial marker in accordance with a virtual cochlear implantation plan and in accordance with the physical manipulation of the boreforming and implantation device during bore formation and during implantation of the cochlear implant.

18. The method according to claim 17, wherein providing tactile feedback includes providing tactile feedback via the boreforming and implantation device when the physical manipulation of the boreforming and implantation device deviates from the virtual cochlear implantation plan.

19. The method according to claim 18, comprising imaging the inner ear, maxillofacial anatomical structures, and fiducial markers engaged with fiducial devices to facilitate alignment with fiducial markers of a virtual cochlear implant plan.

20. The method according to claim 18, wherein engaging the fiducial device with the maxillofacial anatomical structure of a patient includes engaging the fiducial device with the maxilla of a patient or with one or more teeth of the maxilla.

21. The method according to claim 18, wherein engaging the fiducial device with the maxillofacial anatomical structure of the patient includes engaging the splint device with the maxilla or with one or more teeth of the maxilla of the patient.

22. The method according to claim 18, further comprising providing tactile feedback to enable bore formation and implantation device movement according to a virtual cochlear implant plan, and to physically prevent bore formation and implantation device movement that deviates from the virtual cochlear implant plan.

23. The method according to claim 18, further comprising providing tactile feedback to enable bore formation and movement of the implantation device along a route to the inner ear as defined by a virtual cochlear implant plan, and to physically prevent bore formation and movement of the implantation device from deviating from the route defined by the virtual cochlear implant plan.

24. The method according to claim 18, wherein forming a virtual cochlear implant plan includes defining virtual boundaries around anatomical structures to be avoided by the boreforming and implantation device during bore formation and implantation of the cochlear implant, and providing tactile feedback further includes providing tactile feedback via the boreforming and implantation device when the boreforming and implantation device comes into contact with any of the virtual boundaries during bore formation or implantation of the cochlear implant.

25. The method according to claim 18, further comprising providing tactile feedback by vibrating the boreforming and implantation device if the movement of the boreforming and implantation device deviates from the virtual cochlear implantation plan.

26. The method according to claim 18, wherein physically regulating the motion of the boreforming and implantation device includes physically regulating the motion of the boreforming and implantation device via a robotic arm physically engaged with the boreforming and implantation device and the motion of a fiducial device via a tracking arm, the robotic arm responding to a controller to physically regulate the physical operation of the boreforming and implantation device according to a virtual cochlear implantation plan.

27. The method according to claim 18, wherein the robotic arm comprises a plurality of arm segments engaged in serially via their respective joints, and the motion of the boreforming and implantation device is to be physically controlled by adjusting one or more degrees of freedom of at least one joint of the robotic arm's joints.

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

29. The method according to claim 18, comprising engaging the tracking arm with a fiducial device such that the tracking arm is in a state of physical communication with a fiducial marker via the fiducial device.

30. The method according to claim 18, comprising engaging a tracking arm with a fiducial device such that the tracking arm is in a non-physical communication state with a fiducial marker.

31. The method according to claim 30, wherein engaging the tracking arm with the fiducial device includes engaging the tracking arm with the fiducial device via a wireless communication configuration, a Wi-Fi communication configuration, an electrical communication configuration, an electromechanical communication configuration, an optical communication configuration, a magnetic communication configuration, an electromagnetic communication configuration, or an infrared communication configuration, such that the tracking arm is in a non-physical communication state with the fiducial marker.

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

33. The method according to claim 1, wherein the intracranial procedure includes an intracranial procedure in a region around the base of the skull, and the formation of a virtual procedure plan includes forming a virtual procedure plan for transnasally forming a bore that penetrates the patient's skull and enters the region around the base of the skull, and for accessing the target intracranial anatomical structure by penetrating the bore in alignment with and relative to a fiducial marker.

34. The method according to claim 33, wherein forming a virtual treatment plan includes defining a virtual intranasal boundary around intranasal anatomical structures to be avoided by the treatment device while forming a bore.

35. The method according to claim 34, comprising physically adjusting the movement of the treatment device via a robotic arm and with respect to a fiducial marker, in accordance with a virtual treatment plan and in accordance with the physical manipulation of the treatment device during the formation of a bore and access to the target intracranial anatomical structure, such that the movement of the treatment device is constrained within a virtual intranasal cavity boundary.

36. The method according to claim 34, further comprising providing tactile feedback when the procedure device comes into contact with a virtual intranasal cavity boundary while forming a bore or accessing a target intracranial anatomical structure.

37. The method according to claim 33, wherein the treatment device includes at least a first end effector configured to form a bore, and is positioned to receive the at least first end effector and to form a virtual treatment plan, which includes defining a virtual intranasal boundary configured as a frustum having a large diameter end and an opposing small diameter end, wherein the frustum is configured and positioned to avoid intranasal anatomical structures, the small diameter end being positioned around an internal nasal location to form a bore penetrating the skull.

38. The method according to claim 37, comprising physically adjusting the movement of the treatment device via a robotic arm and with respect to a fiducial marker, in accordance with a virtual treatment plan and in correspondence with the physical manipulation of the treatment device and the first end effector while forming a bore and accessing the target intracranial anatomical structure, so that the movement of the treatment device and the first end effector is constrained within a virtual intranasal cavity boundary.

39. The method according to claim 37, further comprising providing tactile feedback when the treatment device of the first end effector comes into contact with a virtual intranasal cavity boundary while forming a bore or accessing a target intracranial anatomical structure.

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