Splint device for a guided surgical robot

Abstract

A splint device for robot-guided surgery, comprising an elongate, co-extensive first splint portion and a second splint portion, each splint portion defining spaced-apart release holes between a first end and a second end. A first separating device is provided between and extends along the first splint portion and the second splint portion. A tracking portion engages and extends outwardly from the first splint portion or the second splint portion and has a movement mounting portion engaging with the tracking portion. A second separating device extends between one of the release holes in the first splint portion and one of the pressure release holes in the second splint portion, wherein the second separating device is arranged to be severable to facilitate adjustment of the lengths of the first splint portion and the second splint portion and of the first separating device. The splint device may include a tool calibration device or a reference marking element provided in a predetermined configuration relative to the movement mounting portion.

Description

Technical Field

[0001] This application relates to surgical robots and associated guidance systems, and more particularly, to a splint device for forming fiducial and / or tracking markers for a guidance system of a surgical robot. Background Art

[0002] Robotic systems are increasingly being used in surgical procedures. One such example involves surgical robots for dental procedures. Such robots are typically associated with a guidance system for guiding the surgical instruments implemented by the surgical robot. The guidance system can also be configured to participate in the surgical pre - planning process, either by participating in collecting and / or analyzing patient data and planning the surgical procedure, or by relying on pre - planned data to guide the surgical instruments for the surgical procedure.

[0003] In certain surgical procedures, some surgical robot systems rely on fixed reference points associated with the patient's body to guide the surgical robot. That is, some such surgical robot systems define a reference frame relative to the patient's body in order to account for or otherwise compensate for patient movement or motion during the surgery (whether during pre - planning or during the actual surgical procedure itself). The reference point must also be repeatable such that multiple engagements / disengagements (i.e., the time period between pre - planning and the actual surgical procedure) do not change the reference frame implemented by the surgical robot or its associated guidance system.

[0004] In certain instances, a reference point (or the connection between the guidance system and the patient that defines the reference point) implemented by a guidance system for a surgical robot can be achieved by, for example, an optical modality, a mechanical modality, an acoustic modality, or other suitable and appropriate tracking / guidance modalities or combinations thereof. In certain modalities, particularly used in dental surgical applications, one mechanical modality for forming a reference point (i.e., a " fiducial marker") can be achieved, for example, by attaching / fixing a rigid element to the patient's head / tooth. In certain cases, such a rigid element can be referred to as a splint and can include a splint (see, for example, the prior art in Figures 1, 2A, and 2B). Such a splint typically can include: for example, a retainer portion that holds one or more teeth (i.e., by means of an adhesive substance such as an acrylic material applied between the retainer portion and the tooth); a mounting portion (i.e., a mounting arm) that connects the retainer portion to a separate motion mount; and the motion mount itself, which can include an attachment point for a tracking portion associated with the guidance system of the surgical robot (i.e., where, for example, a reflective marker can be mounted to the attachment point for optical tracking of the fiducial marker, or the attachment point can include a fixed position for forming a mechanical connection for mechanical tracking of the fiducial marker, or the attachment point can be otherwise configured to receive an appropriate element associated with any other suitable tracking arrangement for the fiducial marker).

[0005] In such cases, it may be preferable that, throughout the surgical procedure, the retainer portion be as rigid (robust) as possible (i.e., the structure of the retainer itself and its fixation to the patient's teeth). However, it may also be preferable that the retainer can be easily removed when the surgical procedure is completed. In certain cases, it may be preferable that, for example, the splint can be repeatedly removed and replaced between a pre-planned procedure (i.e., a CT scan) that may occur on one day (when the splint must be in place to capture the fiducial marker associated with it in a scan) and a surgical procedure that may occur on another day (where the surgical procedure requires the splint to be in place to track / guide the surgical procedure). In other cases, it may be preferable that a single splint configuration be available or applicable, for example, as a universal fitting device, in a wide range of patient populations. Additionally, it may be desirable that the splint have a minimum number of separate components, or if separate components are included, such separate components be integrated into the overall splint assembly or firmly attached as part of the overall splint assembly.

[0006] For example, prior art splint devices such as those shown in FIGS. 1, 2A, and 2B also require careful balancing of the adhesive material to be applied (i.e., dental acrylic resin) in order to effectively and rigidly mount the retainer portion to the patient's teeth. For example, if too little adhesive material is applied in the retainer portion, the splint device may easily separate from the teeth because the amount of adhesive material may be insufficient to bond the retainer to the teeth to adequately resist the forces applied thereto during the surgical procedure. However, if too much adhesive material is applied to the retainer portion, the excess adhesive material may flow into the tooth undercuts (i.e., portions of the tooth where the tooth narrows towards the gum line and / or the space between the teeth), and at the end of the surgical procedure, the retainer portion will not be easily removable, for example, without drilling into the cured adhesive material to remove the retainer portion from one or more teeth. In such a case, the retainer portion may not be reusable for a particular patient, and if a further surgical procedure is required, a new retainer portion may also be needed, including a new mounting portion for fiducial and / or tracking markers.

[0007] Accordingly, there is a need for a splint device that forms fiducial markers for a guidance system of a surgical robot, for example, for use in dental surgery, that addresses these and other limitations of prior art devices. SUMMARY OF THE INVENTION

[0008] Aspects of the present disclosure meet the above and other needs. In one particular aspect, the present disclosure provides a splint device for robotic-guided surgery. Such a device includes: an elongate first splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; and an elongate second splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, wherein the second splint portion extends coextensively with the first splint portion. A first separability device is disposed between the first splint portion and the second splint portion and extends longitudinally between respective first ends and respective second ends of the first splint portion and the second splint portion. A tracking portion engages and extends outwardly from the first splint portion or the second splint portion, wherein the tracking portion has a motion mount that engages the tracking portion. A second separability device extends between one of the release holes in the first splint portion and one of the relief holes in the second splint portion, wherein the second separability device is arranged to be severable to facilitate adjustment of the lengths of the first splint portion and the second splint portion and the first separability device.

[0009] Another aspect of the present disclosure provides a splint device for robotic-guided surgery. Such a device includes: an elongate first splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; and an elongate second splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, wherein the second splint portion extends coextensively with the first splint portion. A first separating device is disposed between the first splint portion and the second splint portion and extends longitudinally between respective first ends of the first splint portion and the second splint portion to respective second ends. A tracking portion engages with the first splint portion or the second splint portion and extends outwardly from the first splint portion or the second splint portion, wherein the tracking portion has a motion mount that engages with the tracking portion. A tool calibration device engages with the first splint portion, the second splint portion, the first separating device, or the tracking portion, wherein the tool calibration device is disposed in a predetermined configuration relative to the motion mount.

[0010] Another aspect of the present disclosure provides a splint device for robotic-guided surgery. Such a device includes: an elongate first splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; and an elongate second splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, wherein the second splint portion extends coextensively with the first splint portion. A first separating device is disposed between the first splint portion and the second splint portion and extends longitudinally between respective first ends of the first splint portion and the second splint portion to respective second ends. A tracking portion engages with the first splint portion or the second splint portion and extends outwardly from the first splint portion or the second splint portion, wherein the tracking portion has a motion mount that engages with the tracking portion. A fiducial marker element is received in a recess defined by an outer surface of the first splint portion, the second splint portion, the first separating device, or the tracking portion, wherein the fiducial marker element is received in a predetermined configuration relative to the motion mount.

[0011] Accordingly, the present disclosure includes, but is not limited to, the following example embodiments:

[0012] Example Embodiment 1: A splint device for robot-guided surgery, the device comprising: an elongated first splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; an elongated second splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, the second splint portion extending coextensively with the first splint portion; a first separating means disposed between the first splint portion and the second splint portion and extending longitudinally from between the respective first ends of the first splint portion and the second splint portion to between the respective second ends; a tracking portion engaged with and extending outwardly from the first splint portion or the second splint portion, the tracking portion having a motion mounting portion engaged with the tracking portion; and a second separating means extending between one of the release holes in the first splint portion and one of the pressure release holes in the second splint portion, wherein the second separating means is arranged to be severable to facilitate adjustment of the lengths of the first splint portion and the second splint portion and of the first separating means.

[0013] Example Embodiment 2: The device according to any of the foregoing or following example embodiments or combinations thereof, wherein the motion mounting portion is integrally formed with the tracking portion.

[0014] Example Embodiment 3: The device according to any of the foregoing or following example embodiments or combinations thereof, wherein the tracking portion extends from the first end or the second end of the first splint portion or the second splint portion.

[0015] Example Embodiment 4: The device according to any of the foregoing or following example embodiments or combinations thereof, wherein the second separating means comprises a reduced cross-sectional thickness of the first splint portion and the second splint portion between one of the release holes in the first splint portion and one of the release holes in the second splint portion.

[0016] Example Embodiment 5: The device according to any of the foregoing or following example embodiments or combinations thereof, wherein the first splint portion and the second splint portion interact with the first separating means to jointly form an elongated channel having an inner surface defining a recess, and wherein the first separating means defines a reduced cross-sectional thickness between the first splint portion and the second splint portion and relative to the first splint portion and the second splint portion so as to define a groove extending between the respective first ends and second ends of the first splint portion and the second splint portion in the inner surface.

[0017] Example Embodiment 6: The device according to any of the foregoing or following example embodiments or combinations thereof, wherein the groove is arranged to receive a separator which extends along the groove such that the separator and the first splint portion define a first part of the elongated channel and the separator and the second splint portion define a second part of the elongated channel.

[0018] Example Embodiment 7: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the first separating device defines one or more holes, each hole extending from the outer surface of the elongated channel to the groove, and the one or more holes are spaced along the first separating device between the respective first and second ends of the first and second clamping portions.

[0019] Example Embodiment 8: A device according to any of the foregoing or following example embodiments or a combination thereof, including a fiducial marking element received in a recess defined by the outer surface of the first clamping portion, the second clamping portion, the first separating device, or the tracking portion, the fiducial marking element being received in a predetermined configuration relative to the motion mounting portion.

[0020] Example Embodiment 9: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the fiducial marking element is spherical, the recess is hemispherical, or is an elongated concave channel arranged to receive the spherical fiducial marking element.

[0021] Example Embodiment 10: A device according to any of the foregoing or following example embodiments or a combination thereof, including a tool calibration device engaged with the first clamping portion, the second clamping portion, the first separating device, or the tracking portion, the tool calibration device being set in a predetermined configuration relative to the motion mounting portion.

[0022] Example Embodiment 11: A clamping device for robot-guided surgery, the device comprising: an elongated first clamping portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; an elongated second clamping portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, the second clamping portion extending coextensively with the first clamping portion; a first separating device disposed between the first clamping portion and the second clamping portion and extending longitudinally between the respective first ends and the respective second ends of the first and second clamping portions; a tracking portion engaged with the first clamping portion or the second clamping portion and extending outwardly therefrom, the tracking portion having a motion mounting portion engaged therewith; and a tool calibration device engaged with the first clamping portion, the second clamping portion, the first separating device, or the tracking portion, the tool calibration device being set in a predetermined configuration relative to the motion mounting portion.

[0023] Example Embodiment 12: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the motion mounting portion is integrally formed with the tracking portion.

[0024] Example Embodiment 13: A device according to any of the foregoing or following example embodiments or combinations thereof, wherein the tracking portion extends from a first end or a second end of the first clamping portion or the second clamping portion.

[0025] Example Embodiment 14: A device according to any of the foregoing or following example embodiments or combinations thereof, comprising a fiducial marking element received in a recess defined by an outer surface of the first clamping portion, the second clamping portion, the first separating means or the tracking portion, the fiducial marking element being received in a predetermined configuration relative to the movement mounting portion.

[0026] Example Embodiment 15: A device according to any of the foregoing or following example embodiments or combinations thereof, wherein the fiducial marking element is spherical, the recess is hemispherical, or is an elongate concave channel arranged to receive the spherical fiducial marking element.

[0027] Example Embodiment 16: A device according to any of the foregoing or following example embodiments or combinations thereof, comprising a second separating means extending between one of the release holes in the first clamping portion and one of the pressure release holes in the second clamping portion, wherein the second separating means is arranged to be severable to facilitate adjustment of the lengths of the first clamping portion and the second clamping portion and the first separating means.

[0028] Example Embodiment 17: A device according to any of the foregoing or following example embodiments or combinations thereof, wherein the second separating means comprises a reduced cross-sectional thickness of the first clamping portion and the second clamping portion located between one of the release holes in the first clamping portion and one of the release holes in the second clamping portion.

[0029] Example Embodiment 18: A device according to any of the foregoing or following example embodiments or combinations thereof, wherein the first clamping portion and the second clamping portion interact with the first separating means to jointly form an elongate channel having an inner surface defining a recess, and wherein the first separating means defines a reduced cross-sectional thickness between the first clamping portion and the second clamping portion and relative to the first clamping portion and the second clamping portion so as to define a groove extending between corresponding first and second ends of the first clamping portion and the second clamping portion in the inner surface.

[0030] Example Embodiment 19: A device according to any of the foregoing or following example embodiments or combinations thereof, wherein the groove is arranged to receive a separator, the separator extending along the groove such that the separator and the first clamping portion define a first portion of the elongate channel and the separator and the second clamping portion define a second portion of the elongate channel.

[0031] Example Embodiment 20: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the first separating device defines one or more holes, each hole extending from the outer surface of the elongated channel to the groove, and the one or more holes are spaced apart along the first separating device between the respective first and second ends of the first and second clamping portions.

[0032] Example Embodiment 21: A clamping device for robot-guided surgery, the device comprising: an elongated first clamping portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; an elongated second clamping portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, the second clamping portion extending coextensively with the first clamping portion; a first separating device disposed between the first and second clamping portions and extending longitudinally between the respective first ends and the respective second ends of the first and second clamping portions; a tracking portion engaging with the first or second clamping portion and extending outwardly therefrom, the tracking portion having a motion mounting portion engaging with the tracking portion; and a fiducial marking element received in a recess defined by the outer surface of the first clamping portion, the second clamping portion, the first separating device, or the tracking portion, the fiducial marking element being received in a predetermined configuration relative to the motion mounting portion.

[0033] Example Embodiment 22: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the motion mounting portion is integrally formed with the tracking portion.

[0034] Example Embodiment 23: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the tracking portion extends from the first or second end of the first or second clamping portion.

[0035] Example Embodiment 24: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the fiducial marking element is spherical, the recess is hemispherical, or an elongated concave channel arranged to receive the spherical fiducial marking element.

[0036] Example Embodiment 25: A device according to any of the foregoing or following example embodiments or a combination thereof, including a second separating device extending between one of the release holes in the first clamping portion and one of the pressure release holes in the second clamping portion, wherein the second separating device is arranged to be cuttable to facilitate adjustment of the lengths of the first and second clamping portions and the first separating device.

[0037] Example Embodiment 26: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the second separating device includes a reduced cross-sectional thickness of the first clamping part and the second clamping part located between one release hole of the first clamping part and one release hole of the second clamping part.

[0038] Example Embodiment 27: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the first clamping part and the second clamping part interact with the first separating device to jointly form an elongated channel having an inner surface defining a recess, and wherein the first separating device defines a reduced cross-sectional thickness between the first clamping part and the second clamping part and relative to the first clamping part and the second clamping part so as to define a groove in the inner surface extending between the respective first and second ends of the first clamping part and the second clamping part.

[0039] Example Embodiment 28: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the groove is arranged to receive a separator that extends along the groove such that the separator and the first clamping part define a first part of the elongated channel and the separator and the second clamping part define a second part of the elongated channel.

[0040] Example Embodiment 29: A device according to any of the foregoing or following example embodiments or a combination thereof, wherein the first separating device defines one or more holes, each hole extending from the outer surface of the elongated channel to the groove, and the one or more holes are spaced apart along the first separating device between the respective first and second ends of the first clamping part and the second clamping part.

[0041] Example Embodiment 30: A device according to any of the foregoing or following example embodiments or a combination thereof, including a tool calibration device that engages with the first clamping part, the second clamping part, the first separating device, or the tracking part, and the tool calibration device is arranged in a predetermined configuration relative to the movement mounting part.

[0042] These and other features, aspects, and advantages of the present disclosure will be apparent by reading the following detailed description and the accompanying drawings briefly described hereinafter. The present disclosure includes any combination of two, three, four, or more features or elements set forth in this disclosure, whether or not such features or elements are described as explicitly combined or otherwise recited in the specific embodiments described herein. Unless otherwise expressly provided in the context of the present disclosure, the present disclosure is intended to be read as a whole such that any separable feature or element thereof in any of its aspects and embodiments should be considered as contemplated, i.e., as combinable.

[0043] It should be understood that the inventive content provided herein is merely for summarizing some exemplary aspects to provide a basic understanding of some aspects of the present disclosure. Thus, it should be understood that the above exemplary aspects are merely examples and should not be construed as narrowing the scope or spirit of the present disclosure in any way. It should be understood that the scope of the present disclosure includes many potential aspects, and some of these aspects will be further described below in addition to those summarized herein. Moreover, through the following detailed description in conjunction with the accompanying drawings, other aspects and advantages of these aspects disclosed herein will become apparent, and the drawings illustrate the principles of the described aspects. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] After generally describing the present disclosure as above, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and in which:

[0045] FIG. 1 schematically shows a splint device of the prior art that engages with a representative model of a patient's oral cavity to provide fiducial markers and / or tracking markers for a guidance system of a surgical robot for dental surgery;

[0046] FIGS. 2A and 2B schematically show a splint device of the prior art that engages with a representative model of a patient's oral cavity to provide fiducial markers and / or tracking markers for a guidance system of a surgical robot for dental surgery (FIG. 2A), and the splint device of the prior art is disengaged from the representative model of the patient's oral cavity (FIG. 2B);

[0047] Figure 3A and Figure 3B schematically shows different perspective views of a splint device according to an aspect of the present disclosure that is arranged to provide fiducial markers and / or tracking markers for a guidance system of a surgical robot;

[0048] Figure 4A and Figure 4B schematically shows a representative cross-sectional elevation view of a splint device for a guidance system of a surgical robot according to an aspect of the present disclosure, wherein the splint device is configured to facilitate removability. And

[0049] Figure 5A and Figure 5B schematically shows different perspective views of a splint device according to an aspect of the present disclosure that provides a fiducial marker arrangement for a guidance system of a surgical robot. DETAILED DESCRIPTION

[0050] The present disclosure will now be described more fully with reference to the accompanying drawings, in which certain aspects of the present disclosure are shown but not all aspects. In fact, the present disclosure may be embodied in many forms and should not be construed as limited to the aspects set forth herein; rather, these aspects are provided so that the present disclosure will satisfy applicable legal requirements. Like reference numerals always indicate like elements.

[0051] For example, as Figure 3A and Figure 3B shown, certain aspects of the present disclosure provide a splint device 100 for use, for example, in a dental procedure in conjunction with a guidance system of a surgical robot. However, those skilled in the art will understand that the concept of the splint device disclosed herein as forming fiducial and / or tracking markers, or otherwise for use in a reference frame of a surgical robot system, is applicable to other surgical procedures that do not involve dental procedures, such as orthopedic surgery, otolaryngology, and neurosurgery. Thus, the aspects of the present disclosure presented herein are merely examples of the applicability of the disclosed concepts and are not intended to be limiting in any way.

[0052] Such a splint device 100 implemented in conjunction with a guided surgical robot may include, for example, an elongate first splint portion 200 having a first longitudinal end 200A and a second longitudinal end 200B and defining longitudinally spaced release holes 300; and an elongate second splint portion 400 having a first longitudinal end 400A and a second longitudinal end 400B and defining longitudinally spaced release holes 500, wherein the second splint portion 400 generally coextends with the first splint portion 200. A tracking portion 600 engages with the first splint portion 200 or the second splint portion 400 and extends outwardly from the first splint portion or the second splint portion. More specifically, in certain aspects, the tracking portion 600 extends from the first end 200A, 400A or the second end 200B, 400B of the first splint portion 200 or the second splint portion 400. In certain cases, the tracking portion 600 has a motion mount 700 that engages with the tracking portion. A first separating device 800 is disposed between the first splint portion 200 and the second splint portion 400 (e.g., see Figure 3B ). In certain aspects, the first separating device 800 extends longitudinally between the respective first ends 200A, 400B of the first splint portion 200 and the second splint portion 400 to between the respective second ends 200B, 400B.

[0053] In certain cases, a second separating device 900 (e.g., see Figure 3A)extends between one of the release holes 300A or 300B of the first splint portion 200 and one of the pressure relief holes 500A or 500B in the second splint portion 400, wherein the second separating device 900 is arranged to be severable to facilitate adjustment of the lengths of the first splint portion 200 and the second splint portion 200 and of the first separating device 800. Adjustment of the length of the splint device 100 via the second separating device 900 can facilitate, for example, the implementation of the splint device 100 for various different size applications (e.g., adult teeth or child teeth). Further, since the splint device 100 is typically applied using an adhesive material (e.g., acrylic), the adhesive force is a function of the surface area to which the adhesive material is adhered. Thus, a shorter splint device will have a smaller adhesive surface area than a longer splint device and will thus be easier to remove at the end of the surgical procedure than a longer splint. In some aspects, the second separating device 900 includes a reduced cross-sectional thickness of the first splint portion 200 and the second splint portion 400 between one of the release holes 300 of the first splint portion 200 and one of the release holes 500 of the second splint portion 400. The reduced cross-sectional thickness of the second separating device 900 may but does not necessarily intersect the slot 850 of the first separating device 800. In other aspects, a plurality of second separating devices 900 may be provided along the first splint portion 200 and the second splint portion 400 to provide multiple adjustments of the length of the splint device 100.

[0054] In other cases, the tool calibration device 1000 (e.g., see Figure 3B or Figure 3A ) engages with the first splint portion 200, the second splint portion 400, the first separating device 800, or the tracking portion 600, wherein the tool calibration device 1000 is provided in a predetermined configuration relative to the motion mount 700. The tool calibration device 1000 can be configured, for example, as a receptacle or other suitable surface feature for receiving the end effector (e.g., the tip of a drill) of a surgical instrument attached to a surgical robot. In some cases, the tool calibration device 1000 is integrally formed with a particular component of the splint device 100, or in other cases, the tool calibration device can be a separate and discrete element (e.g., a durable element such as a metal element, a ceramic element, or other suitable element). Since the tool calibration device 1000 is in a known configuration relative to the motion mount 700, the tool calibration device 1000 provides confirmation or calibration when interacting with the end effector of the surgical robot, i.e., the end effector that is precisely tracked relative to the surgical robot, for performing a surgical procedure. In some cases, the tool calibration provision 1000 is radiopaque such that its configuration relative to the motion mount 700 can be determined and / or confirmed by imaging analysis.

[0055] In other cases, the fiducial marker element 1100 (e.g., see Figure 5A and 5B ) is received within a recess 1200 defined by an outer surface of the first splint portion 200, the second splint portion 400, the first separability device 800, or the tracking portion 600, wherein the fiducial marker element 1100 is received in a predetermined configuration relative to the motion mounting portion 700. In certain aspects, the splint device 100 defines a plurality of recesses 1200 that are arranged to receive a plurality of fiducial marker elements 1100. For example, in some aspects, the fiducial marker element 1100 is spherical, the recess 1200 is hemispherical, or an elongate concave channel arranged to receive a spherical fiducial marker element 1100. Once secured to the respective recess 1200, whether by interference fit (e.g., press fit), overmolding, or an adhesive material (e.g., epoxy resin) provided with the recess, the (one or more) fiducial marker elements 1100 are substantially embedded within the splint device 100. Additionally, in some aspects, the recess 1200 is oriented such that an adhesive material (e.g., epoxy resin) is held in place, e.g., by gravity, within the recess 1200 and is fixed / embedded at the location of the fiducial marker element 1100. Since the (one or more) fiducial marker elements 1100 are in some aspects radiopaque, the (one or more) fiducial marker elements 1100 can be detected by imaging analysis (e.g., CT scan). Thus, in certain instances, the (one or more) fiducial marker elements 1100 are radiopaque and can be distinguished from the splint device 100 (e.g., formed of a plastic / polymer material) and an adhesive material (e.g., acrylic) used to adhere the splint device 100 to a patient. Since the (one or more) fiducial marker elements 1100 are all embedded within the splint device 100, the field of view of an imaging analysis (e.g., CT scan) can be reduced.

[0056] In some aspects, the first splint portion 200 and the second splint portion 400 and the first separability providing member 800 are integrally formed as a single assembly. In other aspects, the first splint portion 200 and the second splint portion 400, the first separability device 800, and the tracking portion 600 are integrally formed as a single assembly. In still other aspects, the motion mounting portion 700 is integrally formed with the tracking portion 600. In certain cases, the motion mounting portion 700 (e.g., see Figure 3A - 3B or Figure 5A - 5B) defines a central positioning receiving portion 725 surrounded by three or more protrusions 750 that are angled and spaced apart. Such a motion mounting portion 700 is generally configured to receive a mounting portion (not shown) that includes a tracking device or a complementary structure that engages with a tracking device. The tracking device can include, for example, a physically connected tracking device, such as a tracking arm connected to a surgical robot. In other cases, the tracking device can include, for example, a non-physically connected tracking device, such as an optical tracking device, a magnetic tracking device, a wireless or WiFi tracking device, an electromagnetic tracking device, an inductive tracking device, or any other form of tracking device that does not require a physical connection between the tracking device attached to the motion mounting portion 700 and the surgical robot. In either case, integrating the motion mounting portion 700 into the tracking portion 600 provides repeatable engagement with the tracking device and interchangeable engagement between different types of tracking devices. The integration of the motion mounting portion 700 can be further accomplished, for example, by molding, machining, and / or 3D printing. In still other aspects, the second separability device 900, the tool calibration device 1000, and / or (one or more) recesses 1200 are integral with the overall assembly of the splint device 100. When formed as an integral assembly, if necessary or appropriate, the splint device 100 can be formed, for example, using any suitable forming process such as injection molding, casting, or machining.

[0057] In some aspects, the first splint portion 200, the second splint portion 400, and the first separability providing member 800 interact to jointly form an elongated channel (e.g., see Figure 4A - 4B ), and wherein the first separability device 800 defines a reduced cross-sectional thickness 825 between the first splint portion 200 and the second splint portion 400 and relative to the first and second splint portions 200, 400. The first splint portion 200 and the second splint portion 400 cooperate with the reduced cross-sectional thickness 825 to define a groove 850 in the inner surface 1300, wherein the groove 850 extends longitudinally between respective first ends 200A, 400A and second ends 200B, 400B of the first splint portion 200 and the second splint portion 400. The groove 850 is arranged to receive a separator 875, wherein the separator 870 extends along the groove 850. Thus, the separator 875 and the first splint portion 200 cooperate to define a first longitudinally extending portion 1325 of the elongated channel, and the separator 865 and the second splint portion 400 cooperate to define a second longitudinally extending portion 1350 of the elongated channel. In this case, the first portion 1325 and the second portion 1350 of the longitudinally coextending elongated channel are separated by the separator 875 such that, for example, adhesive material deposited in the first portion 132 does not interact with or contact adhesive material deposited in the second portion 135.

[0058] Any excess adhesive material within the first portion 1325 and / or the second portion 1350 of the elongate channel is otherwise released by an adhesive material flow that exits the elongate channel through the respective release holes 300, 500 toward the outer surface 1400. In this way, when removing the splint device 100, the first separability device 800 can be appropriately cut (e.g., by a drill, saw, cutter, or any other suitable cutting device) along the entire length of the first splint portion 200 and the second splint portion 400 (e.g., from the first end portions 200A, 400A to the second end portions 200B, 400B). In some aspects, the separator 875 (e.g., see Figure 5B ) can be a different material, a different color, etc. from the first splint portion 200, the second splint portion 400, and the first separability device 800, so as to provide a mark for the appropriate cutting of the first separability device 800 (i.e., when the first separability device 100 is completely cut to allow the removal of the splint device 100, the separator 875 will appear as a different color, a different material, etc.). Additionally, since the separator 875 (e.g., see Figure 4B ) extends into the elongate channel (i.e., effectively separates the first separability device 800 from the underlying teeth to which the splint device 100 is applied), the separator 875 can also protect the underlying teeth from damage by the tool used to cut the first separability device 800 by providing a mark for the appropriate cutting of the first separability device 800 before reaching the underlying teeth. When the first separability device 800 is appropriately cut, due to no or limited interaction between the adhesive materials deposited in the first portion 1325 and the second portion 1350 of the elongate channel, the first splint portion 200 and the second splint portion 400 are removed separately by applying removal forces in opposite directions to each of the first splint portion 200 and the second splint portion 400.

[0059] In some aspects, the first separability device 800 (e.g., see Figure 3A - 3B or Figure 5A - 5B)Defines one or more holes and / or slots 1375, each hole and / or slot extending from the outer surface 1400 of the elongated channel through the reduced cross-sectional thickness 825 and into the slot 850, wherein the one or more holes and / or slots 1375 are spaced apart along a first separability arrangement 800 (longitudinally) between respective first ends 200A, 400A and second ends 200B, 400B of the first splint portion 200 and the second splint portion 400. In some aspects, these holes / slots 1375 may be supplemented by, for example, one or more depressions or recesses 1380 scattered between the continuous holes / slots 1375, wherein the depression / recess 1380 may cooperate with the holes / slots 1375 to serve as a guide for a cutting / cutting-off tool. Thus, the first separability device 800 is cut off, for example, by cutting through the reduced cross-sectional thickness 825 to reach the slot 850 / separator 875, thereby allowing the removal of the splint device 100 in separate cross-sections, for example, by applying forces in opposite directions to the first splint portion 200 and the second splint portion 400.

[0060] Benefiting from what is taught in the above description and the associated drawings, those skilled in the art in the technical field related to the embodiments of the present disclosure will conceive of many modifications and other embodiments of the invention described herein. Therefore, it should be understood that the embodiments of the present invention are not limited to the specific embodiments disclosed, and various modifications and other embodiments will be included within the scope of the present invention. In addition, although the above description and the associated drawings describe example embodiments in the context of certain example combinations of elements and / or functions, it should be understood that different combinations of elements and / or functions can be provided by alternative embodiments without departing from the scope of the present disclosure. In this regard, for example, combinations of elements and / or functions different from those explicitly described above are also contemplated within the scope of the present disclosure. Although specific terms are used in the text, they are used in a general and descriptive sense and not for purposes of limitation.

[0061] It should be understood that although the terms first, second, etc. will be used herein to describe various steps or calculations, these steps or calculations should not be limited by these terms. These terms are only used to distinguish one operation or calculation from another. For example, a first calculation may be referred to as a second calculation, and similarly, a second step may be referred to as a first step, without departing from the scope of the present disclosure. As used herein, the terms "and / or" and the " / " symbol include any and all combinations of one or more of the associated listed items.

[0062] As used herein, the singular forms "a", "an" and "the" are also intended to include the plural forms unless the context clearly dictates otherwise. It should also be understood that when the terms "comprises", "comprising", "includes" and / or "including" are used herein, they specify the presence of the stated feature, integer, step, operation, element, and / or component, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof. Thus, the terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting.

Claims

1. A splint device for robot-guided surgery, the device comprising: An elongated first splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; An elongated second splint portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, the second splint portion extending coextensively with the first splint portion; A first separating device disposed between the first splint portion and the second splint portion and extending longitudinally from between the respective first ends of the first splint portion and the second splint portion to between the respective second ends; A tracking portion engaging with the first splint portion or the second splint portion and extending outwardly from the first splint portion or the second splint portion, the tracking portion having a movement mounting portion engaging with the tracking portion; A fiducial marker element received in a recess defined by an outer surface of the first splint portion, the second splint portion, the first separating device, or the tracking portion, the fiducial marker element being spherical and the recess being hemispherical or an elongated concave channel arranged to receive the fiducial marker element, the fiducial marker element being received in the recess in a predetermined configuration relative to the movement mounting portion; and a second separating device extending between one of the release holes in the first splint portion and one of the pressure release holes in the second splint portion, wherein the second separating device includes a reduced cross-sectional thickness of the first splint portion and the second splint portion between the one of the release holes in the first splint portion and the one of the release holes in the second splint portion, and the reduced cross-sectional thickness is arranged to be cuttable to facilitate adjustment of the lengths of the first splint portion and the second splint portion and the first separating device.

2. The device according to claim 1, wherein The movement mounting portion is integrally formed with the tracking portion.

3. The device according to claim 1, characterized in that, The tracking portion extends from the first end or the second end of the first splint portion or the second splint portion.

4. The device according to claim 1, wherein The first splint portion and the second splint portion interact with the first separating device to jointly form an elongated channel having an inner surface defining a recess, and wherein the first separating device defines a reduced cross-sectional thickness between the first splint portion and the second splint portion and relative to the first splint portion and the second splint portion to define a groove extending between the respective first ends and second ends of the first splint portion and the second splint portion in the inner surface.

5. The device according to claim 4, characterized in that, The groove is arranged to receive a separator, the separator extending along the groove such that the separator and the first splint portion define a first portion of the elongated channel and the separator and the second splint portion define a second portion of the elongated channel.

6. The device according to claim 4, wherein The first separating device defines one or more holes, each hole extending from the outer surface of the elongated channel to the groove, and the one or more holes are spaced along the first separating device between the respective first and second ends of the first and second clamping portions.

7. The device according to claim 1, characterized in that Comprising a tool calibration device, the tool calibration device being engaged with the first clamping portion, the second clamping portion, the first separating device or the tracking portion, and the tool calibration device being arranged in a predetermined configuration relative to the movement mounting portion.

8. A clamping device for robot-guided surgery, the device comprising: An elongated first clamping portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes; An elongated second clamping portion having a first longitudinal end and a second longitudinal end and defining longitudinally spaced release holes, the second clamping portion extending coextensively with the first clamping portion; A first separating device disposed between the first clamping portion and the second clamping portion and extending longitudinally between the respective first ends and the respective second ends of the first clamping portion and the second clamping portion; A tracking portion engaged with the first clamping portion or the second clamping portion and extending outwardly from the first clamping portion or the second clamping portion, the tracking portion having a movement mounting portion engaged therewith; a fiducial marking element received in a recess defined by the outer surface of the first clamping portion, the second clamping portion, the first separating device or the tracking portion, the fiducial marking element being spherical, the recess being hemispherical, or an elongated concave channel arranged to receive the fiducial marking element, the fiducial marking element being received in the recess in a predetermined configuration relative to the movement mounting portion; And A tool calibration device engaged with the first clamping portion, the second clamping portion, the first separating device or the tracking portion, the tool calibration device being radiopaque and arranged in a predetermined configuration relative to the movement mounting portion.

9. The apparatus according to claim 8, wherein The movement mounting portion is integrally formed with the tracking portion.

10. The device according to claim 8, characterized in that, The tracking portion extends from the first end or the second end of the first clamping portion or the second clamping portion.

11. The device according to claim 8, characterized in that Comprising a second separating device extending between one of the release holes of the first clamping portion and one of the pressure release holes of the second clamping portion, wherein the second separating device is arranged to be severable to facilitate adjustment of the lengths of the first clamping portion and the second clamping portion and the first separating device.

12. The device according to claim 11, characterized in that The second separating device includes a reduced cross-sectional thickness of the first clamping portion and the second clamping portion between the one release hole of the first clamping portion and the one release hole of the second clamping portion.

13. The device according to claim 8, characterized in that, The first splint portion and the second splint portion interact with the first separating device to jointly form an elongated channel having an inner surface defining a recess, and wherein the first separating device defines a reduced cross-sectional thickness between the first splint portion and the second splint portion and relative to the first splint portion and the second splint portion so as to define a groove in the inner surface extending between the respective first and second ends of the first splint portion and the second splint portion.

14. The device according to claim 13, characterized in that, The groove is arranged to receive a separator, the separator extending along the groove such that the separator and the first splint portion define a first portion of the elongated channel and the separator and the second splint portion define a second portion of the elongated channel.

15. The device according to claim 13, characterized in that, The first separating device defines one or more holes, each hole extending from an outer surface of the elongated channel to the groove, the one or more holes being spaced along the first separating device between the respective first and second ends of the first splint portion and the second splint portion.

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