Splinting device for guided surgical robots

Abstract

A splint device (100) for use in robotic-guided surgery includes first and second elongated splint portions (200, 400), each splint portion having opposing longitudinal ends and an interface edge extending between the ends, wherein the respective interface edges (250, 450) are arranged to complement each other. First and second alignment elements (800A, 800B) engaged with the first and second splint portions are arranged to interact so as to define a substantially uniform gap between the first and second interface edges from the first end to the second end of the first and second splint portions. A threaded member (900) is engaged between the first and second splint portions and is arranged to advance the first and second interface edges toward each other in response to advancement of the threaded member. A tracking portion (1000) having a kinematic mounting portion (1100) engaged therewith is engaged with the first or second splint portion and extends outwardly therefrom. An associated method is also provided.

Description

Technical Field

[0001] The present application relates to surgical robots and associated guidance systems, and more particularly, to a splint assembly that forms fiducial markers 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 used in dental procedures. Such robots are often associated with guidance systems that guide the surgical instruments performed by the surgical robot. This guidance system can also be configured to participate in the surgical pre-planning process, either by participating in the collection and / or analysis of patient data and planning the surgical procedure, or by relying on pre-planning data to guide surgical instruments to perform the procedure.

[0003] Some surgical robotic systems rely on fixed reference points associated with the patient's body to guide the surgical robot during certain surgical procedures. That is, some such surgical robotic 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 surgery (either during pre-planning or during the actual surgical procedure itself). This reference point must also be repeatable so that multiple engagements / disengagements (i.e., the time period between pre-planning and the actual surgical procedure) do not alter the reference frame implemented by the surgical robot or its associated guidance system.

[0004] In certain cases, the reference point implemented by the guidance system for the surgical robot (or the connection between the guidance system and the patient that defines the reference point) can be implemented, for example, by an optical modality, a mechanical modality, an acoustic modality, or other suitable and appropriate tracking / guidance modalities, or a combination thereof. In certain modalities, particularly for use in dental surgery applications, a mechanical modality for forming a reference point (i.e., a "fiducial marker") can be implemented, for example, by attaching / fixing a rigid element to the patient's head / teeth. 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 may typically include, for example, a retainer portion that clamps one or more teeth (i.e., by means of an adhesive substance such as an acrylic material applied between the retainer portion and the teeth); a mounting portion (i.e., a mounting arm) that connects the retainer portion to a separate kinematic mounting portion; and the kinematic mounting portion itself, which may include an attachment point for a tracking portion associated with a guidance system of a surgical robot (i.e., where, for example, a reflective marker may be mounted to the attachment point for optical tracking of a fiducial marker, or the attachment point may include a fixed location for forming a mechanical connection thereto for mechanical tracking of a fiducial marker, or the attachment point may be otherwise configured to receive appropriate elements associated with any other suitable tracking arrangement for a fiducial marker).

[0005] In such cases, it may be preferable that the retainer portion be as rigid (robust) as possible throughout the surgical procedure (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 be easily removed when the surgical procedure is completed. In some cases, it may be preferable to repeatedly remove and replace the splint, for example, between a pre-planned procedure (i.e., a CT scan) that may occur on one day (when the splint must be in place so that its associated fiducial markers can be captured in the scan) and a surgical procedure that may occur on another day (wherein 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 construction be usable or applicable across a wide range of patient populations, for example as a universal fitting device. Furthermore, it may be desirable that the splint have a minimum of separate components, or if separate components are included, that such separate components are integrated into or securely attached as part of an overall splint assembly.

[0006] For example, the prior art splinting devices shown in Figures 1, 2A, and 2B also require a careful balance of the adhesive material (i.e., dental acrylic) to be applied in order to effectively and rigidly mount the retainer portion to the patient's teeth. For example, if too little adhesive material is applied to the retainer portion, the splinting device may easily separate from the tooth because the amount of adhesive material may not be sufficient to bond the retainer to the tooth to fully 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 undercut (i.e., the portion of the tooth where the space between the teeth narrows towards the gum line and / or the teeth), and at the end of the surgical procedure, the retainer portion will not be removable, for example, without drilling into the cured adhesive material to remove the retainer portion from the tooth / teeth. In this case, the retainer portion may not be reusable for a particular patient, and if further surgery is required, a new retainer portion, including a new mounting portion for the reference markers and / or tracking markers, may also be required.

[0007] Thus, there is a need for a splint assembly that forms a fiducial marker for a guidance system of a surgical robot, such as used in dental surgery, that addresses these and other limitations of prior art arrangements. Summary of the Invention

[0008] Aspects of the present disclosure address the above and other needs. In one particular aspect, the present disclosure provides a splinting device for use in guided robotic surgery. Such a device includes an elongated first splint portion having a first longitudinal end and a second longitudinal end, and a first interface edge extending therebetween. An elongated second splint portion has a first longitudinal end and a second longitudinal end, and a second interface edge extending therebetween. The second splint portion is coextensive with the first splint portion, wherein the second interface edge is arranged to be complementary to the first interface edge. An alignment device includes a first alignment element engaged with the first splint portion and a second alignment element engaged with the second splint portion, the first and second alignment elements being arranged to interact with each other such that, when the first and second splint portions are advanced toward each other, a substantially uniform gap is defined between the first and second interface edges from respective first ends to respective second ends of the first and second splint portions. A threaded member is engaged between the first and second splint portions and is arranged to advance the first and second interface edges toward each other in response to advancement of the threaded member relative to the first and second splint portions. A tracking portion is engaged with the first cleat portion or the second cleat portion and extends outwardly therefrom, wherein the tracking portion has a kinematic mounting portion engaged therewith.

[0009] Another aspect of the present disclosure provides a method for applying a splint device to facilitate guided robotic surgery. Such a method includes engaging a first elongated splint portion with a coextensive second elongated splint portion, wherein each splint portion has a first longitudinal end and a second longitudinal end and an interface edge extending between the first and second ends, wherein the interface edges are arranged to complement each other such that a first alignment element engaged with the first splint portion and a second alignment element engaged with the second splint portion interact with each other, wherein the first splint portion or the second splint portion has a tracking portion engaged therewith and extending outwardly therefrom, and wherein the tracking portion has a kinematic mounting portion engaged therewith. A threaded member is engaged between the first and second splint portions, wherein the threaded member is arranged to be guided by the interacting first and second alignment elements in response to advancement of the threaded member relative to the first and second splint portions such that the first and second interface edges advance toward each other, thereby defining a substantially uniform gap between the first and second interface edges from the respective first ends to the respective second ends of the first and second splint portions as the first and second splint portions advance toward each other.

[0010] Therefore, the present disclosure includes, but is not limited to, the following example embodiments:

[0011] Example embodiment 1: A splint device for guided robotic surgery, the device comprising: an elongated first splint portion having a first longitudinal end and a second longitudinal end, and a first interface edge extending therebetween; an elongated second splint portion having a first longitudinal end and a second longitudinal end, and a second interface edge extending therebetween, the second splint portion being coextensive with the first splint portion, wherein the second interface edge is arranged to be complementary to the first interface edge; an alignment device comprising a first alignment element engaged with the first splint portion and a second alignment element engaged with the second splint portion, the first alignment element and the second alignment element being arranged to be mutually aligned and a second chute assembly comprising a first chute and a second chute assembly having a first end and a second end, the first chute assembly comprising a first end and a second end, the first end and the second end of the chute assembly comprising a first end and a second end.

[0012] Example Embodiment 2: The device of any preceding or following example embodiment or combination thereof, wherein the first plate portion defines longitudinally spaced release apertures.

[0013] Example Embodiment 3: The device of any preceding or following example embodiment or combination thereof, wherein the second plate portion defines longitudinally spaced release apertures.

[0014] Example embodiment 4: The device according to any preceding or following example embodiment or any combination thereof, wherein the kinematic mounting portion is integrally formed with the tracking portion.

[0015] Example Embodiment 5: The device of any preceding or following example embodiment or combination thereof, wherein the tracking portion extends from the first end or the second end of the first cleat portion or the second cleat portion.

[0016] Example embodiment 6: An apparatus according to any preceding or following example embodiment or a combination thereof, wherein the first alignment element is a frustoconical receiving portion defined by the first clamping plate portion, the frustoconical receiving portion having a major diameter and a minor diameter, wherein the major diameter of the frustoconical receiving portion points toward the second clamping plate portion, and wherein the second alignment element is a frustoconical protrusion extending from the second clamping plate portion, the frustoconical protrusion having a major diameter and a minor diameter, wherein the minor diameter of the frustoconical protrusion points toward the first clamping plate portion.

[0017] Example embodiment 7: A device according to any of the preceding or following example embodiments or a combination thereof, wherein the alignment device includes a first alignment device and a second alignment device, and wherein a threaded member engaged between the first clamping plate portion and the second clamping plate portion is arranged between the first alignment device and the second alignment device.

[0018] Example embodiment 8: A device according to any of the foregoing or following example embodiments or a combination thereof, comprising a separability device extending across the first clamping plate portion and the second clamping plate portion between the first alignment device or the second alignment device and the first longitudinal end or the second longitudinal end of the first clamping plate portion and the second clamping plate portion, wherein the separability device is arranged to be cuttable to facilitate the adjustability of the length of the first clamping plate portion and the second clamping plate portion.

[0019] Example embodiment 9: The device according to any preceding or following example embodiment or combination thereof, wherein the separability means comprises a reduced cross-sectional thickness of the first and second plate portions.

[0020] Example embodiment 10: The device according to any of the preceding or following example embodiments or a combination thereof, includes a reference marker element, which is received by a recess defined by the outer surface of the first clamping plate portion, the second clamping plate portion or the tracking portion, and the reference marker element is received in a predetermined configuration relative to the kinematic mounting portion.

[0021] Example embodiment 11: The device according to any preceding or following example embodiment or combination thereof, wherein the fiducial marker element is spherical and the recess is hemispherical or an elongated concave channel arranged to receive the spherical fiducial marker element.

[0022] Example embodiment 12: The device according to any of the preceding or following example embodiments or a combination thereof, includes a tool calibration device, which is engaged with the first clamping plate portion, the second clamping plate portion or the tracking portion, and the tool calibration device is set in a predetermined configuration relative to the kinematic mounting portion.

[0023] Example embodiment 13: A method of applying a splint device to facilitate guided robotic surgery, the method comprising: engaging an elongated first splint portion with a coextensive elongated second splint portion, each splint portion having a first longitudinal end and a second longitudinal end and an interface edge extending between the first end and the second end, and the interface edges being arranged to complement each other so that a first alignment element engaged with the first splint portion and a second alignment element engaged with the second splint portion interact with each other, the first splint portion or the second splint portion having a tracking portion engaged therewith and extending outwardly therefrom, and the tracking portion having a kinematic mounting portion engaged therewith; and engaging a threaded member between the first splint portion and the second splint portion, the threaded member being arranged to advance the first interface edge and the second interface edge toward each other in response to advancement of the threaded member relative to the first splint portion and the second splint portion, guided by the interacting first alignment element and the second alignment element, so that when the first splint portion and the second splint portion advance toward each other, a substantially consistent gap is defined between the first interface edge and the second interface edge from the respective first end to the respective second end of the first splint portion and the second splint portion.

[0024] Example embodiment 14: A method according to any preceding or following example embodiment or a combination thereof, wherein joining the first splint portion and the second splint portion includes joining the first splint portion and the second splint portion to form an elongated channel having a cross-section defining a recess, and wherein the method further includes applying an impression material within the recess along the elongated channel.

[0025] Example embodiment 15: A method according to any preceding or subsequent example embodiment, or a combination thereof, wherein the first clamp portion and the second clamp portion each define a longitudinally spaced release hole, wherein the recess of the slender channel is arranged to receive an object therein, and wherein engaging a threaded member between the first clamp portion and the second clamp portion includes advancing the threaded member between the first clamp portion and the second clamp portion so as to advance the first clamp portion and the second clamp portion toward each other around the object until excess impression material is released through the release hole to secure the first clamp portion and the second clamp portion to the object via the impression material therebetween.

[0026] Example Embodiment 16: The method of any preceding or following example embodiment or combination thereof, comprising depositing additional impression material in a gap between the first interface edge and the second interface edge as the first and second plate portions are advanced toward each other.

[0027] Example Embodiment 17: The method of any preceding or following example embodiment, or a combination thereof, comprising integrally forming the motion mount portion with the tracking portion.

[0028] Example Embodiment 18: The method of any preceding or following example embodiment or combination thereof, comprising engaging a tracking portion with the first end or the second end of the first or second cleat portion such that the tracking portion extends therefrom.

[0029] Example embodiment 19: The method according to any of the foregoing or subsequent example embodiments, or a combination thereof, comprises: forming a first alignment element as a frustoconical receiving portion defined by a first clamping plate portion, the frustoconical receiving portion having a large diameter and a small diameter, wherein the large diameter of the frustoconical receiving portion points toward the second clamping plate portion; and forming a second alignment element as a frustoconical protrusion extending from the second clamping plate portion, the frustoconical protrusion having a large diameter and a small diameter, wherein the small diameter of the frustoconical protrusion points toward the first clamping plate portion.

[0030] Example embodiment 20: A method according to any preceding or following example embodiment, or a combination thereof, wherein the first alignment element and the second alignment element define an alignment device, wherein the clamping device includes the first alignment device and the second alignment device, and wherein engaging the threaded member between the first clamping plate portion and the second clamping plate portion includes engaging the threaded member between the first clamping plate portion and the second clamping plate portion such that the threaded member is disposed between the first alignment device and the second alignment device.

[0031] Example embodiment 21: A method according to any of the foregoing or subsequent example embodiments, or a combination thereof, includes forming a separable device extending across the first clamping plate portion and the second clamping plate portion between the first alignment device or the second alignment device and the first longitudinal end portion or the second longitudinal end portion of the first clamping plate portion and the second clamping plate portion, the separable device being arranged to be cuttable to facilitate adjustability of the length of the first clamping plate portion and the second clamping plate portion.

[0032] Example Embodiment 22: The method of any preceding or following example embodiment or combination thereof, wherein forming the separability means comprises forming the separability means as a reduced cross-sectional thickness of the first and second plate portions.

[0033] Example Embodiment 23: The method of any preceding or following example embodiment or combination thereof, comprising engaging a fiducial marker element with a recess defined by an outer surface of the first cleat portion, the second cleat portion, or the tracking portion in a predetermined configuration relative to the kinematic mount.

[0034] Example embodiment 24: A method according to any preceding or subsequent example embodiment or a combination thereof, wherein engaging the reference marker element with the recess comprises engaging the spherical reference marker element with a hemispherical recess or a recess of an elongated concave channel, the recess of the hemispherical recess or the elongated concave channel being arranged to receive the spherical reference marker element.

[0035] Example Embodiment 25: The method of any preceding or following example embodiment, or a combination thereof, comprising engaging a tool calibration device with the first clamping plate portion, the second clamping plate portion, or the tracking portion in a predetermined configuration relative to the kinematic mount.

[0036] These and other features, aspects, and advantages of the present disclosure will become apparent upon reading the following detailed description and the accompanying drawings, which are briefly described below. The present disclosure includes any combination of two, three, four, or more features or elements set forth in this disclosure, regardless of whether such features or elements are described herein as being explicitly combined or otherwise described in the specific embodiments described herein. Unless otherwise expressly provided in the context of this disclosure, this disclosure is intended to be read as a whole, such that any separable feature or element of the present disclosure should be considered as intended, i.e., as combinable, in any of its aspects and embodiments.

[0037] It should be understood that the summary of the invention provided herein is merely to summarize some example aspects in order to provide a basic understanding of some aspects of the present disclosure. Thus, it should be understood that the above-mentioned example 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, some of which will be further described below in addition to those summarized herein. In addition, other aspects and advantages of these aspects disclosed herein will become apparent from the following detailed description in conjunction with the accompanying drawings, which illustrate the principles of the aspects. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Having generally described the present disclosure above, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and in which:

[0039] FIG1 schematically illustrates a prior art splint assembly engaged with a representative model of a patient's mouth to provide fiducial and / or tracking markers for a guidance system of a surgical robot used in dental surgery;

[0040] 2A and 2B schematically illustrate a prior art splint device engaged with a representative model of a patient's mouth to provide fiducial markers and / or tracking markers for a guidance system of a surgical robot for dental surgery ( FIG. 2A ), and disengaged from the representative model of the patient's mouth ( FIG. 2B );

[0041] Figure 3A Schematically illustrates a perspective view of a splint device according to one aspect of the present disclosure, the splint device being configured to provide a fiducial marker and / or tracking marker for a guidance system of a surgical robot;

[0042] Figure 3B schematically illustrates a plan view of an alignment device for two parts of a splinting device arranged to provide fiducial and / or tracking markers for a guidance system of a surgical robot according to one aspect of the present disclosure; and

[0043] Figure 4 -10 schematically and collectively illustrate a method of implementing a splint device for a guidance system of a surgical robot according to one aspect of the present disclosure, wherein the splint device is configured to facilitate removability. DETAILED DESCRIPTION

[0044] The present disclosure will now be described more fully with reference to the accompanying drawings, which illustrate some, but not all, aspects of the disclosure. Indeed, 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 disclosure will satisfy applicable legal requirements. Like reference numerals refer to like elements throughout.

[0045] For example, Figure 3A The particular aspects of the present disclosure shown provide a splinting device 100 for use with a guidance system of a surgical robot, such as in dental surgery. However, those skilled in the art will appreciate that the concepts of the splinting device disclosed herein, as a means of forming fiducial markers and / or tracking markers, or otherwise serving as a reference system for a surgical robotic system, may be applicable to other surgical procedures not involving dental surgery, such as plastic surgery, otolaryngology surgery, 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.

[0046] Such a splint device 100 implemented in conjunction with a guided surgical robot may include, for example, an elongated first splint portion 200 (e.g., a tongue portion) having a first longitudinal end 200A and a second longitudinal end 200B, a first interface edge 250 extending between the first end 200A and the second end 200B, and in some cases defining longitudinally spaced release holes 300 (e.g., see Figure 6 and Figure 7 The elongated second splint portion 400 (e.g., cheek portion) has a first longitudinal end 400A and a second longitudinal end 400B, has a second interface edge 450 extending between the first end 400A and the second end 400B, and in some cases defines longitudinally spaced release holes 500 (e.g., see Figure 6 and 7 ). The second plate portion 400 is generally coextensive with the first plate portion 200, wherein the second interface edge 450 is arranged to be complementary to the first interface edge 250, e.g. Figure 3A and Figure 3B shown.

[0047] In some respects, e.g. Figure 3A and 3B As shown, the splint assembly 100 includes at least one alignment assembly 800A or 800B, wherein each alignment assembly includes a first alignment element 825A or 825B that engages the first splint portion 200 and a second alignment element 850A or 850B that engages the second splint portion 400. In certain aspects, the splint assembly 100 includes at least two alignment assemblies 800A, 800B, wherein one of the alignment assemblies 800A includes a first alignment element 825A that engages the first splint portion 200 and a second alignment element 850A that engages the second splint portion 400, and the other of the alignment assemblies 800B includes a first alignment element 825B that engages the first splint portion 200 and a second alignment element 850B that engages the second splint portion 400.

[0048] In some aspects, the corresponding first alignment elements 825A and / or 825B and second alignment elements 850A and / or 850B are constructed to complement each other. Figure 3BAs shown, the first alignment elements 825A and / or 825B can be frustoconical receiving portions defined by the first plate portion 200, wherein the frustoconical receiving portions have a major diameter 825A1 and / or 825B1 and a minor diameter 825A2 and / or 825B2, wherein the major diameter 825A1 and / or 825B1 of the frustoconical receiving portions is directed toward the second plate portion 400. Accordingly, the second alignment elements 850A and / or 850B can be frustoconical protrusions extending from the second plate portion 400, wherein the frustoconical protrusions have a major diameter 850A1 and / or 850B1 and a minor diameter 850A2 and / or 850B2, wherein the minor diameter 850A2 and / or 850B2 of the frustoconical protrusions is directed toward the first plate portion 200. However, those skilled in the art will appreciate that the alignment device(s) may be constructed and arranged in many different ways, in place of or in addition to the constructions / arrangements disclosed herein, and that the examples disclosed herein are not limited in any way in this regard.

[0049] Typically, the first alignment elements 825A and / or 825B and the second alignment elements 850A and / or 850B are arranged to interact with each other (e.g., the alignment protrusions are received by the alignment receivers) such that when the first and second plate portions 200, 400 are advanced toward each other, a substantially uniform gap 875 is defined between the first interface edge 250 and the second interface edge 450 from the respective first ends 200A, 400B to the respective second ends 200B, 400 of the first and second plate portions 200, 400 (e.g., see Figure 3B ).

[0050] In certain aspects, the threaded member 900 is engaged between the first and second cleat portions 200, 400 and is arranged to advance the first and second interface edges 250, 450 toward each other in response to advancement of the threaded member 900 relative to the first and second cleat portions 200, 400. For example, the second cleat portion 400 defines an unthreaded aperture 925 arranged to allow the threaded member 900 to pass therethrough, while the first cleat portion 200 defines a threaded aperture 950 arranged opposite the unthreaded aperture 925 and configured to threadedly engage the threaded member 900. Thus, threading the threaded member 900 through the unthreaded hole 925 and engaging the threaded hole 950 while simultaneously engaging the alignment devices 800A, 800B forms a mechanism for advancing / retracting the first and second cleat portions 200, 400 relative to each other while maintaining a substantially consistent gap 875 between the first and second interface edges 250, 450 as the threaded member 900 advances or retracts relative to the threaded hole 950. For example, Figure 3AAs shown, in the case where the clamping plate device 100 includes the first alignment device 800A and the second alignment device 800B, the screw member 900 engaged between the first clamping plate part 200 and the second clamping plate part 400 is provided between the first alignment device 800A and the second alignment device 800B.

[0051] In some aspects, the tracking portion 1000 is coupled to the first cleat portion 200 or the second cleat portion 400 and extends outwardly therefrom. Figure 3A In the embodiment of the present invention, the tracking portion 1000 is engaged with the second (cheek) splint portion 400. More specifically, in some aspects, the tracking portion 1000 extends from the first end 200A, 400B or the second end 200B, 400B of the first splint portion 200 or the second splint portion 400. In some cases, the tracking portion 1000 has a kinematic mounting portion 1100 engaged therewith. In some aspects, the kinematic mounting portion 1100 is integrally formed with the tracking portion 1000.

[0052] In some cases, the kinematic mounting portion 1100 (see, e.g., Figure 3A ) defines a centrally located receiving portion 1125 surrounded by three or more angularly spaced protrusions 1150. Such a kinematic mounting portion 1100 is typically 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 may include, for example, a physically connected tracking device, such as a tracking arm that is connected to a surgical robot. In other cases, the tracking device may 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 kinematic mounting portion 1100 and the surgical robot. In either case, the integration of the kinematic mounting portion 1100 into the tracking portion 1000 provides for repeatable engagement with the tracking device, as well as interchangeable engagement between different types of tracking devices. The integration of the kinematic mounting portion 1100 may be further accomplished, for example, by molding, machining, and or 3D printing.

[0053] In other cases, the separable device 1200 (see, e.g., Figure 3A) extends across the first portion 200 and the second plate portion 400 between the first alignment device 800A or the second alignment device 800B and the first longitudinal end 200A, 400A or the second longitudinal end 200B, 400B of the first and second plate portions, wherein the separable device 1200 is arranged to be severable to facilitate adjustment of the length of the first and second plate portions 200, 400. The adjustability of the length of the splint device 100 via the separable device 1200 can facilitate, for example, implementation of the splint device 100 for a variety of different sized applications (e.g., adult teeth or children's teeth). In some aspects, the separable device 1200 includes a reduced cross-sectional thickness extending across the first and second plate portions 200, 400. In other aspects, multiple separable devices 1200 can be provided along the first and second plate portions 200, 400 to provide multiple adjustabilities of the length of the splint device 100.

[0054] In other cases, the tool calibration apparatus 1300 (see, for example, Figure 3A ) is engaged with the first clamping plate portion 200, the second clamping plate portion 400, or the tracking portion 1000, wherein the tool calibration device 1300 is arranged in a predetermined configuration relative to the kinematic mounting portion 1100. The tool calibration device 1300 can be configured, for example, as a receptacle or other suitable surface feature for receiving an end effector (e.g., the tip of a drill bit) of a surgical instrument attached to the surgical robot. In some cases, the tool calibration device 1300 is integrally formed with a specific component of the clamping plate 100, or in other cases, the tool calibration device 1300 can be a separate and discrete element (e.g., a durable element such as a metal element, a ceramic element, or other suitable element). Because the tool calibration device 1300 is in a known configuration relative to the kinematic mounting portion 1100, the tool calibration device 1300 provides confirmation or calibration when interacting with the end effector of the surgical robot, i.e., accurately tracking the end effector relative to the surgical robot for a procedure. In some cases, the tool calibration device 1300 is radiopaque so that its configuration relative to the kinematic mounting portion 1100 can be determined and / or confirmed by imaging analysis.

[0055] In other cases, the fiducial marker element 1400 (see, for example, Figure 3A) are received by recesses (not shown) defined by an outer surface of the cleat assembly 100 or the tracking portion 600 (e.g., an outer surface of the second cleat portion 400), wherein the fiducial marker element 140 is received in a predetermined configuration relative to the kinematic mounting portion 1100. In certain aspects, the outer surface of the cleat assembly 100 defines a plurality of recesses arranged to receive a corresponding plurality of fiducial marker elements 1400. For example, in certain aspects, the fiducial marker elements 1400 are spherical and the recesses are hemispherical or elongated concave channels arranged to receive the spherical fiducial marker elements 1400. Once secured with the corresponding recesses, whether by an interference fit (e.g., press fit), overmolding, or an adhesive material (e.g., epoxy) provided with the recesses, the fiducial marker element(s) 1400 are substantially embedded within the cleat assembly 100. Furthermore, in certain aspects, the recesses are oriented such that the adhesive material (e.g., epoxy) remains fixed / embedded in position within the recesses, such as by gravity. Because the fiducial marker element(s) 1400 are radiopaque in certain aspects, they can be detected by imaging analysis (e.g., CT scan). Thus, in certain circumstances, the fiducial marker element(s) 1400 are radiopaque and can be distinguished from the splint device 100 (e.g., formed of a plastic / polymer material). Because the fiducial marker element(s) 1400 are embedded within the splint device 100, the field of view of the imaging analysis (e.g., CT scan) can be reduced.

[0056] In certain aspects, the first and second cleat portions 200, 400 interact to collectively form an elongated channel 1450 (see, e.g., Figure 4 ), the elongated channel having an inner surface defining a recess (e.g., a "U" channel in cross section). In this case, the elongated channel 1450 is arranged and configured to receive a bite registration material or dental impression material 1500 therein, for example, wherein such material may comprise, for example, a vinyl polysiloxane material. However, one skilled in the art will appreciate that such example materials are not limiting in any way, and that many other materials may be suitable, for example, to conform to the patient's tooth structure without adhering to the tooth surface itself. Thus, once the impression material 1500 is deposited, for example, on Figure 4 , the splint device 100 is then applied to an object, such as a tooth or jaw of a patient undergoing dental surgery. However, those skilled in the art will appreciate that the application of the splint device 100 and subsequent procedures need not involve a human patient. For example, the splint may be applied to a dummy patient to facilitate user training, for demonstration purposes, or to validate the device / system itself.

[0057] As previously described, once the clamping device 100 is applied to an object, the threaded member 900 can be advanced in threaded engagement with the threaded hole 950 defined by the first clamping plate portion 200 to advance the first clamping plate portion 200 toward the second clamping plate portion 400 and secure the object therebetween while maintaining a substantially consistent gap 875 between the first interface edge 250 and the second interface edge 450, e.g., Figure 5 As shown. Figure 6 As shown, in some cases, additional impression material 1500 may be applied in the gap 875 between the first interface edge 250 and the second interface edge 450 as the first and second clamping plate portions are advanced toward each other by advancement of the threaded member 900 .

[0058] When the first and second plate portions 200, 400 are advanced toward an object (e.g., see Figure 8 ), any excess impression material 1500 within the elongated channel 1450 is released by the flow of impression material out of the elongated channel through the corresponding release holes 300, 500 toward the outer surface of the first splint portion 200 and / or the second splint portion 400 (see, for example, Figure 6 and Figure 7 ). In this way, the splint device 100 is secured to an object, such as the patient's teeth / jaw. When the impression material 1500 solidifies, the splint device 100 is thereby securely fastened to the object (e.g., the patient's teeth or jaw) without significantly adhering to the surface of the teeth / jaw, as compared to adhesive materials such as acrylic. The solidified / cured impression material 1500 has sufficient hardness to provide a secure and rigid mounting of the splint device 100 to the patient's teeth / jaw, in combination with the pressure applied to the splint device 100 by the first splint portion 200 and the second splint portion 400 pushing against each other via the threaded member 900. In some cases, such as Figure 9 As shown, the first splint portion 200 and the second splint portion 400 can be advanced toward each other by the threaded member 900 until the first interface edge 250 and the second interface edge 450 contact each other, thereby fully securing the splint device 100 to the patient's teeth / jaw. Figure 10 As shown, removal of the splint device 100 thus becomes a matter of retracting the threaded member 900 from the threaded hole 950 of the first splint part 200, which releases the pressure exerted by the first splint part 200 and the second splint part 400 on the impression material 1500 and allows the splint device 100 to be removed from the object (because the impression material will not adhere to the splint device 100 either).

[0059] Thanks to the teachings of the above description and the associated drawings, those skilled in the art to which the embodiments of the present disclosure relate will appreciate 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 may 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 that are different from those explicitly described above are also contemplated within the scope of the present disclosure. Although specific terms are used herein, they are used in a general and descriptive sense, and not for purposes of limitation.

[0060] It should be understood that although the terms first, second, etc. are 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 operation or calculation. For example, the first calculation can be called the second calculation, and similarly, the second step can be called the first step without departing from the scope of this disclosure. As used herein, the term "and / or" and the " / " symbol include any and all combinations of one or more associated listed items.

[0061] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that when the terms "comprises," "comprising," "includes," and / or "including" are used herein, they specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof. Therefore, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

Claims

1. A splinting device for guided robotic surgery, comprising: an elongated first cleat portion having a first longitudinal end and a second longitudinal end and a first interface edge extending therebetween; an elongated second plate portion having a first longitudinal end and a second longitudinal end and a second interface edge extending therebetween, the second plate portion being coextensive with the first plate portion, wherein the second interface edge is arranged in addition to the first interface edge; a threaded member engaged between the first and second cleat portions and arranged to advance the first and second interface edges toward each other in response to advancement of the threaded member relative to the first and second cleat portions; a tracking portion engaged with the first cleat portion or the second cleat portion and extending outwardly therefrom, the tracking portion having a kinematic mounting portion engaged therewith; as well as anda first end of the second cam portion and a second end of the second cam portion, wherein the first end of the second cam portion and the second end of the second cam portion are aligned with each other to form a circle around the first end of the cam portion and the second end of the cam portion.

2. The device according to claim 1, characterized in that The first cleat portion defines longitudinally spaced release apertures.

3. The device according to claim 1, characterized in that The second cleat portion defines longitudinally spaced release apertures.

4. The device according to claim 1, characterized in that The kinematic mounting portion is integrally formed with the tracking portion.

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

6. The device according to claim 1, characterized in that The first alignment element is a frustoconical receiving portion defined by the first clamping plate portion, the frustoconical receiving portion having a major diameter and a minor diameter, wherein the major diameter of the frustoconical receiving portion is directed toward the second clamping plate portion, and wherein the second alignment element is a frustoconical protrusion extending from the second clamping plate portion, the frustoconical protrusion having a major diameter and a minor diameter, wherein the minor diameter of the frustoconical protrusion is directed toward the first clamping plate portion.

7. The device according to claim 1, characterized in that The alignment device includes a first alignment device and a second alignment device, and wherein the threaded member engaged between the first clamping plate part and the second clamping plate part is provided between the first alignment device and the second alignment device.

8. The device according to claim 7, characterized in that comprising a separability device extending across the first splint part and the second splint part between the first alignment device or the second alignment device and the first longitudinal end or the operative second longitudinal end of the first splint part and the second splint part, wherein the separability device is arranged to be severable to facilitate adjustability of the length of the first splint part and the second splint part.

9. The device according to claim 8, characterized in that The separability means comprises a reduced cross-sectional thickness of the first and second plate portions.

10. The device according to claim 1, characterized in that A fiducial marker element is included, the fiducial marker element being received by a recess defined by an outer surface of the first cleat portion, the second cleat portion, or the tracking portion, the fiducial marker element being received in a predetermined configuration relative to the kinematic mounting portion.

11. The device according to claim 10, characterized in that The fiducial marker element is spherical and the recess is hemispherical or an elongated concave channel arranged to receive the spherical fiducial marker element.

12. The device according to claim 1, characterized in that A tool calibration device is included, the tool calibration device being engaged with the first clamping plate portion, the second clamping plate portion, or the tracking portion, the tool calibration device being disposed in a predetermined configuration relative to the kinematic mount.

13. A method of assembling a splinting device, the method comprising: engaging a first elongated cleat portion with a coextensive second elongated cleat portion, each cleat portion having a first longitudinal end and a second longitudinal end and an interface edge extending between the first and second ends, the interface edges being arranged to complement each other such that a first alignment element engaged with the first cleat portion and a second alignment element engaged with the second cleat portion interact with each other to align the first cleat portion with the second cleat portion, the first cleat portion or the second cleat portion having a tracking portion engaged therewith and extending outwardly therefrom, and the tracking portion having a kinematic mounting portion engaged therewith; and and a second cam portion adapted to align the first and second cam portions when the first and second cam portions are moved toward each other by the first and second cam portions, respectively.

14. The method according to claim 13, characterized in that Joining the first and second plate portions includes joining the first and second plate portions to form an elongated channel having a cross-section defining a recess, and wherein the method further includes applying an impression material within the recess along the elongated channel.

15. The method according to claim 14, characterized in that The first clamp portion and the second clamp portion each define a longitudinally spaced release hole, wherein the recess of the elongated channel is arranged to receive an object therein, and wherein engaging the threaded member between the first clamp portion and the second clamp portion includes advancing the threaded member between the first clamp portion and the second clamp portion to advance the first clamp portion and the second clamp portion toward each other around the object until excess impression material is released through the release hole to secure the first clamp portion and the second clamp portion to the object via the impression material therebetween.

16. The method according to claim 15, characterized in that Included is depositing additional impression material in the gap between the first interface edge and the second interface edge as the first and second clamping plate portions are advanced toward each other.

17. The method according to claim 13, wherein This includes integrally forming the motion mounting portion with the tracking portion.

18. The method according to claim 13, characterized in that This includes engaging the tracking portion with the first end or the second end of the first cleat portion or the second cleat portion such that the tracking portion extends therefrom.

19. The method according to claim 13, wherein include: The first alignment element is formed as a frustoconical receiving portion defined by the first clamping plate portion, the frustoconical receiving portion having a major diameter and a minor diameter, wherein the major diameter of the frustoconical receiving portion is directed toward the second clamping plate portion; and the second alignment element is formed as a frustoconical protrusion extending from the second clamping plate portion, the frustoconical protrusion having a major diameter and a minor diameter, wherein the minor diameter of the frustoconical protrusion is directed toward the first clamping plate portion.

20. The method according to claim 13, wherein The first alignment element and the second alignment element define an alignment device, wherein the clamping device includes a first alignment device and a second alignment device, and wherein engaging the threaded member between the first clamping plate part and the second clamping plate part includes engaging the threaded member between the first clamping plate part and the second clamping plate part such that the threaded member is disposed between the first alignment device and the second alignment device.

21. The method according to claim 20, characterized in that It includes a separability device extending across the first clamping plate part and the second clamping plate part between the first alignment device or the second alignment device and the first longitudinal end or the second longitudinal end of the first clamping plate part and the second clamping plate part, and the separability device is arranged to be cuttable to facilitate the adjustability of the length of the first clamping plate part and the second clamping plate part.

22. The method according to claim 21, characterized in that Forming the separability means includes forming the separability means as a reduced cross-sectional thickness of the first and second plate portions.

23. The method according to claim 13, wherein This includes engaging a fiducial marker element with a recess defined by an outer surface of the first cleat portion, the second cleat portion, or the tracking portion in a predetermined configuration relative to the kinematic mount.

24. The method according to claim 23, wherein Engaging the fiducial marker element with the recess includes engaging a spherical fiducial marker element with a recess that is a hemispherical recess or an elongated concave channel arranged to receive the spherical fiducial marker element.

25. The method according to claim 13, wherein This includes engaging a tool calibration device with the first clamping plate portion, the second clamping plate portion, or the tracking portion in a predetermined configuration relative to the kinematic mount.

Images