SPLINT DEVICE FOR GUIDED SURGICAL ROBOT

A splint device for guided robotic surgery, includes an arcuate splint body having first and second ends and opposing concave and convex surfaces. The splint body defines a plurality of holes spaced apart between the first and second ends, with each hole extending between the concave and convex surfaces. A tracking portion is engaged with the convex surface of the splint body between the first and second ends such that at least one of the holes is disposed between the tracking portion and each of the first and second ends. The tracking portion extends outwardly from the convex surface and has a kinematic mount engaged therewith.

BACKGROUND

Field of the Disclosure

The present application relates to surgical robots and associated guidance systems and, more particularly, to a splint device for forming a fiducial marker and/or a tracking marker for the guidance system of a surgical robot in instances of a fully or partially edentulous patient.

Description of Related Art

Robotic systems are being increasingly implemented in surgical applications. One such example involves a surgical robot used in dental surgery. Such robots are often associated with a guidance system used to guide the surgical instrument implemented by the surgical robot. The guidance system may also be configured to be involved in the surgical pre-planning process, whether by being involved in gathering and/or analyzing patient data, and planning the surgical procedure, or by relying upon pre-planning data to guide the surgical instrument to conduct the surgical procedure.

In particular surgical procedures, some surgical robotic systems rely upon a fixed reference point associated with the patient's body for guiding the surgical robot. That is, some such surgical robotic systems define a frame of reference with respect to the patient's body so as to account or otherwise compensate for movements or motion of the patient during the procedure, whether during pre-planning or during the actual surgical procedure itself. This reference point must also be repeatable such that multiple engagements/disengagements (i.e., periods between pre-planning and the actual surgical procedure) do not change the frame of reference implemented by the surgical robot or the guidance system associated therewith.

In particular instances, the reference point (or the connection between the guidance system and the patient to define that reference point) implemented by the guidance system for the surgical robot may be accomplished through, for example, an optical modality, a mechanical modality, an acoustic modality, or other suitable and appropriate tracking/guiding modality, or combination thereof. In some modalities, particularly used in dental surgery applications, one mechanical modality for forming the reference point (i.e., a “fiducial marker”) may be accomplished, for example, by attaching/securing a rigid element to the head/teeth of the patient. Such a rigid element, in some instances, may be referred to as and may comprise a splint. Such a splint may generally include, for instance, a retainer portion that grips one or more of the teeth (i.e., by way of an adhesive substance, such as an acrylic material applied between the retainer portion and the teeth), a mounting portion (i.e., mounting arm) that connects the retainer portion to a separate kinematic mount, and the kinematic mount, itself, which may comprise an attachment point for a tracking portion associated with the guidance system for the surgical robot (i.e., wherein, for instance, reflective markers may be mounted to the attachment point for optical tracking of the fiducial marker, or the attachment point may include a securing site for forming a mechanical connection therewith for mechanical tracking of the fiducial marker, or the attachment point may otherwise be configured to receive an appropriate element associated with any other suitable tracking arrangement for the fiducial marker).

In such instances, it may be preferable for the retainer portion to be as rigid as possible (i.e., the structure of the retainer itself, as well as the fixation thereof to the teeth of the patient) throughout the surgical procedure. However, it may also be preferable for the retainer portion to be readily removable when the surgical procedure is complete. In some instances, it may be preferable for the splint to be reproducibly removed and replaced, for example, between the pre-planning procedure (i.e., a CT scan) which may occur on one day (when the splint must be in place so the fiducial marker(s) associated therewith are captured in the scan), and the surgical procedure may occur on another day (wherein the surgical procedure requires the splint to be in place for tracking/guiding the surgical procedure). In other instances, it may be preferable that a single splint configuration be usable or adaptable across a wide population of patients, for example, as a universal fit (size) device. In addition, it would be desirable for such a splint to be readily applicable to fully or partially edentulous patients (i.e., patients not having sufficient teeth or teeth structure capable of supporting the application of a conventional splint thereto). Since such a splint device would not be reliant upon the patient having teeth or sufficient teeth structure for the application thereof, it would also be desirable for the splint device to be applicable to other parts of the patient to facilitate other types of guided robotic surgery. Further, it may be desirable to have a minimum of separate components of the splint, or if separate components are included, that such separate components are integrated into or are firmly and securely affixed as part of the overall splint assembly. In some instances, it may be desirable for the splint to be re-usable for the particular patient.

As such, there exists a need for a splint device for forming a fiducial marker for the guidance system of a surgical robot used, for example, in dental surgery, and particularly for fully or partially edentulous patients in dental surgery, or other types of surgery, which addresses these and other limitations of prior art devices.

SUMMARY OF THE DISCLOSURE

The above and other needs are met by aspects of the present disclosure which, in one particular aspect, provides a splint device for guided robotic surgery. Such a device comprises an arcuate splint body having first and second ends and opposing concave and convex surfaces. The splint body defines a plurality of holes spaced apart between the first and second ends, with each hole extending between the concave and convex surfaces. A tracking portion is engaged with the convex surface of the splint body between the first and second ends such that at least one of the holes is disposed between the tracking portion and each of the first and second ends. The tracking portion extends outwardly from the convex surface and has a kinematic mount engaged therewith.

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

Example Embodiment 1: A splint device for guided robotic surgery, said device comprising an arcuate splint body having first and second ends and opposing concave and convex surfaces, the splint body defining a plurality of holes spaced apart between the first and second ends, each hole extending between the concave and convex surfaces; and a tracking portion engaged with the convex surface of the splint body between the first and second ends such that at least one of the holes is disposed between the tracking portion and each of the first and second ends, the tracking portion extending outwardly from the convex surface and having a kinematic mount engaged therewith.

Example Embodiment 2: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein each hole is arranged to receive a sleeve therein.

Example Embodiment 3: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein the sleeve is comprised of a metallic material or a ceramic material.

Example Embodiment 4: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein the sleeve is arranged as a drill guide or a fastener guide.

Example Embodiment 5: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein the kinematic mount is integrally formed with the tracking portion.

Example Embodiment 6: The device of any preceding or subsequent example embodiment, or combinations thereof, comprising a separability provision extending across the splint body between adjacent holes, wherein the separability provision is arranged to be severable so as to facilitate adjustability of a length of the splint body.

Example Embodiment 7: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein the separability provision comprises a reduced section thickness of the splint body between adjacent holes.

Example Embodiment 8: The device of any preceding or subsequent example embodiment, or combinations thereof, comprising a fiducial marker element received by a depression defined by an outer surface of the splint body or the tracking portion, the fiducial marker element being received in a predetermined disposition relative to the kinematic mount.

Example Embodiment 9: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein the fiducial marker element is spherical and the depression is hemispherical or an elongate concave channel arranged to receive the spherical fiducial marker element.

Example Embodiment 10: The device of any preceding or subsequent example embodiment, or combinations thereof, comprising a tool calibration provision engaged with the splint body or the tracking portion, the tool calibration provision being disposed in a predetermined disposition relative to the kinematic mount.

Example Embodiment 11: The device of any preceding or subsequent example embodiment, or combinations thereof, wherein the concave surface of the splint body is arranged to conform to a mandibular curvature or a maxillary curvature.

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

DETAILED DESCRIPTION OF THE DISCLOSURE

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

Particular aspects of the present disclosure, as shown, for example, inFIGS.1A and1Bprovide a splint device100for use with a guidance system of a surgical robot, for instance, in dental surgery. One skilled in the art, however, will appreciate that the concept of the splint device disclosed herein as forming a fiducial marker and/or a tracking marker, or otherwise a frame of reference for a surgical robotic system may find applicability to other surgical processes not involving dental surgery, such as, for example, orthopedic surgery, ENT surgery, and neurosurgery. As such, the aspects of the disclosure presented herein are merely examples of the applicability of the disclosed concepts and are not intended to be limiting in any manner. That is, aspects of the splint device disclosed herein may be otherwise applicable to various parts of the patient to facilitate other types of surgery, besides dental surgery. As disclosed herein, aspects of the splint device100are particularly described and illustrated as being applicable to partially or fully edentulous patients for providing a surgical splint for facilitating guided robotic dental surgery, though one skilled in the art will appreciate that the splint concepts associated with these aspects may be otherwise applicable to various parts of the patient to facilitate other types of surgery, besides dental surgery.

Such a splint device100, for example, for fully or partially edentulous patients, and implemented in conjunction with a guided surgical robot may comprise an arcuate splint body200having opposed first and second ends200A,200B and a concave surface300opposing a convex surface400. The splint body200further defines a plurality or series of holes spaced apart between the first and second ends200A,200B, wherein each hole500extends between the concave and convex surfaces300,400(e.g., each hole500extends to and through the concave surface300and to and through the convex surface400). A tracking portion600is engaged with the convex surface400of the splint body200, between the first and second ends200A,200B of the splint body200. In particular aspects, the tracking portion600is engaged with the convex surface400of the splint body200, between the first and second ends200A,200B of the splint body200, such that at least one of the holes500is disposed between the tracking portion600and each of the first and second ends200A,200B. The tracking portion600extends outwardly from the convex surface400and has a kinematic mount700engaged therewith.

In some aspects, in an example application such as dental surgery, at least the concave surface300of the arcuate splint body200is configured and arranged to substantially conform to a mandibular curvature or maxillary curvature of the patient anatomy. In other aspects, a separability provision800extends across the splint body200(e.g., across the convex surface400) between two adjacent holes. In some instances, the separability provision800is arranged to be severable so as to facilitate adjustability of a length of the splint body200, for example, to better conform to mandibular/maxillary curves of different dimensions. That is, the adjustability of the length of the splint body100via the separability provision800can facilitate, for example, the implementation of the splint device100to a variety of different size applications (e.g., adult or child's mandible/maxilla) The separability provision800, in some aspects, comprises a reduced section thickness of the splint body200between adjacent holes500, whether in relation to the concave surface300or the convex surface400of the splint body200. In other instances, multiple severability provisions800can be provided along the concave surface300and/or the convex surface400of the splint body200to provide for multiple adjustability of the length of the splint body200of the splint device100.

In some aspects, the splint body200and the separability provision800are integrally formed as a single assembly. In other aspects, the splint body200, the separability provision800, and the tracking portion600are integrally formed as a single assembly. In still other aspects, the kinematic mount700is integrally formed with the tracking portion600. The kinematic mount700, in some instances, defines a central locating receptacle725surrounded by three or more angularly spaced-apart protrusions750. Such a kinematic mount700is generally configured to receive a complementarily-configured mount (not shown) including or engaged with a tracking provision. The tracking provision can include, for example, a physically connected (e.g., mechanical) tracking provision such as a tracking arm connected to the surgical robot. In other instances, the tracking provision can include, for example, a non-physically connected tracking provision 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 provision affixed to the kinematic mount700and the surgical robot. In either instance, the integration of the kinematic mount700into the tracking portion600provides for repeatable engagement with the tracking provision, with interchangeable engagement between different types of tracking provisions. The integration of the kinematic mount700can further be accomplished, for example, through molding, machining, and or 3D printing. When formed as an integral assembly, the splint device100may be formed, for example, using any suitable formation procedure such as injection molding, casting, or machining, as necessary or appropriate.

As previously disclosed, the splint body200defines a plurality or series of holes spaced apart between the first and second ends200A,200B, wherein each hole500extends between the concave and convex surfaces300,400(e.g., each hole500extends to and through the concave surface300and to and through the convex surface400), and wherein the tracking portion600is engaged with the convex surface400of the splint body200, between the first and second ends200A,200B of the splint body200, such that at least one of the holes500is disposed between the tracking portion600and each of the first and second ends200A,200B. In some aspects, the holes500immediately on either side of the tracking portion600are substantially equidistantly spaced therefrom.

In some aspects, each hole500along the splint body200is arranged to receive a sleeve550therein. The sleeves550, in some instances, are comprised of a durable material such as, for example, a metallic material or a ceramic material. In this manner, for instance, the sleeves550may be arranged as a drill guide for drilling a pilot hole, for example, in the mandible/maxilla (i.e., the splint body200is placed against the mandible/maxilla in a dental procedure, and the pilot hole(s) are drilled with an appropriate drill bit through the corresponding sleeve(s)550disposed within the corresponding hole(s)500). Once the pilot hole(s) are drilled in the mandible/maxilla, a fastener (not shown) such as a fixation screw can be advanced through the sleeve(s)550(e.g., the sleeve550is arranged as a fastener guide) and into the pilot hole(s) in the mandible/maxilla to secure the splint body200in place on the patient's mandible/maxilla. One skilled in the art will appreciate that the sleeves550are optional, in that the holes500/splint body200themselves may be configured and arranged to accomplish the function and/or purpose of the sleeves550with respect to a drill guide and/or fastener guide as disclosed herein. In any instance, the splint device100is secured to the mandible/maxilla in a dental procedure by way of the disclosed fasteners.

In some instances, a tool calibration provision1000is engaged with the splint body200or the tracking portion600, wherein the tool calibration provision1000is disposed in a predetermined disposition relative to the kinematic mount700. The tool calibration provision1000may be configured, for example, as a receptacle or other suitable surface feature for receiving the end effector (e.g., a tip of a drill bit) of a surgical instrument affixed to the surgical robot. The tool calibration provision1000, in some instances, is formed integrally with the particular component of the splint device100or, in other instances, 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 provision1000is in a known disposition relative to the kinematic mount700, the tool calibration provision1000, upon interaction with the end effector of the surgical robot, provides a confirmation or calibration that the end effector is accurately tracked in relation to the surgical robot for conducting a procedure. In some instances, the tool calibration provision1000is radiopaque such that the disposition thereof with respect to the kinematic mount700can be determined and/or confirmed through imaging analysis.

In yet other instances, a fiducial marker element900(see, e.g.,FIG.1B) is received by a depression (not shown) defined by an outer surface (e.g., the convex surface400) of the splint body200or the tracking portion600, wherein the fiducial marker element900is received in a predetermined disposition relative to the kinematic mount700. In particular aspects, the outer surface of the splint device100defines a plurality of depressions arranged to receive a corresponding plurality of fiducial marker elements900. For example, in some aspects, the fiducial marker element900is spherical and the depression is hemispherical or an elongate concave channel arranged to receive the spherical fiducial marker element900. Once secured with the respective depression, whether through an interference fit (e.g., a press fit), by overmolding, or with an adhesive material (e.g., epoxy) disposed with the depression, the fiducial marker element(s)900are essentially embedded within the splint device100. Moreover, in some aspects, the depressions are oriented such that the adhesive material (e.g., epoxy) is retained, such as by gravity, at the location in the depression at which the fiducial marker element900is secured/embedded. Since the fiducial marker element(s)900are radiopaque in some aspects, the fiducial marker element(s)900can be detected through imaging analysis (e.g., a CT scan). Accordingly, in particular instances, the fiducial marker element(s)900are radiopaque and can be differentiated from the splint device100(e.g., formed of a plastic/polymeric material), the sleeves550(e.g., formed of a metallic or ceramic material), and the fasteners (e.g., metal) used for securing the splint device100to the patient. Since the fiducial marker element(s)900are all embedded with the splint device100, the field of view of the imaging analysis (e.g., the CT scan) can be reduced.

Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these disclosed embodiments pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that embodiments of the invention are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the invention. For example,FIGS.2A and2Bschematically illustrate a top view and a side profile view of a splint device100applicable, for example, to a medial portion of a maxilla or mandible of a fully or partially edentulous patients and arranged to provide a fiducial marker and/or a tracking marker for a guidance system for a surgical robot, according to one aspect of the present disclosure. As shown, such a splint device100is configured similarly to the embodiment shown inFIGS.1A and1B, with the splint body200configured to extend substantially symmetrically about an arc in each direction from a center line toward the first and second ends200A,200B. Thus, the center line of the splint body200is configured to be applied to the medial portion of the mandible with the first and second ends200A,200B extending substantially similarly in either direction about the mandible. In addition, the tracking portion600extends from a medial portion of the convex surface400of the splint body200. Moreover, though not particularly described here, the embodiment illustrated inFIGS.2A and2Bcan include the enumerated elements previously described in relation toFIGS.1A and1B, even if not particularly illustrated, as will be understood by a person of skill in the art. Several of those enumerated elements are indicated inFIGS.2A and2B.

FIG.2Cschematically illustrates a splint device according to the aspect of the disclosure shown inFIGS.2A and2B, wherein a first one of such a splint device100A is applied to the mandible and a second one of such a splint device100B is inverted and applied to the maxilla. Of further note in regard to the embodiment shown inFIGS.2A and2Bis the obtuse angle defined between the splint body200and the tracking portion600. In this regard, as applied to the mandible or the maxilla, as shown inFIG.2C, the obtuse angle allows for the tracking portion600to clear the patient's (lower or upper) lip upon installation of the splint body200to the mandible or the maxilla. For example, such a configuration of the splint device would allow the patient to close their mouth and lips about the tracking portion600instead of the lips remaining parted.

FIGS.3A and3Bschematically illustrate a top view and a bottom view of a splint device100applicable, for example, to a medial portion of a maxilla of a fully or partially edentulous patients and arranged to provide a fiducial marker and/or a tracking marker for a guidance system for a surgical robot, according to still another aspect of the present disclosure. More particularly, due to the particular soft tissue anatomy about the maxilla (e.g., the nasal spine extending between the upper lip and the gum about the medial portion of the maxilla), the splint body200of the embodiment shown inFIGS.3A and3Bincludes and defines a concave relief portion200C about the medial portion of the splint body200(e.g., medially between the first and second ends200A,200B) which is arranged to receive and accommodate the nasal spine therein. The concave relief portion200C thus provides for a more comfortable splint device100in procedures involving the maxilla.

In other respects, the embodiment shown inFIGS.3A and3Bis similar to the embodiment shown inFIGS.2A and2Band, even though indicated as being particularly applicable to the maxilla, can also be inverted and applied to the mandible as will be understood by a person of skill in the art. Also, the embodiment shown inFIGS.3A and3Bcan also include the obtuse angle defined between the splint body200and the tracking portion600according to the embodiment shown inFIGS.2A and2B, if necessary or desired. In addition, though not particularly described here, the embodiment illustrated inFIGS.3A and3Bcan include the enumerated elements previously described in relation toFIGS.1A-Band2A-B, even if not particularly illustrated, as will be understood by a person of skill in the art. Several of those enumerated elements are indicated inFIGS.3A and3B.FIGS.3C and3Dschematically illustrate a splint device100according to the aspect of the disclosure shown inFIGS.3A and3B, applied to a maxilla.

Moreover, although the foregoing descriptions and the associated drawings describe example embodiments in the context of certain example combinations of elements and/or functions, it should be appreciated that different combinations of elements and/or functions may be provided by alternative embodiments without departing from the scope of the disclosure. In this regard, for example, different combinations of elements and/or functions than those explicitly described above are also contemplated within the scope of the disclosure. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

It should be understood that although the terms first, second, etc. may 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 termed a second calculation, and, similarly, a second step may be termed a first step, without departing from the scope of this disclosure. As used herein, the term “and/or” and the “I” symbol includes any and all combinations of one or more of the associated listed items.