Clamp device for guided surgical robot

Abstract

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

Description

Technical Field

[0001] This application relates to surgical robots and associated guidance systems, and more specifically, to a splint device for forming reference marks and / or tracking marks for a guidance system of a surgical robot in patients who are completely or partially edentulous. Background Technology

[0002] Robotic systems are increasingly being used in surgical procedures. One such example involves surgical robots used in dental surgery. These robots are typically associated with a guidance system used to guide surgical instruments performed by the robot. This guidance system can also be configured to participate in the pre-operative planning process, either by participating in the collection and / or analysis of patient data and planning the surgical procedure, or by relying on pre-planned data to guide surgical instruments to perform the procedure.

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

[0004] In certain situations, a reference point (or the connection between the guidance system defining the reference point and the patient) implemented by a guidance system for a surgical robot can be achieved, for example, through optical, mechanical, acoustic, or other suitable and appropriate tracking / guiding methods or combinations thereof. In some methods, particularly in dental surgical applications, a mechanical method for forming a reference point (i.e., a “reference marker”) can be achieved, for example, by attaching / fixing a rigid element to the patient’s head / teeth. In some cases, such a rigid element can be called a splint and may include a splint. Such clamps typically include, for example, a retainer portion that holds one or more teeth (i.e., by means of an adhesive material 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 motion mount; and the motion mount itself, which may include attachment points for a tracking portion associated with a guidance system of a surgical robot (i.e., wherein, for example, a reflective marker may be mounted to an attachment point for optical tracking of a reference marker, or the attachment point may include a fixed position for forming a mechanical connection with it for mechanical tracking of a reference marker, or the attachment point may be otherwise configured to receive appropriate elements associated with any other suitable tracking arrangement for a reference marker).

[0005] In this context, it may be preferable that the retainer portion be as rigid (strong) 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 once the surgical procedure is complete. In some cases, it may be preferable, for example, that the splint can be repeatedly removed and replaced between pre-planned procedures (i.e., CT scans) that may occur on one day (when the splint must be in place to capture the associated reference marks in the scan) and surgical procedures that may occur on another day (where the surgical procedure requires the splint in place to track / guide the procedure). In other cases, it may be preferable that a single splint construction is available or applicable, for example, as a universal fitting (size) device to a wide range of patients. Furthermore, it is desirable that such splints be readily applicable to patients who are completely or partially edentulous (i.e., patients who do not have sufficient teeth or tooth structure to support the application of conventional splints). Since the application of such splint devices will not depend on the patient having teeth or sufficient tooth structure, the splint devices can also be applied to other parts of the patient's body to facilitate other types of guided robotic surgery. Furthermore, it is desirable that the splint has a minimal number of individual components, or if individual components are included, such individual components are integrated into or securely attached as part of the overall splint assembly. In some cases, it is desirable that the splint be reusable for a particular patient.

[0006] Therefore, there is a need for a splint device that forms reference marks for guiding systems of surgical robots, for example, for dental procedures, particularly for patients who are completely or partially edentulous in dental or other types of surgeries, which addresses these and other limitations of existing devices. Summary of the Invention

[0007] The aspects of this disclosure satisfy the above and other needs, and in one particular aspect, this disclosure provides a splint device for guided robotic surgery. Such a device includes an arcuate splint body having a first end and a second end, and opposing concave and convex surfaces. The splint body defines a plurality of holes spaced apart between the first end and the second end, wherein each hole extends between the concave and convex surfaces. A tracking portion engages with the convex surface of the splint body between the first end and the second end, such that at least one hole 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 motion mounting portion that engages with the tracking portion.

[0008] Therefore, this disclosure includes, but is not limited to, the following example embodiments:

[0009] Example Embodiment 1: A splint device for guided robotic surgery, the device comprising an arcuate splint body having a first end and a second end, and opposing concave and convex surfaces, the splint body defining a plurality of holes spaced apart between the first end and the second end, each hole extending between the concave and convex surfaces; and a tracking portion engaging with the convex surface of the splint body between the first end and the second end, such that at least one hole is disposed between the tracking portion and each of the first and second ends, the tracking portion extending outward from the convex surface and having a motion mounting portion engaging with the tracking portion.

[0010] Example Embodiment 2: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein each hole is arranged to receive a sleeve therein.

[0011] Example 3: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein the sleeve is made of a metallic or ceramic material.

[0012] Example Embodiment 4: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein the sleeve is arranged as a drilling guide or a fastener guide.

[0013] Example Embodiment 5: A device according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein the motion mounting portion and the tracking portion are integrally formed.

[0014] Example Embodiment 6: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof includes a separating device that extends across the clamp body between adjacent holes, wherein the separating device is arranged to be cut to facilitate adjustment of the length of the clamp body.

[0015] Example Embodiment 7: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein the separability device includes a reduced cross-sectional thickness of a clamping body located between adjacent holes.

[0016] Example Embodiment 8: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof includes a reference marking element received by a recess defined by the outer surface of the clamp body or the tracking portion, the reference marking element being received in a predetermined configuration relative to the motion mounting portion.

[0017] Example Embodiment 9: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein the reference marker element is spherical, the recess is hemispherical, or an elongated concave channel arranged to receive the spherical reference marker element.

[0018] Example Embodiment 10: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof includes a tool calibration device that engages with a clamp body or a tracking portion, the tool calibration device being configured in a predetermined arrangement relative to a motion mounting portion.

[0019] Example Embodiment 11: An apparatus according to any of the foregoing or hereinafter described example embodiments or combinations thereof, wherein the concave surface of the clamp body is arranged to conform to the curvature of the mandible or the curvature of the maxilla.

[0020] These and other features, aspects, and advantages of this disclosure will become clear from the following detailed description and the accompanying drawings, which are briefly described below. This disclosure includes any combination of two, three, four, or more features or elements set forth in this disclosure, whether such features or elements are described herein as explicitly combined or otherwise recited in the specific embodiments described herein. Unless expressly specified in the context of this disclosure, this disclosure is intended to be read holistically such that any separable features or elements of this disclosure should be considered contemplated, i.e., considered composable, in any of its aspects and embodiments.

[0021] It should be understood that the inventive summary provided herein is merely a summary of some exemplary aspects to provide a basic understanding of some aspects of this disclosure. Therefore, it should be understood that the foregoing exemplary aspects are merely examples and should not be construed as limiting the scope or spirit of this disclosure in any way. It should be understood that the scope of this disclosure includes many potential aspects, some of which will be further described below in addition to those summarized herein. Furthermore, other aspects and advantages of these aspects disclosed herein will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which illustrate the principles of the aspects. Attached Figure Description

[0022] Having described the present disclosure in general above, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

[0023] Figure 1A and Figure 1B Different perspective views of a splint device according to one aspect of the present disclosure are schematically shown. The splint device is suitable for patients, for example, those who are completely or partially edentulous, and is arranged to provide reference marks and / or tracking marks for a guiding system of a surgical robot.

[0024] Figure 2A and Figure 2B A top view and a side profile of a splint device according to another aspect of this disclosure are schematically shown. The splint device is suitable for the middle portion of the maxilla or mandible of a patient, for example, who is completely or partially edentulous, and is arranged to provide reference marks and / or tracking marks for a guiding system of a surgical robot.

[0025] Figure 2C It schematically shows the following based on Figure 2A and Figure 2B The splint device of a certain aspect of the present disclosure is shown, wherein a first splint device is applied to the mandible, while a second splint device is inverted and applied to the maxilla.

[0026] Figure 3A and Figure 3B A top and bottom view schematically illustrate a splint device according to another aspect of this disclosure, adaptable to, for example, the middle portion of the maxilla in a patient who is completely or partially edentulous, and arranged to provide reference markers and / or tracking markers for a surgical robot's guidance system; and

[0027] Figure 3C and Figure 3D It schematically shows the following based on Figure 3A and Figure 3B The clamping device of a certain aspect of this disclosure is shown. Detailed Implementation

[0028] 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. In fact, the disclosure may be implemented 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. The same reference numerals throughout indicate the same elements.

[0029] For example, such as Figure 1A and Figure 1B As shown, a specific aspect of this disclosure provides a splint device 100 for use, for example, in dental procedures, 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 a reference system for forming reference marks and / or tracking marks, or otherwise used in surgical robot systems, is applicable to other surgical procedures not involving dental procedures, such as orthopedic surgery, otolaryngology surgery, and neurosurgery. Therefore, the aspects of this disclosure presented herein are merely examples of the applicability of the disclosed concept and are not intended to be limited in any way. That is, aspects of the splint device disclosed herein can be applied in other ways to various parts of a patient to facilitate types of procedures other than dental procedures. As disclosed herein, aspects of the splint device 100 are specifically described and illustrated for use with partially or completely edentulous patients, although those skilled in the art will recognize that the splint concept associated with these aspects can be applied in other ways to various parts of a patient to facilitate types of procedures other than dental procedures.

[0030] For example, such a splint device 100, used for patients who are completely or partially edentulous and implemented in conjunction with a guided surgical robot, may include an arcuate splint body 200 having opposing first ends 200A and second ends 200B, and a concave surface 300 opposite a convex surface 400. The splint body 200 also defines a plurality or a series of holes spaced apart between the first ends 200A and the second ends 200B, wherein each hole 500 extends between the concave surface 300 and the convex surface 400 (e.g., each hole 500 extends to and through the concave surface 300, and extends to and through the convex surface 400). A tracking portion 600 engages with the convex surface 400 of the splint body 200 between the first ends 200A and the second ends 200B. In a particular aspect, the tracking portion 600 engages with the convex surface 400 of the clamping body 100 between a first end 200A and a second end 200B, such that at least one hole 500 is provided between the tracking portion 600 and each of the first end 200A and the second end 200B. The tracking portion 600 extends outward from the convex surface 400 and has a motion mounting portion 700 that engages with the tracking portion.

[0031] In some aspects, in example applications such as dental surgery, at least the concave surface 300 of the curved splint body 200 is constructed and arranged to substantially conform to the mandibular or maxillary curvature of the patient's anatomy. In other aspects, the dissociative device 800 extends across the splint body 200 between two adjacent holes (e.g., across the convex surface 400). In some cases, the dissociative device 800 is arranged to be cuttable to facilitate adjustment of the length of the splint body 200, for example, to better conform to different sizes of mandibular / maxillary curvature. That is, adjustment of the length of the splint body 100 via the dissociative device 800 can facilitate, for example, implementation of the splint device 100 for applications of various sizes (e.g., mandibular / maxillary bones of adults or children). In some aspects, the dissociative device 800 includes a reduced cross-sectional thickness of the splint body 200 between adjacent holes 500, whether relative to the concave surface 300 or the convex surface 400 of the splint body 100. In other cases, multiple separation devices 800 may be provided along the concave surface 300 and / or convex surface 400 of the clamp body 200 to provide multiple adjustments to the length of the clamp body 200 of the clamp device 100.

[0032] In some respects, the clamp body 200 and the separation device 800 are integrally formed as a single component. In other respects, the clamp body 200, the separation device 800, and the tracking portion 600 are integrally formed as a single component. In still other respects, the motion mount 700 is integrally formed with the tracking portion 600. In some cases, the motion mount 700 defines a central positioning reception portion 725 surrounded by three or more angledly spaced protrusions 750. Such motion mounts 700 are generally configured to receive a mount (not shown) that includes a tracking device or a complementary structure engaging with a tracking device. The tracking device may include, for example, a physically connected (e.g., mechanical) tracking device, such as a tracking arm attached 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 motion mount 700 and the surgical robot. In either case, the motion mounting portion 700 is integrated into the tracking portion 600, providing 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. When formed as a monolithic assembly, the clamping device 100 can be formed, if necessary or appropriate, using, for example, any suitable forming process such as injection molding, casting, or machining.

[0033] As previously described, the clamp body 200 defines a plurality or a series of holes spaced apart between a first end 200A and a second end 200B, wherein each hole 500 extends between a concave surface 300 and a convex surface 400 (e.g., each hole 500 extends to and through the concave surface 300, and extends to and through the convex surface 400), and wherein a tracking portion 600 engages with the convex surface 400 of the clamp body 100 between the first end 200A and the second end 200B of the clamp body 200, such that at least one hole 500 is provided between the tracking portion 600 and each of the first end 200A and the second end 200B. In some respects, the holes 500 adjacent to either side of the tracking portion 600 are substantially equidistant from the tracking portion.

[0034] In some respects, each hole 500 along the splint body 200 is arranged to receive a sleeve 550 therein. In some cases, the sleeve 550 is made of a durable material, such as a metallic or ceramic material. In this way, for example, the sleeve 550 can be arranged as a drilling guide, for example, for drilling guide holes in the mandible / maxilla (i.e., during a dental procedure, the splint body 200 is placed against the mandible / maxilla, and guide holes are drilled using a suitable drill bit through the corresponding sleeves 550 disposed in the respective holes(one or more) 500). Once the guide holes(one or more) are drilled in the mandible / maxilla, fasteners such as fixing screws (not shown) can be advanced through the sleeves(one or more) 550 (e.g.). For example, sleeve 550 is arranged as a fastener guide and enters one or more guide holes in the mandible / maxilla to secure splint body 200 in place on the patient's mandible / maxilla. Those skilled in the art will understand that sleeve 550 is optional, as the hole 500 / splint body 200 itself can be constructed and arranged to achieve the function and / or purpose of sleeve 550 relative to the drill guides and / or fastener guides disclosed herein. In any case, splint assembly 100 is secured to the mandible / maxilla during dental procedures using the disclosed fasteners.

[0035] In some cases, the tool calibration device 1000 engages with the clamp body 200 or the tracking portion 600, wherein the tool calibration device 1000 is configured in a predetermined manner relative to the motion mount 700. The tool calibration device 1000 may be constructed as, for example, a receiving portion or other suitable surface feature for receiving an end effector (e.g., a drill tip) of a surgical instrument attached to a surgical robot. In some cases, the tool calibration device 1000 is integrally formed with a specific component of the clamp assembly 100, or in other cases, the tool calibration device may 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 1000 is in a known configuration relative to the motion mount 700, the tool calibration device 1000 provides confirmation or calibration, i.e., precise tracking of the end effector relative to the surgical robot, for surgical procedures when interacting with the end effector of the surgical robot. In some cases, the tool calibration device 1000 is radiopaque, allowing its configuration relative to the motion mount 700 to be determined and / or confirmed by imaging analysis.

[0036] In other cases, the reference marker element 900 (for example, see...) Figure 1BThe reference marker element 900 is received by a recess (not shown) defined by the outer surface (e.g., convex surface 400) of the clamp body 200 or the tracking portion 600, wherein the reference marker element 900 is received in a predetermined configuration relative to the motion mounting portion 700. In certain aspects, the outer surface of the clamp device 100 defines a plurality of recesses arranged to receive corresponding plurality of reference marker elements 900. For example, in some aspects, the reference marker element 900 is spherical, the recess is hemispherical, or an elongated concave channel arranged to receive a spherical reference marker element 900. Once fixed to the corresponding recess, whether by interference fit (e.g., press fit), overmolding, or adhesive material (e.g., epoxy resin) provided with the recess, one or more reference marker elements 900 are substantially embedded within the clamp device 100. Furthermore, in some aspects, the recess is oriented such that the adhesive material (e.g., epoxy resin) is held in the recess, for example by gravity, at the position where the reference marker element 900 is fixed / embedded. Because the reference marker elements(s) 900 are radiopaque in some respects, they can be detected by imaging analysis (e.g., CT scans). Therefore, in certain cases, the reference marker elements(s) 900 are radiopaque and can be distinguished from the splint assembly 100 (e.g., made of plastic / polymer material), the sleeve 550 (e.g., made of metal or ceramic material), and the fasteners used to secure the splint assembly 200 to the patient. Since the reference marker elements(s) 900 are all embedded within the splint assembly 100, the field of view for imaging analysis (e.g., CT scans) can be reduced.

[0037] Benefiting from the description and accompanying drawings, those skilled in the art will conceive of many modifications and other embodiments of the invention described herein. Therefore, it should be understood that the embodiments of the invention are not limited to the specific embodiments disclosed, and various modifications and other embodiments are included within the scope of the invention. For example, Figure 2A and Figure 2B A top view and a side profile of a splint device 100 according to one aspect of this disclosure are schematically shown. This splint device is suitable for, for example, the middle portion of the maxilla or mandible of a patient who is completely or partially edentulous, and is arranged to provide reference markers and / or tracking markers for a surgical robot's guidance system. As shown, such a splint device 100 is configured similar to... Figure 1A and 1BIn the illustrated embodiment, the splint body 200 is configured to extend substantially symmetrically about an arcuate portion in each direction from a centerline toward a first end 200A and a second end 200B. Therefore, the centerline of the splint body 200 is configured to be applied to the middle portion of the mandible, wherein the first end 200A and the second end 200B extend substantially similarly in either direction around the mandible. Furthermore, a tracking portion 600 extends from the middle portion of the convex surface 400 of the splint body 200. Additionally, although not specifically described herein, Figure 2A and Figure 2B The embodiments shown may include previous information regarding Figure 1A and Figure 1B The listed elements, even without specific description, will be understood by those skilled in the art. Figure 2A and Figure 2B The image shows some of these listed elements.

[0038] Figure 2C It schematically shows the following based on Figure 2A and Figure 2B The splint device of a certain aspect of this disclosure is shown, wherein the first of such splint devices 100A is applied to the mandible, while the second of such splint devices 100B is inverted and applied to the maxilla. Regarding Figure 2A and Figure 2B In the illustrated embodiment, further attention is paid to the obtuse angle defined between the clamp body 200 and the tracking portion 600. In this respect, as Figure 2C As shown, when applied to the mandible or maxilla, the obtuse angle allows the tracking portion 600 to separate the patient's (lower or upper) lip when the splint body 200 is attached to the mandible or maxilla. For example, this configuration of the splint device would allow the patient to close their mouth and lips around the tracking portion 600, rather than keeping the lips separated.

[0039] Figure 3A and Figure 3B The diagram schematically illustrates a top and bottom view of a splint device according to another aspect of this disclosure, adapted for, for example, the middle portion of the maxilla in a patient who is completely or partially edentulous, and arranged to provide reference markers and / or tracking markers for a surgical robot's guiding system. More specifically, due to specific soft tissue anatomy surrounding the maxilla (e.g., the nasal ridge extending between the upper lip and the gingiva surrounding the middle portion of the maxilla), Figure 3A and 3BThe splint body 200 of the illustrated embodiment includes and defines a concave release portion 200C around a middle portion of the splint body 200 (e.g., the middle portion between a first end 200A and a second end 200B), the concave release portion being arranged to receive and accommodate the nasal spine therein. Therefore, in surgeries involving the maxilla, the concave release portion 200C provides a more comfortable splint device 100.

[0040] In other respects, Figure 3A and Figure 3B The illustrated embodiments are similar to Figure 2A and Figure 2B The illustrated embodiment, and even though it is indicated that it is particularly suitable for the maxilla, can also be inverted and applied to the mandible, as those skilled in the art will understand. Furthermore, if necessary or required, Figure 3A and Figure 3B The illustrated embodiments may also include, according to Figure 2A and Figure 2B The illustrated embodiment defines an obtuse angle between the clamp body 200 and the tracking portion 600. Furthermore, although not specifically described herein, Figure 3A and Figure 3B The embodiments shown may include previous information regarding Figure 1A-1B and Figure 2A-2B The described and enumerated elements, even if not specifically described, will be understood by those skilled in the art. Figure 3A and Figure 3B The image shows some of these listed elements. Figure 3C and Figure 3D It schematically shows the following based on Figure 3A and Figure 3B The splint device 100, which is applied to the maxilla according to a certain aspect of the present disclosure, is shown.

[0041] Furthermore, although the foregoing description and associated drawings describe exemplary 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 this 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 this disclosure. Although specific terms are used herein, they are used in a general and descriptive sense and not for limiting purposes.

[0042] It should be understood that while 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 used only 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 this 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.

[0043] As used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms, unless clearly stated otherwise herein. It should also be understood that when the terms “comprises,” “comprising,” “includes,” and / or “including” are used herein, they specify the presence of said features, integrals, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integrals, 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 splint device for guided robotic surgery, the device comprising: An arc-shaped clamp body having a first end and a second end, as well as opposing concave and convex surfaces, the clamp body defining a plurality of holes spaced apart between the first end and the second end, each hole extending between the concave and convex surfaces; A sleeve, which is received in each of the plurality of holes and arranged as a drilling guide or fastener guide; The tracking portion engages with the convex surface of the clamp body between the first end and the second end, such that at least one hole is provided between the tracking portion and each of the first end and the second end, the tracking portion extending outward from the convex surface; A motion mounting part, which engages with the tracking part; as well as A reference marking element is received in a recess defined by the outer surface of the clamp body, the reference marking element being received in a predetermined configuration relative to the motion mounting portion.

2. The apparatus according to claim 1, characterized in that, The sleeve is made of metal or ceramic materials.

3. The apparatus according to claim 1, characterized in that, The motion mounting part is integrally formed with the tracking part.

4. The apparatus according to claim 1, characterized in that, Includes a separating device that extends across the clamp body between adjacent holes, wherein the separating device is arranged to be cut to facilitate adjustment of the length of the clamp body.

5. The apparatus according to claim 4, characterized in that, The separating device includes a reduced cross-sectional thickness of the clamp body located between adjacent holes.

6. The apparatus according to claim 1, characterized in that, The reference marker element is spherical, and the recess is hemispherical or an elongated concave channel arranged to receive the spherical reference marker element.

7. The apparatus according to claim 1, characterized in that, The device includes a tool calibration device that engages with the clamp body or the tracking portion, and the tool calibration device is configured in a predetermined manner relative to the motion mounting portion.

8. The apparatus according to claim 1, characterized in that, The concave surface of the main body of the clamp is arranged to conform to the curvature of the mandible or the maxilla.

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