Head stabilization simulation system

Abstract

A head stabilization system that can be used for simulations to stabilize a patient's head during a medical procedure includes a head clamp with an adapter assembly that selectively accepts a computer device configured to execute an application. In a virtual reality environment, the head clamp is represented by a virtual head clamp, and the patient's head is represented by the virtual head of a virtual patient. Movements of the head clamp based on instructions or feedback from the application, or use without user guidance, are displayed on a display as movements of the virtual head clamp relative to the virtual head of the virtual patient. The application can also guide the user to operate the head clamp to achieve stabilization. This system can be used for education and training.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 342,309, filed May 16, 2022, entitled "Head Stabilization Simulation System," the disclosure of which is incorporated herein by reference.

Background Art

[0002] During certain medical procedures, it may be necessary or desirable to immobilize the entire body or a part of a patient so as to keep the patient or the part of the patient stationary. In certain neurological procedures, the part to be immobilized may include the patient's head and / or neck. Certain devices and methods can be used to immobilize a particular part of a patient. For example, a skull clamp is a type of head fixation device that can be used to fix a patient's head and / or neck. A skull clamp is typically manually adjusted with respect to the patient's skull and applies sufficient force to the skull to immobilize the patient. If the skull clamp is not correctly positioned with respect to the skull, displacement may occur during a medical procedure, causing problems. Therefore, it is desirable to provide appropriate education and training to users who may be responsible for attaching a head fixation device such as a skull clamp to a patient's head during certain medical procedures. Various head stabilization devices and methods of using them have been manufactured and used, but prior to the present inventor(s), no one has made or used an invention as described herein.

Brief Description of the Drawings

[0003] This specification concludes with claims that particularly point out and distinctly claim the invention. The invention, however, is better understood from the following detailed description of certain embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements.

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[0004] The drawings are not limiting in any sense, and it is envisioned that the various embodiments of the present invention can be implemented in a variety of other ways including ways not necessarily shown in the drawings. The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate some aspects of the present invention and are useful in explaining the principles of the present invention in conjunction with the description. However, it is understood that the present invention is not limited to the exact arrangements shown.

DETAILED DESCRIPTION OF THE INVENTION

[0005] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which illustrates one of the best modes contemplated for carrying out the present invention. It is understood that the present invention is capable of other different and distinct aspects without departing from the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0006] I. Exemplary Skull Clamp with Adapter Assembly As mentioned above, properly applying a skull clamp to a patient to stabilize the patient during a medical procedure is an important aspect of the entire medical procedure. Therefore, having a function to simulate patient stabilization using a head fixation or stabilization device such as a skull clamp is useful not only for user training but also for planning surgical strategies and techniques to be used during an actual procedure. The following sections and paragraphs will describe an exemplary simulation system.

[0007] FIGS. 1-4 show an exemplary head stabilization simulation system 10 including a head fixation or stabilization device in the form of a skull clamp 100. The skull clamp 100 includes a frame 102 consisting of a first arm 104 and a second arm 106. Each arm 104, 106 defines an upright portion 108, 110 and a lateral or base portion 112, 114, respectively. The first and second arms 104, 106 are adjustable in relative position to change the space between them to accommodate the heads of patients of various sizes. For example, in this example, the skull clamp 100 includes a ratchet system that can bring the first arm 104 and the second arm 106 closer to each other. This ratchet system of the skull clamp 100 further includes an actuator 105 that can be used to release or disengage the ratchet system to allow the first arm 104 and the second arm 106 to move further apart from each other.

[0008] The first arm 104 includes a stabilization assembly 116, and the second arm 106 includes a stabilization assembly 118. Each of the stabilization assemblies 116, 118 is configured to receive at least one stabilization function (not shown), which is, in some examples, a cranial pin and, in some other examples, a pad. Further, the cranial clamp 100 may be configured to use a combination of stabilization function types, i.e., some pins and some pads, in the same usage configuration. As will be understood by those skilled in the art, the cranial clamp 100 is selectively connectable to other structures such as one or more swivel adapters, a base unit, an operating table, etc. when used to stabilize a patient's head.

[0009] The cranial clamp 100 also includes an adapter assembly 120 configured to selectively receive a computer device such as the computer device 400 described below. The adapter assembly 120 is connectable to the cranial clamp 100, and this connection can be either a fixed or permanent connection or a selective connection such that the adapter assembly 120 can be selectively connected to the cranial clamp 100. In the case of a fixed or permanent connection, the adapter assembly 120 can be configured integrally or as a single unit with the cranial clamp 100. In the present example shown in FIGS. 1 and 2, the adapter assembly 120 is formed as part of the first arm 104 of the cranial clamp 100. In FIGS. 3 and 4, the adapter assembly 120 is formed as part of the second arm 106 of the cranial clamp 100. In still other embodiments, it will be understood by those skilled in the art that the adapter assembly 120 is removable and reattachable from the cranial clamp 100 at either the first arm 104 or the second arm 106. Regardless of the connection means to the cranial clamp 100, the adapter assembly 120 is connectable to the cranial clamp 100 in a consistent and repeatable manner such that the position (i.e., the coordinates of the three-dimensional system) and orientation (i.e., the tilt or angle around the axes of the three-dimensional system) of the adapter assembly 120 relative to the cranial clamp 100 are known or defined.

[0010] In this example, the adapter assembly 120 includes a cradle 122 configured to hold or receive a computer device. The cradle 122 is configured to selectively hold the computer device in a fixed position relative to the cranial clamp 100. In this way, when the computer device is connected to the cradle 122, it is held in the same manner by the cradle 122. In this example, a set of fixed stops 124 are disposed at a position closest to the cranial clamp 100 so that the computer device can be attached or connected to the cradle 122 in a fixed position, where, for example, as shown in FIG. 3, the cranial clamp 100 and the computer device 400 are connected to each side respectively. Based on the known position and orientation of the adapter assembly 120 and the ability to consistently attach the computer device to the cradle 122 of the adapter assembly 120 in the same position, the position and orientation of the computer device relative to the cranial clamp 100 become known or defined. In this way, the position and orientation of the computer device can be associated with the position and orientation of the cranial clamp 100.

[0011] As best shown in FIGS. 1 and 3, the adapter assembly 120 is formed or configured to include a void 128 that provides access for a user to grasp the frame 102 of the cranial clamp 100. In this way, the user can hold, manipulate, or move the cranial clamp 100 as normally done in an actual procedure without being interfered with by the adapter assembly 120. More specifically, in this example, the user can grasp the first and second arms 104, 106 of the cranial clamp 100 without being interfered with by the adapter assembly 120.

[0012] In one example, the skull clamp 100 is manufactured by rapid prototyping or 3D printing, which may not be suitable for use in physically stabilizing an actual patient. In such an example, the adapter assembly 120 can be formed as part of a larger skull clamp 100. If the skull clamp 100 is a rapid prototype or 3D printed structure, various weights 126 can be added to the skull clamp 100 to give the skull clamp 100 a weight and feel that is the same as or similar to that of a skull clamp used in an actual patient stabilization procedure.

[0013] II. Exemplary Skull Clamp with Dual Adapter Assembly FIGS. 5 and 6 show another exemplary head stabilization simulation system 12 that includes a skull clamp 200 that includes adapter assemblies 220, 221. In this example, the skull clamp 200 is identical to the skull clamp 100 described above, except that instead of having one adapter assembly, it has a pair of adapter assemblies 220, 221. In this regard, the skull clamp 200 includes a frame 202 that is composed of a first arm 204 and a second arm 206. Each arm 204, 206 defines an upright portion 208, 210 and a lateral or base portion 212, 214, respectively. The first and second arms 204, 206 are adjustable in their relative positions and can change the space therebetween to accommodate the heads of patients of various sizes. For example, in this example, the skull clamp 200 includes a ratchet system that can bring the first arm 204 and the second arm 206 closer to each other. This ratchet system of the skull clamp 200 also includes an actuator 205 that can be used to release or disengage the ratchet system to allow the first arm 204 and the second arm 206 to be moved further apart from each other.

[0014] The first arm 204 includes a stabilization assembly 216, and the second arm 206 includes a stabilization assembly 218. Each of the stabilization assemblies 216, 218 is configured to accommodate at least one stabilization function (not shown), which in some examples is a cranial pin and in some other examples is a pad. Further, the cranial clamp 200 may be configured for a combination of stabilization function types, i.e., using some pins and some pads in the same usage configuration. As will be understood by those skilled in the art, the cranial clamp 200 is selectively connectable to one or more other structures such as a swivel adapter, a base unit, an operating table, etc. when used to stabilize a patient's head.

[0015] Regarding the adapter assemblies 220, 221, each is configured to selectively receive a computer device such as the computer devices 400, 401 described later. The adapter assembly 220 is connectable to the second arm 206 of the cranial clamp 200, and the adapter assembly 221 is connectable to the first arm 204 of the cranial clamp 200. Further, the connection between the adapter assemblies 220, 221 and the cranial clamp 200 can be either a fixed or permanent connection, or a selective connection where either or both of the adapter assemblies 220, 221 are selectively connectable to the cranial clamp 200. In the case of a fixed or permanent connection, the adapter assemblies 220, 221 can be formed integrally or singly with the cranial clamp 200. In yet other aspects, it will be understood by those skilled in the art that the adapter assemblies 220, 221 are removable and reattachable from the cranial clamp 200 at their respective first arm 204 and second arm 206. Regardless of the connection means to the cranial clamp 200, the adapter assemblies 220, 221 can be connected to the cranial clamp 200 in a repeatable manner at the same location, so that the position (i.e., coordinates within a three-dimensional system) and orientation (i.e., tilt or angle around an axis within a three-dimensional system) of each adapter assembly 220, 221 relative to the cranial clamp 200 are known or defined.

[0016] In this example, each adapter assembly 220, 221 includes respective cradles 222, 223 configured to hold or receive a computer device. In this example, cradle 222 houses computer device 400 and cradle 223 houses computer device 401. Cradles 222, 223 are configured to selectively hold respective computer devices 400, 401 in a fixed position relative to the skull clamp 200. In this way, computer devices 400, 401 are held in the same manner by their respective cradles 222, 223 each time the computer devices 400, 401 are connected to their respective cradles 222, 223. In this example, to enable computer devices 400, 401 to be attached or connected to their respective cradles 222, 223 in the same position, each adapter assembly 220, 221 includes a pair of fixed stops 224, 225 located at the position closest to the skull clamp 200, and the attached computer devices 400, 401 contact on one side, as shown in FIG. 5. Based on the known position and orientation of each adapter assembly 220, 221 and the repeatable attachment of computer devices 400, 401 to the same position on each adapter assembly 220, 221, the position and orientation of computer devices 400, 401 relative to the skull clamp 200 are known or defined. In this way, the position and orientation of computer devices 400, 401 can be associated with the position and orientation of the skull clamp 200.

[0017] The cranial clamp 200 includes dual adapter assemblies 220, 221 and two computer devices 400, 401. In some embodiments, the position and orientation of computer device 401 are recognized based on communication between computer devices 400, 401. For example, one computer device can be a primary computer device having an initial position and an initial orientation, and the other computer device can be a secondary computer device whose position and orientation are determined with reference to the primary computer device.

[0018] As described above, the cranial clamp 200 includes a function of adjusting the width by changing the relative positions of the first arm 204 and the second arm 206. The advantages of the cranial clamp 200 provided with dual adapter assemblies 220, 221 and computer devices 400, 401 are that the width setting or configuration of the cranial clamp 200 can be determined. For example, not only can the position and orientation of the cranial clamp 200 be associated with one or both of the computer devices 400, 401, but also based on the communication between the computer devices 400, 401, the distance between them can be determined and associated with the distance between the first arm 204 and the second arm 206 to set or configure the width of the cranial clamp 200.

[0019] As best shown in FIGS. 5 and 6, the adapter assemblies 220, 221 are formed or configured such that each includes a void 228, 229, whereby a user can grasp the frame 202 of the cranial clamp 200. In this way, the user can hold, operate, or move the cranial clamp 200 as normally done in an actual procedure without being interfered with by the adapter assemblies 220, 221. More specifically, in this example, the user can grasp the first and second arms 204, 206 of the cranial clamp 200 without being interfered with by the adapter assemblies 220, 221.

[0020] Regarding manufacturing, in one aspect, the skull clamp 200 is manufactured by rapid prototyping or 3D printing, but this may not be suitable for use in physically stabilizing an actual patient. In such an example, the adapter assemblies 220, 221 can be formed as part of a larger skull clamp 200. If the skull clamp 200 is a rapid prototype or 3D printed structure, various weights 226 can be added to the skull clamp 200 to make the weight and feel of the skull clamp 200 the same or similar to that of a skull clamp used in an actual patient stabilization procedure.

[0021] III. Exemplary Computer Devices, Applications, and Connecting Devices FIG. 7 shows a schematic diagram of an exemplary computer device 400. It should be understood that the computer device 401 is configured in some aspects in the same manner as the computer device 400, so the following description regarding the computer device 400 also applies equally to the computer device 401.

[0022] As shown in FIG. 7, computer device 400 includes a power source or supply 402, which may be a battery in some cases. Computer device 400 also includes a processor 404, a memory 406, a storage 408, and a display 410. In this example, since display 410 is configured as a touch screen display, it also functions as an input device. Computer device 400 also includes various sensors such as a GPS sensor 412, an accelerometer 414, a gyroscope 416, and a magnetometer 418. Computer device 400 also includes a network device or adapter 422 that includes, among other things, a near field communication (NFC) tag 420, as well as a cellular phone adapter, a Bluetooth adapter, and a Wi-Fi adapter. Computer device 400 also includes one or more instruction sets 424. In one example, one instruction set 424 is stored locally in storage 408 and / or memory 406 and is composed of operating system software for operating computer device 400. In such an embodiment or other embodiments, another set of one or more instruction sets 424 is configured as an application 500, as further described below.

[0023] Computer device 400 can be associated with a connection device 426 that is external to computer device 400 and is connected to computer device 400 either wired or wirelessly. In one example, an exemplary connection device 426 is composed of an external display 428. In one example, external display 428 is a monitor located at a location remote from computer device 400. In another example, connection device 426 includes glasses or goggles with a display, and the user can wear the glasses or goggles to display the content received from computer device 400 and displayed on the glasses or goggles. In yet another example, connection device 426 includes another computer device that may be capable of detecting and / or pairing with computer device 400.

[0024] As shown in FIG. 7, application 500 is associated with computer device 400. Application 500 is composed of a series of instructions executable on computer device 400. In some embodiments, application 500 is a software application that can be installed locally on computer device 400 and executed from computer device 400. In other embodiments, application 500 is a software application that is only partially installed locally and can be accessed and executed from a location remote from computer device 400. Thus, application 500 is deployed in the cloud and becomes part of a cloud computing architecture, and all or part of application 500 can be accessed via the Internet. In this example, application 500 is available on various mobile computing platforms such as Android and Apple, for example, in their respective app stores. When application 500 is downloaded from the app store to computer device 400, it can be launched from computer device 500. When application 500 is launched, simulation software configured to operate in conjunction with a head fixation or stabilization system such as the above-described cranial clamps 100, 200 is opened.

[0025] Considering the teachings herein, one of ordinary skill in the art will understand various ways of using computer device 400 in combination with connection device 426 and application 500. Further, one of ordinary skill in the art will understand various ways of creating computer-executable code and / or instructions for performing the stabilization simulation steps and processes described herein.

[0026] IV. Exemplary Use Figures 8 through 10 illustrate exemplary usage of the head stabilization simulation systems 10, 12 described herein. Although exemplary usage is shown and described in order herein, this is for convenience of explanation, and it should be understood that the exact order of the steps described herein may vary. Referring first to FIG. 8, a user desiring to perform a head stabilization simulation, in step 600, launches application 500 from computer device 400. For an initial simulation, step 600 may include, in addition to execution of application 500, downloading and installation of application 500 onto computer device 400. For other repeated simulations, step 600 may include only launching application 500 from computer device 400.

[0027] When the application 500 is launched, depending on the embodiment, an option to input information regarding the stabilization simulation may be presented to the user. Depending on the embodiment of the application 500, it includes predefined information that the user can select. Such predefined information is in the form of a selection menu in a drop-down list or is presented in another easily selectable form. For example, at step 602, patient parameters are selected. This includes the patient's posture (prone position, supine position, lateral position, etc.), the patient's anatomical details (weight, age, size, bone density, etc.), the location of the surgical target (which area or part of the patient's head or brain will be the surgical site during the operation), and the like. At step 604, procedure parameters are selected. This includes the type of procedure, the planned route or trajectory for accessing the target surgical site, and the like. At step 606, parameters of the stabilization device are selected. These include, among other things, the skull clamp model being used, the adapter assembly configuration (single adapter assembly or dual adapter assembly), the stabilization function (pin configuration and / or pad configuration), and other devices actually used for stabilization (swivel adapter, base unit, table adapter, operating table, etc.). At step 608, a key performance indicator (KPI) report is selected. Based on the simulated stabilization that has been performed, it includes indicators such as the ergonomic evaluation of the surgeon, the patient positioning evaluation, the device selection evaluation, and time. At step 610, test or evaluation parameters are selected. This may be an optional step (along with any of steps 602, 604, 608) as preparation for later evaluating the user who performs the stabilization simulation. In some embodiments, at step 610, the goal or benchmark for each KPI is determined. For example, goals or benchmarks regarding the ergonomic evaluation of the surgeon, the patient positioning evaluation, the device selection evaluation, and / or the time taken to complete the simulated stabilization can be determined and set in the application 500.As will be further described below, using these target KPIs, application 500 can evaluate a user's performance against them and output an overall score or assessment of the user's performance.

[0028] Regarding the KPIs described above, when considering the ergonomic evaluation of a surgeon, specific objective information can be used to assign or determine evaluations and / or targets or benchmarks. For example, in some cases, it may be desirable for the path or trajectory taken during the surgery to align with the direction of gravity. When there is a high degree of alignment between these two, a more desirable value, which may result in a high or low numerical value depending on the approach, is assigned to the KPI evaluation. For example, in one aspect, an evaluation of 100 may be considered the best (i.e., 100 represents the minimum deviation between the path or trajectory and the direction of gravity). However, in other aspects, an evaluation of 0 may be considered the best (i.e., 0 represents the minimum deviation between the path or trajectory and the direction of gravity). Other information or elements that can be considered in the ergonomic KPI evaluation of a surgeon are the amount and quality of the field of view. For example, when stabilization is achieved in a way that maximizes the field of view or meets a minimum acceptable level (i.e., the stabilization device does not obstruct the surgeon's view of the surgical site), a better KPI evaluation is assigned. Additionally, information such as the position and axis of the patient's head can also affect the field of view and the overall ergonomic evaluation of the surgeon.

[0029] Regarding the KPIs for patient positioning assessment, information regarding the patient's final position and orientation is used to evaluate the risk of patient injury or trauma. The length of time the patient is maintained in a particular position may also be a factor. When the risk of patient injury is low due to simulated stabilization, a more desirable KPI assessment is assigned. Conversely, when the risk of patient injury or trauma is high, a less desirable KPI assessment is assigned. In one example where the stabilization function used consists of one or more skull pins, the pinning assessment can be either a stand-alone KPI or incorporated as a factor within the KPIs for patient positioning assessment. When considering the pinning assessment, elements to consider include the pinning shape (i.e., whether a triangular pinning shape exists), the position of the pins (i.e., whether two of the three pins are located below the line dividing the skull into two hemispheres, i.e., whether the position of the pins avoids the area of the forehead that would leave a cosmetic scar rather than being hidden within the hairline), and the depth of the pinning into the bone structure (whether the insertion depth and required force are suitable for the patient's specific bone structure). Other elements or considerations regarding the position of the pins include whether the pins are within a safe area. The safe area is understood to be a position that avoids vulnerable areas where there may be blood vessels and nerve structures in the head, as well as bones where fractures or damage may occur when pinning the bone. In the safe area, it is also considered to avoid previous craniotomy defects, subcutaneous artificial or foreign structures, and the orbits and auricles. Other factors or considerations regarding the pinning position include whether the pins of the two-pin locker arm stabilization assembly are placed first and then a single pin on the opposite side, whether a single pin is placed in an area of raised bone, whether all pins avoid the neurovascular structure as described above, whether the pins are placed in a triangle on the same side, whether two of the three pins are placed below the cranial hemisphere, and / or whether the penetration angle of the pins is 90 degrees or perpendicular to the skull. FIG. 11 shows an exemplary stabilization marked with a skull clamp 802 and a triangular pinning shape 804 as described above.

[0030] Regarding the KPIs for machine selection evaluation, application 500 can include a library or database of machines proposed or recommended based on the input of specific patients and procedures. Based on this, if the user selects a machine that matches the proposed or recommended machine, a more desirable KPI evaluation is assigned. Considering the teachings of this specification, various other parameters that can be included in application 500 will be apparent to those skilled in the art.

[0031] When the various parameters described above are input into application 500, at step 612, computer device 400 is attached to cranial clamps 100, 200 via respective adapter assemblies 120, 220, 221. When computer device 400 is connected to the adapter assembly, the simulation is started at step 614. Further, as described above, the order of the steps shown in FIG. 8 is not fixed, and the steps can be executed in any order and do not need to be executed exactly in the order shown.

[0032] Referring to FIGS. 9 and 10, at step 616, the user visualizes the virtual reality environment 700 on the display. This display is, in one example, the display 410 of computer device 400. In other examples, this display is a display external to computer device 400, i.e., the display of glasses or goggles, a remote monitor, etc. In the virtual reality environment 700 displayed on the display, the user observes the virtual cranial clamps 300 representing the physical cranial clamps 100, 200. Further, the user observes the virtual representation of the patient's head 310 in the virtual reality environment 700.

[0033] In step 618, the user operates the physical cranial clamps 100, 200 to change their position and / or orientation. For example, the user grasps the cranial clamp 100 or the cranial clamp 200 according to the setting, and moves the cranial clamp to change its position and / or orientation. As described above, the change in position refers to the change in spatial three-dimensional coordinates, and the change in orientation refers to the axes in the three-dimensional system, that is, the X, Y, and Z axes, for example, the change in the inclination or angle around the X, Y, and Z axes defined by the cranial clamp.

[0034] In step 620, the user visualizes the virtual reality environment 700 on the display and observes the movement of the virtual cranial clamp 300 relative to the virtual head of the patient 302 based on or imitating the movement of the physical cranial clamp 100 or the cranial clamp 200 according to the situation.

[0035] In step 622, the application 500 is in the education mode or the training mode. In this mode, the user operates the position and / or direction of the cranial clamp 100 or the cranial clamp 200 according to the cranial clamp being used. This operation is performed according to the instructions from the application 500. In other words, in this education mode or training mode using the application 500, the application 500 instructs or guides the user on how to operate the position and / or direction of the cranial clamps 100, 200 in order to achieve acceptable virtual patient stabilization or optimal virtual patient stabilization in the virtual reality environment 700.

[0036] In step 624, the application 500 is in a test or evaluation mode. In this mode, the performance of the user who performs virtual stabilization is evaluated. In this mode, the application 500 does not step - by - step instruct or guide the user as described above with respect to step 622. Instead, the application 500 can monitor the movements that the user makes with the cranial clamps 100, 200 to achieve virtual stabilization and then provide feedback as an output such as a KPI report. Similarly, as described above, the order of the steps shown in FIG. 9 is not fixed, the steps can be executed in any order, and it is not necessary to execute them exactly in the order shown.

[0037] When depicting the virtual skull clamp 300 within the virtual reality environment 700 based on the movement of the physical skull clamps 100, 200, such a correlation and depiction are feasible as described above because the computer device 400 can be connected to the skull clamps 100, 200 at known positions and orientations with respect to the skull clamps 100, 200. Based on this baseline or the correlation of the known initial positions and orientations between the computer device 400 and the skull clamps 100, 200, when the computer device 400 is attached to the skull clamps 100, 200 and the computer device 400 is moved with the various sensors described above and the position and / or orientation changes, the same changes in position and / or orientation are reflected in the skull clamps 100, 200. Further, this data is an input to the application 500, and the virtual skull clamp 300 is drawn to mimic or reflect the movement of the physical skull clamps 100, 200. As shown in the exemplary virtual reality environment 700, since the actual skull clamps used in the actual procedure may not include an adapter assembly, the virtual skull clamp 300 is shown without an adapter assembly to provide a more realistic visual experience. Considering the teachings herein, various other ways of correlating the position and orientation of the physical skull clamp to the virtual skull clamp and depicting it using the application 500 and the computer device 400 or similar applications and / or computer devices will be apparent to those skilled in the art.

[0038] V. Others It should be understood that one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered independently of each other. Various suitable ways of combining the teachings described herein will be readily apparent to those skilled in the art in view of the teachings described herein. Such modifications and changes are intended to be included within the scope of the claims.

[0039] Although various embodiments of the present invention have been shown and described, those skilled in the art can further adapt the methods and systems described herein by making appropriate changes without departing from the scope of the present invention. Some of such potential changes have been mentioned, but other changes will be obvious to those skilled in the art. For example, the examples, embodiments, shapes, materials, dimensions, ratios, steps, etc. described above are illustrative and not essential. Therefore, the scope of the present invention should be considered from the perspective of the following claims, and it is understood that it is not limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A system for simulating the stabilization of a patient's head, comprising: (a) a skull clamp; (b) an adapter assembly connectable to the skull clamp at a defined position and orientation relative to the skull clamp, the adapter assembly being configured to selectively receive a computer device configured to access an application for correlating a first position and a first orientation of the computer device with a second position and a second orientation of the skull clamp;

2. The system according to claim 1, wherein the application is configured to educate or train a user to stabilize the patient's head using the skull clamp.

3. The system according to claim 2, wherein the application enables depiction of the skull clamp and the second position and the second orientation within a virtual reality environment showing the second position and the second orientation of the skull clamp relative to the patient's head.

4. The system according to claim 3, wherein the depiction of the skull clamp in the virtual reality environment shows the skull clamp with the adapter assembly not being part of the skull clamp or the adapter assembly not being connected to the skull clamp.

5. The system according to any one of claims 1 to 4, wherein the skull clamp comprises a first arm and a second arm, and the first arm and the second arm are adjustable relative to each other to adjust a distance between the first arm and the second arm.

6. The system according to any one of claims 1 to 4, wherein at least a part of the adapter assembly is integrally formed with the skull clamp.

7. The system according to any one of claims 1 to 4, wherein the skull clamp comprises two or more stabilization assemblies, and each of the two or more stabilization assemblies has a stabilization function configured to contact the patient's head to stabilize the patient's head.

8. The system according to any one of claims 1 to 4, wherein the adapter assembly defines a space that enables the user to directly grasp a part of the skull clamp without contacting the adapter assembly.

9. The system according to any one of claims 1 to 4, wherein the computer device includes a processor, a set of executable instructions, a memory configured to store the set of executable instructions, and a display, and the set of executable instructions provides access to the application.

10. The system according to any one of claims 1 to 4, further comprising (c) a computer device selectively connectable to the adapter assembly, and (d) an application accessible from the computer device, the application including simulation software for simulating stabilizing the patient's head using the skull clamp.

11. The system according to any one of claims 1 to 4, further comprising a display communicating with the computer device, the display being configured to depict a virtual reality environment in which the skull clamp and the patient's head are virtually represented, and the movement of the skull clamp correlating with the movement of the skull clamp virtually represented in the virtual reality environment.

12. A system for simulating stabilization of a patient's head, (a) a skull clamp, and (b) a pair of adapter assemblies connectable to the skull clamp at a first defined position and a first defined direction, and at a second defined position and a second defined direction with respect to the skull clamp, respectively, wherein a first adapter assembly of the pair of adapter assemblies is configured to selectively receive a first computer device configured to access an application for correlating a first position and a first direction of the first computer device with a second position and a second direction of the skull clamp, and a second adapter assembly of the pair of adapter assemblies is configured to selectively receive a second computer device configured to communicate with the first computer device.

13. The system according to claim 12, wherein the second computer device is configured to access an application for correlating a third position and a third direction of the second computer device with the second position and the second direction of the skull clamp.

14. The system according to claim 13, wherein the application is configured to correlate the first position and the first orientation of the first computer device with the third position and the third orientation of the second computer device.

15. The system according to claim 14, wherein the skull clamp includes a first arm and a second arm, and the correlation between the first position and the first direction of the first computer device and the third position and the third direction of the second computer device indicates a distance between the first arm and the second arm of the skull clamp.

16. The system according to claim 15, wherein the first arm and the second arm are adjustable relative to each other so as to adjust the distance between the first arm and the second arm.

17. The system according to any one of claims 12 to 16, wherein the application enables depiction of the cranial clamp and the second position and the second direction in a virtual reality environment showing the second position and the second direction of the cranial clamp with respect to the depiction of the patient's head.

18. The system according to any one of claims 12 to 16, wherein the cranial clamp comprises two or more stabilization assemblies, and each of the two or more stabilization assemblies has a stabilization function configured to contact the patient's head to stabilize the patient's head.

19. The system according to any one of claims 15 to 16, wherein at least a part of the first adapter assembly of the pair of adapter assemblies is integrally formed with the first arm, and at least a part of the second adapter assembly of the pair of adapter assemblies is integrally formed with the second arm.

20. The system according to any one of claims 12 to 16, wherein each adapter assembly defines a space that enables the user to directly grasp the cranial clamp without contacting the adapter assembly.

21. The system according to claim 17, wherein the depiction of the cranial clamp in the virtual reality environment shows the cranial clamp in a state where the adapter assembly is part of the cranial clamp or not connected to the cranial clamp.

22. The system according to any one of claims 12 to 16, wherein the skull clamp is a rapid prototype or 3D printed skull clamp.

23. A method of performing a simulation to stabilize a patient's head using a skull clamp with an adapter assembly, the method comprising the following steps. (a) Launch the application including simulation software for stabilizing the patient's head from a computer device. (b) Attach the computer device using the adapter assembly. (c) Visualize a virtual reality environment on a display, observe a virtual skull clamp represented by the skull clamp, and observe a virtual head of a virtual patient. (d) Operate the skull clamp. (e) Visualize the virtual reality environment on a display and observe the movement of the virtual skull clamp simulating the movement of the skull clamp with respect to the virtual head of the virtual patient. (f) Operate the skull clamp according to instructions of the application to achieve a desired position and orientation of the virtual skull clamp with respect to the virtual head of the virtual patient and achieve virtual stabilization.

24. The method according to claim 23, further comprising selecting parameters of a stabilization device within the application.

25. The method according to claim 24, further comprising selecting patient parameters within the application.

26. The method according to any one of claims 23 to 25, further comprising selecting procedure parameters within the application.

27. The method according to any one of claims 23 to 25, further comprising selecting a KPI report within the application. Claim 28 A method according to any one of claims 23 to 25, further comprising selecting test or evaluation parameters within said application.

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