Head stability simulation system

Abstract

A head stabilization system that may be used to simulate a stabilized patient's head during a medical procedure includes a skull clip having an adapter assembly that selectively receives a computing device configured to execute an application. In a virtual reality environment, the skull clip is represented by a virtual skull clip and the patient head is represented by a virtual head of a virtual patient. Movement of the skull clip based on instructions or feedback from the application or non-guided use from the user is displayed on the display as movement of the virtual skull clip relative to the virtual head of the virtual patient. The application can also guide the user to manipulate the skull clip to achieve successful stabilization. The system can be used for education and training.

Description

priority

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

[0002] During certain medical procedures, it may be necessary or desirable to stabilize all or a portion of a patient so that the patient or a portion of the patient is immobile. In certain neurosurgical procedures, the stabilized portion may include the patient's head and / or neck. Certain devices and methods may be used to stabilize a portion of a patient. For example, a skull clamp is a type of head stabilization device that can be used to stabilize the patient's head and / or neck. The skull clamp is typically manually adjusted relative to the patient's skull to apply a sufficient amount of force on the skull to stabilize the patient. If the skull clamp is not correctly positioned relative to the skull, slippage may occur during the medical procedure, which may cause problems. Therefore, it is desirable to provide comprehensive education and training to users who may be responsible for applying head stabilization devices such as skull clamps to the patient's head during certain medical procedures. Although various head stabilization devices and methods of using them have been manufactured and used, it is believed that no one has manufactured or used the invention described herein before the inventor. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings in which like reference numerals represent like elements.

[0004] Figure 1 A front perspective view of an exemplary skull clamp for simulated patient stabilization is depicted.

[0005] Figure 2 Depicted Figure 1 Posterior perspective view of the skull clamp.

[0006] Figure 3 A front perspective view of another exemplary skull clamp for simulated patient stabilization is depicted.

[0007] Figure 4 Depicted Figure 3 Posterior perspective view of the skull clamp.

[0008] Figure 5 A front view of another exemplary skull clamp for simulated patient stabilization is depicted.

[0009] Figure 6 Depicted Figure 5 Posterior view of the skull clamp.

[0010] Figure 7 A schematic diagram depicting exemplary computing devices, applications, and connected devices that may be used with the skull clamps described herein.

[0011] Figure 8 and Fig. 9 A flow chart depicts an exemplary method of simulating a stable patient head using the applications and systems described herein.

[0012] Fig.10 Depicted is a schematic diagram of an exemplary physical skull clamp and an exemplary virtual skull clamp and virtual patient head shown on an exemplary display.

[0013] Fig.11 A view of a stabilized patient's head along with reference markers is depicted.

[0014] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be implemented in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it is understood that the invention is not limited to the precise arrangements shown. Detailed Description

[0015] The following description of some examples of the present invention should not be used to limit the scope of the present invention. Through the following description, other examples, features, aspects, embodiments and advantages of the present invention will become obvious to those skilled in the art, and the following description is by way of example, and is one of the best modes for implementing the present invention and envisioning. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and non-restrictive in nature.

[0016] I. Exemplary Skull Clamp with Adapter Assembly As described above, properly applying a skull clamp to a patient to stabilize them for a medical procedure is an important aspect of the overall medical procedure. Therefore, having the ability to simulate patient stabilization using a head fixation or stabilization device such as a skull clamp can be beneficial in training the user and planning strategies and techniques to be used during an actual procedure. The following sections and paragraphs describe an exemplary simulation system.

[0017] Figure 1-Figure 4An exemplary head stabilization simulation system 10 is illustrated, which includes a head fixation or stabilization device in the form of a skull clamp 100. The skull clamp 100 includes a frame 102 composed of a first arm 104 and a second arm 106. Each arm 104, 106 defines a corresponding upright portion 108, 110 and a transverse portion or base portion 112, 114. The first arm 104 and the second arm 106 are adjustable in their relative positions to change the space between them to accommodate patient heads of various sizes. For example, in this example, the skull clamp 100 includes a ratchet system that allows the first arm 104 and the second arm 106 to move closer together. The ratchet system of the skull clamp 100 also includes an actuator 105, which can be used to release or loosen the ratchet system so that the first arm 104 and the second arm 106 can be moved further away from each other.

[0018] The first arm 104 includes a stabilization assembly 116, and the second arm 106 includes a stabilization assembly 118. Each stabilization assembly 116, 118 is configured to receive at least one stabilization feature (not shown), which may be a skull pin in some examples, or a pad in some other examples. In addition, the skull clamp 100 can be configured to use a combination of stabilization feature types, i.e., some pins and some pads in the same use configuration. As will be appreciated by those of ordinary skill in the art, when the skull clamp 100 is used to stabilize the patient's head, the skull clamp 100 may be selectively connected to other structures, such as one or more of a swivel adapter, a base unit, an operating table, etc.

[0019] The skull clamp 100 also includes an adapter assembly 120 that is configured to selectively receive a computing device, such as the computing device 400 discussed later. The adapter assembly 120 can be connected to the skull clamp 100, and the connection can be a fixed or permanent connection or a selective connection, whereby the adapter assembly 120 can be selectively connected to the skull clamp 100. In a fixed or permanent connection arrangement, the adapter assembly 120 can be formed uniformly or integrally with the skull clamp 100. Figure 1 and Figure 2 In the example shown, the adapter assembly 120 is formed as part of the first arm 104 of the skull clamp 100. Figure 3 and Figure 4In the present example shown, the adapter assembly 120 is formed as part of the second arm 106 of the skull clamp 100. In other variations, one of ordinary skill in the art will recognize that the adapter assembly 120 can be detachable and reattachable to the skull clamp 100 at the first arm 104 or the second arm 106. Regardless of the connection method to the skull clamp 100, the adapter assembly 120 can be connected to the skull clamp 100 in a consistent and repeatable manner such that the position (i.e., coordinates in a three-dimensional system) and orientation (i.e., inclination or angulation about an axis in a three-dimensional system) of the adapter assembly 120 relative to the skull clamp 100 is known or defined.

[0020] In this example, the adapter assembly 120 includes a bracket 122 configured to hold or receive a computing device. The bracket 122 is configured to selectively hold the computing device in a consistent position relative to the skull clamp 100. In this manner, each time the computing device is connected to the bracket 122, the computing device is held by the bracket 122 in the same manner. In this example, to facilitate consistent installation or connection of the computing device to the bracket 122, there is a pair of fixed stops 124 located closest to the skull clamp 100, where the installed computing device will contact on one side, such as, for example, Figure 3 4 is shown with respect to the skull clamp 100 and the computing device 400. The position and orientation of the computing device relative to the skull clamp 100 is known or defined based on the known position and orientation of the adapter assembly 120, and the consistent and repeatable mounting of the computing device to the bracket 122 of the adapter assembly 120. In this way, the position and orientation of the computing device can be correlated with the position and orientation of the skull clamp 100.

[0021] As in Figure 1 and Figure 3 , the adapter assembly 120 is shaped or configured to include a void space 128 that provides access for a user to grasp the frame 102 of the skull clamp 100. In this manner, the user is able to hold and manipulate or move the skull clamp 100 as they would typically do in an actual procedure without interference from the adapter assembly 120. More specifically, in this example, the user is able to grasp the skull clamp 100 about the first arm 104 and the second arm 106 of the skull clamp 100 without interference from the adapter assembly 120.

[0022] In one example, the skull clamp 100 is manufactured by rapid prototyping or 3D printing, which may not be suitable for actual physical patient stabilization. In such an example, the adapter assembly 120 may be formed as part of a larger skull clamp 100. In some variations where the skull clamp 100 is a rapid prototype or 3D printed structure, various weights 126 may be added to the skull clamp 100 so that the skull clamp 100 may have the same or similar weight and feel as a skull clamp used in an actual patient stabilization procedure.

[0023] II. Exemplary Skull Clamp with Dual Adapter Assembly Figure 5 and Figure 6 Another exemplary head stabilization simulation system 12 is depicted including a skull clamp 200 that includes adapter assemblies 220, 221. In this example, the skull clamp 200 is the same as the skull clamp 100 described above, except that the skull clamp 200, rather than having only one adapter assembly, has a pair of adapter assemblies 220, 221. In this regard, the skull clamp 200 includes a frame 202 consisting of a first arm 204 and a second arm 206. Each arm 204, 206 defines a respective upright portion 208, 210 and a transverse portion or base portion 212, 214. The first arm 204 and the second arm 206 are adjustable in their relative positions to change the space between them to accommodate patient heads of various sizes. For example, in this example, the skull clamp 200 includes a ratchet system that allows the first arm 204 and the second arm 206 to move closer. The ratchet system of the skull clamp 200 also includes an actuator 205 that can be used to release or unfasten the ratchet system so that the first arm 204 and the second arm 206 can move further away from each other.

[0024] The first arm 204 includes a stabilization assembly 216, and the second arm 206 includes a stabilization assembly 218. Each stabilization assembly 216, 218 is configured to receive at least one stabilization feature (not shown), which may be a skull fixation pin in some examples, or a pad in some other examples. In addition, the skull clamp 200 can be configured to use a combination of stabilization feature types, i.e., some fixation pins and some pads in the same use configuration. As will be appreciated by those of ordinary skill in the art, when the skull clamp 200 is used to stabilize the patient's head, the skull clamp 200 may be selectively connected to other structures, such as one or more of a rotation adapter, a base unit, an operating table, etc.

[0025] With respect to the adapter assemblies 220, 221, each adapter assembly is configured to selectively receive a computing device, such as the computing devices 400, 401 discussed later. The adapter assembly 220 may be connected to the second arm 206 of the skull clamp 200, while the adapter assembly 221 may be connected to the first arm 204 of the skull clamp 200. In addition, the connection of the adapter assemblies 220, 221 to the skull clamp 200 may be a fixed or permanent connection or a selective connection, whereby either or both of the adapter assemblies 220, 221 may be selectively connected to the skull clamp 200. In a fixed or permanent connection arrangement, the adapter assemblies 220, 221 may be formed uniformly or integrally with the skull clamp 200. In yet other variations, one of ordinary skill in the art will recognize that the adapter assemblies 220, 221 may be detachable and reattachable to the skull clamp 200 at the respective first and second arms 204, 206. Regardless of the connection method with the skull clamp 200, the adapter assemblies 220, 221 can be connected to the skull clamp 200 in a consistent and repeatable manner so that the position (i.e., coordinates in a three-dimensional system) and orientation (i.e., tilt or angulation around an axis in a three-dimensional system) of each adapter assembly 220, 221 relative to the skull clamp 200 is known or defined.

[0026] In the present example, each adapter assembly 220, 221 includes a respective bracket 222, 223 configured to hold or receive a computing device. In the present example, bracket 222 receives computing device 400, while bracket 223 receives computing device 401. Brackets 222, 223 are configured to selectively retain respective computing devices 400, 401 in a consistent position relative to skull clamp 200. In this manner, computing devices 400, 401 are retained by respective brackets 222, 223 in the same manner each time computing devices 400, 401 are connected to respective brackets 222, 223. In the present example, to facilitate consistent installation or connection of computing devices 400, 401 to respective brackets 222, 223, each adapter assembly 220, 221 includes a pair of fixed stops 224, 225 positioned proximate to skull clamp 200, wherein as shown in FIG. Figure 5 As shown, the corresponding mounted computing devices 400, 401 will be in contact on one side. Based on the known position and orientation of each adapter assembly 220, 221, and the consistent and repeatable mounting of computing devices 400, 401 with the corresponding adapter assembly 220, 221, the position and orientation of computing devices 400, 401 relative to skull clamp 200 is known or defined. In this way, the position and orientation of computing devices 400, 401 can be related to the position and orientation of skull clamp 200.

[0027] In the case of a skull clamp 200 having dual adapter assemblies 220, 221 and two computing devices 400, 401, in some variations, the position and orientation of computing device 401 is known, for example, based on communications between computing devices 400, 401. For example, one computing device may be a primary computing device of initial position and orientation, while the other computing device may be a secondary computing device, where the position and orientation of the secondary computing device is determined relative to the primary computing device.

[0028] As described above, the skull clamp 200 includes the ability to adjust the width by changing the position of the first arm 204 and the second arm 206 relative to each other. A benefit of the skull clamp 200 having the dual adapter assemblies 220, 221 and the computing devices 400, 401 is that the width setting or configuration of the skull clamp 200 can be determined. For example, not only can the position and orientation of the skull clamp 200 be correlated with one or both of the computing devices 400, 401, but based on the communication between the computing devices 400, 401, the distance between them can be determined and correlated with the distance between the first arm 204 and the second arm 206, thereby indicating the width setting or configuration of the skull clamp 200.

[0029] As in Figure 5 and Figure 6 , the adapter assemblies 220, 221 are shaped or configured to each include a void space 228, 229 that provides access for a user to grasp the frame 202 of the skull clamp 200. In this manner, the user is able to hold and manipulate or move the skull clamp 200 as they would normally do in an actual procedure without interference from the adapter assemblies 220, 221. More specifically, in this example, the user is able to grasp the skull clamp 200 around the first arm 204 and the second arm 206 of the skull clamp 200 without interference from the adapter assemblies 220, 221.

[0030] With respect to manufacturing, in one variation, the skull clamp 200 is manufactured by rapid prototyping or 3D printing, which may not be suitable for actual physical patient stabilization. In such an example, the adapter assemblies 220, 221 may be formed as part of a larger skull clamp 200. In some variations where the skull clamp 200 is a rapid prototype or 3D printed structure, various weights 226 may be added to the skull clamp 200 so that the skull clamp 200 may have the same or similar weight and feel as a skull clamp used in an actual patient stabilization procedure.

[0031] III. Exemplary Computing Devices, Applications, and Connected Devices Figure 7A schematic diagram of an exemplary computing device 400 is shown. In some variations, computing device 401 is configured identically to computing device 400, and thus it should be understood that the following description of computing device 400 may apply equally to computing device 401.

[0032] like Figure 7 As shown, computing device 400 includes a power supply or supply 402, which is a battery in some instances. Computing device 400 also includes a processor 404, a memory 406, a storage device 408, and a display 410. In this example, display 410 is also used as an input device because display 410 is configured as a touch screen display. Computing device 400 also includes various sensors, such as GPS sensor 412, accelerometer 414, gyroscope 416, and magnetometer 418. Computing device 400 also includes a near field communication (NFC) tag 420 and a network device or adapter 422, which includes a cellular adapter, a Bluetooth adapter, and a Wi-Fi adapter, etc. Computing device 400 also includes one or more groups of instructions 424. In one example, a group of instructions 424 is locally stored on storage device 408 and / or memory 406, and includes operating system software for operating computing device 400. In such variations or other variations, another of the one or more sets of instructions 424 includes an application 500 as discussed further below.

[0033] Computing device 400 can be associated with connected device 426, which can be external to computing device 400 and connected to computing device 400 by wire or wireless connection. In one instance, exemplary connected device 426 includes external display 428. In one example, external display 428 is a monitor located remotely from computing device 400. In another example, connected device 426 includes glasses or goggles equipped with a display so that a user can wear the glasses or goggles and view content received from computing device 400 and displayed on the glasses or goggles. In yet another example, connected device 426 includes a separate computing device that can be detected and / or paired with computing device 400.

[0034] like Figure 7As shown, the application 500 is associated with the computing device 400. The application 500 includes a set of instructions that can be executed by the computing device 400. In some variations, the application 500 is a software application that can be installed locally on the computing device 400 and run from the computing device 400. In other variations, the application 500 is a software application that can be installed locally only in part and accessed and run from a location away from the computing device 400. In this way, the application 500 can be located in the cloud and is part of a cloud computing architecture, where all or part of the application 500 can be accessed via the Internet. In this example, the application 500 can be available on various mobile computing platforms (including Android and Apple), such as in the respective application stores of the various mobile computing platforms. Once downloaded from the application store to the computing device 400, the application 500 can be launched from the computing device 500. Launching the application 500 opens the simulation software, which is configured to operate with a head fixation or stabilization system such as the skull clamp 100, 200 described above.

[0035] Given the teachings herein, one of ordinary skill in the art will recognize various ways to use computing device 400 in conjunction with connected device 426 and application 500. In addition, one of ordinary skill in the art will recognize various ways to create computer executable code and / or instructions to perform the steps and processes of stable simulation described herein.

[0036] IV. Exemplary Uses Figure 8-Figure 10 10, 12 are shown as an exemplary use of the head stabilization simulation system 10, 12 described herein. It should be understood that although one or more exemplary uses are shown and described in sequence herein, this is for ease of explanation, and the exact order of the steps described herein may vary. First, reference is made to Figure 8 , at step 600, a user desiring to perform a head stabilization simulation launches application 500 from computing device 400. For an initial simulation, step 600 may include downloading and installing application 500 on computing device 400 in addition to executing application 500. For other repeated simulations, step 600 may simply include launching application 500 from computing device 400.

[0037] As application 500 is started, in some variations, options are presented to the user to input information about the stabilization simulation. In some variations, application 500 includes predefined information from which the user can select. Such predefined information can be in the form of a selection menu in a drop-down list, or presented in some other easily selectable manner. For example, step 602 involves selecting patient parameters. Among other things, patient parameters can include matters such as: the patient's position (i.e., prone, supine, lateral, etc.), the patient's anatomical details (i.e., weight, age, size, bone density, etc.) and the surgical target location (i.e., which range or area of ​​the patient's head or brain will be the operating site during surgery). Step 604 involves selecting surgical parameters. Among other things, these surgical parameters can include matters such as: the type of surgery and the planned path or trajectory to enter the desired surgical site. Step 606 involves selecting stabilization device parameters. These stabilization device parameters may include, among other things, items such as: the skull clamp model being used, the adapter assembly configuration (i.e., single adapter assembly or dual adapter assembly), stabilization features (i.e., fixation pin configuration and / or pad configuration), and any other equipment that will be used in the actual stabilization (i.e., rotation adapter, base unit, table adapter, operating table, etc.). Step 608 involves selecting a key process indicator (KPI) report. Based on the simulated stabilization performed, the key process indicator report will include metrics such as: surgeon ergonomic rating, patient positioning rating, device selection rating, time, etc. Step 610 involves selecting test or evaluation parameters. This can be an optional step (along with any of steps 602, 604, 608) to prepare for the evaluation of the user performing the stabilization simulation later. In some variations, step 610 involves determining a target or benchmark for each KPI. For example, a target or benchmark for the following items can be determined and set in application 500: surgeon ergonomic rating, patient positioning rating, device selection rating, and / or the time taken to complete the simulated stabilization. As discussed further below, using these target KPIs, the application 500 can evaluate the user's performance against these and output an overall score or rating regarding the user's performance.

[0038] With respect to the KPIs discussed above, when considering the surgeon ergonomics rating, certain objective information may be used to assign or determine the rating and / or target or benchmark. For example, in some cases, it is desirable that the path or trajectory taken during surgery is aligned with the direction of gravity. If the degree of alignment between the two is high, the KPI rating will be assigned a more ideal value, which may be a higher or lower number, depending on the method. For example, in one variation, a rating of 100 may be considered optimal (i.e., where 100 represents the minimum deviation between the path or trajectory and the direction of gravity), whereas in some other variations, a rating of 0 may be considered optimal (i.e., where 0 represents the minimum deviation between the path or trajectory and the direction of gravity). Other information or factors that may be considered in the surgeon ergonomics KPI rating are the quantity and quality of the field of view. For example, in the case where stabilization is achieved in a manner that maximizes or meets the minimum acceptable level of the field of view, a better KPI rating will be assigned (i.e., the stabilization device does not obstruct the surgeon's observation of the target surgical site). In addition, information such as the position and axis of the patient's head may also affect the field of view and / or the overall surgeon ergonomics rating.

[0039] In terms of the KPI of patient positioning rating, information about the final position and orientation of the patient is used to assess the risk of injury or trauma to the patient. The time the patient remains in a given position can also be a factor. In the case where the simulated stabilization results in a low risk of injury to the patient, a more ideal KPI rating is assigned. Conversely, in the case of a high risk of injury or trauma to the patient, a less ideal KPI rating is assigned. In an example where the stabilization features used include one or more skull fixation pins, the pinning rating can be an independent KPI or a factor incorporated into the KPI as a patient positioning rating. When considering the pinning rating, factors to be considered may include, among others: pinning geometry (i.e., whether there is a triangular pinning geometry), pinning position (i.e., whether two of the three pins are located below the skull equator; whether the pinning position avoids the forehead area that will leave a cosmetic scar and is hidden within the hairline) and the pinning depth relative to the bone structure (i.e., whether the insertion depth and the required force are suitable for the patient's given bone structure). Other factors or considerations of the pinning position include whether the pin is located in a safe zone. The safe zone is understood to be a location that avoids the following: vascular and neuronal structures in the head, and areas where the bones are fragile such that fracture or injury may occur when pinning the bones. The safe zone may also consider avoiding previous craniotomy defects, subcutaneous artificial or foreign structures, and the orbit and auricle. Other factors or considerations for pinning location include whether the pins of a 2-pin rocker stabilization assembly are placed first, followed by the contralateral single pin, whether the single pins are placed in an area of ​​​​the spinal bone, whether all pins avoid neurovascular structures as described above, whether the pins are placed in an equilateral triangle, whether two of the three pins are placed below the equator, and / or whether the penetration angle of the pin is 90 degrees or perpendicular to the skull. Fig.11 An exemplary stabilization device is depicted with markings illustrating a skull clamp and equatorial line 802 and triangular pinning geometry 804 as described above.

[0040] In terms of the KPI for device selection rating, the application 500 may include a library or database of suggested or recommended devices based on specific patient and procedure inputs. Based on this, when the user selects a device that matches the suggested or recommended device, a more ideal KPI rating will be assigned. Various other parameters that may be included in the application 500 will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0041] With the various parameters entered into the application 500, at step 612, the computing device 400 is mounted to the skull clamp 100, 200 via the corresponding adapter assembly 120, 220, 221. With the computing device 400 connected to the adapter assembly, at step 614, the simulation begins. Additionally, as described above, Figure 8The order of the steps depicted in the drawings is not fixed, such that the steps may occur in any order and need not be performed in the exact order shown.

[0042] refer to Fig. 9 and Fig.10 , at step 616, the user visualizes the virtual reality environment 700 on a display, which in one variation is the display 410 of the computing device 400. In other variations, the display may be a display external to the computing device 400, i.e., an eyeglass or goggle display, a remote monitor, etc. In the virtual reality environment 700 shown on the display, the user observes the virtual skull clamp 300 representing the physical skull clamp 100, 200. Additionally, the user observes the virtual representation 310 of the patient's head in the virtual reality environment 700.

[0043] At step 618, the user manipulates the physical skull clamp 100, 200 to change the position and / or orientation of the physical skull clamp. For example, the user will grasp the skull clamp 100 or the skull clamp 200 according to the setting and move the skull clamp to change the position of the skull clamp and / or change the orientation of the skull clamp. As described above, the change of position refers to the change of the three-dimensional coordinates in space, while the change of orientation refers to the change of the tilt or angulation around the axis in the three-dimensional system (i.e., the X-axis, Y-axis, and Z-axis defined by the skull clamp, for example).

[0044] At step 620 , the user visualizes the virtual reality environment 700 on a display to observe the movement of the virtual skull clamp 300 relative to the patient's virtual head 302 based on or mimicking the movement of the physical skull clamp 100 or skull clamp 200 , as the case may be.

[0045] At step 622, the application 500 is in an educational or training mode. In this mode, the user manipulates the position and / or orientation of the skull clamp 100 or the skull clamp 200 (as the case may be, which may depend on which skull clamp is being used). This manipulation is performed according to instructions from the application 500. In other words, in this educational or training mode of using the application 500, the application 500 instructs or guides the user how to manipulate the position and / or orientation of the skull clamp 100, 200 to achieve acceptable virtual patient stabilization or optimal virtual patient stabilization in the virtual reality environment 700.

[0046] At step 624, the application 500 is in a testing or evaluation mode. In this mode, the user's performance in performing virtual stabilization is evaluated. In this mode, the application 500 does not instruct or guide the user in a step-by-step manner as described above with respect to step 622. Instead, the application 500 monitors the user's movements using the skull clamp 100, 200 to achieve virtual stabilization, and can thereafter provide feedback as an output in a KPI report or the like. Similar to as described above, Fig. 9The order of the steps depicted in the drawings is not fixed, such that the steps may occur in any order and need not be performed in the exact order shown.

[0047] When the virtual skull clamp 300 is depicted within the virtual reality environment 700 based on the movement of the physical skull clamp 100, 200, such association and depiction is achievable because, as described above, the computing device 400 can be connected to the skull clamp 100, 200 at a known position and orientation relative to the skull clamp 100, 200. Based on this baseline or known initial position and orientation correlation between the computing device 400 and the skull clamp 100, 200, and with the computing device 400 mounted to the skull clamp 100, 200, when the computing device 400 having the various sensors described above is moved to change its position and / or orientation, the skull clamp 100, 200 will also undergo the same change in position and / or orientation. In addition, this data is an input to the application 500, so the virtual skull clamp 300 is depicted so that it simulates or mirrors the movement of the physical skull clamp 100, 200. As shown in the exemplary virtual reality environment 700, the virtual skull clamp 300 is shown without the adapter assembly to provide a more realistic visual experience, as an actual skull clamp used in an actual surgery may not include an adapter assembly. Various other ways of correlating and depicting the position and orientation of a physical skull clamp with a virtual skull clamp using application 500 and computing device 400 or similar applications and / or computing devices will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0048] V. Others It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any 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 isolated from each other. In view of the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0049] Various embodiments of the present invention have been shown and described, and further adjustments to the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the appended claims, and should be understood not to be limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A system for simulating a stable patient head, the system comprising: (a) Skull clamp; and (b) an adapter assembly connectable to the skull clamp at a defined position and orientation relative to the skull clamp, wherein the adapter assembly is configured to selectively receive a computing device configured to access an application for correlating a first position and a first orientation of the computing 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 use the skull clamp to stabilize a patient's head.

3. The system according to claim 2, wherein: The application enables depiction of the skull clamp and the second position and the second orientation of the skull clamp within a virtual reality environment, the virtual reality environment showing the second position and the second orientation of the skull clamp relative to a 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 without the adapter assembly that is part of or connected to the skull clamp.

5. The system according to any one of claims 1 to 4, wherein: The skull clamp includes a first arm and a second arm that 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 portion 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 includes two or more stabilization components, wherein each of the two or more stabilization components includes a stabilization feature configured to contact a 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 void space that allows a user to directly grasp a portion of the skull clamp without contacting the adapter assembly.

9. The system according to any one of claims 1 to 4, wherein: The computing device includes a processor, a set of executable instructions, a memory configured to store the set of executable instructions, and a display, wherein 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) the computing device selectively connectable to the adapter assembly; and (d) The application accessible from the computing device, wherein the application includes simulation software for simulating the use of the skull clamp to stabilize a patient's head.

11. The system of any one of claims 1 to 4, further comprising a display in communication with the computing device, wherein: The display is configured to depict a virtual reality environment in which the skull clamp and the patient's head are virtually represented, and movement of the skull clamp is correlated to movement of the skull clamp virtually represented in the virtual reality environment.

12. A system for simulating a stable patient head, the system comprising: (a) Skull clamp; and (b) a pair of adapter assemblies connectable to the skull clamp at respective first defined positions and first defined orientations relative to the skull clamp and second defined positions and second defined orientations relative to the skull clamp, wherein a first adapter assembly of the pair of adapter assemblies is configured to selectively receive a first computing device, the first computing device being configured to access an application for correlating the first position and first orientation of the first computing device with the second position and second orientation of the skull clamp, and wherein a second adapter assembly of the pair of adapter assemblies is configured to selectively receive a second computing device, the second computing device being configured to communicate with the first computing device.

13. The system according to claim 12, wherein: The second computing device is configured to access the application for correlating a third position and a third orientation of the second computing device with the second position and the second orientation 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 computing device with the third position and the third orientation of the second computing device.

15. The system of claim 14, wherein: The skull clamp includes a first arm and a second arm, wherein a correlation of the first position and the first orientation of the first computing device with the third position and the third orientation of the second computing device indicates a distance between the first arm and the second arm of the skull clamp.

16. The system of claim 15, wherein: 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.

17. A system according to any one of claims 12 to 16, wherein: The application enables depiction of the skull clamp and the second position and the second orientation of the skull clamp within a virtual reality environment, the virtual reality environment showing the depicted second position and the second orientation of the skull clamp relative to a patient's head.

18. The system according to any one of claims 12 to 16, wherein: The skull clamp includes two or more stabilization components, wherein each of the two or more stabilization components includes a stabilization feature configured to contact a 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 portion of the first adapter assembly of the pair of adapter assemblies is integrally formed with the first arm, and at least a portion 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 of the adapter assemblies defines a void space that allows a user to directly grasp the skull clamp without contacting the adapter assembly.

21. The system of claim 17, wherein: The depiction of the skull clamp in the virtual reality environment shows the skull clamp without the adapter assembly that is part of or connected to the skull 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 simulating stabilizing a patient's head using a skull clamp having an adapter assembly, the method comprising the steps of: (a) launching an application from a computing device, wherein the application includes simulation software for stabilizing a patient's head; (b) installing the computing device using the adapter assembly; (c) visualizing a virtual reality environment on a display to observe a virtual skull clamp represented by the skull clamp and to observe a virtual head of a virtual patient; (d) manipulating the skull clamp; (e) visualizing the virtual reality environment on the display to observe movement of the virtual skull clamp relative to the virtual head of the virtual patient that mimics movement of the skull clamp; and (f) manipulating the skull clamp according to the applied instructions to achieve a desired position and orientation of the virtual skull clamp relative to the virtual head of the virtual patient, thereby achieving virtual stabilization.

24. The method of claim 23, further comprising selecting stable device parameters within the application.

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

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

27. The method of any one of claims 23 to 25, further comprising selecting a KPI report within the application.

28. The method of any one of claims 23 to 25, further comprising selecting a test or assessment parameter within the application.

Images