System for visualization including organic and inorganic materials

Abstract

A system for visualizing organic and inorganic materials includes an inorganic data file of an inorganic material (e.g., an Implant), a viewing device, and a visualization. The image guided procedure includes, for example, a medical procedure. The system includes harmonization of the at least one inorganic data file of the inorganic material, and at least one image file of the organic material (e.g., patient or subject), and / or one or more of: the organic material (e.g., patient or subject), at least one image data of a comparative organic material (e.g., patient or subject), and a physical model of the organic material and / or inorganic material. The system includes configuring the inorganic data file to include at least one of a surface and at least one negative space.

Description

SYSTEM FOR VISUALIZATION INCLUDING ORGANIC AND INORGANIC MATERIALSCROSS REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This application claims priority to U.S. provisional patent application serial number 63 / 727,464, filed on December 3, 2024, the contents of which are incorporated in their entirety herein.BACKGROUND

[0002] Medical interventions often require invasive procedures. Medical imaging is often used to guide these procedures; these are called image-guided procedures (“IGPs”) and include abscess aspirations, minimally invasive as well as ‘open’ surgical resections, biopsies and many others. Commonly, the medical imaging modalities computer assisted tomography (“CT”) and a magnetic resonance imaging (“MRI” scan (CT and MRI are collectively referred to as “Scans”) scans are evaluated prior to and during a procedure in order to direct the clinician’s procedure. The underlying goal is to achieve the desired intervention, such as but not limited to: a resection, biopsy, or aspiration of a structure, such that there is minimal disruption to other tissues.

[0003] Invasive medical procedures that require precise approaches rely on imaging to relate the location and relationships between internal structures to the clinician in a meaningful way. Current technologies for this purpose are severely limited, leaving image-guided procedures still within the realm of “guessing” to some extent. The imaging modalities commonly used for image-guided procedures include a Scan. Despite the fact that the images are obtained three-dimensionally, the limitations of previous viewing devices allows for only two-dimensional viewing. These images are visualized as two-dimensional ‘slice’ images and during an image-guided procedure are displayed on a screen physically separate from the patient. This requires the operator to perform the mental process of first re-constructing a three-dimensional image from the series of two- dimensional images and then secondly, mentally superimposing that image onto the patient in order to determine the trajectory of his approach. This process results in inaccuracy and sub- optimal patient outcomes.

[0004] Within the last few decades CT and MRI scanners have developed the ability to acquire the images in true three-dimensional fashion. That is to say, during a CT scan, the patient moveshorizontally through the sensors in the ‘donut’ at the same time that the sensors are moving circularly within the ‘donut.’ This is distinctly different from previous generations of scanners in which the patient moved horizontally through the ‘donut’ incrementally after each revolution of the sensors. The current generation result is a singe data set that represents a single three- dimensional object as opposed to a series of two-dimensional data sets that can be stacked to represent a three-dimensional object. This single, virtual three-dimensional object (“VTDO”) could only be represented as a ‘planar, 2D image’ on a TV screen because a modality to view three- dimensional images in space did not exist; the volume would then be ‘sliced’ into multiple two- dimensional images that are viewed sequentially. With the advent of extended reality devices (including virtual reality, augmented reality and mixed reality), however, a VTDO can now be viewed in a true three-dimensional viewing format.

[0005] Despite the advancement of extended reality devices and VTDO, use of these devices in the medical world requires continued development. For instance, utilizing extended reality devices in training medical personnel fails to tether the information gathered from the scanning technology (e.g., CT or MRI) with the patient. In addition, accuracy remains an issue, in terms of registration, precision with respect to the location and size of incisions during procedures with respect to removal of tissue (e.g., necrotic or otherwise dysfunctional tissue), installation of a prosthetic, implant or foreign body, and / or removal of a prosthetic, implant, or foreign body, and other technological imperfections. Furthermore, patients / subjects suffer discomfort during procedures (e.g., surgical procedures) and / or lack trust and / or comfort prior to procedures (e.g., surgical procedures) as during the pre-procedure meeting, the pati ent / subject is unable to visualize and / or fully appreciate the capabilities of the technology during a medical procedure [by the medical professional and the patient],

[0006] Beyond the medical world, there is a need to be able to more easily correlate a first file of an inorganic material (e.g., an inanimate object, a man-made object) and a second file of an organic material (e.g., an object such as a once living organism).

[0007] Accordingly, it would be desirous to alleviate the aforementioned challenges by way of an improved system, method and apparatus for educational and / or clinical use.SUMMARY

[0008] A system for visualizing inorganic and organic materials is provided. The system includes a data fde of an inorganic material (e.g., a component or substance, an object, an implant, prosthetic, device, model, other foreign body, etc.) and an organic material (e.g., a living organism, a patient, a subject, etc.) The system includes one or more reference images, preferably one or more three-dimensional reference images. The system includes at least one data (e.g., design) fde regarding the inorganic material (e.g., the at least one inorganic data fde), a viewing device, and may include an image data regarding an organic material. The viewing device provides a visualization of the at least one inorganic data fde. The at least one inorganic data fde is harmonized (e.g., through the visualization) with the organic data fde. A surface or surface model (e.g., a surface) of the at least one inorganic data fde is harmonized (e.g., through the visualization) with the at least one organic image data fde. The surface, through the visualization, harmonizes negative space of the at least one inorganic data fde with the at least one organic material image data. In further embodiments, such visualization is further harmonized with the organic material from or similar to the organic material that is the subject of the at least image data fde, and / or a physical model of or similar to the inorganic material that the at least one inorganic data fde was generated from, and / or a physical model of or similar to the organic material that the at least one organic material data fde was generated from in order to assist a user of the visualization in correspondence to the inorganic material and / or organic material represented in vivo or in vitro, or by way of a physical organic material, or by way of a physical inorganic material model.

[0009] In some embodiments, at least one inorganic data fde includes a surface. The surface is configured from, for instance, the inorganic data fde (e.g., the CAD or schematic of the prosthetic, implant, device, etc.) by software and / or inputs from a user. Said differently, a user, through an interface device (and / or viewing device), manipulates the at least one inorganic data file (e.g., the CAD or schematic) and resects-out the body of the inorganic material subject of the at least one inorganic data fde, thereby leaving the perimeter of the inorganic material, or in other words, the surface. The manipulation of the at least one inorganic data fde by the user can be one or more direct and discrete entries or commands entered into interface device (and / or viewing device), and / or could be a pre-programmed command that the software in concert with the controller and the interface device (and / or viewing device) is programmed to execute and then performs / executes the command. Such creation of the surface can be done to the at least one inorganic data fde prior to submitting such at least one inorganic data fde into the system for visualizing inorganic andorganic materials. Alternatively, such creation of the surface can be done after the at least one inorganic data file is submitted into the system for visualizing inorganic and organic materials. In this latter embodiment, the surface may be configured through the use of registration through the viewing device (and / or interface device).

[0010] In some embodiments, at least one inorganic data file includes a negative space. The negative space is configured from, for instance, the inorganic data file (e.g., the CAD or schematic of the prosthetic, implant, device, etc.) by software and / or inputs from a user. Said differently, a user, through an interface device (and / or viewing device), manipulates the at least one inorganic data file (e.g., the CAD or schematic) and resects-out the body of the inorganic material subject of the at least one inorganic data file, and fills in that resected-out body and filled to be opaque, semitransparent, or transparent, and may further include a filter or other visual marker, or in other words, the negative space. The manipulation of the at least one inorganic data file by the user can be one or more direct and discrete entries or commands entered into interface device (and / or viewing device), and / or could be a pre-programmed command that the software in concert with the controller and the interface device (and / or viewing device) is programmed to execute and then performs / executes the command. Such creation of the negative space can be done to the at least one inorganic data file prior to submitting such at least one inorganic data file into the system for visualizing inorganic and organic materials. Alternatively, such creation of the negative space can be done after the at least one inorganic data file is submitted into the system for visualizing inorganic and organic materials. In this latter embodiment, the negative space may be configured through the use of registration through the viewing device (and / or interface device).

[0011] In some embodiments, the at least one inorganic data file includes a surface and a negative space. In some of these embodiments, either or both of the surface and the negative space may be created and configured within the at least one inorganic data file prior to submitting the at least one inorganic data file into the system for visualizing inorganic and organic materials. In some of these embodiments, either or both of the surface and the negative space may be created and configured to the at least one inorganic data file after the at least one inorganic data file is submitted into the system for visualizing inorganic and organic materials. In this latter embodiment, either or both of the surface and the negative space may be configured through the use of registration through the viewing device (and / or interface device).

[0012] For clarity, in some embodiments, both of the surface and the negative space are created and configured within the at least one inorganic data file prior to submitting the at least one inorganic data file into the system for visualizing inorganic and organic materials. For clarity, in some embodiments, both of the surface and the negative space are created and configured within the at least one inorganic data file after submitting the at least one inorganic data file into the system for visualizing inorganic and organic materials. For clarity, in some embodiments, the surface is created and configured within the at least one inorganic data file prior to submitting the at least one inorganic data file into the system for visualizing inorganic and organic materials, and the negative space is created and configured to the at least one inorganic data file after submitting the at least one inorganic data file to the system for visualizing inorganic and organic materials. For clarity, in some embodiments, the negative space is created and configured within the at least one inorganic data file prior to submitting the at least one inorganic data file into the system for visualizing inorganic and organic materials, and the surface is created and configured to the at least one inorganic data file after submitting the at least one inorganic data file to the system for visualizing inorganic and organic materials. For clarity, in some embodiments, the surface and the negative space is created and configured within the at least one inorganic data file prior to submitting the at least one inorganic data file into the system for visualizing inorganic and organic materials, and thereafter, either or both of the surface and negative space may be further modified or configured, by the user and / or through a program in concert with the controller, viewing device (and / or interface device) such as through registration.

[0013] A system for visualizing organic and inorganic materials is provided. The system includes procedures with one or more reference images, preferably one or more three-dimensional reference images. The procedure is an in vivo procedure and includes, for instance, organic material such as a patient or subject and / or an in vitro procedure including, for instance, inorganic material. Such procedures include a prosthetic, implant, device, or other foreign body. The system includes at least one data (e.g., design) file regarding a prosthetic, implant, device, or other foreign body (e.g., the at least one inorganic data file), a viewing device, may include a patient or subject, may include a medical professional or trainee, may include a user of the viewing device, may include image data regarding a patient or subject, and may include a physical model. The viewing device provides a visualization of the at least one inorganic data file regarding the prosthetic, implant, device, or other foreign body. The at least one inorganic material file of the prosthetic, implant,device, or other foreign body, is harmonized (e.g., through the visualization) with the patient or subject. A surface of the at least one inorganic data fde of the prosthetic, implant, device, or other foreign body, is harmonized (e.g., through the visualization) with the at least one image data of the patient or subject. The surface, through the visualization, harmonizes negative space of the prosthetic, implant, device, or other foreign body, with the at least one image data and the patient / subject and / or physical model in order to assist a user of the visualization to position the prosthetic, implant, device, or other foreign body within the patient / subject.

[0014] The visualization may further include an image data of the patient or subject thereby creating one or more reference images (such as one or more three-dimensional reference images). The at least one image data of the patient or subject is also harmonized with the at least one inorganic data file of the prosthetic, implant, device, or other foreign body, and may also include the patient or subject or a physical model of or similar to the prosthetic, implant, device, or other foreign body, and / or of or similar to the patient or subject.

[0015] The system enables in vitro procedures in addition to in vivo procedures, as described in greater detail below. A physical model is a three-dimensional physical model that is generated from the at least one image data and / or the at least one inorganic data file and is printed by a three- dimensional printing apparatus. As such, the physical model is a three-dimensionally printed model.

[0016] One or more controllers are utilized to select, transmit and may also process or configure the inorganic data file, and / or image data file. The controller utilizes one or more types of algorithms optionally in the form of software to facilitate the aforementioned inorganic data file. In embodiments including image data, the controller may also utilize one or more types of algorithms optionally in the form of software to facilitate the aforementioned image data collection, transmission, segmentation, generation of a visualization. In embodiments including a physical model, the controller utilizes one or more types of algorithms optionally in the form of software to facilitate the aforementioned generation of a physical model in addition to the visualization.

[0017] Regarding the inorganic data file, the one or more controllers may select, transmit and / or process or configure the at least one inorganic data file, where the processing may be external tothe viewing device or may be internal to the viewing device. The processing may include user inputs by way of the viewing device and / or an interface device. Where the processing is external to the viewing device, the one or more controllers may transfer the at least one inorganic data file to the viewing device. The processing and / or configuration of the at least one inorganic data file may include user defined selections such as segmentation and / or registration.

[0018] Regarding, for example, the image data, the one or more controllers transfer the at least one image data and / or at least one inorganic data file to a three-dimensional printing apparatus. One or more controllers transfer the at least one image data and / or at least one inorganic data file to a viewing device. The at least one image data is segmented by way of user inputs to the controller, an interface device or a viewing device

[0019] Other techniques to refine the inorganic data file (and in certain embodiments the at least one image data) include registration, volume rendering, and windowing, which can be done by way of a controller, an interface device or a viewing device.

[0020] The viewing device includes a screen such as a monitor and / or is optionally a wearable device. The viewing device may have extended reality capability. The at least one image data may include a VTDO.

[0021] The aforementioned will be described in greater detail below, including apparatus’, processes, and / or other terminology useful in appreciating the same.

[0022] The imaging device is capable of obtaining image data such that a three-dimensional image can be generated. The imaging device is thusly, at minimum, a camera, or a plurality of cameras configured to create a three-dimensional image. The imaging device is optionally a medical imaging device. The imaging device is optionally capable of three-dimensional scanning technology such as a CT scanner or an MRI machine. Imaging devices are discussed in greater detail below.

[0023] The at least one image data that is obtained from an imaging device such as a CT scanner or MRI machine is called a volume, represents a three-dimensional object and that object can be said to be made up of voxels. A voxel is the representation of a point in space and is the three- dimensional analogue of a pixel; each voxel has four values: “x”, “y” and “z” which describe itslocation within a Cartesian coordinate system, and “p” which describes its appearance in some way (color or gray tone).

[0024] When viewing a scan in a two-dimensional platform, all the pixels within a given two- dimensional plane are usually depicted; the appearance of each pixel on a screen relative to each other can be varied by a process called “windowing” in which contrast and brightness settings are adjusted to make certain pixel values more evident. The same process can be applied to a volume (the three-dimensional image data from a scan) in a process called “volume rendering”.

[0025] Volume rendering is distinct from segmentation. In segmentation, specific voxels are selected from the overall volume and those voxels are grouped into a new three-dimensional volume, called a model. By devising specific parameters for selecting which voxels are included in the model, specific anatomic and histologic structures can be isolated from the scan volume and depicted as individual structures themselves. Segmentation software allows a user to select specific structures depicted within a scan by defining algorithms that set appropriate parameters for different structures. The result is the ability to pull specific body parts, such as bones, blood vessels or specific tissues, organs, organ systems, etc., out of the CT scan and view them as individual three-dimensional structures. In certain embodiments, machine learning algorithms are utilized. The output file from a segmentation program represents a new VTDO, depicting a specific set of anatomic structures from the scan.

[0026] This output file - the at least one image data- is transferred to a controller with one or more algorithms. The controller and such one or more algorithms include appropriate software systems and hardware. The controller transfers the image data to the three-dimensional printing apparatus to create a physical model such as a three-dimensionally printed model (“TDPM”) of the anatomic structures.

[0027] The at least one inorganic data file (and in certain embodiments, the at least one image data) is optionally a VTDO. The VTDO is optionally configured into a three dimensional object (“TDO”) by either the controller or the three-dimensional printing apparatus.

[0028] In some embodiments, the at least one image data, VTDO, or TDO are utilized by the three- dimensional printing apparatus to create the physical model (e.g., TDPM) representative of theinformation received from the object that underwent the imaging device and / or the scanning technology (e.g., CT or MRI).

[0029] The controller transfers the inorganic data file (and in certain embodiments, the at least one image data) into the viewing device to create a visualization. The visualization is an image. The visualization is optionally a three-dimensional image. The visualization is optionally a VTDO. The VTDO is optionally configured into an optical three-dimensional object (“OTDO”) by the controller. In certain embodiments having the at least one image data, VTDO or OTDO is a manifestation of the information received from the object that underwent the scanning technology (e.g., CT or MRI).

[0030] A viewing device is provided and enables a user to see (e.g. visualize) a manifestation of the inorganic data file (and in certain embodiments, the at least one image data), the VTDO, or the OTDO. The inorganic data file (and in certain embodiments, the at least one image data) is in a suitable file format such that a visualization for the user is provided. The viewing device is optionally an interface device, or other devices as contemplated herein, including monitors (e.g., screens) and extended reality devices.

[0031] An interface device provides a visualization of the information (e.g., the at least one image data) to a user, where such visualization is a manifestation of the inorganic data file (and in certain embodiments, the at least one image data) by way of a VTDO or OTDO. The interface device is optionally interactive such that the user is able to input information and / or request information from or with the device. The interface device optionally has a graphical user interface (“GUI”), or is otherwise able to receive inputs from a user and / or provide outputs / information to the user, by way of a touchpad, mouse, stylus, a user’s digit, dictation, body movement, etc. Accordingly, an interface device is optionally also a viewing device.

[0032] Extended reality (“XR”) is an inclusive term, used to refer to all modalities that involve user immersion to the point of creation of a ‘new reality’ . Virtual reality (“VR”), augmented reality (“AR”) and mixed reality (“MR”) are all types of XR. VR hardware devices and software applications are commercially available. VR requires the user to be ‘in a black box’, seeing only the computer-generated reality with no sense of the external (real world) reality. In an AR platform, the user sees the external reality (either through clear lens glasses or external videocameras projecting to the user’s eyes) as well as the computer-generated reality. In true AR, however, the computer-generated images are superficially added to the external reality, with no meaningful interaction between the computer images and the real world. AR devices are limited and not widely commercially available. In MR, the hardware device gains spatial awareness and is able to topographically survey and interpret the surrounding environment. With this ability, computer generated images can be placed truly ‘within’ the external reality, providing a dramatic effect. MR requires the capabilities of an AR device and there are a small number of hardware devices becoming available that are specifically designed for MR use.

[0033] In an MR environment, computer generated images can recognize objects in the real world; through a process called registration, a computer-generated object can be ‘linked’ to a stationary object in the real world in a specific scale and orientation. The computer-generated image will then remain in the correct position, orientation and scale, regardless of the position of the viewer. In the case of medical scans, models can be created via segmentation from organic material (e.g., a patient or subject) scan to depict a specific structure, such as the skeleton. When the model and the organic material (e.g., a patient or subject) are then viewed through a mixed reality device, the model can be registered to the organic material (e.g., a patient or subject) to orient the internal structures in the correct anatomical position relative to the actual organic material (e.g., a patient or subject). This harmonization of the model on the organic material (e g., a patient or subject) achieves a level of virtual “x-ray” vision.

[0034] The inorganic data file) is configured into a VTDO. With regard to image data, a scan as contemplated herein may be used to create an image data, or optionally a VTDO.

[0035] The VTDO is optionally modified into an OTDO in order to generate (e.g., manifest) a visualization through a viewing device.

[0036] In embodiments including a physical model, the VTDO is modified into a three- dimensional object (“TDO”) in order to generate (e.g., create or build) a physical model such as a TDPM of substantially identical components (e.g., where the VTDO is of image data of an organic material, such TDPM may include substantially identical anatomical components as the organic material itself is the subject of the image data file).

[0037] The VTDO is generated and represents a subset structure. Optionally, the subset structure is an internal structure of the object that is a subject to the scan that is the target of the procedure. Such an object is, as a non-limiting example, at least a portion of organic material (e.g., a patient, or subject) and / or inorganic material (e.g., an implant, prosthetic, device, or other foreign body). The OTDO (or other suitable fde and in a suitable file format) is generated and represents additional external structure to allow for accurate registration. In certain embodiments, the OTDO is generated and represents the external structure of the object (e.g., organic material such as a patient or subject, inorganic material such as an implant, prosthetic, other foreign body, an object such as a medical instrument, etc.) that is the subject to the scan. In certain embodiments, the OTDO is generated and represents the internal structure of the object that is the subject to the scan. In certain embodiments, the OTDO is generated and represents both the internal and external structure of the object that is the subject to the scan. The OTDO is informative to the investigation of the object and potential procedures related thereto. The physical model such as a TDPM contains the identical structures, but also contains an overlying layer of structures (e.g., a first material, a second material, tissue systems such as skin, organ surface, etc.) that obfuscate viewing the targeted internal structures by way of, for instance, the naked eye. The OTDO is visualized through an appropriate XR (e.g., MR or AR) reality headset.

[0038] Using any number of available registration techniques, numerous embodiments are provided. For instance, a first OTDO of an inorganic material (e.g., implant or prosthetic) is harmonized with a second OTDO of an organic material (e.g., a patient or subject). For instance, an OTDO (e.g., the first OTDO and / or the second OTDO) may be harmonized with the organic material (e.g., patient or subject) and / or in certain embodiments, the physical model such as a TDPM in at least a sufficiently correct orientation and scale. In certain embodiments, an OTDO (e.g., the first OTDO and / or the second OTDO) may be harmonized with the patient or subject and / or in certain embodiments, the physical model such as a TDPM in precisely the correct orientation and scale. The user can utilize the visualization during a medical procedure (e g., an examination, a biopsy, a surgery, an arthroplasty, etc.), where the one or more OTDO’s is(are) by virtue of harmonization a visual guide. The user can utilize the visualization and perform a pre- surgical plan, including, for example, a mock procedure, on the physical model such as a TDPM, where the one or more OTDO’s operate as a visual guide (e.g., by harmonization).

[0039] The term “harmonized” refers to the notion of being able to co-locate a first OTDO with a second OTDO, an OTDO with an inorganic material, an OTDO with an organic material, and / or an OTDO with a physical model, such that when one or more OTDO’s manipulated by an operator of the viewing device and / or interface (or as in some embodiments, more specifically the XR viewing device or interface associated therewith) and the user views the visualization through the viewing device, the visualization (e.g., manifestation) of the one or more OTDO‘s (optionally in concert with the organic material, inorganic material, and / or a physical model at any location of the one or more OTDO’s. Such harmonization is done with at least one of precise co-location of the one or more OTDO’s (optionally in concert with the organic material, inorganic material, and / or a physical model. In certain embodiments, the precision of the co-location of the one or more OTDO’s (optionally in concert with the organic material, inorganic material, and / or a physical model) is at least 80%, or at least 90%. In certain embodiments, the accuracy of the colocation of the one or more OTDO’s (optionally in concert with the organic material, inorganic material, and / or a physical model) is at least 80%, or at least 90%. In such fashion, the OTDO is visualized as an overlay and / or superimposition onto another OTDO (and / or optionally in concert with the organic material, inorganic material, and / or a physical model) such that the operator of the viewing device is able to manipulate the viewing device and / or interface device in order to see a specific portion of the one or more OTDO’s, where such specific portion of the one or more OTDO’s representing inorganic material and / or organic material may not be, without the one or more OTDO’s viewable to the naked eye.

[0040] According to one aspect of the present disclosure, a system for visualizing organic and inorganic materials is provided. The system includes at least one inorganic data file. The at least one inorganic data file regards or correlates to an inorganic material, or at least one inorganic material.

[0041] The system includes one or more viewing devices. The one or more viewing devices is(are) configured to display a visualization of the at least one inorganic material with the at least one inorganic data file harmonized with at least one of an organic material, at least one image data file, and a physical model.

[0042] The system includes the visualization of the inorganic material having a surface of the inorganic material.

[0043] In any of the aspects or embodiments described above or herein, the system may further include a surface having a partition. The partition defines a first surface and a second surface. The partition separates a first surface and a second surface.

[0044] In any of the aspects or embodiments described above or herein, the surface includes a first perimeter. The surface further includes a second perimeter.

[0045] In any of the aspects or embodiments described above or herein, the surface includes a first perimeter that is in an outer perimeter. The surface further including a second perimeter is the partition.

[0046] In any of the aspects or embodiments described above or herein, the surface includes a first visual marker.

[0047] In any of the aspects or embodiments described above or herein, the surface further includes a second visual marker. The second visual marker is different from the first visual marker.

[0048] In any of the aspects or embodiments described above or herein, the first visual marker corresponds to a first surface. The second visual marker corresponds to a second surface.

[0049] In any of the aspects or embodiments described above or herein, the first surface and the second surface are separated by the partition.

[0050] In any of the aspects or embodiments described above or herein, the surface includes at least one negative space. The at least one negative space regards or correlates to an interior region of the Implant.

[0051] In any of the aspects or embodiments described above or herein, the inorganic data file is configured by a user and / or software. The inorganic data file may be configured prior to the inorganic data file being submitted into the system. The inorganic data file may be configured after being submitted into the system. The inorganic data file may be configured before being submitted into the system and after being submitted into the system.

[0052] The inorganic data file may be configured to include a surface and / or at least one negative space. Each or both of the surface and the at least one negative space may be configured before being submitted into the system and / or after being submitted into the system.

[0053] In any of the aspects or embodiments described above or herein, the at least one inorganic material includes an interior region. The at least one negative space is associated with the interior region.

[0054] In at least one aspect according to the present disclosure, a system for visualizing organic and inorganic materials is provided. The system includes at least one inorganic data file. The at least one inorganic data file regards or correlates to an inorganic material, or at least one inorganic material.

[0055] The system includes one or more viewing devices. The one or more viewing devices is(are) configured to display a visualization of the at least one inorganic material with the at least one inorganic data file harmonized with at least one of an organic material, at least one image data file, and a physical model.

[0056] The system includes the visualization of the inorganic material having at least one negative space of the inorganic material.

[0057] In at least one aspect according to the present disclosure, the at least one negative space is defined by at least one first perimeter. The at least one negative space is further defined by at least one second perimeter.

[0058] In at least one aspect according to the present disclosure, the at least one first perimeter is an outer perimeter. The at least one second perimeter is an inner perimeter.

[0059] In at least one aspect according to the present disclosure, the at least one negative space includes a partition defining a first negative space and a second negative space. The partition separates a first surface and a second surface.

[0060] In at least one aspect according to the present disclosure, the first perimeter is an outer perimeter. The second perimeter is the partition.

[0061] In at least one aspect according to the present disclosure, the at least one negative space includes a first visual marker.

[0062] In at least one aspect according to the present disclosure, the at least one negative space includes a second visual marker. The second visual marker is different from the first visual marker.

[0063] In at least one aspect according to the present disclosure, the first visual marker corresponds to a first negative space. The second visual marker corresponds to a second negative space.

[0064] In at least one aspect according to the present disclosure, the first negative space and the second negative space are separated by a partition.

[0065] In at least one aspect according to the present disclosure, the at least one negative space is within a surface of the inorganic material.

[0066] In any of the aspects or embodiments described above or herein, the inorganic data fde is configured by a user and / or software. The inorganic data file may be configured prior to the inorganic data file being submitted into the system. The inorganic data file may be configured after being submitted into the system. The inorganic data file may be configured before being submitted into the system and after being submitted into the system.

[0067] The inorganic data file may be configured to include a surface and / or at least one negative space. Each or either of the surface and the at least one negative space may be configured before being submitted into the system and / or after being submitted into the system.

[0068] The foregoing features and elements may be combined in various combinations without exclusivity, unless expressly indicated otherwise. For example, aspects and / or embodiments of the present disclosure may include any one or more of the individual features or elements disclosed above and / or below alone or in any combination thereof. These features and elements as well as the operation thereof will become more apparent in light of the following description and the accompanying drawings. It should be understood, however, the following description and drawings are intended to be exemplary in nature and non-limiting.BRIEF DESCRIPTION OF THE DRAWINGS

[0069] FIG. 1 depicts an illustration of an embodiment according to the present disclosure.

[0070] FIG. 2 depicts an illustration of an embodiment according to the present disclosure.

[0071] FIG. 3 depicts a sectional illustration of an embodiment of the patient or subject including an Implant according to present disclosure.

[0072] FIGS. 4-4A each depict depicts an illustration of an embodiment of the visualization according to present disclosure.

[0073] FIG. 5 depicts a sectional illustration of an embodiment of the visualization harmonized with at least one image data fde according to present disclosure.

[0074] FIG. 6 depicts a sectional illustration of an embodiment of the visualization harmonized with a patient or subject according to present disclosure.

[0075] FIG. 7 depicts an illustration of an embodiment of the physical model according to the present disclosure.

[0076] FIG. 8 depicts an illustration of an embodiment of a visualization harmonized with a physical model according to the present disclosure.

[0077] FIGS. 9-9A each depict an illustration of a visualization according to the present disclosure.

[0078] FIGS. 10-10A each depict an illustration of a visualization according to the present disclosure.

[0079] FIGS. 11-11 A each depict an illustration of a visualization according to the present disclosure.

[0080] FIG. 12 depicts an illustration of an embodiment of a visualization according to the present disclosure.

[0081] FIGS. 13-13A depicts embodiments of the interface according to the present disclosure.

[0082] FIGS. 14-14A depicts embodiments of the interface according to the present disclosure.DETAILED DESCRIPTION

[0083] Referring generally to exemplary FIGS. 1-3, the present disclosure includes a system 20 for visualizing organic and inorganic materials. The system 20 for visualizing organic and inorganic materials includes at least one viewing device 24. The at least one viewing device 24 is configured to provide a visualization 28 from at least one inorganic data file 26, at least one organic image data 32. The visualization 28 harmonizes the at least one inorganic data file 26 and the at least one organic material file 32.

[0084] The system 20 for visualizing organic and inorganic materials includes, for example, a medical procedure. The medical procedure may include inorganic material 22 such asan implant, prosthetic, other foreign body, or other device attached to or positioned within a patient or subject, (collectively, an “Implant”). The system for visualizing organic and inorganic materials 20 includes at least one viewing device 24, at least one inorganic data file 26 that may include at least one Implant data file of the Implant 22, a visualization 28 (by way of the at least one viewing device 24) including a harmonization of the at least one inorganic data file 26 of the Implant 22 and at least one or more of: organic material such as a patient or subject 30, at least one organic material file 32 that may include at least one image data of the patient or subject 30, at least one image data 32 of a comparative patient or subject 30, and a physical model 34 of a patient or subject 30, a physical model 34 of a comparative patient or subject 30, a physical model of the Implant 22, a physical model of a comparative Implant 22, the Implant (or a comparative Implant) 22, a physical model of a patient or subject (or comparative patient or subject) 30 with the Implant (and / or a comparative Implant) 22.

[0085] As shown in FIG. 12, the system for visualizing organic and inorganic materials 20 may further include an object 36. The system for visualizing organic and inorganic materials 20 may further include an interface device 38. The system for visualizing organic and inorganic materials 20 may further include at least one medical professional 40. The system for visualizing organic and inorganic materials 20 may further include at least one tracker 42 associated with at least one of the Implant 22, the object 36, and / or a medical professional 40.

[0086] In some embodiments, the visualization 28 may include at least one organic image data (e.g., at least one image data) 32 of the patient or subject 30, and / or a physical model 34 of the patient or subject 30. The visualization 28 may be harmonized with the patient or subject 30, the at least one image data 32 of the patient or subject 30, and / or a physical model 34 of the patient or subject 30.

[0087] In some embodiments and as exemplified in FIG. 2, the system for visualizing organic and inorganic materials 20 may include an imaging device (e.g., a medical imaging device) 58 or other device capable of (i) compiling information to generate image data that can be regressed into an image, or (ii) capturing an image, is provided. In some embodiments, one or more controllers 52 are provided. In addition to the aforementioned, several methods are provided, including interactive steps with the interface device 38 that may be included in a viewing device24, where the viewing device 24 may include segmentation 82 and / or registration 84 (see FIGS. 13-14A). These components and methods will be described in greater but non-limiting detail below, including optional components and steps.

[0088] As shown in exemplary FIGS. 4-4A, in some embodiments, the visualization 28 includes the surface (e.g., the silhouette, the periphery, or the perimeter) 44 of the at least one inorganic data file (e.g., at least one Implant data file) 26 such that the interior region 46 of the at least one inorganic data file (e.g., at least one Implant data file) 26 is removed. The visualization 28 includes the negative space 48 of the interior region 46 of the at least one inorganic data file (e.g., at least one Implant data file) 26. The surface 44 defines the silhouette, the periphery, or the perimeter of the negative space 48 of the at least one inorganic data file (e.g., at least one Implant data file) such that the negative space 48 is opaque, semi-transparent, or transparent, and may further include a filter or other visual marker (e.g., one or more colors, monochromatic, or gradient of colors, pattern, etc.) 136. In some embodiments, there is a first visual marker 136A and a second visual marker 136B. The first visual marker 136A is different from the second visual marker 136B. Each of the first visual marker 136A and second visual marker 136B distinguish a first portion 70 from a second portion 74. The visualization 28 of the surface 44 and / or the negative space 48 of the inorganic material (e.g., Implant) 22 is harmonized with the patient or subject 30. The visualization 28 of the surface 44 and / or defining the negative space 48 of the at least one inorganic data file (e.g., at least one Implant data file) 26 is harmonized with the at least one organic material image data (e.g., at least one image data) 32 of the patient or subject 30. In some embodiments, the visualization 28 of the surface 44 and / or the negative space 48 of the at least one inorganic data file (e.g., at least one Implant data file) 26 is harmonized with the physical model (e g., the TDPM) 34 of the organic material (e g., a patient or subject) 30. In some embodiments, the visualization 28 of the surface 44 and / or negative space 48 of the at least one inorganic data file (e.g., at least one Implant data file) 26 is harmonized with the at least one organic material image data (e.g., at least one image data) 32 of the organic material (e.g., a patient or subject) 30 and the organic material (e.g., a patient or subject) 30, and / or optionally, the physical model (e.g., the TDPM) 34.

[0089] In some embodiments, the negative space 48 of the at least one inorganic data file (e g., at least one Implant data file) 26 is included in the visualization 28 without the surface 44.

[0090] In some embodiments described above or herein, the inorganic data fde (e.g., at least one Implant data file) 26 is configured by a user 50 and / or software. The inorganic data file (e.g., at least one Implant data file) 26 may be configured prior to the inorganic data file (e.g., at least one Implant data file) 26 being submitted into the system 20. The inorganic data file (e.g., at least one Implant data file) 26 may be configured after being submitted into the system 20. The inorganic data file (e.g., at least one Implant data file) 26 may be configured before being submitted into the system 20 and after being submitted into the system 20.

[0091] The inorganic data file (e.g., at least one Implant data file) 26 may be configured to include a surface 44 and / or at least one negative space 48. Each or both of the surface 44 and the at least one negative space 48 may be configured before being submitted into the system 20 and / or after being submitted into the system 20.

[0092] The medical procedure may include a surgical procedure (e.g., an arthroplasty), a training simulation for a medical procedure, a hybrid training simulation and medical procedure, a walk-through consultation, combinations thereof, etc. The medical procedure may include a surgical procedure, such as an arthroplasty, a procedure to install, remove, and / or replace an Implant.

[0093] As contemplated above and as exemplified in FIG. 3, the inorganic material 22 may include a non-living or man-made object, including, for instance, an Implant 22. Implant 22 includes an implant, prosthetic, or other device attached to or positioned within a patient or subject. While FIG. 3 is exemplary and demonstrates a shoulder Implant 22, it is appreciated that any Implant 22 and any portion of a patient or subject 30, a physical model 34, etc., are within the scope of the present disclosure. The Implant 22 may include one or more Implants 22, such as a first Implant 22, a second Implant 22A, a third Implant 22B, . . . and an nth Implant 22N. In embodiments with multiple Implants 22, such Implants may have a correlation, may be compatible with each other, and / or supplement each other, etc.. Multiple Implants 22 may also be similar or identical, or one may be a newer version of the other. For instance, Implant 22 may be an existing Implant 22 that is attached to and / or within a patient or subject 30 (or physical model (e.g., a TDPM thereof) 34), while Implant 22A is a replacement to Implant 22 that will be attached to and / or inserted into the patient or subject 30 (or physical model (e.g., a TDPM thereof) 34). Insuch embodiments, Implant 22 may be similar to or identical to Implant 22A. In such embodiments, Implant 22 and Implant 22A may relate to the same region or tissue system for a patient or subject 30, but may vary from each other with respect to material, shape, structure, and / or functionality. For instance, Implants 22 and 22Amay be pedicle screws utilized in the same procedure or related procedures. For instance, Implants 22 and 22A may supplement each other (e.g., component parts, such as a bone plate and a screw, a bio-compatible ultra-high molecular weight bearing material for a socket and a metallic (e.g., stainless steel, titanium, etc.) or ceramic ball, neck, and / or stem) such that neither Implant 22 and 22A would be an effective treatment [as an Implant 22] or medical procedure for a patient or subject 30 on its own.

[0094] The inorganic material (e.g., Implant) 22 includes a three-dimensional structure having a volume and a mass. As contemplated, multiple inorganic materials 22 (e.g., a first inorganic material 22 and a second inorganic material 22A, etc.) may have the same or different structures, including different volumes and / or masses. As contemplated, multiple Implants 22 (e.g., a first Implant 22 and a second Implant 22A, etc.) may have the same or different structures, including different volumes and / or masses.

[0095] Referring back to exemplary FIGS. 1-2, at least one inorganic data file (e.g., at least one Implant data file) 26 is provided. The at least one inorganic data file (e.g., at least one Implant data file) 26 includes a schematic and / or other technical information of the at least one inorganic data file (e.g., at least one Implant data file) 22. The at least one inorganic data file (e.g., at least one Implant data file) 26 may include multiple two-dimensional schematics (e.g., a plan, top view, bottom view, front view, back view, side view, elevation views, isometric views, angled views, etc.), photographs, renderings in two-dimensional or three-dimensional format, three-dimensional drawings (e.g., by way of software sold under the name CAD, PRO-E, Solid WORKS, etc.), Bill of Materials (BOM) information, other information that may be included in the foregoing such as: material(s), component parts, quality specifications, dimensions, tolerances, etc., and also fourdimensional files including three-dimensional files over time (e.g., where time is the fourth dimension) when subjected to certain conditions or parameters; where any or all of these types of files may be in an original condition (e.g., unaltered) or in a modified condition (e.g., the at least one inorganic data file 26 may include the surface 44 and / or negative space 48 (e.g., prior tosegmentation 82), and / or where the at least one inorganic data file 26 is overlaid onto at least one organic image data 32 (e.g., prior to registration 84).

[0096] The at least one inorganic data file 26 may include two or more inorganic data files 26A, 26B, . . . 26N, where each of the inorganic data files 26A, 26B may include different information or different types of files that are known, such as those file types that are known for being utilized by and / or created by the aforementioned software packages. The at least one Implant data file 26 may include two or more Implant data files 26A, 26B, . . . 26N, where each of the Implant data files 26A, 26B may include different information or different types of files that are known, such as those file types that are known for being utilized by and / or created by the aforementioned software packages. Such at least one inorganic data file (e.g., at least one Implant file) 26 may include a VTDO or an OTDO, or may be converted into a VTDO or OTDO.

[0097] The at least one inorganic data file 26 is configured for use with the system 20. In some embodiments, the at least one data file 26 is configured before submitting the at least one data file 26 to the system 20. In some embodiments, the at least one data file 26 is configured after submitting the at least one data file 26 to the system 20. In some embodiments, the at least one data file 26 is configured before submitting the at least one data file 26 to the system 20, and also after submitting the at least one data file 26 to the system. Such embodiments will be described in greater detail below.

[0098] The viewing device 24 is used by a viewer 50 such as a user or operator, or in further non-limiting examples, such as a medical professional or trainee 40, a patient or subject 30, etc., to see (e.g. view, visualize) a representation of the at least one inorganic data file (e.g., at least one Implant data file) 26 (and in certain embodiments, the one or more organic image data (e.g., the one or more image data) 32. For the purposes of the present disclosure, viewer, user, and operator are used interchangeably and all are referred to by reference numeral 50. The viewing device 24 provides a visualization 28 of the at least one inorganic data file (e.g., at least one Implant data file) 26 (and in certain embodiments, the one or more organic image data (e.g., the one or more image data) 32 to the viewer 50 without completely obfuscating the viewer’s 50 ability to see by way of the naked eye (or as assisted by glasses, contacts, etc.).

[0099] The viewing device 24 includes a screen. The viewing device 24 is optionally attached to a controller 52 (as discussed in greater detail below) or is a standalone screen or a plurality (e.g., series, an array, etc.) of screens. The one or more screens may be generally planar or may be arcuate, having a curvature such that one or more edges of the screen is in a second plane parallel to a first plane in which a center portion of the screen is. The viewing device 24 may include a projection by way of a projector and a generally planar surface such as a projection screen. The viewing device 24, in some embodiments, is held by, worn by, or attached to a user 50. In certain embodiments, the viewing device 24 is an XR device, such as a VR, MR, and / or AR device. In such embodiments, the viewing device 24 is worn about the user’s 50 head, such as over the user’s 50 eyes. In such embodiments, the viewing device is, including without limitation: HOLOLENS, OCULUS PRO, APPLE VISION PRO, MAGIC LEAP ONE, GOOGLE GLASS, MO VERIO BT300, NVIS, BROTHER AIRSCOUTER, WD-100, ARYZON, METAVISION, PICOLINKER, , and / or VUZIX M300. For simplicity, any viewing device 24 may be referred to by reference numeral 24.

[0100] A viewing device 24 may include an interface device 38. Alternatively, an interface device 38 may be separate from a viewing device 24. Regardless, the viewing device 24 and the interface device 38 are in communication with each other such that commands from the interface device 38 are directed (by way of a controller 52) to the viewing device 24. Such communication may be electronic, mechanical, electromechanical, thermal, electro-thermal, combinations thereof, etc. Such communication may be by physical means or wireless means (e.g., wi-fi, li-fi, etc.).

[0101] An interface device 38 is configured to include a graphical user interface (GUI), a keyboard, mouse, stylus, digit (i.e., a finger), dictation, body movement, etc. For simplicity, any interface device 38. The interface device 38 is configured any may include features such that a viewer 50 is able to interact with the one or more inorganic data file (e.g., one or more Implant data file) 26 (that is optionally configured as a VTDO or further optionally as an OTDO), such as by way of a graphical user interface (GUI), a keyboard, mouse, stylus, digit (i.e., a finger), dictation, body movement, etc. The interface device 38 includes menus or commands 68 configured such that the viewer 50 is able to set or define parameters with respect to viewing the one or more inorganic data file (e.g., one or more Implant data file) 26 (that is optionally configured as a VTDO or further optionally as an OTDO) (and in certain embodiments, the at least one organicdata file (e.g., at least one image data) 32 that is optionally configured as a VTDO, or further optionally as an OTDO).

[0102] Organic image data (e.g., image data) 32 of the organic material (e.g., a patient or subject) 30 includes at least a portion or region of the organic material (e.g., the patient or subject) 30, such as the axial region, the appendicular region, the head, neck, torso, pelvis, lower extremities, upper extremities, etc.. The organic image data (e.g., image data) 32 can include a coronal, sagittal or cross-sectional portion or region of the patient or subject 30. The image data 32 of the patient or subject 30 includes specific tissues and / or tissue or organ systems such as without limitation: the lymphatic system, circulatory system, respiratory system, endocrine system, nervous system, reproductive system, digestive system, urinary system, integumentary system, muscular system, skeletal system, etc. Optionally, the organic image data (e.g., image data) 32 includes the entirety of the organic material (e.g., the entire body of the patient or subject) 30. Optionally, organic image data (e.g., image data is a VTDO or an OTDO) 32, whereby the organic image data (e.g., image data) 32 regards any and all tissues / organs within a given portion of the body of the patient or subject 30. Organic image data 32 may include inorganic material 22 (e.g., the patient or subject 30 with one or more Implants 22 and / or one or more objects (e.g., one or more medical instruments) 36). For simplicity and for this reason, the present disclosure will generally refer to image data 32.

[0103] As shown in exemplary FIGS, 6 and 11-11A, image data 32 related to a patient or subject 30 includes data regarding external features 54 such as external anatomical features 54 (e.g., the epidermis, or other features, including superficial features viewable to the naked eye) as well as internal features 56 such as internal anatomical features 56 (e.g., the lungs) that are obfuscated by external features 54 such as external anatomical features 54. For further simplicity, an external feature 54 is often an external anatomical feature 54, and as such, any external feature may be referred to by reference numeral 54. Similarly, an internal feature 56 is often an internal anatomical feature 56, and as such, any internal feature may be referred to by reference numeral 56.

[0104] Referring back to exemplary FIGS. 1-2, in certain embodiments, a second set of image data 32A is provided. This second set of image data 32A regards the organic material (e.g.,patient or subject) 30 in a second condition that is different than the organic material (e.g., patient or subject) 30 in a first condition captured in the first image data 32. Alternatively, the second set of image data 32A regards a different organic material (e.g., different patient or subject) 30 than the first image data 32 of the first organic material (e.g., first patient or subject) 30. Alternatively, the second set of image data 32A regards a medical professional or trainee 40 who is performing a related medical procedure. In such alternative embodiment, the second set of image data 32A regarding the medical personnel includes the region(s) of the medical professional’s or trainee’s 40 body that will interact in the medical procedure, such as the medical person’s appendage(s), arm(s), hand(s), digit(s), (i.e., finger(s)), etc. For simplicity, any image data 32 referred to herein, such as without limitation, a first set of image data, a second set of image data, etc. may be identified simply by reference numeral 32.

[0105] In certain embodiments, image data 32 (that is optionally configured as a VTDO or further optionally as an OTDO) includes a first set of image data 32, a second set of image data 32A, and a third set of image data 32B. Optionally, a fourth set of image data 32 is provided, and further optionally, an nthset of image data 32N. In such embodiments, the second set of image data 32A, the third set of image data 32B, and the fourth set of image data 32 are from one or more of the organic material (e.g., a patient or subject) 30 in a second state, third state, fourth state, a benchmarking organic material (e.g., a benchmarking patient or subject) 30 that is different than the organic material (e.g., the patient or subject) 30, and / or that of a medical professional or trainee 40. It follows that an nthset of image data 32N may be provided, whereby such nthset of image data 32N regards one or more of an nthstate of the organic material (e.g., the patient or subject) 30, a second state of a benchmarking organic material (e.g., a benchmarking patient or subject) 30, an nthbenchmarking organic material (e.g., a benchmarking patient or subject) 30, an nthmedical professional or trainee 40, etc..

[0106] The at least one image data 32 (that is optionally configured as a VTDO or further optionally as an OTDO) can be in a variety of electronic file formats, such as .OBJ, .MTL (e.g., file format for color and shading generally utilized with a .OBJ file), .STL, .3MF, .X3D, WLR, etc. In certain embodiments and as discussed in further detail below, the image data 32 utilized is from the same root file to generate the physical model 34 and as utilized by the viewing device 24,albeit the root file (e g., VTDO) is configured into a TDO for the physical model 34 and an OTDO for the visualization 28.

[0107] In addition to the aforementioned inputs, biometric information can be included in the system for visualizing organic and inorganic materials 20. Biometric sensors are worn and / or otherwise utilized routinely by people, such as watches (e.g., sold by APPLE®, GARMIN®, etc.) heartrate monitors, and other biometric sensing devices used, for instance, under the mattress during sleep. These sensors accumulate biometric information about a person, including heart rate, blood pressure, hydration (e.g., body fluid percentage), power (e g., wattage) physical effort exerted, steps taken, other body movement, distance traveled, elevation gained or lost, etc. These sensors are often included with hardware including a viewing device 24 and / or an interface device 38, and include software applications that enable users to input additional information such as height and weight, hydration (e.g., fluid consumption) and are thus able to estimate caloric burn, body mass index (BMI), VO2 max, etc. These sensors are often in communication with other applications that suggest means to support mindfulness and other wellness behaviors. In total, any or all of this information can be supported of modeling how a patient or subject might age with an Implant 22 and / or how best to conduct an arthroplasty. In some embodiments, at least one biometric information file 100 is also provided. The at least one biometric information file 100 is received by the controller 52 and regressed by software. The at least one biometric information file 100 is assessed and utilized in projecting a condition of the patient or subject 30, and as such, is used in concert with the at least one image data 32.

[0108] The at least one biometric information file 100 may include a first biometric information file 100A, a second biometric information file 100B . . . and an nth biometric information file 100N. In embodiments including at least two biometric information files 100A, 100B, each may include different biometric information about a patient or subject 30, or may include different biometric information about different patients or subjects 30, 30A, etc.. As will be discussed further below, this may include dynamic information, or in other words, how the kinesiology of the organic material (e.g., the patient or subject) 30 and / or including the inorganic material (e.g., the Implant ) 22. The kinesiologic information may be derived from biometric information 100, and / or provided by imaging equipment 58 as contemplated below.

[0109] Referring now to exemplary FIG. 2, the one or more image data 32 regarding an object are obtained by an imaging device 58. Said differently, the one or more image data 32 are obtained by an imaging device 58 capable of capturing an image of an object 36 and / or organic material (e.g., a patient or subject) 30 and / or inorganic material (e.g., an Implant) 22. Examples of such imaging devices 58 include those generally obtained by way of a scanning technology such as a probe (e.g., ultrasound), CT, micro-CT, MRI, where such scanning technologies can be facilitated by nuclear imaging by way of PET, and / or any other imaging capable of generating at least a 2-d image that can be combined with at least one other 2-d image to form a 3-d image. Such images are generated with the support of the aforementioned examples of medical imaging devices (“MID”) 58. The one or more image data 32 regarding an object (e.g., medical instrument) 36 and / or organic material (e.g., a patient or subject) 30 and / or inorganic material (e.g., an Implant) 22 can also be generated by a scanning technology and / or by other means, including a technical drawing of the object (e.g., medical instrument) 36, an SEM photo thereby used as a basis for a technical drawing, extrapolating / rendering the object (e.g., medical instrument) 36 and / or organic material (e.g., a patient or subject) 30 and / or inorganic material (e.g., an Implant) 22 through use of indicators positioned on the object (e.g., medical instrument) 36 and / or organic material (e.g., a patient or subject) 30 and / or inorganic material (e.g., an Implant) 22such as by way of a VICON system, etc.. Such technologies are also useful in monitoring movement of an object (e.g., medical instrument) 36 and / or organic material (e.g., a patient or subject) 30 and / or inorganic material (e.g., an Implant) 22, from a first position to an nthposition, thereby enabling visualizations 28 such as overlays and renderings to simulate a procedure and / or even offer dynamic information about the object 36 (e.g., how the object 36 is able to move, the kinesiology of the object 36, such as, for instance, gait, range of motion, arm swing, etc.).

[0110] As exemplified in FIG. 8, the physical model 34 is created from the at least one image data 32 and / or at least one inorganic data file 26. The physical model 34 is a tangible representation of the organic material (e.g., patient / subject) 30 or as otherwise described herein (e.g., a benchmarking patient or subject 30), regarding external anatomical features 55 (e.g., the epidermis) as well as internal anatomical features 57 (e.g., the lungs) and / or the at least one inorganic data file (e.g., of the Implant) 26. The physical model 34 of the organic material (e.g., the patient or subject) 30 includes at least a portion or region of the organic material (e.g., the patient or subject) 30, such as the axial region, the appendicular region, the head, neck, torso,pelvis, lower extremities, upper extremities, etc.. The physical model 34 can include a cross- sectional or sagittal portion or region of the organic material (e.g., the patient or subject) 30. The physical model 34 of the organic material (e.g., the patient or subject) 30 includes specific tissues and / or tissue or organ systems such as without limitation: the lymphatic system, circulatory system, respiratory system, endocrine system, nervous system, reproductive system, digestive system, urinary system, integumentary system, muscular system, skeletal system, etc.. Optionally, the physical model 34 includes the entire body of the organic material (e.g., the patient or subject) 30. Preferably, physical model 34 is a TDPM, whereby the physical model 34 regards any and all tissues / organs within a given portion of the body of the organic material (e.g., the patient or subject) 30. For the purposes of the present disclosure, any reference to “physical model” 34 includes a TDPM and other physical models. For simplicity, any physical model 34 is referred to by reference numeral 34.

[0111] The physical model 34 such as a TDPM includes a support structure 60 including a platform 62. The support structure 60 optionally includes a series of linkages and joints enabling the physical model 34 to be moved into different positions. The physical model 34 is attached to the support structure 60 and / or optionally is created with the physical model 34 by the three- dimensional printing apparatus 64.

[0112] In some embodiments as exemplified in FIG. 1, a second physical model 34A is provided. This second physical model 34A information regards the organic material (e.g., the patient or subject) 30 and / or the at least one second inorganic data file (e.g., the Implant) 26Ain a second condition that is different than the first organic material (e.g., the patient or subject) 30 and / or the at least one first inorganic data file (e.g., the Implant) 26 in a first condition captured in the first physical model 34. Alternatively, the second physical model 34A regards a different organic material (e.g., a patient or subject) 30 and / or the at least one inorganic data file (e.g., the Implant) 26 than the first physical model 34 of the first organic material (e.g., the patient or subject) 30 and / or the first at least one inorganic data file (e.g., the Implant) 26. It follows that an nthphysical model 34N may be provided, whereby such nthphysical model 34N regards one or more of an nthstate of the patient or subject 30, a second state of a benchmarking patient or subject 30, an nthbenchmarking patient or subject 30, etc. Any such physical model 34 according to the present disclosure is optionally a TDPM 34.

[0113] By way of a non-limiting example and as shown in FIG. 9, a representation of a TDPM 34 created from the same VTDO as the augmented reality image depicted in FIG. 8, such as an OTDO. The TDPM 34 is optionally created from a TDO, configured from the VTDO.

[0114] Further embodiments may include a medical professional 40, where at least a portion of the medical professional 40 interacts with the patient or subject 30 and / or the physical model (e.g., the TDPM) 34. In such embodiments, at least a portion of the medical professional 40 may include one or more trackers 42.

[0115] In further embodiments and as exemplified in FIG. 12, an object 36 may be included such as a medical instrument (e.g., a probe, surgical implement, knife, laser, scissor, saw, etc ). The object 36 interacts with the patient or subject 30, the physical model (e.g., the TDPM) 34, and / or the medical professional 40. Such object 36 may include one or more trackers 42.

[0116] In further embodiments where the viewing device 24 utilizes XR technologies such as MR (e.g., the XR device 24), one or more trackers 42 can be placed on a user 50, medical professional or trainee 40, or object 36 to enable the XR device 24 to identify the location of such portion of a user 50 and / or portion of an object 36 having the one or more trackers 42. Utilization of one or more trackers 42 enables the viewing device 24 to further harmonize the visualization 28 (e.g., VTDO or OTDO) and TDPM 34 with what is being mapped by the one or more trackers 42 (e.g.’s: a portion of a user 50 such as a hand, a portion of an object 36, or further items such as a medical instrument 36, a portion of a prosthesis, combinations thereof, etc.).

[0117] As exemplified in FIGS. 7-8, in some embodiments, the one or more trackers 42 are configured on the inorganic material (e.g., Implant) 22, an object 36, the medical professional or trainee 40, and / or the user 50, such that as the inorganic material (e.g., Implant) 22, the object 36, and / or the user 50 engage with (e.g., interact with, move toward to be proximal to, penetrate, manipulate, are inserted into, are placed within, etc.) a respective layer 66 (e.g., going from the external anatomy 54 to the internal anatomy 56) of the organic material (e.g., patient or subject) 30 and / or the physical model (e.g., the TDPM) 34, the visualization 28 likewise correlates a respective layer 66 (e.g., going from external features 54 to internal features 56). In some embodiments, the one or more trackers 42 are configured on the inorganic material (e.g., Implant) 22, an object 36, the medical professional or trainee 40, and / or the user 50 such that when, throughthe viewing device 24 and / or the interface device 38, while the user 50 and / or the object 36 including the one or more trackers 42 engages with (e.g., interacts with, moves towards to be proximal to, penetrate, manipulate, etc.) a respective layer 66 (e.g., going from the external anatomy 54 to the internal anatomy 56) and a user 50 switches (by way of a menu or command 68 selection as in FIGS. 13 and 14) from a visualization 28 of a first tissue or organ system 86Ato a second tissue or organ system 86B, the second tissue or organ system 86B is provided on the visualization 28 with the inorganic material (e.g., Implant) 22, the object 36, the medical professional or trainee 40, the and / or user 50 with one or more trackers 42 engaging with (e.g., interact, move proximal toward, penetrate, manipulate, are inserted into, are placed within, etc.) the physical model (e.g., the TDPM) 34.

[0118] In some embodiments, a tracker 42 includes a unique identifier (e.g., a bar code, a QR code, or other scanning code, and / or combinations thereof). Such unique identifier 42 is mapped with or attached to (e.g., physically or electronically) to the inorganic material (e.g., Implant) 22, an object 36, a medical professional or trainee 40, and / or the user 50, etc.. In certain embodiments, the unique identifier 42 is mapped with or attached to a specific aspect of the inorganic material (e.g., Implant) 22, an object 36, a medical professional or trainee 40, and / or the user 50, etc., that will be engaging with (e.g., interacts with, moved proximal towards, manipulating, and / or penetrating, are inserted into, are placed within, etc.) the organic material (e.g., patient or subject) 30 and / or the physical model (e g., the TDPM) 34.

[0119] Referring to FIGS. 7-8, in some embodiments, the inorganic material (e.g., Implant) 22 may include a tracker (e.g., a unique identifier) 42 on a first portion 70 (e.g., first region 70A, first end 70B, or first surface 70C), where any of such may include an exterior portion 72 of the inorganic material (e.g., Implant) 22. Alternatively, the inorganic material (e.g., Implant) 22 may include a tracker (e.g., a unique identifier) 42 on a second portion 74 (e.g., a second region 74A, second end 74B, or second surface 74C), where any of such may include an interior portion 76 of the inorganic material (e.g., Implant) 22. In some embodiments, the inorganic material (e.g., Implant) 22 includes a first tracker (e.g., a unique identifier) 42 on first portion 70 (e.g., first region 70A, first end 70B, or first surface 70C), and a second tracker (e.g., a unique identifier) 42A on a second portion 74 (e.g., a second region 74A, second end 74B, or second surface 74C). The secondportion 74 (e.g., a second region 74A, second end 74B, and / or second surface 74C) is different from the first portion 70 (e.g., a first region 70A, first end 70B, and / or first surface 70C).

[0120] Positioning one or more trackers 42, 42A may improve location and / or placement of the inorganic material (e.g., Implant) 22 by referencing a first portion 70 (e.g., first region 70A, first end 70B, or first surface 70C) that is, for instance on the exterior portion 72 of the inorganic material (e.g., Implant) 22 that engages with (e.g., interacts with, moved proximal towards, manipulating, and / or penetrating, are inserted into, are placed within, etc.) the organic material (e g., patient or subject) 30 and / or the physical model (e.g., the TDPM) 34. Positioning one or more trackers 42, 42A may improve location and / or placement of the inorganic material (e.g., Implant) 22 by referencing a second portion 74 (e.g., a second region 74A, second end 74B, or second surface 74C) that is, for instance on the interior portion 76 of the inorganic material (e.g., Implant) 22 such that the interior region 46 (e.g., the negative space 48) of the inorganic material (e.g., Implant) 22 is identified and can be utilized to co-locate with the visualization 28. In addition, positioning one or more trackers 42, 42A on an interior portion 76 of the inorganic material (e.g., Implant) 22 may improve accuracy in locating the inorganic material (e.g., Implant) 22 when in vivo. Positioning one or more trackers 42, 42A on the inorganic material (e.g., Implant) 22, where a first tracker 42 is positioned on a first portion (e.g., a first region 70A, first end 70B, and / or first surface 70C), and positioning a second tracker 42Ais positioned on a second portion (e.g., a second region 74A, second end 74B, and / or second surface 74C), may improve accuracy in identifying the geometry and positioning of the inorganic material (e.g., Implant) 22 in the visualization 28 and / or as the inorganic material (e.g., Implant) 22 engages with (e.g., interacts with, moved proximal towards, manipulating, and / or penetrating, are inserted into, are placed within, etc.) the organic material (e.g., patient or subject) 30 and / or the physical model (e.g., the TDPM) 34.

[0121] In some embodiments, the inorganic material (e.g., Implant) 22 may include a tracker (e.g., a unique identifier) 42 on a first portion 70 (e.g., first region 70A, first end 70B, or first surface 70C), where any of such may include a first component of the inorganic material (e.g., Implant) 22, or a first inorganic material (e.g., Implant) 22. Alternatively, the inorganic material (e.g., Implant) 22 may include a tracker (e.g., a unique identifier) 42 on a second portion 74 (e.g., a second region 74A, second end 74B, or second surface 74C), where any of such may include a second component of the inorganic material (e g., Implant) 22A, or a second inorganic material(e g., Implant) 22A. In some embodiments, the inorganic material (e.g., Implant) 22 includes a first tracker (e.g., a unique identifier) 42 on a first portion 70 (e.g., first region 70A, first end 70B, or first surface 70C), and a second tracker (e.g., a unique identifier) 42A a second portion 74 (e.g., a second region 74A, second end 74B, or second surface 74C).

[0122] Positioning one or more trackers 42, 42A may improve location and / or placement of the inorganic material (e.g., Implant) 22 that engages with (e.g., interacts with, moved proximal towards, manipulating, and / or penetrating, are inserted into, are placed within, etc.) the patient or subject 30 and / or the physical model (e.g., the TDPM) 34. As an example, a first tracker 42 is positioned on a first component of the inorganic material (e.g., Implant) 22 or a first inorganic material (e.g., Implant) 22 and a second tracker 42A is positioned on a second component of the inorganic material (e g., Implant) 22A or a second inorganic material (e.g., Implant) 22A. Such trackers 42, 42A may improve locating each component or inorganic material (e.g., Implant) 22, 22A that are configured to either cooperate as an organic system (e.g., Implant System, e.g., a bearing and a bearing surface, a screw and a plate, etc.) 78 or are configured for similar use (e.g., a first inorganic material (e.g., Implant) 22 for a left joint, such as a shoulder, elbow, writs, hip, knee, or ankle, a second inorganic material (e.g., Implant) 22Afor a right joint, such as a shoulder, elbow, wrist, hip, knee, or ankle).

[0123] In other embodiments, the unique identifier 42 is, in one embodiment, mapped with or attached to the handle of an object 36 such as a medical instrument 36. In other embodiments, the unique identifier 42 is, in one embodiment, mapped with or attached to the tip of the medical instrument 36 used for a procedure (e.g., providing treatment, medication, making an incision, grasping a tissue or organ, etc.). Such unique identifier 42 is scanned by the viewing device 24 and / or the interface device 38 (e.g., a computer, a scanner, a camera, an XR device). The tracker 42 (e.g., the unique identifier) is utilized to harmonize the portion of a user 50 and / or object (e.g., a medical instrument) 36 including the tracker 42 with the visualization 28 and organic material (e.g., patient or subject) 30 and / or the physical model (e.g., the TDPM) 34. In this fashion, the portion of the user 50 and / or object (e.g., medical instrument) 36 by way of the tracker 42 is shown in the visualization 28 while engaging with (e.g., interacting, moving proximally toward, physically, manipulating, touching, are inserted into, are placed within, are inserted into, are placedwithin, etc.) the organic material (e.g., patient or subject) 30 and / or the physical model (e.g., the TDPM) 34 are harmonized.

[0124] In further embodiments, more than one tracker 42 each including a unique identifier is associated with more than one portion or aspects of a user 50 and / or one or more objects (e.g., medical instrument(s)) 36. Accordingly, a further holistic representation can be mapped and presented in the visualization 28 as more than one mapped portion 80 of at least one user 50 and / or the object(s) (e.g., medical instrument(s)) 36 engages with (e.g., interacts with, moves proximally towards, manipulates, penetrates, physically engages, etc.) the TDPM 34 and are harmonized.

[0125] In further embodiments, one or more trackers 42 including a unique identifier are associated with one or more portions of the user 50 and / or one or more objects (e.g., medical instrument(s)) 36. Accordingly, one or more portions of at least one user 50 and / or one or more portions of one or more objects (e.g., medical instrument(s)) 36 are mapped portions 80 and presented in the visualization 28 as such one or more portions of at least one user 50 and / or one or more portions of one or more objects (e.g., medical instrument s)) 36 engage with (e.g., interacts with, moves proximally towards, manipulates, penetrates, physically engages, are inserted into, are placed within, etc.) the physical model (e.g., the TDPM) 34 and are harmonized.

[0126] By way of a non-limiting example and as shown in FIG. 6, a representation of a visualization 28 such as an OTDO represents a section of the shoulder region of a human subject including an Implant 22. The visualization 28 includes at least one inorganic data file (e.g., at least one Implant data file) 26 configured as a VTDO and / or further optionally as an OTDO, and also at least one image data 32. The VTDO and / or OTDO was created by segmentation 82 of the at least one image data 32 generated by a CT scanner (e.g., imaging equipment) 58 depicting the shoulder and arm of a human subject and is visualized with INTRAVISION XR software from DICOM Director, LLC, and viewed as an OTDO through the MICROSOFT HOLOLENS 2A viewing device 24.

[0127] Referring now to exemplary FIGS. 4-6, 9-11 A, the at least one inorganic data file (e.g., at least one Implant data file) 26 configured into a VTDO and / or further optionally as an OTDO is viewable on the viewing device 24 and by way of software or user inputs, is registered to the physical model 34 created from the same image data. By way of software or user inputs,additional modifications can be made, including segmentation 82, volume rendering, windowing, etc.

[0128] The visualization 28 of the inorganic material (e.g., Implant) 22 includes a surface 44. The surface may include a first perimeter 44A. In some embodiments, the first perimeter 44A is directed to a first component of the inorganic material (e.g., Implant) 22. The surface may include a second perimeter 44B. In some embodiments, the second perimeter 44B is directed to a second component of the inorganic material (e.g., Implant) 22A. In some embodiments, both the first perimeter 44A and the second perimeter 44B are directed to outer perimeters of the components of the inorganic material (e.g., Implant) 22, 22A. In some embodiments, the first perimeter 44A and the second perimeter 44B are directed to portions of the inorganic material (e.g., Implant) 22. For example, FIGS. 4-4A show a first perimeter 44A associated with a first portion of the inorganic material (e.g., Implant) 22 and a second perimeter 44B associated with a second portion of the inorganic material (e.g., Implant) 22.

[0129] In some embodiments, the visualization of the inorganic material (e.g., Implant) including a surface 44 has a first perimeter 44A directed towards an outer perimeter of the inorganic material (e.g., Implant) 22. The surface 44 includes a second perimeter 44B directed towards an interior perimeter of the inorganic material (e.g., Implant) 22. The interior perimeter 44B may include a boundary such as, for instance, a bore (e.g., a through-hole for a screw).

[0130] It is understood by one of skill in the art that there may be a nth perimeter 44N depending on the number of components of an inorganic material (e.g., Implant) 22, and / or the number of outer perimeters and interior perimeters. By way of example, a bone plate may include multiple bores, and as such, have interior perimeters 44B, 44C . . . 44 N-l, 44N.

[0131] In some embodiments, at least one inorganic data file 26 includes a surface 44. The surface 44 is configured from, for instance, the inorganic data file (e.g., the CAD or schematic of the prosthetic, implant, device, etc.) 26 by software and / or inputs from a user 50. Said differently, a user 50, through an interface device 38 (and / or viewing device 24), manipulates the at least one inorganic data file (e.g., the CAD or schematic) 26 and resects-out the body of the inorganic material 22 subject of the at least one inorganic data file 26, thereby leaving the perimeter of the inorganic material 22, or in other words, the surface 44. The manipulation of the at least oneinorganic data file 26 by the user 50 can be one or more direct and discrete entries or commands 68 entered into interface device 38 (and / or viewing device 24), and / or could be a pre-programmed command 68 that the software in concert with the controller 52 and the interface device 38 (and / or viewing device 24) is programmed to execute and then performs / executes the command. Such creation of the surface 44 can be done to the at least one inorganic data file 26 prior to submitting such at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. Alternatively, such creation of the surface can be done after the at least one inorganic data file is submitted into the system for visualizing inorganic material(s) 22 and organic material(s) 30. In this latter embodiment, the surface 44 may be configured through the use of registration 84 through the viewing device 24 (and / or interface device 38).

[0132] The visualization 28 of the inorganic material (e.g., Implant) 22 includes negative space 48 where the interior region 46 of the inorganic material (e.g., Implant) 22 is. The negative space 48 may include a first negative space 48A. In some embodiments, the first negative space 48A is directed to a first component of the inorganic material (e.g., Implant) 22. In some embodiments, the negative space 48 includes a second negative space 48B. In some embodiments, the second negative space 48B includes a second component of the inorganic material (e.g., Implant) 22A. In some embodiments, the first negative space 48A and the second negative space 48B are directed to portions of the inorganic material (e.g., Implant) 22, 22A. For instance, FIGS. 10A-10B show first negative space 48A associated with a first portion 70 of the inorganic material (e g., Implant) 22 and a second negative space 48B associated with a second portion 74 of the inorganic material (e.g., Implant) 22.

[0133] In some embodiments, the visualization 28 of the Implant 22 including a surface 44 has a first negative space 48A directed towards a first region 70A of the inorganic material (e.g., Implant) 22. The surface 44 includes a second negative space 48B directed towards a second region 74A of the inorganic material (e.g., Implant) 22. The first negative space 48A may be separated from the second negative space 48B by a partition 88 or other feature (e.g., structural).

[0134] It is understood by one of skill in the art that there may be an nth negative space 48N depending on the number of components of an inorganic material (e.g., Implant) 22, and / or the number of negative spaces 48. By way of example, a hip replacement inorganic material (e.g.,Implant) 22 may have a first negative space 48A associated with the stem, a second negative space 48B associated with a neck region, a third negative space 48C associated with the ball, a fourth negative space 48D associated with the socket, etc., and as such, there may be negative spaces 48 A, 48B . . . 48N-1, 48N. Such negative spaces 48-48N may be configured differently (e.g., a first visual marker, a second visual marker, etc.) in the visualization to indicate different materials for various components or sections of the inorganic material (e.g., Implant) 22, and / or may indicate different tissues (e.g., organ system(s)) 86 a portion of the inorganic material (e.g., Implant) 22 engages with. For instance, the visual marker(s) 136, 136A, 136B may include different colors, translucencies, opacities, patterns such as stripes, chevrons, houndstooth, plaid, argyle, checkered, hashed, paisley, herringbone, combinations thereof, etc.. In some embodiments, the viewing device 24 includes haptics such that when the user 50 interacts with the visualization 28 and / or the harmonized organic material (e.g., patient or subject) 30, inorganic material (e.g., Implant) 22, object 36, and / or physical model (e g., the TDPM) 34, the user 50 has at least one tactile sensation. The at least one tactile sensation includes a first tactile sensation for a first portion 70 (e.g., a first component or section, a first layer, etc.), a second tactile sensation for a second portion 74 (e.g., a second component or section, a second layer, etc.), where the second tactile sensation is different from the first tactile sensation. The at least one tactile sensation may include vibrations of equal or different length, pulse, frequency, magnitude, combinations thereof, etc..

[0135] In some embodiments, at least one inorganic data file 26 includes a negative space 48. The negative space 48 is configured from, for instance, the inorganic data file (e.g., the CAD or schematic of the prosthetic, implant, device, etc.) 26 by software and / or inputs from a user 50. Said differently, a user, through an interface device 38 (and / or viewing device 24), manipulates the at least one inorganic data file (e.g., the CAD or schematic) 26 and resects-out the body of the inorganic material 22 subject of the at least one inorganic data file 26, and fills in that resected-out body and filled to be opaque, semi-transparent, or transparent, and may further include a filter or other visual marker 136, or in other words, the negative space 48. The manipulation of the at least one inorganic data file 26 by the user 50 can be one or more direct and discrete entries or commands 68 entered into interface device 38 (and / or viewing device 24), and / or could be a pre-programmed command that the software in concert with the controller 52 and the interface device 38 (and / or viewing device 24) is programmed to execute and then perform s / executes the command. Such creation of the negative space 48 can be done to the at least one inorganic data file 26 prior tosubmitting such at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. Alternatively, such creation of the negative space 48 can be done after the at least one inorganic data file 26 is submitted into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. In this latter embodiment, the negative space 48 may be configured through the use of registration 84 through the viewing device 24 (and / or interface device 38).

[0136] In some embodiments, the at least one inorganic data file 26 includes a surface 44 and a negative space 48. In some of these embodiments, either or both of the surface 44 and the negative space 48 may be created and configured within the at least one inorganic data file 26 prior to submitting the at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. In some of these embodiments, either or both of the surface 44 and the negative space 48 may be created and configured to the at least one inorganic data file 26 after the at least one inorganic data file 26 is submitted into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. In this latter embodiment, either or both of the surface 44 and the negative space 48 may be configured through the use of registration 84 through the viewing device 24 (and / or interface device 38).

[0137] For clarity, in some embodiments, both of the surface 44 and the negative space 48 are created and configured within the at least one inorganic data file 26 prior to submitting the at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. For clarity, in some embodiments, both of the surface 44 and the negative space 48 are created and configured within the at least one inorganic data file 26 after submitting the at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. For clarity, in some embodiments, the surface 44 is created and configured within the at least one inorganic data file 26 prior to submitting the at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30, and the negative space 48 is created and configured to the at least one inorganic data file 26 after submitting the at least one inorganic data file 26 to the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. For clarity, in some embodiments, the negative space 48 is created and configured within the at least one inorganic data file 26 prior to submitting the at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22and organic material(s) 30, and the surface 48 is created and configured to the at least one inorganic data file 26 after submitting the at least one inorganic data file 26 to the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30. For clarity, in some embodiments, the surface 44 and the negative space 48 is created and configured within the at least one inorganic data file 26 prior to submitting the at least one inorganic data file 26 into the system 20 for visualizing inorganic material(s) 22 and organic material(s) 30, and thereafter, either or both of the surface 44 and negative space 48 may be further modified or configured, by the user and / or through a program in concert with the controller 52, viewing device 24 (and / or interface device 38) such as through registration 84. In any of these embodiments, an additional visualization 28 includes configuration, further configuration, or reconfiguration to provide additional surfaces 48 and / or additional negative spaces 48, as needed by any and all users, additional users, in various views with various criteria (e.g., segmented 82 in a specific configuration), for harmonization with one or more organic image data files 32, patients or subjects 30, and / or physical models 34.

[0138] Referring to exemplary FIGS. 9-11 A, the visualization 28 may include two- dimensions, three-dimensions, and / or four-dimensions (e.g., the fourth dimension being time). In some embodiments, photogrammetry is used to combine one or more two-dimensional organic image data files 32 (or visualizations 28) to create a three-dimensional organic image data file 32 (or visualization 28). In some embodiments, photogrammetry is used to combine one or more two-dimensional inorganic data files 26 (or visualizations 28) to create a three-dimensional inorganic data files 26 (or visualization 28).

[0139] Referring now to FIGS. 9-9A, in embodiments including at least two two- dimensional visualizations 28, each of the at least two two-dimensional visualizations may include at least one view 90. In some embodiments, the two-dimensional visualizations include at least a first view 90A of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., a plan view) and a second view 90B of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., an elevation view). In such embodiments, the surface 44 may include a first perimeter section 44A and a second perimeter section 44B in a first view where at least one of the first perimeter section 44A and a second perimeter section 44B in the second view 90B are different from those in the first view. In such embodiments, the surface 44 may include a first perimeter section 44A and a second perimeter section 44B in a first view where at least one of the firstperimeter section 44A and a second perimeter section 44B in the second view 90B are the same as those in the first view 90A.

[0140] In embodiments including at least two two-dimensional visualizations 28, at least one view 90 includes a first view 90A may include a first negative space 48A and the second view 90B may include a second negative space 48B. The first negative space 48 A and the second negative space 48B may include at least a portion of the same negative space 48. For instance, the first view 90Amay include a bottom view and the second view 90B may include a top view, where the bottom view and the top view include at least a portion of the same negative space 48. In yet further embodiments, a first view 90A may include a first sectional view, and a second view 90B may include a second sectional view, where the first sectional view and the second sectional view include at least a portion of the same negative space 48. For instance, the first view 90A may include a bottom view and the second view 90B may include a top view, where the bottom view and the top view include at least a portion of a different negative space 48. In yet further embodiments, a first view 90A may include a first sectional view, and a second view 90B may include a second sectional view, where the first sectional view and the second sectional view include at least a portion of a different negative space 48.

[0141] In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “stitch”) at least two organic image data files 32, each of which may be in two dimensions and configure the at least two organic image data files 32 into at least one three-dimensional organic image data file 32 (or visualization 28). In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “stitch”) at least two organic image data files 32, each of which may be in two or three dimensions, and configure the at least two organic image data files 32 into at least one three-dimensional organic image data file 32 (or visualization 28).

[0142] In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “stitch”) at least two image data files 26, each of which may be in two dimensions and configure the at least two inorganic data files 26 into at least one three-dimensional organic image data file 26 (or visualization 28). In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “stitch”) at least two inorganic data files 26, each of which may be in two or threedimensions, and configure the at least two inorganic data files 26 into at least one three- dimensional inorganic image data file 26 (or visualization 28).

[0143] In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “stitch”) at least one organic image data file 32 and at least one inorganic data file 26, each of which may be in two dimensions and / or three dimensions, and configure the at least one organic image data file 32 and the at least one inorganic data files 26 into at least one organic image data file 26 that includes the inorganic material 22 [subject of the at least one inorganic data file 26] (or visualization 28). Registration or other co-locating functions may be performed by the user and / or software to configure the inorganic data file 26 to the appropriate location of the respective organic image data file 32. The resultant organic image data file 32 may be in two-dimensions or three- dimensions. In embodiments including at least two organic image data files 32 and at least two inorganic data files 26, the resultant organic image data file(s) 32 may include one or more two- dimensional organic image data files 32 and / or one or more three-dimensional organic image data files 32, where such one or more organic image data files 32 includes the inorganic material 22 [subject of the at least one inorganic data file 26],

[0144] Referring now to FIGS. 10-10A, in embodiments including at least two three- dimensional visualizations 28, each of the at least two three-dimensional visualizations may include at least one view 90. The at least one view 90 includes a first view 90A of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., an upper angled view) and a second view 90B of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., a lower angled view). In such embodiments, the surface 44 may include a first perimeter section 44A and a second perimeter section 44B in a first view 90A where at least one of the first perimeter section 44A and a second perimeter section 44B in the second view 90B are different from those in the first view 90A. In such embodiments, the surface 44 may include a first perimeter section 44A and a second perimeter section 44B in a first view 90A where at least one of the first perimeter section 44A and a second perimeter section 44B in the second view 90B are the same as those in the first view 90A. By way of the controller 52, software and / or a command 68 by way of the viewing device 24 and / or interface device 38, the first view 90Amay be moved (e.g., rotated, slid, translated, etc.) to the second view 90B, where at least a portion of the surface 44 is within both the first view 90A and the second view 90B. By way of the controller 52, software and / or acommand68 by way of the viewing device 24 and / or interface device 38, the first view 90A may be moved (e.g., rotated, slid, translated, etc.) to the second view 90B, where at least a portion of the surface 44 that is in the first view 90A is not in the second view 90B.

[0145] In embodiments including at least two three-dimensional visualizations 28, each of the at least two three-dimensional visualizations may include at least one view 90. The at least one view 90 includes a first view 90A of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., an upper angled view) and a second view 90B of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., a lower angled view). The first view 90A may include a first negative space 48A and the second view 90B may include a second negative space 48B. The first negative space 48 A and the second negative space 48B may include at least a portion of the same negative space 48. In yet further embodiments, a first view 90A may include a first sectional view (e.g., of a volume), and a second view 90B may include a second sectional view (e.g., of a volume), where the first sectional view and the second sectional view include at least a portion of the same negative space 48. In yet further embodiments, a first view 90A may include a first sectional view, and a second view 90B may include a second sectional view, where the first sectional view (e.g., of a volume) and the second sectional view (e.g., of a volume) include at least a portion of a different negative space 48. By way of the controller 52, software and / or a command 68 by way of the viewing device 24 and / or interface device 38, the first view 90A may be moved (e.g., rotated, slid, translated, etc.) to the second view 90B, where at least a portion of the negative space 48 is within both the first view 90A and the second view 90B. By way of the controller 52, software and / or a command 68 by way of the viewing device 24 and / or interface device 38, the first view 90A may be moved (e.g., rotated, slid, translated, etc.) to the second view 90B, where at least a portion of the negative space 48 in the first view 90A is not in the second view 90B.

[0146] Referring now to FIGS. 11-11 A, in embodiments including at least two fourdimensional visualizations 28, each of the at least two four-dimensional visualizations may include at least one view 90 with at least one time increment 92. The at least one view 90 includes a first view 90A of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e g., an upper angled view) at a first time increment 92A and a second view 90B of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e g., a second upper angled view) at asecond time increment 92B. Tn such embodiments, the surface 44 of each of the first view 90A and the second view 90B may be substantially similar. In such embodiments, the tissue 86 surrounding the surface 44 may be different (e.g., the tissue 86 in the first view 90A is healthy or in a healthier state than in the second view 90B). In such embodiments, the surface 44 in each of the first view 90A and the second view 90B may be different. In such embodiments, the tissue 86 surrounding the surface 44 may be substantially similar (e.g., the tissue 86 is shown with two different inorganic materials (e.g., two different Implants) 22, 22A such that the tissue 86 is in the same general condition but modified only to suit each of the respective Implants 22, 22A). In such embodiments, the first view 90A may include at least one inorganic data file (e.g., at least one Implant data file) 26 in a new condition. In such embodiments, a second view 90B may include at least one Implant data file 26A in a used condition, thus showing at least some wear or failure. The used condition shown in the at least one inorganic data file (e.g., at least one Implant data file) 26A may include specifications of a used Implant 22 or that of a hypothetical used Implant 22 based on a regression and / or projection of the condition of the inorganic material (e.g., Implant) 22 based on a variety of factors. In such embodiments, the surface 44 may include a first perimeter section 44A and a second perimeter section 44B in a first view 90A where at least one of the first perimeter section 44A and a second perimeter section 44B in the second view 90B are different from those in the first view. In such embodiments, the surface 44 may include a first perimeter section 44A and a second perimeter section 44B in a first view 90A where at least one of the first perimeter section 44A and a second perimeter section 44B in the second view 90B are the same as those in the first view 90A. By way of the controller 52, software and / or a command by way of the viewing device 24 and / or interface device 38, the first view 90A may be moved from the first time increment 92A to a second time increment 92B for the second view 90B, where at least a portion of the surface 44 is within both the first view 90A and the second view 90B. By way of the controller 52, software and / or a command 68 by way of the viewing device 24 and / or interface device 38, the first view 90A may be moved from the first time increment 92A to a second time increment 92B for the second view 90B, where at least a portion of the surface 44 is not in both the first view 90A and the second view 90B.

[0147] In embodiments including at least two four-dimensional visualizations 28, each of the at least two four-dimensional visualizations may include at least one view 90 at a time increment 92. The at least one view 90 includes a first view 90A of the at least one organic datafile (e.g., at least one Implant data file) 26 at a first time increment 92A and a second view 90B of the at least one inorganic data file (e.g., at least one Implant data file) 26 (e g., a second upper angled view) at a second time increment 92B. In such embodiments, the surface 44 of each of the first view 90A and the second view 90B may be substantially similar. In such embodiments, the tissue 86 surrounding the surface 44 may be different (e.g., the tissue 86 in the first view 90A is healthy or in a healthier state than in the second view 90B). In such embodiments, the surface 44 in each of the first view 90A and the second view 90B may be different. In such embodiments, the tissue 86 surrounding the surface 44 may be substantially similar (e.g., the tissue 86 is shown with two different inorganic materials (e.g., two different Implants) 26, 26A such that the tissue 86 is in the same general condition but modified only to suit each of the respective inorganic materials (e.g., Implants) 26, 26A). In such embodiments, the first view 90A may include at least one inorganic data file (e.g., at least one Implant data file) 26 in a new condition and at a first time increment 92A. In such embodiments, a second view 90B may include at least one inorganic data file (e.g., at least one Implant data file) 26A in a used condition, thus showing at least some wear or failure, and at a second time increment 92B. The used condition shown in the at least one inorganic data file (e.g., at least one Implant data file) 26A may include specifications of a used inorganic material (e.g., Implant) 26A or that of a hypothetical used inorganic material (e.g., Implant) 26A based on a regression and / or projection of the condition of the inorganic material (e g., Implant) 26A based on a variety of factors. The first view 90A may include a first negative space 48A and the second view 90B may include a second negative space 48B. The first negative space 48A and the second negative space 48B may include at least a portion of the same negative space 48. In yet further embodiments, a first view 90A may include a first sectional view (e.g., of a volume), and a second view 90B may include a second sectional view (e.g., of a volume), where the first sectional view 90A and the second sectional view include at least a portion of the same negative space 48. In yet further embodiments, a first view 90Amay include a first sectional view, and a second view 90B may include a second sectional view, where the first sectional view (e.g., of a volume) and the second sectional view (e.g., of a volume) include at least a portion of a different negative space 48. By way of the controller 52, software and / or a command 68 by way of the viewing device 24 and / or interface device 38, the first view 90Amay be moved from a first time increment 92A to a second time increment 92B for the second view 90B, where at least a portion of the negative space 48 is within both the first view 90A and the second view 90B. Byway of the controller 52, software and / or a command 68 by way of the viewing device 24 and / or interface device 38, the first view 90A may be moved from a first time increment 92A to a second time increment 92B for the second view 90B, where at least a portion of the negative space 48 is not in both the first view 90A and the second view 90B.

[0148] It is understood by those of skill in the art that functionality of a two-dimensional visualization 28 may be included in that of a three-dimensional visualization 28 and a fourdimensional visualization. It is further understood by those of skill in the art that the functionality of a three-dimensional visualization 28 may be included in that of a four-dimensional visualization 28.

[0149] In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “unstitch”) an organic image data file 32, and configure the organic image data file 32 into at least one two-dimensional and / or three-dimensional organic image data file 32 (or visualization 28). In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “unstitch”) an inorganic image data file 26, and configure the inorganic image data file 26 into at least one two- dimensional and / or three-dimensional inorganic image data file 26 (or visualization 28). In some embodiments, photogrammetry is provided and utilized to correlate (e.g., “unstitch”) an organic image data file 32 including an inorganic material 22, and configure the organic image data file 32 into at least one two-dimensional and / or three-dimensional organic image data file 32 (or visualization 28) and at least one two-dimensional and / or three-dimensional inorganic data file 26.

[0150] The internal features 56 shown in the visualization 28 on the viewing device 24 can be selected as contemplated above such that a certain tissue 86 and / or portion of an organ system is shown while tissues and / or portions of organ systems 86a are hidden. For clarity and convenience, organs and / or organ systems, a type of tissue or system of tissue, will also be referred to by reference numeral 86. Similarly, a physical model (e.g., a TDPM) 34 can be created by selectively including only certain tissue and / or portion of an organ system 86. By way of nonlimiting example, FIG. 5 shows bones (e.g., a tissue or organ system) 86 (which are at least one of the internal anatomical features 54) covered by the dermis (e.g., a tissue or organ system) 86A (which is at least one of the external anatomical features 54) (e.g., soft tissue 86). Segmentation82 methods and programs are known and those generally available are considered for purposes of the present disclosure.

[0151] Referring now to FIGS. 9-11 A , the visualization 28, as seen through the viewing device 24 by the user 50, harmonizes the at least one inorganic data fde (e.g., at least one Implant data fde) 26 with the external features 54. In some embodiments, the visualization 28 with the at least one inorganic data fde (e.g., at least one Implant data fde) 26 is also harmonized with the inorganic material (e.g., Implant) 22 (e.g., to check consistency between the inorganic material (Implant) 22 and the at least one inorganic data fde (e g., at least one Implant data fde) 26, to see if there are deviations in tolerances of the inorganic material (Implant) 22 or if the inorganic material (Implant) 22 has wear from existing use). The visualization 28, as seen through the viewing device by the user 50, harmonizes the at least one inorganic data fde (e.g., at least one Implant data fde) 26 with the internal features 56. In some embodiments, the visualization 28 with the at least one inorganic data fde (e.g., at least one Implant data fde) 26 is also harmonized with the inorganic material (Implant) 22 (e.g., to check consistency between the inorganic material (Implant) 22 and the at least one inorganic data fde (e.g., at least one Implant data fde) 26, to see if there are deviations in tolerances of the inorganic material (Implant) 22, if the inorganic material (Implant) 22 has wear from existing use, or if the inorganic material (Implant) 22 was modified or customized for the organic material (e.g., patient or subject) 30). The visualization, 28, as seen through the viewing device 24 by the user 50, harmonizes the at least one inorganic data fde (e.g., at least one Implant data fde) 26 with, as selected by the user 50, both the external features 54 and the internal features 56 such that the at least one inorganic data fde (e.g., at least one Implant data fde) 26 is shown in an in vivo configuration (e.g., as if the inorganic material (Implant) 22 is within the organic material (e.g., patient or subject) 30), or shown at various stages during a medical procedure (e.g., as if the inorganic material (Implant) 22 being removed from or inserted into the organic material (e.g., patent or subject) 30). In such embodiments, the one or more inorganic data files (e.g., at least one Implant data fde) 26 is configured thereafter as a VTDO and / or further optionally as an OTDO for the visualization 28 through the viewing device 24 (e.g., as seen by the User 50). Harmonization between the visualization 28 of the at least one inorganic data fde (e.g., at least one Implant data fde) 26, and the external features 54 and / or internal features 56, may include at least one image data 32 and / or the organic material (e g., patient or subject) 30, and may further include the inorganic material (e.g., Implant) 22. Such visualizations 28 or 28A include asurface(s) 44 and / or at least one negative space 48 of the at least one inorganic data fde (e.g., the at least one Implant data fde) 26. Such surface(s) 44 and / or at least one negative space 48 are configured, further configured, or reconfigured through the visualization 28, or said differently, by way of the user 50 interfacing with the viewing device 24 and / or interface device 38 and executing one or more commands 68.

[0152] The visualization 28 including the at least one inorganic data file (e.g., at least one Implant data file) 26 may include harmonization with the organic material (e.g., patient or subject) 30, the physical model (e g., a TDPM) 34, an inorganic material (e.g., Implant) 22 (e.g., where the inorganic material (e.g., Implant) 22 is within an organic material (e.g., patient or subject) 30, or is within a physical model (e.g., a TDPM) 34) where tissues (e.g., an organ system, the muscular system, etc.) 86 are selected (e.g., shown in the visualization) and certain tissues 86A are not selected (e.g., hidden from the visualization 28). Such visualization 28 includes a surface(s) 44 and / or at least one negative space 48 of the at least one inorganic data file (e.g., the at least one Implant data file) 26. Such surface(s) 44 and / or at least one negative space 48 are configured, further configured, or reconfigured through the visualization 28, or said differently, by way of the user 50 interfacing with the viewing device 24 and / or interface device 38 and executing one or more commands 68.

[0153] Through the viewing device 24, one or more respective layers 66 of the visualization 28 including the at least one inorganic data file (e g., at least one Implant data file) 26 correlate to one or more respective layers 66 on or within the inorganic material (Implant) 22, the organic material (e.g., patient or subject) 30, and / or the physical model (e.g., the TDPM) 34. Said differently, the visualization 28 through the viewing device 24 harmonizes the at least one inorganic data file (e.g., at least one Implant data file) 26 with the inorganic material (Implant) 22, the organic material (e.g., patient or subject) 30, and / or the physical model (e.g., the TDPM) 34.

[0154] By way of example, the external features 54 of the organic material (e.g., patient or subject) 30 correlates to the external features 54 shown in the visualization 28 through the viewing device 24. By way of a second example, as the medical professional 40 interacts with the organic material (e.g., patient or subject) 30 by way of internal features 56, the visualization 28 as shown through the viewing device 24 shows correlating internal features 56. The external features 54and / or internal features 56 through the visualization 28 can be selected on the viewing device 24 and / or an interface device 38 as contemplated above such that a certain tissue and / or portion of an organ system 86 is shown while others are hidden.

[0155] By way of example, the external anatomical features 55 of the physical model 34 correlates to the external features 54 shown in the visualization 28 through the viewing device 24. By way of a second example, as the user 50 interacts with the physical model 34 by way of internal anatomical features 57, the visualization 28 as shown through the viewing device 24 shows correlating internal features 56. The external features 54 and / or internal features 56 through the visualization 28 can be selected on the viewing device 24 and / or an interface device 38 as contemplated above such that a certain tissue and / or portion of an organ system 86 is shown while others are hidden.

[0156] Similarly, a physical model 34 can be created by selectively including only certain tissue and / or portion of an organ system 86.

[0157] In some embodiments, the visualization 28 includes at least one inorganic data fde (e.g., at least one Implant data file) 26 including material composition and / or mechanical properties that enable projections for potential failure modes. In some embodiments, the visualization 28 includes at least one inorganic data file (e.g., at least one Implant data file) 26 created from one or more used Implant(s) 22(N) thereby showing wear or fatigue over time. Such visualizations 28 are advantageous in that the visualization 28 demonstrates how the inorganic material (Implant) 22 may function over a period of time (e.g., the inorganic material (e.g., Implant) 22 life cycle).

[0158] In certain embodiments, the external anatomical features 55 of the physical model 34 are the same as the external anatomical features 54 in the visualization 28 as seen by the user 50 through the viewing device 24. In such embodiments, the one or more image data 32 optionally configured thereafter as a VTDO and / or further optionally as a TDO generated the physical model 34, and also optionally configured as a VTDO and / or further optionally as an OTDO for the visualization 28. In certain embodiments, the internal anatomical features 57 of the physical model 34 are the same as the internal features 56 seen by the user 50 through the viewing device 24. In such embodiments, the one or more image data 32 generates both the physical model 34 and thevisualization 28 [as seen by the user 50 through the viewing device 24], Such visualization 28 may include a surface(s) 44 and / or at least one negative space 48 of the at least one inorganic data fde (e.g., the at least one Implant data fde) 26. Such surface(s) 44 and / or at least one negative space 48 are configured, further configured, or reconfigured through the visualization 28, or said differently, by way of the user 50 interfacing with the viewing device 24 and / or interface device 38 and executing one or more commands 68. Such surface(s) 44 and / or the at least one negative space 48 is harmonized with the physical model 34.

[0159] In certain embodiments, a first image data set 32 corresponds to a first organic material (e.g., second patient or subject) 30 and a second image data set 32A corresponds to a second organic material (e.g., second patient or subject) 30A. Alternatively, a first image data set 32 corresponds to an organic material (e.g., patient or subject) 30 in a first condition and a second image data set 32A corresponds to an organic material (e.g., patient or subject) 30 in a second condition. The at least one inorganic data file (e.g., at least one Implant data file) 26 representing the Implant is harmonized with the first image data set 32 and / or the second data set 32A. In some embodiments, at least one inorganic data file (e.g., at least one Implant data file) 26A representing the Implant is harmonized with the second data set 32A and / or the first data set 32. In either embodiment, a physical model (e.g., TDPM) 34 is generated by way of the three-dimensional printing apparatus 64 from the first image data set 32. In either embodiment, a second physical model (e.g., TDPM) 34A may also be generated by way of the three-dimensional printing apparatus 64 from the second image data set 32A. In an example of such embodiments, each of the first physical model (e.g., the TDPM) 34 and the second physical model (e.g., the TDPM) 34A may include either of the at least one first inorganic data file (e.g., at least one first Implant data file) 26 or the at least one second inorganic data file (e.g., at least one first Implant data file) 26A. The visualization 28 [as seen by a user 50 of the viewing device 24] is generated from the first image data set 32 and the at least one first inorganic data file (e.g., at least one first Implant data file) 26. A second visualization 28A [as seen by a user 50 of the viewing device 24] is generated from the second image data set 32A and the at least one second inorganic data file (e.g., at least one second Implant data file) 26A. The user 50 of the viewing device 24, by way of registration 84, is able to generally co-locate the visualization 28 to the physical model (e.g., the TDPM) 34 or 34A such that one or more respective layers 66 of the visualization 28 generally correspond to one or more layers 66 of the physical model (e.g., the TDPM) 34 or 34A. Harmonizing the visualization28 or 28A with the physical model (e.g. TDPM) 34A or 34, respectively, may help the user 50 (e.g., an organic material (e.g., patient or subject) 30 or 30A, and / or a medical professional or trainee 40) make comparisons between different organic materials (e.g., patients or subjects) 30 or 30A, and / or an organic material (e.g., patient or subject) 30 in a first condition versus a second condition, including where a first inorganic material (e g., Implant) 26 (e.g., of a first type, a first component, in a first condition, for a left side joint) is different from a second inorganic material (e.g., Implant) 26A (e.g., of a second type, a second component, in a second condition, for a rightsidejoint, etc.). Such visualizations 28 or 28A include a surface(s) 44 and / or at least one negative space 48 of the at least one inorganic data file (e.g., the at least one Implant data file) 26. Such surface(s) 44 and / or at least one negative space 48 are configured, further configured, or reconfigured through the visualization 28, or said differently, by way of the user 50 interfacing with the viewing device 24 and / or interface device 38 and executing one or more commands 68.

[0160] Referring again to FIG. 12, in further embodiments, an object (e.g., a medical instrument) 36 is provided. The object 36 may include at least one tracker 42. The object 36 is included in the visualization 28. The object 36 interacts with the at least one inorganic data file (e.g., at least one Implant data file) 26 (e.g., a VTDO) in the visualization 28. The object 36 may interact with the surface 44 (e.g., engage a portion of the perimeter) of the at least one inorganic data file (e.g., at least one Implant data file; e.g., a VTDO) 26. The object 36 may engage with negative space 48 of the at least one inorganic data file ((e.g., at least one Implant data file; e.g. a VTDO) 26. Furthermore, the user 50 may configure, further configure, or reconfigure either or both of the surface (e.g., the first surface, the second surface, . . . the nth surface) 44 and / or the negative space (e.g., the at least one negative space) 48 of the at least one inorganic data file (e.g., the at least one Implant data file; e.g., a VTDO) 26. Configuration may include registration through the visualization 28, or said differently, by way of the user 50 interfacing with the viewing device 24 and / or interface device 38 and executing one or more commands 68. The visualization 28 may include the at least one organic material (e.g., patient or subject) 30. The object 36 interacts with the at least one organic material (e.g., patient or subject) 30. The object 36 interacts with the external features 54 of the organic material (patient or subject) 30. The object 36 interacts with the internal features 56 of the at least one organic material (e.g., patient or subject) 30. In some embodiments, the visualization 28 may include the at least one physical model (e.g., the TDPM)34. Tn some of these embodiments, the object 36 may also interact with the external features 54 and / or the internal features 56 of the at least one physical model (e.g., a TDPM) 34.

[0161] In further embodiments, an organic material (e.g., patient or subject) 30 and / or a physical model 34 and the visualization 28 including at least one inorganic data fde (e.g., at least one Implant data fde) 26 and optionally at least one image data 32 and optionally are provided in concert with an object 36 (e.g., a medical instrument). A first set of image data 32 is associated with the organic material (e.g., patient or subject) 30 and / or a physical model 34. The viewing device 24 provides a visualization 28 of the at least one inorganic data file (e.g., at least one Implant data file) 26 and optionally a first set of image data 32. The visualization 28 via the viewing device 24 or interface device 38 is registered to at least the organic material (e.g., patient or subject) 30 and / or the physical model 34. At least a second inorganic data file (e.g., at least one second Implant data file) 26A and optionally a second set of image data 32A is provided and relates to one or more of the following: the organic material (e.g., patient or subject) 30 (e.g., with an inorganic material (e.g., Implant) 22, or 22A) in a second state [that is different than the first state having the first inorganic material (e.g., Implant) 22 and optionally that led to the first set of image data 32], In one such embodiment, the at least one second inorganic data file (e.g., at least one second Implant data file) 26Aand optionally the at least second set of image data 32A regards the organic material (e g., patient or subject) 30 in a second state that is different than the first state [having the inorganic material (e.g., Implant) 22 and optionally that led to the first set of image data 32], whereby the first state and the second state regard extents or extreme conditions of at least a portion of the organic material (e.g., patient or subject) 30 during the procedure. For instance, if the medical procedure regards a knee and at least surrounding portions of a leg, the first state is optionally when the knee is with an existing / used Implant 22, and the second state is optionally when the knee includes a new Implant 22A. Similar to the aforementioned exemplary embodiments, the internal features 56 in the visualization 28 by way of the viewing device 24 can be selected as contemplated above such that a certain tissue and / or portion of an organ system 86 is shown while others are hidden. Similarly, a physical model 34 can be created by selectively including only certain tissue and / or portion of an organ system 86.

[0162] As exemplified in FIG. 12, in embodiments utilizing XR technologies such as MR, the inorganic material (e.g., Implant) 22, the organic material (e.g., patient or subject) 30, thephysical model (e.g., aTDPM) 34, an object (e.g., a medical instrument) 36, a medical professional 40, and / or a user 50, etc., that may be subject to a visualization 28 by way of the XR viewing device 24 (e.g. MR viewing device 24) can be seen as-is. For instance, a portion of the user 50 such as an arm or hand may be viewable in the visualization 28, and similarly, implements or objects 36 are also viewable (e.g., tables, medical instruments, etc.) in the visualization 28. In some embodiments, a portion of the user 50 is a mapped portion 80 such that the interface device 38 and / or XR viewing device 24 will respond to and / or perform specific tasks upon specific body movement of the mapped portion 80. For instance, when using HOLOLENS®, one or both of a user’s 50 wrists and one or both of a user’s index fingers are mapped portions 80. Upon a user 50 putting his / her index finger 80A on one hand on his / her wrist (e.g., the upper side or the lower side of the wrist) 80B adjacent the other hand will prompt a menu and / or command 68 to the viewing device 24 and / or interface device 38. In certain embodiments, once a user 50 putting his / her index finger 80A on one hand on his / her wrist 80B adjacent the other hand and a menu 68 is prompted, the viewing device 24 and / or the interface device 38 will allow the user 50 to enter a further command 68 manually or virtually. In other embodiments, a button or a menu 68 is viewable and / or can be interacted with on the viewing device 24 and / or interface device 38. The user 50 is able to, by virtue of the user’s finger 80A being a mapped portion 80, is able to virtually touch the button 68 (at least as seen on the visualization 28 created by the viewing device 24) and thereby make a selection or other command 68 in accordance with the button identified by reference numeral 68. Such examples of portions of a user’s 50 body that are mapped portions 80 are exemplary and nonlimiting.

[0163] Harmonization will vary in clarity due to variations in precision, accuracy, and system limitations including the resolution of the viewing device 24, processing speeds of the controller 52 and / or the viewing device 24 and / or the interface device 38, refresh rate of the viewing device 24, internet connection speed of the viewing device 24, the interface device 38, and / or the controller 52, etc..

[0164] The system for visualizing organic and inorganic materials 20 includes a system controller 52. The system controller 52 is in communication with other components (e.g., the viewing device 24, the three-dimensional printing apparatus, 64, the imaging device 58, the interface device 38, etc.). The system controller 52 may be in communication with thesecomponents to control and / or receive signals therefrom to perform the functions described herein. The system controller 52 may include any type of computing device, computational circuit, processor(s), CPU, computer, or the like capable of executing a series of instructions that are stored in memory, including the ability to execute what is often referred to as a machine learning algorithm. The instructions may include an operating system, and / or executable software modules such as program fdes, system data, buffers, drivers, utilities, and the like. The executable instructions may apply to any functionality described herein to enable the inspection system to accomplish the same algorithmically and / or coordination of system components. The system controller 52 includes or is in communication with one or more memory devices. The present disclosure is not limited to any particular type of memory device, and the memory device may store instructions and / or data in a non-transitory manner. Examples of memory devices that may be used include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, and / or any device that stores digital information, including cloud storage 94. The system controller 52 may include, or may be in communication with, an interface such as either or both of an input device that enables a user to enter data and / or instructions, and may include, or be in communication with, an interface device configured, for example to display information (e.g., a visual display that may be the same or different from the viewing device 24), or to transfer data, etc. Such interface enables a digital board, display screen, a GUI, and / or XR. Communications between the system controller 52 and other system components may be via a hardwire connection or via a wireless connection and include cloud networking / storage 94, including radio frequency, blue tooth, wi-fi, li-fi, etc.. The system for visualizing organic and inorganic materials 22 is powered by known means and components may have separate and / or different power sources (e.g., electrical, battery, fuel cell, etc.).

[0165] Software systems compatible with the aforementioned imaging devices 58 such as MID’s 58 are suitable for generating the VTDO, TDO, and / or OTDO of the present disclosure. Software systems compatible with the aforementioned viewing devices 24 such as but not limited to XR devices 24 include without limitation: the INTRAVISION XR or VSI made by APOQLAR are suitable for generating the OTDO of the present disclosure. Software systems compatible with the aforementioned three-dimensional printing apparatus’ 64 such as but not limited to the INTRAVISION XR are suitable for generating the OTDO of the present disclosure.

[0166] Artificial intelligence by way of one or more machine learning algorithms (e.g., a neural network) is(are) optionally included in the software of the present disclosure.

[0167] Referring back to FIG. 2, Once the three-dimensional printing apparatus 64 receives the at least one set of image data (or VTDO or TDO) 32 and / or at least one inorganic data file (e.g., at least one Implant data file) 26, a TDPM 34 can be generated. Optionally, the user 50 can, via an interface 38, provide inputs to confirm specifications of the TDPM 34 to be generated, including, for instance, at least one biometric information file 100. Optionally, the user 50 of the three-dimensional printing apparatus 64 is provided information with respect to the TDPM 34 to be generated and the three-dimensional printing apparatus 64, also by an interface 38. Suitable three-dimensional printing apparatus 64 include those that remove material from an object to generate a TDPM 34, and / or also by way of additive manufacturing. Exemplary three-dimensional printing apparatus 64 are made by STRATASYS® or similar other manufacturers, and include exemplary models such as those sold as the 8 Series such as the J850 PRO. The user 50 may select options such as one or more different colors and / or one or more different materials to further depict at least one tissue or organs 86 and / or one or more inorganic materials (e.g., one or more Implants) 22 in the TDPM 34. Each of a first color or material is identified by reference numeral 96. Each of a second color or material is identified by reference numeral 98. One of skill in the art appreciates that there may be more than two colors and / or more than two materials utilized with a given TDPM. Such one or more materials are optionally selected based on material and mechanical properties that simulate the one or more tissues or organs 86 and / or or one more inorganic materials (e.g., one or more Implants) 22. In some exemplary embodiments, at least two colors and / or at least two different materials are provided in the TDPM 34, where each of the at least two colors and / or at least two different materials are representative of at least two different tissues or organs 86a, 86b and / or at least two different inorganic materials (e.g., Implants) 22, 22A. Materials utilized in such three-dimensional printing apparatus 64 include various resins, metals, etc..

[0168] The controller 52 is operatively connected to the viewing device 24, instructing the viewing device 24. In some embodiments, the controller 52 is instructed by user 50 inputs on an interface 38 (such as an input device that includes but is not limited to: a keyboard, mouse, stylus, GUI, etc.). The controller 52 provides the at least one inorganic data file (e.g., the at least oneImplant data file) 26 and / or at least one set of image data 32 and / or at least one biometric information file 100 to the viewing device 24 in a suitable file format such as, without limitation, a .OBJ, MTL (e.g., file format for color and shading generally utilized with a .OBJ file), .STL, 3MF, .X3D, .WLR, etc.. The controller 52 transmits the at least one Implant data file 26 and / or at least one set of image data (or VTDO) 32 in the aforementioned file format to the viewing device 24 and the viewing device 24 thusly receives the at least one inorganic data file (e.g., the at least one Implant data file) 26, at least one set of image data (or VTDO) 32 and / or at least one biometric file 100 in such suitable file format. The controller 52 includes software and / or algorithms capable of submitting the instructions to the viewing device 24. The controller 52 is equipped to store and process the at least one inorganic data file (e.g., the at least one Implant data file) 26, at least one set of image data (or VTDO) 32 and / or at least one biometric file 100, as contemplated in the present disclosure. Optionally, the viewing device 24 is equipped to store and process the at least one inorganic data file (e.g., the at least one Implant data file) 26, at least one set of image data (or VTDO) 32, and / or at least one biometric file 100 as contemplated in the present disclosure.

[0169] In some embodiments, the controller 52 is not operatively connected to the viewing device 24 and as such, the at least one Implant data file 26 and / or the at least one set of image data 32 is transferred to the viewing device 24 by way of an external drive or other forms of electronic communication such as a cloud storage 94 location, email, etc.

[0170] In certain embodiments, utilizing a viewing device 24, controller 52, and interface device 38, with specific properties is desirous, particularly if relating to a specific type of medical procedure (as will be discussed in greater detail below). For instance, one or more of the following properties may be preferable: resolution, processing speed, random access memory (RAM), internet connection speed, upload rate, download rate, internet signal strength, etc. In some embodiments, the viewing device 24, controller 52, and interface device 38, has 2 gigabytes of RAM, 4 gigabytes of RAM, 8 gigabytes of RAM, 16 gigabytes of RAM, 24 gigabytes of RAM, 32 gigabytes of RAM, 48 gigabytes of RAM, or between 2 gigabytes and 48 gigabytes of RAM. In some embodiments, the viewing device 24, controller 52, and interface device 38, has a refresh rate of at least 60HZ, at least 120HZ, or at least 240HZ, or between 60HZ and 240HZ. In some embodiments, the viewing device 24 includes a minimum resolution of 780P, 1080P, 2140P, 4280P,etc. In some embodiments, the viewing device 24 is at least one XR device. In some such embodiments, the viewing device 24 is at least one VR, AR and / or MR device.

[0171] As exemplified in FIGS. 13-14A, various menu options 68 are provided on the visualization 28 by way of the XR device which is both an interface device 38 and a viewing device 24. Menu options 68 such as the main menu 102, home 104, back 106, save (and optionally, save offline) 108, segmentation 82, cutting plane 110, boundary box (or registration) 84, and information (or settings, support, profile, etc.) 112 are provided. In greater detail, the cutting plane option enables a user to view only a portion of the visualization 28 (e.g., OTDO). By way of example, the visualization 28 (e.g., OTDO) may include an entire section of the organic material (e.g., the entire torso of a patient or subject) 30, and the user can choose to limit the visualization 28 to only a portion of the organic material (e.g., the torso) 30. The boundary box (or registration) 84 allows a user to harmonize the visualization 28 to the inorganic material (e.g., Implant 22), the organic material (e.g., the patient or subject) 30, the object 36, and / or physical model (e.g., TDPM) 34. The boundary box (or registration) 84 includes nodes 114 that allow the user to align the visualization 28 to the inorganic material (e.g., Implant) 22, the organic material (e.g., patient or subject) 30, the object 36, and / or the physical model (e.g., the TDPM) 34. Optionally, branding 116 is provided on the screen.

[0172] Upon selecting the segmentation 82 option, additional menu options are provided. Segmentation 82 options such as a fixation wire (e.g., kwire) 118, fiducials 120, bones 122, and soft tissue 124 allow the user to select certain of tissues or organs 86 that will be a part of the visualization 28. Optionally a “select all” 126 option is available enabling a user to segment 82 with multiple tissue or organ systems 86, and / or also with a fixation wire 118 such as a surface feature format and / or the kwire format. Further menu options include “remove from cut” 138, where a user may select one or more segmentation 82 options to be removed at a certain section, along a certain axis, or in a certain plane. One of skill in the art appreciates that other menu options 68 are possible. With regard to FIGS. 13 and 13 A, the menu option for soft tissue 124 was selected by the user 50. With regard to FIGS. 14 and 14A, the menu option for bones 122 was selected by the user 50.

[0173] Further menu options enable recording and saving, and thereafter playing back the recording. During such a recording, additional features such as rewind 128, play 130, and / or fast forward 132 are provided. Such features allow for rewinding or fast-forwarding the recording or projection / simulation at a specific time interval (e.g. 10 seconds, 20 seconds, 30 seconds, etc.), and an exemplary time interval bar 134 (running horizontally across within the lower third of the visualization 28) can be seen on FIGS. 6A-6C, where FIG. 6B shows the video has elapsed by way of the progress circle on the time interval bar 134. The play 130 button may also function as a stop or pause button.

[0174] While the present disclosure exemplifies menus 68 in various locations such as on the left-hand side, top, and bottom, menus 68 and prompts can be provided in other locations, including the center and / or the right-hand side. Similarly, the order of menu options 68 can vary depending on the software and / or user preferences. Similarly, other synonyms, acronyms or abbreviations may be utilized for names of menu 68 options.

[0175] In some embodiments, a physical model 34 may be included, particularly for embodiments including a training simulation, a hybrid training simulation and surgical procedure, and / or a walk-through consultation. In such embodiments, a three-dimensional printing apparatus 64 may be included (e.g., utilized to generate the physical model such as a TDPM 34). In such embodiments, an imaging device 58 may be included (e.g., to generate the one or more image data 32 of the organic material (e.g., the patient or subject) 30 utilized by the three-dimensional printing apparatus 64 to generate the physical model such as a TDPM 34).

[0176] The present disclosure is useful in a number of in vitro and / or in vivo procedures, including those delivering medical care to a patient 30, training medical professionals 40, performing research, etc. The present disclosure, by way of the visualization 28 viewable by way of the at least one viewing device 24 (e.g., more than one viewing device 24 such that multiple medical personnel and / or students and / or patients can engage with and / or simply view the visualization 28, and others can engage both with a viewing device 24 harmonized with the physical model such as a TDPM 34) and controller 52, and optionally by way of the at least one physical model such as a TDPM 34 (e.g., more than one TDPM 34 that are replicates and / or are variants), and further includes activities such as virtual or remote consultation, virtual or remotementoring, medical procedure planning, medical procedure practice, and also guidance during a medical procedure. Such activities may include multiple users utilizing computers, mobile devices, tablets, etc., with headsets, and / or other scenarios where multiple users having XR viewing devices 28 such as XR headsets and are thusly able to engage with the visualization 28. In some such embodiments, certain users may have “view only” ability or further limited functionality such that only their local visualization 28 is modified, while other users may have unlimited ability and are thus able to modify functionality of the visualization 28 for more than one user.

[0177] While the principles of the disclosure have been described above in connection with specific apparatuses and methods, it is to be clearly understood that this description is made only by way of example and not as limitation on the scope of the disclosure. Specific details are given in the above description to provide a thorough understanding of the embodiments. However, it is understood that the embodiments may be practiced without these specific details.

[0178] It is noted that the embodiments may be described as a process which is depicted as a flowchart, a flow diagram, a block diagram, etc. Although any one of these structures may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be rearranged. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc.

[0179] The singular forms “a” “an” and “the” refer to one or more than one, unless the context clearly dictates otherwise. For example, the term “comprising a specimen” includes single or plural specimens and is considered equivalent to the phrase “comprising at least one specimen”. The term “o” refers to a single element of stated alternative elements or a combination of two or more elements unless the context clearly indicates otherwise. As used herein, “comprise” means “includes”. Thus, “comprising A or B” means “including A or B, or A and B” without excluding additional elements.

[0180] It is noted that various connections are set forth between elements in the present description and drawings (the contents of which are included in this disclosure by way of reference). It is noted that these connections are general and, unless specified otherwise, may be direct or indirect and that this specification is not intended to be limiting in this respect. Anyreference to attached, fixed, connected or the like may include permanent, removable, temporary, partial, full and / or any other possible attachment option.

[0181] No element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase “means for.” As used herein, the terms “comprise”, “comprising”, or any other variation thereof, are intended to cover a nonexclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0182] While various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts, and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative embodiments as to the various aspects, concepts, and features of the disclosure- such as alternative materials, structures, configurations, methods, devices, and components, and so o- may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional embodiments and uses within the scope of the present application even if such embodiments are not expressly disclosed herein. For example, in the exemplary embodiments described above within the Detailed Description portion of the present specification, elements may be described as individual units and shown as independent of one another to facilitate the description. In alternative embodiments, such elements may be configured as combined elements. It is further noted that various method or process steps for embodiments of the present disclosure are described herein. The description may present method and / or process steps as a particular sequence. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art wouldappreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the description should not be construed as a limitation.

Claims

What is claimed is:

1. A system for visualizing organic and inorganic materials , comprising: at least one inorganic data fde of an inorganic material; one or more viewing devices, the one or more viewing devices is configured to display a visualization of the inorganic material with the at least one inorganic data file harmonized with at least one of an organic material, at least one image data file, and a physical model; and wherein the visualization of the inorganic material includes a surface of the inorganic material.

2. The system according to claim 1, wherein the surface includes a partition defining a first surface and a second surface.

3. The system according to claim 2, wherein the surface includes a first perimeter and a second perimeter.

4. The system according to claim 3, wherein the first perimeter is an outer perimeter, and the second perimeter is the partition.

5. The system according to claim 1, wherein the surface includes a first visual marker.

6. The system according to claim 5, wherein the surface includes a second visual marker that is different from the first visual marker.

7. The system according to claim 6, wherein the first visual marker corresponds to a first surface, and wherein the second visual marker corresponds to a second surface.

8. The system according to claim 1, wherein the surface includes at least one negative space of an interior region of the inorganic material.

9. The system according to claim 8, wherein the at least one inorganic data file is configured to include either or both of the surface and the at least one negative space, and wherein the at least one inorganic data file is configured either before being submitted into the system, or is configured after being submitted into the system.

10. The system according to claim 9, wherein the inorganic material includes the interior region, and wherein the at least one negative space is associated with the interior region.

11. A system for visualizing organic and inorganic materials , comprising:at least one inorganic data file of an inorganic material; one or more viewing devices, the one or more viewing devices is configured to display a visualization of the inorganic with the at least one inorganic data file harmonized with at least one of an organic material, at least one image data file, and a physical model; and wherein the visualization of the inorganic material includes at least one negative space of the inorganic material.

12. The system of claim 11, wherein the at least one negative space is defined by at least one first perimeter and at least one second perimeter.

13. The system of claim 12, wherein the at least one first perimeter is an outer perimeter, and the at least one second perimeter is an inner perimeter.

14. The system according to claim 12, wherein the at least one negative space includes a partition defining a first negative space and a second negative space.

15. The system according to claim 14, wherein the first perimeter is an outer perimeter, and the second perimeter is the partition.

16. The system according to claim 11, wherein the at least one negative space includes a first visual marker.

17. The system according to claim 16, wherein the at least one negative space includes a second visual marker that is different from the first visual marker.

18. The system according to claim 17, wherein the first visual marker corresponds to a first negative space, and wherein the second visual marker corresponds to a second negative space.

19. The system according to claim 18, wherein the first negative space and the second negative space are separated by a partition.

20. The system according to claim 19, wherein the at least one negative space is within a surface of the inorganic material.

21. A system for visualizing organic and inorganic materials 20 according to any preceding claim, comprising: at least one inorganic data file 26 of an inorganic material 22; one or more viewing devices 24, the one or more viewing devices 24 is configured to display a visualization 28 of the inorganic material 22 with the at least one inorganic data file 26harmonized with at least one of an organic material 30, at least one image data 32, and a physical model 34; and wherein the visualization 28 of the inorganic material 22 includes a surface 44 of the inorganic material 22.

22. The system 20 according to any preceding claim, wherein the surface 44 includes a partition 88 defining a first surface 70C and a second surface 74C.

23. The system 20 according to any preceding claim, wherein the surface 44 includes a first perimeter 44 A and a second perimeter 44B.

24. The system 20 according to any preceding claim, wherein the first perimeter 44A is an outer perimeter, and the second perimeter 44B is the partition 88.

25. The system 20 according to any preceding claim, wherein the surface 44 includes a first visual marker 136A.

26. The system 20 according to any preceding claim, wherein the surface 44 includes a second visual marker 136B that is different from the first visual marker 136.

27. The system 20 according to any preceding claim, wherein the first visual marker 136A corresponds to a first surface 70C, and wherein the second visual marker 136B corresponds to a second surface 74C.

28. The system 20 according to any preceding claim, wherein the surface 44 includes at least one negative space 48 of an interior region 46 of the inorganic material 22.

29. The system 20 according to any preceding claim, wherein the at least one inorganic data file 26 is configured to include either or both of the surface 44 and the at least one negative space 48, and wherein the at least one inorganic data file 26 is configured either before being submitted into the system 20, or is configured after being submitted into the system 20.

30. The system 20 according to any preceding claim, wherein the inorganic material 22 includes the interior region 46, and wherein the at least one negative space 48 is associated with the interior region 46.

31. A system for visualizing organic and inorganic materials 20 according to any preceding claim, comprising: at least one inorganic data file 26 of an inorganic material 22;one or more viewing devices 24, the one or more viewing devices 24 is configured to display a visualization 28 of the inorganic material 22 with the at least one inorganic data file 26 harmonized with at least one of an organic material 30, at least one image data file 32, and a physical model 34; and wherein the visualization 28 of the inorganic material 22 includes at least one negative space 48 of the inorganic material 22.

32. The system 20 of any preceding claim, wherein the at least one negative space 48 is defined by at least one first perimeter 44A and at least one second perimeter 44B.

33. The system 20 of any preceding claim, wherein the at least one first perimeter 44A is an outer perimeter, and the at least one second perimeter 44B is an inner perimeter.

34. The system 20 according to any preceding claim, wherein the at least one negative space 48 includes a partition 88 defining a first negative space 48 A and a second negative space 48B.

35. The system 20 according to any preceding claim, wherein the at least one first perimeter 44A is an outer perimeter, and the at least one second perimeter 44B is the partition 88.

36. The system 20 according to any preceding claim, wherein the at least one negative space 48 includes a first visual marker 136A.

37. The system 20 according to any preceding claim, wherein the at least one negative space 48 includes a second visual marker 136B that is different from the first visual marker 136A.

38. The system 20 according to any preceding claim, wherein the first visual marker 136A corresponds to a first negative space 48A, and wherein the second visual marker 136B corresponds to a second negative space 48B.

39. The system 20 according to any preceding claim, wherein the first negative space 48A and the second negative space 48B are separated by a partition 88.

40. The system 20 according to any preceding claim, wherein the at least one negative space 48 is within a surface 44 of the inorganic material 22.

Images