System and method for simulating surgical anatomy of human body

Abstract

The present invention relates to systems and methods for simulating surgical anatomy of a human body for purposes of beginner anatomical teaching and advanced surgical teaching, and more particularly, to devices for reproducing a part of a human head or other anatomical part of a human body, reproducing associated anatomy, spatial motion, and methods of surgical pathways thereof.

Description

[0001] This application is a divisional application of the invention patent application with application number "202080016771.3" filed on January 14, 2020 and invention name "Medical learning device based on integrated physics and virtual reality for studying and simulating surgical methods at anatomical locations". Technical Field

[0002] The present invention relates generally to the field of simulation of human surgical anatomy, such as for the purposes of anatomical and surgical teaching. Background Art

[0003] The anatomy of the skull and brain, and more generally, of the central nervous system, exhibits a high degree of complexity. Therefore, understanding it and learning its three-dimensional morphology requires intensive study and repeated practical and observational exercises both on models and on anatomical items in the context of the anatomy laboratory. Since it is not always possible to gain direct experience in the operating room, these exercises require models that are as faithful to reality as possible. In every case, regardless of the possibility of access to the operating room, the learning curve of neuroanatomy and neurosurgery remains long.

[0004] As for the nervous system, especially the skull and the structures contained therein, the complexity is even greater due to the complex spatial relationships and microsurgical possibilities.

[0005] When performing opening of the cranial cavity (craniotomy) for surgical intervention, the view of the interior and of the brain and other anatomical structures is extremely necessarily limited to what is strictly necessary: ​​the extent of the exposed area must be reduced as much as possible in order to increase the patient's tolerance of the surgical treatment and reduce the risk of complications.

[0006] Additionally, it is important to note that due to the magnification of the microscope, the views are often upside down and have anatomical relationships and perspectives that are difficult to visualize and understand.

[0007] For the reasons stated above, even small errors in the spatial orientation of the anatomical part being intervened (in this case the head) or in the positioning of the craniotomy opening (although this also applies, for example, to interventions on the bone marrow or other anatomical regions) can cause significant problems for visualization of the surgical target and compromise the outcome of the intervention.

[0008] Since the patient is positioned on the bed before the intervention begins (before the skin is incised), it is necessary to accurately predict the internal surgical view before the surgical access (surgical approach). For example, in the case of the brain, once the patient is positioned and anesthesia is induced, the head is fixed to a grip (headboard) and remains fixed for the entire duration of the procedure. Therefore, once the intervention begins, the surgeon's possible adjustments are extremely limited and only related to his own position relative to the surgical field. Therefore, the positioning of the patient's head requires a high degree of familiarity with the anatomy and three-dimensional visualization capabilities, which allow the surgeon to foresee which is the appropriate view before opening. An error in the positioning of the patient's head constrains the surgeon to operate in an ergonomically unsuitable position for the entire duration of the intervention, which is usually several hours in duration. The surgeon's uncomfortable and unnatural position can cause muscle fatigue, produce positional jitters, which can impair the fluidity and quality of the microsurgical procedure. Potential incorrect positioning of the head can also change the perception of the perspective relationship between anatomical structures, disorienting the surgeon and increasing the risk of errors (incorrect partial resection of a tumor, when in fact it can be completely resected; accidental damage to anatomical structures to be preserved).

[0009] Equipment for studying anatomy consisting of anatomical models that reproduce the skull and, in some cases, the structures contained therein, is commercially available. These models make it possible to study anatomy by reproducing the central nervous system, usually using an anatomical display, or by breaking down the parts, in other words, not a surgical display (by means of a craniotomy).

[0010] Commercially available devices typically include a reproduction, such as the cranial cavity, and one or more internal structures (brain, brainstem, nerves, blood vessels) inside the head, with varying degrees of approximation and simplification (rigid structures, smaller structures not shown or reproduced as parts of larger structures, etc.).

[0011] Typically, intracranial contents are thus represented by a series of rigid modular elements, each of which reproduces a part of the brain.

[0012] This solution, although it provides a useful supplement to basic research on the central nervous system (medical and surgical degree courses), also has some disadvantages.

[0013] The first problem is that access to the cranial interior of these models is usually not through an opening corresponding to a neurosurgical approach, but rather through a mechanical disassembly of model fragments and thus through an anatomical rather than surgical logic of representation (eg, crude sectioning).

[0014] One consequence of this limitation is that students are unable to learn the correct perspective of the various internal components relative to each other from a surgical perspective (several centimeters of craniotomy), which can also vary significantly depending on the positioning of the skull opening and the three-dimensional spatial orientation of the skull.

[0015] Furthermore, smaller but still important elements, such as blood vessels and nerves, are often not shown as separate parts but as parts of larger elements and this does not allow the user / student to understand them in their correct position and significance as this does not allow the surgeon to perform proper studies and adequate preparation for the intervention.

[0016] Other devices that are able to represent greater anatomical detail are often limited in the type of physical consistency of the structure itself as well as the surface appearance. Therefore, since surgical learning is not only about visual learning but also about microsurgical manipulation, these rigid devices do not provide the relevant type of tactile experience in teaching terms.

[0017] Another drawback of currently available dissection devices is that they do not make it possible to reproduce the various dissection steps of soft tissues, such as scalp tissue (cutting the skin, cutting subcutaneous and muscle tissue, performing a craniotomy, cutting the meninges).

[0018] Another disadvantage of the prior art is that students at an advanced stage (doctors in specialized neurosurgery training) are unable to simulate surgical locations on the surgical field or perform microsurgical operations on biological tissue using appropriate surgical instruments with currently available equipment.

[0019] Another shortcoming of the prior art is that, while it is possible to have physical anatomical models that can simulate microsurgical perspectives, these models do not suggest the steps of performing a surgical procedure (eg, cutting the skin, etc.). Summary of the invention

[0020] The main purpose of the present invention is to implement a device that reproduces the morphology of the skull or a part thereof, its contents or other anatomical areas of the nervous system or other body parts and simulates surgical access and its spatial movements, with the aim of at least partially overcoming the problems of the prior art.

[0021] These and other objects, as will become clearer hereinafter, are achieved by a system for simulating the movement and form of a human anatomical part, the system comprising: a digital image processing system; a three-dimensional physical module for partially representing a human anatomical part, comprising a container defining a volume defined in the context of a predetermined anatomical position, the container including a plurality of anatomical elements, the container having an opening representing a predetermined surgical window for performing surgery within the anatomical position included in the container; a support movable in three dimensions to position and orient the physical module in three-dimensional space; a plurality of associated markers positioned on the container and the anatomical elements, each of the plurality of markers being adapted to identify a position and one or more features of the container or associated anatomical part in three-dimensional space, and transmitting information about the position and about the one or more features to the digital image processing system; an image acquisition system adapted to capture images of the container, the anatomical elements and the markers, and transmit them to the image processing system, the image processing system being adapted to generate an augmented reality view based on information received from the markers and from the image acquisition system, and to represent the view on a monitor.

[0022] In a preferred embodiment of the invention, the container represents a portion of a human skull and the opening is a craniotomy / craniectomy window.

[0023] Preferably, the anatomical elements include one or more of the following: cerebral / cerebellar parenchyma, brain stem, cranial nerves, arterial / venous vessels, venous sinuses, meninges (dura mater, arachnoid mater, pia mater), biological fluids (cerebrospinal fluid, blood), and each of the multiple anatomical elements included in the container is made of a material that reproduces the physical characteristics of the corresponding real anatomical element.

[0024] In one possible embodiment, the opening of the container is covered so as to simulate an integral portion of a human skull corresponding to a predetermined surgical window for performing surgery within the anatomical portion included in the container, the portion of the human skull being prepared to be cut during a surgical simulation of a craniotomy / craniectomy intervention.

[0025] The support may be connected to the image processing system and arranged to transmit information about the position and orientation of the container to the digital image processing system. In this case, the augmented reality view generated and displayed by the digital image processing system is also based on the information received from the support. In a preferred embodiment, the support comprises three concentric spherical caps, each of which is arranged to move along one of the spatial coordinates of the three-dimensional Cartesian system.

[0026] In a preferred embodiment, the portion representation module is arranged to receive a plurality of interchangeable containers, each interchangeable container representing a different portion of the anatomical location.

[0027] The invention also relates to an interchangeable container representing a portion of the human anatomy, comprising a plurality of anatomical elements, which container is suitable for use in the above-mentioned system.

[0028] Another aspect of the present invention implements a method for simulating the movement and form of a human anatomical part through a system as described above, the method comprising the following steps: acquiring representations of multiple anatomical elements through an image acquisition system; receiving information about the position and orientation of a container from a movable support; obtaining information about the position and one or more features of the anatomical element associated with each marker from at least one marker; generating an augmented reality view of the anatomical part and representing the view on a monitor.

[0029] In a preferred embodiment, the method is used for simulating a neurosurgical procedure and is characterized by the sequential integration of a virtual simulation phase based on a virtual representation of the surgical scene and a physical simulation phase based on a physical representation of the scene. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The characteristics and advantages of the device and method according to the invention will become more apparent from the following description of an embodiment thereof given by way of non-limiting example with reference to the accompanying drawings, in which:

[0031] Figure 1 is an overall view of a surgical simulator according to a preferred embodiment of the present invention;

[0032] Figure 2 and 3 Shows Figure 1 The components of the simulator;

[0033] Figure 4 shows an example rendering of an anatomical portion (in this case a brain portion) container in a surgical simulator according to a preferred embodiment of the present invention;

[0034] Figure 5a , 5b and 6 show two possible types of supports for surgical simulators;

[0035] Figure 7 illustrates the interaction between a mobile device with an augmented reality (AR) application and a surgical simulator;

[0036] Figure 8 A simulator with markings for augmented reality according to a preferred embodiment of the present invention is shown;

[0037] Fig. 9 shows possible uses of the system according to a preferred embodiment of the present invention;

[0038] Fig.10 The general hardware used in the system according to the preferred embodiment of the present invention is schematically shown. DETAILED DESCRIPTION

[0039] The present invention relates to a system and method for simulating human surgical anatomy, intended for both elementary anatomical teaching and advanced surgical teaching, and more particularly to an apparatus for reproducing a portion of a human head or other human anatomical part, the associated anatomy, spatial motion and surgical approach. The present invention is potentially applicable to all conventional surgical disciplines and thus potentially to all human anatomical positions. The application illustrated here is neurosurgery, but experts in the field will readily appreciate that it can be extended to other fields with appropriate adaptations.

[0040] The device according to the present invention is intended for the purpose of studying and learning the surgical anatomy of the nervous system or other anatomical locations. Without wishing to limit the scope of application, this discussion will focus on the central nervous system, in particular the neuroanatomical structures located within the cranial cavity (cerebral / cerebellar parenchyma, brainstem, cranial nerves, arterial / venous vessels, venous sinuses). It is not difficult for those skilled in the art to understand that the system and model of the present invention can be applied to the study and study of the anatomy of other parts of the nervous system, such as the spine, or even under appropriate adjustments, to completely different anatomical regions.

[0041] The embodiments of the present invention described below relate to an apparatus for simulating neurosurgical scenarios, mainly aiming at the following two objectives:

[0042] -Study and expert training in the field of neurosurgery

[0043] - Preoperative planning and simulation of specific ("patient-specific") neurosurgical scenarios.

[0044] A neurosurgical approach refers to a specific access route to a neuroanatomical structure or region (e.g., within the cranium). In the case of the brain, this depends on a precise cranial window, i.e., a craniotomy. The discipline of neurosurgery offers a number of approaches that are standardized in technical terms, and these approaches are differentiated on the basis of the cranial region in which they are produced. For example, frontal approach, temporal approach, etc. Neurosurgical approaches offer various steps, such as skin incision, craniotomy (performing a craniotomy), etc.

[0045] In neurosurgery, especially in cranial neurosurgery, every neurosurgical scenario relies on precise craniotomy, and each craniotomy provides a standard sequence of preceding and following surgical steps: skin incision, dissection of subcutaneous / muscle tissue, drilling, craniotomy, removal of bone flap, dural incision, intracranial exploration of soft tissues (brain, vascular structures, nerves).

[0046] The simulation device according to a preferred embodiment of the present invention is designed and developed to simulate different neurosurgical scenarios. In particular, it reproduces each of the steps provided in the simulation method with the help of a series of physical components (such as material models) and virtual components (such as 3D animation, augmented reality, etc.). Combining these elements in sequence reproduces the complete process workflow required to perform the neurosurgical methods compiled by the academic community. The simulation device according to a preferred embodiment of the present invention can also include pathological scenes in addition to normal anatomical scenes, that is, scenes without displaying pathology. In some cases, these scenes can reproduce real cases.

[0047] In a preferred embodiment of the invention, each surgical scenario (or simulation) is characterized by 2 different elements:

[0048] -Purpose of simulation

[0049] - Development and implementation of models and physical and technical components involved in the simulated execution of a complete surgical procedure, taking into account the purpose of the simulation.

[0050] Based on these characteristics, the simulation of each surgical scenario is implemented with different levels of complexity and completeness in its physical and digital components.

[0051] The device according to the preferred embodiment of the present invention is considered to be an analog system because:

[0052] It is designed in a multidisciplinary format or as a set of specialized simulation devices. The present description specifically relates to neurosurgery use. A person skilled in the art will readily appreciate that the device according to the present invention may also be modified and adapted for use in other anatomical / surgical locations, such as: maxillofacial surgery, otolaryngology, plastic surgery, spinal surgery, thoracic surgery, cardiac surgery, gynecology and urology, plastic surgery.

[0053] It is based on a combination of technologies and performs surgery using multiple components, both physical and virtual, of different nature, which, when properly configured, coexist and cooperate to implement a complete simulation of a specific surgical procedure or a specific pathological condition.

[0054] One of the advantages of the simulation device according to the preferred embodiment of the invention is the possibility of focusing on representing a defined anatomical scene. For example, in the case of neurosurgery, such a scene may constitute a portion of a human skull and the anatomical structures contained therein (cerebral hemispheres, brain stem, arterial and venous vessels, nerves, tissues, etc.).

[0055] The physical components have integrated therein virtual components (software applications interconnected with the anatomical model and based on 3D technology, immersive reality, augmented reality) that are involved in carrying out all and / or some of the surgical steps provided.

[0056] The main features of the simulation device according to the preferred embodiment of the present invention are as follows:

[0057] 1) Provides the user with surgical and anatomical perspectives of the neuroanatomy (inverted view through small access port), unlike standard anatomical models.

[0058] 2) Provides information about the type of triangle (X, Y and Z) that is exactly where it is in space relative to the head or body part of which a part is represented. Note that anatomical structures (especially in neurosurgery) are perceived completely differently depending on the position of the head, given the depth and reduced access space. A few degrees completely changes the perspective, affecting the surgeon's recognition of structures and visual spatial orientation.

[0059] 3) Provide users with interaction with a realistic physical environment that faithfully represents the tactile and visual experience of the specific surgical scenario being studied, as well as the size constraints (surgical space) and manipulation restrictions imposed by visual instruments such as surgical microscopes.

[0060] 4) The integrated use of different digital technologies (e.g., 3D animation, augmented reality, immersive reality, etc.) and physical technologies (e.g., ultra-soft synthetic materials) that are simultaneously and / or sequentially involved in implementing the complete sequence of steps of a personal experience (surgical procedure).

[0061] For example, if the purpose of the simulation is to learn the technique and manual experience of micro-suturing cerebral arterial vessels, the steps of opening and closing the skull are implemented using digital technology, while the physical components of the simulation will need to represent as realistically as possible the brain mass, which the user must retract to open an access path to the underlying blood vessels to be sutured, and the blood vessels themselves, for the actual suturing steps of the blood vessels, which will be performed manually (real tactile and visual experience) using an appropriate needle and thread and appropriate surgical equipment (training in manual and visual-spatial skills and surgical ergonomics).

[0062] In a specific embodiment of the invention relating to a human skull, the system of the invention comprises a physical module 100 such as Figure 1As shown, the module includes a container 101 simulating a part of the cranial cavity, and the container 101 has an opening 103 that allows surgical access to the interior. The opening 103 has the function of simulating a craniotomy window, which is obtained by craniotomy in preparation for surgical intervention. The material and shape of the container 101 can vary depending on the use requirements and the manufacturer's choice. In particular, the material must ensure that tactile and visual feedback (hyper-realistic anatomical model) is provided that is as close as possible to the actual properties of the anatomical structure represented. According to a preferred embodiment of the present invention, it may contain one or more of the following materials: silicone and polyurethane rubber, silicone gel, resin, expanded polyurethane (see Table A). The selected materials are used to reproduce the consistency, reaction to deformation, gloss and color of organic tissues. In particular, gel and silicone rubber provide Shore softness index and elastic recovery time when deformed, similar to brain tissue, muscle tissue and fat tissue. At the same time, rubber has a higher typical elasticity than harder materials, and together with some resins, has a degree of fragility and fragility similar to cartilage and ligament tissue. Finally, expanded polyurethane simulates the consistency and appearance of human cancellous bone and compact bone tissue, respectively, due to its internal porosity and external density.

[0063] Table 1

[0064]

[0065]

[0066] The shape of the container 101 must meet the requirements of studying and simulating the brain. The opening 103 allows the user / student / surgeon to see and access the brain model portion container in the container 101.

[0067] The container 101 is adapted to contain a model 105 of a portion of the anatomy of interest, in this case the brain, as well as models of all other neuroanatomical elements (eg brainstem, blood vessels, nerves).

[0068] In a device preferably represented according to the invention, the representation of both the cranial cavity and its contents is local, i.e. an arbitrarily defined volume slice (e.g. a cubic volume) will be represented. The purpose of this is to better focus the user's attention on a precise area, which can be accessed through a craniotomy window at a specific location, and to allow the interchangeability of the internal parts of the device in order to switch from one surgical scenario to another completely different surgical scenario. This choice is intended to simulate a real situation, in which the accessibility of the interior of the cranial cavity has objective limitations due to the volume slices of the cranial cavity performed on a hypothetical patient, which, for obvious reasons, must be limited as much as possible. Moreover, this choice contributes to the implementation of a device of reduced size and low cost, which, with the help of the visual assistance of augmented reality, can more easily simulate the movements of, for example, an entire human skull, which actually completes the whole, of which the physical volume slice is only a part.

[0069] The material of the brain model may vary, but should be suitable for reproducing the physical characteristics (consistency, hardness level, plasticity / elasticity, deformation / recovery rate) and appearance (gloss, color, surface pattern) of the human brain. In a preferred embodiment of the invention, the brain model is formed of silicone, but another material that can appropriately simulate the characteristics of the represented anatomical part may alternatively be used.

[0070] In one possible embodiment of the device, the craniotomy opening (a model with the skull or other tissue still closed) may not be present by default, but instead reproduced by a closure composed of a material similar to human bone that will be surgically removable using surgical tools (surgical drill, etc.) due to the modular nature of the device and the low cost of disposable replacement parts. This option would allow students / trainees to practice in neurosurgery, making the teaching experience more realistic.

[0071] Surgical Box (BXO)

[0072] In a preferred embodiment of the present invention, the container 101, hereinafter also referred to as a box for surgery (BXO), is open at the top and has a hemispherical portion at the bottom, such as Figure 2 The dimensions of the container were developed to represent a realistic surgical space. The BXO is configured to house within it a neuroanatomy model from a specific surgical scenario, which will be introduced by assembling the module (described in more detail below).

[0073] The BXO is provided for attaching an upper module called the opening area, which represents the part of the skull with a specific surgical window (in this case the craniotomy) and is described below, and which also serves as the upper closure of the BXO 101 and is locked via a specific locking system ( Figure 3) remains secured to the container, the locking system will be integral to the container. The upper portion (upper edge) of the BXO is configured to accommodate any rubber gasket to provide a seal when liquid materials are used in the scene.

[0074] In a preferred embodiment of the invention, the lower portion of the container is substantially hemispherical and is designed to interface correctly with a corresponding support system, referred to as a support base (described below), which has corresponding concave surfaces for allowing the BXO 101 to rotate in all directions once installed. There are also grooves for locking the BXO in a fixed position by interlocking. The shape of the container 101 and the means by which it interfaces / connects to the base depends on the specific structure of the base and the fixing system, which can have various characteristics: A common and necessary feature of the base and its interaction with the container 101 is to allow the container 101 to perform all (or some) movements that are useful for simulating the real movements of the skull as part of the human body.

[0075] Part of the volume of the BXO is provided and developed to accommodate other electrical or electronic equipment or liquid materials required to configure more realistic surgical scenarios (such as blood circulation simulation).

[0076] According to the embodiment described and illustrated here, the lower hemispherical surface of the BXO may include a cylindrical recess forming a system for connecting and locking the container on the positioning base (registered European model 004254506-0001, with movement function of the BXO along a quantifiable Cartesian axis).

[0077] In a preferred embodiment of the invention, a plurality of containers are provided, each corresponding to a brain portion and an associated craniotomy window, thereby allowing different regions of the brain to be simulated and studied with surgical access from various positions and inclinations. The craniotomy windows are intended to simulate various methods commonly used in neurosurgery. In a preferred embodiment of the invention, craniotomy windows are provided for one or more of the following skull portions:

[0078] - Standard pterional (frontotemporal);

[0079] -Mini wing points;

[0080] -Unilateral frontal area;

[0081] - Bilateral frontal (trans-sinus);

[0082] -Temporal region;

[0083] - Anterior orbital

[0084] -Fronto-orbitozygomatic (FOZ);

[0085] -Frontal-temporal-orbital-zygomatic region;

[0086] -Sagittal plane;

[0087] - supraorbital;

[0088] - Occipital center

[0089] - Occipital center;

[0090] - In the middle of the occipital bone;

[0091] - Lateral side of the occipital bone;

[0092] - Postsigmoid sinus;

[0093] - Anterior to the petrous bone;

[0094] -After the petrous bone.

[0095] The Open Operation Zone component (hereinafter referred to as OZ - "Open Zone") is the upper cover of the BXO, connected and fixed to the upper part of the BXO. The OZ models the external surface of the scene.

[0096] In the context of neurosurgery, it denotes the portion of the skull of interest from a specific approach and is often referred to as a craniotomy.

[0097] Those skilled in the art will readily appreciate that further specialization of the craniotomy opening is possible, with a greater number of regions and sub-regions, just as it is possible to combine two or more adjacent regions into a single opening. It is therefore clear that the more limited the region, the higher the accuracy of the representation of the model.

[0098] The opening (hereinafter also defined as OZ) may already comprise a hole representing a surgical access opening, implemented with dimensional characteristics and shape according to standard techniques, or closed or half-open depending on whether the purpose of the simulation includes physically performing a craniotomy.

[0099] In some cases, the OZ has more access apertures, which corresponds to different possible approaches that can be performed in the same reference surgical area. In the case of neurosurgery, this can occur, for example, in the frontotemporal region, where it is possible to make various accesses that partially overlap or in some cases are closed to each other, such as a supraorbital access as part of a broad frontotemporal.

[0100] In the context of neurosurgery, the OZ represents a portion of the skull and therefore represents rigid bone and therefore is composed of a rigid material. The type of material used varies depending on the intended use. If the scenario provides the actual steps of opening the skull or drilling the bone, a variable density material is used to form the OZ to reflect the various types and layers of cancellous bone. If the scenario does not provide simulated physical activity on the bone components, the material used is a rigid plastic material similar to BXO.

[0101] In the context of neurosurgery, the OZ is usually composed of soft tissue, so the component is formed using materials of different properties that are partly rigid (the outer frame of the OZ) and partly soft and simulate the specific anatomical features of this surgical procedure.

[0102] The OZ is characterized by reproducing a surface anatomical slice of the human body region in question from a specific surgical scenario and, as described above, was developed to be combined with and affixed to the BXO to form a single cohesive container.

[0103] like Figure 4 As shown, the shape of the BXO container 101 is adapted to enclose the internal anatomical part of the brain. Multiple anatomical parts (hereinafter also referred to as APs) may be involved in the simulation scenario, and their number, shape and material depend on the goal of the scenario they are intended for.

[0104] In practice, a particular surgical scenario may be implemented in different versions depending on the type of simulation for which it was developed.

[0105] For example, in the pterional approach, the AP is the brainstem, some cranial nerves, an arterial / venous vascular tree model, a portion of the left cerebral hemisphere, and a portion of the right cerebral hemisphere. In the development of this scenario, some pathological components (e.g., tumors, aneurysms, etc.) can also be added.

[0106] The anatomical part may be formed only in its physical form, interacting with the user only by touch and vision. In another embodiment of the invention, the anatomical part may be equipped with sensors capable of measuring parameters that can be used to assess artificial performance (e.g., performance of a vascular bypass) or physical parameters such as forces applied to the anatomical model (e.g., mechanical stress parameters on the brain parenchyma that can be used to identify critical ranges of possible iatrogenic damage). These parameters may optionally be monitored using specific dedicated software that can also provide real-time feedback or performance statistics.

[0107] In a preferred embodiment of the invention, the container 101 is supported by a controllable support 107 which has the purpose of simulating the movement of a skull in three-dimensional space, a portion of which is represented by the container 101. It is possible to use a simple support with a support base without the need for a mechanism to measure and control its position in three-dimensional space, but it is obvious that for objects where positioning accuracy is necessary, a precise positioning system is preferred. Two possible embodiments of the support base will be described below by way of example. The simplest version of the support 107 is better shown below with reference to FIG5 , while Figure 6A more complex stand with a goniometric base is shown, and a European model or design (number 004254506-0001) has been registered in the name of the owner of the present patent application. An expert in the field will appreciate that other solutions are possible depending on the intended use and required accuracy of the learning system.

[0108] Internal Anatomy Module (IAM)

[0109] The internal anatomy module (intracranial in this case) contains all the specific deep anatomical structures of the surgical scenario (such as specific blood vessels and nerves, etc.). This module will be called IAM (Internal Anatomy Module). The IAM is a functional reference component used to implement the specific surgical scenario it is developed for. In one possible embodiment, the BXO container 101 is a simple generic shell, on which the specific IAM will be installed, which is an assembly module of the internal anatomical structures depending on the environment and requirements.

[0110] The development of an IAM makes it possible to separate the general components of the learning system from the scenario-specific components. Therefore, the development of an IAM is particularly complex and critical to the success of the overall scenario development.

[0111] The IAM is developed to be housed inside the BXO (which may have a square profile in one possible embodiment of the invention): the IAM slides vertically inside the BXO and is supported on 4 support brackets inside the BXO.

[0112] The IAM contains the anatomical elements that play a role in the surgical scenario it is developed in. For example, in the above-mentioned pterional neurosurgery scenario, the IAM contains part of the patient's tentorium cerebelli and part of the skull contour, into which the optic nerve inserts and from which the internal carotid artery emerges.

[0113] Figure 4 An embodiment of an IAM for a pterional neurosurgery scenario is shown.

[0114] The design and anatomical shape of the IAM were developed in such a way that other components of the surgical scene are assembled within its volume.

[0115] The IAM is preferably formed using a soft or semi-rigid material depending on the circumstances and in any case as close to practical as possible, or it may be composed of a rigid plastic material or polyurethane or metal or rubber or silicone material or a mixture of the above.

[0116] Support base

[0117] The support base is the component of the system described here that makes it possible for the BXO to be translated in any plane, rotated, and fixed in one position.

[0118] Two possible example embodiments are described:

[0119] a. Standard dual function base (Fig. 5a and 5b)

[0120] b.Angle measuring base ( Figure 6 Registered EU model number 004254506-0001)

[0121] a. Standard dual function base

[0122] The base has a substantially cylindrical shape with a through hole in the center. In a preferred embodiment, the material used for the base is ABS (Acrylonitrile Butadiene Styrene).

[0123] The two surfaces of the support base are developed differently in order to provide different functions depending on whether the BXO is packaged on one side or the other.

[0124] One side ( Figure 5a ) contains a concave surface corresponding to the convex surface of the BXO hemisphere. When the BXO is housed on this side, it can easily rotate freely around the X, Y and Z axes of space while having a fixed center of rotation. Movement in this mode occurs freely or without the possibility of decomposing or angularly quantizing the movement.

[0125] In this mode, the user simulates the surgical steps of positioning the patient's head by observing the movement of the patient's entire skull: Using an augmented reality application, a model of the patient's head is displayed and in this way it is observed how the surgical viewpoint changes when changing the degree of rotation (for viewing the BXO and its contents) ( Figure 7 ) is possible.

[0126] The communication between the BXO and the digital application takes place via a suitable marker, which is mounted at a point of the same BXO and which, once introduced into the frame, generates a projection of the model in a consistent position and consistent with the real model, representing its integration (for example, the entire head of a patient superimposed in virtual form on a physical head part). In another possible embodiment, the marker is replaced by a sensor for measuring spatial distances and positions.

[0127] The other side of the base ( Figure 5b ) is unfolded in such a way that at the central through hole, there is a groove that can accommodate the BXO in an interlocking manner and fix it in a specific position.

[0128] Thus, when the BXO is positioned on this side of the base, it remains locked and is prevented from performing any rotation. In this position, the user can apply stronger retraction forces on the model using the appropriate surgical instruments provided because the BXO is stable and secure.

[0129] The side profile of the base contains a groove developed to close the movable locking system of the base at the supporting plane.

[0130] On both (upper and lower) surfaces, the base may provide grooves for accommodating rubber retaining rings which form a soft contact of the base supporting the flat surface, thereby not scratching the flat surface and giving the base greater friction in sliding, limiting its mobility on the flat surface.

[0131] b.Angle measuring base

[0132] like Figure 6 As shown, this base 600 has the purpose of quantifying the different degrees of movement of the BXO and, therefore, the patient's head. The positioning of the patient's head plays a fundamental role in planning neurosurgical procedures, since a few degrees can change the visual perspective of the intracranial target to be reached and make it more difficult to reach. Furthermore, incorrect positioning of the head can negatively affect the surgical position that the surgeon must assume, compromising the quality of the surgical procedure itself.

[0133] A positioning base is a system of concentric spheres and a spherical cover (e.g. a hemisphere) that can control and measure rotations about three axes in space.

[0134] The first spherical cap 601 is used to orient the system along the X-axis.

[0135] A second spherical cap 603 within the first cap 601 is used to orient the system along the Y-axis.

[0136] Inside the first two covers, there is a third cover 605 for the Z axis, which can also be a complete sphere, as it does not have to contain more spheres.

[0137] In particular, this enables three main rotations of the head:

[0138] -Rotation

[0139] -Flexor stretch

[0140] - Lateral tilt

[0141] Academically, each neurosurgical approach is associated with a specific range of excursion in terms of rotation, flexor extension, and lateral tibial extension, naturally taking into account the anatomical variations between individuals and the specific type of pathology.

[0142] The three movements on the goniometric base are independent and quantifiable. Each of them occurs along a graduated measurement scale 607 that reports the degree of rotation applied. Once the desired rotation has been applied, the user locks the system via the appropriate locking screw. Each rotation is applied and controlled independently of the others and has its own locking screw.

[0143] In a preferred embodiment of the invention, at the top, the base has an attachment system that corresponds to the grooves on the hemispherical surface of the lower part of the BXO (as described above).

[0144] When the BXO is positioned on the base using the provided connection system, the base's rotation system will produce a rotation angle on the BXO that corresponds to the true angle of the patient's entire head and the appropriately measured (and indicated on the positioning base) rotation angle of the patient's head. Once the rotation angles have been applied as indicated in the academic textbook for the specific surgical procedure, the user can visually consider how the surgical perspective changes when changing a single rotation angle. In this way, the user will understand through direct experience the perspective effect of the individual rotation angles applied.

[0145] Likewise, a BXO system developed for a specific case (patient specific) will be able to allow the ideal positioning angle for the analytical case to be simulated.

[0146] In a preferred embodiment of the invention, the physics module 100 can be connected to a data processing system provided with appropriately developed software making it possible to reconstruct an augmented reality simulation of a human skull and its contents, for example on the screen of a mobile device.

[0147] This occurs through the recognition of the moment when a specific physical graphic element (marker) is brought into the frame by the camera of the device (smartphone or tablet). In this way, on the basis of triangulation calculations, it is possible to reconstruct the position, rotation and movement of the virtual camera in the 3D scene corresponding to the camera of the device in use, subsequently superimposing the image of the 3D model of the correct perspective on the streaming video from this camera. In this way, the image of reality is augmented with 3D content or with real-time 3D animation of the neurosurgical method associated with the marker itself or the 3D model.

[0148] The software also makes it possible to combine augmented reality with virtual reality (hereinafter referred to as VR) using a universal viewing device capable of accommodating a smartphone, giving users the option of enjoying augmented reality moving within an object hands-free.

[0149] It becomes possible to integrate more sensors that return physical interaction parameters to the software. The software receives signals from the physical module 100 originating from the user's interaction with the device itself. These signals may include the movement of the container 101 (and, for augmented reality simulations, the movement of the entire imaginary skull) with the aid of the freedom of movement of the support 107. In another embodiment of the invention, the model of the anatomical part 105 (e.g., brain matter) is provided with sensors that detect physical stress parameters on the anatomical model (e.g., retraction pressure on the brain); these sensors will optionally be able to provide parameters useful for learning manual skills that play a role in the correct microsurgical manipulation of anatomical structures.

[0150] The integration between the physical components of the above-described system and the augmented reality simulation performed using computing tools is one of the essential features of the simulation system according to the invention.

[0151] In a preferred embodiment of the invention, the steps of the surgical procedure are represented by a partially digital (through animation, images, interaction with digital models and / or objects on a mobile device) and partially physical (interaction with a physical model of the surgical scene) system.

[0152] Augmented reality technology is used to represent the digital model. In particular, each surgical scene has an AR marker that can be recognized by the APP ( Figure 7 and Figure 8 ).

[0153] Once the APP is activated on the mobile device and the marker is brought into view by the device's camera, the APP recognizes the marker and activates the correct process or module for the scene that the marker refers to.

[0154] From that moment on, while keeping the markers in the frame using the device's camera, the real image is augmented by a digital APP that integrates the scene with digital components and objects superimposed on the real image in the camera frame. In particular, regarding the neurosurgical case, the physical model represents all structures from the external skeleton to the intracranial structures, while the augmented reality represents all the soft tissues of the skull.

[0155] In a preferred representation of the invention, each surgical scenario has a corresponding digital module that implements one or more steps of the surgical procedure by interacting with the physical platform (composed of the BXO, supporting substrate, OZ, AAM, and AP).

[0156] The app uses an augmented reality (AR) component to integrate images of physical modules and provide a complete view of the patient, skull, and / or other anatomical parts that have no physical equivalent.

[0157] In another embodiment of the present invention, a virtual reality component is used which allows

[0158] Provide greater ability to contextualize the surgical scenario (thus being able to more directly influence the user’s emotional state, with the goal of training him / her to manage interventions in terms of emotions and perception)

[0159] Group simulations, even at a distance, can be performed where there is more than one user at a time, but they are physically in different places and far away from each other.

[0160] In this case, the mobile device is the viewing device for the immersive reality ( Fig. 9 ), through which the user is brought into a virtual reality (e.g., an operating room) where he / she performs surgical tasks by interacting with the learning system and other virtual actors (e.g., other trainees).

[0161] In the case of the pterional approach, the APP can implement the steps of positioning the head and opening the skull (craniotomy) until intracranial access is available. During the positioning phase, the APP displays the patient's complete skull by superimposing a digital image on the image of the physical module, so that the user has a perfect awareness of which skull part is simulated and how rotations around the three spatial axes affect and potentially influence the surgical scenario.

[0162] During the opening step, the app shows an animation of the steps to open the soft skull tissue to reach the inside of the skull. In particular, once the meninges (dura mater) are opened, the app shows the physical brain contained in the device, encouraging him / her to perform exercises on the physical model.

[0163] At this point, the user continues to engage in exploration of the anatomy by using appropriate surgical instruments to retract brain tissue and manipulate deeper anatomical structures. When the user completes the exploration, returning to the digital app, it is possible that the surgical closure animation will follow in the same manner as the opening was displayed.

[0164] Fig.10A general purpose computer used in a system according to a preferred embodiment of the present invention is shown. This general description includes any device with processing capabilities, although with different levels of complexity and functionality (e.g., computers, mobile terminals, smart phones, servers, network routers, proxy servers). Computer 1050 consists of various units connected in parallel to system bus 1053. In detail, one or more microprocessors 1056 control the operation of the computer, RAM 1059 is directly used as the working memory of microprocessor 1056, and ROM 1062 contains the basic code for the initial loading activity (boot) of the system. Various peripheral units are connected to local bus 1065 through appropriate interfaces. In particular, these peripheral units can include a large-capacity memory formed by a hard disk 1071 and one or more external memories, which include various types of carriers (e.g., SD cards, USB keys, memory linked to the cloud) 1074. In addition, computer 1050 can include and / or be connected to input devices 1077 (e.g., keyboard, mouse, tracking point, camera, webcam) and output devices 1080 (e.g., screen, printer). Network interface card 1083 is used to connect computer 1050 to a network. The bridge unit 1086 forms an interface between the system bus 1053 and the local bus 1065. Each microprocessor 1056 and the bridge unit 1056 can operate as a master agent and request exclusive access to the system bus 1053 to transfer information. The arbiter 1089 manages requests for access to the system bus 1053, preventing conflicts between requesters. Similar considerations apply to systems that are slightly different or based on different network configurations. Other components besides those described may be present in certain situations and in certain embodiments (e.g., PDAs, mobile phones, etc.).

[0165] The device described in this patent application has the purpose of simulating the movements and morphology of a human anatomical part, such as a part of the human skull and brain. This simulation has the advantage of making it possible to study the anatomical part of interest and to recreate conditions as close as possible to the reality in which a surgeon finds himself when performing an intervention on the anatomical part. In general, the method comprises the following steps:

[0166] - acquiring a representation of a plurality of anatomical elements by an image acquisition system;

[0167] - receiving information about the position and orientation of the container from the movable support;

[0168] - obtaining, from each of the plurality of markers, information on a location and one or more features of an anatomical element associated with each marker;

[0169] -Generate an augmented reality representation of the anatomical part and represent the view on a monitor.

[0170] The method for simulating neurosurgical procedures according to a preferred embodiment of the present invention is characterized by the sequential integration of a virtual simulation phase based on a virtual representation of a surgical scene and a physical simulation phase based on a physical representation of the scene. The method can be used, for example, for AR / VR representation and management of a human skull model and parts of the central nervous system contained therein. The method is implemented and operated on a data processing system connected to the above-mentioned device, and the user / student / surgeon can interact with the data processing system through input / output instruments that make it possible to simulate inspections and surgical intervention actions on the skull and the model using augmented reality representation.

[0171] The device and the method described above are susceptible of numerous modifications and variations within the scope of the invention: moreover, all the details may be replaced by other technically equivalent elements, without thereby departing from the scope of protection of the invention.

[0172] In practice, the materials used, as long as they are compatible with the specific use, as well as the dimensions, may vary according to requirements and to the state of the art.

Claims

1. Systems for simulating the motion, form, surgical approach, positioning and movement of human anatomical parts in three-dimensional space, including: A three-dimensional physics module for representing a defined volume of a human anatomical portion, comprising a container of defined volume, the container comprising a plurality of internally interchangeable anatomical elements, the container having an opening, the opening representing a predetermined surgical access path for performing surgery within the anatomical portion included in the container, wherein a portion of the volume of the container is provided and developed to contain liquid materials required to configure a realistic surgical scenario; a support, movable in three dimensions to position and orient the container in three-dimensional space; Digital image processing system; at least one marker associated with and positioned on the anatomical element, each of the at least one marker being adapted to identify a position and one or more features of the associated anatomical part in three-dimensional space and to transmit information about the position and about the one or more features to the digital image processing system; an image acquisition system adapted to capture images of the container, the anatomical element and the at least one marker and transmit them to a digital image processing system, the image processing system being adapted to integrate the information received from the at least one marker and from the image acquisition system with the additional virtual elements so as to generate an augmented reality view of the anatomical volume and layers that completes the partial physical representation of the anatomical part, and to represent the view on the monitor, Therein, the anatomical part is equipped with sensors capable of measuring parameters used to evaluate manual performance or physical parameters.

2. The system according to claim 1, wherein: The digital image processing system and the image acquisition system are integrated into a single system.

3. The system according to claim 1, wherein: The anatomical part consists of a plurality of layers and / or volumes, and wherein the physical three-dimensional module has a virtual component, which is integrated in such a way that at least one of the layers and / or volumes of at least one slice of the anatomical part is physically represented by the three-dimensional physical module, and at least one of the layers and / or volumes of the anatomical part is digitally represented virtually, and the at least one physical representation and the at least one virtual representation are integrated together to implement an augmented reality representation and simulate a sequence of surgical steps of a predetermined procedure or a predetermined pathological condition.

4. The system according to claim 1, wherein: The container is adapted to house a plurality of internally interchangeable anatomical modules comprising anatomical elements, each anatomical module representing an anatomical layer of a represented anatomical part.

5. The system according to claim 1, wherein: The container represents a predetermined volume of a human skull and the access path is a craniotomy / craniectomy window for allowing access to internal anatomical elements.

6. The system according to claim 5, wherein: The physical module represents a subset of the skull volume and elements of the intracranial anatomical structures, while the augmented reality represents the integration of the remaining skull volume and the remaining extracranial anatomical layers, sequentially completing the surgical steps of the procedure for surgical access to internal anatomical components by alternating physical and virtual representations of the structures involved.

7. The system according to any one of claims 5 and 6, wherein: The anatomical elements include one or more of the following: cerebral / cerebellar parenchyma, brain stem, cranial nerves, arterial / venous vessels, venous sinuses, meninges (dura mater, arachnoid mater, pia mater), biological fluids (cerebrospinal fluid, blood), each of the multiple anatomical elements included in the container is made of a material that reproduces the physical characteristics of the corresponding real anatomical element.

8. The system according to any one of claims 5 and 6, wherein: The opening of the container is covered so as to simulate an integral portion of a human skull corresponding to a predetermined surgical window for performing surgery within the anatomical portion included in the container, the portion of the human skull being prepared to be cut during a surgical simulation of a craniotomy / craniectomy intervention.

9. The system according to claim 1, wherein: The support is connected to the image processing system and is arranged to transmit information about the position and orientation of the container to the digital image processing system.

10. The system according to claim 9, wherein: The augmented reality view generated and displayed by the digital image processing system is also based on the information received from the support.

11. The system according to any one of claims 9 and 10, wherein: The support comprises three concentric spherical caps, each of which is arranged to move along one of the spatial coordinates of a three-dimensional Cartesian system.

12. The system of claim 1, wherein: The image acquisition system develops representations of multiple anatomical elements, multiple 3D animations, multiple pieces of useful information for guiding surgical tasks, multiple models corresponding to surgical instruments linked to specific landmarks, and multiple pieces of information derived from all of these landmarks.

13. A container representing a portion of a human anatomy, comprising a plurality of anatomical elements, the container being suitable for use with the system of claim 4.

14. A method for simulating the movement and form of a human anatomical part by means of a system according to any one of the preceding claims, the method comprising the following steps: acquiring representations of multiple anatomical elements via an image acquisition system; receiving information from the movable support regarding the position and orientation of the container; acquiring, from at least one marker, information regarding a location and one or more characteristics of an anatomical element associated with each marker; Information received from the at least one marker and from the image acquisition system is integrated with additional virtual elements to generate an augmented reality view of the anatomical volume and layers that completes the partial physical representation of the anatomical portion, and the view is presented on a monitor.

15. A method of simulating a neurosurgical procedure using the method of claim 14, characterized in that Sequential integration of a virtual simulation phase based on a virtual representation of a surgical scenario and a physical simulation phase based on a physical representation of the scenario.

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