[go: up one dir, main page]

WO2021056123A1 - Dispositif et système de simulation de chirurgie laparoscopique pour effectuer un procédé planifié de formation avancée, avec une évaluation intégrale des aptitudes en chirurgie laparoscopique effectuée à distance et en différé; et procédé associé - Google Patents

Dispositif et système de simulation de chirurgie laparoscopique pour effectuer un procédé planifié de formation avancée, avec une évaluation intégrale des aptitudes en chirurgie laparoscopique effectuée à distance et en différé; et procédé associé Download PDF

Info

Publication number
WO2021056123A1
WO2021056123A1 PCT/CL2020/050078 CL2020050078W WO2021056123A1 WO 2021056123 A1 WO2021056123 A1 WO 2021056123A1 CL 2020050078 W CL2020050078 W CL 2020050078W WO 2021056123 A1 WO2021056123 A1 WO 2021056123A1
Authority
WO
WIPO (PCT)
Prior art keywords
module
data
user
simulator device
training
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CL2020/050078
Other languages
English (en)
Spanish (es)
Inventor
Julián Emanuel VARAS COHEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pontificia Universidad Catolica de Chile
Original Assignee
Pontificia Universidad Catolica de Chile
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pontificia Universidad Catolica de Chile filed Critical Pontificia Universidad Catolica de Chile
Publication of WO2021056123A1 publication Critical patent/WO2021056123A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G09B23/32—Anatomical models with moving parts
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G09B23/34—Anatomical models with removable parts

Definitions

  • the invention that is the subject of the present Patent of Invention application is inserted in the field of training in medical education, in particular it refers to a portable laparoscopic surgery simulator device, a system to carry out a training procedure and remote evaluation using said simulator device and said remote and deferred training and evaluation procedure; the one that helps doctors to train to master the basic skills of laparoscopic surgery, allowing to simulate real surgical conditions outside the surgical ward and to access a remote evaluation system of their abilities.
  • video endoscopic techniques require a plurality of much smaller incisions.
  • an incision is made for a video endoscopic camera and two or more incisions to insert surgical instruments.
  • the diameters of the surgical instruments and the probe for the video endoscopic camera are made as small as practical, to minimize the size of the incisions that are required.
  • the endoscope is used to allow the surgeon to view, in real time, the surgical field and the manipulation of endoscopic instruments within that field.
  • surgeon observes a two-dimensional image of the surgical field.
  • the ability to work from a two-dimensional image of the surgical field, while manipulating instruments remotely, requires a significant amount of training. It is critical that surgeons learn and then practice video endoscopic skills that will help them identify structures and carefully control endoscopic instruments, to ensure that surgical procedures are performed accurately and to avoid unnecessary damage to surrounding tissue.
  • Such trainers generally include a housing in which a simulated anatomical structure is placed, students can manipulate the instruments that pass through the openings in the housing to gain confidence in skills such as suturing and knotting.
  • a simulator can also help simulate a full procedure, where skills are combined into a suitable model, again without endangering a patient.
  • a laparoscopic cholecystectomy retractal of a gallbladder
  • the most common laparoscopic procedure performed is a combination of grasping, dissecting, trimming, and cutting. All these skills can be simulated, and in fact the procedure itself can be performed on a simple model.
  • Optimal training of the type described in the present application requires, on the one hand, devices that allow creating realistic environments, especially referring to the size of the operating field, which in the case of existing devices, do not allow to regulate the size of the device to simulate different physical structures that patients may have and even providing the possibility of achieving a total collapse of the device to obtain a compact size that allows easy transfer.
  • laparoscopic comprising a visual system, an acceleration sensor module and an evaluation system, in which the visual system is used to acquire three-dimensional coordinate data from the equipment;
  • the acceleration sensor module is used to acquire the speed and stability data in motion of the equipment;
  • the evaluation system is used to calculate and store the data acquired by the visual system and the acceleration sensor module and to export a report of the training completion condition.
  • a system for training and development of skills in laparoscopic surgeries is also necessary that allows a more complete evaluation, not only of the finite movement of the instruments at the tissue or organ level, but also allows evaluating the development of the professional in their immediate environment. , both in their movements and in certain indicators of stress that must also be controlled during exercise, such as the heart rate rate for minute, heart or respiratory rate; in the same way, an apparatus is necessary that allows the regulation of the size of the operative field so that it adjusts to different realities.
  • the present invention relates to a portable laparoscopic surgery simulator device, a laparoscopic surgery simulation system to carry out a planned advanced training procedure, with comprehensive evaluation of laparoscopic surgical skills, and an advanced training procedure for the development of laparoscopic surgical skills, which allows to perform simulation exercises and obtain a comprehensive assessment of skills remotely and delayed.
  • the main objective of the simulator device is to allow simulated training of surgical procedures, specifically laparoscopic surgery, for the development of basic operating skills.
  • Another objective of the simulator device is to allow the realistic conditioning of the operative field, being able to regulate its size according to different simulated situations, which gives it an advantage over what exists, in that it does not allow to regulate the internal cavity shape and only allow a fully open or closed position for easy portability.
  • Yet another objective of the present invention is to provide a laparoscopic surgery simulation system to carry out a planned advanced training procedure, with comprehensive evaluation of laparoscopic surgical skills, performed remotely and delayed; where it allows a comprehensive evaluation of the performance of the student or doctor in training, based not only on the capture of the operating field, but also based on the capture of images of the student's body in motion, see how it is positioned, how it moves the arms, your body, your expressions and the capture of biometric information that allows you to evaluate the level of stress during your training.
  • An additional objective of the simulator device is to provide the means that allow the storage or transmission of the captured data to be subsequently evaluated remotely by one or more tutors.
  • the simulator device for advanced laparoscopic skills training comprises a portable casing that has an internal cavity that defines a work area of adjustable volume, formed by an upper mobile component and a lower fixed component.
  • the upper movable component and the lower fixed component of the housing are formed of rigid material; while the upper mobile component is formed by an outer cover and an inner cover of rigid material, sealed together to generate an inner chamber where electronic components are safely arranged against liquid splashes, which It allows that when there are fluids (simulating artificial blood for example) and this comes out in jet, it is not damaged or there is a short circuit in the electronic components.
  • the upper mobile component of the housing simulates the shape of a human anatomy torso and comprises a series of openings for inserting laparoscopic instruments that reach the interior cavity of the device and are provided with rubber inserts that hold said instruments; Between this series of openings there is at least one opening located in the longitudinal central axis of the casing, which allows to carry out simulations of gynecological surgeries, since its central position simulates access to the lower abdomen area related to organs such like ovaries or uterus.
  • the lower fixed component of the casing is a rigid frame with an open lateral area, like the letter "C” that defines a free central area where a removable tray can be placed that contains the surgical work samples, those that are normally ex vivo tissue.
  • the simulator device also comprises a central control and data processing module, capable of controlling different electronic components of the device through a user interface means arranged outside the housing.
  • This user interface means is graphic and auditory, comprising a resistive screen panel, LCD panel type, configured to enter digital commands that can be activated with the user's fingers and display graphic information for communication with the user, in conjunction with a micro transmitter module. of auditory cues that reinforce responses to the user.
  • the simulator device allows the interior cavity of the housing to present an adjustable volume to simulate different types of patients (with more or less interior space such as "pediatric laparoscopic surgery (a baby) or a morbidly obese, or” average "person). The height can be saved as a "scene” in favorites within the control on the screen panel, and thus by configuring these scenarios one can train with the ideal space according to the training program that is being done.
  • the regulation of the interior volume is achievable by an automated means of lifting that allows moving the upper mobile component both in a parallel and inclined manner with respect to the fixed lower component of the casing, as it is made up of robotic telescopic pillars activated by high-performance electric actuators.
  • power related to a motor and where said automated means is connected to the central control module, which allows its regulation remotely, which in a preferred embodiment of the invention is a manual command formed by a push button arranged in the outer cover of the upper movable component of the housing.
  • the command is digital, operable through the user interface, where a menu related to this raising, lowering or tilting action of the upper casing component is displayed.
  • this automated lifting means is made up of an automated pantograph mechanism activated by high-power electric actuators, which is also connected to the central control module that allows its regulation remotely, also indicated in the user interface or related to a push button type manual command.
  • This ability to regulate the size or volume of the interior cavity of the casing also allows the device to adopt a compact position with no lifting of the upper component with respect to the lower component, where this total compact position is adopted in the off state of the device when it is not in use, allowing that due to its reduced size, it can be easily carried, for example, inside a suitcase that can be specially designed for your transportation in a safe manner.
  • the device further comprises a high resolution video capture medium arranged inside the casing, which is a compact video camera that avoids the delay time in the reproduction of the image.
  • a high resolution video capture medium arranged inside the casing, which is a compact video camera that avoids the delay time in the reproduction of the image.
  • the video camera used in the present simulator device is at least 128 FPS (frames per second) at 1080p (pixels), with direct output via HDMI cable to an HD digital splitter, which allows it to be sent to any LED monitor or OLED with HDMI input an image without delay between what happens and what is seen.
  • the control of said camera is digital and is managed remotely as it is coupled with the central control module of the simulator device, manageable from the user interface.
  • the focal length must be adjustable to be able to work very close (example 3cm) or at a distance (example 12cm). With this it is possible to see important details of the tissues, either synthetic or ex-vivo within the simulator.
  • a suture can be made with a 6/0 diameter needle and join 2 tubes of up to 1 mm (millimeter) thanks to the arrangement of the chamber in front of the tissues. With this you can reproduce even the most difficult exercise possible without losing image quality.
  • Color saturation is important when doing advanced surgery exercises, because when one simulates blood, the intense red color tends to saturate the color processor of most conventional webcam-type cameras or others.
  • the interior camera of the simulator together with the interior lighting with warm and cold light LEDs, allows a sharp image faithful to reality, which is reinforced by an automatic and manual target control function commanded from the interface panel of Username.
  • the device comprises a robotic clamping means of the interior video camera, which comprises a robotic arm coupled to the internal cavity of the housing, is pivoting on four axes thanks to servo-motorized actuators that allow panning, tilting and increasing the camera's point of view; Said actuators comprise, in turn, means for controlling their position, allowing optical zoom (3x) and mixed digital (5x) to be made.
  • the controls of the robotic arm of the camera are digital, associated with the central control module and controlled from the user interface.
  • the robotic arm control means are manual, operable from a gamepad style joystick located on the top movable component of the case.
  • the simulator device also has an external means of capturing images, consisting of a front camera that allows monitoring the ergonomics of the user, in addition to the identity of the user while training. This allows a teacher to correct the bad habits of incorrect positions, both of the student's hands and body, without being in person.
  • This front camera is also connected to the central control module and is located on the upper face of the mobile component of the housing, close to the edge opposite the edge where the student is positioned.
  • the interior lighting means of the housing comprise at least two [240mW] LED strips of 6000 ° K color temperature, providing 720 lumens; located at a distance from each other and pointing towards the center of the working area of the lower fixed component of the housing.
  • the interior lighting means of the housing comprise at least two flexible tapes of diffuse LED patches, of [240mW] of 6000 ° K of color temperature, that provide 720 lumens; located at a distance from each other and pointing towards the center of the working area of the lower fixed component of the housing.
  • the simulator device also comprises a storage medium for the captured video images, which comprises a removable memory card, of the SD card type, connected to the control and data processing module.
  • the device also has electronic connectors, consisting of at least two HDMI multimedia ports, an HDMI signal splitter connected to the interior video camera; at least one wired digital and analog signal input port; and a conventional connector to a power source.
  • the simulator does not incorporate a monitor, allowing it to be ultra portable and easy to transport in a box specially designed for this. By having universal HDMI video output ports, the simulator can connect to any display with this type of input.
  • Today's actual operating room monitors are all over 21 inches, while most simulators on the market only offer the 15-inch maximum capability; This simulator allows you to connect to a screen independent of its size, and its image quality ranges from HD, FULL HD to 4K.
  • the simulator device allows data collection and remote and remote control, such as data on hours of use and on, auto error detection and reporting, protocols on and off remotely; These characteristics are facilitated by the presence of a wireless connection module for remote management and supervision of the device, which includes a multiband router and a GPRS / 3G / 4G antenna, connected to the central control module and embedded in a SIM-card. housed in the housing in a protected manner to prevent unauthorized tampering.
  • the aforementioned central control and data processing module comprises a microprocessor programmed to control the operation of the device by receiving signals from different components, processing them, executing orders according to pre-established parameters and issuing feedback signals to the user.
  • the signals it receives come from sensors arranged in the device, specifically from sensors placed in the automated means that regulates the volume of the internal cavity of the housing, from sensors arranged in the internal device for capturing high-resolution digital video images and of sensors arranged in their associated robotic clamping means, of sensors arranged in the external video camera, of sensors of the interior lighting means of the housing, of sensors integrated into the openings for inserting laparoscopic instruments to verify their presence and of sensors on the user interface panel.
  • the central control module manages the power of the simulator lighting, the controlled lifting of the upper mobile component of the housing, the sound and graphical feedback for the user in the interface, the switching on, off and manipulation of the internal device. capture of high resolution digital video images and the positioning of the robotic arm that holds it; allows the user, through the interface panel, to digitally command the device on and off, the lifting of the automated means that regulates the volume of the internal cavity of the casing, the device on, off and positioning Internal high resolution video digital image capture and interior lighting levels in the housing cavity.
  • the central control and data processing module is remotely controllable through the wireless connection module comprising the multiband router and an antenna GPRS / 3G / 4G, and can even be remotely blocked, which is favorable in a remote service environment delivered against the payment of a subscription.
  • the carcass can have a shape corresponding to a part of the human body or organism in which this type of surgery can be carried out, preferably it has the shape of a human torso and is made of a resistant and non-deformable material, which can be selected from a group comprising: fiberglass, wood, metal, polymer, vinyl, organic or mineral material.
  • the training device contains a connection to a power transformer, to be connected to the conventional 110-220V electrical network, depending on the characteristics of the local electrical network.
  • this invention is a laparoscopic surgery simulation system to carry out a planned procedure of advanced training, with remote and delayed evaluation, where this evaluation is comprehensive, by combining not only an image capture of the laparoscopic surgical skills developed within the simulator device, but also integrates the images of the user captured by the front camera arranged on the outside of the housing and a series of biometric signals that give indications on the level of stress and fatigue that the user experiences during training.
  • the system comprises the simulator device described above, which allows to simulate real conditions of a surgery and captures video images of both the training activity inside the device and the outside related to the ergonomics and movements of the user; It also includes a biometric multi-sensor module to capture biometric indicators of the user during the training process; It comprises a remote training evaluation module and a captured data processor and manager module that integrates data acquired from the simulator device and the biometric multi-sensor module, processes and sends them, in data packet mode, to the remote evaluation module of training.
  • the aforementioned biometric multi-sensor module comprises a device with a series of sensors applicable in different parts of the user's body, capable of sending information to the captured data manager module preferably wirelessly through a connectivity protocol, of the type Bluetooth
  • This biometric multi-sensor module is capable of measuring acceleration signals in three axes for active members of the user; measures muscle recruitment signals through non-invasive differential electromyography; measures signs and figures of merit of muscle exhaustion, tetanization and fasciculation; measures heart rate, pulse and net eye movement.
  • the sensors arranged to perform these measurements can be muscle measurement electrodes, heart rate monitors, and / or net eye movement sensors.
  • the component of the system referred to as the manager module and the captured data processor is an apparatus that can be linked to the simulator device and to the remote training module; It includes a rigid casing of reduced size that facilitates its portability.
  • the manager module also comprises wired connectivity means formed by at least one HDMI input to acquire images from the video outputs of the simulator device; one main power port to the power source and at least one input port of wired analog and digital signals comprising a 10 to 12-pin port with 8 channels for acquiring wired signals.
  • wireless connectivity which consist of a “Bluetooth” protocol for the acquisition of data from devices with this communication method, where these devices can be devices chosen from the group of health monitoring bracelets, Smartwatches , Thermometers, multi-sensor devices, etc; It also includes a “Wi-Fi” protocol that provides connectivity to the internet and the local network where the administrator module is installed; and a ZigBee connectivity protocol for the acquisition of field sensors related to room conditions, lighting, among others.
  • the administrator module also comprises graphic and auditory interface means that allow communication with the user, formed by a touch panel, of the LCD screen type, for displaying graphics and interaction with the user by means of digital commands; while the interaction responses of the administrator module are through graphics displayed on the touch panel and sound emitters integrated into the module.
  • the manager module also comprises a first central management processor for first layer activities, a second processor for performing high-level tasks such as capturing, compressing, saving and sending high definition videos; a third processor dedicated to graphical interface events and a removable data storage medium.
  • the first central management processor for first layer activities, it performs activities of communication coordination, initial boot and reset of parameters, watchdog for restarting frozen processes, contingency management and test modes of faults, management of energy and power sources, coordination for multiplexing / demultiplexing of wired signals and controlling and manipulating the connection to the central network point; being able to be an 8-bit processor.
  • the second processor includes the ability to connect to mass storage systems or to connect to removable storage media. It performs high-level tasks such as capturing, compressing, saving and sending high-definition videos; being able to be a 32-bit processor. It is supported by electronic filtering and sub-sampling that allows to lighten compression tasks, being these carried out at the hardware level; This provides conditions of lower consumption, greater robustness and lower operating temperature, thus prolonging the useful life of the equipment and avoiding the use of mechanical systems such as extraction fans.
  • the third processor of the manager module is dedicated to graphic interface events, performs event detection tasks on the touch panel, displays graphics on the LCD screen, interfaces with remote control smartphone applications and interfaces with the aforementioned remote evaluation module. of training.
  • the newly detailed data processor and manager module contains acquisition stages that allow the input of high definition signals at high refresh rates such as 1920x1080 pixels at 120 frames per second.
  • high definition signals such as 1920x1080 pixels at 120 frames per second.
  • a pre-filtering and sub-sampling stage has been conceived that immediately optimizes these characteristics according to the available bandwidth, even reaching resolutions and refresh rates sufficient for a correct evaluation.
  • This concept has been carried out with the inclusion of aspect conversion, audio banding and frame-per-second subsampling, through all-electronic stages (no synchronous processing).
  • this video already subsampled and filtered, is acquired by the 32-bit processor and is compressed in current standards of high performance and compatibility such as H.264, to be able to be sent to the remote training evaluation module.
  • Storage in this process is important and critical, so the system includes a storage medium that is removable in cases where connectivity went from a limited state to a null state;
  • an SD card has been proposed, which supports high transfer rates, large volumes of data on a removable medium that can be read by all operating systems.
  • the video and data recordings must be able to be extracted and recorded on an external computer, to then be sent to the remote training evaluation module.
  • the manager and data processing module in addition to acquiring video signals, allows the reception of signals and figures of merit from multiple external sensors and accessories, supporting functions such as: 3-axis acceleration signal measurement for active user members , through 2 channels of 3 axes (6 channels in total); measurement of muscle recruitment signals through non-invasive differential surface electromyography, using 4 to 8 channels; measurement of signs and figures of merit of muscle exhaustion, tetanization and fasciculation, through 2 channels; user heart rate measurement; net eye movement; environmental conditions such as temperature, humidity, light and noise levels; status signals of compatible equipment, such as the simulator device, where it will capture and record the operating conditions of the equipment. In the case of the laparoscopic simulator, it will be the simulator light power; vector of position angles of the robotic arm holding the camera; and sensing of ports (inserts for trocars) used / not used.
  • the component of the system referred to as a remote training evaluation module comprises a remote mass storage medium for data, interactive graphic interface means, an interactive multi-user access environment with a set of training patterns.
  • the remote mass data storage medium comprises a remote storage server, of the cloud storage type; while the interactive graphical interface means comprise a set of graphical displays on the screen that allow executing commands and displaying multi-user access responses, applicable on any computerized electronic device, such as a smartphone, a tablet or a computer.
  • the multi-user interactive access environment comprises a computer-implementable program that allows the user to access the massive data storage medium through the interactive graphical interface, where he can access different levels of planned training.
  • the invention also includes the advanced training procedure for the development of laparoscopic surgical skills, which allows simulation exercises and obtaining a comprehensive evaluation of skills remotely, is done through the training system of the type described above, as with the device also described; wherein the method comprises the steps of: i) obtaining data from video images and biometric data of the user performing a training exercise; ii) generating a data package integrating the obtained video image data and biometric data; iii) send the generated data packet to the remote mass storage medium; iv) evaluate the sent data package and integrate feedback data from the evaluating user; v) sending the evaluated data packet to the remote mass storage medium; vi) visualize the evaluated data packet and receive integrated feedback.
  • the step of obtaining data from video images of the user performing a training exercise involves the steps of: a) entering the system activation command in a graphic interface means arranged in the housing of the simulator device used by a user in training; b) entering the activation command for an automated means of lifting the housing of the simulator device; c) enter the activation command for the administrator and data processor module; d) plug an HDMI cable into an HDMI signal splitter output on the simulator device and connect it to an external display medium, such as a high resolution monitor where the user can see their training in real time; e) inserting laparoscopic instruments through the different openings arranged in the housing of the simulator device; f) install biometric sensors on the user and verify connection with the data manager module; g) verify the capture of images from the external camera; h) connect the administrator and data processor module with the remote training module; i) start laparoscopic surgery simulation exercise.
  • the step of obtaining biometric data from the user is carried out with the multi-sensor module and involves a wireless connection with the administrator and data processor module to whom it sends the captured signals, where the wireless connection can be carried out through a protocol Bluetooth connectivity.
  • the step of generating a data packet integrating the data from video images and biometric data obtained is carried out by the data processor administrator module, and involves a pre-filtering and sub-sampling stage that immediately optimizes these characteristics according to the width of the data. available band and a later stage of compression.
  • the pre-filtering and subsampling stage includes aspect conversion, audio banding, and frame-per-second subsampling, through all-electronic stages.
  • the integration of the video image data and biometric data is synchronized by means of a timestamp with respect to the videos.
  • the step of sending the generated data package to the remote mass storage module involves entering the multi-user interactive access environment and adding the data package to a specific training session of the registered user through the interactive graphical interface module.
  • Entering the multi-user interactive access environment module implies that the administrator module makes a connection, which can be wireless, with a local Internet network and directly sends the data packet.
  • entering the multi-user interactive access environment module implies that the administrator module stores the data package on a removable storage medium, from which the information is then extracted to be sent to the network through a computer connected to the multi-user interactive access environment.
  • the step of evaluating the sent data packet and integrating feedback data from the evaluating user involves connecting a computer or electronic communication device to the multi-user interactive access environment module, accessing the content of a registered user, viewing the packet of data in video form, review and incorporate feedback in the form of observations directly into the revised video.
  • the evaluation observations made by the evaluating user comprise signals in audio, text, video or drawing format that are integrated into the data package in the form of video.
  • Figure 1 shows an isometric view of the simulator device.
  • Figure 2 shows a top plan view of the simulator device.
  • Figure 3 shows a bottom plan view of the housing of the simulator device.
  • Figure 4 shows an isometric view of the lower fixed component of the simulator device housing.
  • Figure 5 shows a longitudinal section view of the simulator device.
  • Figure 6 shows an isometric view of a second embodiment of the automated lifting mechanism of the simulator device.
  • Figure 7 shows a side elevation view of the simulator device in a state of maximum elevation.
  • Figure 8 shows a side elevation view of the simulator device in compact state.
  • Figure 9 shows a bottom plan view of the simulator device.
  • Figure 10 shows a cross-sectional view of the simulator device.
  • Figure 11 shows a schematic plan view of the interior of the simulator device housing.
  • Figure 12 shows a rear elevation view of the movable component of the simulator device housing.
  • Figure 13 shows a schematic view of the advanced training system, containing the simulator device, a biometric multi-sensor module, a remote evaluation module and an administrator module.
  • Figure 14 shows a diagram of the biometric multi-sensor module.
  • Figure 15 shows an isometric view of the data processor manager module of the system.
  • Figure 16 shows a rear view of the system data processor manager module.
  • Figure 17 shows a diagram of the internal components of the system's data processor manager module.
  • Figure 18 shows a schematic of the components of the remote training evaluation module.
  • Figure 19 shows a flow chart of the procedure for conducting advanced laparoscopic skills training.
  • the simulator device (1) for advanced laparoscopic skills training comprises a portable casing (10) formed by an upper mobile component (12) and a lower fixed component (13), which define a internal cavity (11) with adjustable volume thanks to an automated means of lifting and tilting (30).
  • the simulator device (1) also comprises a central control and data processing module (not illustrated), capable of controlling different electronic components of the simulator device in response to commands given by the user through an interface means (20) user disposed outside the casing (10).
  • the simulator device (1) also has an external means for capturing images, consisting of a front camera (60) that allows monitoring the ergonomics of the user, in addition to the identity of the user while training.
  • the upper mobile component (12) of the housing simulates the shape of a human anatomy torso, it comprises the interface means (20), which is a graphical and auditory interface, including a resistive display panel, LCD panel type.
  • the upper mobile component (12) also has a series of openings (14) for inserting laparoscopic instruments, where said openings are provided with rubber inserts (15) that hold the instruments.
  • This series of openings (14) includes at least one central opening (141) located in the longitudinal central axis of the housing (10). As seen in FIG. 3 and FIG.
  • the lower fixed component (13) of the casing (10) is a rigid frame (130) with an open side area (131) and a free central area (132) where you can place a removable tray (not illustrated) that contains the surgical work samples that make up the work area.
  • the upper movable component (12) of the casing (10) is formed by an outer cover (120) and an inner cover (121) of rigid material, sealed together to generate an interior chamber where electronic components are safely arranged against liquid splashes.
  • the internal cavity (11) of adjustable volume is generated thanks to the aforementioned automated means (30), which is made up of robotized telescopic pillars (301) that include a system of high power electric actuators driven by a motor (304), where said automated means (30) is connected to the central control module and is manageable by means of a command.
  • automated means (30) which is made up of robotized telescopic pillars (301) that include a system of high power electric actuators driven by a motor (304), where said automated means (30) is connected to the central control module and is manageable by means of a command.
  • said command corresponds to a manual command formed by a push button (303) arranged on the outer cover (120) of the upper mobile component (12) (also visible in FIG. 2).
  • said command corresponds to a digital command operable from the user interface means (20) arranged outside the housing (10).
  • the automated means (30) is made up of an automated pantograph mechanism (302), driven by high-power electric actuators driven by a motor and where said automated means is connected to a command that has the same alternatives as the preferred embodiment, that is, it can be a manual command or a digital command.
  • the automated means (30) allows the upper mobile component (12) to be moved in a parallel or inclined manner with respect to the lower fixed component (13), so that in the device's operating state, the casing (10) can generate the largest interior volume in the interior cavity (11) with the maximum extension of the telescopic pillars (301), as illustrated in FIG.7; meanwhile, in the non-operating state of the device and / or of transfer, the volume of the interior cavity (11) is reduced to a minimum with the maximum contraction of the telescopic pillars (301), as illustrated in FIG. 8 .
  • the simulator device also comprises a high-resolution video capture medium, arranged inside the casing (10), which is a camera ( 40) compact video that avoids the delay time in the reproduction of the image, of at least 128 FPS (frames per second) at 1080p (pixels), with direct output via HDMI cable to an HD digital splitter, which Allows you to send an image to any LED or OLED monitor with HDMI input with no delay between what happens and what is seen.
  • the control of said camera (40) is digital and is managed remotely as it is coupled with the central control module of the simulator device, manageable from the user interface (20).
  • the camera (40) (also illustrated in FIG.
  • a robotic holding means which comprises a robotic arm (50) coupled to the lower face of the upper mobile component (12) of the housing, it is a pivoting arm in four axes thanks to servo-motorized actuators that allow panning, tilting and increasing the camera's point of view.
  • control means of the actuators of the pivoting robot arm are manual, operable from a gamepad style command (not illustrated) arranged in the upper movable component of the housing.
  • the interior lighting means comprise at least two [240mW] LED strips of 6000 ° K color temperature, providing 720 lumens.
  • the interior lighting means of the housing comprise at least two flexible tapes of diffuse LED patches, of [240mW] of 6000 ° K color temperature, providing 720 lumens.
  • the device (1) also has electronic connector means (80), illustrated in the
  • FIG.12 formed by at least two HDMI multimedia ports, an HDMI signal splitter connected to the indoor video camera; at least one wired digital and analog signal input port, and a conventional connector to a power source; all arranged in the upper mobile component (12) of the simulator device (1).
  • the simulator device also comprises a storage medium for the captured video images, given by a removable memory card, SD card type (not illustrated), connected to the control and data processing module.
  • the simulator device allows data collection and remote and remote control, such as data on hours of use and on, auto error detection and reporting, protocols on and off remotely; These characteristics are facilitated by the presence of a wireless connection module (90) (not illustrated) for remote management and supervision of the device, which comprises a multiband router and a GPRS / 3G / 4G antenna, connected to the central control module and embedded in a SIM-card, housed in the housing in a protected way to prevent unauthorized manipulation.
  • a wireless connection module (90) (not illustrated) for remote management and supervision of the device, which comprises a multiband router and a GPRS / 3G / 4G antenna, connected to the central control module and embedded in a SIM-card, housed in the housing in a protected way to prevent unauthorized manipulation.
  • the invention of the present application also refers to a system (2), schematically illustrated in FIG. 13, which allows to carry out an advanced training planned procedure, with comprehensive evaluation of laparoscopic surgical skills, performed in a remote and delayed, where this system includes the simulator device (1) just described, where this simulator device allows to simulate real conditions of a surgery and captures video images of both the training activity inside the device and outdoors related to ergonomics and user movements;
  • the system further comprises a biometric multi-sensor module (3) to capture biometric indicators of the user during the training process; a remote training evaluation module (4) and an administrator module (5) captured data processor that integrates the data acquired from the simulator device and the biometric multi-sensor module, processes and sends them, in data packet mode to the remote training evaluation module, so it can be linked to the simulator device (1) and to the remote training module (4).
  • the biometric multi-sensor module (3) comprises a device with a micro-processor (31), a charging port (32) of the micro USB type, and a removable battery-type power source (33 ), a series of sensors applicable in different parts of the user's body, capable of sending information to the captured data manager module wirelessly or by wire; where said sensors can be muscle measurement electrodes, heart rate monitors, and / or net eye movement sensors, deployed in the form of a heart rate monitor connector (34), clips for measurement electrodes (35) and a clip for a reference electrode (36 ).
  • the captured data processor manager module (5) as illustrated in FIG.
  • wired connectivity means shown in FIG. 16, formed by at least one HDMI input (53) to acquire images from the video outputs of the simulator device; a main power supply port to the power source (54) and at least one wired analog and digital signal input port (55) comprising 10 to 12 pins with 8 channels for acquiring wired signals.
  • the manager module (5) also comprises wireless connectivity means (56), which consist of a "Bluetooth” protocol (561) for data acquisition from devices with this communications method, where these devices can be devices chosen from the group of health monitoring wristbands, Smartwatches, Thermometers, multi-sensor devices, etc; It also includes a "Wi-Fi” protocol (562) that provides connectivity to the internet and the local network where the administrator module is installed; and a ZigBee connectivity protocol (563) for the acquisition of field sensors related to room conditions, lighting, among others.
  • a Bluetooth (561) for data acquisition from devices with this communications method, where these devices can be devices chosen from the group of health monitoring wristbands, Smartwatches, Thermometers, multi-sensor devices, etc. It also includes a "Wi-Fi” protocol (562) that provides connectivity to the internet and the local network where the administrator module is installed; and a ZigBee connectivity protocol (563) for the acquisition of field sensors related to room conditions, lighting, among others.
  • Wi-Fi Wireless Fidel
  • the administrator module (5) also comprises a first central management processor (570) for first layer activities, a second processor (571) to perform high-level tasks such as the capture, compression, saving and sending of high definition videos ; a third processor (572) dedicated to graphical interface events; and a removable data storage medium (58) of the SD card type.
  • the system component mentioned as remote training evaluation module (4) comprises a multi-user interactive access environment module (43) that incorporates a graphical interface module interactive (42) and is linked to a remote mass data storage module (41).
  • the remote massive data storage module (41) comprises a remote storage server, of the cloud storage type; while the interactive graphical interface module (42) comprises a set of graphic displays on the screen that allow executing commands and displaying multi-user access responses, applicable on any computerized electronic device, such as a smartphone, a tablet or a computer. .
  • the multi-user interactive access environment module (43) comprises a computer-implementable program that allows the user to access the massive data storage module (41) through the interactive graphical interface module (42), where they can access different levels of planned training.
  • the invention of the present application also refers to an advanced training procedure for the development of laparoscopic surgical skills, which allows to perform simulation exercises and obtain a comprehensive evaluation of skills remotely, this procedure is performed through the system (2) training of the type described above, where, as shown schematically in the diagram of FIG. 19, the procedure comprises the steps of: i) obtaining data from video images and biometric data of the user performing an exercise of training; ii) generating a data package integrating the obtained video image data and biometric data; iii) send the generated data packet to the remote mass storage medium; iv) evaluate the sent data package and integrate feedback data from the evaluating user; v) sending the evaluated data packet to the remote mass storage medium; vi) visualize the evaluated data packet and receive integrated feedback.

Landscapes

  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Mathematical Analysis (AREA)
  • Mathematical Physics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Algebra (AREA)
  • Computational Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Mathematical Optimization (AREA)
  • Medical Informatics (AREA)
  • Pure & Applied Mathematics (AREA)
  • Business, Economics & Management (AREA)
  • Educational Administration (AREA)
  • Educational Technology (AREA)
  • Theoretical Computer Science (AREA)
  • Instructional Devices (AREA)
  • Endoscopes (AREA)

Abstract

Dispositif simulateur pour formation avancée des aptitudes laparoscopiques permettant de simuler des conditions réelles d'une chirurgie; système de simulation de chirurgie laparoscopique pour effectuer un procédé planifié de formation avancée avec évaluation complète des aptitudes en chirurgie laparoscopique, effectuée à distance et en différé; et procédé associé. Ledit système simulateur comprend a) un bâti portable; b) un module de commande centrale; c) un moyen automatisé de levée et d'inclinaison du bâti; d) un moyen de capture de vidéo haute résolution interne; e) un moyen robotisé de fixation du moyen de capture de vidéo; f) un moyen externe de capture d'images; g) un moyen d'interface d'utilisateur; h) des moyens d'éclairage intérieur; i) des moyens de stockage; j) des moyens connecteurs électroniques; k) un module de connexion sans fil pour manipuler et superviser à distance le dispositif, connecté au module de commande centrale. Le système de simulation comprend a) un dispositif simulateur qui permet de simuler des conditions réelles d'une chirurgie et capte des images vidéo aussi bien de l'activité de formation à l'intérieur du dispositif que celle à l'extérieur en relation avec l'ergonomie et les mouvements de l'utilisateur; b) un module multi-capteurs biométriques; c) un module à distance d'évaluation de la formation et d) un module administrateur processeur de données capturées qui intègre les données acquises depuis le dispositif simulateur et du module multi-capteurs biométriques, les traite et les envoie sous forme de paquet de données vers le module à distance d'évaluation de la formation. Le procédé comprend les étapes consistant à i) obtenir des données d'images vidoé et des données biométriques de l'utilisateur; ii) générer un paquet de données; iii) envoyer le paquet de données générées à un module à distance de stockage massif; iv) évaluer le paquet de données envoyé et intégrer des données de rétro-alimentation par l'utilisateur évaluateur; v) envoyer le paquet de données évalué au module à distance de stockage massif; vi) visualiser le paquet de données évalué et recevoir la rétro-alimentation intégrée.
PCT/CL2020/050078 2019-09-27 2020-07-22 Dispositif et système de simulation de chirurgie laparoscopique pour effectuer un procédé planifié de formation avancée, avec une évaluation intégrale des aptitudes en chirurgie laparoscopique effectuée à distance et en différé; et procédé associé Ceased WO2021056123A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CL2019002768A CL2019002768A1 (es) 2019-09-27 2019-09-27 Dispositivo y sistema de simulación de cirugía laparoscópica para llevar a cabo un procedimiento planificado de entrenamiento avanzado, con evaluación integral de las habilidades quirúrgicas laparoscópicas realizada de manera remota y diferida; y el procedimiento asociado.
CL2768-2019 2019-09-27

Publications (1)

Publication Number Publication Date
WO2021056123A1 true WO2021056123A1 (fr) 2021-04-01

Family

ID=75165582

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CL2020/050078 Ceased WO2021056123A1 (fr) 2019-09-27 2020-07-22 Dispositif et système de simulation de chirurgie laparoscopique pour effectuer un procédé planifié de formation avancée, avec une évaluation intégrale des aptitudes en chirurgie laparoscopique effectuée à distance et en différé; et procédé associé

Country Status (2)

Country Link
CL (1) CL2019002768A1 (fr)
WO (1) WO2021056123A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2768590C1 (ru) * 2021-05-21 2022-03-24 Константин Викторович Пучков Портативный симуляционный тренажер для развития мануальных навыков в лапароскопической хирургии
RU216501U1 (ru) * 2022-12-20 2023-02-09 Общество С Ограниченной Ответственностью "Артвижн" Контроллер для виртуальной симуляции ретроградной интраренальной хирургии
CN118264777A (zh) * 2024-05-31 2024-06-28 科弛医疗科技(北京)有限公司 腹腔镜图像云处理方法和系统、存储介质
US12294876B2 (en) 2021-12-10 2025-05-06 T-Mobile Usa, Inc. Location simulation for wireless devices

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070166682A1 (en) * 2003-01-22 2007-07-19 Realsim Systems, Llc. Medical training apparatus
US8328560B2 (en) * 2007-12-03 2012-12-11 Endosim Limited Laparoscopic apparatus
US20140220527A1 (en) * 2013-02-07 2014-08-07 AZ Board of Regents, a body corporate of the State of AZ, acting for & on behalf of AZ State Video-Based System for Improving Surgical Training by Providing Corrective Feedback on a Trainee's Movement
US20140342334A1 (en) * 2013-05-15 2014-11-20 Applied Medical Resources Corporation Hernia model

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070166682A1 (en) * 2003-01-22 2007-07-19 Realsim Systems, Llc. Medical training apparatus
US8328560B2 (en) * 2007-12-03 2012-12-11 Endosim Limited Laparoscopic apparatus
US20140220527A1 (en) * 2013-02-07 2014-08-07 AZ Board of Regents, a body corporate of the State of AZ, acting for & on behalf of AZ State Video-Based System for Improving Surgical Training by Providing Corrective Feedback on a Trainee's Movement
US20140342334A1 (en) * 2013-05-15 2014-11-20 Applied Medical Resources Corporation Hernia model

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2768590C1 (ru) * 2021-05-21 2022-03-24 Константин Викторович Пучков Портативный симуляционный тренажер для развития мануальных навыков в лапароскопической хирургии
US12294876B2 (en) 2021-12-10 2025-05-06 T-Mobile Usa, Inc. Location simulation for wireless devices
RU216501U1 (ru) * 2022-12-20 2023-02-09 Общество С Ограниченной Ответственностью "Артвижн" Контроллер для виртуальной симуляции ретроградной интраренальной хирургии
CN118264777A (zh) * 2024-05-31 2024-06-28 科弛医疗科技(北京)有限公司 腹腔镜图像云处理方法和系统、存储介质

Also Published As

Publication number Publication date
CL2019002768A1 (es) 2021-07-19

Similar Documents

Publication Publication Date Title
JP7679505B2 (ja) ポータブル腹腔鏡訓練器
US11990055B2 (en) Surgical training model for laparoscopic procedures
US10902745B2 (en) Neuro-endoscope box trainer
US20220375620A1 (en) Surgical Simulation System With Coordinated Imagining
Gallagher et al. Objective psychomotor skills assessment of experienced, junior, and novice laparoscopists with virtual reality
EP3467805B1 (fr) Modèle d'apprentissage chirurgical pour des interventions laparoscopiques transluminales
WO2021056123A1 (fr) Dispositif et système de simulation de chirurgie laparoscopique pour effectuer un procédé planifié de formation avancée, avec une évaluation intégrale des aptitudes en chirurgie laparoscopique effectuée à distance et en différé; et procédé associé
KR101822383B1 (ko) 치과 수술 영상 제공시스템
EP3326168B1 (fr) Modèle d'appendicectomie
US20190336226A1 (en) Training system for robot-assisted laparoscopic surgery
ES2534140B1 (es) Procedimiento y dispositivo para el aprendizaje y entrenamiento de operaciones de cirugía laparoscópica e intervenciones similares
Sun et al. Virtually transparent epidermal imagery for laparo-endoscopic single-site surgery
US20240346953A1 (en) Surgical simulation scope system
CN221551342U (zh) 腹腔镜手术模拟训练装置
US20240071254A1 (en) Biaxial controller for a minimally invasive surgery tool, a camera for minimally invasive surgery training and a system for minimally invasive surgery training
Domínguez Velasco Augmented reality surgical navigation as training model in neurosurgery: ventriculostomy procedures
KR20220070746A (ko) 생체 신호 모니터링 기능과 멸균 기능이 내장된 포터블 내시경 장치
Andrews et al. Simulation as a Tool to Enhance Learning & Education

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20867135

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20867135

Country of ref document: EP

Kind code of ref document: A1