WO2019234056A1 - Simulating a sentinel lymph node biopsy surgical technique - Google Patents

Abstract

In an aspect, a device is provided for simulating a sentinel lymph node biopsy surgical technique in a human body region. The device comprises a surgical pad including layer and non-layer components jointly simulating the human body region. The layer and non- layer components are detachably attachable to each other, and the non-layer components include a first simulated sentinel lymph node with a wireless signal emitter to simulate radiation emitted by the first sentinel lymph node. The device further comprises a probe tool simulating a real probe and comprising a head including a wireless signal detection sensor to detect the wireless signal emitted by the wireless signal emitter of the first simulated sentinel lymph node.

Description

SIMULATING A SENTINEL LYMPH NODE BIOPSY SURGICAL TECHNIQUE

This application claims the benefit of European Patent Application EP18382394.7 filed 05 June 2018.

The present disclosure relates to devices for simulating a sentinel lymph node biopsy surgical technique in a human body region.

BACKGROUND

Sentinel lymph node biopsy is a surgical technique that is performed on patients with e.g. breast cancer and that allows obtaining accurate information of lymph nodes in e.g. the axilla. This information may be very useful to establish a prognosis in patients and to plan subsequent complementary treatment, with e.g. radiotherapy and chemotherapy.

Thanks to cancer prevention campaigns, through mammography aimed at the general population, tumours are diagnosed in progressively less advanced stages, with very small measures and with less involvement of the regional lymph nodes. Interest in e.g. breast cancer conservative surgery including, among others, the sentinel lymph node biopsy has considerably grown in the last years. The lymph nodes have reached a great prominence in this area. Lymph nodes help to determine if cancer cells have acquired the ability to spread to other parts of the body. A sentinel lymph node is the first lymph node where these cancer cells are established.

The metastatic involvement of the regional lymph nodes has been shown to be a major determinant of survival outcome in patients having different cancer types (i.e breast cancer, cutaneous melanoma, etc.). In these tumours the standard technique to identify lymphatic metastases at the earliest stage is the sentinel lymph node biopsy. This is a selective surgical procedure that is usually performed with a low rate of morbidity.

The sentinel lymph node biopsy typically requires a previous marking stage using a radio-pharmaceutical to cause the union of a radionuclide with a molecule that has an affinity for the organ to be studied. Radionuclides are unstable atoms that emit a certain type of detectable radiation with a suitable instrument. The radiopharmaceutical is applied to the tumour to track it and check how far it propagates.

This technique allows preventing the removal of all the lymph nodes in human body region to know if the disease has left the local area to the axillary lymph nodes. If a ganglion is tested negative, it means that the rest of the ganglia are negative, whereas if it is tested positive then it is when it will have to be removed.

An object of the present disclosure is to provide devices for simulating a sentinel lymph node biopsy surgical technique with e.g. training purposes to better ensure success of the real surgery.

SUMMARY

In an aspect, a device is provided for simulating a sentinel lymph node biopsy surgical technique in a human body region. The device comprises a surgical pad including layer and non-layer components jointly simulating the (desired or affected) human body region. The layer and non-layer components are detachably attachable to each other, and the non-layer components include a (or at least one) first simulated sentinel lymph node with a wireless signal emitter to simulate radiation emitted by the first sentinel lymph node. The device further comprises a probe tool simulating a real probe and comprising a head including a wireless signal detection sensor to detect the wireless signal emitted by the wireless signal emitter of the (or each) first simulated sentinel lymph node. The human body region may correspond to a region in e.g. a groin, an axilla, a neck, etc.

The surgical pad and the probe tool may be provided separately or jointly, e.g. in a simulation kit.

With the proposed device, very realistic sentinel lymph node biopsies may be simulated as many times as required to e.g. provide an optimal training to corresponding medical staff. This complete training may significantly increase the possibilities of success and accuracy of the real surgery to be finally performed.

The disclosed device may permit transitioning from one scenario to another in a relatively quick and easy way by decoupling and coupling layer/non-layer suitable components. A simple substitution of one or more of the layer/non-layer components may allow the simulation of a different body region, morphology and/or pathology from a simulation to next one. For example, one or more components with a specific size and/or shape and/or placed in a particular position and/or location in the surgical pad may simulate a body region, morphology and/or pathology completely different from previous one(s) and very close to reality.

All or part of the layer/non-layer components may be shaped and/or sized and/or arranged in the surgical path according to generic or standard anatomy, morphology. A more customized approach may also be implemented based on e.g. a three dimensional (3D) reconstruction of layer/non-layer components from one or more medical images taken to a given patient. The 3D reconstruction may be implemented e.g. via a 3D printing technique.

The medical images may be obtained through e.g. X-rays, ultrasounds, Computed Tomography, etc. and may e.g. anticipate some difficulty of a hypothetical sentinel lymph node biopsy to be performed in/on the patient. A proper combination of certain layer/non-layer components according to the medical images may allow simulating a body region, morphology and/or pathology very close to reality. The biopsy operation may thus be simulated as many times as deemed necessary in order to ensure, as far as possible, the overcoming of the anticipated difficulties.

The coupling and decoupling (or attachment and detachment) between different layer/non-layer components may be implemented through, for example, a click, snap, clip mechanism or similar. This feature may allow a quick and easy transition between different medical scenarios with simple clicks between corresponding click, snap or clip portions in affected layer/non-layer components.

The wireless signal emitter in the first simulated sentinel lymph node permits simulating radiation from the first sentinel lymph node and, hence, its affectation by corresponding radiopharmaceutical. The wireless signal sensor in the probe tool is configured to detect the wireless signal from the first simulated sentinel lymph node, so that detection of the first sentinel lymph node by the probe tool is simulated very realistically.

The sentinel lymph node may be spherically shaped, although other shapes are also possible such as e.g. oval shape, ovoid shape, non-uniform shape, etc. A sentinel lymph node may be generally shaped according to its malignity or benignity condition depending on medical fundamentals.

In some examples, at least some of the layer and non-layer components may be made of silicone, which may include some modifier(s) and/or catalyser(s) to make said components as realistic as possible. For example, the layer components may be configured to simulate (some of) the most relevant biological layers (or human tissues) such as e.g. epidermis, fascia, grease, musculature, etc. and the non-layer components may be configured to simulate biological noble structures such as e.g. vascular elements (arteries, veins), nervous elements, tendons, etc. The “simulation” device may comprise a control unit to control electric/electronic components in the device, and suitable connections between control unit and electric/electronic components. The control unit may perform such a control by executing suitable computer program(s) aimed at that. The connections may permit the control unit and electric/electronic components to exchange signals between them. Said exchangeable signals may include control signals, sensor signals, etc. For example, the control unit may send control signals to the signal emitter in the simulated lymph node for causing start or end of wireless signal emission to simulate radiation from the simulated lymph node.

The non-layer components may further include a (or at least one) second simulated sentinel lymph node without wireless signal emitter to simulate non-emission of radiation by the second lymph node. Absence of radiation from said second sentinel lymph node permits simulating benignity of the node and, therefore, non-detectability through radiation by the probe tool. Non radiation related features described with respect to first simulated sentinel lymph node(s) with wireless signal emitter may be similarly applied to this second simulated sentinel lymph node(s) without wireless signal emitter.

At least some of the layer components may include a reinforcement mesh to enable simulation of at least some of the following surgical actions: cutting of the layer, stretching with forceps, suture of the layer, etc. This feature may further improve the realism of the simulations.

In some configurations, at least some of the layer components may include one or more reserves of a liquid that simulates blood configured to cause spread of the simulated blood upon cutting or rupture of the layer. Said reserves may be e.g. (small) deposits or similar distributed (more or less uniformly) in corresponding layer component. These deposits (or similar) may be configured to be cut or broken by a surgical tool and to accordingly cause leakage and spreading of the liquid contained therein, in same or similar way that real blood behaves when a human tissue is cut or broken. Realism of simulations is further increased with such a feature.

The simulation device may further comprise a closed liquid circuit including at least some of the non-layer components simulating an artery and a vein, and a liquid impeller to produce an artery-to-vein flow of a liquid that simulates blood. Such simulated artery and vein may have a shape of pipe or tube with suitable dimensions. The liquid impeller may be controlled by the control unit through corresponding control signals. The closed liquid circuit may thus provide an improved realistic scenario which may be very suitable for e.g. complete training of medical personnel.

The liquid impeller may comprise e.g. a pump and an actuator of the pump to generate pulses in the artery-to-vein flow of the liquid that simulates blood. The actuator of the pump may be adjustable to change the pulses in the artery-to-vein flow of the simulated blood. For that end, the control unit may provide suitable control signals to the actuator of the pump to generate the simulated pulses according to a pulse pattern provided by competent user. The pump may be e.g. an injection pump. These characteristics may provide even more realistic simulation conditions. In particular, the proposed pulse adjustment may permit approaching simulation conditions to very real conditions for a given patient with determined pulse parameters.

The closed liquid circuit may include a pressure reducing system in a junction between the simulated artery and the simulated vein to eliminate or attenuate the pulses of the artery-to-vein flow from the simulated artery towards the simulated vein. This pressure reducing system may also be controlled by the control unit (through suitable control signals) to accommodate the simulated pulses to very realistic conditions. With such a pressure/pulse reduction, a more naturalistic scenario may be provided wherein blood pulses may be present only in the simulated artery and absent in the simulated vein.

The pressure reducing system may comprise an intermediate deposit or similar between the simulated artery and the simulated vein to accumulate pulsed liquid from the simulated artery and to provide non-pulsed or less pulsed liquid to the simulated vein. In particular, the intermediate deposit may comprise a membrane for pressure or pulse absorption to implement the pursued pressure/pulse reduction or elimination. A unidirectional valve in a connection between the simulated artery and the intermediate deposit may facilitate the artery-to-deposit flow of the simulated blood. A unidirectional valve in a connection between the intermediate deposit and the simulated vein may facilitate the deposit-to-vein flow of the simulated blood.

The simulated (arterial) pulse may be used as a tactile guidance method during interventions in certain regions, such as e.g. inguinal region, similarly as in real medical scenarios.

The closed liquid circuit may comprise a main deposit of the simulated blood that may include a liquid level sensor to detect a rupture and/or liquid leakage in the closed liquid circuit. Upon such detection, corresponding sensor signal(s) may be sent by the liquid level sensor to the control unit to cause execution of responsive actions. For example, the control unit may generate in this case an alarm signal indicating that something wrong (or inacceptable) has been done during the simulation that may have damaged the patient. This alarm may be notified to corresponding user/operator in a variety of manners, such as e.g. through audible means, visible means, haptic means, a combination thereof, etc.

The aforementioned (injection) pump of the liquid impeller may be coupled with the main deposit through a unidirectional deposit-to-pump valve. A piston of the (injection) pump may be connected with a servomotor (actuator) with the function of driving the piston to therefore propel the simulated blood to artery 202, i.e. in an artery-to-vein direction.

The non-layer components (in the surgical pad) may comprise a metallic filament simulating a nerve and a conductivity and/or resistance sensor to detect a voltage and/or resistivity variation due to contact or cut or rupture of the metallic filament by another metallic element simulating a surgical tool. Upon such detection, a sensor signal representing the detected voltage and/or resistivity variation may be transferred to the control unit to cause performance of responsive actions, such as e.g. triggering an alarm, recording of data on the anomalous situation, simulation of a muscular contraction, etc.

In particular, the non-layer components may comprise a simulated tendon and an actuator of the tendon to simulate a (muscular) contraction in the human body region in response to e.g. a voltage and/or resistivity variation detected by the conductivity and/or resistance sensor. In this case, the control unit may send a control signal to the actuator of the tendon to cause the contraction. The magnitude of the contraction may be proportional to the detected voltage and/or resistivity variation. The actuator of the tendon may be based on e.g. servomotor(s). These features may provide big doses of realism to the simulation so that corresponding training of medical staff may be optimal and success of subsequent real surgery may be better ensured.

The probe tool may include a motion sensor system to measure motion of the probe tool during the simulation of the sentinel lymph node biopsy surgery. In particular, said motion sensor system may include at least one of a magnetometer, accelerometer, gyroscope, combination thereof, etc. With this characteristic(s) the use of the probe tool may be exhaustively tracked to verify the actuation of medical staff during the simulation. Motion signals may be received by the control unit to undertake such tracking which may comprise e.g. recording of said signals/data, suitable processing for medical staff evaluation, etc. Motion sensors may be internal or external to the probe tool with (same or similar) tracking purposes. For instance, the simulation device may use an external tracking system (as motion sensor system) based on e.g. three- dimensional (3D) vision with optical landmarks on the probe tool.

In general, the control unit may receive sensor signals from any of the sensors that may include the simulation device and may generate control signals depending on the received sensor signals. Said control signals may be sent to corresponding non-sensor components in the device, such as e.g. actuators, to generate very realistic conditions during the surgery simulation. Details about this control performed by the control unit are provided in other parts of the description.

The simulation device may further comprise an interactive user interface controlled by the control unit to implement different interactive functions. These interactive functions may aimed at e.g. realizing different (types of) simulations, visualizing readings or measures from different sensors and actuators during simulation(s), obtaining results of the evaluation of the performance of the simulation(s), etc. Details about this interface and interactive functions are provided in other parts of the description.

In a further aspect, a surgical pad is provided including layer and non-layer components jointly simulating a (desired or affected) human body region. The layer and non-layer components are detachably attachable to each other, and the non-layer components include a (or at least one) simulated sentinel lymph node with a wireless signal emitter to simulate radiation emitted by the sentinel lymph node.

In a still further aspect, a probe tool is provided simulating a real probe and comprising a head including a wireless signal detection sensor to detect a wireless signal emitted by a wireless signal emitter of a simulated sentinel lymph node.

These and other advantages and features will become apparent in view of the detailed description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting examples of the present disclosure will be described in the following, with reference to the appended drawings, in which:

Figure 1 is a block diagram schematically illustrating a simulation device according to examples; Figure 2 is a schematic view illustrating a surgical pad for a simulation device according to examples;

Figure 3 is a schematic view illustrating non-layer components in a surgical pad for a simulation device according to examples; and

Figure 4 is a schematic view illustrating a probe tool for a simulation device according to examples.

DETAILED DESCRIPTION OF EXAMPLES

Figure 1 is a block diagram schematically illustrating a device for simulating a sentinel lymph node biopsy surgical technique in a human body region according to examples. As shown in the figure, the simulation device may comprise a surgical pad 100 and a probe tool 101.

The surgical pad 100 may include layer and non-layer components (or modules) jointly simulating the human body region. The layer and non-layer components may be detachably attachable to each other. The non-layer components may include a first simulated sentinel lymph node with a wireless signal emitter to simulate radiation emitted by the first sentinel lymph node. Details about layer/non-layer components (or modules) are provided in other parts of the description.

The probe tool 101 may be configured to simulate a real probe and may comprise a head including a wireless signal sensor to detect the wireless signal emitted by the wireless signal emitter of the first simulated sentinel lymph node. Details about examples of probe tool 101 are provided in other parts of the description.

The surgical pad 100 may comprise sensors 102, actuators 103, a simulated nervous system 104, a simulated vascular system 105, etc. The simulated nervous system 104 may comprise at least some of the sensors 102, actuators 103, non-layer components (or modules) in the surgical pad 100, etc. The simulated vascular system 105 may also comprise at least some of the sensors 102, actuators 103, non-layer components in the surgical pad 100, etc. Details about this type of components (or modules) are provided in other parts of the description.

The simulation device may further comprise a control unit 106, a user interface 108 and a database 107 (or repository) to store data about users, simulation results, etc. The control unit 106 may be configured to control the whole simulation device by e.g. executing a computer program aimed at that purpose. Said control may include recording corresponding data in the database 107 from e.g. sensors 102, actuators 103, etc. along with results produced by simulations such as e.g. data on user performance, evolution, etc. Examples of data storable in the database 107 (by the control unit 106) may include e.g. blood levels, state of the nervous 104 system, data from the probe tool 101 , etc. More details about said control performed by the control unit 106 are provided in other parts of the description.

Figure 2 is a schematic view illustrating a surgical pad 200 for a simulation device according to examples. As shown in the figure, the surgical pad 200 may be formed by different layer and non-layer components. The layer components may comprise e.g. a simulated epidermis layer 212, simulated grease layers 207, 210, 21 1 , a simulated muscle layer 201 , simulated fascia layers 208, 209, etc. The non-layer components may include e.g. simulated veins 203, 204, a simulated artery 202, a simulated nerve 205, a simulated tendon 206, etc.

Figure 3 is a schematic view illustrating non-layer components in a surgical pad 300 for a simulation device according to examples. Same simulated muscular layer 201 , simulated artery 202, simulated veins 203, 204, simulated nerve 205 and simulated tendon 206 or similar elements as the ones of previous Figure 2 are shown in this figure but, in this case, they are fully or almost-fully visible since layer components covering them in Figure 2 have been omitted in Figure 3. Lymph nodes 301 , 302 are also shown in the view of Figure 3, a first simulated lymph node 302 including a wireless signal emitter 303 to simulate radiation, and a second simulated lymph node 301 not including any emitter to simulate no radiation. Emission of radiation from lymph node 302 simulates malignity of said node 302, whereas non-emission of radiation from lymph node 301 simulates benignity of said node 301.

In the examples of Figure 2 and Figure 3 or similar, the layer components 201 , 207 - 209, 210 - 212 may be made of a material with properties similar to the ones of real human tissues/layers. For example, the layer components 201 , 207 - 209, 210 - 212 may be made of silicone or similar material. The silicone may be modified with e.g. catalysers and/or other types of modifiers, in order to simulate as better as possible the features of real human tissues. A reinforcement mesh may be integrated in all or some of the layer components to simulate e.g. hardness conditions of human tissues/layers. With such an integrated mesh, certain surgical actions may be simulated more realistically, such as e.g. cutting of the layer, stretching with forceps, suture of the layer, etc. One or another material, more or less modified, with or without mesh may be taken into account to realistically simulate tissue features of a given layer. For example, since muscle tissue is harder than grease, a simulated muscle layer may include a reinforcement mesh while a simulated grease layer may not include such a mesh. In general, different types of tissue layers may be simulated in the indicated manners, such as e.g. epidermis, fascia, grease, musculature, etc.

The non-layer components 202 - 206, 301 , 302 may be configured according to principles similar to the ones described with respect to layer components 201 , 207 - 209, 210 - 212. One or another material, more or less modified, with or without mesh may be taken into account to realistically simulate tissue features of a given non-layer body element. Examples of such non-layer body elements are simulated vascular elements (arteries, veins) 202 - 204, simulated nervous elements 205, simulated tendons 206, simulated lymph nodes 301 , 302, etc. The non-layer components 202 - 206, 301 , 302 may have non-layer shapes. For example, simulated vascular elements may be pipe or tubular shaped, simulated tendons may be hollowed or semi-hollowed or non-hollowed cylindrical/tubular shaped; simulated nerves may be filament shaped; simulated lymph nodes may be sphere or oval or ovoid shaped; etc.

Manufacturing of layer and non-layer components may be based on a 3D reconstruction from medical images, such as e.g. images obtained via X-rays, ultrasounds, Computed Tomography, etc. Three-dimensional (3D) printing techniques may be used to perform such a 3D reconstruction. Layer and non-layer components may also be manufactured based on generic/standard models according to medical, anatomy, morphology fundamentals.

The coupling and decoupling (or attachment and detachment) between different layer/non-layer components may be implemented through, for example, a click or snap or clip mechanism or similar. This feature may allow a quick and easy transition between different medical scenarios by simply“clicking” between layer/non-layer components to be assembled.

Simulation devices according to present disclosure may comprise a closed liquid circuit including e.g. the simulated artery 202 and simulated veins 203, 204 of Figures 2 and 3, and a liquid impeller (not shown) to produce a simulated artery-to-vein flow of a liquid simulating blood. The impeller may comprise a pump and an actuator of the pump (not shown) to generate pulses in the simulated artery-to-vein flow of the simulated blood. The actuator of the pump may be adjustable (by control unit 106) to change the pulses in the simulated artery-to-vein flow of the simulated blood.

The closed liquid circuit may include a pressure reducing system in a junction between simulated artery 202 and the simulated vein(s) 203, 204 to eliminate or attenuate the pulses of the simulated artery-to-vein flow from the simulated artery 202 to simulated vein 203, 204. The pressure reducing system may comprise an intermediate deposit (not shown) between simulated artery 202 and simulated vein(s) 203, 204. This intermediate deposit may be configured to receive/accumulate pulsed liquid from the simulated artery 202 and to provide non-pulsed or less pulsed liquid to the simulated vein(s) 203, 204.

The simulated artery 202 may be connected with the intermediate deposit through a unidirectional valve according to artery-to-deposit direction. This unidirectional valve connecting the simulated artery 202 and the intermediate deposit may include a membrane for pressure (or pulse) absorption/reduction. The simulated vein(s) 203, 204 may be connected with the intermediate deposit through a further unidirectional valve according to deposit-to-vein direction. The closed liquid circuit may comprise a main deposit of simulated blood including a liquid level sensor to detect a rupture and/or liquid leakage in the closed liquid circuit. When rupture and/or liquid leakage in the closed liquid circuit is detected, an alarm may be triggered, and/or a bad score may be attributed to medical operator, etc. This may be implemented through the control unit 106 based on receiving sensor signals and producing reactive control signals depending on the received sensor signals, according to same or similar principles as the ones herein described with respect to other functionalities or scenarios.

The non-layer components may comprise a metallic filament 205 to simulate a nerve and a conductivity and/or resistance sensor (not shown) to detect a voltage and/or resistivity variation in the metallic filament 205. This voltage and/or resistivity variation may be indicative of e.g. a contact or cut or rupture of the metallic filament 205 by another metallic element simulating a surgical tool. Sensor signal(s) may be sent by the conductivity and/or resistance sensor to the control unit 106 for implementing responsive actions to voltage and/or resistivity variation(s).

In the above sense, an example of reactive action may be a muscular contraction caused by e.g. contact or cut or rupture of the simulated nerve 205 by simulated metallic surgical tool. This reactive action may be provoked by controlling a simulated tendon 206 and associated actuator (not shown) comprised in the non-layer components of the surgical pad 200. Such a control may be performed by the control unit 106 by sending suitable control signals to the actuator of the simulated tendon 206 to actuate on the simulated tendon 206 depending on the detected voltage and/or resistivity variation. For example, the intensity of said actuation may be proportional to the detected voltage and/or resistivity variation.

In some configurations, at least some of the layer/non-layer components may include a sensing surface (e.g. a sensor-equipped mesh) in/on regions that should not be contacted or touched by surgical tool (e.g. probe tool 101 ) during biopsy simulation. This sensing layer (not shown) may be configured to detect a pressure exerted by the surgical tool. The presence of the sensing layer may allow performing simulations with a greater degree of realism. It may also offer the possibility to evaluate more rigorously whether the probe tool 101 has been used correctly or incorrectly by corresponding user (or operator, student, surgeon, etc.). Control unit 106 may receive sensor signals from the sensing surface representing undue contact/touching and the control unit may e.g. store said received sensor signals, generate control signals depending on such received sensor signals, etc. The stored sensor signals may be used by the control unit to evaluate medical operator’s performance. The control signals may be generated to cause reactive actuations in response to undue contact/touching, such as e.g. a (muscular) contraction by actuating on simulated tendon 206 through corresponding actuator of the tendon.

In other examples, simulated arteries 202 and/or simulated veins 203, 204 may comprise a sensing surface that may be similar to the above one, in order to detect when a simulated vascular element 202 - 204 has been unduly contacted by surgical tool 101. Since such a situation may (seriously) damage a patient, an alarm may be triggered to warn medical operator, a bad qualification may be attributed to medical operator, etc. In particular, control unit 106 may trigger such an alarm signal, may attribute said bad qualification, etc. depending on received signals from the sensing surface or similar.

Figure 4 is a schematic view illustrating a probe tool for a simulation device according to examples. As shown in the figure, a probe tool 400 may comprise a main body 401 , a micro-controller 402, a motion sensor system 403, a warning system 404, a (scanning) head 406, a neck 405 connecting the main body 401 and the head 406, a wireless signal sensor 407 in the head 406, a communication and power port 408, etc.

The main body 401 may include an ergonomic handgrip and a hollow part to fully or partially house other elements such as e.g. micro-controller 402, motion sensor system 403, warning system 404, etc. The micro-controller 402 may be configured e.g. to receive sensor data from the motion sensor system 403, wireless signal sensor 407, etc. and to communicate with corresponding control unit 106.

The motion sensor system 403 may comprise at least one of a magnetometer, accelerometer, gyroscope, etc. with e.g. three degree of freedom, to determine a trajectory followed by the probe 400 in real time during biopsy simulation. The warning system 404 may comprise e.g. a low frequency auditory buzzer, LED vectors for visual information, etc. to emit visual/audio signals as a warning or similar. For instance, a variable sound may be produced by e.g. the auditory buzzer depending on a radiation level or intensity detected by the wireless signal sensor 407. This variable sound may be generated simulating a real probe as an auditory guide indicating distance and orientation of the probe tool 101 with respect to a simulated malign lymph node 302.

The wireless signal sensor 407 may be configured to detect wireless signal(s) from wireless signal emitter 303 in simulated sentinel lymph node 302. Emission of wireless signals (i.e. simulated radiation) from simulated lymph node 302 simulates malignity of said node 302, so detection of such wireless signals by the wireless signal sensor 407 simulates detection of simulated malign node 302. Conversely, non-emission of wireless signals from simulated lymph node 301 (without wireless signal emitter) simulates benignity of said simulated node 301 , so detection of said simulated node 301 by the probe tool 400 cannot occur. The wireless signal(s) may be based on, for example, Bluetooth (e.g. BLE - Bluetooth 4.0 Low Energy), NFC, Zig bee, Wi-Fi, etc. or any known technology suitable for the pursued aim. The wireless signal sensor 407 may also comprise, in some examples, a (High sensitivity) Hall-effect sensor whenever it is compatible with corresponding wireless signal emitter 303.

The communication and power port 408 may be configured to implement a communication between electronic components in the probe tool 400 and central control unit 106, sending data captured by sensors (e.g. motion sensor system 403), receiving data for actuators (e.g. warning system 404), etc. The communication and power port 408 may also be configured to supply power to electronics in the probe 400 from corresponding power source.

In any of the previously described examples or similar, the simulation device may comprise a monitor or display to display various types of images. These images may be images obtained by cameras located in/on the surgical pad 100 and/or the probe tool 101 , cameras arranged to record the performance of the user (operator, student, surgeon, etc.), etc. Besides the images about the biopsy simulation in progress, images of an ideal execution of the biopsy may also be displayed for guiding the user (operator, student, surgeon, etc.). These images of the ideal biopsy may be displayed superimposed on the images of the biopsy in progress for comparative purposes, for example.

The display may be touch-type, as part of the user interface 108 configured to make possible an appropriate communication and interaction between the student (or user, operator, etc.) and the biopsy simulation device. Said user interface 108 may comprise, for example, data input modules and output modules or modules for generating information. Control unit 106 may send suitable signals to the display for visualizing different a diversity of data, such as e.g. data on simulations performed or to be performed, readings from sensors 102 and/or actuators 103 (in the surgical pad 100) and/or probe tool 101 , data on evaluation of medical staff’s performance, etc.

The data input modules may be constituted by the said touch screen and, if required, a keyboard, a trackball or the like, and pedals for allowing access to or activation of certain functions, such as e.g. moving from one screen to another in a menu, accepting an option, etc. The inclusion of pedals as input module allows making the student familiar with the use of the pedals used in the operating room in a real situation.

The output modules may also include said touch screen and, if required, speakers (not shown). The speakers may allow the user interface 108 to emit audio to provide the students with an aid during the execution of the exercises, and also to emulate the real conditions of an operating room playing recorded sounds during a real situation, etc. The output modules may also comprise the system of haptic responses commented in other parts of the description.

The biopsy simulation device may allow performing exercises in tutorial mode, for example. The tutorial mode may provide the student with a series of aids so that the student may perform the exercises correctly. These aids may be provided during execution (or biopsy simulation) time, even though instructions may also be provided prior to the execution of the simulated biopsy.

As discussed in other parts of the description, different sensory channels may be used to transmit this aid information. For example, this support information may be transmitted through auditory channels, visual channels, and even force feedback channels. The tutorial mode may be applied as first stage in a training course, for example, in order to reduce the need for a "human" mentor.

Any of the examples described in the present disclosure may present, therefore, a high level of modularity and versatility. In particular, different modules used to simulate the (biological) part of the human body may be detachably attachable to each other through a coupling system of easy execution. For example, the coupling system may be a click, snap, clip mechanism or similar, so that a simple "click" may be sufficient to assemble the desired modules or components. These modules/components may be, therefore, easily interchangeable in order to simulate different scenarios with different morphologies, volumes, pathologies, etc. for performing different simulation exercises with large doses of realism.

The coupling between components may further comprise a universal connector to ensure the electrical connectivity between modules/components. This connectivity may allow that electrical power (from a power supply) reaches any electronic element (e.g. sensors) arranged in any module/component. The electrical connectivity may also permit proper transmission of data signals between electronic elements (e.g. sensors, actuators) arranged in any of the modules/components and the control unit 106 (computing system, Personal Computer, etc.).

According to the aforementioned modular approach, in some biopsy simulation devices of example, the control unit may be part of a base station. The base station may further comprise a display, speakers, a power supply, a support base, etc. The support base may be configured to support the surgical pad 100.

The electronic elements that may be arranged in the surgical pad 100 and/or the probe tool 101 may comprise LEDs, extraction sensors, sensor-equipped meshes, etc. At least part of these electronic elements may be easily attachable with the layer/non-layer components in the surgical pad 100. According to the purpose of providing a high level of modularity and versatility, said coupling may be, for example, a snap, clip, click coupling or similar mechanism.

In the case of electronic elements integrated in the layer/non-layer components of the surgical pad 100, said components may share at least some of the corresponding electronic elements. For example, said shared (or common) electronics may comprise a microprocessor configured to interact with the central control unit. This microprocessor may, for example, provide an identifier of the medical scenario (body part, morphology, anatomy, pathology, etc.) simulated by the surgical pad 100 so that the control unit may select control software that is compatible with such surgical pad 100 in particular. Said selection of software may also be performed depending on an exercise of biopsy operation selected by the user, for example.

Although only a number of examples have been disclosed herein, other alternatives, modifications, uses and/or equivalents thereof are possible. Furthermore, all possible combinations of the described examples are also covered. Thus, the scope of the present disclosure should not be limited by particular examples, but should be determined only by a fair reading of the claims that follow.

Claims

1. Device for simulating a sentinel lymph node biopsy surgical technique in a human body region, comprising:

a surgical pad including layer and non-layer components jointly simulating the human body region, the layer and non-layer components being detachably attachable to each other, and the non-layer components including a first simulated sentinel lymph node with a wireless signal emitter to simulate radiation emitted by the first sentinel lymph node; and

a probe tool simulating a real probe and comprising a head including a signal detection sensor to detect the wireless signal emitted by the wireless signal emitter of the simulated first sentinel lymph node.

2. Device according to claim 1 , wherein at least some of the layer and non-layer components are made of silicone.

3. Device according to any of claims 1 or 2, wherein the layer components are configured to simulate different biological layers in the human body region, including at least some of epidermis, fascia, grease, musculature.

4. Device according to any of claims 1 to 3, wherein the non-layer components are configured to simulate different biological noble structures in the human body region, including at least some of vascular elements, nervous elements, tendons.

5. Device according to any of claims 1 to 4, wherein the non-layer components include a second simulated sentinel lymph node without a wireless signal emitter to simulate non-emission of radiation by said second lymph node.

6. Device according to any of claims 1 to 5, wherein at least some of the layer components include a reinforcement mesh to enable simulation of at least some of the following surgical actions: cutting of the layer, stretching with forceps, suture of the layer.

7. Device according to any of claims 1 to 6, wherein at least some of the layer components include one or more reserves of a liquid simulating blood configured to cause spread of the simulated blood upon cutting or rupture of the layer.

8. Device according to any of claims 1 to 7, comprising a closed liquid circuit including at least some of the non-layer components simulating an artery and a vein, and a liquid impeller to produce an artery-to-vein flow of a liquid simulating blood.

9. Device according to claim 8, wherein the liquid impeller comprises a pump and an actuator of the pump to generate pulses in the simulated artery-to-vein flow of the liquid simulating blood.

10. Device according to claim 9, wherein the actuator of the pump is adjustable to change the pulses in the simulated artery-to-vein flow of the liquid simulating blood.

1 1. Device according to any of claims 9 or 10, wherein the closed liquid circuit includes a pressure reducing system in a junction between the simulated artery and the simulated vein to eliminate or attenuate the pulses of the simulated artery-to-vein flow from the simulated artery towards the simulated vein.

12. Device according to claim 11 , wherein the pressure reducing system comprises an intermediate deposit between the simulated artery and the simulated vein to accumulate pulsed liquid from the simulated artery and to provide non-pulsed or less pulsed liquid to the simulated vein.

13. Device according to claim 12, wherein the pressure reducing system comprises a unidirectional valve connecting the simulated artery to the intermediate deposit.

14. Device according to claim 13, wherein the unidirectional valve connecting the simulated artery to the intermediate deposit includes a membrane for pressure or pulse absorption.

15. Device according to any of claims 12 to 14, wherein the pressure reducing system comprises a unidirectional valve connecting the intermediate deposit to the simulated vein.

16. Device according to any of claims 8 to 15, wherein the closed liquid circuit includes a main deposit of the liquid simulating blood including a liquid level sensor to detect a rupture and/or liquid leakage in the closed liquid circuit.

17. Device according to any of claims 1 to 16, wherein the non-layer components comprise a metallic filament simulating a nerve and a conductivity and/or resistance sensor to detect a voltage and/or resistivity variation due to contact or cut or rupture of the metallic filament by another metallic element simulating a surgical tool.

18. Device according to claim 17, wherein the non-layer components comprise a simulated tendon and an actuator of the tendon to simulate a contraction in the human body region in response to a voltage and/or resistivity variation detected by the conductivity and/or resistance sensor.

19. Device according to any of claims 1 to 18, wherein the probe tool includes a motion sensor system to measure motion of the probe tool during sentinel lymph node biopsy surgery.

20. Device according to claim 19, wherein the motion sensor system includes at least one of a magnetometer, accelerometer, gyroscope.