REANIMATIONSPHANTOM

Description

Technical area

[0001] The invention relates to a resuscitation phantom for practical training of resuscitation measures, with a phantom body simulating the human torso, in which a fluid line system is arranged which schematically simulates the human blood circulation and comprises arterial and venous fluid line sections which can be assigned to the human abdomen and groin area and which are fluidically connected to a pump, wherein the pump is a manually actuated, mechanical pump which is arranged within the phantom body, which is designed in one or more parts, in the region of the human sternum, which is elastically deformable in this region, and a phantom head simulating the human head is attached to the phantom body, with a mouth-like opening which is fluidically connected to a bag simulating the human lung.

[0002] In the field of resuscitation, results from recent years have shown that reducing the duration of cardiac and circulatory arrest, i.e., no-flow time, has a significant impact on the survival and neurological outcome of resuscitation patients. A minimum of no-flow time can only be achieved if everyone involved in resuscitation measures has perfect command of their role and the procedures are coordinated with the actions of other team members. This can only be achieved through appropriate training. With the inclusion of extracorporeal cardiopulmonary resuscitation in the current guidelines, a highly invasive procedure is being incorporated into the extended resuscitation algorithm.The integration of cannulation during high-quality conventional resuscitation with minimal no-flow time and the parallel performance of all advanced resuscitation measures places entirely new demands on team training and the associated simulation. A training phantom should offer the possibility of practicing cannulation as a single-task training, but also allow for the simulation of the highly complex overall situation. State of the art

[0003] Well-known resuscitation phantoms enable either the practice of resuscitation, e.g. including intubation, chest compressions, insertion of intravenous access, simulation of defibrillation, etc., or the practice of pure cannulation with subsequent connection of a pump to a closed system.

[0004] Known resuscitation phantoms for practicing pure resuscitation are described, for example, in publications EP 1 623 403 B1, EP 2 430 628 B1, or WO 1994 / 05000 A1. They typically feature a doll-like replica of the human upper body with a head, through whose mouth and nose openings, artificial respiration can be performed in continuous alternation with cardiac massage. These model mannequins, which are schematically modeled after the human body, are designed to provide the person practicing on the mannequin with the most realistic tactile impression possible when performing artificial respiration and cardiac massage.

[0005] EP 1 230 634 B1 describes a device for simulating mouth-to-mouth resuscitation and cardiac massage, which can also be used to practice defibrillation. The doll-like replica of the human upper body and head area has electrodes attached to the flexible chest plate.

[0006] A known resuscitation phantom for practicing cannulation can be found in WO 2017 / 127724 A1 and comprises a human body dummy comprising the upper body and groin area. Within the body dummy, which is primarily made of silicone, are laid fluid lines that simulate the human arterial and venous blood circulation in a highly schematic manner. These lines are connected to an extracorporeal fluid reservoir via a groin section by a pump. For the purpose of puncture and cannulation, so-called cannulation windows are provided in the chest, neck, and right groin area, beneath which the arterial and venous fluid line sections are arranged. With this known simulation device, the puncture and insertion of medical instruments into the fluid line system can be practiced, and the flow changes within the fluid line system resulting from cannulation can be detected and monitored.

[0007] Furthermore, such training manikins enable the practice of cannulations for the purpose of establishing a fluidic connection to an extracorporeal fluid circuit, which may include, for example, an extracorporeal membrane oxygenation (ECMO) machine. Such resuscitation manikins are known in the literature and on the market as ECMO trainers or ECMO resuscitation manikins.

[0008] US 2015 / 0279237 A1 discloses a resuscitation phantom with a mechanical fluid pump and a fluidically connected fluid line system, which includes venous and arterial fluid line sections. Furthermore, the phantom has a head with a mouth opening and fluidically connected lungs. In particular, the pump mechanism implements the function of a mitral valve and an aortic valve.

[0009] The publication WO 2009 / 010898 A2 describes a phantom that can be transmitted through the ultrasound and can also be punctured.

[0010] The publication US 2008 / 0131855 A1 discloses a complex phantom for practicing a birth process, which has, among other things, sensors and RFID chips.

[0011] The document US 2017 / 0076635 A1 discloses a training phantom limited to a human limb. Description of the invention

[0012] The invention is based on the object of developing a resuscitation phantom for the practical training of resuscitation measures, comprising a phantom body simulating the human torso, in which a first fluid line system is arranged which schematically simulates the human circulatory system and comprises arterial and venous fluid line sections assigned to the human abdomen and groin area, which are fluidically connected to a pump, in such a way that a consistent simulation of all resuscitation scenarios can be carried out on a single resuscitation phantom. The possible resuscitation scenarios should include the following measures: Basic Life Support (BLS), comprising resuscitation measures such as mouth-to-mouth resuscitation or mouth-to-nose resuscitation and cardiac massage, professional cardiopulmonary resuscitation (CPR) using mechanical resuscitation aids, e.g.in the form of mechanical systems for performing chest compressions, extracorporeal cardiopulmonary resuscitation (eCPR), comprising the implantation of an extracorporeal support system.

[0013] The novel resuscitation manikin is intended to enable simulation training for all persons involved in resuscitation measures, i.e. laypersons, emergency physicians, perfusionists, rescue service personnel and other medical professionals.

[0014] The solution to the problem underlying the invention is defined in claim 1. Claims 10 and 11 each relate to a system for practical training of resuscitation measures using a resuscitation phantom according to the invention. Features that advantageously further develop the inventive concept are the subject of the dependent claims and the further description, particularly with reference to the exemplary embodiments.

[0015] The resuscitation phantom according to the invention according to the features of the preamble of claim 1 is characterized in that the pump fluidically connected to the first fluid line system is a manually operable, mechanical pump arranged within the phantom body, which is formed in one or more parts, in the region of the human sternum. The phantom body is elastically deformable in the region of the sternum in order to actuate the pump by external force or pressure exerted on the phantom body. In the region of the human upper abdomen and in the region of the human right and / or left groin, the phantom body provides an opening below each of which at least the arterial or venous fluid line section of the first fluid line system runs in sections and in each of which a physically sonographically and punctureable body is arranged or inserted.In addition, the first fluid line system and the pump are fluidically connected to a second fluid line system, along which at least one fluidic interface is arranged, to which a fluidic control and / or regulating unit for specifying and / or varying an absolute and / or pulsatile fluid flow pressure within the first fluid line system is connected.

[0016] The phantom head, which is permanently or detachably attached to the phantom body, is used with the mouth-like opening provided there and optionally additional nostril openings for practicing mouth-to-mouth resuscitation or mouth-to-nose resuscitation or mask-bag resuscitation via a face mask, which is characterized by the most realistic haptics possible with regard to the ventilation resistance during inspiration and the restoring force that comes into play during expiration. For this purpose, at least the mouth-like opening is connected to at least one bag simulating the human lung via at least one air-conducting channel. In addition, the filling pressure that can be generated and experienced through ventilation of the area of ​​the sternum within the phantom body, ieof the thoracic cavity, which is fluidically connected to the mouth-like opening and optionally to the nostril openings via at least one air-conducting channel, is determined by the limited volume present within the phantom body.

[0017] The replica of the mouth-like opening and the airway channel within the phantom head are designed to anatomically replicate the upper airway down to below the larynx. This allows for the realistic practice of inserting airway devices, i.e., various ventilation tubes into the throat (laryngeal mask airway, LM airway, LT airway) or via the larynx into the trachea (endotracheal tube, ETT), either without (LM airway, LT airway) or with (ETT airway) additional instruments (laryngoscope). To monitor success, breathing sounds can be monitored via a stethoscope. This subset of emergency care, which goes beyond mouth-to-mouth or mouth-to-nose ventilation or ventilation with a face mask and bag attached ("bag-mask ventilation"), is commonly referred to as advanced airway management.

[0018] In the absence of advanced airway management, a technically correct and successful implementation of mouth-to-mouth ventilation, mouth-to-nose ventilation, or bag-mask ventilation requires correct head and neck positioning. This means that the lower jaw must be advanced (mandibular protrusion) and the head / neck must be hyperextended (reclination). Failure to do these measures can make successful ventilation impossible. This condition is addressed in the phantom head via a blocking mechanism that compresses the air-carrying tube in the absence of reclination / mandibular protrusion.

[0019] The mechanical pump mounted at the level of the sternum within the thoracic cavity of the phantom body is designed and arranged in such a way that it can be actuated by uniaxial shock-like pressure caused by a force directed vertically from top to bottom onto the sternum of a resuscitation phantom lying horizontally on its back, and in doing so provides a haptically perceivable mechanical resistance that largely corresponds to the situation of a cardiac massage that can be performed on a human.

[0020] Thus, the resuscitation phantom according to the solution includes all the facilities for carrying out simulated ventilation and cardiac massage.

[0021] The manually operated, mechanical pump is capable of establishing a directed, pulsatile system flow within the first fluid line system when actuated, which ceases when the mechanical pump is not actuated. The mechanical properties of the pump, such as compression depth, pressure point, independent, relieving return of the pump to its initial state, as well as the operation of the mechanical pump, i.e. the frequency of the compression force manually applied to the pump, have a decisive influence on the system flow generated within the first fluid line system. The system flow within the arterial and venous fluid line sections of the first fluid line system can also be detected using an external mobile ultrasound device and made visible and tangible using appropriate imaging techniques for the people training on or with the resuscitation phantom.

[0022] For the purpose of coupling ultrasound waves to the arterial and venous fluid line sections of the first fluid line system with as little loss as possible, the resuscitation phantom provides openings in the human upper abdomen and in the human right and / or left groin area. These openings are each covered or filled with a physically transmissible body, preferably made of medical synthetic gel. In principle, alternative materials for covering or filling the openings provided in the phantom body, such as ballistic gelatin or similar materials that exhibit physically transmissible properties, are also suitable. Furthermore, it is also possible to perceive the pulsatile system flow established by the pump within the first fluid line system haptically using the tactile pressure waves via the medical synthetic gel or similarly elastic material.

[0023] The transducer and punctureable bodies are preferably non-transparent so that they cover the fluid line sections running within the phantom body invisibly for persons practicing on the resuscitation phantom.

[0024] The puncture procedure and the subsequent cannulation are preferably carried out with ultrasound assistance, so that the person in question can practice using both a puncture or cannulation instrument and an ultrasound head for visual representation of the injection or cannulation procedure using an ultrasound image.

[0025] The resuscitation phantom offers the possibility of performing puncture and cannulation in at least two different areas of the phantom body, thus enabling the simulation of different puncture situations and, where appropriate, their direct impact on systemic flow. This allows for a more realistic cannulation experience, as well as better representation of qualitative aspects of resuscitation and, above all, their interactions and dependencies, such as the aforementioned compression depth, pressure point, and compression frequency, all of which have a decisive influence on systemic flow.

[0026] The use of a mobile ultrasound device, whose ultrasound head is placed on the surface of one of the transducer bodies in the area of ​​the openings, generates ultrasound cross-sectional images of the fluid line sections running directly beneath or within the transducer body that are to be punctured.

[0027] In an extended embodiment, an electrically, magnetically or electromagnetically detectable unit is arranged within the phantom body in the region of at least one of the openings, preferably in the form of an RFID chip, in order to, on the one hand, dispense with the need for a real ultrasound device (in such a case, the puncture process is virtually represented on an ultrasound simulation device, triggered by the detectable unit), and, on the other hand, to be able to virtually generate and visually represent the representation and experience of further intracorporeal areas of the resuscitation phantom.

[0028] In particular, the use of RFID technology can be used to simulate cardiac findings, reversible causes of cardiovascular conditions, puncture needle and / or cannula misplacements, therapy controls, etc. With the help of an externally operable RFID antenna, which is manually guided over the resuscitation phantom in the area of ​​the openings or other body regions ("regions of interest"), the detectable unit, designed as an RFID chip, can be recorded. Any stored or programmable information can be retrieved from this unit and visually presented to the person concerned in a suitable manner, or such a visual presentation can be triggered on a suitable display device.

[0029] Above all, the solution-based resuscitation phantom enables the practice of performing extracorporeal cardiopulmonary resuscitation, or eCPR for short, which, according to the 2015 guidelines, must be taken into account when primary resuscitation efforts have failed or special interventions are necessary to correct reversible causes.

[0030] For this purpose, the resuscitation phantom provides at least one fluidic interface along the second fluid line system, to which an extracorporeal fluid circuit can be fluidically coupled. This circuit provides the fluidic control and / or regulation unit for specifying and / or varying an absolute and / or pulsative fluid flow pressure within the first fluid line system. Optionally, a fluid reservoir and / or a degassing unit are additionally provided along the second fluid line system.

[0031] By providing a second fluid line system connected in parallel to the first fluid line system, which can be connected to an open reservoir or to a controllable or regulatable fluidic system, for example, for simulating a patient, various variable pressures can be specified throughout the entire fluid line system, particularly in the first fluid line system along which the puncturing and cannulation areas are located. Furthermore, realistic resuscitation scenarios can be generated and simulated that extend beyond the time of cannulation. By connecting a fluidic control and / or regulating unit, via which the absolute and / or pulsatile fluid flow pressure within the first fluid line system can be individually specified, specific medical scenarios that may occur during resuscitation can be simulated.In particular, earlier perfusion phases as well as case constellations in the handling of extracorporeal circulation that are primarily difficult to handle from a cardiotechnical perspective, such as the suction of the venous cannula due to the occurrence of vasoplegia, can be simulated and practiced in this way. Brief description of the invention

[0032] The invention is described below, without limiting the general inventive concept, using exemplary embodiments with reference to the drawings. They show: Fig. 1 Top view of a resuscitation phantom designed according to the solution, Fig. 2 Representation of the first and second fluid line system with mechanical pump, Fig. 3 Fluid couplings with modularly replaceable fluid line section. Ways of implementing the invention, industrial applicability

[0033] Figure 1shows a plan view of a resuscitation phantom 1 designed according to the solution, which has a phantom body 2 simulating the human torso and a groin area 3 immediately adjacent to it, which includes a left and right upper thigh area 3', 3". A phantom head 4 is attached to the shoulder area of ​​the phantom body 2, which has a mouth-like opening 5 and two nostril openings 6, which are fluidically connected to the mouth-like opening 5.

[0034] For the purpose of carrying out mouth-to-mouth respiration as realistically as possible, the mouth-like opening 5 and the nostril openings 6 are fluidically connected via at least one air channel running inside the phantom head 4 and phantom body 2 to a bag simulating the human lung, which is arranged in the region of the sternum 7.

[0035] Before the Figure 1illustrated openings 12, 13, 14, each closed with a transducer and punctureable body 9, 10, 11, within the phantom body 2 as well as the right and left upper thigh areas 3', 3", reference is made to the explanation of the fluid line system arranged inside the resuscitation phantom 1, which is shown in Figure 2 is illustrated.

[0036] Figure 2 illustrates the fluid line system arranged within the resuscitation phantom. The central component is a manually operated, mechanical pump 15, which is arranged within the phantom body 2 in the area of ​​the human sternum 7. Fluidically connected to the manually operated pump 15 is a first fluid line system 16, which is Figure 2The first fluid line system 16 schematically simulates the human bloodstream and consists of venous 17 and arterial 18 fluid line sections assigned to the human abdomen, as well as venous 19 and arterial 20 fluid line sections assigned to the human groin area. For the purpose of puncturing and cannulation, in the abdomen area, Figure 1 removable opening 14 and in the left and right upper thigh area 3', 3" each below the Figure 1 The openings 12, 13 shown are arranged as closely as possible to the human anatomy in terms of shape, size and relative spatial arrangement of arterial and venous fluid lines. Figure 2 These areas are also covered by Figure 1 removable, transducable and punctureable bodies 9, 10, 11.

[0037] When the pump 15 is actuated, a fluid flow is generated along the first fluid line system 16 by the Figure 2 The flow pattern oriented towards the arrows shown is engraved, which, starting from the pump 15, first flows through the arterial fluid sections 18, 20 and subsequently through the venous fluid sections 19, 17.

[0038] In the area of ​​the venous and arterial fluid line sections 17, 18 assigned to the abdomen, a second fluid line system 21 is fluidically connected, which flows parallel to the first fluid line system 16 and is also fed and driven by the manually operated pump 17. A fluid interface 22 is provided along the second fluid line system 21, to which an extracorporeal fluid circuit 23 can be coupled. At least one of the following components 24 can be fluidically coupled along the extracorporeal fluid circuit 23 outside the resuscitation phantom 1: fluid reservoir, fluidic control and / or regulating unit for specifying and / or varying an absolute and / or pulsatile fluid flow pressure within the first fluid line system, degassing unit, and patient simulator.

[0039] The Figure 2 The second fluid line system 21 shown is in Figure 1indicated by the lines 21' leading away from and to the resuscitation phantom 1.

[0040] In view of the Figure 2 illustrated first and second fluid line system 16, 21 and the manually operable mechanical pump 15 fluidically connected thereto can be seen on the Figure 1Puncture and cannulation procedures can be carried out on the resuscitation phantom 1 shown as follows: Openings 12, 13, and 14 are completely covered with the transducer and punctureable bodies 9, 10, and 11, which are made of non-transparent material. This creates a situation that is as realistic as possible. A conventional mobile ultrasound device is preferably suitable for the precise location of the fluid line sections to be punctured, located directly beneath bodies 9 to 11. Since the transducer bodies 9, 10, and 11 are preferably made of a medical synthetic gel, this hardly causes any artifacts or interference with the ultrasound localization. The person involved in the puncture and cannulation can, in principle, perform an ultrasound-monitored vascular puncture in the area of ​​openings 12 and 13, as well as check the position of the wire and cannulas.Typically, no puncture is performed in the area of ​​the opening 14, but rather the position of a guide wire is checked with the aid of an ultrasound head, which is placed in the area of ​​the openings 12, 13 after a puncture and advanced along the fluid lines.

[0041] Alternatively, or in combination with performing an ultrasound-monitored puncture and cannulation, an RFID chip can be arranged in the area of ​​at least one of the openings 12, 13, 14, which can be detected by a simulated ultrasound probe with an RFID antenna. Instead of a live image of the body region scanned by a real ultrasound probe, an ultrasound device can be simulated using RFID technology and, in conjunction with cross-sectional images stored on a data storage device, can be visualized on a corresponding display device. Furthermore, additional RFID chips can be attached at suitable locations within the phantom body, thereby increasing the complexity of medical training tasks, for example, by adding complex constellations of findings or pathologies.

[0042] In order to make the preparation of the resuscitation model 1 between multiple uses as short and simple as possible, it is important to replace the punctured and thus leaking fluid line sections as quickly and easily as possible. Figure 3 shows a preferred structure for a rapid, modular replacement of punctured fluid line sections 25, 26, along which a transducer and punctureable body, preferably in the form of a medical synthetic gel 9, 10, is arranged. Thus, the punctured fluid line sections 25, 26, including the body, for example, 9, which surrounds the fluid line sections in a matrix-like manner, can be separated from the rest of the fluid line system via ball valve quick-release couplings 27 and replaced with new fluid line sections including the body.

[0043] Such a modular design also facilitates re-venting after a change of the puncture site and limits or reduces the consumables when using the resuscitation phantom according to the solution to a minimum.

[0044] For user-friendly handling and a fixed position locking of the quick couplings 27 as well as a related fixed positional predefined positioning of the punctureable fluid line sections 25, 26, the quick couplings 27 are fastened via corresponding holders 28 inside the phantom body 1.

[0045] In a preferred embodiment, the resuscitation phantom provides an elastic fluid reservoir 29 on the side of the venous fluid line sections to prevent these venous fluid line sections from collapsing during use of a resuscitation aid and additionally to realize the simulation of a central venous pressure (CVP) in combination with a fluidic component 24 integrated within the additional extracorporeal circuit 23. Furthermore, this reservoir 29 is used to automatically eliminate air bubbles from the fluid system. List of reference symbols

[0046] 1Resuscitation phantom 2Phantom body 3Groin area 3Right upper thigh area 3Left upper thigh area 4Phantom head 5Mouth-shaped opening 6Nostril opening 7Sternum 8N.N. 9, 10, 11Transmissible and punctureable body 12, 13, 14Opening 15Manually operated pump 16First fluid line system 17Venous fluid line section assigned to the abdomen 18Arterial fluid line section assigned to the abdomen 19Venous fluid line section assigned to the groin area 20Arterial fluid line section assigned to the groin area 21Second fluid line system 21Supply and drainage line 22Fluidic interface 23Extracorporeal fluid circuit 24Component 25, 26Punctureable fluid line section 27Quick-release ball coupling 28Mechanical holder 29Elastic reservoir

Claims

1. A resuscitation dummy (1) for the practical training of resuscitation measures, comprising a dummy body (2), which models the human torso and in which a first fluid line system (16) is arranged, which models the human blood circulation system in schematised form and comprises arterial and venous fluid line portions (17, 18, 19, 20) that can be associated with the human abdomen and groin area (3) and that are fluidically connected to a pump, wherein the pump (20) is a mechanical pump that can be manually actuated and that is arranged within the dummy body (2), which is formed from one or more parts, in the area of the human sternum (7), the dummy body being elastically deformable in said area, and a dummy head (4) which models the human head is attached to the dummy body (2), with a mouth-like opening (5), which is fluidically connected to a bag modelling the human lung, characterised in that the dummy body (2) has one opening (12, 13, 14) each in the area of the human upper abdomen and in the area of the human right and / or left groin region (3), under each of which openings at least the arterial or venous fluid line portion (17, 18, 19, 20) partly runs and in each of which openings a body (9, 10, 11) that can be physically examined sonographically and punctured is arranged, and in that the first fluid line system (16) and the pump (15) are fluidically connected to a second fluid line system (21), along which at least one fluidic interface (22) is arranged, to which a fluidic open-loop and / or closed-loop control unit (24) for presetting and / or varying an absolute and / or pulsatile fluid flow pressure within the first fluid line system (16) is connected.

2. The resuscitation dummy according to claim 1, characterised in that an electrically, magnetically or electromagnetically detectable unit is implemented at least in the area of one of the openings (12, 13, 14) within the dummy body (2).

3. The resuscitation dummy according to claim 2, characterised in that the unit is an RFID chip which is detectable by an externally manageable RFID antenna.

4. The resuscitation dummy according to any one of claims 1 to 3, characterised in that the body (9, 10, 11) that can be physically examined sonographically and punctured comprises medicinal synthetic gel.

5. The resuscitation dummy according to any one of claims 1 to 4, characterised in that the venous and / or arterial fluid line portions (17, 18, 19, 20) penetrate the body (9, 10, 11) that can be physically examined sonographically and punctured.

6. The resuscitation dummy according to any one of claims 1 to 5, characterised in that two fluid couplings (27) are arranged at a distance from one another along the arterial and / or venous fluid line portion (17, 18, 19, 20) in such a way that the fluid line portion (17, 18, 19, 20) can be replaced section by section in the region of one of the openings (12, 13, 14).

7. The resuscitation dummy according to claim 6, characterised in that the fluid couplings (27) are fixedly or releasably connected to the dummy body (2).

8. The resuscitation dummy according to any one of claims 1 to 7, characterised in that the dummy head (4) is attached fixedly or removably fixedly to the dummy body (2), and in that the bag modelling the human lung extends into the region of the sternum (7) inside the dummy body (2) and is surrounded so as to be delimited thereby in such a way that, during resuscitation, realistic haptics can be modelled with regard to resuscitation resistance and a restoring force as a function of a filling pressure inside the bag.

9. The resuscitation dummy according to any one of claims 1 to 8, characterised in that the second fluid line system (21) is fluidically connected indirectly or directly to the pump (15) and parallel to the first fluid line system (16), and in that the second fluid line system (21) has a fluid line portion which runs outside the dummy body (2) and along which the fluidic interface (22) is arranged.

10. A system for the practical training of resuscitation measures with a resuscitation dummy (1) according to any one of claims 1 to 9, characterised in that a diagnostic ultrasound probe is provided, the ultrasound waves of which are able to propagate through the body that can be physically examined sonographically and punctured and are able to detect the arterial and / or venous fluid line portion (17, 18, 19, 20), and in that, by means of a puncture needle, the detected fluid line portion can be punctured through the body that can be physically examined sonographically and punctured.

11. A system for the practical training of resuscitation measures with a resuscitation dummy (1) according to any one of claims 3 to 9, characterised in that a detector is provided for detecting the electrically, magnetically or electromagnetically detectable unit, and in that the detector is connected indirectly or directly to an output unit for the visual, acoustic and / or haptically perceptible representation of information transmitted between the detector and the detectable unit.