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WO2018149858A1 - Procédé pour système de simulation et d'évaluation pour dispositifs de traitements médicaux - Google Patents

Procédé pour système de simulation et d'évaluation pour dispositifs de traitements médicaux Download PDF

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Publication number
WO2018149858A1
WO2018149858A1 PCT/EP2018/053637 EP2018053637W WO2018149858A1 WO 2018149858 A1 WO2018149858 A1 WO 2018149858A1 EP 2018053637 W EP2018053637 W EP 2018053637W WO 2018149858 A1 WO2018149858 A1 WO 2018149858A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
simulation
patient
artificial replacement
medical device
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/EP2018/053637
Other languages
German (de)
English (en)
Inventor
Holger Bluemler
Alexander Schroers
Yannick Froese
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.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
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
Priority claimed from EP17156336.4A external-priority patent/EP3364322A1/fr
Priority claimed from EP17156335.6A external-priority patent/EP3363480A1/fr
Priority claimed from EP17156333.1A external-priority patent/EP3364321A1/fr
Priority claimed from EP17156332.3A external-priority patent/EP3364320A1/fr
Priority claimed from EP17156330.7A external-priority patent/EP3364319A1/fr
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Priority to EP18705143.8A priority Critical patent/EP3582820A1/fr
Publication of WO2018149858A1 publication Critical patent/WO2018149858A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders

Definitions

  • the invention is in the field of simulation systems for medical treatments, in particular for treatments performed on dialysis machines.
  • the present invention proposes a method according to claim 1.
  • Dialysis machines are blood treatment devices in which a fluid of a patient is supplied via a fluid line to a fluid treatment component, through which Treated fluid treatment component and the fluid line, which can be divided into an arterial and a venous branch, is returned to the patient.
  • Examples of such blood treatment devices are in particular hemodialysis machines.
  • Such a blood treatment device is the subject of DE 198 49 787 C1 of the Applicant, the content of which is hereby incorporated in full in the disclosure of the present application.
  • Dialysis is a procedure for purifying the blood of patients with acute or chronic renal insufficiency. Basically, a distinction is made here between methods with an extracorporeal blood circulation, such as hemodialysis, hemofiltration or hemodiafiltration and peritoneal dialysis, which has no extracorporeal blood circulation.
  • the blood is passed in an extracorporeal blood circulation through the blood chamber of a dialyzer, which is separated from a dialysis fluid chamber by a semipermeable membrane.
  • the dialysis fluid chamber is traversed by a blood electrolyte contained in a certain concentration dialysis fluid.
  • the substance concentration of the blood electrolytes in the dialysis fluid corresponds to the concentration of blood electrolytes in the blood of a healthy person.
  • the patient's blood and the dialysis fluid on both sides of the semipermeable membrane are generally passed countercurrently at a predetermined flow rate.
  • a pressure gradient from the blood side to the dialysate side is established on the dialysis membrane, for example by a pump which removes dialysate from the dialysate circuit downstream of the dialysis filter on the dialysate side, water passes from the patient's blood via the dialysis membrane into the dialysate circuit. This process, also referred to as ultrafiltration, leads to a desired dehydration of the patient's blood.
  • ultrafiltrate is withdrawn from the patient's blood by applying a transmembrane pressure in the dialyzer, without dialysis fluid being conducted past the side of the membrane of the dialyzer opposite the patient's blood.
  • a sterile and pyrogen-free substituate solution can be added to the patient's blood.
  • this Substituatains is added upstream of the dialyzer or downstream, it is called pre- or post-dilution. The mass transfer occurs convectively during hemofiltration.
  • Hemodiafiltration combines the methods of hemodialysis and hemofiltration. There is both a diffusive mass transfer between the patient's blood and dialysis fluid via the semipermeable membrane of a dialyzer, as well as a filtration of plasma water contained in the blood by a pressure gradient on the membrane of the dialyzer.
  • hemodialysis, hemofiltration and hemodiafiltration are usually performed with automatic hemodialysis machines, such as those sold by the applicant.
  • Plasmapheresis is a blood treatment procedure in which the patient's blood is separated into the blood plasma and its corpuscular components (cells). The separated blood plasma is purified or replaced with a substitution solution, and the purified blood plasma or the substitution solution is returned to the patient.
  • peritoneal dialysis the abdominal cavity of a patient is filled via a guided through the abdominal wall catheter with a dialysis fluid having a concentration gradient of blood substances such as electrolytes (for example, sodium, calcium and magnesium) against the body's own fluids.
  • blood substances such as electrolytes (for example, sodium, calcium and magnesium) against the body's own fluids.
  • peritoneum a membrane peritoneum
  • the dialysis fluid in the abdominal cavity of the patient, now mixed with the toxins transferred from the body is exchanged.
  • osmotic processes can Transfer water from the patient's blood via the peritoneum into the dialysis fluid and drain the patient.
  • the method for peritoneal dialysis is usually carried out with the aid of automatic peritoneal dialysis machines, such as those sold by the Applicant.
  • Dialysis machines as an example of complex medical devices, have extensive functions. To control these functions, medical devices such as dialysis machines are equipped with at least one control unit. These may include one or more central processing units (CPUs) or microcontrollers controlled by software programs. In light of the disclosure of the present invention, it is not essential that the described methods be performed by one or more controllers. Accordingly, a plurality of control devices that perform individually or in combination with the described methods, as a control device. The software programs are usually kept in an internal storage device. Additional storage devices may be provided for storing other information, such as treatment data.
  • CPUs central processing units
  • microcontrollers controlled by software programs.
  • the software programs are usually kept in an internal storage device. Additional storage devices may be provided for storing other information, such as treatment data.
  • operability of a device here is understood to mean the device-operator interaction in the broadest sense. All actions that must be carried out on the device by the operator or the design of messages directed from the device to the operator fall under the term usability. For example, improved operability results in an operator quickly finding a particular touchkey (operating button) on the touchscreen display of a dialysis machine that he wishes to operate, or a particular display that he wishes to perceive. Likewise, improved usability can be understood, for example, to mean that certain steps, for example the upgrading of dialysis machines with disposable articles, such as tubing sets or dialysis filters, can be performed better by the operator.
  • an artificial replacement patient also called a dummy patient.
  • an artificial replacement patient equipped with devices essential to the treatment under consideration.
  • a device is, for example, an at least rudimentary vascular system whereby the artificial replacement patient can interact with the medical device for the purpose of performing a treatment.
  • the operating parameters of this artificial replacement patient are advantageously also externally controllable and observable.
  • operating parameters are taken to mean settings and measured values which can be assigned to the respective device.
  • the blood pump rate of a dialysis machine is an operating parameter, as well as the measured blood pressure or the measured blood temperature in the extracorporeal blood circulation.
  • the word "operating parameter” may designate the state of each part of a device or a device network, in particular of actuators, sensors and control devices.
  • extracorporeal blood circulation also refers in the following to means and devices, in particular disposable articles, such as tubes , Filters, drip chambers, etc., which form an extracorporeal blood circulation as described above, irrespective of whether or with which fluid it is filled.
  • an unfilled or filled with a medicinal liquid such as dialysate, blood or blood substitute extracorporeal blood circulation is included.
  • FIG. 1 shows an exemplary overall view of a system according to the invention for simulating a medical treatment on a medical device designed as a hemodialysis machine
  • FIG. 2 shows exemplary embodiments of an artificial replacement patient according to the invention
  • FIG. 3 shows an exemplary embodiment of a fluid system according to the invention of the replacement artificial patient
  • Figure 4 shows the representation of a test person with several exemplary people sensors according to the invention
  • Figure 5 shows a schematic representation of an exemplary embodiment of a medical device according to the invention
  • FIG. 6 shows an exemplary schematic flow diagram for a method according to the invention.
  • FIG. 1 shows an overall view of a system 100 according to the invention for simulating a medical treatment on a medical device.
  • the system extends over an observation and control room 103 and a simulation room 102.
  • the simulation room 102 contains the devices involved in the simulation, in particular the medical device 101, and the artificial replacement patient 105. and during the simulation, the test person 106.
  • the simulation room 102 is part of the simulation environment.
  • an observer 1 10 can observe the processes in the simulation room 102 through an opening 11 in a wall. It can be provided that the opening 1 1 1 is closed by a semi-transparent mirror, which is transparent only in the direction of the simulation space.
  • various control and recording devices 104a and 104b may be provided be that control the course of the simulation and record what's happening.
  • audio and video recording devices are provided which record the events in the simulation room 102, such as the camera 109 in FIG. 1.
  • the simulation system comprises a medical device 101, which is shown in Figure 1 as a hemodialysis machine, and an artificial replacement patient 105.
  • the artificial replacement patient 105 may as shown in Figure 1 have a human form, for example in the form of a doll to a real human patient as realistic as possible to replace.
  • the simulation system may comprise one or more further devices 107, via which influence on the medical treatment to be simulated can be taken.
  • the medical treatment in the simulation room can be influenced via one or more control units 104a, b.
  • the design of the control units is incidental, possible include stationary computers, as shown in Figure 1, as well as mobile devices such as smartphones or tablet PCs.
  • Such a controller is configured to affect the simulated treatment.
  • it is correspondingly programmed with software and is in data communication with the devices involved in the simulated treatment.
  • Data communication can be wired or wireless. Suitable for this purpose are known to the expert devices and methods, such as local area network (LAN), wireless local area network (WLAN), Bluetooth, NFC (Near Field Communication) or other wireless communication technologies, or optical data transmission, for example by infrared.
  • the influence on the treatment can be run-controlled, ie the treatment is controlled on the basis of a predetermined programmed sequence.
  • Another option is manual control via a corresponding user interface.
  • the observer 1 10 can intervene at any time in an ongoing treatment and initiate various medical situations to which the subject 106 is to respond.
  • a manual control can be provided a mobile version of the control device, whereby the observer can carry the control unit with him and thus stay in spatial proximity to the test person or the medical device.
  • Influencing treatment can also be accidental. In this way, neither the observer 110 nor the subject 106 knows which influence of the treatment is next invoked by the controller. Thus it is excluded that the simulation of the treatment is restricted or influenced by the observer's personal preferences.
  • the subject 106 who may be, for example, a dialysis nurse or a dialysis doctor, may carry with him a mobile computer 15 which may serve as an input / output possibility for information concerning the simulated medical treatment.
  • a mobile computer 15 which may serve as an input / output possibility for information concerning the simulated medical treatment.
  • the hemodialysis apparatus shown in simplified form in FIG. 1 comprises an operator interface 1 18, for example designed as a touchscreen display, and at least one pumping means 1 13, with which blood or a medical fluid can be pumped in an extracorporeal blood circuit.
  • the extracorporeal circulation of the simulation environment comprises an arterial blood tube 16 and a venous blood tube 17 and a dialysis filter 112.
  • the arterial and venous blood tubes 16 and 17 are at the puncture site 14 with a fluid system in the arm 108 of the artificial replacement patient connected.
  • the fluid system in the arm 108 of the artificial replacement patient comprises other devices (not shown in Figure 1), which have an influence on the extracorporeal blood circulation.
  • means may be provided with which both the fluid pressure and the flow in the arterial or in the venous blood tube 1 16 and 1 17 can be influenced.
  • human blood replacement liquid as a medical liquid embodiment, is pumped through the dialysis filter 1 12.
  • the replacement fluid flows through one or several additional devices 107 that may affect the extracorporeal blood circulation.
  • the entire system from FIG. 1 is configured and programmed for carrying out a method for simulating a medical treatment of a patient on a medical device.
  • the method includes several aspects:
  • the subject 106 may be asked a task related to the treatment or medical device.
  • This task can be, for example, to make the medical device ready for a specific treatment.
  • an operator-device interaction on the operator interface 1 18 may be necessary via the operator guidance offered there.
  • the subject is observed in coping with the task.
  • a variety of sensors can be used, which are referred to below with the generic term personal sensors.
  • This observation may include a camera surveillance (possibly including sound monitoring).
  • other physiological parameters of the subject can be monitored.
  • the pulse of the test person can be monitored via a corresponding sensor (for example a heart rate monitor).
  • the skin conductance, the exact heart activity (ECG), the brain waves (EEG) or also the eye movement can be monitored.
  • sensors known to those skilled in the art are used whose measured values can be unambiguously assigned to a specific action, for example by linking the video recording and the sensor measured values with unique time values (time stamp).
  • eye-tracker devices For the determination of the eye movement so-called eye-tracker devices can be used, which evaluate, for example, via a video recording of the eyes of the test person and in the direction of the test person, where the subject is currently looking straight.
  • the data obtained by monitoring the subject may be analyzed for the qualification and usability and safety of the medical device.
  • the degree of excitement of the test person can be determined via the personal sensors.
  • suitable sensors measure, for example, the heart activity, brain currents and the skin conductivity of the subject.
  • a faster heartbeat, increased skin conductivity as a result of excessive sweating or specific brain waves suggest an increased level of arousal (stress).
  • stress arousal
  • conclusions about the operability of the medical device can be made about the recording of the viewing direction of the test person. Hectic eye movements that do not target relevant operating points of the medical device after an adequately short time can allow conclusions to be drawn about an improvement in the operating structure of the medical device. If, for example, the operator has long had to search for a specific menu item on the user interface, this gives the device developer an indication that the operator guidance still has room for improvement. This is particularly relevant if the test person is familiar with a previous version of the medical device to be examined and a further development with regard to operability is to be investigated.
  • the task for the subject can also be the performance of a simulated treatment.
  • a treatment is usually associated with the process of upgrading the medical device described above. It includes actions to be performed on the artificial replacement patient 105 to facilitate interaction between artificial replacement patient 105 and the medical device, such as a hemodialysis machine 101.
  • the dialysis machine should be upgraded and adjusted according to the treatment to be simulated.
  • the test person will, for example, fill and rinse the extracorporeal blood circulation analogously to a real treatment.
  • the blood substitute fluid is kept in a separate container.
  • one or more external devices 107 which may affect the medical treatment to be simulated, may be connected or already connected.
  • the influence of the external device 107 on the medical treatment to be simulated may include, for example, reducing, stopping or diverting the fluid flow through the arterial or venous line. This simulates a partial or complete kinking of the corresponding line, or an interruption of the fluid circuit, for example, by slipping out of a needle at the puncture site.
  • the technical means of the device 107 are arranged within the artificial replacement patient. This increases the realism of the simulated treatment.
  • FIG. 2 shows embodiments of the artificial replacement patient.
  • the individual embodiments differ in the degree of realism of the artificial replacement patient with regard to a human patient.
  • the artificial replacement patient serves in its embodiments as a device for reproducing various human characteristics.
  • human characteristics may include both physical characteristics such as age, sex, weight, race, height, etc., or even the appearance of the eyes (eye image).
  • human characteristics also includes instantaneous states of body parts, organs or body fluids, such as executed movement of parts of the human body, state of the human pulse, viscosity of the fluid in the vascular system, temperature of the fluid in the vascular system, state of respiration, etc. ,
  • Other human characteristics include, among other things, the state of mind, the current well-being or even human vocalizations.
  • human characteristics includes, in particular, all of the properties of a real patient that may be of relevance to the treatment of the patient on the medical device.
  • the artificial replacement patient does not have to resemble a real human.
  • the embodiment 201 of the artificial replacement patient has only the puncturing parts 14 with the fluid lines 204 and 205, which realize the arterial (204) and venous (205) access point to the simulated vascular system of the replacement patient.
  • These fluid conduits may include, for example, medical luer lock connectors to which the extracorporeal blood circuit having corresponding counterparts may be connected.
  • the embodiment 202 of the artificial replacement patient additionally has a replica of a human head, which may have other devices to simulate real human behavior or reactions can.
  • Another embodiment of the artificial replacement patient can be seen as a replica of a human arm 203.
  • This also has a puncture site 1 14 and, like the embodiment 201 may be equipped with fluid lines 204 and 205.
  • the arm replica 203 there are fluid lines 206 and 207 that mimic the real vascular system of a human.
  • liquid can run into the arm via a fluid connection (for example, 204) provided for this purpose, and liquid can run out of the arm via a fluid connection (for example, 205) provided for this purpose.
  • the flows and pressures in the fluid lines 206 and 207 may be independently adjustable. This is indicated in FIG. 2 in that both the fluid line 206 and the fluid line 207 have an inlet and an outlet.
  • These fluid lines can be influenced by independent devices, such as pumps, fluid reservoirs, valves (not shown in FIG. 2), etc.
  • embodiment 105 shows an artificial replacement patient most similar in shape to a real human patient.
  • the purpose of these various embodiments of the artificial replacement patient is to adapt the complexity and the equipment of the artificial replacement patient to the goal of the simulation.
  • the artificial replacement patient has the properties at least necessary for the objective of the simulation.
  • a hypothetical perfect replica of a real patient would be ideal in terms of realism, but would unnecessarily increase the cost of a simulation task that does not require this realism.
  • the artificial replacement patient may have the following characteristics:
  • the artificial replacement patient may be a puppet of normal human stature.
  • the artificial replacement patient may have characteristics of this group in its execution.
  • the artificial replacement patient may have features of elderly patients, demented patients, obese patients or pediatric patients in its stature.
  • the external features relate to the stature and appearance of the artificial replacement patient, while the overall system may be configured to simulate the particular characteristics of a patient population.
  • These properties which are defined in particular by the control of the artificial replacement patient, relate to the medical, physiological and psychological features of the respective patient group.
  • Another way to simulate real patients as accurately as possible and to increase the quality of the qualification of medical staff, is to equip the artificial replacement patients with artificial eyes. This makes it possible to train the medical staff in terms of eye diagnostics.
  • the background of such an eye simulation is that certain circumstances that can occur in a real treatment can be reflected in the patient's eye image.
  • a waking person could be differentiated from a sleeping patient, in which the eyes are opened on the one hand and shown with closed eyelids on the other hand.
  • a theatrical eye-twisting in conjunction with another parameter, e.g. falling blood pressure, pointing to a threatening fainting of the patient.
  • the image may also indicate restlessness, anxiety or tiredness.
  • the artificial replacement patient's head may be equipped with small monitors placed in the eye openings for the purpose of eye simulation can.
  • a possible other embodiment comprises a pair of spectacles that can be placed on the replacement artificial patient, the spectacle lenses being monitors.
  • the monitors are controlled in such a way that they represent the image of human eyes. These images can be animated or can comprise video sequences in order to simulate the changes in the representation of human eyes as realistically as possible.
  • the monitors are OLED displays. OLED displays offer a wide viewing angle, so that medical personnel can easily view the simulated eyes from any location. Furthermore, the OLED display technology offers the possibility to create curved monitors to simulate a real eyeball as realistic as possible. Another embodiment of the eye simulation provides to project the eye image.
  • Another embodiment of the artificial patient provides that this is equipped with a speaker. This can be used to simulate vocalisations of a real patient. The artificial patient is thus virtually given a "voice.”
  • human utterances or sounds may be output via the loudspeaker, for example, to needs such as hunger, thirst, or necessary toilet use of the simulated patient, or expression of the medical condition, such as breathing sounds or moaning, and the medical staff must respond according to the particular utterance and, if necessary, perform certain operations on the artificial replacement patient.
  • verbal interaction between artificial replacement patients and medical personnel may also be assessed.
  • provision may be made for medical personnel to respond to specific utterances of the artificial replacement patient ideally in the form of specific answers or targeted inquiries.
  • the remarks of the medical staff can be recorded via microphones.
  • speech recognition technology can be used.
  • another person may also rate the utterances.
  • the vocalizations of the artificial replacement patient can be output controlled, ie they are stored as a file and are output at certain times.
  • vocalizations may also be randomly issued in terms of both the nature and timing of the utterance.
  • the utterances are picked up by a microphone, for example from the monitoring room, from a real person, for example a trainer or a dialysis doctor, and output via the loudspeaker of the artificial replacement patient. In this way, it is possible to react flexibly to the overall situation during the simulation.
  • Vocations of the artificial patient may be coupled with the control of other means of the artificial patient.
  • sounds that indicate discomfort may be linked to the means that influence the fluid pressure in the simulated vascular system of the artificial replacement patient being controlled to simulate derailing blood pressure.
  • the artificial substitute patient can be assigned a character typical of a certain patient group in which characteristic vocalizations are played.
  • a demented patient can be simulated.
  • Dementia patients are a growing challenge in the dialysis environment. For example, if the exercising subject closes on a demented patient because of the characteristic vocalizations of the artificial replacement patient, he or she should be more alert to the patient's restless behavior followed, possibly followed by a needle loss, so slipping out of the needles or medical connectors that connect the extracorporeal blood circulation with the (simulated) vascular system of artificial replacement patient. This can be evaluated by monitoring the exercising subject as previously described.
  • the training subject can also adjust the communication between him and the artificial replacement patient.
  • the number and type of demands of the exercising subject on the artificial replacement patient may vary depending on their configuration, i. according to the group of patients he is to simulate. For example, children require a different type of communication than demented patients.
  • the verbal utterances of the exercising subject directed to the artificial patient can be correspondingly recorded and evaluated, whereby this evaluation can be incorporated with regard to the qualification of the exercising subject.
  • the verbal utterances of the artificial replacement patient can be output in any language.
  • exercising subjects of any nationality can practice on the simulation system.
  • the foreign language ability of the test person can be evaluated or trained.
  • the patient's vascular system is connected via a neck catheter. It can be provided that a corresponding connection to the artificial patient is present.
  • the artificial replacement patient may have actuators to simulate respiratory motion.
  • respiration can be simulated, possibly also in conjunction with the loudspeaker, in which the actuators are controlled such that, for example, the thorax is raised and lowered periodically.
  • Corresponding breath sounds can make the simulation of the breathing activity even more realistic.
  • the respiratory simulation can be associated both with the assumed emotional state of excitement and with the medical situation of the artificial replacement patient.
  • the respiratory simulation can be controlled in such a way that sleep or anxiety of the artificial replacement patient is simulated. This is particularly beneficial when combined with eye simulation: closed eyes and regular deep breath suggest sleep, eyes wide open and irregular shallow breath indicate anxiety. A simulated drop in blood pressure combined with poor simulated respiration indicates a cardiovascular problem.
  • the artificial replacement patient may have actuators for simulating a pulse.
  • the simulation of a heartbeat can be carried out, for example, via the pulsed operation of fluid pumps, which promote the blood replacement fluid in the simulated vascular system of the artificial patient.
  • appropriately controlled flow restrictors are also conceivable.
  • a mechanical actuator for example a lifting magnet, generates a tactile pulse.
  • an audible heartbeat is generated within the artificial replacement patient.
  • the pulse thus generated can be controlled in the manner already described in order to simulate various medical indications or patient conditions.
  • blood pressure measurements which the medical staff can perform on the arm of the artificial replacement patient
  • a speaker may be built into the blood pressure cuff that determines the result of the measurement.
  • a low blood pressure measured in this way would encourage blood pressure-raising measures, such as changes in the ultrafiltration rate, and perhaps, at shorter intervals, the success of this measure.
  • Such a countermeasure can cause the simulated blood pressure to return to normal.
  • the means for influencing the blood pressure in the vascular system of the artificial are actuated correspondingly in order to indicate a normalization of the blood pressure for the medical staff.
  • the artificial replacement patient performs real movements.
  • it can be equipped with appropriate actuators, such as electric motors, which move via corresponding mechanisms such as limbs.
  • the patient chair can be controlled, for example, the backrest or a legrest can be moved by a motor.
  • the patient movement can simulate a restless patient. Due to the movement of the artificial replacement patient, for example, a real needle loss or a real hose kink situation can be generated.
  • the simulated patient movement can also be coupled with other devices of the artificial replacement patient, for example with the means for pulse generation or with the means for sound generation.
  • FIG. 3 shows in a more detailed representation an embodiment of the simulated vascular system of the artificial replacement patient with parts of the extracorporeal blood circulation.
  • a first fluid circuit is formed, which is formed from the elements reservoir 301, fluid line 320, drip chamber 302, pump 303, throttle valve 310, fluid line 322, valve 304 and fluid line 323.
  • the throttle valve 310 makes it possible to change the fluid flow and the fluid pressure independently of the pump 303.
  • the fluid conduits 324 corresponding to an artery of a true patient and the fluid conduit 325 corresponding to a vein of a true patient.
  • the two fluid lines 324 and 325 can be connected to each other via the valve 309.
  • the valve 304 conducts in normal operation and is only blocked for filling the entire circuit.
  • the valve 309 When filling the valve 309 is opened accordingly, so that the fluid lines 324 and 325 are connected to each other.
  • the entire fluid system of the artificial arm 203 may be filled with blood substitute fluid, for example, from the reservoir 301.
  • the valve 309 In normal operation, the valve 309 is locked.
  • the two fluid lines 324 and 325 are further connected via the 3-way valve 305 and 306 and via the proportional valves 307 and 308 (throttle valves) to the first fluid circuit (fluid lines 322 and 323).
  • the individually controllable proportional valves 307 and 308 can be used to influence the fluid flow and the fluid pressure within the fluid lines 324 and 325 individually.
  • the 3-way valve 305 may connect the fluid line 324 to either the fluid lines 322 or the outside air.
  • the 3-way valve 306 may connect the fluid line 325 to either the fluid line 323 or the fluid line 326, which leads to the overflow of the reservoir 301.
  • the fluid conduits 324 and 325 may be externally connected to the extracorporeal blood circuit of a dialysis machine 310.
  • the connection can be produced, for example, as already shown in FIG. 1 via medical Luer lock connectors 204 and 205, which can establish a fluid connection to the vascular system of the artificial replacement patient by means of hollow needles (shown by dashed lines in FIG. 3).
  • a blood pump of the dialysis machine 310 can additionally influence the flows and fluid pressures in the individual fluid connectors. All flows and fluid pressures can be monitored via corresponding sensors, as exemplarily in FIG. 3, the pressure sensor 328 and the flow sensor 329.
  • the two squeezing devices 330 and 331 serve to selectively influence the fluid lines 16 and 17 in order, for example, to simulate kinking of the blood hoses.
  • a squeezing device can have a movable piston which squeezes a deformable tube in a fluid-tight manner or obstructs the flow through this tube.
  • An alternative squeezing device is, for example, a controllable hose clamp.
  • the actuators and sensors of the system shown in FIG. 3 are controllable or readable. For this purpose, they are data-technologically connected to at least one control unit (not shown in FIG. 3), which sends control commands to the actuators and can receive sensor data from the sensors.
  • Such a control allows a variety of medical situations to be simulated.
  • control unit If, for example, an arterial needle loss is to be simulated, ie the arterial needle slipping out of the puncture site, the following steps can be initiated by the control unit:
  • the 3-way valve 305 is controlled by the control unit such that it connects the fluid line 324 with the outside air, whereupon air enters the circulation and thus into the arterial access by sucking the blood pump of the dialysis machine.
  • a commonly used for dialysis equipment sensor for determining the fluid pressure upstream of the blood pump measures in accordance with a pressure change within the access tube (in Figure 3 fluid line 1 17), since the fluid line 1 17 is no longer connected to the acting as a pressure source pump 303, but via the 3-way valve 305 with the atmospheric external pressure.
  • Dialysis machines are usually equipped with a variety of safety devices to monitor treatment and ensure patient safety. So for example, a measured sudden pressure change within an access line (17 or 16) may be interpreted by a safety device of the dialysis machine as a needle loss, whereupon the dialysis machine is placed in a safe mode of operation, for example, by shutting off the extracorporeal blood circulation, stopping the blood pump, and corresponding alarm message an operator interface.
  • Another indication of a needle loss may be a drop in blood level in the venous drip chamber of the dialysis machine (not shown in FIG. 3), which may be detected by corresponding level sensors.
  • the 3-way valve 306 is actuated by the control unit in such a way that it connects the fluid line 325 to the fluid line 326, whereupon blood replacement fluid is pumped from the blood pump of the dialysis machine into the reservoir 301.
  • the patient's blood would be released from the blood pump of the dialysis machine without further action.
  • the blood substitute fluid is prevented from escaping uncontrollably into the open, in that the 3-way valve 306 establishes the fluid connection between the fluid conduits 325 and 326, whereby the blood substitute fluid is pumped into the reservoir 301.
  • the pressure P1 in the reservoir 301 at the overflow 327 corresponds to the atmospheric external pressure.
  • the reservoir 301 may be equipped to ensure this pressure at this point, for example, with an opening to the outside.
  • a safety device of the dialysis machine thus measures in the case of simulated venous needle loss, the pressure at the outlet of the overflow, which corresponds to a needle located in air, and triggers the follow-up actions already described, for example, shut off the extracorporeal blood circulation, stop the blood pump, corresponding alarm message on a operator interface.
  • Another critical situation that may arise during a dialysis treatment involves the aspiration of the arterial needle on the vessel wall of the punctured vessel (usually a fistula in chronic dialysis). Aspiration of the arterial needle in reality results in decreasing blood flow and a strong negative pressure in the arterial access line. This can be triggered for example by a corresponding control of the proportional valve 307.
  • the control device of the simulation system accordingly controls the proportional valve 307 to reduce the flow into the fluid line 324. Since the blood pump of the dialysis machine 301, which is generally designed as a tube roller pump continues to pump with unchanged pumping speed and the flow remains constant due to the increased by the proportional valve 307 flow resistance upstream of the blood pump of the dialysis machine, the fluid pressure there.
  • the safety device of the dialysis machine 301 determines this sunken fluid pressure and outputs a corresponding warning message.
  • the blood pump is designed, for example, as a centrifugal pump
  • the security device of a dialysis machine 301 would also detect this and issue appropriate messages or initiate actions such as transferring the dialysis machine to a safe operating mode.
  • Another critical situation that may arise during a dialysis treatment involves the kinking of an access or return line (1 16, 1 17), which is also called Kinking.
  • Such a kinking of an access line can be simulated, for example, by activating the squeezing devices 330 and / or 331.
  • Activation of the squeezer 330 results in an increase in the fluid pressure downstream of the blood pump of the dialysis machine 301.
  • Activation of the squeezer 331 results in a sudden lowering of the fluid pressure upstream of the blood pump of the dialyzer 301. Both can be detected by the safety device of the dialysis machine and can cause corresponding messages or actions.
  • the consequences of kinking an access line are partly identical to the consequences of other errors. For example, aspiration of the arterial needle has the same consequences as the kinking of the arterial access line 1 17. In a real treatment situation, the medical staff can check whether the access line is bent.
  • this condition is artificially caused in the simulated treatment, it may happen that the medical staff can not optically recognize the cause, especially if the devices used for this purpose (for example, squeezing devices 330, 331) are not visible. You can, for example, hidden away in a housing (107), or the activation process is simply not visually recognizable by the design of the devices.
  • the devices used for this purpose for example, squeezing devices 330, 331
  • You can, for example, hidden away in a housing (107), or the activation process is simply not visually recognizable by the design of the devices.
  • signaling devices for example LEDs, which indicate the operating state of the device to be mounted on such devices for influencing the simulated treatment, the activation or operating state of which is otherwise imperceptible.
  • the squeezing device 331 is activated and a signaling device assigned to it, for example an LED, is lit.
  • a slipping out of a needle if it does not actually happen in the simulation, but the consequences are caused by the corresponding driving of devices (driving the 3-way valve 306), by a signaling device at the puncture site, for example a chain of red LEDs, which symbolizes a trace of blood.
  • the dialysis machine itself is controlled by the control device of the simulation system for the output of warnings.
  • the dialysis machine is designed such that the simulation system has access to the control of the dialysis machine.
  • the pump 303 is in one embodiment a centrifugal pump.
  • Centrifugal pumps also referred to as impeller pumps
  • the fluid system illustrated in FIG. 3 makes it possible to set the fluid pressures and the flows in the individual branches in the artificial patient arm 203 independently of one another, for example by correspondingly controlling the proportional valves 307 and 308 (throttle valves). All the actuators (pumps, valves) of the fluid system of Figure 3 are designed to be quiet in one embodiment, to give the medical staff involved in the simulated treatment, no other evidence of disturbances than those that would occur in reality ,
  • the viscosity of the blood substitute fluid can be influenced.
  • a magnetorheological and / or electrorheological fluid can be used as the blood substitute fluid.
  • a magnetorheological fluid contains magnetically polarisable particles, such as carbonyl iron powder, which are affected by an applied magnetic flux
  • Electrorheological fluids can be influenced by the application of an electric field in their viscosity.
  • Another possibility for influencing the viscosity of the blood substitute fluid consists in admixing substances which influence the viscosity, for example hydroxyethyl starch, abbreviated HES or polyethylene glycol, PEG for short. These can be kept in containers and, if necessary, mixed with the blood substitute fluid in order to increase their viscosity. A lowering of the viscosity takes place for example by adding water.
  • hydroxyethyl starch abbreviated HES or polyethylene glycol, PEG for short.
  • the increase in the viscosity of the blood can be simulated by filtering off water via the dialysis membrane (ultrafiltration).
  • Dialysis machines can be equipped with appropriate viscosity sensors that can detect such a change in the viscosity of the blood substitute fluid.
  • the temperature of the blood substitute fluid is adjustable.
  • heating / cooling devices known to those skilled in the art may be provided, which bring about a selectable temperature of the blood substitute fluid.
  • About the temperature of the blood substitute fluid can simulate other medical situations, such as fever or freezing of the patient.
  • Dialysis machines are often equipped with sensors for temperature detection in extracorporeal blood circulation. Thus, in the event of a deviation of the blood temperature from an expected value, an alarm message can be output to which the subject has to react, for example with manual determination of the body temperature and taking countermeasures.
  • FIG. 4 shows a test person 401 training on the simulation system 100 (analogous to the test person 106 from FIG. 1) with a plurality of monitoring devices 402, 403, 404, which serve to monitor the behavior and physiological parameters of the exercising person 401. So can be detected via a so-called eye-tracking glasses 402, on which point the subject looks.
  • the glasses 402 are equipped with cameras, which are directed on the one hand to the eyes of the test person and on the other hand in the direction of view. Using a special evaluation logic, it can be calculated from the two camera images on which point the test person 401 is looking.
  • the expert knows eye-tracking devices, for example, from WO2004066097A2.
  • the speed with which certain operating points on the dialysis machine are targeted can be a measure of how well the subject knows the dialysis machine involved in the simulation. It can also be assessed how safely and quickly the subject executes necessary actions on the artificial replacement patient.
  • An act on the artificial replacement patient may be in response to Simulated medical events may be required, for example, a needle loss can be simulated in the manner already described, whereby it is assessed how quickly and purposefully, ie without a long search, the gaze of the test person on the potential source of error, in this case the puncture site is addressed.
  • the monitoring of the viewing direction of the subject 401 can also serve to obtain information about the operability of a medical device. For example, it can be assessed whether a particular operating concept leads to a fast and safe operation by evaluating the viewing directions during operation. Such assessment, for example as part of a risk analysis, may also relate to medical procedures, such as certain provisions for upgrading the medical device or handling the patient.
  • FIG. 4 shows, for example, a device 403 for measuring blood pressure, pulse, skin moisture or skin resistance, etc., which can be used as indicators of physical and psychological stress.
  • the device 403 is exemplified in FIG. 4 in the form of a bracelet.
  • the device 404 symbolizes a device for detecting any physiological parameters, such as body temperature, EKK, EEG, respiratory rate, etc.
  • the necessary explanations are known in the art from the prior art.
  • the physiological parameters thus acquired are set in relation to the simulated treatment and evaluated by experts in order to be able to make statements about the subject and / or the simulation environment (usability, medical procedures).
  • the recorded physiological parameters can be combined with the audio and video recording, which is included in the evaluation accordingly.
  • the requirements for medical assistants are usually lower than those for regular medical staff, although here too a distinction can be made between, for example, "qualified to take care of normal treatment” or “qualified to care for acute treatment” or “qualified to take care of intensive care”
  • the degree of qualification differs from the tasks set in the simulation, ie the medical or technical situations in the treatment simulation differ according to the degree of qualification to be certified, for example "simple” for medical assistants, "normal” for regular medical personnel or “difficult”"for medical staff in intensive care units or doctors. By returning such qualification certifications, it is guaranteed that the medical staff will continue their education and thus ensure the quality and safety of the treatment.
  • any parameters recorded during the simulation can be used.
  • the number of correctly resolved tasks during a treatment simulation may be related to the time spent doing so.
  • the measured physiological parameters of the subject may also be included in such certification.
  • the test person 401 may carry a mobile computer 15 (tablet PC or smartphone) with him.
  • the mobile computer 115 may have loaded and execute software that supports the simulation in a variety of ways.
  • the test person 401 can be shown a choice of possible causes for the medical situation that has occurred.
  • the subject can Choose a cause that seems right to her.
  • the selection can be documented and evaluated, with the assessment including whether the selection was correct and how quickly the subject made the selection. These factors can be incorporated into the certification of the subject.
  • the mobile computer 1 15 offers an online help. For example, if the subject has difficulty responding properly to a simulated medical situation, online help may be provided that provides specific background information about the medical situation that has occurred. Such online help may have access to external databases.
  • test person communicates directly with an expert via the mobile computer 1 15.
  • an audio and / or video transmission may be provided, which takes place between test person and expert. It is thus possible for an expert to communicate directly with the subject to answer questions, give hints or give instructions.
  • the mobile computer 1 15 is programmed for this purpose with appropriate software that can interact with the control software of the rest of the simulation environment.
  • data connections between the mobile computer 1 15 and the control and recording devices 104a and 104b, as well as to other networks, such as the Internet may be provided. These data connections are advantageously wireless.
  • the camera, microphone and loudspeaker of the mobile computer which is often standard, can be used.
  • the described methods performed by the mobile computer may also be performed by the medical device.
  • an operator interface of the medical device designed as a touchscreen display can be used as an input / output device analogous to the version with the mobile computer.
  • the medical device is equipped with a camera, a microphone and a speaker, about which the subject with experts in already described manner communicates.
  • the medical device is adapted to establish audiovisual communication with a remote device.
  • the medical device is programmed for this purpose with appropriate software that can interact with the control software of the rest of the simulation environment.
  • FIG. 5 shows a schematic representation of a medical device 501 (analogous to the medical device 101 of FIG. 1 designed as a hemodialysis device) with essential components.
  • the medical device 501 is i.d.R. equipped with an operator interface 502, which is advantageously designed as a touch screen display, so a screen with touch-sensitive surface for receiving operator inputs.
  • Medical devices are i.d.R. controlled by one or more controllers, which can be advantageously software programmed.
  • a control unit (singular) always includes a plurality of control devices.
  • the software required for this purpose can be stored in a data memory, which can also be used for data storage of other data.
  • the medical device 501 is exemplarily provided with two control devices 503 and 505 with respective separate data memories 504 and 506.
  • the control device 503 can serve as a central control device for controlling the operation of the medical device, while the control device 505 can act as a safety and monitoring control device independently of the state of the control device 503.
  • the medical device 501 can be equipped with at least one actuator 507a to 507n and at least one sensor 508a to 508n.
  • Actuators are in particular electromechanical converters such as pumps, valves, motors, actuators, speakers, etc., but also heat or cold generators or else Hydraulic or pneumatic elements. Actuators and sensors cooperate to perform the treatment possible with the medical device 501 and are thereby controlled and monitored by the controllers 503 and 503 and 505, respectively.
  • the actuators 507a to 507n and the sensors 508a to 508n may be connected to the control unit 503 or to the control units 503 and 505 for data purposes. In FIG. 5, a data exchange between two components is symbolized by a double arrow.
  • the medical device 501 in FIG. 5 has, by way of example, at least one data bus 509a and 509b.
  • the data buses 509a and 509b may also be separate and independent of each other.
  • the data buses can in particular be designed according to the industry standard CAN.
  • the medical device 501 has for data exchange with external devices or networks via a data interface 510. This can be configured as desired, for example as a cable connection or wirelessly.
  • the data transmission can take place according to any data transmission protocol; in particular, common Internet protocols such as Transmission Control Protocol / Internet Protocol (TCP / IP) can be used. However, proprietary data transfer protocols can also be used.
  • TCP / IP Transmission Control Protocol / Internet Protocol
  • proprietary data transfer protocols can also be used.
  • the data interface can influence the control unit of the medical device 501.
  • the medical device 501 may be configured such that further control devices, such as the control and recording devices 104a and 104b interact with the control device of the medical device via the data interface to the medical device according to the medical treatment to be simulated.
  • the medical device 501 be brought either by driving actuators in the appropriate state.
  • sensor values that is to say the output parameters of the sensors 508a to 508n
  • the control unit of the medical device sets according to its programming as a result of these manipulated sensor values an alarm situation and outputs a corresponding alarm message preferably on the operator interface 502. A test person participating in the simulation system can react to this displayed alarm message.
  • the sensor value of the venous pressure sensor so the sensor that measures the blood pressure in the venous blood hose could be manipulated so that the control unit of the hemodialysis machine on the loss of venous Needle closes, representing a potential health hazard for a connected patient.
  • the dialysis machine can interrupt the treatment and go into a safe operating state (for example, stopping the blood pump, disconnecting the patient's blood tubes).
  • An alarm message corresponding to the manipulated sensor value for example "venous pressure alarm" can be output by the hemodialysis machine.
  • the external control and recording device (104a, 104b) at the same time also activates a signaling device at the puncture site of the artificial replacement patient 105, for example a chain of red LEDs, which symbolizes a blood trace.
  • a signaling device for example a chain of red LEDs, which symbolizes a blood trace.
  • test person participating in the simulation inputs the cause of the alarm message diagnosed by him into the mobile computer 15, which in turn is in data communication with the external control and control unit Recording device (104a, 104b) and so can submit the input of the test person.
  • the medical device 501 may be programmed in the manner already described, and to fulfill the same tasks as the mobile computer 1 15.
  • the external control and recording device may be programmed to verify the input of the subject.
  • the external controller may cause the real arterial pressure value to be communicated back to the internal controller of the hemodialysis machine. l.d.R. the subject must also confirm elimination of the cause of the alarm on the hemodialysis machine operator interface, whereupon he / she can proceed with the treatment.
  • the medical device 501 has additional devices, in particular actuators, in order to specifically influence the medical device.
  • the blood tubes can be closed by a controllable clamp (electromechanical, pneumatic or hydraulic) to simulate Kinking, so squeezing a tube, or be introduced via an additional pump air in the extracorporeal blood circulation to simulate a leak.
  • the medical device involved in the simulation system can be designed such that certain operating conditions, such as alarm conditions, are actually brought about, or else only the control of the medical device is manipulated so that it closes on an alarm condition, although it is not actually present.
  • the medical device may be configured such that the external control and recording device (104a, 104b) has access to its basic control functions. This may involve a pure software based implementation, but may also require additional hardware that manipulates the traffic between the internal control device (503, 505) of the medical device 501 and the actuators (507a-n) and sensors (508a-n) can.
  • alarms may relate to pressure alarms in the extracorporeal blood circulation and in the dialysate circuit.
  • Possible other alarms are blood leak alarms, for example in the case of extracorporeal blood leaks or in the rupture of the dialyzer membrane, in which blood from the blood circulation passes into the dialysate circuit and can be detected there by a blood leak sensor.
  • air entering the extracorporeal blood circulation can trigger a corresponding alarm.
  • all actuators for example the blood pump, can be manipulated in order to obtain, for example, a failure of the actuator. It is also possible to simulate a complete failure of the power supply, for example by driving a relay that separates the hemodialysis machine from the power supply.
  • Leakages in the extracorporeal bloodstream can also be simulated by fluid in a collection bag held by some hemodialysis machines to capture leaking fluids. Escaping liquid can also be collected first in a gutter and a Moisture sensor are supplied.
  • a dedicated pump may be provided, but it may also be provided a valve that controllably branches off the extracorporeal blood circulation fluid.
  • a moisture sensor which is maintained to detect leaking fluid
  • a moisture sensor which is maintained to detect leaking fluid
  • it can also be performed via an additional pump or a branch valve real liquid to the humidity sensor. It can be provided that the test person must remove the liquid before the treatment can be continued, which corresponds to a real treatment to a large extent.
  • the operating states that can be brought about by the further control devices correspond mutatis mutandis to abnormal operating states, since they cause or simulate errors or alarm states.
  • FIG. 6 is a schematic flow diagram of a method in accordance with the teachings of the present invention.
  • the method starts in step 601.
  • the simulation is started.
  • This record may include the recording of all possible parameters of the exerciser, for example by the monitoring devices 402, 403, 404 in FIG. 4, which serve to monitor the behavior and physiological parameters of the exercising person 401.
  • the recording of the simulation may also include the audio and video recording (for example, with the camera 109 in FIG. 1).
  • the recording of the simulation may also include recording all operating parameters of the devices involved, in particular the (medical) devices involved in the simulation and the artificial patient.
  • the operating parameters of a device in the broadest sense indicate the current state of the device. These may include state parameters of actuators and sensors of the device, variable values of the software control, current and voltage profiles of the electrical supply, etc., and are linked to a unique point in time.
  • the recording may also include that all entries that the test person in the mobile computer 1 15 or a corresponding programmed medical device and also the outputs, in particular the display output of the mobile computer 1 15 or the medical device are stored.
  • the recording of the simulation in step 602 is done by appropriate means, such as the control and recording devices 104a and 104b in Figure 1, which may be computerized.
  • the accumulated data can be stored locally in the control and recording devices 104a and 104b and / or in a remote storage medium, for example in a server connected by a data network, or in a cloud of data (cloud).
  • the purpose of the simulation recording is to link the actions and condition of the subject during the simulation with the processes and conditions of the devices involved in the simulation and the artificial patient.
  • the recording is performed in one embodiment at least until completion of the method in step 605.
  • the initiation of a state change of the simulation environment occurs.
  • a change of state of the simulation environment serves to simulate a specific scenario which can occur during a real treatment.
  • all the devices involved in the simulation, in particular the medical device and the artificial replacement patient can be controlled in the manner already described in such a way that they assume a specific state.
  • the environmental variables in the simulation room 102 are influenced, for example, the lighting, the temperature, the ventilation or the humidity in the simulation room 102 changed or noises are recorded via speakers.
  • an abort criterion of the simulation is checked.
  • Such an abort criterion can be an operator input, for example, of the observer 110, which terminates the method as a result.
  • Other abort criteria may also be an expired timer, which realizes a fixed simulation time, or the occurrence of a deleterious situation during the simulation that necessitates an immediate abort of the simulation.
  • step 605 takes place, namely the termination of the simulation. If the abort criterion does not arrive, step 603 is executed again.
  • Termination of the simulation may include placing the devices involved in the simulation in a safe state.
  • control and recording devices 104a, b may also be present as an integral part of a medical device involved in the simulation of a medical treatment.
  • Method according to aspect A1 with the additional step Providing an artificial replacement patient as part of the simulation environment, wherein the artificial replacement patient can interact with the medical device for the purpose of a simulated treatment execution and whose operating parameters are controllable and observable.
  • simulation data can be selected from the following group: physiological data of a test subject; Focus points of a subject;
  • Actuating the medical device and / or a device interacting with the medical device such that the medical device and / or the device interacting with the medical device transfers its current operating state into another operating state.
  • Method according to aspect A2 according to which the initiation of the change of state of the simulation environment comprises:
  • A8 The method of any one of the preceding aspects, wherein initiating the state change of the simulation environment is characteristic of a particular medical situation.
  • A1 Method one of the aspects A2 to A10, according to which the artificial replacement patient is equipped with a fluid system having at least one fluid line connectable to an external fluid system, and wherein the fluid system of the artificial replacement patient is configured such that the flow and the fluid pressure in the at least one fluid line can be influenced independently of one another.
  • A13 Method according to one of the preceding aspects, according to which the recorded simulation data are used to evaluate the qualification of a test person.
  • A14 Method according to one of the preceding aspects, according to which the recorded simulation data are used to evaluate the usability of the medical device.
  • A15 Method according to one of the preceding aspects, according to which the medical device is a blood treatment device and in particular is set up for dialysis.
  • A17 A method according to any one of the preceding aspects, wherein initiating the change of state of the simulation environment is characteristic of a particular medical situation.
  • a system comprising: a medical device as part of a simulation environment whose operating parameters are controllable and observable; at least one device for recording simulation data, at least for the duration of the simulation; at least one person sensor adapted to detect data relating to a test person located in simulation room which is part of the simulation environment, characterized by at least one control device, which is data-technologically connected to the medical device and the at least one person sensor is; wherein the at least one control device is configured to initiate a state change of the simulation environment.
  • System according to aspect B1 comprising an artificial replacement patient as part of the simulation environment, wherein the artificial replacement patient can interact with the medical device for the purpose of a simulated treatment execution and its operating parameters are controllable and observable, and which is data-technically connectable to the at least one control device.
  • B3. System according to one of the preceding aspects B1 -B2, according to which the at least one person sensor is adapted to detect parameters which may be selected from the following group: physiological data of a subject; Focus points of a subject;
  • the at least one control device is connected in terms of data with devices for setting environment variables of the simulation environment, which are thus identified by the Control device are adjustable, and the at least one control device is configured so that it performs the following step upon initiation of a state change of the simulation environment:
  • the environmental variables of the simulation space may be selected from a group comprising:
  • a system according to any of aspects B2 to B8, wherein the artificial replacement patient is of human form and is equipped with at least one of the following: artificial eyes that are controllable such that their visual appearance is changeable; a speaker; at least one actuator adapted to move at least a portion of the artificial replacement patient; at least one actuator which is arranged and configured in the artificial replacement patient such that a tactile pulse is generated by the activation of the actuator.
  • a system according to any of aspects B2 to B9, wherein the interaction of the artificial replacement patient with the medical device comprises a simulated treatment design, means being provided for fluid transport of at least one fluid between the medical device and the artificial replacement patient.
  • B1 A system according to aspect B10, comprising means for controllably inhibiting or obstructing fluid transport.
  • B12 A system according to aspect B5 or B6, comprising a computer with operator interface configured and programmed for a plurality of selectable causes for a particular medical situation, the current operating state of the medical device or the current operating state of the device or device interacting with the medical device Current operating state of the artificial replacement patient corresponds to display on the operator interface and to receive an input of the test person, which corresponds to a selected and indicated cause of this medical situation, and process data processing.
  • B13 System according to one of the aspects B1 - B12, according to which the medical device is a blood treatment device and in particular is set up for dialysis.
  • a software program or software program product for operating the system of aspect B12 having computer readable and executable program instructions stored on a data carrier which, when executed by the computer, program the computer to provide a plurality of selectable causes for the particular medical situation displayed on the operator interface and to receive an input of the test person, which corresponds to a selected and displayed cause, and to process data processing.
  • B15 A software program or software program product for operating the system according to any one of aspects B1-B13 with program instructions readable and executable by the at least one controller and which, when executed by the at least one controller, program the at least one controller thereto to initiate the state change of the simulation environment and / or to process the recorded simulation data and / or to process the data captured by the at least one person sensor.
  • Medical device comprising at least one device for controllable induction of an abnormal operating state of the medical device.
  • the at least one device for controllable induction of an abnormal operating state comprises at least one first control device, at least one actuator and at least one sensor and a data interface, which is set up for data exchange with a second control device, characterized in that the medical device is adapted to make in a mode of operation the at least one actuator and the at least one sensor of the second control device to be controlled and controlled.
  • Medical device according to one of the aspects C1 - C2, according to which the medical device is a blood treatment device and in particular is set up for dialysis.
  • Medical device which can be upgraded with disposable articles for the development of an extracorporeal blood circulation, according to which the at least one device for the controllable induction of an abnormal operating state can be selected from the following group:
  • Means for interrupting the power supply of the blood treatment device are provided.
  • a medical device wherein the means for introducing air into the extracorporeal blood circuit is a pump.
  • a medical device according to aspect C4, wherein the means for interrupting extracorporeal blood circulation is an electromechanical, pneumatic or hydraulic clamp.
  • a medical device wherein the means for sequestering fluid outside the extracorporeal blood circuit comprises a pump or is a valve that branches fluid from the extracorporeal blood circuit.
  • Medical device according to one of the aspects C1 - C7 with an artificial replacement patient, who interacts with the medical device during a treatment execution.
  • Medical device according to aspect C4 with disposable articles upgraded to form an extracorporeal blood circulation.
  • a medical device according to any one of the aspects C1 - C1 1 having at least one operator interface, the medical device being configured and programmed to display a plurality of selectable causes of the induced abnormal operating state on the operator interface and Operator input, which corresponds to the selection one of the displayed cause to receive and process data processing.
  • a medical device comprising a camera, a microphone and a speaker, wherein the medical device is adapted to establish an audiovisual communication with a remote device.
  • a software program or software program product for operating the medical device according to one of aspects C12 or C13, with program instructions readable and executable by the at least one controller and stored on a data carrier which, when executed by the at least one controller, program the at least one controller thereto to display a variety of selectable causes of the induced abnormal operating condition on the operator interface and to receive and process an operator input corresponding to the selection of one of the indicated causes.
  • Liquid system for receiving a medical fluid comprising: a first fluid conduit and a second fluid conduit, wherein the first fluid conduit and the second fluid conduit are connectable to at least one external fluid conduit, characterized in that the fluid system comprises actuators with which the respective flow and the respective fluid pressure in the first fluid line and in the second fluid line are independently adjustable.
  • Liquid system according to aspect D1 comprising a liquid reservoir having an inlet and a drain, wherein the inlet and the outlet are connectable to each other via a first valve, and in the resulting by the connection between inlet and outlet first fluid circuit, a liquid pump arranged to circulate the liquid in the first fluid circuit, and wherein upstream of the first valve, there is a fluid connection to the first fluid line and fluidly connected to the second fluid line downstream of the first valve.
  • Liquid system according to one of the aspects D1 - D3, wherein in the first fluid line, a first 3-way valve is arranged, that in a first operating mode, the upstream of the first 3-way valve lying portion of the first fluid line with the downstream of the first 3-way valve lying portion of connects the first fluid line and connects in a second operating mode lying downstream of the first 3-way valve portion of the first fluid line with the ambient air.
  • D5 Liquid system according to one of the aspects D1 - D4, according to which the liquid reservoir has an overflow, which is arranged in normal operation above the liquid level in the liquid reservoir, and wherein the overflow leads a fluid line to a second 3-way valve, which is arranged in the second fluid line wherein, in a first mode of operation, the second 3-way valve connects the portion of the second fluid line upstream of the second 3-way valve to the portion of the second fluid line downstream of the second 3-way valve and downstream of the second 3-way valve in a second mode of operation Portion of the second fluid line with the fluid line leading from the overflow to the second 3-way valve connects.
  • D6 Liquid system according to one of the aspects D1 - D5, wherein in each case a means for adjusting the flow is arranged in the first liquid line and in the second liquid line.
  • D7 Liquid system according to one of the aspects D1 to D6, according to which in the first fluid circuit, a means for adjusting the flow is arranged.
  • D8 Liquid system one according to one of the aspects D1 - D7, according to which a drip chamber is arranged in the first fluid circuit.
  • Fluid system according to any one of D1 - D8, wherein means are provided to influence the viscosity of the fluid located in the fluid conduits.
  • Liquid system according to aspect D10 according to which at least one puncture site on the artificial human arm is provided for connecting the first and / or second fluid line with at least one external fluid line and at least one puncture site at least one optical signaling device is provided.
  • Liquid system one according to one of the aspects D1 - D12, according to which the connection of the first fluid line and the second fluid line with the at least one external fluid line can be produced by hollow needles, which are movable by actuators such that the respective hollow needle slips out of the first or second fluid line, or that the respective hollow needle is moved to the inner boundary surface of the connected fluid conduit.
  • D14 Liquid system according to one of the aspects D1 - D13, according to which the actuators are controllable and / or readable by a control device and / or sensors are provided, the sensors are arranged to determine the flow and / or the liquid pressure in the fluid system, and wherein the actuators and the sensors are controllable and / or readable by a control device.
  • D15 Liquid system according to one of the aspects D1 - D13, according to which the actuators are controllable and / or readable by a control device and / or sensors are provided, the sensors are arranged to determine the flow and / or the liquid pressure in the fluid system, and wherein the actuators and the sensors are controllable and / or readable by a control device.
  • Liquid system further comprising a liquid reservoir having an inlet and a drain, wherein the inlet and the outlet via a first valve are connected to each other and in the resulting by the connection between inlet and outlet first fluid circuit, a liquid pump is arranged to circulate the Liquid is arranged in the first fluid circuit, and wherein upstream of the first valve there is a fluid connection to the first fluid line and downstream of the first valve is a fluid connection to the second fluid line.
  • D17 Liquid system according to aspect D9, according to which the liquid is a magnetorheological and / or electrorheological fluid and the means for influencing the viscosity of the fluid are adapted to build up a magnetic or electric field in the fluid.
  • D18 Liquid system according to aspect D9, according to which the means for influencing the viscosity of the liquid located in the fluid lines are adapted to supply means to the liquid which influence the viscosity of the liquid.
  • a liquid system according to aspect D18, according to which the means supplied to the liquid may be selected from the following substances:
  • E1 Device for simulating at least one human characteristic, the simulation of the at least one human characteristic being controllable and / or controllable by a control device, characterized in that the human characteristic is the vascular system, the replica of the vascular system comprising: a fluid system for receiving a medical fluid having a first fluid conduit and a second fluid conduit, the first fluid conduit and the second fluid conduit connectable to at least one external fluid conduit and wherein the fluid system comprises actuators with which the respective flow and the respective fluid pressure in the first fluid conduit and in the second fluid conduit are independently adjustable, and / or that the human characteristic is the appearance of human eyes, wherein the simulation of the appearance The human eye comprises: artificial eyes, which are controllable so that their visual appearance is changeable.
  • at least one additional human property can be selected from the following group: human vocalizations; physical movement; human pulse; Viscosity of the fluid in the vascular system;
  • the replica of the human vocalizations comprises: a speaker through which human vocalizations can be output, and wherein the replica of the physical movement comprises, at least one actuator adapted to move at least a portion of the artificial replacement patient, and wherein the replica of the human pulse comprises, at least one actor so arranged and configured in the artificial replacement patient the control of the actuator is generated a tactile pulse and wherein the replica of the viscosity of the liquid in the vascular system comprises means for influencing the viscosity of the liquid in the liquid system, and wherein the simulation of the temperature of the liquid in the vascular system comprises that a heating - Cooling devices is provided, with which the temperature of the liquid in the fluid system can be influenced, and wherein the replica of the breathing comprises that the actuator, which is adapted to move at least a part of the artificial replacement patient, for moving the ribcage of the artificial n replacement patients is set up and is controlled such that the movement generated periodically raises and lowers the chest.
  • the means by which the viscosity of the fluid in the fluid system can be influenced include: that the fluid in the fluid system is a magnetorheological and / or electrorheological fluid and means are provided which are adapted to a magnetic or electric field to build up in the liquid, or that means are provided which are adapted to supply substances to the liquid, which influence the viscosity of the liquid.
  • the shape of the human body may have different characteristics, wherein the characteristics may relate to the following features:
  • E6 Device according to one of the aspects E1-E5, according to which at least one puncture part is provided for connecting the first and / or second fluid line with at least one external fluid line and at least one puncturing part at least one optical signaling device is provided.
  • E7 Device according to one of the aspects E1 - E5, according to which the artificial eyes comprise monitors or the projection of an eye image.
  • E8 Device according to aspect E1, according to which the artificial eyes are designed as a device in the form of spectacles, wherein controllable monitors are mounted instead of the spectacle lenses, and wherein the monitors can be controlled in such a way that the representation of human eyes is displayed on them.
  • a method of simulating a condition of a human characteristic comprising the following steps:
  • Control of the reproduction of the human characteristic such that the reproduction corresponds to a selectable state of the human characteristic E10.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
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  • Biomedical Technology (AREA)
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  • Physics & Mathematics (AREA)
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  • Mathematical Analysis (AREA)
  • General Business, Economics & Management (AREA)
  • Medicinal Chemistry (AREA)
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  • Educational Administration (AREA)
  • Educational Technology (AREA)
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  • External Artificial Organs (AREA)

Abstract

L'invention a trait au domaine des systèmes de simulation destinés à des traitements médicaux, notamment à des traitements qui sont effectués au moyen d'appareils de dialyse. L'invention concerne par ailleurs un procédé permettant de mettre en oeuvre des traitements médicaux sans impliquer la participation de patients humains réels et de les évaluer.
PCT/EP2018/053637 2017-02-15 2018-02-14 Procédé pour système de simulation et d'évaluation pour dispositifs de traitements médicaux Ceased WO2018149858A1 (fr)

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Application Number Priority Date Filing Date Title
EP18705143.8A EP3582820A1 (fr) 2017-02-15 2018-02-14 Procédé pour système de simulation et d'évaluation pour dispositifs de traitements médicaux

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
EP17156336.4A EP3364322A1 (fr) 2017-02-15 2017-02-15 Dispositif et procédé pour un système de simulation et d'évaluation de dispositifs de traitement médical
EP17156335.6A EP3363480A1 (fr) 2017-02-15 2017-02-15 Système de liquide pour un système de simulation et d'évaluation pour dispositifs de traitement médical
EP17156333.1A EP3364321A1 (fr) 2017-02-15 2017-02-15 Appareil technique médical pour un système de simulation et d'évaluation pour dispositifs de traitement médical
EP17156333.1 2017-02-15
EP17156332.3A EP3364320A1 (fr) 2017-02-15 2017-02-15 Système de simulation et d'évaluation pour dispositifs de traitement médical
EP17156332.3 2017-02-15
EP17156330.7 2017-02-15
EP17156330.7A EP3364319A1 (fr) 2017-02-15 2017-02-15 Procédé pour un système de simulation et d'évaluation pour dispositifs de traitement médical
EP17156335.6 2017-02-15
EP17156336.4 2017-02-15

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
US12374236B2 (en) 2022-01-27 2025-07-29 Fresenius Medical Care Holdings, Inc. Dialysis training using dialysis treatment simulation system

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DE19849787C1 (de) 1998-10-28 2000-02-24 Fresenius Medical Care De Gmbh Blutbehandlungsgerät
WO2002003355A2 (fr) * 2000-06-30 2002-01-10 University Of Florida Procede, systeme et appareil pour la formation a l'utilisation de dispositifs medicaux
WO2004066097A2 (fr) 2003-01-23 2004-08-05 Tengshe Vishwas V Systeme et procede de poursuite oculaire
WO2008021462A2 (fr) 2006-08-18 2008-02-21 Fresenius Medical Care Holdings, Inc. Capteur d'humidité
US20140099617A1 (en) * 2012-10-10 2014-04-10 Richard D. Tallman, JR. Patient simulation system for medical services or diagnostic machines
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DE19849787C1 (de) 1998-10-28 2000-02-24 Fresenius Medical Care De Gmbh Blutbehandlungsgerät
WO2002003355A2 (fr) * 2000-06-30 2002-01-10 University Of Florida Procede, systeme et appareil pour la formation a l'utilisation de dispositifs medicaux
WO2004066097A2 (fr) 2003-01-23 2004-08-05 Tengshe Vishwas V Systeme et procede de poursuite oculaire
WO2008021462A2 (fr) 2006-08-18 2008-02-21 Fresenius Medical Care Holdings, Inc. Capteur d'humidité
US20140099617A1 (en) * 2012-10-10 2014-04-10 Richard D. Tallman, JR. Patient simulation system for medical services or diagnostic machines
CA2923191A1 (fr) * 2016-03-08 2016-05-06 Cae Healthcare Canada Inc Systeme de simulation de patient adapte pour une interaction avec un appareil medical

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12374236B2 (en) 2022-01-27 2025-07-29 Fresenius Medical Care Holdings, Inc. Dialysis training using dialysis treatment simulation system

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