WO2019234588A1

WO2019234588A1 - Test device and method for testing a measuring probe, and use of a respirator for testing the measuring probe

Info

Publication number: WO2019234588A1
Application number: PCT/IB2019/054582
Authority: WO
Inventors: Matthias Van Der Staay
Original assignee: Imt Analytics Ag
Priority date: 2018-06-04
Filing date: 2019-06-03
Publication date: 2019-12-12

Abstract

The invention relates to a test device for testing a measuring probe. The test device has a medical device (10), said medical device (10) having a measuring probe connection (13) which can be connected to a measuring probe by means of a measuring probe line (15) in order to exchange probe measurement values, and the medical device (10) has a sensor connection (12) which can be connected to a sensor unit by means of a sensor line (14) in order to exchange sensor measurement values. A test unit (18) is provided in order to test the measuring probe, said test unit having at least one test algorithm. The test algorithm is designed to determine a test curve after detecting at least one first probe measurement value from the measuring probe and after detecting at least one first sensor measurement value from the sensor unit. The invention additionally relates to a method for testing a measuring probe and to the use of a respirator for testing a measuring probe.

Description

Apparatus and method for testing a probe and use of a ventilator to test the probe

The invention relates to a test apparatus and a method for testing a probe and the use of a ventilator for testing a probe according to any one of the independent claims.

Esophageal manometry is a medical procedure primarily used in the field of gastroenterology (gastrointestinal medicine) and for the detection of motility disorders (motility disorders) of the esophagus. In this case, probes, for example. An inflatable balloon, inserted into the esophagus of a patient, filled with air and carried out using the probe pressure measurement in the esophagus of the patient.

By the pressure measurement in the esophagus, the functions of the lower esophageal sphincter at the stomach entrance and the

Swallowing muscles checked. It is useful to treat heartburn and dysphagia, but also in unclear cases of asthmatic complaints and laryngeal inflammation in preparation for a pH-metry. (https://www.knnikum-lueneburq.de/anqemeine-in-ernere-medizin- gastroenterojogle-fynktjonsdiagoostlk ^ esophagusmanometde /)

In the area of mechanical ventilation, the probe is also inserted into the esophagus and placed so that it can absorb the pressures prevailing in the pleural space. Because the lungs line the pleural cavity, this pressure can be considered as "external pressure of the lung," or the pressure between the patient's lungs and thoracic wall.This pressure is used as a surrogate of pressure in the pleural space for medical purposes.

The probes are offered in different variants from different manufacturers, whereby the optimal handling or use of the probes is manufacturer-specific. It is common for manufacturers of measuring probes to measure esophageal pressure Specify filling volume of the measuring probe. This has the disadvantage that following the manufacturer's instructions can yield very inaccurate measurement results when using the probe in the patient.

Mojoli et al. presented in 2016 different clues as to how the esophageal pressure measurement and the filling volume of an inflatable balloon probe interact with each other. In this case, an inflatable balloon probe was gradually filled with air and determines the elasticity of the balloon wall at different balloon filling conditions and measured the respective esophageal pressure.

A disadvantage of this known solution is that it can not be recognized whether the filling volume in the balloon probe is too high or too low.

WO 2016/046707 A1 discloses a device for artificial nutrition of a patient by means of a probe for introducing nutritional substances into the stomach of a patient. The probe includes a first inflatable balloon for sensing the pressure in the esophagus of a patient and a pneumatic circuit having pumping means connected to at least one inlet / outlet port for inflating / deflating the balloon. The device has a calibration unit for calibrating the optimal probe volume, wherein a first probe volume is preset and during a predetermined period of time an esophageal pressure in the probe and a ventilation pressure in the pneumatic circuit are detected.

A disadvantage of the known solution is that for calibrating the optimal probe volume of the probe, the probe must be filled with a first minimum probe volume so that the optimal probe volume can be determined. This makes the calibration process time consuming and error prone.

It is the object of the present invention to overcome one or more disadvantages of the prior art. In particular, a test device and / or a method for testing a measuring probe should be provided, which allows an optimal adjustment of the filling volume of a measuring probe.

This object is achieved by the device and method defined in the independent claims. Advantageous developments are set forth in the figures, the description and in particular in the dependent claims.

The test device according to the invention for testing a measuring probe has a medical apparatus. The medical apparatus has a measuring probe connection, which can be connected to a measuring probe by means of a measuring probe line for exchanging probe measured values. The medical apparatus has a sensor connection, which can be connected to a sensor unit by means of a sensor line for the exchange of sensor measured values. There is a test unit for testing the measuring probe, wherein the test unit has at least one test algorithm which is designed to determine a test curve after detecting at least one first probe reading from the probe and after detecting at least one first sensor reading from the sensor unit.

With this test device, the filling volume of different measuring probes can be checked easily and reproducibly. A correct filling of the probe increases the accuracy of an esophageal pressure measurement. The esophageal pressure depends on the filling volume of the probe, the size of the probe and the nature of the patient's esophagus. Regardless of the specifications of the manufacturer of the probe, each probe can be optimized for the reliable measurement of esophageal pressure using either the test device or the test unit.

Advantageously, the test unit has an arithmetic unit in which the test algorithm is executed so that at least the test curve can be created directly in the test apparatus. This precisely specifies the different probes, allowing the user to quickly handle the probe being used. Advantageously, the test algorithm is designed to determine a test curve after detecting at least one further probe reading from the probe and after detecting at least one further sensor reading from the sensor unit. Thus, a test curve can be determined, which in addition to mathematical lines also describes a higher mathematical function, such as a polynomial. For this purpose, a plurality of probe measured values from the measuring probe and a plurality of sensor measured values are advantageously detected by the sensor unit.

Preferably, an input device for triggering a holding maneuver is provided, with which at least the removal of a fluid, in front of the sensor unit can be interrupted. Thus, the user can actively start the testing of the probe on the test device, whereby a false triggering of the holding maneuver is prevented. This sensor unit can be designed as a flow sensor, with a fluid hose connection to the medical apparatus and with a further fluid hose connection to the patient, wherein the flow sensor can be flowed through by a fluid. Between the medical apparatus and the flow sensor, a first tubing is arranged and between the flow sensor and a patient, a further tubing is arranged. Typically, a flow sensor is flowed through in a first direction with the fluid and then flows through in the first direction opposite another direction. In this case, the fluid is supplied to or removed from the sensor unit, wherein the removal or the supply of the fluid can take place either in the first direction or in the further direction. During the holding maneuver described here, the removal or supply of the fluid is interrupted by the sensor unit, so that a flow through the sensor unit can be prevented and the at least one first sensor measured value can be detected. In the holding maneuver, the hose line is essentially interrupted between the at least one sensor unit and the medical apparatus, so that the removal of the fluid can be prevented in front of the sensor unit. Preferably, the input device is electrically connected to the test unit and connectable with at least one valve device for interrupting the discharge of the fluid in front of the sensor unit, so that the input device can easily trigger the interruption of the discharge of the fluid and thus the holding maneuver. In this case, the test unit may be configured, in response to an actuation of the input device by a user to create a control command with which the at least one valve device interrupts the removal of the fluid in front of the sensor unit, whereby a holding maneuver can be triggered. In this case, the test unit can be electrically or pneumatically connected to the at least one valve device by means of a control line, so that the holding maneuver can be reliably triggered. A valve device may be a valve, a flapper, a pump or the like. As an electrical connection is here in addition to a cable connection and a wireless connection, such as a wireless connection, such as a Bluetooth® or a WLAN or I_AN understood.

In particular, the at least one valve device for interrupting the discharge of the fluid is arranged in the medical apparatus, so that the removal of a fluid in front of the sensor unit with the aid of the medical apparatus can be interrupted easily. Thus, any leakage can be prevented, so that the test algorithm of any leaks in a hose remains unaffected and the test curve is reproducible created in such cases.

Alternatively or additionally, the at least one valve device for interrupting the discharge of the fluid is arranged on a hose line in front of the sensor unit. In this case, the at least one valve device is electrically connected to the input device and the test unit by means of a control line, so that the input device can trigger the interruption of the discharge of the fluid through the sensor unit.

Alternatively or additionally, a further valve device for interrupting the discharge of the fluid is arranged in the sensor unit. The flow can be interrupted directly in the sensor unit. Alternatively or additionally, the input device is suitable for selecting a measuring probe. Typically, the measuring probe can be easily selected by means of the input device, for example, depending on the respective manufacturer of the measuring probe, and then the holding maneuver be carried out, so that incorrect operation of the testing device or faulty testing of the measuring probe is prevented.

Advantageously, the input device is connected to the test unit. Thus, the synchronization between the test algorithm and holding maneuvers can be easily realized. Furthermore, manufacturer-specific parameters of the measuring probe, such as, for example, the material of the measuring probe, the structure of the measuring probe, etc. can be forwarded to the testing unit.

Advantageously, the medical apparatus has a memory unit which is connected to the input device and / or in which manufacturer-specific parameters of the various measuring probes can be stored, as a result of which the particular measuring probe used can easily be selected and / or manufacturer-specific parameters can be simply entered and easily called up

Advantageously, the memory unit is connected to the computing unit of the test unit, whereby an already determined test curve can be stored and retrieved. This allows the user to retrieve historical test curves at the test fixture.

Advantageously, the medical apparatus has a recognition device, whereby the respective measuring probe of the respective manufacturer is automatically recognizable, so that manufacturer-specific parameters of the measuring probe can be activated as presettings on the medical apparatus.

In particular, the medical apparatus is a respirator, whereby only a single apparatus can be used as a medical apparatus and test apparatus.

Preferably, the at least one first probe reading is a probe pressure reading, whereby the esophageal pressure is easily determinable. Alternatively or additionally, the at least one first sensor measured value is a sensor pressure measured value, whereby the determination of the optimum filling volume of the measuring probe is improved.

Preferably, a display unit is provided and at least one determinable on the basis of the test curve test value displayed on the display unit. This allows the user to visually recognize the optimum filling volume, allowing for rapid probe testing. For example, the test value can be represented as a percentage of the maximum filling volume of the test probe to be tested.

Advantageously, the display unit is arranged on the medical apparatus, whereby a compact construction of the test apparatus is possible.

Advantageously, the input device is integrated in the display unit or combined with the display unit. Typically, a touchscreen is used, so that the operator on the test device, for example, the respective probe on the display unit can easily select and / or start the holding maneuver on the display unit.

Alternatively or in addition, the test curve can be displayed on the display unit, whereby an accurate and immediate testing of the probe is possible.

Preferably, the test curve can be displayed as a graphic animation, whereby the cognitive recording of the user of the measuring probe is excited during testing and thus the testing of the measuring probe is carried out more accurately.

In particular, the test value can be displayed as an animated bar graph, as a result of which the user of the test apparatus immediately detects too high or too low filling volumes in the probe during the test of the measuring probe and can react to them promptly.

The medical apparatus preferably has at least one measuring transducer which converts the at least one first probe measured value and the at least one first sensor measured value into measuring signals. The Measurement signals are generated directly in the medical apparatus, thus minimizing the susceptibility to error during measurement signal transmission.

Alternatively, the medical apparatus has a measuring transducer, which converts the at least one first probe measured value into a measuring signal, and has a further measuring transducer, which converts the at least one first sensor measured value into measuring signals. This allows the probe measurement value and the sensor measurement value to be measured simultaneously or in parallel and to perform a more accurate determination of the test curve.

Preferably, the sensor unit is connected to the medical apparatus, wherein the sensor unit is in particular a flow sensor or a pressure sensor. These sensors allow for accurate determination of proximal pressure during patient ventilation and are also excellent for determining the optimal fill volume of the probe.

Alternatively or additionally, a measuring probe is connected to the medical apparatus, with which a direct determination of the filling volume of the measuring probe can be carried out.

Preferably, the probe is an inflatable balloon probe. Thus, the filling volume of the probe is easily varied.

A further aspect of the invention relates to a method for testing a measuring probe with a test apparatus, the method comprising the following steps: a) carrying out a holding maneuver, wherein at least the removal of a fluid in front of a sensor unit is interrupted;

b) detecting at least a first measured value change at the sensor unit or at the measuring probe;

c) detecting at least a first probe reading with the probe; d) detecting at least a first sensor reading with the sensor unit, wherein steps a) to d) are performed simultaneously;

e) carrying out a test algorithm in a test unit, wherein a test curve is determined with the aid of the at least one detected first probe measured value and the at least one detected first sensor measured value.

With this method, the optimal filling volume of different measuring probes can be checked easily and reproducibly. Regardless of the specifications of the manufacturer of the probe, each probe can be optimized for measuring esophageal pressure. Optionally, the measuring probe is introduced in advance into a Meßsondenprüfvorrichtung, which has for this purpose an opening, whereby the measuring probe is positioned in a particular tubular test chamber and then filled with the fluid. In this case, gas, such as oxygen and / or air is typically used as the fluid. The method described herein is applicable regardless of the position of the probe in the tube-like test chamber and regardless of the structure or the nature of the probe.

Advantageously, an input device is actuated before step a), and subsequently a control command for carrying out the holding maneuver is created by the test unit and transferred to a valve device. Thus, a simple interruption of the discharge of the fluid and thus the holding maneuvers can be done easily.

As Meßsondenprüfvorrichtung a dummy is used, for example, wherein the tubular test chamber serves as an esophagus, whose diameter and / or nature can be changed.

In particular, the at least one sensor measured value is a sensor pressure measured value and the at least one probe measured value is a probe pressure measured value, so that a testing of the measuring probe which is as close to the application as possible is made possible. In particular, the method for testing a probe is carried out with the test device described above, whereby the probing of probes of different manufacturers is reproducibly possible.

During step a), steps b), c) and d) are advantageously carried out several times, so that a plurality of sensor measured values and probe measured values are recorded during a holding maneuver. The test algorithm thus has several measured values available, which improves the resolution of the test curve.

Advantageously, steps c) and d) are carried out several times, so that a plurality of sensor measured values and a plurality of probe measured values are recorded during a holding maneuver. The test algorithm thus has several measured values available, which improves the resolution of the test curve. Thus, a test curve can be determined, which in addition to mathematical lines also describes a higher mathematical function, such as a polynomial.

Advantageously, the step a) is aborted after a predetermined time interval, so that an incorrect operation can be prevented. Typically, the maximum time interval is about 12 seconds [s], so the user can be quickly alerted to the faulty operation.

Preferably, the at least one first measured value change in step b) takes place due to the exertion of an external force on the measuring probe. Typically, the external force is applied to the probe by the user or by a device for applying a force to the probe, whereby the at least one first change in the measured value can be easily carried out.

Advantageously, the external force is transmitted to the outer wall of the probe and thus can be easily converted into a pressure. In addition, spontaneous breathing is simulated with the manikin so that exerting the external force on the probe can be reduced. Thus Spontaneous breathing acts as a reduction of the external force to be transmitted to the probe and is also detected as a change in measured value.

Advantageously, the external force is exerted on the probe indirectly. An indirect application of force to the probe protects the outer wall of the probe.

Preferably, step e) is carried out only if the at least one first measured value change exceeds a minimum value, whereby the correct execution of the method for testing the measuring probe can be controlled.

Advantageously, the at least one first measured value change is a pressure measurement value change, whereby the testing of the measuring probe is simplified.

Advantageously, the minimum value of the change in the measured pressure value is 1.5 mbar, which ensures that only a slight pressure fluctuation is not interpreted as a change in the measured pressure value.

Preferably, after step e), the calculation of a test information indicative of the probe is performed using the test curve. The test curve typically contains the test information indicative of the probe, so that it can be easily evaluated and thus a simple determination of the optimal filling volume of the probe from the test curve is possible.

Preferably, steps b) to d) are repeated at least once more, and then at least step e) is carried out. In this way, the test curve can be determined with increased accuracy, as a result of which the test information indicative of the measuring probe can be calculated more accurately. Typically, steps b) to d) are repeated several times - every 1 to 100 milliseconds [ms], ideally 5 ms - repeated and then at least step e) is carried out, whereby the test curve has many checkpoints. The test curve is preferably a test line, as a result of which the test information indicative of the test probe can be determined simply by means of a straight line equation.

Preferably, the test line is determined by means of a straight-line equation with a least-square method or a recursive least-square method or with a least-mean-square method. It is thus possible to use standard evaluation algorithms or calculation methods in the test unit with which the test information indicative of the measuring probe can be determined quickly and reliably. The least square method allows the curve parameters to be determined so as to minimize the sum of the square deviations of the curve from the observed points. The Recursive Least Square method leads to the same solution as the Least Square method. The difference is that the algorithm is constructed recursively. The recursivity allows a use of currently accumulating data with constant complexity in each recursion step. The Least Mean Square method also works in a time-recursive manner, that is, with each new record, the algorithm is run once and the solution is updated. In contrast to the least-square method, the algorithm is based on the gradient method, whereby the gradient is easily determined.

Preferably, the recursive least squares method or the least mean square method is already carried out during steps c) and d), that is, during the detection of the at least one first probe measured value and during the detection of the at least one first sensor measured value , This allows the method described here to be carried out quickly.

Alternatively or additionally, the acquired measured values of steps c) and d) can be temporarily stored in the memory unit and subsequently evaluated, which results in improved testing of the measuring probe.

Preferably, the test information indicative of the probe is the slope of the test curve. The slope of the test curve can be easily determined. Alternatively or additionally, the test information indicative of the probe is the intercept of the test curve. The intercept can be used to immediately determine the optimal fill volume. Both parameters, ie the slope and the intercept, of the test curve can be evaluated quickly and thus easily determine the optimal filling volume of the probe.

Alternatively, the test information indicative of the probe is at least one extreme value (minimum value or maximum value), a curvature or a saddle point. This makes it possible to perform different curve simulations in the test algorithm, which improves the characterization of the test curve and thus simplifies or accelerates the determination of the optimum filling volume of the measuring probe.

Preferably, a test value is determined with the test information indicative of the measuring probe, whereby the optimal filling volume of the measuring probe is easily recognizable for a user.

Preferably, a probe volume index is determined with the test information indicative of the probe. The user thus receives a simple clue to the correct filling volume of the measuring probe. Typically, the probe volume index is a standardized value so that a simple interpretation of the probe's fill volume is possible for the user.

In particular, the probe volume index (MVI) is based on the equation system

"Max (m, 2m) for b> k

MVI =

m is determined for b <k, where m is the slope of the test curve, b is the intercept of the test curve, and k is a positive, real number.

The user receives a simple clue for testing the probe. This gives the user clear and understandable information about the filling quantity in the measuring probe. In other words, can the user can recognize whether the fluid in the probe has to be emptied or the probe has to be filled with the fluid. For example, the user may have too low a fill volume (MVI <1), too high

Filling volume (MVI> 1) and an optimal filling volume (MVI = 1) recognize.

Preferably k is 0, whereby the calculation of the

Probe Volume Index (MVI) is particularly simple, or k is equal to the at least one first probe reading, if the at least one first sensor reading is 0. This will calculate the calculation of the

Probe Volume Index (MVI) performed very accurately.

Preferably, a lower bound (threshold) for the

Defined test value, whereby a minimum filling of the probe can be specified with the fluid. For example, the lower limit for the probe volume index is defined as 0.1. Typically, at a probe volume index below the lower bound, no test curve or indicative test information is calculated or displayed and / or the user is prompted to continue to fill the probe with the fluid.

Alternatively or additionally, an upper limit (threshold) is defined for the test value. Typically, at a probe volume index above the upper bound, no test curve or indicative test information is calculated or displayed and / or the user is prompted to empty the excess fluid from the probe. For example, the upper bound for the probe volume index is 1.9.

The introduction of the upper and lower limits for the test value increases the robustness of the method for testing the probe and prevents misinterpretation of the test values.

Preferably, an acoustic signal is emitted when the lower barrier is undershot or the upper barrier is exceeded. Thus, the user is in an erroneous execution of the here warned early, so that a false interpretation is prevented.

Alternatively or additionally, when the lower barrier is undershot or the upper barrier is exceeded, a visual signal is displayed on a display unit, in particular on the medical apparatus. Thus, the applicant can orient himself to the display on the display unit and set an optimal filling volume in the probe.

In particular, the acoustic signal is an acoustic warning signal, which immediately alerts the user to a filling volume which is unsuitable for the measuring probe to be tested.

In particular, the visual signal is a visual warning signal, whereby the user sees on the display a filling volume which is unsuitable for the probe to be tested.

Preferably, the test curve is displayed on the display unit. This typically allows the user to more easily interpret the test curve and recognize a faulty reading on the display unit.

Alternatively or additionally, the test value is displayed on the display unit so that the user of the method for testing the probe can easily interpret the optimum filling volume. Typically, the test value is displayed in color, which stimulates the cognitive nervous system or cognitive perception of the user. For example, a too high and too low probe volume index is marked red and the optimal probe volume index is marked green.

The test value is preferably displayed on the display unit by means of a graphic animation. For example, the test value can be animated in a bar graph, which stimulates the user's cognitive nervous system more quickly.

Another aspect of the invention relates to the use of a ventilator for testing a measuring probe, in particular for testing an inflatable balloon probe. Thus, the probe can be used on the one hand in the probe testing device described here or also directly in the use of the probe in the esophagus of a living being, especially a human. Preferably, the method described here for testing the measuring probe is used, whereby the filling volume of the measuring probe can be determined particularly well.

Further advantages, features and details of the invention will become apparent from the following description in which embodiments of the invention are described with reference to the drawings.

The list of reference numerals as well as the technical content of the claims and figures are part of the disclosure. The figures are described coherently and comprehensively. Identical reference symbols denote the same components, and reference symbols with different indices indicate functionally identical or similar components.

It shows:

Fig. 1, the inventive test device for testing a

Measuring probe

2 shows a flow chart for the inventive method for

Testing a probe

3 shows a diagram with a test curve for testing a measuring probe, and

Fig. 4, the inventive test device according to FIG. 1 in a

Respirator with the probe placed in a dummy.

FIG. 1 shows the test device according to the invention for testing a measuring probe as a medical apparatus 10. A measuring probe connection 13 is provided at the medical apparatus 10, to which a measuring probe, for example an inflatable balloon, can be connected as a measuring probe line 15 by means of a hose line. The medical apparatus 10 has a sensor connection 12, to which a pressure sensor or a flow sensor means of the sensor line 14 is connectable. The sensor connection 12 and the measuring probe connection 13 are each connected to the medical apparatus 10 with a respective measuring transducer 24 or 25, so that incoming sensor pressure measured values PAW from the pressure sensor and incoming probe pressure values P _es from the inflatable balloon in the medical apparatus 10 can be processed. A detection device 23 can be arranged between the measuring probe connection 13 and the measuring transducer 25, as a result of which the inflatable balloon connected thereto is automatically recognized by the medical apparatus 10. In the medical apparatus 10, a test unit 18 for testing the probe is provided. In the test unit 18, a memory unit 21 and a computing unit 19, a processor is arranged, which are electrically connected to the respective transducers 24 and 25, respectively. In this case, a test algorithm is used to determine a plurality of probe pressure readings P _es and a plurality of sensor pressure readings PAW using a test algorithm. From the test curve, a test value, here the probe volume index MVI, is calculated in the arithmetic unit 19. The test curve or the probe volume index MVI is then displayed on a display unit 20 of the medical apparatus 10. The display unit 20 is designed as a touchscreen, so that the display unit 20 also serves as an input device 22 for triggering or starting a holding maneuver and is integrated therein. The display unit 20 has a bar graph 26, on which the probe volume index MVI can be displayed graphically. The input device 22 is electrically connected to a valve device 30 on or in the medical apparatus 10, so that triggering of the holding maneuver is made possible. The valve device 30 is designed as a valve and prevents the discharge of the fluid in front of a sensor unit.

In addition, the input device 22 can be used for inputting previously known manufacturer-specific parameters of the particular measuring probe to be tested, in particular of the inflatable balloon, or for selecting the respective measuring probe to be tested. FIG. 2 shows a flowchart of the method according to the invention for testing a measuring probe with a testing device as described here. In a first step, a measuring probe, in this case an inflatable balloon probe, and a pressure sensor or flow sensor are connected to the medical apparatus 10 (see FIG. 1), wherein the inflatable balloon probe with its measuring probe line 15 is connected to the measuring probe connection 13 and the pressure sensor whose sensor line 14 is connected to the sensor terminal 12 (step 50). Subsequently, the inflatable balloon probe is inserted into a tubular test chamber of a dummy (step 51) and the inflatable balloon probe, depending on the type of balloon probe or depending on the manufacturer's specifications, filled with air or oxygen as a fluid or the fluid contained therein at least partially drained (Step 52). Thereupon, a holding maneuver is carried out, whereby the discharge of the air before the pressure sensor is interrupted (step a), 53). Simultaneously, a pressure reading change on the pressure sensor or on the inflatable balloon probe is detected (step b), 54) when an external force or pressure of greater than +/- 1.5 mbar is exerted on the inflatable balloon probe (step 55). Simultaneously, the detection of a probe pressure reading P _es with the inflatable balloon probe (step c), 56) and the detection of a sensor pressure reading P _AW at the pressure sensor (step d), 57) are performed. The detected first probe pressure value P _es and the detected first sensor pressure measured value P _AW are forwarded to the arithmetic unit 19 of the test unit 18. Steps 56 and 57 are executed every 5 ms, and up to 2400 times, and subsequently or simultaneously a test algorithm is carried out in the arithmetic unit 19 (step e), 58). The test algorithm determines with the detected probe pressure value P _es and the detected sensor pressure value P _AW a test line which represents the test curve. Subsequently, step c) (step 55) is repeated and further test points on the already determined test curve in the arithmetic unit 19 are determined, wherein steps 56 and 57 continue to be executed, and displayed on the display unit 20 (step 59). Subsequently or simultaneously to step 53, the determination is made of the slope m of the test line and the determination of the intercept b of the test line, these being calculated using a least-square method or a recursive_least_square method or with a least mean square method ( Step 60).

In the next step 61, the probe volume index MVI with the previously determined slope m and the previously determined intercept b based on the system of equations

"Max (m, 2m) for b> k

MVI =

m determined for b <k. Where k is a positive, real number. Thus, the probe volume index MVI is assigned a value between 0 and 2, with a lower bound of 0.1 and an upper bound of 1.9 set in the check unit 18. If the lower limit is undershot or if the upper limit is exceeded, a warning signal is emitted (step 62).

Subsequently, the probe volume index MVI is displayed on the display unit 20 (step 63). Depending on the inflatable balloon probe, an acceptable probe volume index MVI is displayed in green, and an unacceptable probe volume index MVI is shown in red on the display unit 20.

If the probe volume index MVI is acceptable, then the inflatable balloon probe procedure is complete (step 64). For an unacceptable probe volume index MVI, steps 52 through 63 are repeated until an acceptable probe volume index MVI is reached.

FIG. 3 shows a diagram with a representative representation of the test curve, as test line 72 (solid line), for an inflatable balloon probe and an idealized straight line 73 (dashed line), which represents an optimal filling volume in the inflatable balloon probe 117. The Diagram 70 shows the probe pressure value P _es [mbar] on the ordinate and the sensor pressure measured value PAW [mbar] on the abscissa. The Prüfgerade 72 is defined by the equation P + b _it = m * P _A w, where m is the slope of the Prüfgerade and b is the intercept of the Prüfgerade is. For the idealized straight line 73, a slope equal to 1. The equation system previously shown calculates the probe volume index MVI from the test line 72 and displays it on the display unit 20 so that the user of the test device can easily interpret the testing of the inflatable balloon probe. For example, the user can thus immediately recognize a filling volume that is too low (MVI <1), an excessively high filling volume (MVI> 1) and an optimal filling volume (MVI = 1) in the inflatable balloon probe.

FIG. 4 shows a further embodiment of the test device according to the invention, wherein the test unit 118 described above is arranged in a respirator 110. The ventilator 110 has a display unit 120 and is connected to the test unit 118. The test unit 118 is connected via the measuring transducer 125 to the measuring probe connection 113, to which the tubular measuring probe line 115 of the inflatable balloon probe 117 is connected. The ventilator 110 further has an input device 122, at which the holding maneuver can be triggered or started. The inflatable balloon probe 117 is located in the tubular test chamber 138 of the dummy 135. The input device 122 is electrically connected via the test unit 118 with the valve device 140 by means of the control line 123, so that by means of the input device 122, the holding maneuver is triggered. As a valve device 140, a valve in front of the sensor unit 116 is arranged in this embodiment.

The respirator 110 has a gas inlet and outlet 129, on which the sensor unit 116, designed as a T-shaped pressure sensor, is connected to the ventilator 110 via a hose line 130. The test unit 118 is connected via the transducer 124 to the sensor connection 112, to which the sensor line 114 of the sensor unit 116 connected. The sensor unit 116 is connected to a further hose line 131 with the further test chamber 137 of the dummy 135. The test chamber 137 and the test chamber 138 are disposed adjacent to each other in the dummy 135. The dummy 135 is made of an elastic material and has an outer wall 136, which is adjacent to the test chamber 138 and partially surrounds. Thus, the method described herein for testing the inflatable balloon probe 117 can be performed. In this case, the external force is exerted on the outer wall of the inflatable balloon probe, which is transmitted in a measurable pressure value change to the inflatable balloon probe 117. Alternatively, the manikin 135 simulates a spontaneous breathing of a living being, which is to be understood as exerting the external force on the outer wall 136. This results in an indirect power reduction to the inflatable balloon probe 117th

The method described herein for testing the inflatable balloon probe 117 using a ventilator 110 as a test device may also be practiced when the inflatable balloon probe 117 is placed in the esophagus of a living being, such as a human.

LIST OF REFERENCE NUMBERS

10 medical equipment

12 sensor connection

13 probe connection

14 sensor cable

15 probe lead

16 sensor unit

18 test unit

19 arithmetic unit

20 display unit

21 storage unit

22 input device

23 detection device

24 first transducer

25 other transducers

26 bar graph

30 valve device

Pes probe pressure reading

PAW sensor pressure reading

MVI probe volume index m slope

b intercept

50-64 process steps

72 test line

73 Idealized straight line

110 ventilator

112 sensor connection

113 Probe connection

114 sensor line Probe line

Sensor unit inflatable balloon probe

test unit

computer unit

display unit

storage unit

input device

control line

first transducer of other transducers

Pressure sensing port

Hose line further hose line

manikin

Outside wall of 135 test chamber

further test chamber valve device

Claims

claims

1. A testing device for testing a measuring probe, wherein the testing device comprises a medical apparatus (10; HO), in particular a respirator, wherein the medical apparatus (10; 110) has a measuring probe connection (13; 113) which is connected by means of a measuring probe line (15 115) for exchanging probe measured values can be connected to a measuring probe, and has a sensor connection (12; 112) which can be connected to a sensor unit (116) by means of a sensor line (14; 114) for exchanging sensor measured values, a test unit (18 118) for testing the probe, wherein the test unit (18; 118) comprises at least one test algorithm which is designed to detect at least one first probe reading from the probe and after detecting at least one first sensor reading from the sensor unit (116 ) to determine a test curve, and preferably an input device (22, 122) for triggering a holding maneuver vorges is marriage, with the at least the discharge of a fluid, in front of the sensor unit (116) is interruptible.

2. Testing device according to claim 1, characterized in that the input device (22; 122) is electrically connected to the test unit (18; 118) and at least one valve device (30; 140) for interrupting the discharge of the fluid in front of the sensor unit (116). is connectable.

3. Test device according to claim 1 or 2, characterized in that the at least one first probe measured value is a probe pressure measured value (P _es ) and / or the at least one first sensor measured value is a sensor pressure measured value (PAW).

4. Test device according to one of claims 1 to 3, characterized in that a display unit (20; 120) is provided and at least one on the basis of the test curve determinable test value the display unit (20; 120) can be displayed and / or the test curve can be displayed, preferably can be displayed as a graphic animation, in particular as an animated bar graph (26) can be displayed.

5. Testing device according to one of claims 1 to 4, characterized in that the medical apparatus (10, 110) has at least one measuring transducer (24, 25, 124, 125), softens the at least one first probe reading and the at least one first sensor reading respectively converted into measurement signals.

6. Testing device according to one of the preceding claims, characterized in that the sensor unit (116) and / or a measuring probe with the medical apparatus (10; 110) are connected, wherein the sensor unit (116) is in particular a flow sensor or a pressure sensor and the Probe is preferably an inflatable balloon probe (117).

7. A method for testing a measuring probe with a test apparatus, in particular with a test apparatus according to one of claims 1 to 6, wherein the method comprises the following steps:

a) carrying out a holding maneuver, wherein at least the discharge of a fluid, in particular of gas, is interrupted in front of a sensor unit (116);

b) detecting at least a first measured value change, in particular a change in the pressure value, at the sensor unit (116) or at the measuring probe;

c) detecting at least a first probe reading, in particular a probe pressure reading (P _es ), with the probe;

d) detecting at least a first sensor measured value, in particular a sensor pressure measured value (PAW), with the sensor unit (116), the steps a) to d) being carried out simultaneously; e) carrying out a test algorithm in a test unit (18, 118), wherein a test curve is determined with the aid of the at least one detected first probe measured value and the at least one detected first sensor measured value.

8. The method according to claim 7, characterized in that the at least one first measured value change in step b) due to exerting an external force on the measuring probe, in particular indirectly, and preferably step e) is carried out only if the at least one first measured value change exceeds a minimum value.

9. The method according to any one of claims 7 or 8, characterized in that after step e), the calculation of an indicative for the probe test information using the test curve.

10. The method according to any one of claims 7 to 9, characterized in that the steps b) to d) are repeated at least a further time and then at least the steps e) is performed.

11. The method according to any one of claims 7 to 10, characterized in that the test curve is a test line (72) and the test line (72) by means of straight line equation preferably with a least-square method or a recursive least square method or with a least mean square Procedure is determined.

12. The method according to any one of claims 9 to 11, characterized in that indicative of the probe test information is the slope (m) of the test curve and / or the intercept (b) of the test curve.

13. The method according to any one of claims 9 to 12, characterized in that indicative of the for the measuring probe Checking a test value is determined, preferably a probe volume index (MVI) is determined, in particular the probe volume index (MVI) based on the equation system

"Max (m, 2-m) for b> k

MVI =

m is determined for b <k, where m is the slope of the test curve, b is the intercept of the test curve, and k is a positive real number, where k is preferably 0, or k is equal to the at least one first probe reading, if at least a first sensor reading is zero.

14. The method according to claims 13, characterized in that a lower limit is defined for the test value and / or an upper limit is defined for the test value, and preferably at a falling below the lower barrier or exceeding the upper barrier an acoustic signal, in particular an audible warning signal, and / or a visual signal, in particular a visual warning signal is displayed on a display unit (20, 120).

15. The method according to one of claims 7 to 14, characterized in that the test curve is displayed on the display unit (20; 120) and / or the test value is displayed on the display unit (20; 120), preferably by means of a graphic animation.

16. Use of a ventilator for testing a measuring probe, in particular for testing an inflatable balloon probe (117), according to the method according to one of claims 7 to 15.