Method for simulating and detecting potential malfunctions during operation of a medical product, and data system for storing and transmitting potential malfunctions during operation of a medical product - Patents.com

Abstract

The present invention relates to a medical system having a sensor system for directly or indirectly sensing all fault-related conditions in the assemblies of the medical system. The present invention relates to a simulation module which, based on sensor data and selected use cases of the medical system, simulates the use-dependent stability of the components present in the medical system, current operating parameter values, usage history, and symptomatic loads with the aid of previously known wear behavior of the parts, and outputs said stability in a complete or simplified form or as maintenance instructions.

Description

[Technical Field]

[0001] The present invention relates to a medical-technical system comprising a sensor system for directly or indirectly detecting all conditions related to a malfunction in a subassembly of the medical-technical system, and a simulation module, which simulates the effects resulting from actual operating parameter values, usage history, and symptoms based on sensor data and a selected application of the medical-technical system, using known wear characteristics of the components and the application-dependent stability of the components in the medical-technical system, and outputs them in a complete or simplified form or as repair instructions. Preferably, the detected data is collected in the data system and transmitted to a replacement device used in the same location with the same usage behavior. [Background technology]

[0002] In medical technology, devices are generally not monitored by sensors for risk of failure. Preventive maintenance of devices is generally based on preventive replacement of critical components that are at risk of failure during routine maintenance or safety checks.

[0003] In the event of an unexpected increase in component failures, in accordance with valid European and US legal regulations, the manufacturer must inform the client of the prohibition of use in certain circumstances and replace the malfunctioning modules of the device at the client's site.

[0004] There are some systems in the medical arts that provide such sensing by sensors, but not to a very large extent.

[0005] U.S. Patent No. 9,468,447 discloses an orthopedic system. The orthopedic system is provided with a data collection module for recording performance characteristics and a data analysis module for evaluating the measurements. Based on the measurements, the data analysis module analyzes the wear status using a suitable algorithm and outputs maintenance or repair recommendations. No consideration of symptom-dependent wear is described, and no reliable diagnosis of future / possible symptoms-dependent malfunctions is disclosed.

[0006] Outside of medical technology, preventative maintenance or sensor-based diagnostics are more frequently found, but again not to the same extent as disclosed in this invention.

[0007] German patent application DE 102009049931 discloses a diagnostic and maintenance device for switchgears with a data processing device and at least one internal interface device, which communicates with connected devices ready to communicate with the respective switchgear and / or queries and / or processes diagnostic and maintenance information and / or status information thereof and provides and / or outputs and / or displays them as usable and / or machine-readable information to be retrieved. Evaluating application-dependent wear developments is not described, and there is no reliable statement about the application-dependent stability of the components.

[0008] WO 2006 / 034852 discloses a method for diagnosing technical devices, specifically pumps and valves, installed in industrial installations in the process industry. Disturbance variables affecting the devices and their service life are detected by sensor technology, and the data is processed in a simulated manner to determine the expected service life of each device. Various maintenance instructions are stored in a specialized unit and output together with the expected remaining trouble-free operating time of the industrial installation when a low service life threshold is reached for one or several devices. It proposes a diagnosis in industrial installations. Disturbance variables affecting the devices and their service life are detected by sensor technology, and the expected service life is determined by simulation, but symptom-dependent wear considerations are not addressed.

[0009] EP1836576 (search report) discloses a method for determining the time until replacement of a vacuum pump based on the results of a current performance evaluation. For this purpose, a comparison of the currently evaluated diagnostic analysis results with an initial (or baseline) data set is presented, with the aim of enabling a report on the need for pump maintenance based on the pump's performance indicators. It proposes monitoring performance parameters to determine the need for maintenance, but future and application-dependent diagnosis of subsequent wear is not described.

[0010] The invention further comprises a data system for transmitting the information already detected on the device to a replacement device provided in the same location and in the same relation. For this reason, several solutions exist relating to the transmission of information.

[0011] EP 0 497 041 discloses an infusion pump set for configuring a single infusion pump to mimic the pump operation from multiple dedicated infusion pumps. The set includes: · housing means positioned adjacent to the patient for delivering the fluid to the patient; · reservoir means coupled to the housing for holding a liquid; · a delivery means for delivering the fluid from the reservoir to the patient; · Input means for entering patient information; · microprocessor means for controlling the delivery means; a memory module capable of selecting from a set of memory modules and containing a program describing the particular delivery profile characteristics for each dedicated pump; Equipped with. A specially selected memory module is coupled to the microprocessor and the respective control program for the delivery means is loaded, and the delivery means is operated to mimic the respective selected pump.

[0012] A control module of a pump is described, in which several sets of distinct control parameters can be recorded. The handling / adaptation of pump characteristics by various control commands is not described, and no simulation of response behavior is performed, and no adaptation of pump characteristics for different pumps is produced.

[0013] EP 2015804 discloses an infusion set for administering medical liquids, equipped with a data memory for exchanging data with an administration device. The information present in the data memory serves to determine deviations from a prescribed operating state. In the event of a non-regular operating state, a prescribed operating state can be activated automatically or with the assistance of the pump wearer. The handling / adaptation of pump characteristics by various control commands is not described, nor is a simulation of response behavior performed, nor is an adaptation of pump characteristics for different pumps produced.

[0014] Further prior art is disclosed in WO 2006 / 110246 and EP 3557589. [Prior art documents] [Patent documents]

[0015] [Patent Document 1] U.S. Patent No. 9,468,447 [Patent Document 2] German Patent Invention No. 102009049931 [Patent Document 3] International Publication No. 2006 / 034852 [Patent Document 4] European Patent Application Publication No. 1836576 Search Report [Patent Document 5] European Patent No. 0497041 [Patent Document 6] European Patent No. 2015804 [Patent Document 7] International Publication No. 2006 / 110246 [Patent Document 8] European Patent Application Publication No. 3557589 Summary of the Invention [Problem to be solved by the invention]

[0016] Thus, the goal is to sense and indicate possible malfunctions of medical-technical devices and their components. To achieve this goal, parameters of use in normal device applications are sensed and used as a basis for further calculations. [Means for solving the problem]

[0017] To achieve this goal, the present invention provides: A method for detecting and indicating a possible malfunction of a medical technology device is taught. This medical technology device at least one wear-prone component; at least one sensor for sensing an operating parameter of the wear-sensitive component; at least one memory for storing operating parameters with at least one operating parameter limit; at least one computer for calculating the probability of failure; and at least one display unit; Equipped with said computer comparing the operating parameters of the medical-technical device with stored operating parameter limit data and displaying the results in the form of a failure probability and / or remaining usable life and / or remaining number of usable cycles; and a medical-technical device for carrying out such a method. DETAILED DESCRIPTION OF THE INVENTION

[0018] First, the solution according to the invention provides for performing a simulation of the entire system using known component behavior and sensors, thereby determining whether the components will survive their intended use without failure with a certain degree of certainty. Furthermore, according to the invention, the simulation is performed in advance outside the device, and the results of this simulation are assigned to real-life usage scenarios based on defined parameters. The assigned simulation results are then used to determine the risk of component failure.

[0019] The medico-technical device may be, for example, a liquid pump for laparoscopy, arthroscopy, hysteroscopy, urinalysis, or an air insufflation device.

[0020] Such medical technology devices typically include components that are subject to significant wear, such as the motor of a peristaltic pump or the gas pump of an inhaler. Another example is the vacuum pump of an air delivery device. Therefore, to calculate the probability of failure, it is first necessary to detect the details of use in order to sense or simulate wear.

[0021] In the simplest case, the sensor may be a clock that counts down (operation time meter) or the detection of a particular activity with a timestamp and calculation of the duration of use, which may occur for example immediately after sensing.

[0022] However, the sensor may also indicate the detection of the operating current of the electric motor, which in turn allows statements about the already existing wear of the motor to be made.

[0023] Furthermore, the sensors may be measuring means for measuring the flow rate, which, in combination with the parameters of the pump control, make it possible to make statements about the wear of these pumps by comparing the initial values ​​with the realized effects.

[0024] For example, the flow rate of the fluid as a function of the power consumed by the pump can be used as a measure of the wear characteristic. Alternatively, a pressure sensor can be used to measure the pressure at the maximum achievable pressure as a function of the rotational speed of the pump. Another possibility for determining the wear characteristic is the measurement of the imbalance. This can be obtained by measuring the vibration movement of the motor (for example perpendicular to the axis of rotation). However, wear can also be determined acoustically by measuring the noise during operation. A microphone can be used to measure the sound level during operation. A spectral analysis of the acoustic signal can also allow a more precise identification of the worn parts (for example for pump systems with multiple rotating axes, such as peristaltic pumps).

[0025] More complex to evaluate are measurements of dynamics, for example, in fluid flow rate or pressure rise. Another alternative is measurement of the operating temperature of a pump. The sensors used for the respective selected measurement process are known to those skilled in the art and many variations are commercially available, so no further explanation is required here.

[0026] To perform the method, the medical technology device includes a memory in which the data measured by the sensor is stored. When the device is equipped with a communication interface, the data can be transmitted periodically or on demand via the communication interface to other memory devices. These may be, for example, data processing and storage devices in a hospital, a doctor's office, or the device manufacturer's cloud.

[0027] To calculate the probability of failure, it is first necessary to know the load limits of each component and store them in memory, which may be the internal memory of the device, but also in an external memory, for example the manufacturer's cloud.

[0028] In the simplest case, a manufacturer may determine, for example through corresponding testing, that a component can be used with a 95% probability for more than 1000 operating hours before failing. When the sensor is an operating hour meter, a simple display of the number of "safe" hours remaining may be used. Continuing with this example, when a component has already been used for 750 hours, there is a 95% probability that the component can be used for another 250 hours, and it is desirable to service or replace it when it reaches 1000 hours.

[0029] Taking into account the usage behavior to calculate the time to failure of a component can be done, for example, as follows: if the usage is once a week for 6 hours a day, the calculation algorithm simulates in 6-hour steps until a 95% confidence value of the predicted service life of the critical component (service life limit or operating parameter limit, known and stored in the data system) reaches a threshold, and outputs the number of weeks.

[0030] In medical-technical devices according to the invention, wear usually depends not only on the duration of use but also on the intensity of use. In particular in pump systems, wear often depends on the pressure generated by the pump. For example, when a pressure of 35 mmHg is generated, there is a 95% chance that a liquid pump can be used for more than 1000 operating hours, but when a pressure of 70 mmHg is generated, it can only be used for 500 operating hours.

[0031] Therefore, the system according to the invention preferably detects not only the duration of use but also the intensity of use and calculates the probability of failure therefrom.

[0032] It is understood that the actual use of a medical technical device according to the invention depends on several factors. There are hospitals or doctors' offices that are specialized for specific uses, in which the devices are more or less uniformly stressed with regard to the duration and intensity of use. However, there are also hospitals or doctors' offices in which the respective uses of the devices carried out there vary greatly. For this reason, according to the invention, it is preferable to record each individual use of each device and use this in the calculations.

[0033] In this way, actual symptoms are taken into account in the simulation, and known or previously recorded usage periods are also taken into account in this symptom. Feedback of the remaining usable life thus determined (e.g., calculated number of weeks) can be provided via a user interface, starting from a threshold setting, for example as a display or LED signal with an indication of the respective remaining usable life (calculated from previous usage). Furthermore, starting from a threshold setting, initiation of preventive service for preventive replacement of components can be done via optical or acoustic transmission or a communication interface in another system (either a hospital-provided system or the manufacturer's). The transmitted data can include service information with a description of the device ID, the respective components, the specific simulated remaining usable life, the operating period, and the remaining usable life indicated to the user.

[0034] According to the invention, this information can be presented to the user periodically or via a communication interface, at thresholds and on demand. The form of information from the device can be as a display indication, via email, SMS, sound output (voice or acoustic signal) and by communication according to protocols to other systems (purchase planning systems, hospital information systems (HIS), OP planning systems, etc.).

[0035] moreover, Operating parameter limits for all fault-related conditions where functionality is no longer guaranteed, Possible operating conditions or applications (indications), - previous influences in each subassembly depending on the symptom, A data system is claimed, comprising at least:

[0036] Such a data system according to the invention allows the transmission of parameters of another device (e.g., a device usage profile) to another medical technology device with the same or similar design. These other device parameters may be safety-related parameters, such as the maximum pressure or maximum flow rate generated. For example, a user of a medical technology device that provides a specific gas flow rate (e.g., 20 l / min) on demand may be surprised when a replacement device delivers a higher gas flow rate. Therefore, part of the data set transmitted to the replacement device may be the maximum flow rate of the previous device. The user can continue working with the new device as usual. If applicable, the transmitted device usage profile may also include data specific to the other device, such as specific control characteristics and how quickly or slowly it responds to disturbances (e.g., a pressure drop due to a leak during surgery). The use of other parameters for device behavior is also encompassed by the invention.

[0037] Possible points in time for calculating and displaying the failure probability or remaining usable time and / or remaining usable cycles are the start-up of the device (pre-OP, i.e. before application) and the end of the procedure (post-OP, i.e. after application), which the device can identify by certain events, such as the removal of an accessory.

[0038] It will be clear to those skilled in the art that when components subject to wear are serviced or replaced, the stored data can be adapted accordingly, for example by replacing them with new components of the same design and / or by resetting the detected operating hours to zero, which may involve changing the duration of use when using components of higher value.

[0039] The present invention allows the collected and evaluated data to be transmitted to other devices, such as replacement devices of the same design.

[0040] By transmitting the accumulated data to other devices, the present invention allows for the generation of identical system responses to user interactions even when the receiving system does not have an identical design. That is, device behavior can be mimicked to affect the system's response behavior (such as response time). The transmission is performed in such a way that existing prior information about technical behavior is transmitted from the sending / old device to the replacement / receiving device. This can include valid indications (e.g., a certain usage mode is blocked or can only be enabled after payment), recorded user behavior, and adaptations performed based on user behavior and calculated / simulated values.

[0041] Access to these data can be made on the device via a selected menu item and / or automatically at a fixed information time. This may in some cases comprise only a selection, with access to all data being provided by a special interface, such as entry into the memory device as a selection item and / or via a communication interface or network connection (Ethernet, WLAN) and / or when a memory device is connected, in particular via USB when a corresponding device is plugged in. This data can optionally be encrypted and access can be made via authenticating credentials, such as a password.

[0042] The method according to the invention allows preventive maintenance of medical technology devices. The method provides the user (e.g., a doctor), the operator (e.g., a hospital), and / or the device manufacturer with data that allows them to service or replace critical components before a failure occurs. Failure of such components during surgery is prevented for understandable reasons. The method according to the invention ensures that a medical technology device is not (or cannot be) used further when further use would be expected to exceed limiting values. The method according to the invention further allows for service or replacement in due time before parameter limits are reached. [Example]

[0043] A possible sequence of inflation pumps to expand a body cavity may be as follows: · Attach and / or detach a tubing set (alternatively, use user input to turn the device on and off). Simulation of possible component failures using usage behavior / operating parameter information (and history), which is stored in a data structure (possibly also in the cloud). Furthermore, the actual selected usage scenario (representation of multiple pumps) is taken into account for the simulation. The basis for this simulation is the previously determined behavior (stability) of the component under a specific usage scenario. Information such as the likelihood of failure or the duration of use (MTBF) can be provided by the component manufacturer. This simulation is performed before the device is put into use (external or internal to the device) and, based on the applied behavior, determines information about the remaining service life or required replacement before the intended use. The simulation uses sensor data, such as the motor current required for a specific rotation speed during a known phase of use (such as rotation to fill the tube after tube insertion), to determine wear on the drive unit. Sending the results of the simulation to a display device. If a certain threshold is reached, the results of the simulation are also sent to another system, for example HIS / purchasing or the manufacturer's technical service. When a device is replaced, a data structure can be transmitted so that the history of previous usage behavior remains the same, based on what has been simulated. The behavior of the device is identical with respect to user input. This also includes, for example, presetting of operating parameters and suggesting alternative options for operations in menus, or response times for specific changes in certain control characteristics, i.e., set points.

Claims

1. 1. A method for sensing and indicating a possible malfunction of a medical technology device, comprising: said medico-technical device comprising: at least one wear-prone component; at least one sensor for sensing a sound from a pump system having multiple rotating shafts, the sound being an operating parameter of the wear-prone component; at least one memory for storing said operating parameters, including at least one operating parameter limit; at least one computer for calculating the likelihood of failure for a rotating shaft of a wear portion identified by spectral analysis of the acoustic signal from said sensor; and at least one display unit; Equipped with the method further comprising the step of: comparing the operating parameters of the medical technology device with stored operating parameter limit data, and displaying the results in the form of a probability of failure and / or a remaining usable period and / or a remaining usable cycle. A method characterized by:

2. 2. The method of claim 1, wherein the medico-technical device is a liquid pump or an air insufflation device for laparoscopy, arthroscopy, hysteroscopy, urinalysis.

3. The method of claim 1 , wherein the wear-prone component is a motor of a peristaltic pump, a gas pump of an air delivery device, or a vacuum pump of an air delivery device.

4. The method of claim 1 , wherein the measured operating parameter is noise during operation.

5. 2. The method according to claim 1, wherein the measured and / or stored operating parameters are transmitted, encrypted or unencrypted, via an interface of the medical technology device to an intranet or the Internet.

6. 2. The method of claim 1, wherein the memory contains the operating parameter limits or the memory can be re-attached via an interface of the medical technology device.

7. The method of claim 1 , wherein the calculation is performed outside the medical technology device.

8. The method of claim 1 , wherein the calculation is performed at the beginning or end of a medical procedure.

9. 10. The method of claim 1, wherein the indication is via device display, per SMS, email, and / or data transmission in a hospital information system, and optionally an optical and / or acoustic warning signal is output when a parameter limit is reached.

10. 2. The method according to claim 1, wherein when the medical-technical device is replaced, data transmission to a replacement medical-technical device is performed and / or when components subject to wear are replaced, stored data on the duration or intensity of use is updated.

11. A medico-technical device for carrying out the method according to any one of claims 1 to 10, comprising: at least one wear-prone component; at least one sensor for sensing a sound from a pump system having multiple rotating shafts, the sound being an operating parameter of the wear-prone component; at least one memory for storing said operating parameters, including at least one operating parameter limit; at least one computer for calculating the likelihood of failure for a rotating shaft of a wear portion identified by spectral analysis of the acoustic signal from said sensor; and at least one display unit; Equipped with The medical technology device is characterized in that the computer compares the operating parameters of the medical technology device with stored operating parameter limit data and displays the results in the form of the probability of failure and / or remaining usable period and / or remaining usable cycle.