System for monitoring usage conditions of medical device, medical device and monitoring method

Abstract

To make it possible to identify causes that may lead to damage to a medical device by monitoring corresponding usage conditions, and to record appropriate data for predictive diagnosis.SOLUTION: A monitoring system (20) comprises: an accelerometer (22) adapted to detect acceleration of a medical device (10) during handling of the medical device (10); a sensor unit (24) adapted to detect a further condition of the medical device (10) during handling of the medical device (10); and a control unit (26) with a dedicated storage unit (26a), wherein the control unit (26) is operatively connected to the accelerometer (22) and the sensor unit (24) and adapted to derive use data of the medical device (10) from the output data of the accelerometer (22) and the sensor unit (24) and to differentiate based on the respective output data of the accelerometer (22) and the sensor unit (24) between a regular use state and an unintended use state of the medical device (10).SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a monitoring system for monitoring the usage of a medical device, a medical device comprising such a monitoring system, and a monitoring method for operating such a medical device. [Background technology]

[0002] To ensure proper operation of medical devices and equipment, it is necessary to periodically inspect such devices, since malfunctions can cause serious problems during critical therapeutic or surgical interventions in patients. However, currently, inspection of medical devices and equipment is primarily performed by visual inspection to identify external damage or by disassembly to identify internal damage after internal damage is recognized due to the device not functioning as expected during use.

[0003] Therefore, no predictive techniques are used that allow for the identification of expected or already occurring damage to a medical device before it is used, so that failures or unexpected behavior during a medical procedure can be avoided in advance. Furthermore, potential damage to a medical device can only be identified by disassembling the corresponding device, which predicts high costs and long downtimes for the device, resulting in higher operating costs and general inconvenience for users of said devices.

[0004] In particular, trauma to medical devices such as endoscopes or hand instruments can be identified by visual inspection by a trained professional, whereas internal defects caused by physical stress can only be identified after disassembly or through side effects such as image loss or their other functions not functioning properly as expected. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2020 / 375433 [Patent Document 2] US Patent Application Publication No. 2023 / 215269 [Patent Document 3] U.S. Patent Application Publication No. 2020 / 103434 Summary of the Invention [Problem to be solved by the invention]

[0006] It is therefore an object of the present invention to be able to identify possible causes of damage to a medical device by monitoring corresponding usage conditions and to record appropriate data for predictive diagnosis. [Means for solving the problem]

[0007] To this end, the present invention proposes a monitoring system for monitoring the usage status of a medical device, comprising an accelerometer adapted to detect acceleration of the medical device during handling of the medical device, a sensor unit adapted to detect further status of the medical device during handling of the medical device, and a control unit having a dedicated memory unit, wherein the control unit is operatively connected to the accelerometer and the sensor unit and adapted to derive usage data of the medical device from output data of the accelerometer and the sensor unit and to distinguish between normal usage status and unintended usage status of the medical device based on the respective output data of the accelerometer and the sensor unit.

[0008] Thus, the present invention provides a monitoring system in which two different sensor units are used to monitor the usage of a medical device of interest, and a control unit based on the provided data can distinguish whether the corresponding medical device is being used in the intended manner or whether an event has occurred that places the medical device in a state in which damage must be expected or at least suspected. In particular, the use of an accelerometer as the primary sensor unit can detect and record typical usage patterns expected during proper handling or operation of the device, for example, while performing a medical procedure or other expected situations, such as storing, sterilizing, and transporting the aforementioned device, while also detecting unexpected events involving excessive acceleration values, such as impacts or drops with potentially harmful impact parameters. Additional sensor units can be used to perform classification, refinement, verification, and testing of the data provided by the accelerometer, and the data provided by the accelerometer and sensor units can be processed by the control unit in an advantageous manner, as further described below.

[0009] In one possible embodiment, the sensor unit may also be formed by a second accelerometer, which may be of a different type to the first accelerometer and preferably has a larger measurement range, in particular up to at least 200 g. Although such accelerometers with extended measurement ranges have become available in recent years, their power consumption nevertheless increases significantly compared to conventional accelerometers that are optimized for low and inefficient consumption within their reduced measurement range.

[0010] In alternative embodiments, different types of sensors can be used as further sensor units. Possible types of sensors include microphones for detecting sound waves, piezo elements for detecting pressure, temperature sensors, etc. All the aforementioned types of sensors are capable of directly or indirectly detecting a collision of or a collision against the medical device in question, which may be classified as an unintended use situation within the meaning of the present invention.

[0011] To further optimize the power consumption of the corresponding monitoring system according to the present invention, the sensor unit, particularly the second accelerometer, may be adapted to normally be in a low-power standby mode and transition to a functional mode only upon detection of a threshold value. The aforementioned threshold value may relate to a threshold acceleration or a value of a further situation monitored by the sensor unit itself. Thus, in embodiments using a second accelerometer, the second accelerometer may switch from the low-power standby mode to its functional mode only when a certain acceleration is exceeded, and a corresponding signal may be provided by the second accelerometer itself if it is capable of transitioning from the low-power standby mode to its functional mode. In such embodiments, during the standby mode, acceleration data is recorded less frequently or only if the aforementioned threshold value is reached, and upon reaching the threshold, very fine, accurate acceleration data is acquired and recorded in functional mode. Meanwhile, in other embodiments, the second accelerometer may also transition to its functional mode upon detecting that a threshold acceleration value has been reached, e.g., upon receiving an external activation signal from the first accelerometer or the control unit. Similarly, the first accelerometer may also be provided with a low-power mode and transition to its fully functional mode upon detecting small movements to provide appropriate data to the control unit.

[0012] The second accelerometer may in particular have a measurement range of up to 200 g, whereas the first accelerometer, in contrast, has a measurement range of at least 16 g, preferably at least 32 g. Such accelerometers are widely available on the market and have low power consumption, such that they are also used, for example, in mobile phones and smartwatches to track the normal movements of a wearer or user, respectively.

[0013] Although different approaches may be used to distinguish between normal and unintended use conditions, in certain embodiments the control unit may be adapted to distinguish between the two use conditions based on machine learning data previously recorded in the control unit's storage unit. For example, before shipping a monitoring system according to the present invention, extensive experiments may be performed with a corresponding medical device including the monitoring system exposed to both normal and unintended use conditions, and the collected data may be used as training data for an artificial intelligence machine learning system, such as a neural network.

[0014] The monitoring system according to the invention may further comprise a communication unit, in particular a wireless communication unit, operatively coupled to the control unit. By providing such a communication unit, the data recorded by the accelerometer and sensor unit, as well as the data processed by the control unit, may be transmitted in real time, intermittently or upon request by a user to an external data processing system in order to enable external diagnostics to be performed on the past use of the corresponding medical device.

[0015] Additionally or alternatively, the control unit may be further adapted to record usage data in the storage unit for later retrieval, e.g., so that the recorded usage data can be retrieved to investigate past usage of the medical device and perform diagnostics, for example, during periodic inspection of the corresponding medical device.

[0016] The control unit may also be adapted to use artificial intelligence to distinguish between normal and unintended use conditions of the medical device, for example, a neural network in which the accelerometer and corresponding data provided by the sensor unit serve as input.

[0017] According to a further aspect, the present invention relates to a medical device, in particular a reprocessable medical device, comprising the monitoring system according to the present invention as just described. In this context, a reprocessable medical device is understood to be a multi-use medical device that can be processed, for example, in an autoclave for sterilization between uses. However, the monitoring system according to the present invention can of course also be used for disposable devices, for example, to ensure proper handling before medical use, during manufacturing and / or transportation.

[0018] The corresponding medical device may further comprise a stand-alone power source, in particular a rechargeable power source, so that its use and handling can be monitored during periods when an external power source is not readily connected. Thus, for example, in the case of an endoscope, during a surgical procedure the endoscope is connected to an external power source that can also be used to power the sensor unit and the control unit of the monitoring system described above, but by providing the medical device with an additional stand-alone power source, proper handling of the device can also be monitored during times when the device is being transported, sterilized, or otherwise handled without access to an external power source.

[0019] As already briefly mentioned, the present invention can be incorporated into any conceivable type of medical device, but it particularly relates to endoscopes or endoscope cases. It should therefore be understood that medical devices in the sense of the present invention relate not only to surgical instruments or similar devices that come into direct contact with the patient, but also to auxiliary equipment used to handle and transport such medical devices, such as the above-mentioned cases or different types of auxiliary instruments. By monitoring the use of such auxiliary equipment, possible damage to the devices transported therein or used in combination with it can be easily detected.

[0020] According to yet another aspect, the present invention relates to a monitoring method for operating the monitoring system or medical device just described, comprising continuously monitoring acceleration of the medical device by an accelerometer, at least temporarily monitoring a further condition of the medical device by a further sensor unit, deriving, by a control unit, usage data of the medical device from output data of the accelerometer and the sensor unit, and distinguishing between normal and unintended usage conditions of the medical device based on the respective output data of the accelerometer and the sensor unit.

[0021] The monitoring method may further include initially and / or iteratively performing machine learning based on achieving both normal and unintended use conditions with the medical device or different medical devices of the same type prior to using the medical device in its intended monitoring method and context.

[0022] An example of a machine learning technique that can be used in this context includes detecting the connection status of a medical device to an external device, such as a video processor, and evaluating the movement pattern of the medical device based on the detected connection status. This approach is generally based on using different thresholds for different use cases of the device. A specific example of its disconnection from the video processor, such as moving from an operating room to a cleaning department, during which a different movement pattern is expected compared to the use of the device during a medical procedure. By calculating the corresponding duration and measuring the movement pattern, further differentiation of subsequent steps, such as manual cleaning, can be made. Using artificial intelligence, this understanding of this use phase of the device can be improved / learned over time. This makes it possible to distinguish the typical duration of each identified use phase, and based on this, threshold settings can be adjusted to improve system sensitivity, or vice versa. Such processing and corresponding learning of typical use steps of the device can contribute to energy savings by preventing unnecessary device activation and potentially extending battery life.

[0023] Finally, distinguishing between normal and unintended use conditions of the device can include classifying the impact of the medical device. To this end, the corresponding medical device can be dropped from a predetermined height or otherwise impacted in a manner that can be classified as acceptable or unacceptable depending on the structural integrity of the device and its general resilience. Based on recorded experimental data, an acceptable impact can be classified as a normal use condition, while an excessively strong impact, such as a drop from an excessively high height, can be classified as an unintended use condition for further use during operation of the system / device.

[0024] Further features and advantages of the present invention will become more apparent from the following description of embodiments thereof, when viewed in conjunction with the accompanying drawings, which show in particular: [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a schematic diagram of a medical device according to the present invention. [Figure 2] 2 is a schematic diagram of a method for collision classification implemented in the device of FIG. 1; [Figure 3] 2 is a flow chart of a method for using the apparatus of FIG. 1 in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0026] In Figure 1, a medical device in the form of an endoscope is shown schematically and generally designated by the reference numeral 10. The endoscope comprises a housing 12 and typical functional components such as an image sensor, optical lenses, a light guide cable for receiving light from an external light source, etc., which are known to those skilled in the art and are not shown in Figure 1 or described in detail below.

[0027] The endoscope 10 accommodates within its housing 12 a monitoring system 20 according to the present invention, as well as a rechargeable energy storage element, in particular in the form of a rechargeable battery and / or a stand-alone power source 14, such as, for example, an electromechanical energy harvesting unit. The monitoring system 20 comprises a sensor unit formed by an accelerometer 22 for detecting acceleration of the endoscope 10 during handling thereof, a second accelerometer 24 having a larger measurement range compared to the first accelerometer 22, and a control unit 26 having a dedicated storage unit 26a, the control unit 26 being operatively coupled to the two accelerometers 22, 24 and adapted to process corresponding sensor data provided by the accelerometers 22 and 24.

[0028] Referring now to Figure 2, a process for classifying collisions with the endoscope of Figure 1 is shown schematically, in which the endoscope 10 is dropped from different predetermined heights at predetermined angles or orientations, and the corresponding sensor data provided by the accelerometers 22 and 24 during the drop and collisions is recorded for further analysis.

[0029] The experiments are performed multiple times, and the resulting detected acceleration profiles representative of endoscope crashes are fed into appropriate machine learning-based algorithms to define acceptable and unacceptable crashes for the endoscope. Based on the machine learning, the control unit 26 of the endoscope 10 is provided with appropriate data and algorithms to monitor the endoscope 10 during use and take action as to whether an unexpected hard crash is occurring. Corresponding data derived by the control unit 26 based on the data provided by the accelerometers 22, 24 can be stored in the storage unit 26a for subsequent retrieval and / or transferred periodically, in real time, or upon user request to an external server via wired or wireless communication means 28 also provided in the system 20 within the endoscope housing 12.

[0030] 3 shows a flowchart of a monitoring method according to the present invention for operating a medical device such as the endoscope 10 of FIG. 1. First, in step S1, prior to shipping and operation of the endoscope 10, machine learning is performed based on exposing the endoscope 10 to both normal and unintended use conditions; of course, different endoscopes of the same or similar type may be used in the machine learning experiments. Step S1 may be performed, for example, by the method shown in FIG. 2 and described above.

[0031] At a certain point during the life of the endoscope 10, for example when the endoscope 10 leaves its factory and is being shipped to a customer, the acceleration of the medical device begins to be monitored by the accelerometer 22 in step S2, and the monitoring is performed continuously to detect any mishandling of the device 10 in different scenarios.

[0032] At least temporarily, upon detection of further conditions of the medical device, and in the embodiments explicitly described herein, for example, exceeding a threshold acceleration value that activates the second accelerometer to extend the measurement range for acceleration of the device 10, a larger measurement range of acceleration is monitored by the second accelerometer.

[0033] Based on the data provided by the two sensor units 22 and 24 in step S3, the control unit 26 distinguishes between normal and unintended use conditions of the medical device 10 in step S4 and transmits and / or stores the corresponding data for further use. Based on the collected and characterized data, predictive maintenance of the device can be performed and a warning or alert can be output during any appropriate time when mishandling of the device is detected as an unintended use condition. [Explanation of symbols]

[0034] 10 Endoscope (medical device) 12 Endoscope housing 14 Standalone Power Supplies 20 Systems 22 First Accelerometer 24 Second accelerometer (sensor unit) 26 Control Unit 26a Memory Unit 28 Wired or wireless communication means

Claims

1. 1. A monitoring system for monitoring the usage of a medical device, comprising: an accelerometer adapted to detect acceleration of the medical device during handling of the medical device; a sensor unit adapted to detect a further condition of the medical device during handling of the medical device; a control unit having a dedicated storage unit; Equipped with The control unit is operably connected to the accelerometer and the sensor unit, and is adapted to derive usage data of the medical device from output data of the accelerometer and the sensor unit, and to distinguish between normal usage states and unintended usage states of the medical device based on the output data of the accelerometer and the sensor unit, respectively.

2. the sensor unit is formed by a second accelerometer, the second accelerometer being of a different type to the first accelerometer and having a measurement range of at least up to 200 g; The monitoring system of claim 1 .

3. the second accelerometer is normally in a low power standby mode and is adapted to transition to a functional mode upon detection of a threshold value; The monitoring system of claim 2 .

4. the accelerometer has a measurement range of at least 32 g; The monitoring system of claim 1 .

5. the control unit is adapted to distinguish between the normal usage state and the unintended usage state based on machine learning data previously recorded in the storage unit of the control unit; The monitoring system of claim 1 .

6. The monitoring system of claim 1 , further comprising a communication unit operably coupled to the control unit.

7. the control unit is further adapted to record usage data in the storage unit for later retrieval. The monitoring system of claim 1 .

8. the control unit is adapted to use artificial intelligence to distinguish between the normal use state and the unintended use state of the medical device. The monitoring system of claim 1 .

9. A reprocessable medical device comprising the monitoring system of claim 1.

10. Further comprising a rechargeable power supply which is a standalone power supply; The medical device of claim 9.

11. The medical device is an endoscope or an endoscope case. The medical device of claim 9.

12. A monitoring method for operating the monitoring system of claim 1 or the medical device of claim 9, comprising: continuously monitoring the acceleration of the medical device with the accelerometer; at least temporarily monitoring the further condition of the medical device with the sensor unit; deriving, by the control unit, usage data of the medical device from output data of the accelerometer and the sensor unit, and distinguishing between a normal usage state and an unintended usage state of the medical device based on the output data of the accelerometer and the sensor unit, respectively; Monitoring methods including:

13. and further comprising initially and / or iteratively performing machine learning based on achieving both normal and unintended use conditions with the medical device or different medical devices of the same type. The monitoring method of claim 12.

14. As part of the machine learning, the method further includes detecting a connection state of the medical device to an external device, the external device being a video processor, and evaluating a movement pattern of the medical device based on the detected connection state. The monitoring method of claim 13.

15. distinguishing between the normal use condition and the unintended use condition includes classifying a collision of the medical device. The monitoring method of claim 13.

Images