Intrauterine pressure monitoring device and surgical system

Abstract

The present invention relates to the technical field of medical devices, and specifically provides an intrauterine pressure monitoring device and a surgical system. The device includes a first pressure sensor, a second pressure sensor, and a controller. The first pressure sensor is installed at the insertion end of the hysteroscope sheath and detects the first pressure value of the uterine cavity inside the uterine cavity. The second pressure sensor is installed in the infusion pipeline of the perfusion device and detects the infusion pipeline pressure value. The controller obtains the first pressure value and the infusion pipeline pressure value, so as to determine the second pressure value of the uterine cavity through the infusion pipeline pressure value, and determine whether the detection result of the first pressure sensor is unreliable based on the first pressure value with the second pressure value as a reference value. The installation position of the second pressure sensor is different from that of the first pressure sensor, so it is difficult to be affected by the same interference factors, and it avoids the surgical interruption and damage to the uterine cavity caused by measurement errors when it is impossible to know the failure of the pressure sensor or the influence of the environment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intrauterine pressure monitoring device and a surgical system. Background Art

[0002] For women, common gynecological diseases such as endometrial polyps, uterine fibroids, and intrauterine adhesions may cause abnormal uterine bleeding, excessive menstruation leading to hemorrhagic anemia, infertility and other symptoms, causing great damage to the physical and mental health of women. Among them, the prevalence rate of endometrial polyps is as high as 20% - 25%, and the incidence rate of uterine fibroids is 25% - 30%, of which the incidence rate of submucous fibroids can account for 10% - 15% of the incidence rate of uterine fibroids.

[0003] With the development of medical technology and the wide application of endoscopic technology, hysteroscopic surgery has also developed, and intrauterine tissues including submucous fibroids and endometrial polyps can be removed through hysteroscopic surgery.

[0004] During the process of performing hysteroscopic surgery, it is necessary to keep the pressure in the uterine cavity within a certain range, neither too high nor too low. If the pressure is too low, the uterine cavity is not filled, and observation and surgical operations cannot be carried out. If the pressure is too high, it may cause damage to the uterine cavity.

[0005] Currently, pressure monitoring is mainly carried out through a pressure sensor. For example, the Chinese patent document with the publication number CN204632220U describes a hysteroscopic surgery simulation operation device. A pressure sensor is provided in the through hole of the housing, and the force at different angles received by the hemispherical induction block is detected through the pressure sensor. Another example is the Chinese patent document with the publication number CN204839411U, which describes a squeezing type leak-proof hysteroscope. A pressure sensor is installed between the switching valve and the through groove, and the pressure of the uterine distension fluid is measured in real time through the pressure sensor.

[0006] However, the pressure sensor may be affected by interference factors, resulting in untrustworthy pressure measurement results. If the pressure sensor fails or has a measurement error due to environmental interference, it may cause the surgery to be unable to continue, and may even cause damage to the uterine cavity during the surgery. Summary of the Invention

[0007] In order to solve at least one of the above technical problems, the present invention provides an intrauterine pressure monitoring device and a surgical system.

[0008] A first aspect of the present invention provides a uterine cavity pressure monitoring device, which is applied to a surgical system. The surgical system includes a hysteroscope device and an irrigation device. The hysteroscope device includes a hysteroscope sheath. The uterine cavity pressure monitoring device includes: a first pressure sensor installed at the insertion end of the hysteroscope sheath, configured to detect a first pressure value of the uterine cavity inside the uterine cavity; a second pressure sensor installed in the infusion pipeline of the irrigation device, configured to detect the pressure value of the infusion pipeline, wherein the infusion pipeline can communicate with the uterine cavity; and a controller respectively connected to the first pressure sensor and the second pressure sensor, configured to obtain the first pressure value and the pressure value of the infusion pipeline, so as to determine a second pressure value of the uterine cavity through the pressure value of the infusion pipeline, and determine whether the detection result of the first pressure sensor is untrustworthy based on the first pressure value with the second pressure value as a reference value.

[0009] According to an embodiment of the present invention, the types of the first pressure sensor and the second pressure sensor are different.

[0010] According to an embodiment of the present invention, the first pressure sensor is an optical pressure sensor, and the second pressure sensor is a thin film pressure sensor.

[0011] According to an embodiment of the present invention, the number of the first pressure sensors installed at the insertion end of the hysteroscope sheath is 1, and the number of the second pressure sensors installed in the infusion pipeline is 1.

[0012] According to an embodiment of the present invention, a pressure chamber is provided on the infusion pipeline, and the second pressure sensor is installed in the pressure chamber.

[0013] According to an embodiment of the present invention, the method for the controller to determine the second pressure value of the uterine cavity includes: obtaining the height difference between a preset position of the infusion pipeline and the position where the uterine cavity is located, wherein the preset position is determined according to the installation position of the second pressure sensor in the infusion pipeline; obtaining the wall friction coefficient of the infusion pipeline; and determining the second pressure value of the uterine cavity based on the height difference and the wall friction coefficient.

[0014] According to an embodiment of the present invention, when the second pressure sensor is installed in the pressure chamber of the infusion pipeline, the preset position is the position of the pressure chamber, and the position where the uterine cavity is located is determined by the position of the operating table.

[0015] According to an embodiment of the present invention, the manner in which the controller determines whether the detection result of the first pressure sensor is untrustworthy includes: determining the difference between the second pressure value and the first pressure value; and determining that the detection result of the first pressure sensor is untrustworthy when the difference is greater than a preset value.

[0016] According to an embodiment of the present invention, the intrauterine pressure monitoring device further includes: a sound generator and / or a light emitter connected to the controller, the sound generator being configured to receive a sound control signal sent by the controller so as to emit a sound according to the sound control signal, and the light emitter being configured to receive a light control signal sent by the controller so as to emit light according to the light control signal, wherein the sound control signal and the light control signal indicate that the detection result of the first pressure sensor is untrustworthy.

[0017] According to an embodiment of the present invention, the intrauterine pressure monitoring device further includes: a display screen connected to the controller, the display screen being configured to receive display information sent by the controller so as to perform display according to the display information, wherein the display information includes the first pressure value.

[0018] A second aspect of the present invention provides a surgical system, the system including: a hysteroscope device, the hysteroscope device including a hysteroscope sheath; an irrigation device, the irrigation device including an infusion pipeline; and the intrauterine pressure monitoring device according to any of the above embodiments.

[0019] According to an embodiment of the present invention, the irrigation device further includes: a first power unit connected to the infusion pipeline, the first power unit being configured to receive a first driving signal sent by the controller of the intrauterine pressure monitoring device so as to rotate forward according to the first driving signal and thereby deliver distending fluid to the uterine cavity through the infusion pipeline; and a first liquid storage unit connected to the first power unit, the first liquid storage unit being configured to store distending fluid.

[0020] According to an embodiment of the present invention, the first power unit is further configured to receive a second driving signal sent by the controller so as to rotate in reverse according to the second driving signal and thereby aspirate the liquid in the uterine cavity through the infusion pipeline.

[0021] According to an embodiment of the present invention, the hysteroscope device is provided with a first channel that can communicate with the uterine cavity, and the system further includes: a shaver, the shaver being configured to enter the uterine cavity through the channel space of the first channel when extending into the uterine cavity at one end of the first channel so as to operate on human tissues.

[0022] According to an embodiment of the present invention, the shaver includes: a shaving cutter head configured to be driven by a driving force to rotate; and a second power unit connected to the shaving cutter head, the second power unit being configured to receive a third driving signal sent by the controller of the intrauterine pressure monitoring device so as to provide a driving force to the shaving cutter head according to the third driving signal.

[0023] According to an embodiment of the present invention, the hysteroscope device is provided with a second channel capable of communicating with the uterine cavity. The system further includes: a liquid suction device configured to enter the uterine cavity through the channel space of the second channel when one end of the second channel extends into the uterine cavity so as to suck out the waste liquid in the uterine cavity.

[0024] According to an embodiment of the present invention, the liquid suction device includes: a second liquid storage unit configured to receive the waste liquid sucked out from the uterine cavity; and a third power unit connected to the second liquid storage unit, the third power unit being configured to receive a fourth driving signal sent by the controller of the intrauterine pressure monitoring device so as to suck out the waste liquid from the uterine cavity according to the fourth driving signal. Description of the Drawings

[0025] The drawings illustrate exemplary embodiments of the present invention and, together with their description, are used to explain the principles of the present invention. These drawings are included to provide a further understanding of the present invention and are included in this specification and form a part of this specification.

[0026] Figure 1 is a structural block diagram of an intrauterine pressure monitoring device according to an embodiment of the present invention.

[0027] Figure 2 is a structural block diagram of an intrauterine pressure monitoring device according to another embodiment of the present invention.

[0028] Figure 3 is a structural block diagram of an intrauterine pressure monitoring device according to still another embodiment of the present invention.

[0029] Figure 4 is a structural block diagram of an intrauterine pressure monitoring device according to yet another embodiment of the present invention.

[0030] Figure 5 is a structural block diagram of a surgical system according to an embodiment of the present invention. Detailed Embodiments

[0031] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the relevant content and do not limit the present invention. Additionally, it should be noted that for the sake of convenience of description, only the parts related to the present invention are shown in the drawings.

[0032] It should be noted that, without conflict, the embodiments in the present invention and the features in the embodiments can be combined with each other. The technical solution of the present invention will be described in detail below with reference to the accompanying drawings and embodiments.

[0033] Unless otherwise specified, the exemplary embodiments / examples shown are to be understood as providing exemplary features of various details of some ways in which the technical concept of the present invention can be implemented in practice. Therefore, unless otherwise specified, without departing from the technical concept of the present invention, the features of various embodiments / examples can be additionally combined, separated, interchanged, and / or rearranged.

[0034] The terms used herein are for the purpose of describing specific embodiments and are not restrictive. As used herein, unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" are also intended to include the plural forms. In addition, when the terms "comprise" and / or "include" and their variants are used in this specification, it is stated that there are the stated features, wholes, steps, operations, components, assemblies, and / or groups thereof, but it does not exclude the presence or addition of one or more other features, wholes, steps, operations, components, assemblies, and / or groups thereof. It should also be noted that, as used herein, the terms "substantially", "about", and other similar terms are used as approximate terms rather than degree terms, so they are used to explain the inherent deviations of measured values, calculated values, and / or provided values that those of ordinary skill in the art will recognize.

[0035] Taking hysteroscopic surgery as an example, the intrauterine pressure monitoring device and surgical system of the present invention will be described below with reference to the accompanying drawings.

[0036] Figure 1 is a structural block diagram of an intrauterine pressure monitoring device according to an embodiment of the present invention. Refer to Figure 1 , the intrauterine pressure monitoring device of this embodiment is applied to a surgical system, and this surgical system can be used to perform hysteroscopic surgery. The surgical system includes a hysteroscope device and an irrigation device, and the hysteroscope device includes a hysteroscope sheath. The intrauterine pressure monitoring device includes a first pressure sensor S1, a second pressure sensor S2, and a controller 100.

[0037] The first pressure sensor S1 is installed at the insertion end of the hysteroscope sheath, and the first pressure sensor S1 is configured to detect the first pressure value of the uterine cavity U inside the uterine cavity U.

[0038] The second pressure sensor S2 is installed in the infusion pipeline of the perfusion device, and the second pressure sensor S2 is configured to detect the pressure value of the infusion pipeline. Among them, the infusion pipeline can communicate with the uterine cavity.

[0039] The controller 100 is respectively connected to the first pressure sensor S1 and the second pressure sensor S2. The controller 100 is configured to obtain the first pressure value and the pressure value of the infusion pipeline, so as to determine the second pressure value of the uterine cavity U through the pressure value of the infusion pipeline, and determine whether the detection result of the first pressure sensor S1 is untrustworthy based on the first pressure value with the second pressure value as the reference value.

[0040] The uterine cavity pressure monitoring device proposed according to the embodiment of the present invention directly detects the uterine cavity pressure through the first pressure sensor, realizes the indirect detection of the uterine cavity pressure by using the second pressure sensor, and compares the indirect detection result with the direct detection result of the first pressure sensor, so as to be able to timely identify whether the measurement result of the first pressure sensor is untrustworthy. Since the installation position of the second pressure sensor is different from that of the first pressure sensor, it is difficult to be affected by the same interference factors, and the probability of both being damaged at the same time is lower. Moreover, the second pressure sensor is installed in the infusion pipeline of the perfusion device with few interference factors and a safe environment, so it can more accurately identify whether the reading of the first pressure sensor is untrustworthy, avoiding surgical interruption and damage to the uterine cavity caused by measurement errors when the pressure sensor failure or environmental interference cannot be known, and improving the safety of the surgical process.

[0041] The hysteroscope sheath is a component of the hysteroscope device. The hysteroscope sheath can be a tubular structure, which can keep the cervix open and fix the position of the hysteroscope. The hysteroscope sheath has an insertion end. Before performing a hysteroscopy, the insertion end of the hysteroscope sheath will be inserted into the vagina of a female and passed through the cervical orifice into the uterine cavity U, so that the operator can observe the interior of the uterus through the hysteroscope and conduct guidance and positioning inside the uterus.

[0042] The pressure in the uterine cavity U needs to be regulated and maintained. For example, after determining that the position of the hysteroscope is accurate, the expansion solution or normal saline is perfused into the uterus through the operation channel (i.e., the working channel) of the hysteroscope to fill the uterine cavity U and form a surgical operation and visual field space, which is equivalent to regulating the uterine cavity pressure from the initial state to near the desired value. During the operation, the resection of intrauterine tumors and polyp tissues may occur. During the process, situations such as uterine cavity contraction and relaxation, uterine wall perforation, and the absorption of the liquid in the uterine cavity U by the uterus may also occur, which may also cause changes in the uterine cavity pressure. At this time, the uterine cavity pressure needs to be maintained near the desired value.

[0043] By installing the first pressure sensor S1 on the insertion end, the first pressure sensor S1 can enter the uterine cavity U along with the insertion end, and can monitor the pressure value in the uterine cavity U in real time, so that the operator can always grasp the real pressure situation in the uterine cavity U, thereby regulating and maintaining the uterine cavity pressure value. The value fed back by the first pressure sensor S1 can be referred to as the first pressure value.

[0044] The perfusion device can use the operation channel of the hysteroscope to perfuse the uterine cavity with distending fluid to fill the uterine cavity U. The perfusion device is provided with an infusion pipeline, and the infusion pipeline can include a perfusion tube. One end of the perfusion tube enters through the operation channel of the hysteroscope, so as to realize the connection with the uterine cavity U of the uterus. The second pressure sensor S2 monitors the pressure value in the infusion pipeline in real time.

[0045] Exemplarily, the number of the first pressure sensors installed on the insertion end of the hysteroscope sheath can be 1, and the number of the second pressure sensors installed in the infusion pipeline can be 1. The pressure monitoring is realized by only using two pressure sensors, thereby reducing the cost.

[0046] The controller 100 can adopt an MCU (Microcontroller Unit) or other types of chips. For example, the STM32F407IGT6 model chip can be adopted. The STM32F407IGT6 chip integrates high-performance digital signal processing and floating-point units, and has rich peripheral interfaces and functions.

[0047] The controller 100 obtains the first pressure value and the pressure value of the infusion pipeline from the first pressure sensor S1 and the second pressure sensor S2. Among them, when obtaining the pressure value of the infusion pipeline, since the pressure environment in the infusion pipeline is not exactly the same as the pressure environment in the uterine cavity U, it is necessary to process and calculate the pressure value of the infusion pipeline, so as to calibrate the pressure value of the infusion pipeline to the second pressure value. The second pressure value is equivalent to a calculated theoretical value. Compared with the pressure value of the infusion pipeline, it can more truly reflect the pressure situation of the uterine cavity U, so that it can be used as a reference for the uterine cavity pressure, and can more accurately determine whether the detection result of the first pressure sensor is untrustworthy.

[0048] Since the uterine cavity U is the place where the operator performs surgical operations, and during the operation, waste liquid with more impurities will be generated in the uterine cavity, the environment in the uterine cavity is relatively complex and there are many interference factors. The infusion pipeline of the perfusion device can only be used to transport the distending fluid. Compared with the inside of the uterine cavity, the environment is relatively simple and there are fewer interference factors. Therefore, the pressure value measured by the second pressure sensor installed in the infusion pipeline is used as a reference for comparison.

[0049] After obtaining the second pressure value, both the second pressure value and the first pressure value can relatively truly reflect the pressure condition of the uterine cavity U when each sensor is operating normally. Since the second pressure value is equivalent to a calculated theoretical value, the second pressure value can be used as a reference to determine whether there is an obvious difference between the first pressure value, which is equivalent to the detected value, and the second pressure value. If there is no obvious difference, it indicates that the values of the first pressure value and the second pressure value are accurate, thereby determining that the detection result of the first pressure sensor S1 is credible. If there is an obvious difference, it indicates that the value of the first pressure value is inaccurate, thereby determining that the detection result of the first pressure sensor S1 is not credible. The reason may be that the first pressure sensor S1 has failed or been interfered with. It can be understood that the non-credibility in the present invention refers to being difficult to be adopted, that is, the credibility is in doubt, and it is impossible to know whether it is an accurate pressure value, rather than determining that the detection result of the first pressure sensor must be inaccurate, because it is possible that the detection result of the second pressure sensor is inaccurate while the detection result of the first pressure sensor is accurate.

[0050] Exemplarily, the types of the first pressure sensor S1 and the second pressure sensor 2 can be different. For example, the first pressure sensor S1 is an optical pressure sensor, and the second pressure sensor S2 is a thin-film pressure sensor.

[0051] The first pressure sensor S1 can specifically adopt an ultra-miniature fiber optic pressure sensor or an ultra-miniature grating pressure sensor to accurately detect the real pressure in the uterine cavity U. For example, it can monitor the liquid pressure near the cervical orifice in the uterine cavity in real time with a high precision of 1%.

[0052] By setting the first pressure sensor and the second pressure sensor as different types of pressure sensors, setting the first pressure sensor as an optical pressure sensor ensures the accuracy of the uterine cavity pressure reading, and setting the second pressure sensor as a thin-film pressure sensor reduces the cost.

[0053] Figure 2 It is a structural block diagram of a uterine cavity pressure monitoring device according to another embodiment of the present invention. Refer to Figure 2 , a pressure chamber PV can be provided on the infusion pipeline, and the second pressure sensor S2 is installed in the pressure chamber PV.

[0054] The pressure chamber PV can provide a detection environment for the pressure of the infusion pipeline to facilitate the monitoring of the pressure of the pipeline. The pressure chamber PV can also fix the infusion pipeline. The perfusion device can push the liquid to flow through the infusion pipeline by applying pressure to the pressure chamber PV, thereby perfusing the uterine cavity with the distending fluid. The pressure chamber PV is connected to the uterine cavity U, and the second pressure sensor S2 monitors the pressure value in the pressure chamber PV in real time and takes the obtained pressure value as the pressure value of the infusion pipeline.

[0055] Exemplarily, the manner in which the controller 100 determines the second pressure value of the uterine cavity U based on the pressure value of the infusion pipeline may include: obtaining the height difference between a preset position of the infusion pipeline and the position where the uterine cavity U is located, where the preset position is determined according to the installation position of the second pressure sensor on the infusion pipeline; obtaining the wall blockage coefficient of the infusion pipeline; and determining the second pressure value of the uterine cavity U based on the height difference and the wall blockage coefficient.

[0056] The height difference can be determined before the start of the operation. The height difference is the distance between the second pressure sensor S2 and the uterine cavity in the height direction, and it characterizes the difference in the pressure values detected by the two sensors due to different heights. The preset position is determined by obtaining the installation position of the second pressure sensor S2 on the infusion pipeline. For example, if the second pressure sensor S2 is installed in the pressure chamber PV of the infusion pipeline, the above preset position can adopt the position of the pressure chamber PV, and the position where the uterine cavity U is located can be determined by the position of the operating table. For example, the position where the uterine cavity U is located is the sum of the position of the operating table and the preset height. The preset height can be set to 2-5 cm, for example. That is to say, before the start of the operation, the height position of the pressure chamber can be obtained first, and the height position of the operating table can be obtained. The height of the operating table is added to the preset height to obtain the position of the uterine cavity U, and the difference between the height of the uterine cavity U and the height of the pressure chamber is calculated to obtain the above height difference.

[0057] The wall blockage coefficient can be obtained through experimental measurement and is the influence of the inherent property of the infusion pipeline itself on the process of the second pressure sensor reflecting the pressure in the uterine cavity. If the second pressure sensor S2 is installed in the pressure chamber PV, the wall blockage coefficient is the wall blockage coefficient of the wall of the pressure chamber PV.

[0058] Both the height difference and the wall blockage coefficient will affect the process of the second pressure sensor reflecting the pressure in the uterine cavity. Therefore, based on the two and the detection result of the second pressure sensor S2, an operation is performed to calculate the second pressure value of the uterine cavity. It can be understood that some other information that may affect the process of the second pressure sensor reflecting the pressure in the uterine cavity can also be obtained, and the second pressure value of the uterine cavity is calculated by combining this information, the height difference, the wall blockage coefficient, and the detection result of the second pressure sensor S2.

[0059] Exemplarily, the manner in which the controller 100 determines whether the detection result of the first pressure sensor S1 is unreliable based on the first pressure value with the second pressure value as the reference value may include: determining the difference between the second pressure value and the first pressure value; and determining that the detection result of the first pressure sensor S1 is unreliable when the difference is greater than the preset value.

[0060] If the difference between the second pressure value and the first pressure value is greater than the preset value, it indicates that both the first pressure value and the second pressure value may be inaccurate, and the first pressure sensor may malfunction or be interfered. Therefore, the detection result of the first pressure sensor is not credible. If the difference between the second pressure value and the first pressure value is less than or equal to the preset value, it indicates that both the first pressure value and the second pressure value are accurate. Therefore, the detection result of the first pressure sensor is credible.

[0061] Figure 3 is a structural block diagram of an intrauterine pressure monitoring device according to another embodiment of the present invention. Refer to Figure 3 , the intrauterine pressure monitoring device may further include a sound generator. The sound generator is connected to the controller 100 and is configured to receive a sound generation control signal sent by the controller 100 to generate sound according to the sound generation control signal. Among them, the sound generation control signal indicates that the detection result of the first pressure sensor S1 is not credible.

[0062] The sound generator may use a buzzer B. When the controller 100 determines that the difference between the second pressure value and the first pressure value is greater than the preset value, it will send a sound generation control signal to the buzzer B to control the buzzer B to continuously generate sound or generate sound intermittently, thereby prompting the user that the detection result of the pressure detection may be inaccurate.

[0063] Continue to refer to Figure 3 , the intrauterine pressure monitoring device may further include a light emitter. The light emitter is connected to the controller 100 and is configured to receive a light emission control signal sent by the controller 100 to emit light according to the light emission control signal. Among them, the light emission control signal indicates that the detection result of the first pressure sensor S1 is not credible.

[0064] The light emitter may use an LED lamp L1. When the controller 100 determines that the difference between the second pressure value and the first pressure value is greater than the preset value, it will send a light emission control signal to the LED lamp L1 to control the LED lamp L1 to continuously emit light or flash, thereby prompting the user that the detection result of the pressure detection may be inaccurate.

[0065] It can be understood that the intrauterine pressure monitoring device may be provided with only a sound generator without a light emitter and prompt the user only by sound when needed; it may also be provided with only a light emitter without a sound generator and prompt the user only by light when needed; it may also be provided with both a light emitter and a sound generator and prompt the user by both sound and light when needed.

[0066] Figure 4 is a structural block diagram of an intrauterine pressure monitoring device according to still another embodiment of the present invention. Refer to Figure 4, the intrauterine pressure monitoring device may further include a display screen. The display screen is connected to the controller 100 and is configured to receive the display information sent by the controller 100 for display based on the display information. Among them, the display information includes the first pressure value.

[0067] The display screen may adopt a touch liquid crystal screen L2, and the touch liquid crystal screen L2 may be a display screen based on serial port TTL (Transistor-Transistor Logic). After the controller 100 obtains the detection result (intrauterine pressure value) of the first pressure sensor S1, the detection result may be sent to the touch liquid crystal screen L2 for display, so that the operator can control the start and stop of the perfusion device according to the intrauterine pressure value, thereby regulating the pressure of the uterine cavity, or facilitating other operations of the operator. It can be understood that the display information may also include other contents, such as information indicating whether the detection result of the first pressure sensor S1 is untrustworthy.

[0068] Figure 5 is a structural block diagram of a surgical system according to an embodiment of the present invention. Refer to Figure 5 , the surgical system 1000 of the present embodiment can be used to perform hysteroscopic surgery. The surgical system 1000 includes a hysteroscope device, a perfusion device, and an intrauterine pressure monitoring device. Among them, the hysteroscope device and the intrauterine pressure monitoring device can jointly form a hysteroscope equipment.

[0069] The hysteroscope device includes a hysteroscope sheath. The perfusion device includes an infusion pipeline. The intrauterine pressure monitoring device includes a first pressure sensor S1, a second pressure sensor S2, and a controller. Among them, the controller may adopt a microcontroller MCU.

[0070] The first pressure sensor S1 is installed at the insertion end of the hysteroscope sheath. The first pressure sensor S1 is configured to detect the first pressure value of the uterine cavity inside the uterine cavity U.

[0071] The second pressure sensor S2 is installed inside the infusion pipeline of the perfusion device. The second pressure sensor S2 is configured to detect the pressure value of the infusion pipeline. Among them, the infusion pipeline is communicated with the uterine cavity U. The hysteroscope device may be provided with a working channel, which is also called an instrument channel. The instrument channel refers to a hollow pipeline that penetrates the mirror body in the hysteroscope device and can be used to insert surgical instruments. The infusion pipeline can be communicated with the uterine cavity U through the instrument channel of the hysteroscope device. When the hysteroscope sheath is inserted into the vagina of a female and passes through the cervical orifice into the uterine cavity U, the instrument channel provides the condition for surgical instruments to enter the uterine cavity U. At this time, the infusion pipeline can be inserted into the inside of the hysteroscope device through the instrument channel, and then inserted into the uterine cavity U through the instrument channel for the perfusion of the distending fluid.

[0072] The controller MCU is respectively connected to the first pressure sensor S1 and the second pressure sensor S2. For example, the controller MCU is connected to the first pressure sensor S1 and the second pressure sensor S2 through an I2C (Inter-Integrated Circuit) interface. The MCU is configured to obtain the first pressure value and the pressure value of the infusion pipeline, so as to determine the second pressure value of the uterine cavity U based on the pressure value of the infusion pipeline, and determine whether the detection result of the first pressure sensor S1 is untrustworthy based on the first pressure value with the second pressure value as a reference value.

[0073] Exemplarily, the types of the first pressure sensor S1 and the second pressure sensor S2 can be different. For example, the first pressure sensor can be an optical pressure sensor, and the second pressure sensor can be a thin-film pressure sensor. The number of the first pressure sensors installed at the insertion end of the hysteroscope sheath can be 1, and the number of the second pressure sensors installed in the infusion pipeline can be 1.

[0074] It should be noted that for the details not disclosed in the surgical system 1000 of this embodiment, reference can be made to the details disclosed in the uterine cavity pressure monitoring device of the above-mentioned embodiment proposed in this disclosure, which will not be elaborated here.

[0075] According to the surgical system proposed by the embodiment of the present invention, the direct detection of the uterine cavity pressure is carried out through the first pressure sensor, the indirect detection of the uterine cavity pressure is realized by using the second pressure sensor, and by comparing the indirect detection result with the direct detection result of the first pressure sensor, it is possible to timely identify whether the measurement result of the first pressure sensor is untrustworthy. Since the installation position of the second pressure sensor is different from that of the first pressure sensor, it is difficult to be affected by the same interference factors, and the probability of both being damaged at the same time is lower. Moreover, the second pressure sensor is installed in the infusion pipeline of the perfusion device with few interference factors and a safe environment. Therefore, it can more accurately identify whether the reading of the first pressure sensor is untrustworthy, avoiding surgical interruption and damage to the uterine cavity caused by measurement errors when the pressure sensor failure or environmental interference cannot be known, and improving the safety of the surgical process.

[0076] Continue to refer to Figure 5, the infusion line can be provided with a pressure chamber PV, and the second pressure sensor S2 can be installed inside the pressure chamber PV. The manner in which the controller MCU determines the second pressure value of the uterine cavity can include: obtaining the height difference between a preset position on the infusion line and the position where the uterine cavity U is located, where the preset position is determined based on the installation position of the second pressure sensor S2 on the infusion line; obtaining the wall blockage coefficient of the infusion line; and determining the second pressure value of the uterine cavity U based on the height difference and the wall blockage coefficient. Wherein, when the second pressure sensor S2 is installed inside the pressure chamber PV of the infusion line, the preset position can be the position of the pressure chamber PV, and the position where the uterine cavity U is located can be determined by the position of the operating table.

[0077] The manner in which the controller MCU determines whether the detection result of the first pressure sensor S1 is unreliable can include: determining the difference between the second pressure value and the first pressure value; and determining that the detection result of the first pressure sensor S1 is unreliable when the difference is greater than a preset value.

[0078] The uterine cavity pressure monitoring device can further include a sound generator. The sound generator is connected to the controller MCU. For example, the sound generator can be a buzzer B, and the buzzer B can be connected to the GPIO (General-purpose input / output) interface of the controller MCU. The sound generator is configured to receive a sound control signal sent by the controller MCU so as to generate a sound according to the sound control signal. Wherein, the sound control signal indicates that the detection result of the first pressure sensor S1 is unreliable.

[0079] The uterine cavity pressure monitoring device can further include a light emitter. The light emitter is connected to the controller MCU. For example, the light emitter can be an LED lamp L1, and the LED lamp L1 can be connected to the GPIO interface of the controller MCU. The light emitter is configured to receive a light control signal sent by the controller MCU so as to emit light according to the light control signal. Wherein, the light control signal indicates that the detection result of the first pressure sensor S1 is unreliable.

[0080] The uterine cavity pressure monitoring device can further include a display screen. The display screen is connected to the controller MCU. For example, the display screen can be a touch liquid crystal screen L2, and the touch liquid crystal screen L2 can be connected to the UART (Universal Asynchronous Receiver / Transmitter) interface of the controller MCU. The display screen is configured to receive display information sent by the controller MCU so as to display according to the display information. Wherein, the display information includes the first pressure value.

[0081] Continue to refer to Figure 5, the perfusion device may further include a first power unit and a first liquid storage unit. The first power unit is connected to the infusion pipeline, and the first power unit may be configured to receive a first driving signal sent by the controller of the intrauterine pressure monitoring device, so as to rotate forward according to the first driving signal and convey the uterine cavity expansion fluid to the uterine cavity through the infusion pipeline. The first liquid storage unit may be connected to the first power unit, and the first liquid storage unit may be configured to store the uterine cavity expansion fluid.

[0082] The first power unit may include a driving motor and a perfusion pump head P1. The driving motor may adopt a stepping motor M1, and the stepping motor M1 may be an integrated stepping motor, that is, a stepping motor integrated machine, which is a motor system integrating a motor driver and a controller. The stepping motor M1 is connected to the controller MCU, for example, it may be connected to the UART interface of the controller MCU. The first liquid storage unit SB may be a liquid storage bag. The perfusion pump head P1 is connected to the infusion pipeline.

[0083] After receiving the first pressure value fed back by the first pressure sensor S1, the controller MCU may determine whether the first pressure value is within a preset pressure value range. If the first pressure value is lower than the lower limit value in the preset pressure value range, it indicates that the pressure in the uterine cavity U is relatively low. Therefore, the controller MCU generates a first driving signal and sends the first driving signal to the stepping motor M1, so that the perfusion pump head P1 starts to convey the uterine cavity expansion fluid in the first liquid storage unit SB to the uterine cavity U through the infusion pipeline, thereby realizing uterine cavity expansion.

[0084] In the case where a pressure chamber PV is provided in the infusion pipeline, the pressure chamber PV can be used to control the flow rate and pressure of the liquid. In addition, if no pressure chamber is provided in the infusion pipeline, structures such as rollers and impellers can also be used to push the liquid to flow.

[0085] A first temperature sensor N1 may also be provided on the stepping motor M1 to monitor the temperature of the stepping motor M1. The first temperature sensor N1 is connected to the controller MCU, for example, it may be connected to the ADC (Analog to Digital Converter) interface of the controller MCU. The first temperature sensor N1 sends the collected temperature information to the controller MCU, and the MCU can display the temperature value of the stepping motor M1 on the touch liquid crystal screen L2. The first temperature sensor N1 may adopt an NTC (Negative Temperature Coefficient) temperature sensor, and the resistance of the NTC temperature sensor gradually decreases as the temperature rises.

[0086] Exemplarily, the first power unit may also be configured to receive a second driving signal sent by the controller, so as to rotate in reverse according to the second driving signal and aspirate the liquid in the uterine cavity through the infusion pipeline.

[0087] In addition to being able to increase the pressure in uterine cavity U to achieve uterine cavity distension, the first power unit can also be used to reduce the pressure in uterine cavity U to avoid excessive pressure. If the first pressure value received by the controller MCU is higher than the upper limit value in the preset pressure value range, it indicates that the pressure in uterine cavity U is relatively high. Therefore, the controller MCU generates a second drive signal and sends the second drive signal to the stepper motor M1, so that the perfusion pump head P1 starts to aspirate liquid from uterine cavity U, and the liquid will flow back into the delivery channel, thereby achieving pressure reduction. The controller MCU can be set with a reverse time threshold, and the reverse time threshold can be set to 3 seconds. When the reverse duration reaches the reverse time threshold, the reverse automatically stops.

[0088] If the first pressure value received by the controller MCU is within the preset pressure value range, the controller MCU controls the stepper motor M1 to stop rotating. Thus, the perfusion device can keep the uterine cavity pressure within the set range.

[0089] It can be understood that the perfusion device may further include a first microswitch. The first microswitch is the pump tube ready switch SW1 of the perfusion pump head P1. The pump tube ready switch SW1 can be connected to the controller MCU, for example, it can be connected to the GPIO interface of the controller MCU. When the pump tube of the perfusion pump head P1 is ready and meets the normal operation conditions, the pump tube ready switch SW1 automatically turns on, so that the perfusion pump head P1 can be enabled to start and operate normally.

[0090] The perfusion device may further include a second microswitch. The second microswitch is the pressure chamber ready switch SW2 of the pressure chamber PV. The pressure chamber ready switch SW2 is connected to the controller MCU, for example, it can be connected to the GPIO interface of the controller MCU. When the pressure chamber PV is ready and meets the normal operation conditions, the pressure chamber ready switch SW2 automatically turns on, so that the pressure chamber PV can be enabled to start and operate normally.

[0091] Continue to refer to Figure 5 , the hysteroscope device can be provided with a first channel that can communicate with the uterine cavity. The surgical system 1000 may further include a shaver, which is configured to be able to enter the uterine cavity through the channel space of the first channel when extending into the uterine cavity at one end of the first channel, so as to operate on human tissues.

[0092] The first channel is the instrument channel of the hysteroscope device and can insert surgical instruments. When the hysteroscope sheath is inserted into a female's vagina and passes through the cervical orifice into the uterine cavity U, the first channel provides the condition for surgical instruments to enter the uterine cavity U. At this time, the shaver can be inserted into the interior of the hysteroscope device through the first channel, and thus be inserted into the uterine cavity U through the first channel to excise intrauterine tissues such as submucous myomas and endometrial polyps. The shaver and the instrument channel can be connected through an adapter or a connector.

[0093] Exemplarily, the shaver can include a shaving cutter head and a second power unit. The shaving cutter head can be configured to rotate driven by a driving force. The second power unit is connected to the shaving cutter head and is configured to receive a third driving signal sent by the controller of the intrauterine pressure monitoring device, so as to provide a driving force to the shaving cutter head according to the third driving signal.

[0094] The shaving cutter head T can be driven by a driving force to rotate, so as to realize the excision of intrauterine tissues such as submucous myomas and endometrial polyps. The shaver can also include a control handle H, and the control handle H can be detachably connected to the shaving cutter head T. The second power unit can be arranged in the control handle H.

[0095] The second power unit can be connected to the controller MCU. The controller MCU can generate a third driving signal according to the operator's instruction and send it to the second power unit. The second power unit determines the target rotation speed through the third driving signal, and then executes according to the determined rotation speed. The second power unit can include a driving motor. The driving motor can adopt a brushless DC motor M2, that is, a BLDC (Brushless Direct Current Motor) motor. The brushless DC motor M2 can be connected to the controller MCU and receive the third driving signal sent by the controller MCU, so as to operate at the rotation speed indicated by the third driving signal.

[0096] The second power unit can also include a Hall sensor S3. The Hall sensor S3 is installed on the brushless DC motor M2 and can detect the rotation speed of the brushless DC motor M2 by virtue of the characteristic of converting a changing magnetic field into a change in output voltage. The Hall sensor S3 can be connected to the controller MCU and send the detected rotation speed to the controller MCU, so that the controller MCU generates a corresponding control signal, thereby realizing the closed-loop control of the brushless DC motor M2.

[0097] The basis for the controller MCU to generate the third driving signal can be from the hand controller configured for the shaver or from the touch liquid crystal screen L2. For example, the controller MCU generates the third driving signal by obtaining the state of the rotation speed adjustment knob on the hand controller, or obtains the rotation speed value input by the user on the touch liquid crystal screen L2 to generate the third driving signal.

[0098] The hysteroscope device (a device formed by the intrauterine pressure monitoring device and the hysteroscope device together) can be provided with a panel, and a plurality of connectors can be provided on the panel. These connectors are connected to the controller MCU as external input interfaces of the controller MCU. For example, the hysteroscope device can be provided with a front panel, and a first circular connector CN1 can be provided on the front panel. The brushless DC motor M2 and the Hall sensor S3 can be connected to the controller MCU through the first circular connector CN1. The first circular connector CN1 can be connected to the UART interface and the ADC interface of the controller MCU.

[0099] A second temperature sensor N2 can also be provided on the brushless DC motor M2 to monitor the temperature of the brushless DC motor M2. The second temperature sensor N2 is connected to the controller MCU, for example, it can be connected to the ADC interface of the controller MCU. The second temperature sensor N2 sends the collected temperature information to the controller MCU, and the MCU can display the temperature value of the brushless DC motor M2 on the touch liquid crystal screen L2. The second temperature sensor N2 can adopt an NTC (Negative Temperature Coefficient) temperature sensor, and the resistance of the NTC temperature sensor gradually decreases as the temperature rises.

[0100] Continue to refer to Figure 5 , the hysteroscope device can be provided with a second channel, and the second channel can communicate with the uterine cavity. The surgical system 1000 can also include a liquid suction device. The liquid suction device is configured to be able to enter the uterine cavity through the channel space of the second channel when one end of the second channel extends into the uterine cavity, so as to suck out the waste liquid in the uterine cavity.

[0101] The second channel is the instrument channel of the hysteroscope device and can insert surgical instruments. When the hysteroscope sheath is inserted into the vagina of a female and passes through the cervical orifice into the uterine cavity U, the second channel provides the condition for the surgical instrument to enter the uterine cavity U. At this time, the liquid suction device can be inserted into the interior of the hysteroscope device through the second channel, and thus can be inserted into the uterine cavity U through the second channel and communicate with the uterine cavity U. Starting the liquid suction device can suck out the waste liquid in the uterine cavity U and the human tissue cut off by the shaver.

[0102] The liquid suction device can include a second liquid storage unit and a third power unit. The second liquid storage unit is configured to receive the waste liquid sucked out from the uterine cavity. The third power unit is connected to the second liquid storage unit, and the third power unit is configured to receive the fourth driving signal sent by the controller of the intrauterine pressure monitoring device, so as to suck out the waste liquid from the uterine cavity according to the fourth driving signal.

[0103] The second liquid storage unit can be the liquid storage tank CT. The liquid storage tank CT is provided with an inlet, and a suction tube is connected to the inlet. The suction tube can extend into the second channel and through the second channel into the uterine cavity U to suck out the waste liquid from the uterine cavity U. The liquid storage tank CT can be connected to the liquid metering module LM. The liquid metering module LM can include a third pressure sensor installed in the liquid storage tank CT, and the third pressure sensor is used to detect the liquid storage volume of the liquid storage tank CT. The liquid metering module LM analyzes the detection result of the third pressure sensor to obtain the current liquid storage volume. The liquid metering module LM can be connected to the controller MCU and send the obtained current liquid storage volume information to the controller MCU, so that the MCU can prompt and alarm the user when the liquid storage volume is high.

[0104] The hysteroscope device can be provided with a rear panel, and a second circular connector CN2 can be arranged on the rear panel. The liquid metering module LM can be connected to the controller MCU through the second circular connector CN2. A digital isolator module IS2 can be connected between the second circular connector CN2 and the controller MCU. For example, the digital isolator module IS2 can be connected to the GPIO interface of the controller MCU. The digital isolator module IS2 is used to isolate the digital signals between different circuits, thereby protecting the circuits from being affected by electrical interference.

[0105] The third power unit can be connected to the controller MCU. The controller MCU can generate a fourth drive signal according to the operator's instruction and send it to the third power unit. The third power unit determines the start-stop action through the fourth drive signal and then executes according to the determined action.

[0106] The third power unit can include a negative pressure suction pump P2. The negative pressure suction pump P2 can be connected to the controller MCU. For example, it can be connected to the TIM (Timer) interface of the controller MCU and receive the fourth drive signal sent by the controller MCU, so as to start or stop according to the start-stop action indicated by the fourth drive signal. The basis for the controller MCU to generate the fourth drive signal can be from the touch liquid crystal screen L2. For example, the controller MCU generates the fourth drive signal by obtaining the control instruction input by the user on the touch liquid crystal screen L2.

[0107] The liquid storage tank CT is also provided with an outlet, and the negative pressure suction pump P2 is also connected to the outlet. The front panel of the hysteroscope device can be provided with a suction port BP for connection. The negative pressure suction pump P2 can be connected to the outlet of the liquid storage tank CT through the suction port BP. An exhaust port BV communicating with the atmosphere can be arranged on the rear panel of the hysteroscope device. The exhaust port BV is used to discharge the air in the liquid storage tank CT to facilitate accommodating the waste liquid sucked out from the uterine cavity.

[0108] The surgical system 1000 may further include a foot switch. The foot switch is connected to the controller MCU. The foot switch may be provided with a front pedal FB, and the angle of the front pedal FB can be adjusted by stepping on the front pedal FB, thereby changing its own state. The controller MCU obtains the state of the front pedal FB in real time and adjusts the operating states of other devices or equipment according to the state of the front pedal FB, such as controlling the start / stop and rotation speed of the shaver, or controlling the start / stop and rotation speed of the liquid suction device, and so on.

[0109] A third circular connector CN3 may be provided on the front panel of the hysteroscope device, and the front pedal FB may be connected to the third circular connector CN3. An opto-isolator module IS1 may be connected between the third circular connector CN3 and the controller MCU. For example, the opto-isolator module IS1 may be connected to the UART interface of the controller MCU. The opto-isolator module IS1 is used to isolate the power supply and signals, thereby preventing interference and fluctuations of current and voltage.

[0110] A serial interface CN4 may be provided on the rear panel of the hysteroscope device, and the serial interface CN4 may be an RS232-DB9 interface. The serial interface CN4 is connected to the controller MCU, for example, connected to the UART interface of the controller MCU.

[0111] The surgical system 1000 may further include a power supply device. The power supply device may include a switching power supply, which converts alternating current into an appropriate voltage through the switching power supply. For example, the power supply device includes a first switching power supply and a second switching power supply. Among them, the first switching power supply V1 is connected to the power supply PS, and the power supply PS may be an alternating current of 80-264VAC. The first switching power supply can convert the alternating current into 24V direct current. The second switching power supply V2 is connected to the first switching power supply V1 and is used to convert the 24V direct current output by the first switching power supply V1 into 5V / 3.3V direct current. The second switching power supply V2 is also connected to the controller MCU, for example, connected to the VDD terminal of the controller MCU, and is used to input the output 5V / 3.3V direct current into the controller MCU to supply power to the MCU. It can be understood that a fuse F0 may be provided between the power supply PS and the first switching power supply V1.

[0112] The surgical system 1000 may further include a heat dissipation device. The heat dissipation device is used to dissipate heat from the instruments and apparatuses in the surgical system 1000, such as dissipating heat from the perfusion device, the shaver, the liquid suction device, and the power supply device. The heat dissipation device may include a first heat dissipation fan F1 and a second heat dissipation fan F2. These two heat dissipation fans can be respectively installed near different heat-generating devices to dissipate heat from these heat-generating devices. Both the first heat dissipation fan F1 and the second heat dissipation fan F2 are connected to the controller MCU, for example, connected to the controller MCU through the GPIO interface.

[0113] In the description of this specification, the descriptions referring to terms such as "one embodiment / way", "some embodiments / ways", "specific example", or "some examples", etc., mean that the specific features, structures, materials, or characteristics described in connection with the embodiment / way or example are included in at least one embodiment / way or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment / way or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments / ways or examples. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments / ways or examples described in this specification and the features of different embodiments / ways or examples.

[0114] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0115] Those skilled in the art should understand that the above embodiments are only for clearly explaining the present invention and are not intended to limit the scope of the present invention. For those skilled in the art, other changes or modifications can be made on the basis of the above disclosure, and these changes or modifications are still within the scope of the present invention.

Claims

1. An intrauterine pressure monitoring device, which is applied to a surgical system, is characterized in that The surgical system includes a hysteroscope device and an irrigation device. The hysteroscope device includes a hysteroscope sheath. The intrauterine pressure monitoring device includes: A first pressure sensor installed at the insertion end of the hysteroscope sheath, and the first pressure sensor is configured to detect a first pressure value of the uterine cavity inside the uterine cavity; A second pressure sensor installed in the infusion pipeline of the irrigation device, and the second pressure sensor is configured to detect the pressure value of the infusion pipeline, and the infusion pipeline can communicate with the uterine cavity; and A controller respectively connected to the first pressure sensor and the second pressure sensor, and the controller is configured to obtain the first pressure value and the pressure value of the infusion pipeline, so as to determine a second pressure value of the uterine cavity through the pressure value of the infusion pipeline, and determine whether the detection result of the first pressure sensor is untrustworthy based on the first pressure value with the second pressure value as a reference value; A pressure chamber is provided on the infusion pipeline, and the second pressure sensor is installed in the pressure chamber; The pressure chamber is in communication with the uterine cavity, and the second pressure sensor monitors the pressure value in the pressure chamber in real time and uses the obtained pressure value as the pressure value of the infusion pipeline; The manner in which the controller determines the second pressure value of the uterine cavity includes: Obtaining the height difference between a preset position of the infusion pipeline and the position where the uterine cavity is located, and the preset position is determined according to the installation position of the second pressure sensor in the infusion pipeline; Obtaining the wall blockage coefficient of the infusion pipeline; and Determining the second pressure value of the uterine cavity based on the height difference and the wall blockage coefficient.

2. The intrauterine pressure monitoring device according to claim 1, wherein The types of the first pressure sensor and the second pressure sensor are different.

3. The intrauterine pressure monitoring device according to claim 2, wherein The first pressure sensor is an optical pressure sensor, and the second pressure sensor is a thin film pressure sensor.

4. The intrauterine pressure monitoring device according to any one of claims 1-3, characterized in that, The number of the first pressure sensors installed at the insertion end of the hysteroscope sheath is 1, and the number of the second pressure sensors installed in the infusion pipeline is 1.

5. The intrauterine pressure monitoring device according to claim 1, wherein When the second pressure sensor is installed in the pressure chamber of the infusion pipeline, the preset position is the position of the pressure chamber, and the position where the uterine cavity is located is determined by the position of the operating table.

6. The intrauterine pressure monitoring device according to claim 1, characterized in that The manner in which the controller determines whether the detection result of the first pressure sensor is untrustworthy includes: Determining the difference between the second pressure value and the first pressure value; Determining that the detection result of the first pressure sensor is untrustworthy when the difference is greater than a preset value.

7. The intrauterine pressure monitoring device according to claim 1 or 6, characterized in that The intrauterine pressure monitoring device further includes: A sound generator and / or a light emitter connected to the controller, the sound generator is configured to receive a sound control signal sent by the controller so as to make a sound according to the sound control signal, and the light emitter is configured to receive a light control signal sent by the controller so as to emit light according to the light control signal, wherein the sound control signal and the light control signal indicate that the detection result of the first pressure sensor is untrustworthy.

8. A surgical system, characterized in that, The system includes: A hysteroscope device, and the hysteroscope device includes a hysteroscope sheath; An irrigation device, and the irrigation device includes an infusion pipeline; and The intrauterine pressure monitoring device according to any one of claims 1-7.

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