A transvaginal intra-abdominal pressure measuring device and a method of using the same

Abstract

The present invention relates to a transvaginal intra-abdominal pressure measuring device and a method for using the same. The transvaginal intra-abdominal pressure measuring device comprises an MCU (microcontroller unit), a Bluetooth transmitting module and a button battery module. The pressure sensor, the Bluetooth transmitting module and the button battery module are all fixed on the MCU. The MCU is respectively connected to the pressure sensor, the Bluetooth transmitting module and the button battery module. The pressure sensor is located in the vagina and is used to collect intra-abdominal pressure signals and feed the collected pressure signals back to the MCU. The MCU is used for pressure signal collection control and data processing, and sends the processed pressure data to a terminal through the Bluetooth transmitting module. The device can be used to indirectly measure the closed abdominal cavity pressure. The device is a non-invasive pressure measuring device with a compact structure, convenient use and higher comfort, filling the gap in the research and development of devices, instruments or equipment related to transvaginal intra-abdominal pressure measurement in China.

Description

Technical Field

[0001] The invention relates to a transvaginal intra-abdominal pressure measuring device and a use method thereof, belonging to the field of medical devices. Background Art

[0002] There are many cases of monitoring physiological pressure in clinical practice, such as intracranial pressure measurement, intravascular pressure, gastrointestinal pressure, urethra, bladder pressure, rectal pressure measurement, etc. Physiological pressure measurement systems usually use electromechanical transducers to convert pressure into electrical signals that can be processed, displayed and stored. Microelectromechanical system (MEMS)-based physiological pressure monitoring sensors are used in combination with wireless telemetry technology to transmit pressure data collected in the body to a receiver located at an external location (Tan, 2009). It generally includes an implanted sensor and an external receiver. Fully implantable pressure sensors are only used to monitor pressure in fluid-filled environments, such as vascular applications, and are not suitable for measuring body cavities such as the vagina or rectum.

[0003] The abdominal cavity is a perfect closed system. For normal people, pelvic and abdominal dynamics seem to be relatively abstract, because we cannot directly conduct continuous, dynamic, and non-invasive intra-abdominal pressure monitoring. However, we can indirectly measure intra-abdominal pressure, such as through the bladder, rectum, and even the vagina, to indirectly reflect the changes in intra-abdominal pressure. Currently, the methods that can be used to indirectly measure intra-abdominal pressure are:

[0004] Sensor tip catheter: Its sensor is located at the tip of the catheter, which can be placed directly at the physiological position that needs to be monitored. Its sensing is sensitive and accurate (Stoker, 2004), but it requires a fluid-filled environment, and the position and direction of the sensor tip catheter can greatly change the pressure reading (Holt, 1990; Perucchini, 2002). Therefore, it is generally used in the bladder, and the amount of fluid in the bladder also needs to be strictly controlled. It can be used for urodynamic examinations. However, because it is invasive and generally wired, it is not suitable for IAP monitoring during daily activities.

[0005] Fluid-coupled sensors: Fluid-coupled sensors use an incompressible fluid, such as saline, to transmit pressure from the physiological location of measurement to a sensor located at an external location. It can be used to monitor non-fluid-filled environments, such as the vagina or rectum. The fluid-filled tube that transmits the pressure signal can have a significant impact on the measurement accuracy due to the distance between the sensor and the pressure source (Hunziker 1987; Hundley, 2006). In addition, the damping and resonance effects of these systems depend on component characteristics such as the length, diameter, and stiffness of the tubing connecting the sensor to the measurement site (Stoker 2004). Other factors such as air bubbles in the tubing can lead to erroneous pressure measurements (Malbrain 2009). It can be applied to urodynamics. However, it is generally more suitable for measuring IAP under static conditions due to its poor dynamic response to rapid changes in pressure (Johnson et al. 2009). Summary of the invention

[0006] In view of the above problems, the purpose of the present invention is to provide a transvaginal intra-abdominal pressure measuring device and a method of using the same, which can be used to indirectly measure the closed abdominal cavity pressure. It is a non-invasive pressure measuring device with a compact structure, convenient use and higher comfort. It can indirectly measure the intra-abdominal pressure through the vagina. The intra-abdominal pressure will change at any time when people are engaged in daily life and sports activities. The device is placed in the vagina and can monitor the dynamic changes of the intra-abdominal pressure in real time.

[0007] To achieve the above object, the present invention adopts the following technical solutions:

[0008] A first aspect of the present invention provides a transvaginal intra-abdominal pressure measuring device, comprising an MCU, a pressure sensor, a Bluetooth transmitter module and a button battery module, wherein the pressure sensor, the Bluetooth transmitter module and the button battery module are all fixed on the MCU, and the MCU is respectively connected to the pressure sensor, the Bluetooth transmitter module and the button battery module, and the pressure sensor is located in the vagina, and is used to collect intra-abdominal pressure signals and feed the collected pressure signals back to the MCU, and the MCU is used for pressure signal collection control and data processing, and sends the processed pressure data to the terminal via the Bluetooth sending module.

[0009] Furthermore, the MCU and the Bluetooth transmitting module are integrated into a transmission control module.

[0010] Furthermore, the pressure sensor is a BMP280 sensor.

[0011] Furthermore, the button battery module includes a battery holder and a battery mounted on the battery holder, the battery holder is fixedly mounted on the MCU, and the length×width×height dimensions of the transvaginal intra-abdominal pressure measuring device are 22 mm×18 mm×8 mm.

[0012] Furthermore, the Bluetooth transmitting module sends the pressure signal to a terminal for display, and the terminal includes a Bluetooth receiving module. The Bluetooth transmitting module and the Bluetooth receiving module are connected by a Bluetooth signal.

[0013] Furthermore, the MCU, pressure sensor, Bluetooth transmitter module and button battery module are all fixed in the jacket, and the jacket is filled with gas. After being inflated, the jacket forms a handle-like structure with a ring-shaped cross-section and a diameter that gradually decreases from top to bottom.

[0014] Furthermore, an opening is formed at the top of the jacket, the opening is opposite to the button battery module, and the opening is used to replace the battery in the button battery module.

[0015] Furthermore, the outer shell is divided into two cavities, and a set of the MCU, pressure sensor, Bluetooth transmitter module and button battery module are respectively disposed in the two cavities. An opening is disposed at the top of each cavity, and the opening is opposite to the button battery module located in the corresponding cavity. The opening is used to replace the battery in the button battery module.

[0016] Furthermore, an annular fixing bracket is provided on the outer side of the outer sleeve.

[0017] Another aspect of the present invention further provides a method for using the transvaginal intra-abdominal pressure measuring device, based on the transvaginal intra-abdominal pressure measuring device, characterized in that it comprises the steps of:

[0018] Using a pushing device to push the transvaginal intra-abdominal pressure measuring device into the vagina;

[0019] Ask the patient to cough or defecate, and record the pressure change curve at the same time.

[0020] The present invention adopts the above technical solution, which has the following advantages:

[0021] The transvaginal intra-abdominal pressure measuring device comprises an MCU, a pressure sensor, a Bluetooth transmitter module and a button battery module, wherein the MCU is connected to the pressure sensor, the Bluetooth transmitter module and the button battery module respectively. The device can be used to indirectly measure the pressure of the closed abdominal cavity, is a non-invasive pressure measuring device, has a compact structure, is easy to use and is more comfortable, and fills the gap in the development of devices, instruments or equipment related to transvaginal intra-abdominal pressure measurement in China.

[0022] It has fast time response, high measurement accuracy, and can accurately measure changes in vaginal pressure.

[0023] The existing urodynamic examination is the gold standard for monitoring intra-abdominal pressure. It can measure the dynamic changes in intra-abdominal pressure. For example, during the examination, asking the patient to cough or perform a bowel movement (vasaval) can monitor the changes in intra-abdominal pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] By reading the detailed description of the preferred embodiment below, various other advantages and benefits will become clear to those of ordinary skill in the art. The accompanying drawings are only used to illustrate the purpose of the preferred embodiment and are not considered to be limitations of the present invention. In the entire drawings, the same reference numerals are used to represent the same components.

[0025] In the attached picture:

[0026] Figure 1 It is a structural block diagram of an embodiment of a transvaginal intra-abdominal pressure measuring device provided by the present invention;

[0027] Figure 2 is a circuit connection diagram between the MCU and the pressure sensor;

[0028] Figure 3 It is a schematic diagram of the structure of a transvaginal intra-abdominal pressure measuring device;

[0029] Figure 4 It is a curve diagram of pressure change in vitro test of the transvaginal intra-abdominal pressure measuring device;

[0030] Figure 5 It is a curve diagram of the pressure change in the body tested by the transvaginal intra-abdominal pressure measuring device;

[0031] Figure 6 is a schematic structural diagram of a first embodiment of a transvaginal intra-abdominal pressure measuring device including a jacket;

[0032] Figure 7 yes Figure 6 A cross-sectional view of

[0033] Figure 8 yes Figure 6 A top view of

[0034] Fig. 9 A schematic structural diagram of a second embodiment of a transvaginal intra-abdominal pressure measuring device including a jacket;

[0035] Fig.10 yes Fig. 9 A top view of

[0036] Fig.11 It is a schematic diagram of the structure of a transvaginal intra-abdominal pressure measuring device including a jacket surrounded by a fixed bracket; DETAILED DESCRIPTION

[0037] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0038] The embodiment of the present invention provides a transvaginal intra-abdominal pressure measuring device, which includes an MCU, a pressure sensor, a Bluetooth transmitter module and a button battery module, wherein the MCU is connected to the pressure sensor, the Bluetooth transmitter module and the button battery module respectively. The device can be used to indirectly measure the pressure of a closed abdominal cavity, is a non-invasive pressure measuring device, has a compact structure, is easy to use, and is more comfortable, thus filling the gap in the development of devices, instruments or equipment related to transvaginal intra-abdominal pressure measurement in China.

[0039] like Figure 1 and Figure 3 As shown, an embodiment of the present invention provides a transvaginal intra-abdominal pressure measuring device, including an MCU1, a pressure sensor 2, a Bluetooth transmitter module 3 and a button battery module 4, wherein the pressure sensor 2, the Bluetooth transmitter module 3 and the button battery module 4 are all fixed on the MCU1, and the MCU1 is respectively connected to the pressure sensor 2, the Bluetooth transmitter module 3 and the button battery module 4, the pressure sensor 2 is located in the vagina, and is used to collect intra-abdominal pressure signals and feed the collected pressure signals back to the MCU1, the MCU1 is used for pressure signal collection control and data processing, and the processed pressure data is sent to the terminal through the Bluetooth sending module 3.

[0040] The transvaginal intra-abdominal pressure measuring device can be used to indirectly measure the closed abdominal cavity pressure. It is a non-invasive pressure measuring device with a compact structure, convenient use, and higher comfort. It fills the gap in the domestic research and development of devices, instruments or equipment related to transvaginal intra-abdominal pressure measurement.

[0041] Preferably, the MCU1 and the Bluetooth transmitter module 3 are integrated into a transmission control module. The transmission control module can be purchased directly. It needs to have MCU function, Bluetooth transmission function and UART (Universal Asynchronous Receiver and Transmitter) transmission function, and should have a small and exquisite appearance as much as possible to achieve the miniaturization of the device. For example, the XIAO BLE SENSE module of SEEED Studio can be used.

[0042] Preferably, the pressure sensor 2 is a BMP280 sensor. The BMP280 is purchased and is a digital air pressure sensor with high precision and low power consumption, with a relative accuracy of ±0.12 hPa (equivalent to ±1 meter), and can measure pressure and temperature simultaneously.

[0043] The button battery module 4 includes a battery holder and a battery mounted on the battery holder, and the battery holder is fixedly mounted on the MCU 1. Preferably, the button battery module 4 is of CR1220 type.

[0044] like Figure 2 As shown in Table 1, the MCU1 is connected to the pressure sensor 2 through four wires. Specifically, as shown in Table 1, the 3V3 terminal of the MCU is electrically connected to the VCC terminal of the pressure sensor 2, the GND terminal of the MCU is electrically connected to the GND terminal of the pressure sensor 2, the SDA terminal of the MCU1 is electrically connected to the SDI terminal of the pressure sensor, and the SCL terminal of the MCU1 is electrically connected to the SCK of the pressure sensor. After the connection, the MCU1 can realize the acquisition and control of the pressure signal of the pressure sensor 2 through the I2C protocol, and transmit it to the Bluetooth module through the UART protocol after data processing, and then send it to the terminal.

[0045] Programming on the software development platform Arduino IDE realizes the collection and transmission of pressure data and temperature data. By modifying the program code of the development routine (mainly the sampling mode and parameter setting of the pressure sensor) and downloading it to the MCU, the pressure sensor can be controlled to collect pressure and temperature data. The control platform parameters are as follows:

[0046] The software development platform for the transvaginal intra-abdominal pressure measurement device is Arduino IDE 2.0.3;

[0047] The pressure sensor and MCU use I2C protocol for transmission;

[0048] UART protocol is used for transmission between MCU and Bluetooth transmitter module;

[0049] MCU software is obtained by modifying the program code in the development routine;

[0050] Sampling mode and parameter settings of pressure sensor 2: Sampling mode: Normal (normal mode); Pressure oversampling multiple: SAMPLING_X16 (16 times); Filter: Setting: FILTER_OFF (no filtering); Idle time: STANDBY_MS_1 (1ms);

[0051] The final pressure test data is sent wirelessly through the Bluetooth transmitter module, and the receiving end (such as the Bluetooth receiver module in the mobile phone) receives the data and processes it to obtain the pressure curve.

[0052] Table 1 shows the corresponding relationship between the transmission control module (taking XIAO BLE SENSE as an example) and the pressure sensor connection

[0053]

[0054] The Bluetooth transmitting module 3 sends the signal to the terminal for display. The terminal includes a Bluetooth receiving module. The Bluetooth transmitting module and the Bluetooth receiving module 3 are connected by a Bluetooth signal.

[0055] The terminal is preferably a mobile phone terminal.

[0056] The button battery module 4 and the pressure sensor 2 are both fixed on the MCU1 and electrically connected to the MCU1. The length×width×height dimensions of the transvaginal intra-abdominal pressure measuring device are 22mm×18mm×8mm. The transvaginal intra-abdominal pressure measuring device provided by the present invention has a compact structure, high measurement accuracy, and high comfort.

[0057] Experimental results:

[0058] The transvaginal intra-abdominal pressure measuring device provided in Example 1 has been tested both in vitro and in the vagina, and can monitor pressure changes more conveniently, dynamically, and non-invasively. In vitro testing is to place the pressure measuring device module in an inflated, sealed fresh-keeping bag, and suddenly tap the surface with your hand. The test data results are as follows: Figure 4 As shown;

[0059] The test device is placed in a rubber glove as follows Figure 5 As shown, the inflatable glove is placed in the posterior fornix of the vagina, and the patient is asked to cough and perform Vasaval maneuvers. The vaginal pressure test curves are as follows: Z1 and Z2 are the pressure change curves caused by the subject's coughing action; Z3 is the pressure change caused by the subject's Vasaval maneuver (the action of straining to defecate), but at the same time, due to the increased abdominal pressure, the device is slowly squeezed out of the vagina, and the whole process is in line with the actual pressure situation; it can be seen that the device is sensitive to response, the pressure resolution is less than 1Pa, the measurement accuracy is high, the measurement results are in line with expectations, and it can accurately reflect the trend of vaginal pressure changes.

[0060] like Figures 6 to 11 As shown, as another embodiment, the transvaginal intra-abdominal pressure measuring device also includes a jacket, and the MCU1, the pressure sensor 2, the Bluetooth transmitter module 3 and the button battery module 4 are fixed in the jacket 10, and the jacket 10 is filled with gas.

[0061] The outer cover 10 is preferably a silicone outer cover. After being inflated, the outer cover 10 forms a handle-shaped structure with a circular cross section and a gradually decreasing diameter from top to bottom, which can improve comfort when inserted into the vagina.

[0062] The top of the jacket 10 is also formed with an opening 20, and a sealing cover (not shown in the figure) is provided at the opening 20, and the sealing cover is also preferably made of a silicone jacket, and the opening 20 is opposite to the button battery module, and the opening 20 is used to replace the battery in the button battery module. When the battery needs to be replaced, the sealing cover 20 is opened, the battery is taken out and replaced, and after the replacement is completed, the sealing cover is covered and sealed, and the jacket 1 is inflated, and then inserted into the vagina for testing.

[0063] As an embodiment of the present invention, Figures 6 to 8 As shown, the transvaginal intra-abdominal pressure measuring device is a single-cavity pressure measuring device, and the outer shell 10 includes only one cavity, and the length and shape of the outer shell 10 are adapted to the vagina.

[0064] As a second implementation method, Fig. 9 and Fig.10 As shown, the transvaginal intra-abdominal pressure measuring device is a dual-chamber pressure measuring device, and two separated cavities are formed in the outer shell 10, and a transvaginal intra-abdominal pressure measuring device 40 is respectively arranged in the two cavities. An opening 20 is arranged at the top of each cavity, and the opening 20 is opposite to the button battery module located in the corresponding cavity, and the opening is used to replace the battery in the button battery module. The two cavities will be marked with front and back, and the direction will be selected according to the marked position for placement in the vagina, and the changes in the intra-abdominal pressure corresponding to the anterior pelvic cavity and the posterior pelvic cavity will be measured respectively.

[0065] like Fig.11 As shown, further, the outer side of the outer shell is also provided with an annular fixing bracket 50. The fixing bracket is similar to the silicone of the pessary, which is closed before being placed in the vagina and automatically opens after being placed in the vagina, just like an umbrella, which can be closed and opened. As the device is placed, the opening process is automatic, and its purpose is to allow the device to stay in the vagina more firmly and not fall off.

[0066] The present invention also provides a method for using the transvaginal intra-abdominal pressure measuring device, based on the transvaginal intra-abdominal pressure measuring device, comprising the steps of:

[0067] Using a pushing device to push the transvaginal intra-abdominal pressure measuring device into the vagina;

[0068] Ask the patient to cough or defecate, and record the pressure change curve at the same time.

[0069] The propelling device and propelling method involved are similar to vaginal tampons and are pushed into the vagina. When the test is completed, the pressure measuring device is pulled out of the vagina through the pull rope at the bottom.

[0070] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A transvaginal intra-abdominal pressure measuring device, characterized in that: The device is highly integrated, including an MCU, a pressure sensor, a Bluetooth transmitter module and a button battery module, wherein the pressure sensor, the Bluetooth transmitter module and the button battery module are all fixed on the MCU, and the MCU is respectively connected to the pressure sensor, the Bluetooth transmitter module and the button battery module, wherein the pressure sensor is located in the vagina, and is used to collect intra-abdominal pressure signals and feed the collected pressure signals back to the MCU, wherein the MCU is used for pressure signal collection control and data processing, and sends the processed pressure data to the terminal through the Bluetooth transmitter module, wherein the MCU and the pressure sensor are connected through four wires, wherein the 3V3 terminal of the MCU is electrically connected to the VCC terminal of the pressure sensor, and the G terminal of the MCU is electrically connected to the VCC terminal of the pressure sensor. The ND terminal is electrically connected to the GND terminal of the pressure sensor, the SDA terminal of the MCU is electrically connected to the SDI terminal of the pressure sensor, and the SCL terminal of the MCU is electrically connected to the SCK of the pressure sensor. After the connection, the MCU can realize the acquisition and control of the pressure signal of the pressure sensor through the I2C protocol, and transmit it to the Bluetooth module through the UART protocol after data processing, and then send it to the terminal. The sampling mode and parameter settings of the pressure sensor include: the sampling mode is set to normal mode; the pressure oversampling multiple is set to 16 times; the filtering is set to no filtering; the idle time is set to 1ms; the final pressure test data is sent wirelessly through the Bluetooth transmitter module, and the receiving end receives the data and processes it to obtain the pressure curve; It also includes a jacket, in which the MCU, the pressure sensor, the Bluetooth transmitter module and the button battery module are all fixed, and the jacket is filled with gas. After being inflated, the jacket forms a handle-shaped structure with a ring-shaped cross section and a gradually decreasing diameter from top to bottom; During the test, the outer sleeve is placed in the vagina, with the top portion attached to the posterior fornix of the vagina; The MCU and the Bluetooth transmitting module are integrated into a transmission control module; The pressure sensor is a BMP280 sensor, which is a digital air pressure sensor with a relative accuracy of ±0.12hPa and can measure pressure and temperature simultaneously; The button battery module includes a battery holder and a battery mounted on the battery holder. An opening is formed on the top of the jacket, the opening is opposite to the button battery module, and the opening is used to replace the battery in the button battery module. The battery holder is fixedly mounted on the MCU, and the model of the button battery module is CR1220. The outer jacket is divided into two cavities, each of which is provided with a set of the MCU, pressure sensor, Bluetooth transmitter module and button battery module. The top of each cavity is provided with an opening, which is opposite to the button battery module in the corresponding cavity. The opening is used to replace the battery in the button battery module. The two cavities are marked with front and back, and the direction is selected according to the marked site for placement in the vagina to measure the changes in the intra-abdominal pressure corresponding to the anterior pelvic cavity and the posterior pelvic cavity respectively. The outer shell of the outer jacket is made of silicone material, and a ring-shaped fixing bracket is arranged inside the device, and the surface of the fixing bracket is also made of silicone material. The function of the bracket is to help the device to open automatically, that is, the device is generally in a closed state, and as it is inserted into the vagina, the device will automatically open. After use, the device is pulled out of the vagina through the pull rope at the bottom. The insertion and removal process of the device is simple and easy to operate, and can be completed by the test subject by himself without the participation of a second person; The shape of the device and the silicone material better conform to the shape of the human vagina and enhance comfort, and have a certain friction, which can make the device more firmly placed and fit to the vaginal wall without falling off, thereby ensuring the stability and accuracy of the device's pressure measurement.

2. The transvaginal intra-abdominal pressure measuring device according to claim 1, characterized in that: The dimensions of the transvaginal intra-abdominal pressure measuring device are 22 mm×18 mm×8 mm in length×width×height.

3. The transvaginal intra-abdominal pressure measuring device according to claim 1, characterized in that: The Bluetooth transmitting module sends the pressure signal to the terminal for display. The terminal includes a Bluetooth receiving module. The Bluetooth transmitting module and the Bluetooth receiving module are connected by a Bluetooth signal.

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