Pressure monitoring system and pressure monitoring correction method

Abstract

The invention relates to the technical field of medical instruments, and discloses a pressure monitoring system and a pressure monitoring correction method, and the system comprises a puncture pressure measuring unit and a pressure monitoring unit. The puncture pressure measuring unit comprises a catheter and a puncture bag, the pressure monitoring unit comprises a pressure sensor module and a data processing module, an internal channel can be communicated with a target area through a through hole of the catheter, so that pressure data of the target area can be collected in real time through the pressure sensor module in the channel, and a cavity of the puncture bag is communicated with the channel of the catheter; therefore, the pressure in the cavity is consistent with the pressure of the target area, the pressure value in the cavity can be measured by puncturing the puncture bag when needed, pressure data collected by the pressure sensor module can be calibrated through the data processing module, the zero point value of the pressure sensor module is calibrated, the sensor does not need to be taken out or monitoring does not need to be interrupted, and the accuracy of calibration is improved. The long-term stability and the measurement precision of the monitoring system are improved, and the method is suitable for scenes requiring long-time continuous monitoring.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a pressure monitoring system and a pressure monitoring calibration method. Background Technology

[0002] Real-time pressure monitoring of body cavities using pressure monitoring systems can help medical personnel accurately understand a patient's physiological state. These systems typically use pressure sensors (such as silicon-based piezoresistive sensors or fiber optic sensors) as core components implanted within the body cavity to monitor intracavitary pressure. Taking intracranial pressure monitoring as an example, implanting a pressure detection system sensor in the brain to monitor intracranial pressure is the gold standard for clinical assessment of brain pressure, effectively aiding in the diagnosis and treatment of various brain diseases, such as hydrocephalus, traumatic brain injury, and cerebral hemorrhage. However, after implantation, over long-term use, the sensor inevitably experiences drift due to protein adhesion and inflammatory tissue encapsulation on its sensing surface. As usage time increases, the sensor's detection accuracy continuously decreases, affecting the accuracy of the monitoring data and potentially impacting clinical judgment and treatment outcomes. Therefore, implanted pressure monitoring systems struggle to achieve long-term, stable, and accurate pressure monitoring. Summary of the Invention

[0003] This application aims to address at least one of the technical problems existing in the prior art. To this end, this application proposes a pressure monitoring system and a pressure detection and calibration method.

[0004] In a first aspect, the pressure monitoring system of this application includes a puncture pressure measurement unit and a pressure monitoring unit; A puncture pressure measurement unit includes a catheter and a puncture balloon. The catheter has a hollow interior forming a channel. One end of the catheter has a through hole communicating with the channel, so that the channel communicates with a target area outside the catheter. The other end of the catheter is connected to the puncture balloon. The puncture balloon has an interior cavity communicating with the channel. The puncture balloon has a puncture portion, which is configured to close the puncture site after the puncture needle is inserted and removed. The pressure monitoring unit includes a pressure sensor module and a data processing module. The pressure sensor module is disposed in the channel of the conduit and is used to collect pressure data. The data processing module is communicatively connected to the pressure sensor module and is used to process the pressure data. The data processing module is adapted to communicate with an external display device.

[0005] The pressure monitoring system according to the embodiments of this application has at least the following beneficial effects: the internal channel of the catheter can be connected to the target area through the through hole, so that the pressure sensor located at the tip of the catheter can collect the pressure data of the target area in real time. Since the cavity of the puncture balloon is connected to the channel of the catheter, the pressure in the cavity is consistent with the pressure of the target area. Therefore, the pressure value in the cavity can be measured by puncturing the puncture balloon when needed. The pressure data collected by the pressure sensor can be calibrated by the data processing module, thereby calibrating the zero point value of the pressure sensor without removing the sensor or interrupting the monitoring process. This corrects the drift error of the pressure sensor caused by long-term use, improves the long-term stability and measurement accuracy of the monitoring system, and is suitable for scenarios that require long-term continuous monitoring.

[0006] According to some embodiments of the pressure monitoring system of this application, the catheter includes a head end and a connecting part along its length, the head end is connected to the front end of the connecting part, the connecting part is hollow to form the channel, the first through hole is provided on the side wall of the connecting part, and the puncture balloon is connected to the rear end of the connecting part; The head end is closed off from the end of the connecting part, the pressure sensor module is disposed inside the head end, the head end is provided with an opening, the opening corresponds to the position of the sensing surface of the pressure sensor, and the sensing surface is exposed through the opening so that the sensing surface can contact the medium of the target area.

[0007] According to some embodiments of the pressure monitoring system of this application, the opening is provided on the lateral outer wall of the head end, the sensing surface faces the lateral direction of the head end and corresponds to the position of the opening, and is used to sense external pressure through the opening.

[0008] According to some embodiments of the pressure monitoring system of this application, the pressure sensor module includes a substrate and the pressure sensor. The substrate has a front side and a back side disposed opposite to each other. The substrate is provided with a second through hole that penetrates the front side and the back side. The second through hole and the opening are connected. The pressure sensor is connected to the back side of the substrate. The sensing surface and the front side of the substrate face the same direction. The sensing surface is exposed through the second through hole and the opening.

[0009] According to some embodiments of the pressure monitoring system of this application, the pressure sensor module and the data processing module are packaged in the same package, which is disposed inside the head end of the conduit; or, the data processing module is located outside the channel of the conduit, and the communication line of the data processing module runs through the wall of the connecting part and is connected to the pressure sensor module. The pressure sensor of the pressure sensor module can be a MEMS pressure sensor. In use, the pressure sensor module with the MEMS pressure sensor is placed inside the human body to form an independent MEMS pressure measurement system.

[0010] According to some embodiments of this application, the pressure monitoring system includes one of the following solutions: a. The pressure sensor module further includes a temperature sensor and a package. The temperature sensor is connected to the back side of the substrate, and the package covers the pressure sensor and the temperature sensor on the back side of the substrate. The data processing module is located outside the channel of the conduit. The data processing module includes a protective capsule, a signal processing circuit, and a conditioning chip. The protective capsule encloses the signal processing circuit and the conditioning chip inside. The communication line connects the signal processing circuit and the substrate. b. The pressure sensor module further includes a temperature sensor, a conditioning chip, and a package. The temperature sensor and the conditioning chip are both connected to the back side of the substrate. The package covers the pressure sensor, the temperature sensor, and the conditioning chip on the back side of the substrate. The data processing module includes a protective enclosure and a signal processing circuit. The protective enclosure encloses the signal processing circuit inside. The communication line connects the signal processing circuit and the substrate.

[0011] According to some embodiments of the pressure monitoring system of this application, the puncture balloon includes a balloon body and a connector portion connected to the outside of the balloon body; the balloon body has an internal cavity, and at least a portion of the balloon body is configured as the puncture portion; the connector communicates with the cavity, and the rear end of the catheter communicates with the cavity through the connector. In use, the catheter channel can guide intracorporeal pressure to the cavity of the balloon body, and the internal pressure of the cavity can be measured by puncture, forming an independent mechanical pressure measurement system.

[0012] According to some embodiments of the pressure monitoring system of this application, the connector is disposed around the bladder, and the puncture portion of the bladder is exposed on one side of the connector.

[0013] According to some embodiments of the pressure monitoring system of this application, the pressure monitoring system further includes an input module, which is communicatively connected to the data processing module via the communication line. The input module is configured to input calibration data. The data processing module is configured to receive and process the pressure data collected by the pressure sensor module and the calibration data output by the input module to obtain result data. And / or, the pressure monitoring system further includes an output module, which is communicatively connected to the data processing module and is used to output the data processed by the data processing module.

[0014] According to some embodiments of the pressure monitoring system of this application, the output module includes a display device and / or a data transmission unit. The display device is configured to process the result data after processing by the data processing module, and the data transmission unit is configured to wirelessly transmit the result data processed by the data processing module to an external device via WIFI or Bluetooth.

[0015] Secondly, the pressure monitoring and correction method of this application includes: using the pressure monitoring system of the first aspect embodiment above, collecting pressure data of the target area through the pressure sensor; detecting the pressure inside the cavity of the puncture sac to obtain the actual pressure value; and the data processing module performing correction processing on the pressure data according to the actual pressure value.

[0016] The monitoring and correction method according to the embodiments of this application has at least the following beneficial effects: using the above-mentioned pressure monitoring system, the pressure sensor can collect pressure data of the target area in real time, and can measure the pressure value inside the cavity of the puncture sac when needed to obtain the actual pressure value of the target area. Then, the pressure data collected by the pressure sensor can be calibrated by the data processing module, thereby calibrating the zero point value of the pressure sensor, thereby correcting the drift error of the pressure sensor caused by long-term use. The correction method is simple and effective, and does not require removing the sensor or interrupting the monitoring process, which is conducive to improving the long-term stability and measurement accuracy of the monitoring system.

[0017] According to some embodiments of this application, the pressure monitoring and correction method for detecting the pressure inside the cavity of the puncture sac includes: using a pressure detector with a puncture needle to puncture the puncture portion of the puncture sac with the puncture needle to measure the pressure inside the cavity, thereby obtaining the actual pressure value.

[0018] Additional aspects and advantages of this application will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of this application. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of a pressure monitoring system according to an embodiment of this application; Figure 2 This is a schematic diagram of the pressure monitoring system structure according to an embodiment of this application; Figure 3 This is a schematic diagram of the conduit, pressure sensor module, and wires in one embodiment of this application; Figure 4 This is a schematic diagram of the puncture sac in one embodiment of this application; Figure 5 for Figure 4 A schematic diagram of the internal structure of the puncture sac; Figure 6 This is one implementation of the pressure sensor module packaging in one embodiment of this application; Figure 7 This is another implementation of the pressure sensor module packaging in one embodiment of this application; Figure 8 This is yet another implementation of the pressure sensor module encapsulation in one embodiment of this application; Figure 9 This is one implementation of the data processing module in one embodiment of this application; Figure 10 This is a schematic diagram showing the change of zero-point drift of a pressure sensor as a function of test time (date) obtained by conducting a stability test on a pressure sensor module using an embodiment of this application at a temperature of 37°C.

[0020] Figure label: 100; tip 110; connector 120; first through hole 130; Puncture balloon 200; balloon body 210; puncture section 211; cavity 220; connector 230; Pressure sensor module 300; ceramic substrate 301; first pad 302; gold wire 303; pressure sensor 304; temperature sensor 305; conditioning chip 306; transducer 307; second through hole 308; Data processing module 400; protective envelope 401; signal processing circuit 402; protective tube 403; flexible circuit board 404; second solder pad 405; 500 communication lines; External equipment 600; 700 puncture needle. Detailed Implementation

[0021] The following will clearly and completely describe the concept and technical effects of this application in conjunction with embodiments, so as to fully understand the purpose, features and effects of this application. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are all within the scope of protection of this application.

[0022] In the description of the embodiments of this application, if directional descriptions are involved, such as "up", "down", "front", "back", "left", "right" etc., indicating the directional or positional relationship based on the directional or positional relationship shown in the drawings, it is only for the convenience of describing this application and simplifying the description, and is not intended to indicate or imply that the device or device referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0023] In the description of the embodiments of this application, if a feature is referred to as "setting," "fixing," "connecting," or "installing" on another feature, it can be directly set, fixed, or connected to the other feature, or it can be indirectly set, fixed, connected, or installed on the other feature. In the description of the embodiments of this application, if "several" is involved, it means one or more; if "multiple" is involved, it means two or more; if "greater than," "less than," or "exceeds," it should be understood as excluding the stated number; if "above," "below," or "within," it should be understood as including the stated number. If "first" or "second" is involved, it should be understood as used to distinguish technical features, and not as indicating or implying relative importance or implicitly indicating the number of indicated technical features or the order of the indicated technical features.

[0024] This application provides a pressure monitoring system and a pressure monitoring calibration method, which can calibrate pressure sensors externally, thereby effectively solving the shortcomings of reduced monitoring accuracy and data distortion caused by pressure sensor drift.

[0025] refer to Figures 1 to 5 The pressure monitoring system of this application includes a puncture pressure measurement unit and a pressure monitoring unit.

[0026] The puncture pressure measurement unit includes a catheter 100 and a puncture balloon 200. The catheter 100 has a hollow interior forming a channel. One end of the catheter 100 has a through hole 130 communicating with the channel to allow the channel to communicate with a target area outside the catheter 100. The other end of the catheter 100 is connected to the puncture balloon 200. The puncture balloon 200 has a cavity 220 inside, which communicates with the channel. The puncture balloon 200 has a puncture portion 211, which is configured to close the puncture site after the puncture needle 700 has punctured and removed.

[0027] The pressure monitoring unit includes a pressure sensor module 300 and a data processing module 400. The pressure sensor module 300 is disposed in the channel of the conduit 100 and is used to collect pressure data. The data processing module 400 is communicatively connected to the pressure sensor module 300 and is used to process the pressure data. The data processing module 400 is equipped with an internal battery and a Bluetooth communication module, which is suitable for power supply and wireless communication with external display devices.

[0028] The pressure sensor module 300 includes a pressure sensor 304 disposed inside the tip of the conduit 100. The sensing surface of the pressure sensor 304 is configured to contact the medium in the target area to be pressure measured, for collecting pressure data. The data processing module 400 is communicatively connected to the pressure sensor module 300 and is used to process the pressure data.

[0029] The pressure monitoring unit also includes a communication line 500, which runs through the wall of the conduit 100 and connects to the pressure sensor module 300 and the data processing module 400. The data processing module 400 is used to process pressure data and is adapted to make a wireless connection with an external display device via WIFI or Bluetooth.

[0030] In some embodiments, the catheter 100 includes a head end 110 and a connecting portion 120 along its length. The head end 110 is connected to the front end of the connecting portion 120. The connecting portion 120 is hollow to form a channel. A first through hole 130 is provided on the side wall of the connecting portion 120. The puncture balloon 200 is connected to the rear end of the connecting portion 120. Thus, the target area to be tested is connected to the channel inside the catheter 100 through the first through hole 130, and the internal cavity 220 of the puncture balloon 200 is connected through the internal channel to realize the conduction of the medium (e.g., liquid).

[0031] The tip 110 of the conduit 100 is closed off from the end of the connecting portion 120, and the pressure sensor module 300 is disposed inside the tip 110. The tip 110 has an opening that corresponds to the sensing surface of the pressure sensor 304, allowing the sensing surface to contact the medium in the target area. In use, the tip 110 of the conduit 100 is placed inside the target area of ​​the human body, and the medium in the target area contacts the sensing surface of the pressure sensor 304 through the opening of the tip 110, thus allowing the pressure sensor 304 to detect the pressure in the target area in real time.

[0032] In some embodiments, the pressure sensor module 300 may include a substrate 301 and a pressure sensor 304. The substrate 301 has a front side and a back side disposed opposite to each other. The substrate 301 is provided with a second through hole 308 that passes through the front side and the back side. The pressure sensor 304 is connected to the back side of the substrate 301. The sensing surface of the pressure sensor 304 faces the same direction as the front side of the substrate 301. The second through hole 308 communicates with the opening of the tip 110 of the conduit 100. The sensing surface of the pressure sensor 304 is exposed through the second through hole 308 and the opening of the tip 110. For example, the second through hole 308 and the opening of the tip 110 are aligned and aligned with the sensing surface of the pressure sensor 304. In use, the tip 110 of the conduit 100 is placed inside the target area of ​​the human body as the tip of the conduit 100. The medium in the target area contacts the sensing surface of the pressure sensor 304 through the opening of the tip 110 and the second through hole 308 of the substrate 301, so that the pressure sensor 304 can detect the pressure of the target area in real time.

[0033] In some embodiments, the pressure sensor module 300 further includes a temperature sensor 305, a conditioning chip 306, and a package. The temperature sensor 305 and the conditioning chip 306 are both connected to the back side of the substrate 301. The package covers the pressure sensor 304, the temperature sensor 305, and the conditioning chip 306 on the back side of the substrate 301. The data processing module 400 includes a protective shell 401 and a signal processing circuit 402. The protective shell 401 encloses the signal processing circuit 402 inside. The communication line 500 connects the signal processing circuit 402 and the substrate 301.

[0034] As an example, the packaging form of the pressure sensor module 300 can be referenced. Figure 6 and Figure 7 ,in Figure 6 The system employs a wire-bonded package, connecting the pressure sensor 304, temperature sensor 305, conditioning chip 306, and pads 302 on the ceramic substrate 301 via gold wire bonding. The ceramic substrate 301 has a second through-hole 308 aligned with the pressure-sensing surface of the pressure sensor 304 to conduct external pressure. The temperature sensor 305 is a thermistor (NTC) that converts changes in external temperature into an electrical signal, which is then processed by the conditioning chip 306 for temperature compensation during pressure measurement. The entire pressure sensor module 300 is backed with a highly waterproof and biocompatible epoxy resin to reduce the risk of water molecules gradually penetrating the conduit and corroding the circuitry within the pressure sensor module 300 due to prolonged immersion in cerebrospinal fluid, thus preventing short circuits or increased drift.

[0035] Pressure sensor 304 is a MEMS pressure sensor. MEMS (Micro-Electro-Mechanical System) is a thin-film element manufactured using MEMS technology. It senses pressure by measuring changes in electrical properties caused by thin-film deformation. It features a small package size and high sensitivity, meeting the requirements for long-term continuous pressure monitoring when packaged at the front end of a conduit.

[0036] The conditioning chip 306 is a dedicated integrated circuit chip (ASIC) that can be directly packaged on the ceramic substrate 301. Together with the pressure sensor 304 and the temperature sensor 305, it forms a pressure measurement module, which greatly reduces the signal transmission distance, has a fast response speed, and does not distort the signal.

[0037] Transducer 307 is a piezoelectric micromechanical ultrasonic transducer (PMUT) that provides low-frequency, low-intensity ultrasound waves to the catheter and pressure sensor module 300, reducing the formation of surface biofilms. One reason for the significant time drift of pressure sensor 304 is that, due to its long-term implantation in the body, a biofilm forms on the pressure-sensing surface. Biofilm formation involves three stages: bacterial deposition, biofilm formation, and bacterial release. The ultrasound waves generated by transducer 307 can interfere with the bacterial touch sensors, preventing bacteria or proteins from attaching to the catheter or via 308, thus reducing bacterial colonization.

[0038] Figure 7 Another implementation of the pressure sensor module 300 package employs a flip-chip packaging process, reducing the use of gold wires 303 at the pressure sensor 304 end and improving reliability. The sensor's pads 302 and pressure-sensing surface are on the same side, allowing direct mounting to the corresponding pads 302 on the ceramic substrate 301 after ball bonding. The pressure-sensing surface faces the through-hole 308. A sintered glass enamel coating is used to protect the pad connections, preventing water molecules from entering the internal circuitry of the pressure sensor module 300 due to prolonged immersion in cerebrospinal fluid, which could corrode the circuitry and cause short circuits or increased drift.

[0039] In some other embodiments, the pressure sensor module 300 further includes a temperature sensor 305 and a package. The temperature sensor 305 is connected to the back side of the substrate 301, and the package covers the pressure sensor 304 and the temperature sensor 305 on the back side of the substrate 301. The data processing module 400 is located outside the channel of the conduit 100. The data processing module 400 includes a protective capsule 401, a signal processing circuit 402, and a conditioning chip 306. The protective capsule 401 encloses the signal processing circuit 402 and the conditioning chip 306 inside. The communication line 500 connects the signal processing circuit 402 and the substrate 301.

[0040] As an example, Figure 8As another implementation of the above packaging scheme, the front-end pressure sensor module 300 only integrates the pressure sensor 304 and the temperature sensor 305, while the remaining circuits, such as the conditioning chip 306, are all laid out on the back-end data processing module 400. This can minimize the size of the pressure sensor module 300, thereby meeting the needs of more implantation scenarios.

[0041] Figure 9 As one implementation of the data processing module 400, both the protective capsule 401 and the protective tube 403 are made of soft, biocompatible silicone material. This achieves insulation and protection while conforming to the curvature of the patient's skull, preventing stress concentration and avoiding potential risks such as scalp tearing leading to infection. The signal processing circuit 402 includes a power module and a Bluetooth module, providing power to the overall circuitry and enabling Bluetooth pairing with an external display device. It wirelessly transmits intracranial pressure and temperature data collected by the front-end sensors to the external display device for numerical display and data storage. The flexible circuit board 404 has multiple circuit channels and solder pads 405, which can be connected to the corresponding solder pads of the front-end pressure sensor module 300. Compared to traditional enameled wire, the flexible circuit board 404 provides a highly reliable connection method, preventing short circuits or open circuits caused by traction or bending during production or use. It also offers high consistency, significantly improving welding efficiency in the production process.

[0042] Understandably, the pressure sensors in traditional pressure monitoring systems experience a continuous decrease in detection accuracy (time drift) over time due to factors such as long-term creep, relaxation, and aging of the internal materials (e.g., elastomers, polymers), the slow release of residual stress from manufacturing and installation, and long-term drift of electronic component parameters. This affects the accuracy of the monitoring data. Furthermore, the zero-point drift of pressure sensors varies with external influences, making it difficult to establish a consistent relationship between zero-point drift and time, thus hindering the effectiveness of pressure sensor drift prediction and compensation.

[0043] Some literature and engineering practice have demonstrated that the time drift of pressure sensors can be approximately linear under certain conditions, and have verified that it is reasonable and effective to model the time drift of pressure sensors as linear for data representation, prediction and compensation under specific and controlled conditions (such as constant temperature, stable load, specific time scale, etc.).

[0044] In some embodiments of this application, the pressure sensor 304 is connected to the back side of the substrate 301, and the sensing surface of the pressure sensor 304 is exposed through the second through-hole 308 of the substrate 301. That is, the sensing surface of the pressure sensor 304 faces the same direction as the front side of the substrate 301, while the back side of the substrate 301 is encapsulated with encapsulating adhesive, encapsulating the pressure sensor 304 and related functional components and connection structures on the back side of the substrate 301. This allows these functional components, connection structures, and the pressure sensor 304 to operate in a relatively enclosed environment. In a relatively stable working environment and during the middle stage of the equipment's lifespan, the rate of change of the factors that cause the pressure sensor's time drift tends to be constant. The cumulative effect of this constant rate results in an approximately linear shift in the output signal over time.

[0045] Therefore, in some embodiments, the packaging structure minimizes external factors that could affect the measurement of the pressure sensor 304, placing the pressure sensor 304 in a relatively stable encapsulated environment. Furthermore, the operating environment of the pressure sensor 304 is a relatively stable temperature environment, such as the human body cavity (e.g., intracranial cavity), where the influence of thermal zero-point drift is minimal. This allows the zero-point time drift of the pressure sensor 304 to exhibit an approximately linear phenomenon. For example, referencing... Figure 10 The figure illustrates a stability test conducted at 37°C on a pressure sensor module 300 using the packaging method of this application. The zero-point drift of the pressure sensor 304 as a function of the test time (date) is displayed as a line graph. It can be seen that the zero-point drift exhibits an approximately linear relationship with the test time (date).

[0046] By utilizing the near-linear zero-point drift model of pressure sensor 304, the actual pressure in the target area can be effectively predicted or compensated. For example, if the actual pressure value measured by the puncture balloon 200 at a certain time point is Pb, and the measured value obtained by pressure sensor module 300 is Pa, then the time drift X of pressure sensor module 300 is the difference between the sensor-measured value Pa and the true value Pb measured by the puncture balloon 200, i.e., X = Pa - Pb. After obtaining the drift value X, the near-linear model of zero-point drift of pressure sensor 304 can be used to obtain the predicted time drift X' and the predicted pressure value after a period of time. Through periodic correction, the data distortion caused by the zero-point drift of pressure sensor module 300 can be eliminated, effectively extending the reliable operating time of the system.

[0047] In application, the catheter 100 can connect its internal channel to the target area through the first through-hole 130, making the pressure inside the catheter 100 consistent with the pressure in the target area. This allows the pressure sensor module 300 located in the tip 110 to collect pressure data from the target area in real time. Since the cavity 220 of the puncture balloon 200 is connected to the channel of the catheter 100, the pressure within the cavity 220 is consistent with the pressure in the target area. The puncture balloon 200, which can be punctured multiple times, can be made of silicone material and allows for percutaneous puncture to measure the pressure inside the balloon. This allows the pressure value within the cavity 220 of the puncture balloon 200 to be measured when needed. The pressure data collected by the pressure sensor module 300 can then be calibrated by the data processing module 400, thereby calibrating the zero-point value of the pressure sensor module 300 without removing the sensor or interrupting the monitoring process. This corrects drift errors caused by long-term use of the pressure sensor module 300, improving the long-term stability and measurement accuracy of the monitoring system, making it suitable for scenarios requiring continuous monitoring over extended periods.

[0048] Taking advantage of the ability of catheter 100 to transmit gas and liquid pressure, the accurate pressure value of the pressure measurement area transmitted through catheter 100 can be accurately measured via a puncture balloon 200 connected to catheter 100 through subcutaneous puncture. This allows for further estimation of the time drift value of the pressure sensor module 300 in the pressure measurement area. The pressure monitoring system of this embodiment can be applied to long-term pressure monitoring of various body cavities. For example, in the medical field, it can continuously monitor intracranial pressure, intrathoracic pressure, intravascular pressure, or intravesical pressure over extended periods. It effectively overcomes the data distortion problem caused by the time drift of the implanted pressure sensor module 300, ensuring the accuracy and reliability of long-term monitoring data.

[0049] In practical applications, the end of catheter 100 with the first through-hole 130 is inserted into the target area of ​​the body cavity (e.g., intracranial cavity, intrathoracic cavity, intravascular cavity, or bladder). When used for intracranial pressure monitoring, the end of catheter 100 with the first through-hole 130 can be inserted into the intracranial cavity. The puncture balloon 200 is placed subcutaneously, and fluid from the target area is transferred to the cavity 220 of the puncture balloon 200 through the channel inside catheter 100. The pressure sensor module 300 inside catheter 100 collects intracranial pressure data in real time through pressure sensor 304. When calibration is required, the puncture balloon 200 is simply inserted through the puncture device to obtain the actual pressure value in the cavity 220, which is then compared with the data collected by the sensor. The data processing unit then performs zero-point calibration on the sensor. For example, if the actual pressure value measured by the puncture balloon 200 at a certain time point is Pb, and the measured value obtained by the pressure sensor module 300 is Pa, then the time drift X of the pressure sensor module 300 is the difference between the sensor-measured value Pa and the true value Pb measured by the puncture balloon 200, i.e., X = Pa - Pb. After obtaining the value of X, the data processing module 400 adjusts the detected value of the pressure sensor module 300, and the adjusted display value Pc = Pa - X is displayed on the display device. Pc is the pressure value after correcting the time drift, which can accurately reflect the current actual intracranial pressure. Periodic calibration can eliminate data distortion caused by zero-point drift of the pressure sensor module 300, effectively extend the reliable working time of the system, and reduce the risk of misdiagnosis due to data deviation.

[0050] The calibration process does not require removing the pressure sensor module 300 or interrupting monitoring. Calibration can be completed through an external puncture via a subcutaneous puncture balloon 200. The operation is simple and minimally invasive. Furthermore, the pressure sensor module 300 can continuously monitor pressure changes in the target area, resulting in more accurate and reliable data after calibration. This provides a feasible technical solution for long-term or even permanent implantable pressure monitoring, and is particularly suitable for chronic disease management and intensive care scenarios.

[0051] Understandably, the puncture site 211 or the entire puncture sac 200 can be made of an elastic material that can automatically close after the puncture needle 700 is withdrawn. For example, the puncture site 211 can be made of elastic medical-grade silicone. This material has high elasticity and extensibility. When the puncture needle 700 is inserted, the material around the puncture needle 700 is stretched and expanded. After the puncture needle 700 is withdrawn, the elastic restoring force causes the stretched silicone material to rebound in time, thereby closing the puncture channel and maintaining the seal of the puncture sac 200. The puncture needle 700 used for punctures typically has a small diameter, resulting in minimal damage to the puncture sac 200 after puncture. Combined with the rebound properties of the elastic material, this effectively maintains the seal of the puncture sac 200, thus ensuring the stability of the seal after multiple punctures. Simultaneously, the puncture procedure can be safely performed externally without affecting normal patient use or continuous monitoring.

[0052] In some embodiments, the pressure sensor module 300 may be an optional fiber optic pressure sensor module 300 or a silicon diaphragm strain pressure sensor module 300. The pressure sensor module 300 may be encapsulated with biocompatible materials. The pressure sensor module 300 may be flip-chip encapsulated, and the surface material may be phenelzine, biocompatible silicone, or a combination of both to meet biosafety requirements.

[0053] In some embodiments, the catheter 100 includes a tip 110 and a connecting portion 120 along its length. The tip 110 and the connecting portion 120 are hollow. The tip 110 is connected to the front end of the connecting portion 120, allowing the interiors of the tip 110 and the connecting portion 120 to communicate and form a channel. A puncture balloon 200 is connected to the rear end of the connecting portion 120, thereby communicating the channel with the cavity 220 of the puncture balloon 200. The catheter 100 is used to extend into a body cavity, the tip 110 is used to insert into a target area, and the connecting portion 120 connects to a puncture balloon 200 placed subcutaneously or externally, enabling the conduction of gas and / or liquid pressure in the target area.

[0054] refer to Figure 3 The head end 110 is closed off from the end of the connecting part 120. A first through hole 130 is provided on the side wall of the connecting part 120. The number of first through holes 130 can be one or more. Multiple first through holes 130 are spaced apart along the axial direction of the conduit 100, or multiple first through holes 130 are spaced apart along the axial direction of the conduit 100 in multiple rows, and multiple rows of first through holes 130 are spaced apart circumferentially along the head end 110. A pressure sensor module 300 is provided inside the head end 110. The head end 110 is provided with an opening. The pressure sensor 304 can be located inside the opening and its sensing surface is aligned with the opening to sense the pressure medium entering through the opening of the head end 110 and contacting the sensing surface. As an example, the pressure sensor module 300 has a sensing surface facing the side wall of the head end 110. The head end 110 has an opening on its outer side. The sensing surface faces the side of the head end 110 and corresponds to the position of the opening. The sensing surface is used to sense external pressure through the opening, such as the sensing surface being used to sense the pressure of the pressure medium acting on the target body.

[0055] In some embodiments, the head end 110 and the connecting part 120 can be an integrally molded structure, or the head end 110 and the connecting part 120 can be a separate structure, which can be fixedly connected by welding, bonding or threaded connection. The separate structure facilitates the packaging and assembly of the pressure sensor module 300, reducing production difficulty and cost.

[0056] The tip 110 and the connecting part 120 of the catheter 100 can be made of the same material, such as silicone, or they can be made of different materials, such as titanium alloy or ceramic.

[0057] In some embodiments, the pressure sensor module 300 and the data processing module 400 can be encapsulated in the same package, which is disposed within the channel of the catheter 100. It communicates wirelessly with the external device 600 via Wi-Fi or Bluetooth to achieve real-time data transmission and monitoring. The surface of the package is coated with a biocompatible coating to ensure tissue compatibility and sealing stability after long-term implantation. For example, the package can be made of silicone, ceramic, titanium, or biocompatible plastic to meet medical safety requirements and ensure tissue compatibility and stability after long-term implantation.

[0058] Or, refer to Figure 2 In some embodiments, the data processing module 400 is located outside the channel of the conduit 100, and the data processing module 400 is connected to the pressure sensor module 300 via a communication line 500 or wirelessly. When the communication line 500 is used, the data processing module 400 is electrically connected to the pressure sensor module 300 through the communication line 500 located inside the wall of the connecting part 120.

[0059] The data processing module 400 and the communication line 500 can be integrated into a single structure. Alternatively, the data processing module 400 can be equipped with a waterproof interface, and one end of the communication line 500 can be connected to a connector, which connects to the waterproof interface to achieve electrical connection. As an example, in the case of intracranial pressure monitoring, the length of the communication line 500 can be set within 35cm to accommodate the distance between the scalp and skull of adult patients.

[0060] Understandably, the data processing module 400 may be equipped with a battery for battery power, or it may be powered by a combination of capacitor power, wireless power, or battery power and wireless power to provide stable energy support for long-term monitoring.

[0061] refer to Figure 2 and Figures 4 to 5 In some embodiments, the puncture sac 200 may include a sac body 210 and a connector 230 connected to the outside of the sac body 210.

[0062] The capsule 210 has an internal cavity 220, and at least a portion of the capsule 210 is configured as a puncture section 211 to facilitate puncture operations. A connector 230 connects to the cavity 220 of the capsule 210, and the rear end of the catheter 100 is connected to the cavity 220 via the connector 230, forming a communication structure between the catheter 100 and the puncture capsule 200. The connector 230 provides sufficient structural support to the capsule 210, thereby preventing deformation of the capsule 210 under stress during use, which could affect the accuracy and safety of the puncture operation.

[0063] refer to Figure 4In some embodiments, the connector 230 is disposed around the capsule 210, thereby forming good structural support around the capsule 210. The puncture portion 211 of the capsule 210 is exposed on one side of the connector 230. The puncture portion 211 may be located in the top region of the capsule 210, and the wall of the puncture portion 211 forms a relatively flat puncture surface to facilitate puncture operation.

[0064] refer to Figure 1 and Figure 2 In some embodiments, the pressure monitoring system further includes an input module communicatively connected to the data processing module 400. The input module is configured to input calibration data. The input module may include buttons, a touchscreen, or a wireless communication unit, supporting the operator to input calibration data externally. The calibration data may be the actual pressure value obtained through puncture measurement or the difference between the actual pressure value and the value measured by the pressure sensor module 300. The calibration data is wirelessly transmitted to the data processing module 400. The data processing module 400 is configured to receive and process the pressure data collected by the pressure sensor module 300 and the calibration data output by the input module to obtain result data. Thus, the data processing module 400 performs zero-point calibration on the pressure sensor module 300 based on the calibration data. The result data obtained after processing by the data processing module 400 can be displayed through a display module or transmitted via a wireless communication unit (e.g., a WIFI communication unit or a Bluetooth communication unit) to an external device 600, such as a mobile terminal or external monitoring instrument, facilitating real-time viewing and remote monitoring by medical personnel.

[0065] refer to Figure 1 and Figure 2 In some embodiments, the pressure monitoring system may further include an output module communicatively connected to the data processing module 400, used to output data processed by the data processing module 400. The output module may include at least one of a display device and a data transmission unit. The display device is configured to display the result data processed by the data processing module, and the data transmission unit is configured to transmit the result data processed by the data processing module to an external device. When the output module includes a display device and / or a data transmission unit, the display device is configured to display the result data, and the data transmission unit is configured to transmit the result data to the external device 600. For example, the output module may include at least one of a display device, an indicator light, and a wireless data transmission unit. The display device is used to display pressure values ​​and abnormal alarm prompts in real time; the indicator light can be used to emit a light signal warning when the pressure exceeds the limit; and the wireless data transmission unit can realize data transmission with the external device 600, such as a mobile terminal or an external monitoring instrument.

[0066] In some embodiments, the pressure monitoring system may further include the above-mentioned input module and output module. The data processing module 400 is configured to receive and process the pressure data collected by the pressure sensor module 300 and the correction data output by the input module to obtain the result data. The output module is used to output the result data.

[0067] The pressure monitoring and calibration method of this application includes: employing a pressure monitoring system of any of the foregoing embodiments of this application (refer to...). Figures 1 to 5 The pressure sensor module 300 collects pressure data from the target area and detects the pressure within the cavity 220 of the puncture sac 200 to obtain the actual pressure value. The data processing module 400 then corrects the pressure data based on the actual pressure value. Therefore, using this pressure monitoring system, the pressure sensor module 300 can collect pressure data from the target area in real time, and can measure the pressure within the cavity 220 of the puncture sac 200 when needed to obtain the actual pressure value. The data processing module 400 can then calibrate the pressure data collected by the pressure sensor module 300, thereby calibrating the zero-point value of the pressure sensor module 300 and correcting drift errors caused by long-term use. The calibration method is simple and effective, requiring no sensor removal or interruption of the monitoring process, which helps improve the long-term stability and measurement accuracy of the monitoring system.

[0068] In some embodiments of the pressure monitoring and correction method, the method for detecting the pressure inside the cavity 220 of the puncture sac 200 includes: using a pressure detector with a puncture needle 700, puncturing the puncture portion 211 of the puncture sac 200 through the puncture needle 700 to measure the pressure inside the cavity 220, thereby obtaining the actual pressure value.

[0069] In the application of the pressure monitoring system and calibration method of this application embodiment, one end of the catheter 100 is positioned in the target area, while the puncture balloon 200 is located outside the target area. Pressure data of the target area is collected in real time by the pressure sensor module 300 within the catheter 100. The puncture needle 700 is inserted into the cavity 220 of the puncture balloon 200, and the actual pressure value within the cavity 220 is read using an external detection device (e.g., a pressure detector). Based on the actual pressure value, the zero-point offset of the current pressure sensor module 300 can be estimated, thereby correcting the sensor's output data to ensure measurement accuracy.

[0070] When an input module is configured, the actual pressure value obtained from the puncture measurement can be input as calibration data to the data processing module 400. The data processing module 400 then dynamically calibrates the zero point of the pressure sensor module 300 based on the calibration data, ensuring the accuracy and stability of the pressure data during monitoring and improving the long-term reliability and clinical application safety of the system.

[0071] Some pressure monitoring systems employ a method where a pressure sensor module 300 is placed within an external subcutaneous cavity 220. This cavity 220 is connected to the body cavity via a drainage tube, allowing the pressure sensor module 300 to measure pressure indirectly by transmitting fluid pressure within the cavity 220. This method presents several problems. First, if the catheter 100 is obstructed, the pressure measurement method, which transmits hydraulic pressure to the pressure receptor within the cavity 220 via the catheter 100, becomes ineffective. Second, the fluid within the cavity 220 does not participate in cerebral circulation and is normally quiescent. This quiescent state makes it highly susceptible to the deposition of tissue, protein, or hemorrhagic inflammatory substances. Regardless of whether the sensor is placed on the side or bottom, measurement errors occur when these deposits cover the sensor surface. This error, coupled with time drift caused by the denaturation of the pressure receptor encapsulation material, further amplifies the measurement error over time, further shortening the already challenging timeframe for the pressure sensor module 300 to accurately reflect intracranial pressure.

[0072] In other technologies, pressure monitoring systems use an implanted pressure sensor module 300 to detect intracavitary pressure in real time. However, due to the time drift problem of the sensor, it is difficult to achieve long-term stable and accurate pressure monitoring. Therefore, most technologies can only be used temporarily in the short term. Understandably, as an implantable medical device, the pressure sensor module 300 needs to undergo biosafety packaging. Not only must the packaging material meet biosafety requirements, but the packaging thickness also affects monitoring accuracy (increasing the packaging thickness can reduce time drift, but increasing the thickness will reduce detection accuracy). Therefore, given the limited availability of sensor packaging materials, pressure monitoring systems using implantable sensors cannot improve the zero-point time drift defect in long-term monitoring from the perspective of packaging materials and packaging processes. Optimizing packaging materials and processes cannot fundamentally solve this problem. This is the key difficulty for devices using implantable sensor solutions to monitor intracavitary pressure to achieve long-term accurate monitoring.

[0073] In contrast, the pressure monitoring system and calibration method of this application embodiment can place the pressure sensor module 300 inside the body cavity, avoiding the problems existing in placing the pressure sensor module 300 inside the puncture bag 200, and effectively solving the data distortion defects caused by zero-point drift of the pressure sensor module 300. The pressure monitoring system and calibration method of this application embodiment monitors the pressure value of the target area in real time through the in vivo pressure sensor module 300 and combines it with the actual pressure value measured by external physical puncture, so as to recalibrate the zero-point value of the pressure sensor module 300 in vitro, so that the sensor that has developed zero-point drift can continue to monitor accurately. Through periodic external calibration, the zero-point drift of the pressure sensor module 300 during long-term operation is effectively compensated, thereby achieving long-term use.

[0074] Understandably, a long-term or even permanent implantable pressure monitoring system for body cavities means it can remain in the patient's body for an extended period, continuously monitoring pressure changes. This represents a significant advancement in the management of neurocritical care and chronic intracranial diseases, transforming the "intermittent intervention" of existing pressure monitoring technologies into "long-term continuous monitoring." "Intermittent intervention" can be understood as traditional monitoring methods failing to provide continuous data; each pressure reading requires an independent medical procedure, which is intermittent in time and inherently invasive or risky (interventional). "Long-term continuous monitoring," on the other hand, provides complete and continuous data, facilitating more precise decision-making and enabling more accurate and proactive disease management, as well as minimally invasive, personalized medicine. This has high clinical value for patients with chronic diseases requiring long-term monitoring (such as normal pressure hydrocephalus, certain types of hydrocephalus, idiopathic intracranial hypertension, etc.).

[0075] Taking intracranial pressure monitoring as an example, the clinical value of achieving "long-term continuous monitoring" through long-term or even permanent intracranial pressure monitoring systems is mainly reflected in the following aspects, including but not limited to: 1. Precise monitoring and early intervention Real-time dynamic data: Continuous monitoring of changes in ICP (intracranial pressure) helps doctors detect abnormal increases in intracranial pressure (such as cerebral edema, hemorrhage, or hydrocephalus) in a timely manner, thus preventing secondary brain injury.

[0076] Personalized treatment: Adjusting treatment plans based on long-term data (such as the use of dehydrating agents and the timing of cerebrospinal fluid drainage) to reduce the error of empirical treatment.

[0077] 2. Improve chronic disease management For patients with chronic hydrocephalus: Long-term monitoring can optimize valve pressure settings for ventriculoperitoneal shunt (VPS) procedures, reducing the risk of shunt blockage or over-drainage.

[0078] Neurodegenerative diseases, such as normal pressure hydrocephalus, require continuous monitoring to aid in differential diagnosis and guide intervention, thereby improving cognitive and motor function.

[0079] 3. Reduce invasive procedures and complications Avoid repeated punctures: Traditional lumbar punctures or temporary probes require multiple invasive procedures, while permanent systems reduce the risk of infection and bleeding.

[0080] 4. Improve patients' quality of life Freedom of movement and remote management: Patients do not need long-term hospitalization, and some systems support wireless data transmission, enabling home monitoring and improving convenience. It reduces the anxiety of repeated medical visits, and is especially suitable for children or those with mobility impairments.

[0081] 5. Scientific Research and Disease Mechanism Research Long-term data accumulation: revealing the relationship between ICP and disease progression (such as chronic intracranial hypertension after traumatic brain injury), and promoting the development of new therapies.

[0082] 6. The unique value of special populations Postoperative brain tumor patients: Real-time monitoring of intracranial pressure can monitor whether the tumor will recur in the long term and the effect of postoperative radiotherapy and chemotherapy. It can also provide timely warnings of tumor growth and determine whether further surgical intervention is needed by monitoring changes in intracranial pressure data.

[0083] The pressure monitoring system and calibration method of this application provide a solution for long-term implantation in the body for pressure monitoring, and can calibrate the pressure sensor externally. This effectively solves the inherent shortcomings of pressure sensors, such as reduced monitoring accuracy and data distortion due to zero-point drift. Through periodic external calibration, the zero-point drift of the pressure sensor during long-term operation is effectively compensated, thereby enabling long-term use. This solves the problem that implantable monitoring solutions cannot maintain accurate and stable monitoring for a long time, and provides a feasible technical solution for long-term or even permanent implantable pressure monitoring.

[0084] The embodiments of this application have been described in detail above with reference to the accompanying drawings. However, this application is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of this application. Furthermore, unless otherwise specified, the embodiments and features described in the embodiments of this application can be combined with each other.

Claims

1. A pressure monitoring system, characterized in that, include: A puncture pressure measurement unit includes a catheter and a puncture balloon. The catheter has a hollow interior forming a channel. One end of the catheter has a first through hole communicating with the channel to allow the channel to communicate with a target area outside the catheter. The other end of the catheter is connected to the puncture balloon, which has an interior cavity communicating with the channel. The puncture balloon has a puncture portion configured to close the puncture site after the puncture needle is inserted and removed. The pressure monitoring unit includes a pressure sensor module, a data processing module, and a communication line. The pressure sensor module includes a pressure sensor disposed inside the tip of the conduit. The sensing surface of the pressure sensor is configured to contact the medium in the target area to be pressure measured, for collecting pressure data. The communication line runs through the wall of the conduit and connects the pressure sensor module and the data processing module. The data processing module is used to process the pressure data and is adapted to wirelessly connect with an external display device via WIFI or Bluetooth.

2. The pressure monitoring system according to claim 1, characterized in that, The catheter includes a head end and a connecting part along its length. The head end is connected to the front end of the connecting part. The connecting part is hollow to form the channel. The first through hole is provided on the side wall of the connecting part. The puncture balloon is connected to the rear end of the connecting part. The head end is closed off from the end of the connecting part, the pressure sensor module is disposed inside the head end, the head end is provided with an opening, the opening corresponds to the position of the sensing surface of the pressure sensor, and the sensing surface is exposed through the opening so that the sensing surface can contact the medium of the target area.

3. The pressure monitoring system according to claim 2, characterized in that, The opening is located on the lateral outer wall of the head end, and the sensing surface faces the lateral direction of the head end and corresponds to the position of the opening, for sensing external pressure through the opening.

4. The pressure monitoring system according to claim 2, characterized in that, The pressure sensor module includes a substrate and the pressure sensor. The substrate has a front side and a back side disposed opposite to each other. The substrate is provided with a second through hole that penetrates the front side and the back side. The second through hole is connected to the opening. The pressure sensor is connected to the back side of the substrate, and the sensing surface faces the same direction as the front side of the substrate. The sensing surface is exposed through the second through hole and the opening.

5. The pressure monitoring system according to claim 4, characterized in that, The pressure sensor module and the data processing module are encapsulated in the same package, which is located inside the head end of the conduit. Alternatively, the data processing module is located outside the channel of the conduit, and the communication line of the data processing module runs through the wall of the connection and is connected to the pressure sensor module.

6. The pressure monitoring system according to claim 5, characterized in that, The pressure monitoring system includes one of the following solutions: a. The pressure sensor module further includes a temperature sensor and a package. The temperature sensor is connected to the back side of the substrate, and the package covers the pressure sensor and the temperature sensor on the back side of the substrate. The data processing module is located outside the channel of the conduit. The data processing module includes a protective capsule, a signal processing circuit, and a conditioning chip. The protective capsule encloses the signal processing circuit and the conditioning chip inside. The communication line connects the signal processing circuit and the substrate. b. The pressure sensor module further includes a temperature sensor, a conditioning chip, and a package. The temperature sensor and the conditioning chip are both connected to the back side of the substrate. The package covers the pressure sensor, the temperature sensor, and the conditioning chip on the back side of the substrate. The data processing module includes a protective enclosure and a signal processing circuit. The protective enclosure encloses the signal processing circuit inside. The communication line connects the signal processing circuit and the substrate.

7. The pressure monitoring system according to claim 1, characterized in that, The puncture sac includes a sac body and a connector attached to the outside of the sac body; The cavity is provided inside the capsule, and at least a portion of the capsule is configured as the puncture site; The connector communicates with the cavity, and the rear end of the conduit is connected to the cavity through the connector.

8. The pressure monitoring system according to claim 7, characterized in that... The puncture portion of the cyst is exposed on one side of the connector.

9. The pressure monitoring system according to claim 1, characterized in that, The pressure monitoring system further includes an input module, which is communicatively connected to the data processing module via the communication line. The input module is configured to input calibration data. The data processing module is configured to receive and process the pressure data collected by the pressure sensor module and the calibration data output by the input module to obtain result data. And / or, the pressure monitoring system further includes an output module, which is communicatively connected to the data processing module and is used to output data processed by the data processing module.

10. The pressure monitoring system according to claim 9, characterized in that, The output module includes a display device and / or a data transmission unit. The display device is configured to process the result data after it has been processed by the data processing module. The data transmission unit is configured to wirelessly transmit the result data processed by the data processing module to an external device via WIFI or Bluetooth.

11. A pressure monitoring and calibration method, characterized in that, include: The pressure monitoring system according to any one of claims 1 to 10 is used to collect pressure data of the target area through the pressure sensor; The pressure inside the cavity of the puncture sac is measured to obtain the actual pressure value; The data processing module corrects the pressure data based on the actual pressure value.

12. The pressure monitoring and calibration method according to claim 11, characterized in that, The method for detecting the pressure inside the cavity of the puncture sac includes: using a pressure detector with a puncture needle to puncture the puncture portion of the puncture sac with the puncture needle to measure the pressure inside the cavity, thereby obtaining the actual pressure value.

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