Intrafascial compartment pressure and temperature long-term in-vivo monitoring device and method

Abstract

The application is suitable for the technical field of medical devices, and provides a device and a method for long-term in-vivo monitoring of fascia chamber pressure and temperature. The device comprises: an indwelling catheter having a hollow inner cavity constituting a pressure conducting channel; a pressure sensor in sealed communication with the pressure conducting channel, for monitoring the pressure in the fascia chamber; a temperature sensor fixed to the outer wall of the indwining catheter and physically isolated from the pressure conducting channel, for monitoring the tissue temperature in the fascia chamber; a main control module electrically connected with the pressure sensor and the temperature sensor, for receiving and processing pressure signals and temperature signals to generate monitoring data; and a transmission module for transmitting the monitoring data to a terminal device. The application physically isolates the temperature sensor from the pressure conducting channel, thereby ensuring the accuracy of pressure measurement, and improves the evaluation accuracy through joint determination of two parameters, and can realize remote centralized monitoring and improve the monitoring efficiency.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to a device and method for long-term in vivo monitoring of intrafascial pressure and temperature. Background Technology

[0002] Increased intrafascial pressure is a crucial indicator of fascial compartment condition, and the gold standard for measurement is direct pressure measurement within the compartment. The Whiteside method is commonly used in practice, which involves creating a fluid-filled channel within the fascial compartment using a puncture needle and connecting a pressure sensor for measurement. However, pressure monitoring alone can lead to ambiguous interpretations in early or borderline cases. Studies have shown that local temperature within the fascial compartment changes in response to pressure variations, making temperature a valuable auxiliary monitoring parameter.

[0003] Existing technologies face numerous challenges when attempting to integrate multiple sensors. For example, placing a temperature sensor within the liquid channel used for pressure measurement can disrupt hydrostatic equilibrium, easily lead to bubble formation or channel blockage, severely impacting the accuracy of pressure measurements and violating gold standard operational requirements. External non-invasive temperature measurement, on the other hand, cannot accurately reflect the true tissue temperature within the fascial compartment. Furthermore, traditional monitoring equipment typically requires frequent bedside readings by medical staff, which is not only inefficient but also hinders continuous, centralized monitoring of multiple patients, potentially delaying the detection and management of abnormalities.

[0004] Therefore, existing technologies have technical drawbacks such as monitoring only a single parameter, easy interference with core pressure measurement when integrating multiple parameters, unsuitability for long-term storage, and inconvenience for remote centralized monitoring. Summary of the Invention

[0005] This application provides a device and method for long-term in vivo monitoring of intrafascial pressure and temperature, aiming to solve the problems existing in the prior art, such as single monitoring parameters, interference with core pressure measurement when multiple parameters are integrated, and inconvenience for remote centralized monitoring.

[0006] In a first aspect, embodiments of this application provide a long-term in vivo monitoring device for intrafascial pressure and temperature, the device comprising: An indwelling catheter is used to be placed inside a target fascial compartment. The indwelling catheter includes a hollow inner cavity, which forms a pressure transmission channel for transmitting pressure within the fascial compartment. A pressure sensor, sealed and connected to the pressure transmission channel, is used to convert the intrafascial pressure into a pressure signal. A temperature sensor, fixed to the outer wall of the indwelling catheter and physically isolated from the pressure transmission channel, is used to monitor the tissue temperature in the fascial compartment and convert it into a temperature signal; The main control module is electrically connected to the pressure sensor and the temperature sensor respectively, and is used to receive and process the pressure signal and the temperature signal to generate monitoring data; The transmission module is electrically connected to the main control module and is used to transmit the monitoring data to the terminal device.

[0007] In one possible implementation of the first aspect, the device further includes a puncture member detachably inserted inside the indwelling catheter for puncturing and inserting the indwelling catheter into the target fascial compartment.

[0008] In one possible implementation of the first aspect, the device further includes a multi-channel connector and a fluid injection assembly; The multi-channel connector is sealed to the indwelling catheter, the pressure sensor and the fluid injection assembly, respectively. The fluid injection assembly is used to inject fluid into the pressure transmission channel through the multi-channel connector.

[0009] In one possible implementation of the first aspect, the temperature sensor is fixed to the outer wall of the indwelling catheter by an adhesive.

[0010] In one possible implementation of the first aspect, the device further includes a signal transmission line, through which the temperature sensor is electrically connected to the main control module, the signal transmission line extending along the outer wall of the indwelling catheter and fixed to the outer wall of the indwelling catheter.

[0011] In one possible implementation of the first aspect, the main control module is configured as follows: When the pressure value corresponding to the pressure signal reaches a preset pressure threshold, and the decrease in the temperature value corresponding to the temperature signal relative to the initial temperature value reaches a preset temperature change threshold, a prompt signal is generated. The transmission module transmits the prompt signal to the terminal device.

[0012] In one possible implementation of the first aspect, the temperature sensor includes a plurality of temperature sensing elements spaced apart along the axial direction of the indwelling catheter, and the plurality of temperature sensing elements are electrically connected to the main control module via independent signal transmission lines. The main control module is configured to: calculate the axial temperature gradient in the fascia chamber based on multiple temperature values ​​collected by the multiple temperature sensing elements, and generate a gradient prompt signal when the axial temperature gradient reaches a preset gradient threshold.

[0013] Secondly, embodiments of this application provide an in vivo physiological parameter monitoring method based on the device described in the first aspect, the method comprising: The pressure sensor is used to monitor the pressure within the fascia chamber via the pressure transmission channel to obtain a pressure signal; The temperature sensor fixed to the outer wall of the indwelling catheter is used to monitor the tissue temperature within the fascia chamber and obtain a temperature signal. The main control module processes the pressure signal and the temperature signal to generate monitoring data; The monitoring data is transmitted to the terminal device using the transmission module.

[0014] This application embodiment addresses the problem of interference with pressure measurement accuracy caused by integrating temperature sensors in existing technologies. By fixing a temperature sensor to the outer wall of the indwelling catheter and physically isolating it from the hollow cavity constituting the pressure transmission channel, it ensures the accuracy of pressure measurement within the fascial compartment. This structure guarantees the independence and unobstructed flow of the pressure transmission channel, ensuring accurate and reliable pressure monitoring within the fascial compartment. Furthermore, this application can simultaneously collect two key physiological parameters: intrafascial compartment pressure and tissue temperature. By jointly assessing multiple indicators such as increased pressure and decreased temperature, it helps improve the accuracy and specificity of physiological state evaluation, effectively reducing the risk of judgment bias. The transmission module enables real-time transmission of monitoring data to terminal devices, allowing medical staff to centrally monitor multiple patients from locations such as the nurses' station, promptly detect alerts, improve monitoring efficiency and emergency response speed, and reduce the workload of medical staff. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram of the overall system structure according to an embodiment of this application; Figure 2 This is a partially enlarged structural diagram of the tip of the indwelling catheter according to an embodiment of this application; Figure 3 This is a schematic diagram of the signaling interaction timing between the monitoring device and the terminal device according to an embodiment of this application; Figure 4 This is a schematic diagram of a multi-patient centralized monitoring system deployment scenario according to an embodiment of this application.

[0017] In the diagram: 1-Main control module, 1a-Transmission module, 2-Pressure sensor, 3-Display screen, 4-Indwelling needle, 4a-Puncture component, 4b-Indwelling catheter, 5-Temperature sensor, 6-Signal transmission line, 7-Fluid injection component, 8-Multi-channel connector, 9-Pressure transmission channel, 100-Nurse station, 110-Central monitoring terminal, 200A-Ward A, 200B-Ward B, 300-Monitoring device. Detailed Implementation

[0018] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application may also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0019] It should be understood that, when used in this application specification and the appended claims, the term "comprising" indicates the presence of the described features, integrals, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components and / or a collection thereof.

[0020] It should also be understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0021] As used in this application specification and the appended claims, the term "if" may be interpreted, depending on the context, as "when," "once," "in response to determination," or "in response to detection." Similarly, the phrase "if determined" or "if detected [the described condition or event]" may be interpreted, depending on the context, as meaning "once determined," "in response to determination," "once detected [the described condition or event]," or "in response to detection [the described condition or event]."

[0022] Furthermore, in the description of this application and the appended claims, the terms "first," "second," "third," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0023] References to "one embodiment" or "some embodiments" as described in this specification mean that one or more embodiments of this application include a specific feature, structure, or characteristic described in connection with that embodiment. Therefore, the phrases "in one embodiment," "in some embodiments," "in other embodiments," "in still other embodiments," etc., appearing in different parts of this specification do not necessarily refer to the same embodiment, but rather mean "one or more, but not all, embodiments," unless otherwise specifically emphasized. The terms "comprising," "including," "having," and variations thereof mean "including but not limited to," unless otherwise specifically emphasized.

[0024] Unless otherwise defined, all technical and scientific terms used in the embodiments of this application have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used in the embodiments of this application is for descriptive purposes only and is not intended to limit the application. Before further detailed description of the embodiments of this application, the nouns and terms involved in the embodiments of this application are explained, and the nouns and terms involved in the embodiments of this application are subject to the following interpretations.

[0025] Indwelling catheter: refers to a tubular component that can be placed inside a target fascial compartment, having a hollow inner cavity that serves as a pressure conduction channel for transmitting intrafascial pressure. In this application, it is made of a biocompatible flexible polymer material.

[0026] Physical isolation: This refers to the complete separation of the temperature sensor from the pressure transmission channel in terms of spatial structure, with no intrusion, contact, or connection, thereby ensuring that the presence of the temperature sensor will not interfere with the fluid dynamics characteristics within the pressure transmission channel.

[0027] Terminal equipment: refers to electronic devices that can receive, display and process monitoring data and / or prompt signals sent by the transmission module of the device of this application, including but not limited to central monitoring computers, tablet computers or smartphones.

[0028] Axial temperature gradient: refers to the rate of temperature change per unit length along the axis of the indwelling catheter. It is calculated by measuring the temperature values ​​collected by multiple temperature sensors distributed along the catheter and is used to characterize the degree of temperature difference between different locations within the fascial compartment.

[0029] Initial temperature value: refers to the average temperature value or the first stable reading obtained by the temperature sensor after the indwelling catheter is placed into the target fascial compartment and a period of stabilization (such as 2 to 10 minutes, or until the temperature sensor reading fluctuates by no more than ±0.1℃ within 10 consecutive seconds). It serves as a benchmark for subsequent judgment of temperature changes.

[0030] Sealed connection: refers to the connection between two components that has no gas or liquid leakage within the normal operating pressure range (e.g., 0~100 mmHg) and can maintain the accuracy of pressure transmission. This connection is achieved through Luer joints, sealing gaskets, or integral molding.

[0031] Preset pressure threshold, preset temperature change threshold, and preset gradient threshold: These refer to clinical parameters that can be set and adjusted by medical personnel through the input interface of the terminal device or the device itself. The typical range for the pressure threshold is 10–50 mmHg, the typical range for the temperature change threshold is 0.3–2.0℃, and the typical range for the gradient threshold is 0.1–0.5℃ / cm.

[0032] Multi-port connector: refers to a connector with at least three sealed ports for simultaneously connecting an indwelling catheter, a pressure sensor, and a fluid injection assembly to achieve pressure transmission, fluid injection, and venting functions. Examples include a tee Luer connector or a Y / T manifold.

[0033] Fluid injection assembly: refers to a device used to inject fluid into a pressure transmission channel to expel air bubbles, including but not limited to syringes, pre-filled saline cartridges, or automatic infusion pumps.

[0034] Signal transmission line: refers to the insulated wire that connects the temperature sensor and the main control module. It is fixed along the outer wall of the indwelling conduit with adhesive or heat shrink tubing and is used to transmit the temperature signal to the main control module.

[0035] Please see Figure 1 This application provides a long-term in vivo monitoring device for intrafascial pressure and temperature. Through a specific structural design, this device can simultaneously achieve long-term (meaning the monitoring device is continuously placed in the target fascial compartment and collects physiological parameters for no less than 24 hours, as opposed to single or short-term (within a few hours) measurements), in vivo, and remote monitoring of both pressure and temperature parameters without interfering with standard pressure measurements, thereby improving the accuracy of physiological parameter assessment and monitoring efficiency.

[0036] The device provided in this application includes an indwelling catheter 4b, which is placed inside a target fascial compartment of the patient after a puncture procedure. The indwelling catheter 4b has a hollow lumen that serves as a pressure transmission channel 9, its core function being to establish a fluid communication path from the inside of the fascial compartment to the outside for precise transmission of pressure within the fascial compartment. This design aims to comply with the core requirements of the gold standard for pressure measurement (Whiteside method), namely, the need for an unobstructed fluid channel to transmit pressure.

[0037] The device also includes a pressure sensor 2, which is sealed to the external end of the pressure transmission channel 9. Its design aims to accurately convert the fluid pressure transmitted through the pressure transmission channel 9 into an electrical signal. In this way, the subtle pressure changes within the fascial compartment are converted into a pressure signal that can be recognized and processed by the electronic system, solving the problems of inconvenient readings and inability to continuously record pressure using traditional mechanical pressure gauges.

[0038] To achieve dual-parameter monitoring, the device also includes a temperature sensor 5. Its structural feature is that the temperature sensor 5 is fixed to the outer wall of the indwelling catheter 4b and physically isolated from the pressure transmission channel 9. This means that the temperature sensor 5 does not structurally intrude into the hollow cavity of the indwelling catheter 4b. The purpose of this design is to introduce temperature monitoring functionality while avoiding any interference with the pressure measurement pathway, such as the formation of air bubbles, blockage, or alteration of fluid dynamics, thereby solving the technical problem in the prior art where multi-parameter integration inevitably interferes with core pressure measurement. By placing the temperature sensor 5 on the outer wall of the catheter and implanting it along with the catheter into the fascial chamber, accurate in vivo measurement of the actual tissue temperature inside the fascial chamber is achieved.

[0039] The core of the device's control is a main control module 1, which is electrically connected to both the pressure sensor 2 and the temperature sensor 5. The main control module 1 receives and processes the pressure signal converted by the pressure sensor 2 and the temperature signal converted by the temperature sensor 5. It amplifies, filters, and performs analog-to-digital conversion on the raw electrical signals, synthesizing them into structured monitoring data containing pressure and temperature information, providing the data foundation for subsequent display, transmission, and alerts.

[0040] To enable remote monitoring, the device also includes a transmission module 1a, which is electrically connected to the main control module 1. Its function is to wirelessly transmit the monitoring data generated by the main control module 1 to remote terminal devices, such as the central monitoring terminal 110 at the nurses' station. By introducing this transmission module 1a, the problem of traditional monitoring methods requiring medical staff to frequently travel to and from the patient's bedside to take readings is solved, enabling continuous, remote, and centralized monitoring of the patient's physiological parameters.

[0041] Furthermore, in an alternative implementation, please refer to... Figure 2The device also includes a puncture component 4a. This puncture component 4a is detachably inserted inside the indwelling catheter 4b. Its design aims to provide the rigidity and sharpness required for puncture, assisting medical personnel in smoothly penetrating the relatively soft indwelling catheter 4b through the skin and fascia tissue and placing it into the target fascial compartment. After the puncture is completed, the puncture component 4a is completely removed, leaving only the indwelling catheter 4b in the body. This needle-cannula structure solves the problem of the flexible catheter itself being difficult to puncture, while avoiding the tissue damage and irritation that may result from long-term indwelling of a metal needle, thus achieving safe long-term indwelling.

[0042] In another alternative implementation, please refer to Figure 1 The device also includes a multi-channel connector 8 and a fluid injection assembly 7. The multi-channel connector 8 provides a sealed connection to the indwelling catheter 4b, the pressure sensor 2, and the fluid injection assembly 7. The fluid injection assembly 7 is used to inject fluid (such as sterile heparinized saline) into the pressure transmission channel 9 through the multi-channel connector 8. This structure is designed to provide a standardized interface for connecting the pressure measurement line and the venting line. By injecting fluid, all air bubbles in the pressure transmission channel 9 can be expelled, ensuring that the channel is filled with incompressible liquid. This is a crucial step in achieving accurate pressure transmission, as any residual air bubbles will absorb pressure fluctuations due to their compressibility, leading to inaccurate pressure readings. This structure solves the problems of complex manual venting operations, susceptibility to contamination, and unreliable results.

[0043] In one optional embodiment, the temperature sensor 5 is fixed to the outer wall of the indwelling catheter 4b using an adhesive. This fixing method aims to achieve a secure, integrated connection between the temperature sensor 5 and the indwelling catheter 4b, ensuring that the temperature sensor 5 will not shift or fall off throughout the entire process of puncture, placement, and removal. Using a medical-grade biocompatible adhesive ensures the safety and non-toxicity of the fixation point, while also creating a smooth transition and reducing tissue drag during puncture. This simple fixing method achieves reliable integration of the microsensor onto the flexible catheter.

[0044] Furthermore, based on the above embodiment, the device also includes a signal transmission line 6. The temperature sensor 5 is electrically connected to the main control module 1 via this signal transmission line 6, and the signal transmission line 6 extends along the outer wall of the indwelling catheter 4b and is fixed thereto. Its design aims to provide a signal path to the external main control module 1 for the temperature sensor 5 fixed at the front end of the catheter. Fixing the signal transmission line 6 along the outer wall prevents it from floating freely inside the body, reduces irritation to surrounding tissues, and prevents entanglement or breakage during catheter removal. This design solves the technical problem of how to reliably extract in-vivo sensor signals from outside the body.

[0045] In another optional implementation, the main control module 1 is configured to execute specific prompting logic. Specifically, a prompting signal is generated when the pressure value corresponding to the pressure signal reaches a preset pressure threshold, and the decrease in temperature value corresponding to the temperature signal relative to the initial temperature value reaches a preset temperature change threshold. The design principle of this prompting logic is based on the correlation of physiological parameters: when the pressure in the fascia compartment changes, the local tissue temperature also changes accordingly. By setting dual thresholds for pressure and temperature, the specificity and accuracy of the prompts can be improved, effectively filtering out false positive prompts caused by fluctuations in a single parameter (such as temporary pressure increases caused by changes in body position), thereby achieving more reliable detection of abnormal physiological states.

[0046] In another optional embodiment, the temperature sensor 5 includes multiple temperature sensing elements spaced axially along the indwelling catheter 4b, each temperature sensing element being electrically connected to the main control module 1 via an independent signal transmission line. Simultaneously, the main control module 1 is configured to calculate the axial temperature gradient within the fascia chamber based on multiple temperature values ​​collected by these temperature sensing elements, and generate a gradient alert signal when the gradient reaches a preset gradient threshold. This design aims to more sensitively capture the dynamic changes in local temperature. Because temperature changes often occur and develop unevenly, a temperature drop first appears in a localized area, thus forming a significant temperature gradient within the fascia chamber. By monitoring this gradient change, early local temperature anomalies can be detected before the average temperature changes significantly, achieving an earlier and more sensitive alert effect than single-point temperature measurement.

[0047] This application also provides an in vivo physiological parameter monitoring method based on any of the above-described devices. The method first uses the pressure sensor 2 to monitor intrafascial pressure via the pressure transmission channel 9 to obtain a pressure signal. This step enables direct and continuous measurement of the core physiological indicator—intrafascial pressure.

[0048] Simultaneously, this method utilizes the temperature sensor 5, fixed to the outer wall of the indwelling catheter 4b, to monitor the tissue temperature within the fascial compartment and obtain a temperature signal. This step, through physical isolation from pressure measurement, simultaneously acquires another key auxiliary physiological indicator (tissue temperature) while ensuring the in vivo nature and accuracy of the measurement.

[0049] Next, the method utilizes the main control module 1 to process the pressure and temperature signals to generate monitoring data. This step integrates and digitizes the raw signals collected by the front-end sensors, preparing for subsequent analysis, display, and transmission.

[0050] Finally, the method uses the transmission module 1a to transmit the monitoring data to the terminal device. This step sends the patient's real-time physiological parameters to the remote monitoring center, enabling continuous, unattended monitoring of the patient and improving monitoring efficiency.

[0051] Furthermore, in an optional embodiment, before the pressure sensor 2 is sealed to the pressure transmission channel 9, the pressure transmission channel 9 is sealed to the fluid injection assembly 7 via the multi-channel connector 8, and there are no air bubbles inside the pressure transmission channel 9. This step is a crucial preliminary operation to ensure the accuracy of pressure measurement. The principle is that the entire pressure transmission path must be completely filled with incompressible liquid. By first connecting the fluid injection assembly 7 to purge air, and then connecting the pressure sensor 2 for measurement, the strict adherence to the Whiteside gold standard for pressure measurement is ensured, which helps to guarantee the reliability of subsequent pressure data from a methodological perspective.

[0052] To provide a clear and complete description of the technical solution of this application, the following explanation will be given in conjunction with the accompanying drawings. Please refer to... Figure 1 and Figure 2 , Figure 1 This embodiment demonstrates the overall structure. Figure 2 The core puncture component's front-end structure is shown. This embodiment provides a basic dual-parameter monitoring device. Its main control module 1 uses an STM32L low-power microcontroller, paired with a 1.5-inch OLED display 3 for on-site data display. The transmission module 1a uses a medical-grade low-power Bluetooth module with a communication distance set to 30 meters. The puncture component (also referred to as the indwelling needle 4 in this embodiment, its specific structure includes a puncture component 4a and an indwelling catheter 4b). The indwelling catheter 4b uses 20G specification medical-grade polyurethane flexible material, with a length of 40mm, and its inner cavity forms a pressure transmission channel 9. The temperature sensor 5 is an ultra-thin flexible film NTC thermistor with dimensions of 0.6mm × 0.8mm and a thickness of 0.1mm. It is attached and fixed to the outer wall of the front end of the indwelling catheter 4b using medical-grade non-volatile biological epoxy adhesive (an adhesive). Its signal is connected to the main control module 1 through a signal transmission line 6, which extends along and is fixed to the outer wall of the indwelling catheter 4b. Pressure sensor 2 is a medical pressure sensor with a range of 0-100 mmHg and an accuracy of ±1 mmHg. A standard three-way Luer connector is used as a multi-channel connector 8 to connect the indwelling catheter 4b, pressure sensor 2, and a 1 mL syringe (as fluid injection assembly 7). Fluid injection assembly 7 is used to inject sterile heparinized saline solution with a concentration of 1-2 U / mL to remove air.

[0053] The working process of this embodiment is as follows: After pre-operation preparation and equipment debugging, the puncture assembly (including puncture component 4a and indwelling catheter 4b) is punctured into the target fascial chamber, and then the puncture component 4a is pulled out, leaving the indwelling catheter 4b inside the target fascial chamber. In the indwelling fixation and air venting steps, before the pressure sensor 2 is sealed and connected to the pressure transmission channel 9, the fluid injection assembly 7 is sealed and connected to the pressure transmission channel 9 through the multi-channel connector 8. Heparinized saline is injected to ensure that there are no air bubbles in the pressure transmission channel 9. After that, the used fluid injection assembly 7 can be separated from the multi-channel connector 8 and then reconnected to the pressure sensor 2. After connection and monitoring is started, the device performs remote and on-site monitoring. The main control module 1 simultaneously collects pressure and temperature data, displays it on the OLED display screen 3, and sends it to the tablet computer (a terminal device) at the nurse station through the transmission module 1a. The logic of this data interaction process is as follows: Figure 3 As shown. Specifically, the terminal device first sends a configuration command to the monitoring device (e.g., setting the sampling frequency, pressure threshold, temperature change threshold, or temperature gradient threshold). After receiving and applying the configuration parameters, the monitoring device returns a configuration success response. Subsequently, the device enters a continuous monitoring phase, which repeatedly performs the following operations in a loop: the monitoring device continuously uploads the collected pressure and temperature values ​​to the terminal device via a real-time data stream, while periodically sending heartbeat packets to maintain the communication connection and confirm that the device is online. During the loop monitoring process, when the main control module 1 determines that the preset prompting conditions are met (e.g., when the pressure in the fascial compartment is ≥30mmHg and the local tissue temperature is ≥0.5℃ lower than the initial temperature), it enters the branch (alt) logic: the monitoring device immediately sends a prompt signal to the terminal device, and the terminal device, upon receiving the prompt signal, issues an audible and visual alarm or highlights the interface to remind medical personnel to handle the situation promptly. If the prompting conditions are not triggered, normal loop monitoring continues.

[0054] In an optional implementation, based on the above embodiments, the device has been optimized to meet the centralized monitoring needs of multiple wards and multiple patients. Its overall structure is similar to... Figure 1 Similarly, its core structure remains the same. Figure 2As shown. The main control module 1 adds an 8MB flash memory chip to locally cache up to 7 days of monitoring data when the wireless signal is interrupted, and automatically synchronizes after the signal is restored to ensure no data loss. Meanwhile, the prompt threshold is designed to be adjustable via the terminal device. The Bluetooth module of the transmission module 1a is upgraded, extending the communication distance to 50 meters, supporting simultaneous connection of more devices, and assigning a unique patient ID code to each device for easy identification and management by the nurse station software. The indwelling catheter 4b is made of 18G specification FEP (fluorinated ethylene propylene copolymer) material, 45mm in length. FEP material has stronger corrosion resistance and biological stability, making it more suitable for long-term indwelling beyond 5 days. The temperature sensor 5 uses a thin-film Pt100 platinum resistance thermometer, which has better stability and linearity in long-term monitoring, with a temperature measurement accuracy of ±0.2℃. For the application scenarios of this embodiment, please refer to [link to relevant documentation]. Figure 4 As shown. In large orthopedic wards A200A and B200B, multiple patients are each equipped with this monitoring device 300. The central monitoring terminal 110 at the nurse station 100 simultaneously displays multiple real-time data curves via patient ID. When a patient's monitoring data generates an alert signal, the system immediately highlights the patient's information and issues an alert sound, allowing medical staff to quickly locate and verify the information. Its signaling interaction logic is as follows: Figure 3 As shown, logic for remote parameter configuration distribution and data retransmission has been added. This embodiment achieves efficient, centralized, long-term, and reliable monitoring of multiple patients.

[0055] In another alternative implementation, the transmission module 1a can employ different technical solutions. For example, [the following can be used]. Figure 1 The Bluetooth module is replaced with a low-power Wi-Fi module. Network configuration functionality is added to the main control module 1's software, allowing the device to configure the Wi-Fi network name (SSID) and password via the nurse station terminal. After configuration, the device directly sends monitoring data to a designated database or data interface on the hospital server via TCP / IP protocol. For this application scenario, please refer to [link to relevant documentation]. Figure 4 Multiple monitoring devices 300 transmit data to the central monitoring terminal 110 or server via a Wi-Fi network. Any authorized doctor or nurse can access the server to view patient data through any computer or mobile device (terminal device) on the hospital intranet, no longer limited by the transmission distance of Bluetooth. This method enables seamless data roaming and access across wards and floors. Data is centrally stored on the server, facilitating subsequent data analysis, review, and electronic medical record integration. It supports centralized data storage and remote access, facilitating subsequent data analysis and electronic medical record integration.

[0056] Furthermore, to simplify the operation process, the multi-channel connector 8 and the fluid injection assembly 7 can be integrated into a single design. For example, it is not necessary to use... Figure 1 The multi-channel connector 8 (such as a standard three-way Luer connector) and fluid injection assembly 7 (syringe) shown are designed with a custom-made Y-type or T-type manifold as the multi-channel connector. One end of the manifold is connected to the indwelling catheter 4b, and the other end is connected to the pressure sensor 2. The third port is designed as a bayonet for connecting a disposable saline cartridge pre-filled with 0.5 mL of sterile heparinized saline (as the fluid injection assembly). After the physician completes the puncture and removes the puncture component 4a, the pressure sensor 2 and the indwelling catheter 4b are connected to the manifold. Then, a sterile saline cartridge is removed, inserted into the third port of the manifold, and the cartridge's piston is pressed once to complete the fluid filling of the pressure transmission channel 9, ensuring it is free of air bubbles. This process simplifies clinical procedures, reducing multi-step air purging into a single step, decreasing operational complexity and potential infection risks, and improving operational consistency and efficiency.

[0057] In another alternative implementation, to more sensitively capture dynamic changes in local temperature, the temperature sensor 5 of this embodiment includes three temperature sensing elements spaced apart along the axial direction of the indwelling catheter 4b. For example, on a 20G, 40mm long indwelling catheter 4b, a temperature sensing element is fixed at a distance of 10mm, 20mm, and 30mm from its front end, respectively, each being a thin-film NTC thermistor. Each temperature sensing element is electrically connected to the main control module 1 via an independent signal transmission line 6. The software of the main control module 1 is configured to simultaneously acquire the temperature values ​​of the three temperature sensing elements and calculate the axial temperature gradient between adjacent sensing units. Specifically, T1, T2, and T3 represent the temperature values ​​measured by the first, second, and third sensing elements arranged sequentially from the front end to the rear among the three temperature sensing elements distributed along the catheter axial direction. The calculation formula is as follows: G1=(T1-T2) / ΔL; Where G1 represents the temperature gradient between the first and second sensing elements, and ΔL represents the axial distance between adjacent temperature sensing elements, i.e., the spacing between sensing units.

[0058] G2=(T2-T3) / ΔL; Here, G2 represents the temperature gradient between the second and third sensing elements.

[0059] When the main control module 1 determines that the gradient value G1 or G2 has reached the preset gradient threshold (e.g., 0.2℃ / cm), even if the overall average temperature change is not significant, the main control module 1 will generate a gradient prompt signal and send it to the terminal device through the transmission module 1a. This gradient-based prompt is more sensitive than prompts based on a single temperature decrease, providing richer physiological information for monitoring and further improving the accuracy of early assessment.

[0060] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this application.

Claims

1. A long-term in vivo monitoring device for intrafascial pressure and temperature, characterized in that, The device includes: An indwelling catheter is used to be placed inside a target fascial compartment. The indwelling catheter includes a hollow inner cavity, which forms a pressure transmission channel for transmitting pressure within the fascial compartment. A pressure sensor, sealed and connected to the pressure transmission channel, is used to convert the intrafascial pressure into a pressure signal. A temperature sensor, fixed to the outer wall of the indwelling catheter and physically isolated from the pressure transmission channel, is used to monitor the tissue temperature in the fascial compartment and convert it into a temperature signal; The main control module is electrically connected to the pressure sensor and the temperature sensor respectively, and is used to receive and process the pressure signal and the temperature signal to generate monitoring data; The transmission module is electrically connected to the main control module and is used to transmit the monitoring data to the terminal device.

2. The apparatus according to claim 1, characterized in that, The device further includes a puncture member, which is detachably inserted into the indwelling catheter and is used to puncture and insert the indwelling catheter into the target fascial compartment.

3. The apparatus according to claim 1, characterized in that, The device also includes a multi-channel connector and a fluid injection assembly; The multi-channel connector is sealed to the indwelling catheter, the pressure sensor and the fluid injection assembly, respectively. The fluid injection assembly is used to inject fluid into the pressure transmission channel through the multi-channel connector.

4. The apparatus according to claim 1, characterized in that, The temperature sensor is fixed to the outer wall of the indwelling catheter with adhesive.

5. The apparatus according to claim 4, characterized in that, The device also includes a signal transmission line, through which the temperature sensor is electrically connected to the main control module. The signal transmission line extends along the outer wall of the indwelling catheter and is fixed to the outer wall of the indwelling catheter.

6. The apparatus according to claim 1, characterized in that, The main control module is configured as follows: When the pressure value corresponding to the pressure signal reaches a preset pressure threshold, and the decrease in the temperature value corresponding to the temperature signal relative to the initial temperature value reaches a preset temperature change threshold, a prompt signal is generated. The transmission module transmits the prompt signal to the terminal device.

7. The apparatus according to claim 1, characterized in that, The temperature sensor includes multiple temperature sensing elements spaced apart along the axial direction of the indwelling catheter, and each of the multiple temperature sensing elements is electrically connected to the main control module through an independent signal transmission line. The main control module is configured to: calculate the axial temperature gradient in the fascia chamber based on multiple temperature values ​​collected by the multiple temperature sensing elements, and generate a gradient prompt signal when the axial temperature gradient reaches a preset gradient threshold.

8. A method for monitoring in vivo physiological parameters based on the device according to any one of claims 1 to 7, characterized in that, The method includes: The pressure sensor is used to monitor the pressure within the fascia chamber via the pressure transmission channel to obtain a pressure signal; The temperature sensor fixed to the outer wall of the indwelling catheter is used to monitor the tissue temperature within the fascia chamber and obtain a temperature signal. The main control module processes the pressure signal and the temperature signal to generate monitoring data; The monitoring data is transmitted to the terminal device using the transmission module.

9. The method according to claim 8, characterized in that, Before the pressure sensor is sealed and connected to the pressure transmission channel, the pressure transmission channel is sealed and connected to the fluid injection assembly through a multi-channel connector, and there are no air bubbles in the pressure transmission channel.

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