Intracranial measurement-external ventricular drainage integrated device

Abstract

The invention provides an intracranial measurement-external ventricular drainage integrated device which comprises a drainage catheter (1) used for external ventricular drainage, the drainage catheter (1) is provided with a hollow tube cavity, and a sensor assembly (3; 4); a mounting seat (7) integrated with the drainage catheter (1) for mounting and connecting the drainage catheter (1) and the sensor assembly (3; 4); a signal processing and wireless transmitting module (6), which is provided with a wireless transmitting module and a signal processing circuit and is used for processing the signal of the sensor assembly (3; 4) and sending the collected signals to monitoring equipment through the wireless transmitting module, the signal processing and wireless transmitting module (6) is configured to be detachably fixed on the mounting seat (7) and send the signals to the sensor assembly (3; and 4) supplying power and communicating with the power supply.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to an integrated device for intracranial measurement and external ventricular drainage. BACKGROUND

[0002] Intracranial pressure (ICP) monitoring is the most commonly used monitoring method for traumatic brain injury (TBI) and is the cornerstone of contemporary neurocritical care. Intracranial pressure monitoring is of great significance in the treatment of traumatic brain injury and neurocritical illness. Intracranial pressure monitoring can accurately reflect the true situation of intracranial pressure. In the early stage, it can find the pathological and physiological changes of brain perfusion and cerebral blood flow, brain metabolism caused by high intracranial pressure. Once the intracranial pressure changes, the clinic can take appropriate measures in time to reduce the incidence of secondary brain injury caused by high intracranial pressure.

[0003] Generally speaking, intracranial pressure monitoring devices can be divided into invasive intracranial pressure monitoring devices and non-invasive intracranial pressure monitoring devices according to whether they are invasive.

[0004] Invasive intracranial pressure monitoring is the most commonly used monitoring method in clinical practice at present and is the gold standard for intracranial pressure monitoring, which can provide relatively reliable basis for clinical treatment and nursing.

[0005] The mainstream invasive intracranial pressure monitoring device on the market at present mainly consists of a probe with built-in sensors (pressure, temperature, etc.), a monitor and a connecting cable; in the monitoring process, the sensor collects the intracranial information of the patient in real time and processes the signal, converts it into an analog signal, and then transmits the analog signal to the monitor through the cable. The monitor calculates and processes the analog signal and finally displays it.

[0006] The invasive intracranial pressure monitor on the market is basically connected by wire. In the monitoring process, the monitor is connected with the intracranial pressure probe through the cable. Part of the intracranial pressure probe is implanted in the patient's intracranial cavity and part of it is exposed outside the patient's body, which has the risk of infection, bleeding, catheter displacement and cerebrospinal fluid leakage. In terms of data transmission, the analog signal is transmitted to the monitor via the cable. Since the analog signal has weak anti-interference ability, it is easily disturbed in the complex electromagnetic environment of the hospital, resulting in inaccurate monitoring data. In addition, when the monitor cable interface fails or the contact is poor, the intracranial pressure value will also be significantly disturbed. During the operation, the intracranial pressure probe needs to be zeroed. The intracranial pressure probe needs to be connected with the non-sterile cable under the operating table and the monitor, which not only makes the operation inconvenient but also has a high risk of pollution.

[0007] CN119925725A discloses an antibacterial, temperature-measuring, and pressure-measuring intracranial drainage device and its usage method, including a sensor module, a drainage module, a signal processing module, and a kit. The sensor module is mounted on the signal processing module. The drainage device of CN119925725A has a sensor module at its front end that can monitor the patient's intracranial pressure and temperature in real time. The ventricular catheter in the drainage device contains a contrast-enhancing substance, allowing clear visualization of the drainage process under CT scans. The outer wall of the ventricular catheter in the drainage device has an antibacterial coating, which can inhibit bacterial growth during surgery and avoid the risk of secondary infection. It eliminates the need to embed a metal rod in the side wall of the ventricular catheter; instead, a core needle from the kit can be inserted into the intracranial catheter before the sensor module is attached. This avoids the risk of retrograde infection of cerebrospinal fluid due to side wall rupture. The inventive concept of CN119925725A focuses on antibacterial design, specifically providing an antibacterial coating on the outer wall of the catheter. One of the technical drawbacks of CN119925725A is that its overly complex and redundant nested design results in an excessively large size for the antibacterial, temperature measurement, pressure measurement, and intracranial drainage devices. Miniaturization is a crucial design consideration for this product. Furthermore, the CN119925725A kit leads to excessive surgical wounds and pain for patients, which is detrimental to minimizing wound size, postoperative healing, and potential complications.

[0008] Therefore, with the development and changes in technology and application scenarios, there is an urgent need in this field for improved, smaller, more compact intracranial sensing-external drainage devices / components with preferred wireless communication to overcome the above-mentioned technical defects and other technical problems in the prior art.

[0009] The information included in this background section of the specification of this invention, including any references cited herein and any descriptions or discussions thereof, is included for technical reference purposes only and is not intended to limit the scope of the invention. Summary of the Invention

[0010] The present invention is proposed in view of the foregoing and other further ideas. The present invention aims to solve the above-mentioned technical deficiencies and other technical problems.

[0011] This invention proposes a novel integrated component combining wireless intracranial pressure sensing and external ventricular drainage, addressing issues such as high infection risk, large size, susceptibility to data transmission interference, and inconvenient operation associated with existing invasive intracranial pressure monitoring devices. Furthermore, it enables patients requiring cerebrospinal fluid drainage to not only receive real-time intracranial pressure monitoring but also to achieve external drainage of bodily fluids such as cerebrospinal fluid, thereby increasing cerebral perfusion pressure, preventing secondary cerebral ischemia, and improving prognosis.

[0012] More specifically, according to the present invention, an integrated device for intracranial measurement and external ventricular drainage is provided, comprising: a drainage catheter (1) for external ventricular drainage having a hollow lumen in which a sensor assembly (3; 4) for measuring intracranial physiological parameters is installed; a mounting base (7) integrated with the drainage catheter (1) for mounting and connecting the drainage catheter (1) and the sensor assembly (3; 4); and a signal processing and wireless transmission module (6) configured with a wireless transmission module and a signal processing circuit for processing the signals collected by the sensor assembly (3; 4) and transmitting them to a monitoring device via the wireless transmission module, wherein the signal processing and wireless transmission module (6) is configured to be detachably fixed on the mounting base (7), powering the sensor assembly (3; 4) and communicating with it.

[0013] According to one embodiment of the present invention, the mounting base (7) has an inner cavity (12), one side of which is connected to a pipe joint for connecting a drainage conduit (1), and the other side is connected to an external drainage joint (11).

[0014] According to an embodiment of the present invention, the tube connector for connecting the drainage catheter (1) includes a pagoda connector, and the external drainage connector (11) includes a Luer connector for connecting the external ventricular drainage collection device to collect cerebrospinal fluid and other body fluids.

[0015] According to one embodiment of the present invention, the pagoda-shaped structure of the pagoda connector can be adapted to drainage catheters 1 with diameters of Fr6-Fr16, allowing medical staff to temporarily replace drainage catheters of appropriate diameters according to different patients and different clinical scenarios.

[0016] According to an embodiment of the present invention, the integrated intracranial measurement-external ventricular drainage device further includes a flow sensor (8) embedded in the signal processing and wireless module (6) for sensing the drainage flow rate. The flow sensor (8) is configured to communicate with the signal processing and wireless transmission module (6) and transmit the data / signals it senses to the signal processing and wireless transmission module (6).

[0017] According to an embodiment of the present invention, the signal processing and wireless transmission module (6) is further configured with at least one of the following: an alarm (9) configured to emit an audible and / or visual alarm locally when the monitored value of the sensor assembly (3) and / or the flow sensor (8) exceeds a warning threshold; and a solenoid valve (10) configured to close when the drainage flow exceeds a warning threshold or in response to an instruction from the signal processing and wireless transmission module (6).

[0018] According to an embodiment of the present invention, the integrated intracranial measurement-external ventricular drainage device further includes an adapter (5), wherein the sensor assembly (3; 4) passes through the cavity (12) and is electrically and communicatively connected to the signal processing and wireless transmission module (6) via the adapter (5).

[0019] According to one embodiment of the present invention, the signal processing and wireless transmission module (6) may also be equipped with a battery for powering the signal processing and wireless transmission module (6) and the sensor assembly (3; 4).

[0020] According to one embodiment of the present invention, the sensor assembly (3; 4) is suspended at a radially central position within the hollow cavity of the drainage conduit (1), thereby leaving a circumferential gap for drainage between the sensor assembly (3; 4) and the inner wall of the drainage conduit (1).

[0021] According to an embodiment of the present invention, the sensor assembly (3; 4) is selected from the following: a sensor (3) and a wire (4) connected thereto, wherein the sensor (3) includes at least one of a pressure sensor and a temperature sensor; an FPC-integrated sensor probe, which includes a sensor or sensor chip (3) integrated on a strip-shaped flexible circuit board (4), wherein the sensor or sensor chip (3) includes at least one of a pressure sensor chip and a temperature sensor chip.

[0022] According to one embodiment of the present invention, the end of the drainage catheter (1) inserted into the cranium is provided with one or more drainage holes (2) in the form of through holes, the diameter of which is smaller than the inner diameter of the drainage catheter (1).

[0023] According to one embodiment of the present invention, the inner and outer surfaces of the drainage catheter (1) are coated with an antibacterial hydrophilic coating.

[0024] According to an embodiment of the present invention, the antibacterial hydrophilic coating comprises at least one of the following: polyvinylpyrrolidone (PVP), polyacrylamide (PAM)-based hydrogel, polyethylene glycol (PEG), nano silver, titanium dioxide, quaternary ammonium salts, biguanides, and antibiotics.

[0025] According to one embodiment of the present invention, the thickness of the antibacterial hydrophilic coating is in the range of 0.1 to 100 micrometers.

[0026] According to one embodiment of the present invention, the drainage catheter (1) is a silicone tube or a thermoplastic polyurethane rubber (TPU) tube.

[0027] According to one embodiment of the present invention, the silicone tube or TPU tube has a length of 250-600 mm and a diameter of 2.0-5.0 mm.

[0028] According to an embodiment of the present invention, the signal processing and wireless transmission module (6) is configured with an analog-to-digital signal conversion circuit, such that the integrated intracranial measurement-external ventricular drainage device is configured to convert analog signals from the sensor components (3; 4) into digital signals for wireless transmission to a monitoring device. The monitoring device may include at least one of the following: a patient monitor, a remote monitoring system, or a monitoring app installed on a computer or mobile terminal, such as a monitoring app running Linux or iOS.

[0029] According to one embodiment of the present invention, the bottom or side of the mounting base (7) is attached with a fastener, the fastener being selected from at least one of the following: double-sided tape, Velcro, adhesive tape and clip.

[0030] According to one embodiment of the present invention, an observation window is provided on the mounting base near the inner cavity to facilitate observation of the drainage within the inner cavity.

[0031] Further embodiments of the present invention can achieve other advantageous technical effects not listed hereafter, which may be partially described below and can be expected and understood by those skilled in the art after reading the present invention.

[0032] The summary portion of this invention is intended to introduce, in a simplified form, the concepts and options that will be further described in the "Detailed Description" section below to aid the reader in understanding the invention. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. All of the foregoing features are to be understood as merely exemplary, and further features and purposes regarding structures and methods can be gleaned from this disclosure. A more complete display of the features, details, utility, and advantages of the invention is provided in the following written description of various embodiments of the invention, illustrated in the accompanying drawings, and defined in the appended claims. Therefore, the many limiting interpretations of the summary cannot be understood without further reading of the entire specification, claims, and drawings. Attached Figure Description

[0033] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, will become more apparent and the embodiments of the invention will be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0034] Figure 1 The diagram schematically illustrates a longitudinal cross-sectional view of the integrated intracranial measurement and external ventricular drainage device according to Embodiment 1 of the present invention.

[0035] Figure 2 schematically illustrated Figure 1 A three-dimensional schematic diagram of the integrated intracranial measurement-external ventricular drainage device of the embodiment shown.

[0036] Figure 3 yes Figure 2 The three-dimensional schematic diagram shown is a view from roughly opposite directions of the integrated intracranial measurement-external ventricular drainage device. It shows the bottom surface of the mounting base of the integrated intracranial measurement-external ventricular drainage device and the observation window set on it to facilitate observation of the drainage situation.

[0037] Figure 4 yes Figure 2 The exploded three-dimensional diagram of the integrated intracranial measurement-external ventricular drainage device shown illustrates its design where the signal processing and wireless transmission modules are detachably mounted on the mounting base.

[0038] Figure 5 The diagram illustrates a signal processing and wireless transmission module according to an embodiment of the present invention, and its communication connection and control with other components / devices.

[0039] Numbering in the diagram: 1-Drainage conduit; 2-Drainage hole; 3-Sensor; 4-Wire; 5-Adapter; 6-Signal processing and wireless transmission module; 7-Mounting base; 8-Flow sensor; 9-Alarm; 10-Solenoid valve; 11-Luer connector; 12-Inner cavity; 13-Observation window. Detailed Implementation

[0040] In the following description of the accompanying drawings and detailed embodiments, details of one or more embodiments of the invention will be set forth. Other features, objects, and advantages of the invention will become apparent from these descriptions, drawings, and claims.

[0041] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the invention without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0042] Similarly, it should be understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. For example, the use of “including,” “contains,” or “has,” and their variations, is intended to include, in an open-ended sense, the items listed thereafter, their equivalents, and any additional items.

[0043] Unless otherwise limited, the terms “connection,” “linkage,” and their variations are used extensively in this document and may include direct and indirect mechanical and / or electrical connections or linkages.

[0044] The present invention will now be explained and described in more detail with reference to several specific embodiments and accompanying drawings.

[0045] Example One

[0046] A longitudinal cross-sectional view of the integrated intracranial measurement-external ventricular drainage device according to Embodiment 1 of the present invention is shown below. Figures 1-4 As shown.

[0047] The basic components of this integrated intracranial measurement-external ventricular drainage device include a drainage catheter 1, a sensor 3, a wire 4, an adapter 5, a signal processing and wireless transmission module 6, and a mounting base 7.

[0048] The drainage catheter 1 can be a hollow catheter with a length of approximately 250-600 mm and a diameter of 2.0-5.0 mm, such as a hollow silicone tube or a hollow tube made of thermoplastic polyurethane rubber (TPU). The drainage catheter 1 may have a drainage hole 2, through which cerebrospinal fluid and other bodily fluids can be drained externally through the drainage hole 2 and the hollow structure of the drainage catheter 1. The inner and outer surfaces of the drainage catheter 1 may be coated with an antibacterial and hydrophilic coating. The antibacterial coating effectively inhibits the adhesion and growth of bacteria and other microorganisms, effectively reducing the risk of intracranial infection; the hydrophilic coating improves the lubrication of the inner wall of the silicone tube, effectively preventing blockage of the drainage catheter 1.

[0049] Sensor 3 can be a pressure sensor, a temperature sensor, or a pressure-temperature sensor (e.g., an integrated pressure-temperature sensor obtained by integrating a pressure sensing chip and a temperature sensing chip), which can be used to collect intracranial temperature and pressure data of patients.

[0050] The wire 4 can be used to conduct the signal collected by the sensor 3.

[0051] Adapter 5 can be used to connect to signal processing and wireless transmission module 6 for data exchange.

[0052] According to a preferred example, for example Figures 1-2As shown, during installation, the sensor 3 and the wire 4 can be suspended at approximately the radial center or central position of the drainage conduit 1, rather than being embedded in or otherwise attached to the sidewall of the drainage conduit (in some related designs, the sensor and wire are embedded in the sidewall of the drainage conduit, thereby weakening the structural strength of the drainage conduit). This construction and arrangement of the present invention can significantly improve the strength of the drainage conduit 1, enhance the inner diameter of the drainage cavity, prevent blockage, and effectively reduce the risk of rupture of the drainage conduit 1.

[0053] Figure 3 yes Figure 2 The three-dimensional schematic diagram of the integrated intracranial measurement-external ventricular drainage device shown, viewed from roughly opposite directions, illustrates the bottom surface of the mounting base 7 and the observation window 13 located on the bottom surface of the mounting base 7 for easy observation of the drainage process. Figures 1-3 As shown, the mounting base 7 has an inner cavity 12, one side of which communicates with a pipe connector for connecting the drainage catheter 1, and the other side communicates with the external drainage connector 11. The observation window 13 can be a closed window made of transparent material, located in the inner cavity 12, to facilitate observation of the drainage.

[0054] Figure 4 yes Figure 2 The exploded three-dimensional schematic diagram of the integrated intracranial measurement-external ventricular drainage device shown illustrates the design of its signal processing and wireless transmission module 6 and mounting base 7 being detachably installed, for example, through snap-fit ​​or plug-in mechanisms.

[0055] The wire 4 can extend from the mounting base 7, or from the side groove of the inner cavity 12, and then be sealed with a cover plate to keep the inner cavity 12 closed for drainage, preventing infection, and preventing the leakage of cerebrospinal fluid from damaging the signal processing and wireless module 6. This design is similar to a waterproof / liquid-tight seal design, making drainage and monitoring independent and preventing mutual contamination.

[0056] The signal processing and wireless transmission module 6 can be used to process the signals collected by the sensor 3 and transmit the signals collected by the sensor 3 to monitoring equipment, such as patient monitors, mobile terminals, etc., via wireless connection methods such as Bluetooth and WiFi, for calculation and display. The signal processing and wireless transmission module 6 is preferably detachable and can be equipped with, for example, a replaceable / rechargeable battery to support long-term operation of the sensor and circuit board, such as more than 3 days. The wireless connection method provided by the signal processing and wireless transmission module 6 can also reduce the constraints of equipment cables on patients, reduce the workload of medical staff, and prevent dangerous situations such as accidental plugging. Moreover, due to the detachable design of the signal processing and wireless transmission module 6, it is also convenient to directly replace or upgrade old or faulty signal processing and wireless transmission modules 6. When patients need to undergo examinations such as MRI (magnetic resonance imaging), the signal processing and wireless transmission module (6) can be removed to avoid component damage or danger. MRI (magnetic resonance imaging) compatibility has high requirements for electronic components. The detachable design can simplify the design difficulty of the signal processing and wireless transmission module (6) and significantly reduce the manufacturing cost.

[0057] Mounting base 7 can be used to install drainage catheter 1, wire 4, adapter 5, and signal processing and wireless transmission module 6. One end of mounting base 7 can be a pagoda connector for connecting drainage catheter 1; the other end of mounting base 7 can be a Luer connector 11, with a hollow pipe structure in the middle for connecting external ventricular drainage collection device to collect cerebrospinal fluid and other bodily fluids. Fixing devices such as double-sided tape, Velcro, adhesive tape, or clips can be attached to the bottom or side of mounting base 7 to attach the entire signal processing and wireless transmission module 6 to, for example, the patient's scalp, greatly facilitating daily maintenance by medical staff.

[0058] Mounting base 7 can be equipped with solenoid valve 10.

[0059] The signal processing and wireless transmission module 6 can be equipped with a flow sensor 8 and an alarm 9 that are connected to it for communication.

[0060] The flow sensor 8 can be installed on the mounting base 7 at a position in fluid communication with the inner cavity 12 to sense the drainage flow rate. On one hand, the flow sensor 8 can be connected to the signal processing and wireless transmission module 6 to transmit the sensed data / signals to the module. On the other hand, the flow sensor 8 can, for example, be used as... Figure 1 The position shown is embedded in the mounting base 7 and communicates with the drainage in the inner cavity 12. For example, it is embedded in the hole in the mounting base 7 that communicates with the inner cavity 12. This allows for the detection of the drainage flow of body fluids such as cerebrospinal fluid through the mounting base 7, calculation of the drainage flow of the patient's body fluids such as cerebrospinal fluid, monitoring whether the drainage catheter is blocked, and wireless transmission of drainage flow information to monitoring equipment such as a patient monitor, on which the patient's drainage flow information is displayed.

[0061] If the patient experiences excessive drainage or blockage of the drainage tube, alarm 9 can be activated to alert medical staff through flashing lights and / or an alarm sound; and / or an alarm sound can be emitted on the patient monitor. If the patient experiences excessive drainage, solenoid valve 10 can be closed to stop drainage, as detailed in the example. Figure 5 As shown. Medical staff can also set intracranial pressure and intracranial temperature alarm values ​​on the patient monitor. When the patient's intracranial pressure or intracranial temperature is higher or lower than the alarm threshold, the patient monitor can activate the alarm 9 via wireless connection to sound an alarm and remind medical staff to take action.

[0062] When clinicians perform intracranial pressure monitoring, they first perform procedures such as scalp incision and skull drilling on the patient's skull, constructing a puncture channel using a brain puncture needle, and then implanting a drainage catheter 1 (along with sensor 3, lead wire 4, etc.) into the patient's cranium. Sensor 3 collects signals such as intracranial temperature and intracranial pressure, and transmits them via lead wire 4 to, for example, an adapter 5 and a signal processing and wireless transmission module 6. The signal processing and wireless transmission module 6 can process the data and convert the signals collected by the sensor into wireless signals, which can be wirelessly connected to a patient monitor (not shown in the illustration) via Bluetooth, WiFi, etc. After receiving and processing the data from the signal processing and wireless transmission module 6, the patient monitor can display the patient's intracranial pressure, intracranial temperature, and other physiological parameters on the screen.

[0063] Example Two

[0064] Based on Embodiment 1, a control valve, such as a solenoid valve 10, is added to the mounting base 7 to control the drainage fluid. Medical staff can set an upper limit threshold for the patient's drainage volume using a patient monitor, which can wirelessly transmit relevant information to the signal processing and wireless transmission module 6. When the flow sensor 8 on the signal processing and wireless transmission module 6 calculates that the patient's drainage fluid volume exceeds the upper limit threshold set by the medical staff, the signal processing and wireless transmission module 6 can control the closure of the solenoid valve 10 on the mounting base 7 to stop drainage. It can also activate the alarm 9 of the signal processing and wireless transmission module 6, or wirelessly activate the alarm on the patient monitor.

[0065] Example Three

[0066] The pagoda connector (or Green connector) of mounting base 7 can be used with drainage catheters 1 of diameters from Fr6 to Fr16. Medical staff can temporarily replace the drainage catheter 1 with one of appropriate diameter according to different patients and different clinical scenarios.

[0067] Example Four

[0068] This fourth embodiment, based on the probe assembly of the PCT international application filed on July 20, 2023 (International Application No.: PCT / CN2023 / 108432, which claims priority to Chinese patent application 2023102231207), further integrates an external ventricular drainage device, thus forming an integrated component of intracranial pressure sensing and external ventricular drainage device according to this fourth embodiment. In this embodiment, the external ventricular drainage device may refer to, but is not limited to, other methods. Figures 1-2 The illustrated construction and components may include, for example, a drainage conduit 1 with a drainage hole 2 serving as the conduit in this PCT application, wherein an FPC-sensor integrated probe, configured with, for example, a sensor 3 and a wire 4, may be installed in the drainage conduit 1, suspended at approximately the radial center or central position of the drainage conduit 1. The external ventricular drainage device may also include at least some or all of the following: a signal processing and wireless transmission module 6, a mounting base 7, a flow sensor 8, an alarm 9, a solenoid valve 10, and a Luer connector 11, to achieve the intended function and effect. The contents of PCT international application PCT / CN2023 / 108432 and its Chinese patent application "Artificial Intelligence-Assisted Intracranial Monitoring System and Probe Assembly Thereof" (application number 2023102231207) are incorporated herein by reference as if directly described herein.

[0069] Beneficial technical effects

[0070] Some of the beneficial technical effects of the present invention include, but are not limited to, those listed below.

[0071] 1) Wireless transmission: Signals are transmitted using wireless connection methods such as Bluetooth and WiFi, eliminating the need for traditional wired connections. This avoids risks such as infection, bleeding, catheter displacement, and cerebrospinal fluid leakage caused by cables, as well as the problem of interference with analog signals transmitted by cables. This improves the accuracy and reliability of monitoring data, while reducing the constraints of equipment cables on patients, reducing the workload of medical staff, and preventing dangerous situations such as accidental plugging.

[0072] 2) Antibacterial and hydrophilic coatings: The antibacterial coating on the inner and outer surfaces of the drainage catheter can effectively inhibit the adhesion and growth of bacteria and other microorganisms, reducing the risk of intracranial infection; the hydrophilic coating improves the lubrication of the inner wall, prevents the drainage catheter from becoming blocked, and ensures smooth drainage.

[0073] 3) Integration and convenience: The entire device is compactly designed, and the mounting base can integrate and fix all components on the patient's scalp, which is convenient for operation and fixation, improves the convenience of use, and reduces the risk of contamination during operations such as zeroing.

[0074] 4) Increased strength of drainage tube: The sensor and wire are suspended in the radial middle or central position of the drainage tube, and are not embedded in the side wall of the drainage tube, which increases the strength of the drainage tube and reduces the risk of drainage tube rupture.

[0075] 5) Aseptic pre-assembly: The present invention and its above embodiments are preferably provided aseptically, that is, aseptic production, pre-assembly and supply. No doctor needs to assemble during the operation. Drainage catheters and sensors can be directly implanted, which simplifies the doctor's operation process and reduces operation time and infection risk.

[0076] Further technical advantages and beneficial effects in the specific embodiments are listed below.

[0077] In this invention, the pressure and temperature sensor 3 and the wire 4 can be suspended in the middle of the drainage catheter 1, and are not embedded in the side wall of the drainage catheter (unlike the sensor and wire of the intracranial pressure sensor kit from Sofisa, France, which are embedded in the side wall of the drainage catheter). This can significantly improve the strength of the drainage catheter 1 and effectively reduce the risk of drainage catheter rupture. It greatly simplifies the structure of the drainage catheter, simplifies the manufacturing process, and reduces production costs.

[0078] The drainage catheter 1 can be a hollow silicone tube or TPU tube with a length of 250-600 mm and a diameter of Fr6-Fr16. The drainage catheter 1 has a drainage hole 2, and its inner and outer surfaces are coated with an antibacterial and hydrophilic coating. This antibacterial and hydrophilic coating effectively inhibits the adhesion and growth of bacteria and other microorganisms, effectively reducing the risk of intracranial infection. It also improves the lubrication of the inner wall of the drainage catheter 1, effectively preventing blockage. The coating composition can include polyvinylpyrrolidone (PVP), polyacrylamide (PAM)-based hydrogel, polyethylene glycol (PEG), nano-silver, titanium dioxide, quaternary ammonium salts, biguanides, antibiotics, etc. The coating thickness ranges from 0.1 to 100 micrometers.

[0079] The drainage catheter 1 can be provided with 4 or more rows of drainage holes evenly distributed along the circumference of the drainage catheter. The diameter of the drainage holes is set to be smaller than the inner diameter of the drainage catheter to prevent hematoma, brain tissue, etc. from blocking the drainage catheter and improve drainage efficiency.

[0080] The signal processing and wireless transmission module 6 converts the analog signals collected by the pressure and temperature sensors 3 into digital signals, which are then transmitted wirelessly to the patient monitor for calculation and display via Bluetooth, WiFi, or other wireless transmission methods. The signal processing and wireless transmission module 6 is equipped with a battery, supporting the sensors and circuit boards for more than three days of operation. Wireless connectivity reduces the burden of equipment cables on patients, lightens the workload of medical staff, and prevents dangerous situations such as accidental plugging and unplugging.

[0081] The signal processing and wireless transmission module 6 can be configured with a flow sensor 8 and an alarm 9. The flow sensor 8 can monitor and calculate the drainage volume of bodily fluids such as cerebrospinal fluid, monitor whether the drainage catheter is blocked, and wirelessly transmit drainage volume information to the patient monitor, where it is displayed. If the patient experiences excessive drainage or drainage catheter blockage, the alarm 9 can be activated to remind medical staff to perform operations and maintenance. Alternatively, the alarm on the patient monitor can be activated wirelessly. The flow sensor 8 of the signal processing and wireless transmission module 6 can be a miniature flow sensor such as an ultrasonic flow sensor or an electromagnetic flow sensor. The alarm 9 can be an alarm light, a buzzer alarm, etc.

[0082] The fixing base 7 can be used to fix the drainage tube 1, the wire 4, the adapter 5 and the signal processing and wireless transmission module 6; one end of the fixing base 7 is a pagoda-shaped structure, which is used to connect the drainage tube 1; one end of the fixing base 7 is a Luer connector 11, and the middle is a hollow pipe structure, which is used to connect the external ventricular drainage collection device to collect cerebrospinal fluid and other body fluids.

[0083] The mounting base 7 can be equipped with a solenoid valve 10 to control the drainage fluid. When the flow sensor 8 on the signal processing and wireless transmission module 6 calculates that the patient's drainage fluid volume exceeds the upper limit set by medical staff, the signal processing and wireless transmission module 6 controls the solenoid valve 10 on the mounting base 7 to close, stopping the drainage. It also activates the alarm 9 of the signal processing and wireless transmission module 6 to sound an alarm, or activates the alarm of the patient monitor via wireless connection.

[0084] The bottom of the mounting base 7 can be made of double-sided adhesive, which can be attached to the patient's scalp, greatly facilitating the daily maintenance by medical staff.

[0085] The pagoda-shaped structure of the fixed base 7 can be adapted to drainage catheters 1 with diameters of Fr6-Fr16. Medical staff can temporarily replace the drainage catheters 1 with appropriate diameters according to different patients and different clinical scenarios.

[0086] Application scenarios

[0087] The integrated intracranial measurement and external ventricular drainage device of the present invention is suitable for various patients who need intracranial pressure monitoring and external ventricular drainage. It has broad application prospects, especially in neurosurgical intensive care units, operating rooms and other places, and can provide strong support for the diagnosis and treatment of diseases such as craniocerebral trauma, cerebral hemorrhage and brain tumors.

[0088] The foregoing description of several embodiments of the invention has been presented for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the invention to the precise features and / or forms disclosed. Clearly, many modifications and variations can be made in light of the teachings above, all of which fall within the scope of this invention.

[0089] Those skilled in the art should understand that the above descriptions are merely illustrative and depiction of specific embodiments, and do not limit the scope of the present invention in any way. The scope of the present invention is defined only by the appended claims.

Claims

1. An integrated device for intracranial measurement and external ventricular drainage, characterized in that, The integrated intracranial measurement-external ventricular drainage device includes: A drainage catheter (1) for external ventricular drainage, having a hollow lumen in which a sensor assembly (3; 4) for measuring intracranial physiological parameters is installed; A mounting base (7) integrated with the drainage catheter (1) is used for mounting and connecting the drainage catheter (1) and the sensor assembly (3; 4); and The signal processing and wireless transmission module (6) is equipped with a wireless transmission module and a signal processing circuit, which is used to process the signals collected by the sensor components (3; 4) and transmit them to the monitoring equipment through the wireless transmission module. The signal processing and wireless transmission module (6) is configured to be detachably fixed on the mounting base (7), supply power to the sensor components (3; 4) and communicate with them.

2. The integrated device for intracranial measurement and external ventricular drainage according to claim 1, characterized in that, The mounting base (7) has an inner cavity (12), one side of which is connected to a pipe joint for connecting a drainage conduit (1), and the other side is connected to an external drainage joint (11).

3. The integrated device for intracranial measurement and external ventricular drainage according to claim 2, characterized in that, The fitting for connecting the drainage catheter (1) includes a pagoda fitting, and the external drainage fitting (11) includes a Luer fitting.

4. The integrated device for intracranial measurement and external ventricular drainage according to claim 1 or 2, characterized in that, The intracranial measurement-external ventricular drainage integrated device further includes a flow sensor (8) embedded in the signal processing and wireless module (6) for sensing the drainage flow rate. The flow sensor (8) is configured to communicate with the signal processing and wireless transmission module (6) and transmit the data / signals it senses to the signal processing and wireless transmission module (6).

5. The integrated device for intracranial measurement and external ventricular drainage according to claim 4, characterized in that, The signal processing and wireless transmission module (6) is further configured with at least one of the following: An alarm (9) is configured to emit an audible and / or visual alarm locally when the monitored value of the sensor assembly (3) and / or the flow sensor (8) exceeds a warning threshold; and The solenoid valve (10) is configured to close when the flow rate exceeds a warning threshold or in response to an instruction from the signal processing and wireless transmission module (6).

6. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The integrated intracranial measurement-external ventricular drainage device further includes an adapter (5), wherein the sensor assembly (3; 4) passes through the lumen (12) and is electrically and communicatively connected to the signal processing and wireless transmission module (6) via the adapter (5).

7. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The sensor assembly (3; 4) is suspended at the radial midpoint within the hollow cavity of the drainage conduit (1), thereby creating a circumferential gap for drainage between the sensor assembly (3; 4) and the inner wall of the drainage conduit (1).

8. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The sensor assembly (3; 4) is selected from one of the following: A sensor (3) and a wire (4) connected thereto, wherein the sensor (3) includes at least one of a pressure sensor and a temperature sensor; and FPC-integrated sensor probe, comprising a sensor or sensor chip (3) integrated on a strip-shaped flexible circuit board (4), wherein the sensor or sensor chip (3) includes at least one of a pressure sensor chip and a temperature sensor chip.

9. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The end of the drainage catheter (1) inserted into the cranium is provided with one or more drainage holes (2) in the form of through holes, the diameter of which is smaller than the inner diameter of the drainage catheter (1).

10. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The inner and outer surfaces of the drainage catheter (1) are coated with an antibacterial hydrophilic coating.

11. The integrated device for intracranial measurement and external ventricular drainage according to claim 10, characterized in that, The antibacterial hydrophilic coating comprises at least one of the following: polyvinylpyrrolidone (PVP), polyacrylamide (PAM)-based hydrogel, polyethylene glycol (PEG), nano silver, titanium dioxide, quaternary ammonium salts, biguanides, and antibiotics.

12. The integrated device for intracranial measurement and external ventricular drainage according to claim 10, characterized in that, The thickness of the antibacterial hydrophilic coating is in the range of 0.1 to 100 micrometers.

13. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The signal processing and wireless transmission module (6) is equipped with an analog-to-digital signal conversion circuit, which enables the integrated intracranial measurement-external ventricular drainage device to convert analog signals from the sensor components (3; 4) into digital signals and transmit them wirelessly to the monitoring device.

14. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The bottom or side of the mounting base (7) is fitted with a fastener, which is selected from at least one of the following: double-sided tape, Velcro, adhesive tape and clip.

15. The integrated device for intracranial measurement and external ventricular drainage according to claim 2 or 3, characterized in that, An observation window (13) is provided on the mounting base (7) near the inner cavity (12) to facilitate observation of the drainage inside the inner cavity.

16. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The signal processing and wireless transmission module (6) is also equipped with a battery for powering the signal processing and wireless transmission module (6) and the sensor assembly (3; 4).

17. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The monitoring equipment includes at least one of the following: a patient monitor, a remote monitoring system, or a monitoring app installed on a computer or mobile terminal.

18. The integrated device for intracranial measurement and external ventricular drainage according to any one of the preceding claims, characterized in that, The drainage catheter (1) is a silicone tube or a TPU tube, wherein the length of the silicone tube or TPU tube is 250-600mm and the diameter is 2.0-5.0mm.

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