Implantable catheter device for intracranial pressure monitoring

Abstract

The invention provides an implantable catheter device for intracranial pressure monitoring, which comprises an implantable catheter, an extracranial functional shell, a pressure sensor, a flexible diaphragm and a detection circuit board, and is characterized in that the extracranial functional shell is connected with the upper end of the implantable catheter; the implantation catheter comprises a rigid supporting tube section connected into a skull hole in a penetrating mode and a tail end flexible catheter extending into the intracranial space through the skull hole, a detection circuit board is arranged in the extracranial functional shell, and a horizontally-arranged flexible diaphragm is fixedly arranged in an inner cavity of the rigid supporting tube section; the closed space is located on the upper side of the flexible diaphragm and can be used for installing a pressure sensor, the pressure conduction area is located on the lower side of the flexible diaphragm and is responsible for signal transmission, and the pressure sensor is located in the closed space above the flexible diaphragm and electrically connected with the detection circuit board. The tissue damage risk after implantation can be reduced, the comfort level of a patient is improved, the single collection direction is avoided, and the coverage range of a collection area can be enlarged.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an implantable catheter device for intracranial pressure monitoring. Background Art

[0002] Intracranial pressure monitoring is a key medical technology that is widely used in the fields of neurosurgery and critical care medicine for the diagnosis and treatment of diseases such as cerebral hemorrhage, hydrocephalus, and craniocerebral injury. By monitoring changes in intracranial pressure in real time, doctors can assess the progression of the disease, develop treatment plans, and prevent serious complications (such as brain herniation). High-precision intracranial pressure monitoring usually requires the use of an implantable catheter device, which collects the patient's intracranial pressure signal and transmits it to an external monitoring system for data processing.

[0003] Existing implantable intracranial pressure monitoring devices usually include a catheter and a set of pressure sensors. The catheter enters the skull through a skull hole, with its end close to the brain tissue, which is used to capture intracranial pressure and transmit it to the pressure sensor installed in the catheter. In some devices, the design of the catheter end relies only on the bottom opening to transmit intracranial pressure in a single direction. However, this single-point collection method may cause incomplete pressure transmission due to the position of brain tissue, fluid flow path or other interference factors. In addition, the catheters in existing devices are mostly made of rigid materials, which have poor adaptability to the flexible intracranial environment and are prone to compressing brain tissue, causing postoperative discomfort or even damage. Summary of the invention

[0004] The present application provides an implantable catheter device for intracranial pressure monitoring, which is used to solve the problems of single data collection direction of implantable catheter devices used for intracranial pressure monitoring in the prior art and insufficient adaptability of catheters made of rigid materials in flexible intracranial environments.

[0005] The present application is implemented as follows: an implantable catheter device for intracranial pressure monitoring comprises an implant catheter, an extracranial functional shell, a pressure sensor, a flexible diaphragm and a detection circuit board, wherein the extracranial functional shell is connected to the upper end of the implant catheter, the implant catheter comprises a rigid support pipe section inserted into a skull hole and a terminal flexible catheter extending through the skull hole to the intracranial space, the detection circuit board is arranged in the extracranial functional shell, the inner cavity of the rigid support pipe section is fixedly provided with a horizontally arranged flexible diaphragm, the inner cavity of the rigid support pipe section is divided by the flexible diaphragm into a closed space on the upper side of the flexible diaphragm for installing the pressure sensor and a pressure conduction area on the lower side of the flexible diaphragm responsible for signal transmission, the pressure sensor is located in the closed space above the flexible diaphragm and is electrically connected to the detection circuit board;

[0006] The rigid support tube segment is a rigid tube body with a hollow tube structure at the lower end and a cylindrical connecting end at the upper end. The upper end of the rigid support tube segment is located outside the skull and connected to the bottom end of the extracranial functional shell. The other end of the rigid support tube segment extends into the skull hole. The terminal flexible catheter is arranged at the lower end of the rigid support tube segment and connected to the rigid support tube segment as a whole. The inner cavity of the terminal flexible catheter is connected to the inner cavity of the rigid support tube segment to form a pressure conduction channel. The bottom end of the terminal flexible catheter is arranged in an arc-shaped protrusion and is close to the inner cavity of the rigid support tube segment. The surface of the brain tissue, the terminal flexible catheter is provided with a plurality of groups of micropores connected with the inner cavity of the terminal flexible catheter, the plurality of groups of micropores include terminal flow guide holes, lateral pressure transmission holes and inclined pressure transmission holes, the terminal flow guide holes are distributed on the arc-shaped convex surface of the terminal flexible catheter, the lateral pressure transmission holes are circumferentially and horizontally uniformly opened on the side wall of the terminal flexible catheter, the inclined pressure transmission holes are circumferentially and uniformly opened on the side wall of the terminal flexible catheter and are arranged at intervals with the lateral pressure transmission holes, and the inclined pressure transmission holes and the lateral pressure transmission holes are staggered in height.

[0007] In an optional embodiment, the flexible diaphragm is made of medical grade silicone rubber or polyurethane material, the edge of the flexible diaphragm is sealed and connected to the inner cavity wall of the rigid support tube segment by sealant or hot melt process, the inner cavity wall of the rigid support tube segment is fixedly provided with a fixed bracket located above the flexible diaphragm, the fixed bracket includes a circular ring frame and a fixed plate, the annular outer wall of the circular ring frame is fixedly connected to the inner cavity wall of the rigid support tube segment, the upper end of the circular ring frame is fixedly provided with the fixed plate, the bottom end of the fixed plate is provided with a mounting groove for embedding and installing the pressure sensor, the pressure sensor is fixedly installed in the mounting groove at the bottom end of the fixed plate, the sensitive surface of the pressure sensor for sensing the pressure signal faces downward and is bonded to the top surface of the flexible diaphragm by elastic sealant, and the bottom end surface of the circular ring frame is bonded to the circumferential edge of the top surface of the flexible diaphragm.

[0008] In an optional embodiment, the flexible diaphragm is disposed in an inner cavity of the rigid support tube segment close to a side of the terminal flexible catheter.

[0009] In an optional embodiment, a connecting hole for connecting with the rigid support tube segment is provided at the center of the bottom end of the extracranial functional shell, and the top end of the rigid support tube segment is a closed end. The top end of the rigid support tube segment is connected to the connecting hole in a threaded and elastically snap-fit ​​manner. The rigid support tube segment is provided with annular grooves and external threads distributed in sequence up and down on the tube wall portion connected to the extracranial functional shell, and the connecting hole has an internal thread threadedly connected to the rigid support tube segment. The inner wall of the connecting hole is also provided with an elastic buckle elastically snap-fitted with the annular groove. When the rigid support tube segment is threadedly connected to the extracranial functional shell, the elastic buckle can automatically embed into the annular groove on the rigid support tube segment, forming a double lock to prevent loosening.

[0010] In an optional embodiment, the extracranial functional shell is coated with an elastic sealing coating on the threaded connection surface of the connection hole.

[0011] In an optional embodiment, the bottom end of the rigid support pipe section is provided with a circle of circumferentially arranged conical nesting grooves, and the top end of the terminal flexible conduit is provided with a circle of circumferentially arranged conical embedding protrusions that are adapted to the shape of the conical nesting grooves, and the conical embedding protrusions adopt a conical cross-sectional structure that gradually increases from bottom to top, and the terminal flexible conduit is connected to the rigid support pipe section through the conical embedding protrusions, and the conical embedding protrusions are also bonded and fixed together with the conical nesting grooves when connected.

[0012] In an optional embodiment, the inclined pressure transmission hole is located above or below the lateral pressure transmission hole, or the inclined pressure transmission hole is alternately located above and below the lateral pressure transmission hole, the vertical spacing between the inclined pressure transmission hole and the lateral pressure transmission hole is 0.5-2mm, and the inclined pressure transmission hole is arranged to be opened from the outer wall to the inner wall of the terminal flexible catheter in an inclined manner from bottom to top.

[0013] In an optional embodiment, the extracranial functional shell is made of medical titanium alloy, the extracranial functional shell is in the shape of a cylinder or an elliptical shell, and the upper surface of the extracranial functional shell is flat or adopts a streamlined curved surface structure;

[0014] The rigid support tube segment is made of polyetheretherketone material, the length of the rigid support tube segment ranges from 5 mm to 10 mm, the rigid support tube segment is located in the skull hole, and the lower end of the rigid support tube segment is flush with or indented from the bottom end of the skull hole;

[0015] The terminal flexible catheter is made of medical-grade silicone rubber or polyurethane material, and the length of the terminal flexible catheter ranges from 10 mm to 25 mm; the length ratio of the rigid support pipe section to the terminal flexible catheter is set to 1:2-3.

[0016] In an optional implementation, the pressure sensor is a micro piezoresistive sensor, and a MEMS pressure sensor is used.

[0017] In an optional implementation, the detection circuit board is integrated with a signal acquisition module, a signal processing module, a wireless transmission module and a power management module;

[0018] The input end of the signal acquisition module is connected to the output end of the pressure sensor through a cable, and is used to receive the pressure signal collected by the pressure sensor; the input end of the signal processing module is connected to the output end of the signal acquisition module, and is used to filter, amplify and digitize the pressure signal; the wireless transmission module includes a wireless transmission chip and a loop antenna, the input end of the wireless transmission chip is connected to the output end of the signal processing module, and the loop antenna is signal-connected to the wireless transmission chip, and is used to transmit the processed pressure signal to an external device through wireless communication; the output end of the power management module is respectively connected to the power input ends of the signal acquisition module, the signal processing module and the wireless transmission module, and is used to provide power; the loop antenna is embedded in the top inner wall of the extracranial functional shell.

[0019] Compared with the prior art, this application has the following beneficial effects:

[0020] 1. The implant catheter of the present application includes a rigid support tube segment inserted into the skull hole and a terminal flexible catheter extending through the skull hole to the intracranial space. The implant catheter adopts a design method combining a rigid support tube segment and a terminal flexible catheter. The rigid support tube segment provides mechanical stability, which can keep the rigid support tube segment stable in the skull hole, effectively avoiding the position deviation of the implant catheter, thereby ensuring the reliability of signal acquisition. The terminal flexible catheter can enhance the adaptability to the complex soft tissue environment in the skull. By using the terminal flexible catheter to get close to the surface of the brain tissue, the risk of tissue damage after implantation can be reduced, the pressure and friction on the brain tissue can be reduced, and the risk of inflammation and postoperative complications can be reduced, thereby improving the patient's comfort.

[0021] 2. The present application adopts a flexible diaphragm to realize the inner cavity separation design of the rigid support pipe segment. The flexible diaphragm is arranged horizontally in the inner cavity of the rigid support pipe segment, and can separate the inner cavity of the rigid support pipe segment into a closed space on the upper side and a pressure conduction area on the lower side. The edge of the flexible diaphragm is closely fitted with the inner cavity wall of the rigid support pipe segment to form a closed pressure conduction path. Since the flexible diaphragm effectively isolates the closed space where the pressure conduction area and the pressure sensor are located, it can prevent cerebrospinal fluid or external impurities from entering the area where the pressure sensor is located, and provide a stable and clean working environment for the pressure sensor. This isolation design reduces external interference while extending the service life of the pressure sensor and improving the accuracy of pressure acquisition. The establishment of a closed conduction path can effectively reduce the leakage of pressure during the conduction process, thereby improving the integrity and accuracy of pressure transmission. Moreover, the flexible diaphragm can play a buffering role in the pressure transmission process, reducing the direct impact of dynamic pressure fluctuations on the pressure sensor, thereby improving the stability and reliability of monitoring data.

[0022] 3. This application designs the bottom end of the terminal flexible catheter to be an arc-shaped protrusion, and opens multiple groups of microholes on the surface and side walls of the arc-shaped protrusion, including terminal flow guide holes, lateral pressure transmission holes, and inclined pressure transmission holes. These microholes are distributed in a combined manner to achieve a multi-directional pressure collection design. This application collects the pressure directly below the catheter through the terminal flow guide hole, collects the lateral pressure through the lateral pressure transmission hole, and collects the pressure of the oblique flow through the inclined pressure transmission hole, which can greatly improve the coverage of the collection area and make the pressure collection more comprehensive. Even if the pressure collection in one direction is disturbed, the microholes in other directions can still work normally, thereby ensuring the integrity of pressure transmission and the continuity of data. The design of multiple groups of microholes enables the device to provide a more reliable pressure monitoring effect in a complex intracranial environment. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, a brief introduction will be given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0024] Figure 1 An exploded schematic diagram of an implantable catheter device for intracranial pressure monitoring provided by an embodiment of the present application;

[0025] Figure 2 A schematic diagram of the overall structure of an implantable catheter device for intracranial pressure monitoring provided by an embodiment of the present application;

[0026] Figure 3 A schematic diagram of the structure of a rigid support pipe section provided in one embodiment of the present application;

[0027] Figure 4 A schematic diagram of a flexible diaphragm in a rigid support pipe section provided in an embodiment of the present application;

[0028] Figure 5 A three-dimensional schematic diagram of an extracranial functional shell provided in one embodiment of the present application;

[0029] Figure 6 A schematic diagram of the connection between the extracranial functional shell and the rigid support tube segment provided in one embodiment of the present application;

[0030] Figure 7 A schematic diagram of the structure of a terminal flexible catheter provided in one embodiment of the present application;

[0031] Figure 8 A schematic diagram of installing a pressure sensor provided in one embodiment of the present application on a fixed bracket;

[0032] Fig. 9 A schematic diagram of the structure of a detection circuit board provided in one embodiment of the present application.

[0033] Fig.10 A schematic diagram of the structure of a wireless transmission module provided in one embodiment of the present application.

[0034] In the figure, 100, implant catheter; 110, rigid support pipe section; 111, annular groove; 112, external thread; 113, fixed bracket; 1131, circular ring frame; 1132, fixing plate; 114, conical nesting groove; 120, terminal flexible catheter; 121, terminal guide hole; 122, lateral pressure transmission hole; 123, inclined pressure transmission hole; 124, conical embedded protrusion; 200, extracranial functional shell; 210, connecting hole; 211, elastic buckle; 300, pressure sensor; 400, flexible diaphragm; 500, detection circuit board; 510, signal acquisition module; 520, signal processing module; 530, wireless transmission module; 531, wireless transmission chip; 532, loop antenna; 540, power management module. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application is clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work also fall within the scope of protection of the present application.

[0036] See also Figure 1-Figure 10The embodiment of the present application provides an implantable catheter device for intracranial pressure monitoring, including an implant catheter 100, an extracranial functional shell 200, a pressure sensor 300, a flexible diaphragm 400 and a detection circuit board 500. The extracranial functional shell 200 is connected to the upper end of the implant catheter 100. The implant catheter 100 includes a rigid support tube segment 110 inserted into a skull hole and a terminal flexible catheter 120 extending through the skull hole to the intracranial space. A detection circuit board 500 is arranged in the extracranial functional shell 200. A horizontally arranged flexible diaphragm 400 is fixedly arranged in the inner cavity of the rigid support tube segment 110. The inner cavity of the rigid support tube segment 110 is divided by the flexible diaphragm 400 into a closed space on the upper side of the flexible diaphragm 400 for installing the pressure sensor 300 and a pressure conduction area on the lower side of the flexible diaphragm 400 responsible for signal transmission. The pressure sensor 300 is located in the closed space above the flexible diaphragm 400 and is electrically connected to the detection circuit board 500.

[0037] In this embodiment, Figure 1-Figure 4 As shown, the rigid support tube segment 110 is a rigid tube body with a hollow tube structure at the lower end and a cylindrical connecting end at the upper end. The diameter of the cylindrical connecting end at the upper end of the rigid support tube segment 110 is larger than the diameter of the hollow tube body at the lower end, so as to facilitate the installation and connection of the rigid support tube segment 110 and the extracranial functional shell 200. The upper end of the rigid support tube segment 110 is located outside the skull and connected to the bottom end of the extracranial functional shell 200. The other end of the rigid support tube segment 110 extends into the skull hole. The terminal flexible catheter 120 is arranged at the lower end of the rigid support tube segment 110 and is connected to the rigid support tube segment 110 as a whole. The inner cavity of the terminal flexible catheter 120 is connected to the inner cavity of the rigid support tube segment 110 to form a pressure conduction channel. The bottom end of the terminal flexible catheter 120 is arranged in an arc-shaped protrusion and is close to the surface of the brain tissue. The terminal flexible catheter 120 is provided with a pressure conducting channel connected to the terminal flexible catheter 120. The flexible conduit 120 has multiple groups of micropores connected to the inner cavity, and the multiple groups of micropores include terminal flow guide holes 121, lateral pressure transmission holes 122 and inclined pressure transmission holes 123. The terminal flow guide holes 121 are distributed on the arc-shaped convex surface of the terminal flexible conduit 120, the lateral pressure transmission holes 122 are evenly arranged on the side wall of the terminal flexible conduit 120 in an annular direction, and the inclined pressure transmission holes 123 are evenly arranged on the side wall of the terminal flexible conduit 120 in an annular direction and are arranged at intervals with the lateral pressure transmission holes 122, and the inclined pressure transmission holes 123 and the lateral pressure transmission holes 122 are staggered in height.

[0038] The implantable catheter device for intracranial pressure monitoring provided in the embodiment of the present application comprises an implantable catheter 100 including a rigid support tube segment 110 inserted into the skull hole and a terminal flexible catheter 120 extending through the skull hole to the intracranial space. The implantable catheter 100 adopts a design method combining the rigid support tube segment 110 and the terminal flexible catheter 120. The rigid support tube segment 110 provides mechanical stability, which can keep the rigid support tube segment 110 stable in the skull hole, effectively avoiding the position deviation of the implantable catheter 100, thereby ensuring the reliability of signal acquisition. The terminal flexible catheter 120 can enhance the adaptability to the complex soft tissue environment in the skull. By approaching the surface of the brain tissue through the terminal flexible catheter 120, the risk of tissue damage after implantation can be reduced, the pressure and friction on the brain tissue can be reduced, and the risk of inflammation and postoperative complications can be reduced, thereby improving the comfort of the patient.

[0039] At the same time, in the embodiment of the present application, a flexible diaphragm 400 is used to realize the inner cavity separation design of the rigid support pipe segment 110. The flexible diaphragm 400 is horizontally arranged in the inner cavity of the rigid support pipe segment 110, and can separate the inner cavity of the rigid support pipe segment 110 into a closed space on the upper side and a pressure conduction area on the lower side. The edge of the flexible diaphragm 400 is closely fitted with the inner cavity wall of the rigid support pipe segment 110 to form a closed pressure conduction path. Since the flexible diaphragm 400 effectively isolates the closed space where the pressure conduction area and the pressure sensor are located, it can prevent cerebrospinal fluid or external impurities from entering the area where the pressure sensor is located, and provide a stable and clean working environment for the pressure sensor. This isolation design reduces external interference while extending the service life of the pressure sensor and improving the accuracy of pressure acquisition. The establishment of a closed conduction path can effectively reduce the leakage of pressure during the conduction process, thereby improving the integrity and accuracy of pressure transmission. Moreover, the flexible diaphragm 400 can play a buffering role in the pressure transmission process, reducing the direct impact of dynamic pressure fluctuations on the pressure sensor, thereby improving the stability and reliability of monitoring data.

[0040] In addition, in this embodiment, the bottom end of the terminal flexible catheter 120 is designed to be an arc-shaped protrusion, and multiple groups of micropores are opened on the surface and side walls of the arc-shaped protrusion, including the terminal flow guide hole 121, the lateral pressure transmission hole 122 and the inclined pressure transmission hole 123. These micropores are distributed in a combined manner to achieve a multi-directional pressure collection design. In this embodiment, the pressure directly below the catheter is collected through the terminal flow guide hole 121, the lateral pressure is collected through the lateral pressure transmission hole 122, and the pressure of the oblique flow is collected through the inclined pressure transmission hole 123, which can greatly improve the coverage of the collection area and make the pressure collection more comprehensive. Even if the pressure collection in one direction is disturbed, the micropores in other directions can still work normally, thereby ensuring the integrity of pressure transmission and the continuity of data. The design of multiple groups of micropores enables the device to provide a more reliable pressure monitoring effect in a complex intracranial environment.

[0041] In some embodiments, the flexible membrane 400 is made of medical grade silicone rubber or polyurethane material, and the edge of the flexible membrane 400 is sealed and connected to the inner cavity wall of the rigid support tube section 110 by sealant or hot melt process, such as Figure 8 As shown, a fixing bracket 113 located above the flexible diaphragm 400 is fixedly arranged on the inner cavity wall of the rigid support pipe section 110, and the fixing bracket 113 includes a circular ring frame 1131 and a fixing plate 1132. The annular outer wall of the circular ring frame 1131 is fixedly connected to the inner cavity wall of the rigid support pipe section 110, and a fixing plate 1132 is fixedly arranged on the upper end of the circular ring frame 1131. The bottom end of the fixing plate 1132 is provided with a mounting groove for embedding and installing the pressure sensor 300. The pressure sensor 300 is fixedly installed in the mounting groove at the bottom end of the fixing plate 1132. The sensitive surface of the pressure sensor 300 for sensing the pressure signal faces downward and is bonded to the top surface of the flexible diaphragm 400 through an elastic sealant, and the bottom end surface of the circular ring frame 1131 is bonded to the circumferential edge of the top surface of the flexible diaphragm 400.

[0042] In the above structure, the edge of the flexible diaphragm 400 is sealed and connected to the inner cavity wall of the rigid support tube section 110 by means of sealant or hot melt process. This sealing method effectively prevents the leakage of gas or liquid, thereby ensuring the integrity and accuracy of the pressure during the transmission process. The hot melt process can form a uniform and stable sealing layer, which is suitable for long-term implantation and can withstand temperature fluctuations and liquid erosion in the human body, thereby enhancing the mechanical stability of the flexible diaphragm 40 and avoiding the possible falling off or loosening of the edge during long-term use. When the flexible diaphragm 400 is sealed and connected to the inner cavity wall of the rigid support tube segment 110 using sealant, it is necessary to clean the inner cavity wall of the rigid support tube segment 110 and the edge of the flexible diaphragm 400, remove impurities or grease that may affect the bonding effect, select medical-grade sealant (such as silicone glue or polyurethane glue) to meet the biocompatibility requirements of the implant device, and then evenly apply a circle of sealant on the edge of the flexible diaphragm 400, or evenly apply sealant on the contact area of ​​the inner cavity wall of the rigid support tube segment 110, and then directly fit the flexible diaphragm 400 to the target position of the inner cavity wall, and then cure it, so that the flexible diaphragm 400 is firmly connected while maintaining sealing. When the flexible diaphragm 400 is fixed using a hot melt process, a thermoplastic material (such as silicone rubber or polyurethane material of the flexible diaphragm) can be used to form a molten state after heating, and directly bonded to the inner cavity wall of the rigid support tube segment 110. After cooling, the material returns to a solid state and forms a high-strength seal.

[0043] In the selection of materials for making the flexible diaphragm 400, it is necessary to comprehensively consider the biocompatibility, mechanical properties, sealing properties and usage scenario requirements of the material. In the embodiment of the present application, it is particularly suitable to use medical grade silicone rubber to make the flexible diaphragm 400. The flexible diaphragm 400 made of medical grade silicone rubber has good flexibility, is suitable for the requirements of the dynamic pressure conduction path, and can maintain adaptability in the complex intracranial environment. Moreover, it is easy to achieve an efficient sealed connection with the rigid support tube segment 110. It also supports hot melt and molding processes, which is easy to achieve assembly. In addition, it has excellent biocompatibility, is suitable for long-term implantation in the human body, and is safe and reliable.

[0044] The pressure sensor 300 is fixed by the mounting groove of the fixed bracket 113, with its sensitive surface facing downward, and bonded to the top surface of the flexible diaphragm 400 by an elastic sealant. The fixed bracket 113 is composed of a circular ring frame 1131 and a fixed plate 1132, wherein the annular outer wall of the circular ring frame 1131 is fixedly connected to the inner cavity wall of the rigid support pipe section 110 to form a stable installation frame to prevent the pressure sensor 300 from shifting or falling off due to vibration or environmental changes. The fixed plate 1132 provides a precise positioning platform for the sensor to avoid measurement deviations due to installation errors or external forces. The use of elastic sealant can not only make the pressure sensor 300 in close contact with the flexible diaphragm 400 to improve the efficiency of pressure transmission, but also alleviate the mechanical shock that may be generated during the external pressure transmission process and protect the sensitive components of the pressure sensor 300.

[0045] In this embodiment, the dual connection mode of the pressure sensor 300 and the flexible diaphragm 400, i.e., the mechanical fixation of the mounting groove and the bonding of the sensitive surface of the pressure sensor 300 and the flexible diaphragm 400, can optimize the pressure transmission path. The circumferential edge of the top of the flexible diaphragm 400 is bonded to the bottom end surface of the annular frame 1131, which further prevents the flexible diaphragm 400 from loosening or positional displacement. During use, the pressure can directly and effectively act on the sensitive surface of the pressure sensor 300, which can shorten the pressure transmission path and reduce signal attenuation, thereby improving the sensitivity and accuracy of monitoring, so that even under slight pressure changes, high-precision measurements can be achieved.

[0046] In addition, the provision of the annular frame 1131 and the fixing plate 1132 reduces unnecessary structural interference around the pressure sensor 300 and can also enhance the mechanical strength and stability of the device. The optimization of the overall sealing structure allows the bottom end of the annular frame 1131 to be bonded to the circumferential edge of the flexible diaphragm 400 to form an independent pressure transmission closed space. This closed space can effectively isolate the interference of the external environment (such as cerebrospinal fluid) on the pressure transmission path, thereby improving the reliability of the device.

[0047] In some embodiments, the flexible diaphragm 400 is disposed in the inner cavity of the rigid support tube section 110 on a side close to the terminal flexible conduit 120 .

[0048] In the above embodiment, the flexible diaphragm 400 is arranged in the inner cavity of the rigid support pipe section 110 near the end flexible conduit 120. This position layout optimizes the installation position of the flexible diaphragm 400, making it closer to the initial area of ​​pressure transmission, which helps to reduce the path length and interference of pressure during transmission. The flexible diaphragm 400 is close to the pressure acquisition source, which can effectively reduce the attenuation and distortion of the signal and improve the accuracy and real-time performance of pressure transmission. Moreover, the position of the flexible diaphragm 400 is close to the end flexible conduit 120, which optimizes the pressure transmission path. Through such a design, the flexible diaphragm 400 and the pressure sensor 300 will cooperate more closely, and the pressure can be directly transmitted from the end flexible conduit 120 to the diaphragm 400 and act on the sensitive surface of the pressure sensor 300, reducing the redundant links in the transmission path, thereby improving the resolution and sensitivity of pressure transmission, and even small pressure changes can be better and quickly captured. In addition, this installation method reduces the occupation of the top space of the rigid support pipe section 110 by the flexible diaphragm 400, leaving more layout space for the pressure sensor 300 and the connecting cable.

[0049] In some embodiments, Figure 1 and Figure 2 As shown, the center of the bottom end of the extracranial functional shell 200 is provided with a connection hole 210 for connecting with the rigid support pipe section 110, and the top end of the rigid support pipe section 110 is a closed end. Figure 6 As shown, the top end of the rigid support tube segment 110 is connected to the connecting hole 210 in a threaded and elastically clamped manner, and the rigid support tube segment 110 is provided with an annular groove 111 and an external thread 112 distributed successively up and down in the tube wall portion connected to the extracranial functional shell 200, and the connecting hole 210 has an internal thread threadedly connected to the rigid support tube segment 110, and the inner wall of the connecting hole 210 is also provided with an elastic buckle 211 elastically clamped to the annular groove 111, and when the rigid support tube segment 110 is threadedly connected to the extracranial functional shell 200, the elastic buckle 211 can automatically embed into the annular groove 111 on the rigid support tube segment 110, forming a double lock to prevent loosening.

[0050] In this embodiment, optionally, the elastic buckle 211 is an annular structure, which is a fully enclosed ring as a whole. The elastic buckle 211 has an arc-shaped raised surface protruding toward one side of the annular groove 111. The elastic buckle 211 can be made of medical grade stainless steel or PEEK, polyurethane material.

[0051] In the above structure, the threaded connection provides a preliminary mechanical fixation for the rigid support pipe section 110 and the extracranial functional shell 200, ensuring the stability and accuracy of the connection. At the same time, the embedded design of the elastic buckle 211 can provide additional safety protection and enhance the vibration resistance of the overall connection. The double locking structure not only prevents loosening and detachment, but also reduces the wear or damage of the connection parts caused by mechanical stress concentration during long-term use.

[0052] The elastic buckle 211 can be automatically embedded in the process of thread tightening, and form a close fit with the annular groove 111. This design further reduces the tiny gap at the connection and reduces the risk of erosion of the connection area by external fluids (such as cerebrospinal fluid).

[0053] Moreover, this connection design also takes into account the need for disassembly of the device. Through the threaded connection, the rigid support pipe section 110 can be disassembled by rotation when necessary. This flexibility facilitates maintenance and replacement of the device, reduces additional trauma to the patient, and improves the operability of the device.

[0054] In some embodiments, the extracranial functional shell 200 is coated with an elastic sealing coating on the threaded connection surface of the connection hole 210, which can effectively fill the tiny gap that may appear during the threaded connection, thereby improving the sealing performance. The elastic sealing coating is made of medical-grade materials (such as silicone rubber or polyurethane coating), has excellent elasticity and chemical resistance, can maintain stable performance for a long time in the complex environment of the human body, and adapt to changes in humidity and temperature.

[0055] Moreover, the elastic sealing coating can improve the sealing effect and also has a certain damping effect. During the threaded connection process, the elastic sealing coating further improves the connection stability between the rigid support tube section 110 and the extracranial functional shell 200 by increasing the friction force. This damping effect can effectively prevent the threads from loosening due to vibration or long-term use, thereby ensuring the long-term reliability of the device after implantation.

[0056] At the same time, the flexibility of the elastic sealing coating enables it to buffer the stress concentration at the mechanical connection and reduce the damage to the threaded connection surface caused by long-term mechanical fatigue. Especially in the case of slight vibration or displacement, the coating can still maintain the tightness of the connection and extend the service life of the device. In addition, the elastic sealing coating also plays a role in waterproofing and anti-corrosion protection of the connection part, further improving the safety and durability of the device for long-term implantation in the human body.

[0057] In practical applications, the elastic sealing coating can be quickly completed during the production stage by coating, spraying or dipping, and fits perfectly with the threaded connection surface without the need for additional processing or special treatment. This method not only reduces production costs, but also improves the manufacturing and installation efficiency of the device, enabling the device to better meet the needs of large-scale production and surgical implantation.

[0058] In some embodiments, Figure 3 and Figure 4 As shown, the bottom end of the rigid support pipe section 110 is provided with a circle of circumferentially arranged conical nesting grooves 114, and the top end of the terminal flexible conduit 120 is provided with a circle of circumferentially arranged conical embedding protrusions 124 that are adapted to the shape of the conical nesting grooves 114, and the conical embedding protrusions 124 are adopted. The conical cross-sectional structure gradually increases from bottom to top, which is convenient for matching with the conical nesting grooves 114. The terminal flexible conduit 120 is connected to the rigid support pipe section 110 through the conical embedding protrusions 124, and the conical embedding protrusions 124 are also bonded and fixed together with the conical nesting grooves 114 by hot melt adhesive when connected, which further enhances the sealing and stability of the connection.

[0059] In the above structural design, the conical embedded structure achieves uniform mechanical stress dispersion through circumferential distribution, effectively avoiding structural fatigue or damage caused by concentrated force. At the same time, the conical embedded protrusion 124 is also bonded and fixed together with the conical nesting groove 114 by hot melt adhesive when connected. A uniform bonding layer is formed between the conical nesting groove 114 and the conical embedded protrusion 124 by hot melt bonding process, thereby ensuring the sealing of the two and preventing external liquid or gas from entering the connection part. In addition, the matching design of the conical embedded structure also provides convenience for the production and installation of the device. During the assembly process, the guiding role of the conical embedded protrusion 124 and the conical nesting groove 114 simplifies the assembly operation, avoids damage to the catheter due to improper installation, and improves the installation accuracy of the device.

[0060] In some embodiments, the inclined pressure transmission hole 123 is located above or below the lateral pressure transmission hole 122, or the inclined pressure transmission hole 123 is alternately located above and below the lateral pressure transmission hole 122, and the vertical spacing between the inclined pressure transmission hole 123 and the lateral pressure transmission hole 122 is 0.5-2mm, and the inclined pressure transmission hole 123 is arranged to be opened from the outer wall to the inner wall of the terminal flexible conduit 120 in an inclined manner from bottom to top.

[0061] In this embodiment, the inclined pressure transmission hole 123 and the lateral pressure transmission hole 122 are arranged in a spaced manner on a non-same horizontal plane. In the above design, the inclined pressure transmission hole 123 and the lateral pressure transmission hole 122 are arranged in a spaced arrangement, and their vertical spacing is limited to 0.5-2mm. Such a design reduces the problem of uneven pressure distribution that may be caused by the overlap of the pressure conduction paths between the holes, making the pressure conduction effect of each hole clearer. The arrangement at different heights expands the coverage of the catheter pressure transmission path, which helps to more comprehensively reflect the pressure changes in different areas of the skull. At the same time, the reasonable vertical spacing evens out the pressure conduction path between the holes, reducing the risk of pressure concentration in local areas.

[0062] At the same time, in the present embodiment, the inclined pressure transmission hole 123 is opened in an inclined manner from the outer wall to the inner wall from bottom to top, and is evenly distributed in an annular manner on the side wall of the terminal flexible catheter 120. The present embodiment can guide the intracranial pressure to enter the catheter lumen more smoothly through the inclined opening of the inclined pressure transmission hole 123, effectively reducing the resistance in the pressure conduction process. In addition, this inclined direction design has a certain buffering effect on the turbulence that may be caused by the flow of intracranial fluid, making the pressure conduction more stable. The inclined pressure transmission hole 123 also has the function of guiding dynamic pressure changes, which can improve the response efficiency of the device to rapid intracranial pressure fluctuations.

[0063] In addition, the multi-level combination of the inclined pressure transmission hole 123 and the lateral pressure transmission hole 122 forms a structure with a multi-directional pressure introduction path, which increases the diversity and redundancy of pressure transmission. Even if some holes are temporarily unable to transmit pressure normally due to blockage or other factors, other holes can still maintain the pressure transmission function of the device as a whole, thereby significantly improving the fault tolerance of the device. This multi-directional opening layout design can more comprehensively capture the pressure information of different areas in the skull, improve the pressure transmission effect and the reliability of monitoring data. Moreover, the inclined pressure transmission hole 123 and the lateral pressure transmission hole 122 are arranged on the side wall of the terminal flexible catheter in a circumferentially uniform manner. The circumferentially uniformly distributed design can avoid excessive concentration of pressure in the local area of ​​the catheter side wall, and can reduce the interference effect that may occur during the pressure transmission process. Therefore, no matter at what angle the device is implanted, the pressure transmission uniformity and integrity of the catheter side wall can be better maintained, thereby enhancing the adaptability and overall reliability of the device.

[0064] In this embodiment, the vertical spacing between the inclined pressure transmission holes and the lateral pressure transmission holes is limited to 0.5-2mm. Such a reasonable spacing distribution not only avoids the reduction in strength of the terminal flexible conduit 120 that may be caused by too dense openings, but also enables the pressure to be smoothly transmitted between the holes, making the terminal flexible conduit 120 more durable, laying a foundation for the long-term stable operation of the device.

[0065] In some embodiments, the extracranial functional shell 200 is made of medical titanium alloy, and the extracranial functional shell 200 is a cylindrical or elliptical shell, and the upper surface of the extracranial functional shell 200 is flat or adopts a streamlined curved surface structure.

[0066] In this embodiment, the extracranial functional shell 200 is made of medical titanium alloy, which has excellent biocompatibility and is not easy to cause inflammation or rejection after implantation in the human body. At the same time, the high strength and corrosion resistance of titanium alloy materials enable it to be used stably for a long time in a complex biological environment. The extracranial functional shell 200 adopts a streamlined curved surface design, which can reduce external friction after implantation, thereby improving the comfort of the patient.

[0067] Optionally, the rigid support tube segment 110 is made of polyetheretherketone material, the length of the rigid support tube segment 110 ranges from 5 mm to 10 mm, the rigid support tube segment 110 is located in the skull hole, and the lower end of the rigid support tube segment 110 is flush with or indented from the bottom end of the skull hole.

[0068] In this embodiment, the rigid support tube segment 110 is made of polyetheretherketone (PEEK) material, and its length ranges from 5mm to 10mm, and the lower end of the rigid support tube segment 110 is flush with or slightly indented from the bottom end of the skull hole, so as to prevent the lower end of the rigid support tube segment 110 from entering the skull and interfering with the brain tissue. PEEK material has excellent mechanical strength and biocompatibility, and can withstand the mechanical pressure around the skull while reducing the stimulation to the surrounding tissue. Moreover, by limiting the length range and the use and installation position of the rigid support tube segment 110, the rigid support tube segment 110 can maintain long-term implant stability while reducing the risk of postoperative complications.

[0069] The terminal flexible catheter 120 is made of medical grade silicone rubber or polyurethane material, and the length of the terminal flexible catheter 120 ranges from 10 mm to 25 mm; the length ratio of the rigid support tube section 110 to the terminal flexible catheter 120 is set to 1:2-3.

[0070] In this embodiment, the terminal flexible catheter 120 is made of medical grade silicone rubber or polyurethane material, and its length range is set to 10mm to 25mm, and the length ratio with the rigid support pipe section is 1:2-3. The use of such terminal flexible catheter 120 can be close to the surface of brain tissue, and can be adjusted synchronously under the action of slight deformation, so as to maintain good fit with the surface of brain tissue, thereby effectively transmitting intracranial pressure; and the terminal flexible catheter 120 has a certain deformation ability, so it can absorb nonlinear pressure fluctuations caused by external dynamic changes (such as patient movements). The terminal flexible catheter 120 can transmit the real intracranial pressure changes to the inner cavity of the terminal flexible catheter 120 by buffering external interference, avoiding the abnormal pressure conduction path caused by external factors, thereby more stably transmitting the pressure to the inner cavity.

[0071] Moreover, the high elasticity and flexibility of the terminal flexible catheter 120 can make the terminal flexible catheter 120 better adapt to the slight displacement of brain tissue, reduce stimulation to the tissue, and reduce the risk of damage to the implanted device caused by external force. The length ratio between the rigid support tube segment 110 and the terminal flexible catheter 120 is reasonably set to 1:2-3, which can not only ensure the fixing ability of the rigid support tube segment 110, but also retain the flexibility of the terminal flexible catheter 120, thereby ensuring the mechanical properties of the entire implanted catheter 100 while reducing interference in pressure transmission, and also enhancing the overall structural stability of the implanted catheter 100. The high strength of medical titanium alloy and the good mechanical properties of PEEK material enable the device to be used for a long time after being implanted in the human body without failure. The flexible characteristics of the terminal flexible catheter 120 not only improve the sensitivity of pressure signal acquisition, but also enhance the adaptability of the device in a complex biological environment, thereby providing patients with a safer and more reliable use experience.

[0072] Optionally, in some embodiments, the lateral pressure transmission hole 122 is horizontally opened in the middle section of the terminal flexible conduit 120. For example, for a terminal flexible conduit 120 with a length of 15 mm, the lateral pressure transmission hole 122 is opened in a range of 5 mm to 10 mm from the upper end of the terminal flexible conduit 120. For another example, for a terminal flexible conduit 120 with a length of 25 mm, the lateral pressure transmission hole 122 is opened in a range of 8 mm to 17 mm from the upper end of the terminal flexible conduit 120.

[0073] In some embodiments, the pressure sensor 400 is a micro piezoresistive sensor, using a MEMS (micro-electromechanical system) pressure sensor. Specifically, in this embodiment, the pressure sensor 400 uses a Honeywell TruStability TM RSC Series Piezoresistive Silicon Pressure Sensors.

[0074] The micro piezoresistive sensor is highly sensitive and can detect tiny changes in intracranial pressure. Its working principle is to convert pressure signals into resistance changes through the piezoresistive effect, thereby achieving high-precision pressure monitoring. The use of MEMS pressure sensors makes the pressure sensors used more compact and convenient for coordination with other components, reducing the overall space occupancy. Moreover, the low power consumption characteristics of the micro piezoresistive sensor can significantly reduce power requirements, allowing the device to operate stably for a long time under limited battery power conditions, thereby providing patients and medical staff with continuous and reliable pressure monitoring data.

[0075] In some embodiments, Fig. 9 As shown, the detection circuit board 500 integrates a signal acquisition module 510 , a signal processing module 520 , a wireless transmission module 530 and a power management module 540 .

[0076] The input end of the signal acquisition module 510 is connected to the output end of the pressure sensor 400 through a cable to receive the pressure signal collected by the pressure sensor 400; the input end of the signal processing module 520 is connected to the output end of the signal acquisition module 510 to filter, amplify and digitize the pressure signal; Fig.10 As shown, the wireless transmission module 530 includes a wireless transmission chip 531 and a loop antenna 532. The input end of the wireless transmission chip 531 is connected to the output end of the signal processing module 520, and the loop antenna 532 is signal-connected to the wireless transmission chip 531, so as to transmit the processed pressure signal to an external device via wireless communication. The output end of the power management module 540 is respectively connected to the power input end of the signal acquisition module 510, the signal processing module 520 and the wireless transmission module 530, so as to provide power. The loop antenna 532 is embedded in the top inner wall of the extracranial functional shell 200.

[0077] In this embodiment, the signal acquisition module 510, the signal processing module 520, the wireless transmission module 530 and the power management module 540 are integrated on the detection circuit board 500, which not only reduces the complexity of the physical connection, but also reduces the volume and weight of the device, thereby optimizing the signal transmission path between modules, reducing signal interference and loss, and thus improving the efficiency of data transmission. This layout design makes the detection circuit board 500 more functionally concentrated, and provides convenience for the later maintenance and module replacement of the device.

[0078] In use, the signal acquisition module 510 is directly connected to the pressure sensor 400 to receive and transmit the pressure signal. The signal processing module 520 is responsible for filtering, amplifying and digitalizing the pressure signal to ensure the accuracy and availability of the data. The processed data is remotely transmitted through the wireless transmission module 530. The loop antenna 532 is embedded in the top inner wall of the extracranial functional shell 200, so that the wireless signal can reduce obstruction and interference during the transmission process, thereby improving the signal transmission efficiency. At the same time, the loop structure of the loop antenna 532 enables the device to maintain stable communication under different patient postures. The wireless transmission chip 531 used in the wireless transmission module 530 can be used to encode and modulate the pressure data output by the signal processing module 520 to further improve the reliability of data transmission. Since the output of the signal processing module 520 is usually an uncoded digital signal, by setting the wireless transmission chip 531, these signals can be converted into wireless signals (such as radio frequency signals), and the loop antenna 532 is adapted for long-distance transmission. During use, the power management module 540 can provide stable power to the signal acquisition module 510 , the signal processing module 520 , and the wireless transmission module 530 .

[0079] The method of using the implantable catheter device for intracranial pressure monitoring and the surgical implantation process of the embodiment of the present application can refer to the following specific methods:

[0080] 1. Preparation before surgery

[0081] Preoperative evaluation: The doctor diagnoses the patient's abnormal intracranial pressure and determines the specific location suitable for implanting the device.

[0082] Device inspection: Confirm that all components of the device (extracranial functional shell 200, implant catheter 100, pressure sensor 300, flexible diaphragm 400 and detection circuit board 500) are normal and without damage, the circuit functions normally, and the pressure sensor 300 has been calibrated; check whether the terminal flexible catheter 120 and the rigid support tube section 110 are firmly connected, and whether the device has been sterilized.

[0083] 2. Surgical implantation process

[0084] (1) Skull opening

[0085] First, determine the location of the skull hole, and select a suitable skull location for hole making based on the preoperative imaging examination results (such as CT or MRI). Make sure that the hole diameter matches the outer diameter of the rigid support tube section 110. When making the hole, use a skull hole opener to accurately drill the hole to ensure that the hole diameter meets the design requirements. After the hole is made, clean the bone fragments in the skull hole to protect the brain tissue from damage.

[0086] (2) Installation of implanted catheter

[0087] Insert the implant catheter 100 into the skull hole, ensure that the bottom end of the rigid support tube segment 110 is flush with the inner wall of the skull hole or slightly indented to avoid entering the intracranial space, the cylindrical connecting end of the upper end of the rigid support tube segment 110 is located outside the skull, ready to be connected to the extracranial functional shell, when the rigid support tube segment 110 is inserted into the skull hole, the terminal flexible catheter 120 is extended to the intracranial target area, the arc-shaped convex bottom end of the terminal flexible catheter 120 is close to the surface of the brain tissue, and ensure that the multiple groups of micropores (terminal guide holes 121, lateral pressure transmission holes 122 and inclined pressure transmission holes 123) on the terminal flexible catheter 120 are all in the cerebrospinal fluid circulation area. In the process of inserting the implant catheter 100 into the skull hole, due to the flexible characteristics of the terminal flexible catheter 120, the terminal flexible catheter 120 can be naturally bent or adjusted in shape when penetrating the skull hole to adapt to the narrow and curved path of the skull hole. In surgery, the introducer or sheath can be used to help the terminal flexible catheter 120 enter the skull hole. The guide can ensure that the catheter is pushed straight during insertion to avoid unnecessary bending or folding. In addition, a medical-grade lubricating coating (such as a silicone coating) can be applied to the outer surface of the terminal flexible catheter 120 to reduce insertion resistance and prevent damage to the outer surface or the skull hole when penetrating the skull hole.

[0088] (3) Connection of the extracranial functional shell

[0089] The extracranial functional shell 200 is threadedly connected to the upper end of the rigid support tube section 110 through the connecting hole 210, and the elastic buckle 211 is automatically embedded in the annular groove 111 to achieve double locking. An elastic sealing coating can be applied to the threaded connection surface in advance to ensure the sealing and stability of the connection position.

[0090] (4) Check and suture the surgical incision

[0091] Pressure signal test: Check whether the pressure sensor 300 can normally collect intracranial pressure signals and send them to external monitoring equipment through the wireless transmission module 530. After confirming that the signal is stable and the data is correct, the implantation site is sealed.

[0092] Incision suture: After ensuring that the extracranial functional shell 200 is stably fixed, the tissue and skin on the surface of the skull are sutured layer by layer to avoid excessive pressure on the external connection part of the device.

[0093] 3. Postoperative Monitoring

[0094] The changes in intracranial pressure are monitored in real time through an external receiving device to ensure that the pressure sensor 300 and the wireless transmission module 530 are operating normally; the function of the device is checked regularly after surgery to ensure its continued stable operation.

[0095] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit it. Although the present application has been described in detail with reference to the aforementioned embodiments, ordinary technicians in the field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. An implantable catheter device for intracranial pressure monitoring, characterized in that: The invention comprises an implant catheter (100), an extracranial functional shell (200), a pressure sensor (300), a flexible diaphragm (400) and a detection circuit board (500), wherein the extracranial functional shell (200) is connected to the upper end of the implant catheter (100), and the implant catheter (100) comprises a rigid support pipe section (110) inserted into a skull hole and a terminal flexible pipe section (120) extending through the skull hole to the intracranial space, the detection circuit board (500) is arranged in the extracranial functional shell (200), and the rigid support pipe section (110) is connected to the upper end of the implant catheter (100). The flexible diaphragm (400) is fixedly arranged horizontally in the inner cavity of the rigid support pipe section (110), and the inner cavity of the rigid support pipe section (110) is divided into a closed space on the upper side of the flexible diaphragm (400) for installing the pressure sensor (300) and a pressure conduction area on the lower side of the flexible diaphragm (400) responsible for signal transmission by the flexible diaphragm (400). The pressure sensor (300) is located in the closed space above the flexible diaphragm (400) and is electrically connected to the detection circuit board (500); The rigid support tube segment (110) is a rigid tube body with a hollow tube structure at the lower end and a cylindrical connecting end at the upper end. The upper end of the rigid support tube segment (110) is located outside the skull and connected to the bottom end of the extracranial functional shell (200). The other end of the rigid support tube segment (110) extends into the skull hole. The terminal flexible catheter (120) is arranged at the lower end of the rigid support tube segment (110) and is connected to the rigid support tube segment (110) as a whole. The inner cavity of the terminal flexible catheter (120) is connected to the inner cavity of the rigid support tube segment (110) to form a pressure conduction channel. The bottom end of the terminal flexible catheter (120) is arranged in an arc-shaped protrusion and is close to the surface of the brain tissue. The flexible conduit (120) is provided with a plurality of groups of micropores connected to the inner cavity of the terminal flexible conduit (120), the plurality of groups of micropores comprising a terminal flow guide hole (121), a lateral pressure transmission hole (122) and an inclined pressure transmission hole (123), the terminal flow guide hole (121) being distributed on the arc-shaped convex surface of the terminal flexible conduit (120), the lateral pressure transmission hole (122) being uniformly arranged circumferentially on the side wall of the terminal flexible conduit (120), the inclined pressure transmission hole (123) being uniformly arranged circumferentially on the side wall of the terminal flexible conduit (120) and being arranged at intervals with the lateral pressure transmission hole (122), and the inclined pressure transmission hole (123) and the lateral pressure transmission hole (122) being staggered in height.

2. The implantable catheter device for intracranial pressure monitoring according to claim 1, characterized in that: The flexible diaphragm (400) is made of medical grade silicone rubber or polyurethane material. The edge of the flexible diaphragm (400) is sealed and connected to the inner cavity wall of the rigid support pipe section (110) by means of sealant or hot-melt process. A fixed bracket (113) located above the flexible diaphragm (400) is fixedly arranged on the inner cavity wall of the rigid support pipe section (110). The fixed bracket (113) comprises a circular ring frame (1131) and a fixed plate (1132). The annular outer wall of the circular ring frame (1131) is fixedly connected to the inner cavity wall of the rigid support pipe section (110). The fixing plate (1132) is fixedly arranged at the upper end of the circular ring frame (1131), and the bottom end of the fixing plate (1132) is provided with a mounting groove for embedding and mounting the pressure sensor (300). The pressure sensor (300) is fixedly installed in the mounting groove at the bottom end of the fixing plate (1132). The sensitive surface of the pressure sensor (300) for sensing the pressure signal faces downward and is bonded to the top surface of the flexible diaphragm (400) through an elastic sealant. The bottom end surface of the circular ring frame (1131) is bonded to the circumferential edge of the top surface of the flexible diaphragm (400).

3. The implantable catheter device for intracranial pressure monitoring according to claim 1 or 2, characterized in that: The flexible diaphragm (400) is disposed in the inner cavity of the rigid support pipe section (110) on a side close to the terminal flexible catheter (120).

4. The implantable catheter device for intracranial pressure monitoring according to claim 3, characterized in that: A connecting hole (210) for connecting with the rigid support pipe segment (110) is provided at the center of the bottom end of the extracranial functional shell (200); the top end of the rigid support pipe segment (110) is a closed end; the top end of the rigid support pipe segment (110) is connected to the connecting hole (210) by means of threaded connection and elastic snap connection; the rigid support pipe segment (110) is provided with annular grooves (111) and external threads ( 112), the connecting hole (210) has an internal thread threadedly connected to the rigid support tube segment (110), and the inner wall of the connecting hole (210) is also provided with an elastic buckle (211) elastically engaged with the annular groove (111); when the rigid support tube segment (110) is threadedly connected to the extracranial functional shell (200), the elastic buckle (211) can automatically embed into the annular groove (111) on the rigid support tube segment (110), forming a double lock to prevent loosening.

5. The implantable catheter device for intracranial pressure monitoring according to claim 4, characterized in that: The extracranial functional shell (200) is coated with an elastic sealing coating on the threaded connection surface of the connection hole (210).

6. The implantable catheter device for intracranial pressure monitoring according to claim 3, characterized in that: The bottom end of the rigid support pipe section (110) is provided with a circle of circumferentially arranged conical nesting grooves (114), and the top end of the terminal flexible conduit (120) is provided with a circle of circumferentially arranged conical embedding protrusions (124) that are adapted to the shape of the conical nesting grooves (114), and the conical embedding protrusions (124) are adopted. The conical cross-sectional structure gradually increases from bottom to top, and the terminal flexible conduit (120) is connected to the rigid support pipe section (110) through the conical embedding protrusions (124). When the conical embedding protrusions (124) are connected to the conical nesting grooves (114), they are also bonded and fixed together by hot-melt adhesive.

7. The implantable catheter device for intracranial pressure monitoring according to claim 1, characterized in that: The inclined pressure transmission hole (123) is located above or below the lateral pressure transmission hole (122), or the inclined pressure transmission hole (123) is alternately located above and below the lateral pressure transmission hole (122), and the vertical spacing between the inclined pressure transmission hole (123) and the lateral pressure transmission hole (122) is 0.5-2 mm. The inclined pressure transmission hole (123) is arranged to be opened in an inclined manner from bottom to top from the outer wall to the inner wall of the terminal flexible conduit (120).

8. The implantable catheter device for intracranial pressure monitoring according to any one of claims 4 to 7, characterized in that: The extracranial functional shell (200) is made of medical titanium alloy, and is in the form of a cylindrical or elliptical shell. The upper surface of the extracranial functional shell (200) is flat or has a streamlined curved surface structure. The rigid support tube segment (110) is made of polyetheretherketone material, the length of the rigid support tube segment (110) ranges from 5 mm to 10 mm, the rigid support tube segment (110) is located in the skull hole, and the lower end of the rigid support tube segment (110) is flush with or indented from the bottom end of the skull hole; The terminal flexible catheter (120) is made of medical-grade silicone rubber or polyurethane material, and the length of the terminal flexible catheter (120) ranges from 10 mm to 25 mm; the length ratio of the rigid support pipe section (110) to the terminal flexible catheter (120) is set to 1:2-3.

9. The implantable catheter device for intracranial pressure monitoring according to claim 1, characterized in that: The pressure sensor (400) is a micro piezoresistive sensor, and adopts a MEMS pressure sensor.

10. The implantable catheter device for intracranial pressure monitoring according to claim 1, characterized in that: The detection circuit board (500) is integrated with a signal acquisition module (510), a signal processing module (520), a wireless transmission module (530) and a power management module (540); The input end of the signal acquisition module (510) is connected to the output end of the pressure sensor (400) through a cable, and is used to receive the pressure signal collected by the pressure sensor (400); the input end of the signal processing module (520) is connected to the output end of the signal acquisition module (510), and is used to filter, amplify and digitally process the pressure signal; the wireless transmission module (530) includes a wireless transmission chip (531) and a loop antenna (532), the input end of the wireless transmission chip (531) is connected to the output end of the signal processing module (520), and the loop antenna (532) is signal-connected to the wireless transmission chip (531), and is used to transmit the processed pressure signal to an external device through wireless communication; the output end of the power management module (540) is respectively connected to the power input ends of the signal acquisition module (510), the signal processing module (520) and the wireless transmission module (530), and is used to provide power; the loop antenna (532) is embedded in the top inner wall of the extracranial functional shell (200).

Images