Reservoir capable of wireless pressure monitoring

Abstract

The present invention provides a reservoir capable of wireless pressure monitoring. The reservoir comprises a reservoir housing, a ventricular catheter interface, a flexible film, and a wireless pressure sensor. A liquid storage cavity for storing cerebrospinal fluid is formed in the reservoir housing, and an injection window is formed in a top wall of the reservoir housing facing the scalp of a patient. The ventricular catheter interface is arranged in the reservoir housing and is in communication with the liquid storage cavity. The flexible film seals closed the injection window. The wireless pressure sensor comprises a sensor body and an antenna. The wireless pressure sensor is arranged in the reservoir housing and is in contact with the liquid storage cavity so as to acquire an intracranial pressure signal of the patient and transmit the intracranial pressure signal to an external receiver. The wireless pressure sensor is a sensor based on a surface acoustic wave resonator or a film bulk acoustic wave resonator.

Description

Reservoir with wireless pressure monitoring Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a liquid storage bag with wireless pressure monitoring. Background Art

[0002] Intracranial pressure (ICP) refers to the pressure exerted on the skull wall by the contents of the skull: brain tissue, blood, and cerebrospinal fluid (CSF). Under normal circumstances, the combined volume of these three components maintains a dynamic balance with the total volume of the skull, maintaining normal intracranial pressure. Severe craniocerebral injury, cerebral hemorrhage, and other diseases often cause acute increases in intracranial pressure. Chronic diseases such as intracranial tumors or hydrocephalus can also cause varying degrees of increased intracranial pressure. Increased intracranial pressure may affect cerebral blood circulation, leading to decreased perfusion pressure, reduced cerebral blood flow, restricted venous return, intracranial blood stagnation, and even brain compression and displacement. In severe cases, brain herniation may occur, and patients often die from secondary brainstem damage. Therefore, intracranial pressure monitors are one of the commonly used instruments in neurosurgery, used to monitor intracranial pressure in real time and avoid the aforementioned symptoms caused by excessive intracranial pressure. Intracranial hypertension can be treated by draining cerebrospinal fluid, administering the drug mannitol, or performing a craniotomy to reduce pressure.

[0003] Currently, intracranial pressure monitoring can be divided into two categories: non-invasive and invasive. Non-invasive intracranial pressure monitoring (such as anterior fontanelle pressure measurement, intraocular pressure measurement, transcranial Doppler ultrasound cerebral blood flow measurement, bioelectrical impedance method, tympanic membrane displacement test, etc.) is still in the research stage and clinical trial stage, and its accuracy and stability are still unknown. Invasive monitoring is the "gold standard" for intracranial pressure monitoring currently used in clinical practice. Depending on whether the pressure sensor is placed directly in the skull, invasive intracranial pressure monitoring can be divided into implantation method and catheter method.

[0004] Implantable method: The pressure sensor is implanted directly into the skull through a burr hole or craniotomy, with a lead connected to an external monitor. Advantages include a relatively small lead diameter (usually <2 mm), which reduces the risk of cerebral hemorrhage and brain damage. The consequences of lead displacement or breakage are less severe than with the catheter method. Furthermore, the risk of infection is lower. Disadvantages include decompression with the medication mannitol or craniotomy. If decompression requires cerebrospinal fluid (CSF) extraction, a new CSF catheter must be implanted. Catheterized method: A catheter is placed in the ventricle, cisterns, or subarachnoid space. The sensor is external to the skull, where it contacts the CSF in the catheter to measure pressure. Advantages include monitoring ICP while simultaneously reducing it by draining excess CSF. Disadvantages include a relatively large catheter diameter (usually >2.5 mm), which increases the risk of cerebral hemorrhage and brain damage. The CSF in the catheter directly connects the ventricle to the external environment, posing a significant risk of infection. In both methods, the lead or catheter must pass through the skin, preventing closure at the implant site and increasing the risk of infection. Typically, wired monitoring can only last 7 to 10 days. For patients who need longer-term intracranial pressure monitoring, the sensor must be replaced regularly, which not only increases the medical burden but also causes more discomfort to the patient. In addition, the wired monitoring system severely limits the patient's ability to move. This inconvenience requires medical staff to pay special attention to maintaining the sterility of the wires during the nursing process. At the same time, they must also deal with the additional complexity that the wires bring to the nursing process, significantly increasing the difficulty of nursing work.

[0005] To address these clinical pain points and meet the needs of long-term and out-of-hospital monitoring, wireless intracranial pressure monitoring solutions have been proposed. This solution allows the scalp to be sutured after sensor implantation, transmitting the measurement signal through the skin via inductive coupling, reducing the risk of infection and making it suitable for long-term and home monitoring. However, this solution only monitors intracranial pressure and does not drain cerebrospinal fluid to reduce it.

[0006] To this end, a reservoir with intracranial pressure monitoring has been proposed. This solution integrates a pressure sensor within the reservoir, which can be connected to a cerebrospinal fluid (CSF) catheter to guide catheter valve adjustment, detect ventricular catheter blockage, and simultaneously extract CSF. However, existing wireless pressure sensors, such as MEMS and NFC sensors, are mostly based on inductive coupling. These sensors require a coupling coil, resulting in a large implant size. The sensor occupies too much space within the reservoir, hindering CSF extraction or compromising ventricular catheter flushing. Furthermore, inductively coupled wireless pressure sensors suffer from low monitoring accuracy (+ / - 2 mmHg) and drift, low sampling frequency (44 Hz), and complex sensor design and high cost, significantly limiting their widespread adoption. Furthermore, the coupling coil also complicates the design of external receivers, as shown in Figure 1. Summary of the Invention

[0007] In order to overcome the deficiencies of the prior art, the present invention provides a liquid storage capsule with wireless pressure monitoring.

[0008] In order to achieve the above-mentioned objectives, the present invention provides a fluid reservoir with wireless pressure monitoring. It includes a fluid reservoir shell, a ventricular catheter interface, a flexible membrane, and a wireless pressure sensor. The fluid reservoir shell is formed with a fluid storage cavity for storing cerebrospinal fluid, and a withdrawal window is provided on the top wall of the fluid reservoir shell facing the patient's scalp. The ventricular catheter interface is provided in the fluid reservoir shell and communicates with the fluid storage cavity. The flexible membrane seal covers the withdrawal window. The wireless pressure sensor includes a sensor body and an antenna. The wireless pressure sensor is provided in the fluid reservoir shell and contacts the fluid storage cavity to collect the patient's intracranial pressure signal and transmit it to an external receiver. Among them, the wireless pressure sensor is a sensor based on a surface acoustic wave resonator or a thin film bulk acoustic wave resonator.

[0009] According to an embodiment of the present invention, the liquid storage capsule housing is an integrated structure; or, the liquid storage capsule housing includes an upper shell and a lower shell that are split and sealed, and the upper shell and the lower shell are bonded or welded.

[0010] According to one embodiment of the present invention, the volume of the wireless pressure sensor is less than or equal to 10*3*1mm 3 The cross section of the liquid storage capsule shell is circular and the maximum diameter of the cross section is 15 mm to 25 mm, and the height of the liquid storage capsule shell is 5 mm to 10 mm.

[0011] According to one embodiment of the present invention, the fluid storage bag with wireless pressure monitoring further includes a ventricular catheter, one end of the ventricular catheter is connected to the ventricular catheter interface and the other end is implanted in the anterior horn of the patient's ventricle, and the ventricular catheter is connected to the ventricular catheter interface in a split manner or is connected to the ventricular catheter interface in an integral manner.

[0012] According to one embodiment of the present invention, the ventricular catheter interface is provided on the bottom wall or the side wall of the fluid storage bag shell.

[0013] According to one embodiment of the present invention, the flexible membrane is a flexible elastic membrane. When squeezed by external force, the flexible membrane on the fluid storage bag is concave into the fluid storage cavity, increasing the pressure in the fluid storage cavity so that the cerebrospinal fluid in the ventricular catheter flushes the drainage port of the ventricular catheter.

[0014] According to an embodiment of the present invention, the flexible membrane is a flat membrane or a curved membrane with a middle portion convex toward the patient's scalp.

[0015] According to one embodiment of the present invention, the thickness of the flexible membrane is basically the same; or, the flexible membrane includes a needle puncture area located in the middle area and a pressing area located outside the needle puncture area for generating membrane deformation, and the thickness of the needle puncture area is greater than the thickness of the pressing area.

[0016] According to an embodiment of the present invention, the flexible film is any one of natural rubber, silicone film or silica gel film.

[0017] According to one embodiment of the present invention, the fluid storage bag shell is a biocompatible polymer, and the fluid storage bag with wireless pressure monitoring also includes a puncture-proof portion arranged on the inner bottom wall of the fluid storage bag shell. The puncture-proof portion is made of biocompatible metal or a biocompatible polymer with a hardness higher than that of the fluid storage bag shell to prevent the needle from piercing the inner bottom wall of the fluid storage bag shell.

[0018] According to an embodiment of the present invention, the stab-proof portion is made of a biocompatible metal material or a biocompatible polymer having a harder material than the reservoir shell and serves as a part of the antenna.

[0019] According to an embodiment of the present invention, the sensor body is arranged on the inner wall of the liquid storage capsule housing, and the antenna is distributed in the liquid storage capsule housing where the sensor body is located, or the liquid storage capsule housing serves as a part of the antenna.

[0020] According to an embodiment of the present invention, the reservoir housing where the sensor body is located is made of a biocompatible metal material to form one polarization of the antenna.

[0021] According to an embodiment of the present invention, the liquid reservoir housing where the sensor body is located is made of a biocompatible polymer or biocompatible ceramic, and the liquid reservoir housing serves as a part of the antenna.

[0022] According to one embodiment of the present invention, the fluid storage capsule shell where the sensor body is located is a biocompatible polymer or biocompatible ceramic, and the antenna is laid on the inner surface and / or outer surface of the fluid storage capsule shell where the sensor body is located; or, the antenna is embedded in the fluid storage capsule shell where the sensor body is located.

[0023] According to one embodiment of the present invention, when the antenna is laid on the outer surface of the liquid storage bag shell where the sensor body is located or embedded in the liquid storage bag shell where the sensor body is located, the liquid storage bag shell has a wire hole, and both ends of the antenna are fed to the sensor body through the wire hole.

[0024] According to one embodiment of the present invention, the antenna is any one of a circular ring, a wavy ring, a spiral with equal line width, a spiral with unequal line width, a polygonal patch type, or a circular patch type;

[0025] Alternatively, the antenna is a straight line, a broken line, an arc, or a combination of any one or more thereof.

[0026] According to an embodiment of the present invention, the sensor body is disposed on the inner side wall or the inner bottom wall of the liquid storage capsule housing.

[0027] According to one embodiment of the present invention, the sensor body is arranged on the inner bottom wall of the liquid storage capsule housing and is located on the periphery of the projection surface of the flexible membrane;

[0028] Alternatively, the sensor body is arranged on the inner bottom wall of the liquid storage capsule housing, and the liquid storage capsule housing has a protective part extending to the bottom of the flexible membrane and opposite to the sensor body, and the protective part blocks the needle piercing the flexible membrane to protect the sensor body.

[0029] According to one embodiment of the present invention, the fluid storage bag with wireless pressure monitoring also includes a peritoneal / atrial shunt tube interface arranged on the side wall of the fluid storage bag shell and connected to the fluid storage cavity, and the peritoneal / atrial shunt tube interface is detachably connected to a sealing end cap or connected to the patient's peritoneal / atrial shunt tube.

[0030] According to one embodiment of the present invention, the peritoneal / atrial shunt tube interface is detachably connected to the peritoneal / atrial shunt tube, and the fluid reservoir with wireless pressure monitoring further includes a valve disposed on the peritoneal / atrial shunt tube interface or the peritoneal / atrial shunt tube; when the flexible membrane is squeezed to flush the ventricular catheter, the valve automatically closes, and the cerebrospinal fluid in the fluid reservoir will flush toward the ventricular catheter, thereby improving the flushing effect.

[0031] According to one embodiment of the present invention, the materials of the fluid reservoir shell, the ventricular catheter interface, and the peritoneal / atrial shunt tube interface are the same or different, and can be any one of biocompatible metals or biocompatible polymers.

[0032] In summary, the fluid storage capsule with wireless pressure monitoring provided by the present invention can be closed by scalp suture after being implanted under the patient's scalp, thereby cutting off the infection path, reducing the risk of infection, and achieving long-term monitoring. At the same time, it avoids the risk of safety and data loss caused by patients (especially children) pulling out or breaking the wires of the wired monitoring device. The wireless monitoring function greatly improves the convenience of patients during transfer, transportation and free activities. Furthermore, the sensor technology used in the present invention has higher accuracy than existing wired and wireless intracranial pressure monitoring products, and solves the accuracy and drift problems. Compared with wireless products based on LC resonance technology, the present invention realizes the miniaturization of the volume of the wireless pressure sensor, provides support for the miniaturization design of the fluid storage capsule, and makes it more suitable for implantation under the scalp. If the size of the fluid storage capsule is maintained basically the same as that of the prior art, the miniaturized sensor can increase the volume of the fluid storage cavity, thereby discharging more cerebrospinal fluid into the ventricular catheter when pressing the flexible membrane, significantly improving the flushing effect. In addition, the external host and antenna are also smaller in size, which makes the use process more easy to use and comfortable, and can also meet the patient's needs for long-term continuous monitoring.

[0033] In order to make the above and other objects, features and advantages of the present invention more clearly understood, preferred embodiments are given below with reference to the accompanying drawings for detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG1 is a schematic structural diagram of an existing liquid storage capsule equipped with an inductively coupled pressure sensor when reading pressure data.

[0035] FIG2 is a schematic structural diagram of a liquid storage capsule with wireless pressure monitoring provided in the first embodiment of the present invention.

[0036] FIG3 is a schematic diagram showing the fluid reservoir with wireless pressure monitoring shown in FIG2 being implanted under the scalp of a patient.

[0037] FIG4 is a schematic diagram showing the structure of FIG2 after the ventricular catheter is disassembled.

[0038] FIG. 5 is a schematic diagram showing the structure of FIG. 4 after the flexible film is removed.

[0039] FIG6 is a schematic structural diagram of a fluid storage bag with wireless pressure monitoring in another embodiment of the present invention.

[0040] FIG7 is a schematic diagram showing the structure of the fluid reservoir with wireless pressure monitoring shown in FIG6 being implanted under the scalp of a patient.

[0041] FIG8 is a schematic structural diagram of a fluid storage bag with wireless pressure monitoring provided by another embodiment of the present invention.

[0042] FIG9A is a schematic diagram showing the distribution of antennas on the bottom wall or protective thorn portion of the liquid storage capsule shell in the liquid storage capsule with wireless pressure monitoring shown in FIG2 .

[0043] 9B to 9H are schematic diagrams showing the distribution of antennas on the bottom wall or protective thorn portion of the liquid storage capsule shell in a liquid storage capsule with wireless pressure monitoring provided by another embodiment of the present invention.

[0044] FIG10 is a schematic structural diagram of the fluid storage bag with wireless pressure monitoring provided in the second embodiment of the present invention when it is not connected to the ventricle and peritoneal / atrial shunt tube.

[0045] FIG11 is a schematic diagram showing the structure of the shunt pipe port in FIG10 after being connected to the ventricle and peritoneal / atrial shunt pipes.

[0046] FIG12 is a schematic diagram showing the structure of the peritoneal / atrial shunt tube interface in FIG10 when connected to the blocking end cap.

[0047] FIG13 is a schematic structural diagram of a fluid storage bag with wireless pressure monitoring provided by another embodiment of the present invention when it is not connected to a ventricle and peritoneal / atrial shunt tube.

[0048] FIG. 14 is a schematic diagram showing the packaging structure of the surface acoustic wave resonator in the sensor body according to an embodiment of the present invention.

[0049] FIG15 is a cross-sectional schematic diagram of FIG14 after packaging. DETAILED DESCRIPTION

[0050] Example 1

[0051] As shown in Figures 2 to 5, this embodiment provides a fluid reservoir with wireless pressure monitoring, which includes a fluid reservoir shell 1, a ventricular catheter interface 2, a flexible membrane 3, and a wireless pressure sensor 4. The fluid reservoir shell 1 is formed with a fluid storage cavity 11 for storing cerebrospinal fluid, and a suction window 12 is provided on the top wall of the fluid reservoir shell 1 facing the patient's scalp. The ventricular catheter interface 2 is provided in the fluid reservoir shell 1 and is connected to the fluid storage cavity 11. The flexible membrane 3 is sealed and covered on the suction window 12. The wireless pressure sensor 4 includes a sensor body 41 and an antenna 42. The wireless pressure sensor 4 is provided in the fluid reservoir shell 1 and contacts the fluid storage cavity 11 to collect the patient's intracranial pressure signal and transmit it to an external receiver.

[0052] Unlike existing wireless pressure sensors based on inductive coupling, the fluid reservoir with wireless pressure monitoring provided in this embodiment uses the high-frequency industrial, scientific and medical band (ISMband, such as 915MHz or 2.4GHz). The wireless pressure sensor based on radio frequency excitation does not require the use of an inductive coil for coupling, which greatly reduces the volume of the external receiver and the fluid reservoir, so that the fluid reservoir can be miniaturized and can be better implanted under the patient's scalp where space is limited. After minimally invasive implantation, scalp sutures can be performed to effectively avoid the risks caused by percutaneous infection. Furthermore, the excitation based on the radio frequency band also eliminates the need to set up a power supply in the sensor to further reduce the size of the wireless pressure sensor.

[0053] Specifically, the pressure sensor provided by the present invention is a sensor based on a surface acoustic wave resonator (SAW) or a thin film bulk acoustic wave resonator (FBAR). Changes in the surrounding environment (such as temperature, pressure, brain oxygen saturation and other parameters) change the sensor's resonant frequency and the frequency of the echo signal. An external receiver receives the echo signal sent by the wireless pressure sensor and calculates parameters such as temperature, pressure, and brain oxygen saturation based on the frequency of the echo signal. Specifically, this embodiment applies a pressure sensor based on a surface acoustic wave resonator (SAW) or a thin film bulk acoustic wave resonator (FBAR) to a fluid reservoir in a high-frequency band, such as the industrial, scientific and medical band (ISMband, such as 915MHz) or the RFID band (865MHz). Compared to traditional LC inductively coupled pressure sensors with an operating frequency band of 40-400MHz, the high-frequency band does not require a large inductor coil, so the size of the wireless pressure sensor 4 and the external host can be made smaller. Furthermore, in the high frequency band, surface acoustic wave resonators (SAW) and film bulk acoustic wave resonators (FBAR) will have a higher quality factor Q, usually around 3000, which is much higher than the quality factor of LC resonators (the quality factor of LC resonators is Q<300).

[0054] Specifically, the frequency resolution δf, the resonant frequency f0, the quality factor Q, and the signal-to-noise ratio SNR have the following relationship:

[0055] Based on this relationship, it can be concluded that the higher the quality factor (Q), the smaller the frequency resolution (δf), i.e., the higher the frequency accuracy. Therefore, compared to traditional LC resonator-based MEMS sensors, the fluid reservoir with wireless pressure monitoring provided in this embodiment will have a higher frequency response sensitivity and extremely high monitoring capabilities for tiny pressure changes. Furthermore, the improved quality factor (Q) can significantly reduce the resonant bandwidth, making the system noise much smaller than the signal strength, thereby improving the signal-to-noise ratio. Furthermore, a high quality factor (Q) can also provide a more stable resonant response, with less frequency drift and higher linearity. Current clinically used intracranial pressure sensors (such as LC resonator-based MEMS sensors) have an accuracy of just 2 mmHg, which barely meets the required accuracy. However, the high-Q wireless pressure sensor based on a surface acoustic wave (SAW) resonator provided in this embodiment can achieve a sensitivity of 1 mmHg. Given the lower range of intracranial pressure (ICP) (typically 7–15 mmHg), this improved accuracy has significant implications for diagnosis, treatment, and disease management.

[0056] However, the present invention does not impose any restrictions on the specific type of wireless pressure sensor and the way it transmits pressure signals. Other wireless pressure sensors that do not require inductive coupling are within the scope of protection of the present invention. In this embodiment, the fluid reservoir shell 1 is made of a biocompatible metal material; specifically, it can be titanium or stainless steel. However, the present invention does not impose any restrictions on this. In other embodiments, the fluid reservoir shell can also be made of a biocompatible polymer with relatively high hardness (such as polyetheretherketone PEEK, polyaryletherketone PAEK or polytetrafluoroethylene PTFE); or a biocompatible ceramic (such as aluminum oxide or zirconium oxide).

[0057] In this embodiment, the cross-section of the liquid reservoir shell 1 is circular and the maximum diameter of the cross-section is 15mm to 25mm, and the height of the liquid reservoir shell 1 is 5mm to 10mm. Specifically, the size of the liquid reservoir shell 1 can be designed into a variety of different sizes according to the head size of different types of patients such as adults, children and infants. Preferably, the maximum diameter of the cross-section of the liquid reservoir shell 1 can be set to about 15mm, and the height thereof can be about 8mm. However, the present invention does not impose any limitation on this. In other embodiments, the cross-section of the liquid reservoir shell is circular and the maximum diameter of the cross-section can be other values ​​within the range of 10mm to 35mm, and the height of the liquid reservoir shell can also be other values ​​within the range of 4mm to 15mm.

[0058] In this embodiment, the fluid storage bag for wireless pressure monitoring also includes a ventricular catheter 5, one end of which is connected to the ventricular catheter interface 2 and the other end of which is implanted in the anterior horn of the patient's ventricle. Specifically, the ventricular catheter interface 2 is provided on the bottom wall of the fluid storage bag shell 1, and the ventricular catheter 5 is detachably connected to the ventricular catheter interface 2. FIG4 is a schematic diagram of the structure after the ventricular catheter 5 is disassembled. This arrangement allows the fluid storage bag shell 1 and the ventricular catheter interface 2 to be replaced or sold as a whole; similarly, the ventricular catheter 5 can also be replaced or sold as an independent component. However, the present invention does not impose any limitation on this. In other embodiments, the ventricular catheter can also be integrally connected to the ventricular catheter interface. In addition, in other embodiments, the ventricular catheter interface can also be provided on the side wall of the fluid storage bag shell, as shown in FIG6 and FIG7.

[0059] As shown in Figure 3, a fluid reservoir with wireless pressure monitoring is located between the scalp 100 and the skull 200. The diameter of the skull burr hole 300 is typically approximately 2.7 mm. The ventricular catheter 5 is implanted through the skull burr hole 300 into the anterior horn 400 of the ventricle. The scalp 100 is then sutured to close the implantation site, reducing percutaneous infection. The anterior horn 400 of the ventricle is connected to the fluid reservoir 11 via the upper drainage port 51 of the ventricular catheter 5, allowing cerebrospinal fluid to be extracted and medication to be administered. Specifically, the flexible membrane 3 provides a self-sealing seal. When a patient's intracranial pressure is excessively high, a needle can be used to pierce the flexible membrane 3 and extract cerebrospinal fluid from the fluid reservoir to reduce intracranial pressure. Alternatively, medication can be injected into the fluid reservoir 11 via a needle. The medication then penetrates the ventricular catheter interface 2 and the upper drainage port 51 of the ventricular catheter 5 into the patient's ventricles for treatment. In this embodiment, the material of the ventricular catheter interface 2 is the same as that of the reservoir housing 1, both being made of a biocompatible metal material; specifically, titanium or stainless steel. However, the present invention is not limited to this. In other embodiments, the material of the ventricular catheter interface 2 may differ from that of the reservoir housing, employing a biocompatible polymer with a relatively high hardness, such as polypropylene.

[0060] In this embodiment, the volume of the wireless pressure sensor 4 is less than or equal to 10*3*1mm 3In the wireless pressure sensor provided by the present invention, the antenna 42 is made of a very thin diameter biocompatible metal wire or a very thin metal sheet. Compared with the volume of the sensor body 41, the volume of the antenna 42 is very small and almost negligible, so the volume of the wireless pressure sensor 4 is the volume of the sensor body 41. The small volume of the wireless pressure sensor reduces the volume of the liquid storage cavity it occupies. Specifically, the wireless pressure sensor 4 provided in this embodiment has a circular cross-section with a maximum cross-section diameter of 15mm to 25mm and a height of 5mm to 10mm. The space occupied by the liquid storage capsule shell 1 is less than 5.9%. This space occupancy ratio is much smaller than the space occupied by traditional MEMS sensors in the same liquid storage capsule shell, thereby allowing the liquid storage cavity 11 to have a larger liquid storage space.

[0061] The large liquid storage space and the elastic flexible membrane 3 provide conditions for the change of pressure in the liquid storage chamber 11; when in use, force can be applied to the flexible membrane 3 on the liquid storage capsule shell 1 to cause the flexible membrane 3 to be recessed into the liquid storage chamber 11, thereby increasing the pressure in the liquid storage chamber 11 and allowing the cerebrospinal fluid in the liquid storage chamber 11 and the ventricular catheter 5 to flush the drainage port 51 of the ventricular catheter 5, thereby achieving flushing of the ventricular catheter 5 to effectively avoid ventricular catheter blockage and avoid unnecessary catheter replacement surgery. Furthermore, the blockage of the ventricular catheter 5 can also be judged by the rebound time of the flexible membrane 3. As shown in Figure 2, the ventricular catheter drainage port 51 is a plurality of circular drainage holes formed on the front end of the ventricular catheter 5. However, the present invention does not impose any restrictions on the shape of the drainage port of the ventricular catheter, which can be a variety of shapes such as square, oval, and long strip.

[0062] Preferably, the inner diameter of the ventricular catheter 5 is generally approximately 1.3 mm, and the outer diameter is approximately 2.5 mm. The length of the ventricular catheter 5 can be trimmed as needed. The ventricular catheter 5 is typically made of a biocompatible polymer, such as silicone, silica gel, or natural rubber. The circular drainage hole 51 is placed within the lateral ventricle to drain hydrocephalus from the ventricle. However, the present invention is not limited to this.

[0063] Specifically, the flexible membrane 3 is a planar, flexible elastic membrane with a substantially uniform overall thickness. A 25-gauge or smaller needle can be used for cerebrospinal fluid extraction and drug injection. However, this is not a limitation of the present invention. In other embodiments, to increase the number of needle penetrations possible, the overall thickness of the flexible membrane can be set to be thicker, such as approximately 4 mm or even thicker. However, this is not a limitation of the present invention. In other embodiments, the flexible membrane can include a needle puncture zone in the central region and a pressure zone located peripherally to induce membrane deformation, with the needle puncture zone being thicker than the pressure zone. A thicker needle puncture zone can increase the number of needle penetrations and extend the life of the fluid reservoir, while a thinner pressure zone can facilitate compression of the flexible membrane for flushing the ventricular catheter. In other embodiments, the flexible membrane can be thinner in the central region to form the pressure zone, while the edge regions can be thicker to form the needle puncture zone. The present invention also does not impose any limitations on the shape of the flexible membrane. In other embodiments, it may also be a curved surface that is convex toward the patient's scalp to facilitate pressing.

[0064] In this embodiment, the flexible membrane 3 is a silicone membrane. However, the present invention is not limited to this. In other embodiments, the flexible membrane can also be any one of natural rubber, silicone membrane or other biocompatible elastic flexible membrane.

[0065] This embodiment illustrates an example in which the reservoir housing 1 and flexible membrane 3 are made of different materials. However, this is not a limitation of the present invention. In other embodiments, as shown in Figure 8 , both the reservoir housing 1 and flexible membrane 3 can be made of flexible film, either integrally formed or bonded to the bottom of the reservoir housing. The flexible reservoir housing 1 facilitates compression for flushing the ventricular catheter. In this case, the flexible membrane 3 still functions for extracting cerebrospinal fluid or injecting medication. The wall thickness of the flexible membrane 3 can be substantially the same as that of the reservoir housing; alternatively, the wall thickness of the flexible membrane 3 can be greater than that of the reservoir housing 1 to increase the number of needle penetrations and extend the life of the reservoir. In this embodiment, both the reservoir housing 1 and flexible membrane 3 are made of silicone. However, this is not a limitation of the present invention. In other embodiments, both can be made of natural rubber, silicone, or other biocompatible flexible materials.

[0066] In this embodiment, the sensor body 41 is disposed on the inner wall of the reservoir housing 1; specifically, on the inner bottom wall of the reservoir housing 1. To prevent damage to the sensor body 3 due to excessive force when a needle pierces the flexible membrane, the reservoir housing 1 also includes a protective portion extending to the bottom of the flexible membrane 3 and opposite the sensor body 41. This protective portion blocks the needle from piercing the flexible membrane 3, thereby protecting the sensor body 41. However, the present invention is not limited to this. In other embodiments, the sensor body may be located on the inner bottom wall of the reservoir housing, outside the projection of the flexible membrane; alternatively, the sensor body may also be disposed on the inner side wall of the reservoir housing.

[0067] Furthermore, to prevent the needle from piercing the inner bottom wall of the fluid storage capsule shell 1 made of a biocompatible polymer, in this embodiment, the fluid storage capsule with wireless pressure monitoring also includes a puncture-proof portion 6 arranged on the inner bottom wall of the fluid storage capsule shell 1. The puncture-proof portion 6 blocks the needle to prevent the needle from damaging the inner bottom wall of the fluid storage capsule shell 1. Specifically, the puncture-proof portion 6 can be made of a biocompatible metal material, such as orthopedic stainless steel, nickel-titanium alloy and other metals; in this case, the metal puncture-proof portion 6 can also be used as part of the antenna to simplify the antenna structure. However, the present invention does not impose any limitation on this. In other embodiments, the puncture-proof portion can also be made of a biocompatible polymer with higher hardness, such as polypropylene.

[0068] The placement of sensor body 41 within reservoir chamber 11 not only optimizes the design of wireless pressure sensor 4 and improves its performance, but also brings the wireless pressure sensor and antenna closer to the skin surface, minimizing electromagnetic wave loss and achieving better data transmission. Furthermore, in this design, reservoir housing 1 can also serve as part of the sensor antenna, or an antenna structure can be incorporated into the bottom of the reservoir housing.

[0069] In this embodiment, the antenna 42 is located within the reservoir housing 1 where the sensor body 41 is located. Specifically, the reservoir housing 1 where the sensor body 41 is located is made of a non-metallic, biocompatible polymer or biocompatible ceramic, and the antenna 42 is located on the inner surface of the reservoir housing 1 where the sensor body 1 is located, such as the inner bottom wall and / or inner side wall. However, the present invention is not limited to this. In other embodiments, the antenna may be located on both the inner and outer surfaces of the reservoir housing where the sensor body is located; or on the outer surface of the reservoir housing; or the antenna may be embedded within the reservoir housing where the sensor body is located. Alternatively, the reservoir housing may serve as part of the antenna. In other embodiments, when the reservoir housing has a stab-proof portion, the sensor body may be positioned on the stab-proof portion, and the antenna may be arranged on the stab-proof portion and / or the reservoir housing. The antenna may also be configured as any of the configurations shown in Figures 9A to 9G as needed.

[0070] As shown in FIG9A , in this embodiment, the antenna 42 is a circular metal antenna formed on the inner bottom wall of the liquid reservoir shell 1 or on the puncture-proof portion. Typically, the bottom of the liquid reservoir shell 1 is a disk with a diameter between 15 mm and 25 mm, and the material of the liquid reservoir shell 1 is a biocompatible polymer (such as polyetheretherketone PEEK, polyaryletherketone PAEK or polytetrafluoroethylene PTFE); or a biocompatible ceramic (such as alumina or zirconium oxide). The loop antenna or bent loop antenna of FIG9A and 9B is made on the bottom of the liquid reservoir shell 1. The shape of this antenna matches the size and shape of the bottom of the liquid reservoir shell 1, which can reasonably utilize the liquid reservoir space. For example, the loop antenna or bent loop antenna is embedded in the inner bottom wall of the liquid reservoir shell 1 using a metal wire, or is made on the inner bottom wall of the liquid reservoir shell 1 by electroplating.

[0071] For the loop antenna of FIG9A , its circumference can be calculated using the following formula: C = n·λ eff

[0072] Where C is the circumference of the loop antenna, which is usually an integer or fractional multiple of the operating wavelength to achieve resonance; n is the resonant mode (usually 1 is selected, i.e., the fundamental mode); Effective wavelength in the medium; Free space wavelength; c: speed of light (about 3×10 8 m / s); f: antenna operating frequency; ε eff : Effective dielectric constant (the dielectric constant in contact with the cerebrospinal fluid and the dielectric constant in contact with the polymer at the bottom of the reservoir shell 1 are calculated using weighted average).

[0073] In this embodiment, the operating frequency f of antenna 42 is selected to be 915 MHz or 865 MHz. Regarding the effective dielectric constant, since the upper surface of antenna 42 contacts the cerebrospinal fluid, the dielectric constant of the cerebrospinal fluid in this frequency band is approximately 68. The lower surface of antenna 42 contacts the bottom of the reservoir shell 1. When the reservoir shell 1 is made of a biocompatible polymer, the dielectric constant of the lower surface of antenna 42 is approximately 3, and when the reservoir shell 1 is made of ceramic, the dielectric constant of the lower surface of antenna 42 is approximately 10. Therefore, a weighted average formula is used to estimate the effective dielectric constant. Using the above formula, it can be calculated that the antenna diameter is approximately 17 mm at an operating frequency of 915 MHz, and approximately 18 mm at an operating frequency of 865 MHz. In this case, the antenna diameter precisely matches the bottom diameter of the reservoir shell 1 (15 mm to 25 mm). Furthermore, for small-sized reservoirs used by children, a folded loop antenna (9B) can be used to modulate antenna 42 to the corresponding operating frequency.

[0074] However, the present invention is not limited to this. In other embodiments, the antenna may also be any one of a wavy ring (as shown in FIG. 9B ), a spiral of equal width (as shown in FIG. 9C ), a spiral of unequal width (as shown in FIG. 9D ), a polygonal patch (as shown in FIG. 9E ), or a circular patch (as shown in FIG. 9F ). It may also be any one or more combinations of straight lines, broken lines, and arcs. For example, in FIG. 9G , antenna 42 includes a straight line 421 and an arc 422 ; in FIG. 9H , antenna 42 includes a rectangular broken line 423 and a wavy arc 424 . A complex antenna structure can enhance antenna radiation efficiency, but its processing complexity will also be relatively higher. FIG. 9C to FIG. 9H show a structure in which antenna 42 is distributed and laid on the outer surface of the reservoir shell 1 where the sensor body 41 is located and / or embedded in the reservoir shell 1 where the sensor body 41 is located. In this case, the reservoir shell 1 has a wire hole 13 , and both ends of the antenna 42 are fed to the sensor body 41 through the wire hole 13 . 9C and 9D show the antenna structure on the outer surface of the liquid capsule housing 1. Due to the viewing angle, the sensor body is not shown in the figure.

[0075] Although this embodiment illustrates the reservoir housing 1 as a non-metallic biocompatible polymer or biocompatible ceramic, the present invention is not limited thereto. In other embodiments, the reservoir housing where the sensor body resides may also be made of a biocompatible metal material. In this case, the reservoir housing will form one polarization of the antenna. In this case, the reservoir housing serves as part of the antenna, further simplifying the antenna's configuration.

[0076] In this embodiment, the reservoir housing 1 is an integrated structure. However, the present invention is not limited to this. In other embodiments, the reservoir housing may also be a split structure, including an upper shell and a lower shell that are sealed together. The upper shell and the lower shell may be bonded or welded together.

[0077] The fluid storage capsule with wireless pressure monitoring provided in this embodiment can be implanted in patients with acute brain trauma, brain tumors, or cerebral hemorrhage to achieve wireless monitoring and management of intracranial pressure. The following will illustrate the implantation application of the fluid storage capsule with wireless pressure monitoring provided by the present invention in these two types of patients as an example. However, the present invention does not impose any limitation on this. The fluid storage capsule with wireless pressure monitoring provided in this embodiment can be implanted in all patients who need to monitor and manage intracranial pressure.

[0078] Specifically, for patients with acute brain trauma: after the fluid storage capsule with wireless pressure monitoring is implanted, the scalp is sutured, the implantation point is closed, and the infection path is cut off. The intracranial pressure is monitored wirelessly, realizing the monitoring function of the implantation method. When the patient's intracranial pressure is too high, a needle can be used to pierce the scalp and the flexible membrane 3 to extract cerebrospinal fluid, thereby achieving the purpose of reducing intracranial pressure. According to clinical needs and the intracranial pressure data provided by the fluid storage capsule with wireless pressure monitoring, cerebrospinal fluid can be extracted multiple times, or the needle can be fixed by an additional device to continuously discharge cerebrospinal fluid to realize the function of catheter-based intracranial pressure monitoring and cerebrospinal fluid discharge. The fluid storage capsule with wireless pressure monitoring provided by the present invention realizes intracranial pressure monitoring and discharge of cerebrospinal fluid to control intracranial pressure while controlling the risk of infection. In addition, longer-term monitoring can be achieved in the ward, and the wireless function facilitates patients to move freely, and also prevents patients, especially children, from unplugging or damaging the wires of wired monitoring products.

[0079] Patients with brain tumors or cerebral hemorrhage: After craniotomy, a reservoir with wireless pressure monitoring is implanted and the scalp is sutured. Intracranial pressure monitoring can be used to determine whether there is excessive intracranial pressure, bleeding, infection, or other postoperative complications, guiding the extraction of cerebrospinal fluid to relieve intracranial pressure. Alternatively, a needle can be used to pierce the scalp and flexible membrane 3 to extract cerebrospinal fluid for testing to determine bleeding and infection. Medication is injected through the flexible membrane to achieve therapeutic functions. The reservoir with wireless pressure monitoring is suitable for long-term implantation and can remain in the patient's body after discharge. It can regularly monitor intracranial pressure, extract cerebrospinal fluid to reduce intracranial pressure, perform testing and medication, and flush the ventricular catheter 5 by pressing the flexible membrane 3. It is used for postoperative monitoring, rehabilitation, and nursing of patients with tumors and cerebral hemorrhage.

[0080] Example 2

[0081] This embodiment is substantially the same as the first embodiment and its variations, with the following differences: In this embodiment, as shown in FIG10 , the ventricular catheter interface 2 is disposed on the side wall of the fluid reservoir housing 1, and the fluid reservoir with wireless pressure monitoring further includes a peritoneal / atrial shunt tube interface 7 disposed on the other side wall of the fluid reservoir housing 1 opposite the ventricular catheter interface 2 and connected to the fluid reservoir cavity 11. However, the present invention is not limited to this. In other embodiments, as shown in FIG13 , the ventricular catheter interface 2 is disposed on the bottom of the fluid reservoir housing 1, while the peritoneal / atrial shunt tube interface 7 is disposed on the side wall of the fluid reservoir housing 1.

[0082] Furthermore, as shown in FIG11 , in this embodiment, the peritoneal / atrial shunt tube interface 7 is detachably connected to the peritoneal / atrial shunt tube 8. The arrangement of the peritoneal / atrial shunt tube interface 7 and the peritoneal / atrial shunt tube 8 can drain the cerebrospinal fluid in the fluid storage chamber 11 to the patient's peritoneal cavity or atrium. Furthermore, the peritoneal / atrial shunt tube 8 is also provided with a flow control valve with an adjustable opening, and the wireless pressure sensor 4 can also provide guidance for the adjustment of the flow control valve. For example, when the intracranial pressure is high, the doctor can increase the opening of the flow control valve to increase the shunt volume, and when the intracranial pressure is low, the doctor can reduce the opening of the flow control valve to control the intracranial pressure, thereby being well applied to patients who need to have a peritoneal / atrial shunt tube implanted.

[0083] However, for patients who are uncertain whether they need to implant a ventriculoperitoneal / atrial shunt or when the conditions for implantation are not mature, it is necessary to monitor the intracranial pressure. In order to meet the use requirements of such patients, in this embodiment, as shown in FIG12 , the fluid storage bag with wireless pressure monitoring also includes a blocking end cap 9 that is detachably arranged on the peritoneal / atrial shunt interface 7. The detachable arrangement of the peritoneal / atrial shunt 8 and the blocking end cap 9 allows the two to be replaced at different stages of the patient's life. Specifically, a fluid storage bag with wireless pressure monitoring having a blocking end cap 9 is initially implanted to achieve intracranial pressure monitoring, flushing of the ventricular catheter 5, drug administration, and extraction and testing of cerebrospinal fluid. When the patient needs to implant a peritoneal / atrial shunt 8, surgery is performed to remove the blocking end cap 9 and install the peritoneal / atrial shunt 8 to drain the cerebrospinal fluid to the peritoneal cavity or atrium to reduce intracranial pressure, as shown in FIG11 .

[0084] Specifically, for patients with congenital hydrocephalus, normal pressure hydrocephalus or those who need to implant a ventriculoperitoneal / atrial shunt, if the patient has an infection, bleeding or other symptoms in the brain and does not have the ability to implant a shunt, the existing technology is to implant an ordinary fluid reservoir, inject drugs through the fluid reservoir to control the infection or other symptoms, and control the intracranial pressure by extracting cerebrospinal fluid. However, since the existing ordinary fluid reservoir cannot provide intracranial pressure data, it is impossible to provide an accurate basis for the extraction time and quantity of cerebrospinal fluid. The fluid reservoir with wireless pressure monitoring provided by the present invention can provide the patient's intracranial pressure data in real time and accurately, provide an accurate basis for the extraction time and quantity of cerebrospinal fluid, and realize the flushing of the ventricular catheter 5 to avoid its blockage. When the patient meets the conditions for the implantation of a ventriculoperitoneal / atrial shunt, the blocking end cap 9 is removed and the peritoneal / atrial shunt 8 is directly connected to the peritoneal / atrial shunt interface 7 to shunt the cerebrospinal fluid into the peritoneal cavity or atrium.

[0085] Furthermore, when the peritoneal / atrial shunt tube interface 7 is connected to the peritoneal / atrial shunt tube 8, the fluid reservoir with wireless pressure monitoring may further include a valve disposed on the peritoneal / atrial shunt tube interface 7 or the peritoneal / atrial shunt tube 8. When the flexible membrane 3 is squeezed to flush the ventricular catheter 5, the valve leading to the peritoneal / atrial shunt tube automatically closes, allowing the cerebrospinal fluid in the fluid reservoir to flush toward the ventricular catheter 5, thereby enhancing the flushing effect.

[0086] Although this embodiment uses patients with congenital hydrocephalus, normal-pressure hydrocephalus, or those requiring ventriculoperitoneal / atrial shunt implantation as examples, the present invention is not limited thereto. The fluid reservoir with wireless pressure monitoring provided in this embodiment is also applicable to other patients requiring intracranial pressure monitoring and reduction, such as the acute brain trauma patient described in Example 1, patients with brain tumors or cerebral hemorrhage, and patients undergoing lumbar peritoneal shunts.

[0087] The reservoir housing 1, ventricular catheter port 2, and peritoneal / atrial shunt port 7 may be made of the same or different materials, and all three may be biocompatible metals or polymers. When made of the same material, the reservoir housing 1, ventricular catheter port 2, and peritoneal / atrial shunt port 7 may be integrally formed or connected by bonding or welding.

[0088] The specific structures of the fluid reservoir shell 1, the ventricular catheter interface 2, the flexible membrane 3, and the sensor body 41 and the antenna 42 in the wireless pressure sensor 4 and their possible implementation methods are the same as those in the first embodiment and are not described in detail here.

[0089] Furthermore, since the fluid reservoir is a long-term implantable device, to ensure the long-term airtightness of the device, this embodiment uses a quartz-quartz bonding method to encapsulate the surface acoustic wave resonator or thin film acoustic wave resonator in the sensor body 41. Specifically, the surface acoustic wave resonator is used as an example below. As shown in Figure 14, the surface acoustic wave resonator 54 is fabricated on a quartz wafer 52 and the quartz wafer 52 is thinned to less than 100μm. In order to eliminate the pressure sensor drift problem caused by factors such as changes in the ambient temperature and aging of the surface acoustic wave resonator, the sensor body 41 can also introduce another surface acoustic wave resonator 53. This other surface acoustic wave resonator 53 is fabricated on another thicker quartz wafer 51, and its thickness is generally greater than 200μm. The two quartz wafers have the same cut angle and properties. Therefore, factors such as changes in the ambient temperature and aging will simultaneously change the resonant frequencies of the two surface acoustic wave resonators, that is, the difference between the two resonant frequencies remains unchanged (for example, 2MHz), thereby eliminating the pressure sensor drift problem caused by factors such as changes in the ambient temperature and aging of the surface acoustic wave resonator. However, the present invention is not limited to this. In other embodiments, the pressure sensor body 41 may also have only one surface acoustic wave resonator.

[0090] As for the packaging method of the surface acoustic wave resonator, this embodiment uses a quartz wafer 52-a quartz wafer with a cavity 57-another quartz wafer 51 for bonding. However, the present invention does not impose any limitation on this. In other embodiments, a quartz wafer 52-an intermediate layer (glass or metal forming a cavity)-another quartz wafer 51 can also be used for bonding. After packaging, the bonding wires around the two surface acoustic wave resonators form an airtight cavity 58, and the leads 55 and 56 at both ends of the surface acoustic wave resonator are connected to the antenna 42 of the wireless pressure sensor through bonding wires or wafers. The present invention does not impose any limitation on this. In other embodiments, the leads can also be guided to the edge or bottom of the pressure sensor through wafer vias (TWV), glass vias (TGV), or wiring layers (RDL), and then combined with the antenna pins of the pressure sensor.

[0091] The specific operating principle is as follows: an external host transmits electromagnetic waves, which couple via an external antenna and the wireless pressure sensor's antenna 42, stimulating the surface acoustic wave resonators 53 and 54 within the pressure sensor body 41. When the pressure within the liquid reservoir 11 changes, the quartz crystal 52 deforms, changing the frequency of the surface acoustic wave resonator 54. The resonator's echo signal returns to the external host via the sensor antenna 42 and the external antenna. The external host detects the change in frequency of the resonator's return signal and calculates the pressure within the liquid reservoir 11.

[0092] In summary, after the fluid storage capsule with wireless pressure monitoring provided by the present invention is implanted under the patient's scalp, the scalp is sutured and the implantation point is closed to cut off the infection path to achieve long-term monitoring. The wireless monitoring function greatly facilitates the patient's freedom of movement and avoids the risk of the patient, especially children, pulling out or breaking the wires of the wired monitoring device. Furthermore, the small-volume wireless pressure sensor provides conditions for the miniaturized design of the fluid storage capsule, so that it can be well implanted under the patient's scalp. Alternatively, when the size of the fluid storage capsule is basically the same as that of the prior art, the miniaturized wireless pressure sensor also makes the fluid storage chamber have a larger volume; at this time, when the flexible membrane is pressed, more cerebrospinal fluid is discharged from the fluid storage chamber into the ventricular catheter, thereby enhancing the effect of flushing the ventricular catheter.

[0093] Furthermore, the symptoms of ventricular catheter blockage (e.g., headaches, urinary incontinence, and abnormal gait) are similar to those of other diseases. Existing fluid reservoirs cannot determine whether a ventricular catheter is blocked. However, the fluid reservoir with wireless pressure monitoring provided by the present invention can determine whether a ventricular catheter is blocked by monitoring intracranial pressure, thereby avoiding unnecessary catheter replacement surgeries and conserving medical resources.

[0094] The present invention improves upon the existing fluid storage capsule and adds additional functions while maintaining the original functions of medication and extraction of cerebrospinal fluid.

[0095] 1. A wireless pressure sensor is integrated into the reservoir to monitor intracranial pressure. After device implantation, the scalp is sutured, reducing the risk of percutaneous infection associated with conventional intracranial pressure monitoring and spinal fluid catheters.

[0096] 2. When conditions for spinal fluid catheter implantation are not ripe (e.g., due to intracranial hemorrhage, infection, or other symptoms), the device can serve as a temporary CSF drainage device and medication delivery device. It can also replace a spinal fluid catheter, performing the same function, both inside and outside the hospital. The pressure data provided by the device can guide the timing and amount of CSF drainage.

[0097] 3. The device can be implanted for a long time and connected to a conventional cerebrospinal fluid catheter to drain excess cerebrospinal fluid into the abdominal cavity / atrium.

[0098] 4. Periodically compressing the reservoir flushes the ventricular catheter, reducing catheter blockage caused by blood clots, choroid plexus, brain tumor tissue, and CSF deposits. A valve can be installed on the peritoneal / atrial shunt tube interface or on the peritoneal / atrial shunt tube. When the flexible membrane is squeezed to flush the ventricular catheter, the valve leading to the peritoneal / atrial shunt tube automatically closes, allowing CSF in the reservoir to flow into the ventricular catheter, enhancing flushing effectiveness.

[0099] 5. The pressure data output by the device can be used to adjust the valve of the cerebrospinal fluid catheter to avoid excessive or insufficient release of cerebrospinal fluid and maintain normal intracranial pressure.

[0100] 6. It can determine whether the cerebrospinal fluid catheter is blocked and avoid unnecessary catheter replacement surgery.

[0101] Although the present invention has been disclosed above by means of preferred embodiments, this is not intended to limit the present invention. Anyone skilled in the art may make slight changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be determined by the scope of protection required by the claims.

Claims

1. A liquid storage sac with wireless pressure monitoring, characterized in that, Comprising: A liquid storage sac housing, which forms a liquid storage cavity for storing cerebrospinal fluid, and a pumping and injection window is provided on the top wall of the liquid storage sac housing facing the patient's scalp; A ventricular catheter interface, which is arranged on the liquid storage sac housing and communicates with the liquid storage cavity; A flexible membrane, which is hermetically sealed to cover the pumping and injection window; A wireless pressure sensor, which includes a sensor body and an antenna. The wireless pressure sensor is arranged in the liquid storage sac housing and contacts the liquid storage cavity to collect the intracranial pressure signal of the patient and transmit it to an external receiver. Wherein, the wireless pressure sensor is a sensor based on a surface acoustic wave resonator or a thin film bulk acoustic wave resonator.

2. The liquid storage sac with wireless pressure monitoring according to claim 1, wherein, The liquid storage sac housing is of an integral structure; or, the liquid storage sac housing includes an upper housing and a lower housing that are detachably and hermetically connected, and the upper housing and the lower housing are connected by bonding or welding.

3. The liquid storage sac with wireless pressure monitoring according to claim 1, characterized in that, The volume of the wireless pressure sensor is less than or equal to 10*3*1 mm 3 , the cross-section of the liquid storage sac housing is circular and the maximum diameter of the cross-section is 15 mm to 25 mm, and the height of the liquid storage sac housing is 5 mm to 10 mm.

4. The liquid storage sac with wireless pressure monitoring according to claim 1, characterized in that The liquid storage sac with wireless pressure monitoring further includes a ventricular catheter. One end of the ventricular catheter is connected to the ventricular catheter interface and the other end is implanted into the anterior horn of the patient's ventricle. The ventricular catheter is detachably connected to the ventricular catheter interface or integrally connected to the ventricular catheter interface; the ventricular catheter interface is arranged on the bottom wall or the side wall of the liquid storage sac housing.

5. The liquid storage sac with wireless pressure monitoring according to claim 1, characterized in that, The flexible membrane is any one of a natural rubber, a silicone membrane or a silica gel membrane, a flexible elastic membrane. When the flexible membrane on the liquid storage sac is extruded by an external force, it sinks into the liquid storage cavity, increasing the pressure in the liquid storage cavity so that the cerebrospinal fluid in the ventricular catheter flushes the drainage opening of the ventricular catheter.

6. The liquid storage sac with wireless pressure monitoring according to claim 1, wherein, The flexible membrane is a flat membrane or a curved membrane with a middle part protruding towards the direction of the patient's scalp; the thickness of the flexible membrane is basically the same; or, the flexible membrane includes a needle puncture area in the middle area and a pressing area located outside the needle puncture area for generating membrane deformation, and the thickness of the needle puncture area is greater than the thickness of the pressing area.

7. The liquid storage sac with wireless pressure monitoring according to claim 1, characterized in that, The liquid storage sac housing is a biocompatible polymer, ceramic or metal material; the antenna is laid on the inner surface and / or the outer surface of the liquid storage sac housing; or, the antenna is embedded in the liquid storage sac housing; or, the antenna is distributed on the liquid storage sac housing or the liquid storage sac housing is used as a part of the antenna.

8. The liquid storage sac with wireless pressure monitoring according to claim 1, characterized in that, The liquid storage sac with wireless pressure monitoring further includes an anti-puncture part arranged on the inner bottom wall of the liquid storage sac housing. The anti-puncture part is made of a biocompatible metal or ceramic or a biocompatible polymer with a hardness higher than that of the liquid storage sac housing to prevent the needle from piercing the inner bottom wall of the liquid storage sac housing. The antenna is distributed on the anti-puncture part or the anti-puncture part is used as a part of the antenna.

9. The liquid storage sac with wireless pressure monitoring according to claim 1, characterized in that, The sensor body is arranged on the inner bottom wall of the liquid storage sac housing or the anti-puncture part. The liquid storage sac housing has a protection part extending to the bottom of the flexible membrane and opposite to the sensor body. The protection part blocks the needle piercing the flexible membrane and prevents the sensor body from being stabbed.

10. The liquid storage sac with wireless pressure monitoring according to claim 7, characterized in that, When the antenna is laid on the outer surface of the liquid storage sac housing where the sensor body is located or embedded in the liquid storage sac housing where the sensor body is located, the liquid storage sac housing has a wire passing hole, and both ends of the antenna are fed to the sensor body through the wire passing hole.

11. The liquid storage sac with wireless pressure monitoring according to claim 7, characterized in that, The antenna is any one of a circular ring shape, a wave ring shape, an equal line width spiral shape, an unequal line width spiral shape, a polygon patch shape or a circular patch shape; or, the antenna is any one or a combination of a straight line, a broken line, an arc.

12. The liquid storage sac with wireless pressure monitoring according to claim 1, wherein, The liquid storage sac with wireless pressure monitoring further includes an abdominal / atrial shunt tube interface disposed on the side wall of the liquid storage sac housing and communicating with the liquid storage cavity, and a plugging end cap or an abdominal / atrial shunt tube connected to the patient's abdomen is detachably connected to the abdominal / atrial shunt tube interface.

13. The liquid storage sac with wireless pressure monitoring according to claim 12, characterized in that, The liquid storage sac with wireless pressure monitoring further includes a valve disposed on the abdominal / atrial shunt tube interface or the abdominal / atrial shunt tube. When the flexible membrane is squeezed to flush the ventricular catheter, the valve automatically closes, and the cerebrospinal fluid in the liquid storage sac will rush towards the ventricular catheter. The shape and volume of the liquid storage sac are optimized to improve the flushing effect and prevent excessive pressure from damaging the ventricles and brain tissue.

14. The liquid storage sac with wireless pressure monitoring according to claim 13, characterized in that, The materials of the liquid storage sac housing, the ventricular catheter interface, and the abdominal / atrial shunt tube interface may be the same or different, and may be any one of biocompatible metals, biocompatible polymers, or biocompatible ceramics.

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