Liquid storage bag with wireless pressure monitoring function

Abstract

The invention provides a liquid storage bag with a wireless pressure monitoring function. The liquid storage bag comprises a liquid storage bag shell, a ventricular catheter connector, a flexible film and a wireless pressure sensor. A liquid storage cavity used for storing cerebrospinal fluid is formed in the liquid storage bag shell, and a pumping and injecting window is formed in the top wall, facing the scalp of a patient, of the liquid storage bag shell. The ventricular catheter connector is arranged on the liquid storage bag shell and communicated with the liquid storage cavity. And the flexible film covers the pumping and injecting window in a sealing manner. The wireless pressure sensor comprises a sensor body and an antenna, and the wireless pressure sensor is arranged in the liquid storage bag shell and makes contact with the liquid storage cavity so as to collect intracranial pressure signals of a patient and transmit the intracranial pressure signals to an external receiver. Wherein the wireless pressure sensor is a sensor based on a surface acoustic wave resonator or a film acoustic bulk wave resonator.

Description

Technical Field

[0001] The invention relates to the field of medical instruments, 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 total volume of these three maintains a dynamic balance with the total volume of the skull and brain, maintaining the intracranial pressure at a normal level. Severe craniocerebral injury, cerebral hemorrhage and other diseases often cause acute increase in intracranial pressure, and chronic diseases such as intracranial tumors or hydrocephalus can also cause varying degrees of increase in intracranial pressure. Increased intracranial pressure may affect cerebral blood circulation, leading to decreased perfusion pressure, reduced cerebral blood flow, restricted venous return, stagnation of intracranial blood, and even brain compression and brain displacement. In severe cases, brain herniation occurs, and patients often die from secondary brainstem injury. Therefore, the intracranial pressure monitor is one of the commonly used instruments in neurosurgery, which is used to monitor intracranial pressure in real time and avoid the above symptoms caused by excessive intracranial pressure. Intracranial hypertension can be relieved by extracting cerebrospinal fluid, using the drug mannitol, or by cranial craniectomy.

[0003] At present, 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 method, etc.) is still in the research stage and clinical trial stage, and its accuracy and stability are still unable to be judged. 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] Implantation method: The pressure sensor is implanted directly into the skull through a burr hole or craniotomy, and the wire is connected to an external monitor; the advantage is that the wire diameter is relatively small (usually <2mm), the risk of cerebral hemorrhage and brain damage is also small, and the consequences of wire displacement or breakage are smaller than those of the catheter method. And the risk of infection is relatively low compared to the catheter method. The disadvantage is that it can only be decompressed by the drug mannitol or cranial craniectomy. If decompression is required by extracting cerebrospinal fluid, the cerebrospinal fluid catheter needs to be re-implanted. Catheter method: The catheter is placed in the ventricle, cistern or subarachnoid space, and the sensor is outside the skull. It contacts the cerebrospinal fluid in the catheter for pressure measurement. The advantage is that while monitoring intracranial pressure, the intracranial pressure can be reduced by draining excess cerebrospinal fluid. The disadvantage is that the diameter of the catheter is relatively large (usually >2.5mm), which has a high risk of cerebral hemorrhage and brain damage. The ventricle is directly connected to the external environment through the cerebrospinal fluid in the catheter, and the risk of infection is also very high. In both methods, the wire or catheter needs to pass through the skin, resulting in the inability to close the implantation point, which poses a high risk of infection. Typically, wired monitoring can only last for 7 to 10 days. For patients who need longer periods of 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 also have to deal with the additional complexity of the wires to the nursing process, which significantly increases the difficulty of nursing work.

[0005] In order to solve the above pain points in clinical use and meet the needs of long-term monitoring and monitoring outside the hospital, a wireless intracranial pressure monitoring solution has been proposed. This solution can suture the scalp after the sensor is implanted, and transmit the measurement signal through the skin by inductive coupling, which reduces the risk of infection and is suitable for long-term and home monitoring. However, this solution can only monitor intracranial pressure but cannot drain cerebrospinal fluid to reduce intracranial pressure.

[0006] For this reason, some people have proposed a fluid reservoir with intracranial pressure monitoring function. This solution integrates the pressure sensor in the fluid reservoir. The fluid reservoir can be connected to the cerebrospinal fluid catheter to provide guidance for the adjustment of the catheter valve, and can determine the blockage of the ventricular catheter and realize the extraction of cerebrospinal fluid at the same time. However, most of the existing wireless pressure sensors are based on inductive coupling structures, such as MEMS sensors, NFC sensors, etc. These sensors have the problem of large implant volume due to the need to set up coupling coils. After integration, the sensor occupies too much space in the fluid reservoir, which affects the extraction of cerebrospinal fluid or the effect of flushing the ventricular catheter. Furthermore, wireless pressure sensors based on inductive coupling also have problems such as low monitoring accuracy (+ / -2mmHg) and drift, low sampling frequency (44Hz), complex sensor design and high cost, which greatly limit the promotion and use of such products. In addition, the inductively coupled external receiver also has the problem of large size due to the setting of the coupling coil, such as Figure 1 shown. Summary of the invention

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

[0008] In order to achieve the above-mentioned purpose, the present invention provides a fluid storage bag with wireless pressure monitoring. It includes a fluid storage bag shell, a ventricular catheter interface, a flexible membrane and a wireless pressure sensor. The fluid storage bag shell is formed with a fluid storage cavity for storing cerebrospinal fluid, and a pumping window is provided on the top wall of the fluid storage bag shell facing the patient's scalp. The ventricular catheter interface is arranged in the fluid storage bag shell and connected to the fluid storage cavity. The flexible membrane seal covers the pumping window. The wireless pressure sensor includes a sensor body and an antenna, and the wireless pressure sensor is arranged in the fluid storage bag 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 acoustic bulk wave resonator.

[0009] According to an embodiment of the present invention, the liquid storage capsule shell is an integrated structure; or, the liquid storage capsule shell 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 an 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 also 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 separately connected to the ventricular catheter interface, or is integrally connected to the ventricular catheter interface.

[0012] According to an embodiment of the present invention, the ventricular catheter interface is arranged 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. After being squeezed by external force, the flexible membrane on the fluid storage bag is sunken 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 direction of 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 an anti-puncture portion arranged on the inner bottom wall of the fluid storage bag shell, and the anti-puncture portion is made of a 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 / a biocompatible polymer having a harderness than that of the reservoir shell and serves as a part of the antenna.

[0019] According to an embodiment of the present invention, the sensor body is disposed on the inner wall of the liquid storage capsule shell, and the antenna is distributed in the liquid storage capsule shell where the sensor body is located or the liquid storage capsule shell 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 shell where the sensor body is located is a biocompatible polymer or a biocompatible ceramic, and the liquid reservoir shell 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 a 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 an embodiment of the present invention, the antenna is any one of a circular ring, a wavy ring, an equal-width spiral, an unequal-width spiral, a polygonal patch or a circular patch;

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

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

[0027] According to an embodiment of the present invention, the sensor body is arranged on the inner bottom wall of the liquid storage capsule housing and is located at 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 blocking end cap or is 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 storage bag with wireless pressure monitoring also includes a valve arranged 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 is automatically closed, and the cerebrospinal fluid in the fluid storage bag will rush to the ventricular catheter, thereby improving the flushing effect.

[0031] According to one embodiment of the present invention, the materials of the 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, after the reservoir with wireless pressure monitoring provided by the present invention is implanted under the patient's scalp, the implantation point can be closed by scalp suture, thereby cutting off the infection path, reducing the risk of infection, and realizing long-term monitoring. At the same time, the risk of safety and data loss caused by pulling out or breaking the wires of the wired monitoring device for patients (especially children) is avoided. 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 problems of accuracy and drift. Compared with wireless products based on LC resonance technology, the present invention realizes the miniaturization of the volume of wireless pressure sensors, provides support for the miniaturization design of the reservoir, and makes it more suitable for implantation under the scalp. If the size of the reservoir is maintained basically the same as that of the prior art, the miniaturized sensor can increase the volume of the reservoir 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, and the use process has higher ease of use and comfort, which can also meet the needs of patients for long-term continuous monitoring.

[0033] In order to make the above and other purposes, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 The figure shows a schematic diagram of the structure of an existing liquid storage capsule equipped with an inductively coupled pressure sensor when reading pressure data.

[0035] Figure 2 Shown is a schematic structural diagram of a liquid storage bag with wireless pressure monitoring provided in Embodiment 1 of the present invention.

[0036] Figure 3 Shown Figure 2 Schematic diagram of a reservoir with wireless pressure monitoring implanted under a patient's scalp.

[0037] Figure 4 Shown Figure 2 Schematic diagram of the structure after removing the ventricular catheter.

[0038] Figure 5 Shown Figure 4 Schematic diagram of the structure after removing the flexible membrane.

[0039] Figure 6 Shown is a schematic structural diagram of a fluid storage bag with wireless pressure monitoring in another embodiment of the present invention.

[0040] Figure 7 Shown Figure 6 Schematic diagram of the structure of a reservoir with wireless pressure monitoring implanted under the patient's scalp.

[0041] Figure 8 Shown is a schematic structural diagram of a fluid storage bag with wireless pressure monitoring provided by another embodiment of the present invention.

[0042] Fig. 9A Shown Figure 2 The schematic diagram of the distribution of antennas in a liquid storage bag with wireless pressure monitoring on the bottom wall or protective thorns inside the liquid storage bag shell is shown.

[0043] FIG. 9B to FIG. 9H A schematic diagram of the distribution of antennas on the inner bottom wall or protective thorn portion of a liquid storage bladder shell in a liquid storage bladder with wireless pressure monitoring provided in another embodiment of the present invention.

[0044] Fig.10 It is a schematic diagram of the structure of the fluid storage bag with wireless pressure monitoring provided by the second embodiment of the present invention when it is not connected to the ventricle and the abdominal cavity / atrial shunt tube.

[0045] Fig.11 Shown Fig.10 Schematic diagram of the structure after the middle shunt port is connected to the ventricular and peritoneal / atrial shunt tubes.

[0046] Fig.12 Shown Fig.10 Schematic diagram of the structure when the mid-abdominal / atrial shunt tube interface is connected to the occluding end cap.

[0047] Fig.13 It 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 the ventricle and peritoneal / atrial shunt tube.

[0048] Fig.14 FIG. 1 is a schematic diagram of the packaging structure of a surface acoustic wave resonator in a sensor body according to an embodiment of the present invention.

[0049] Fig.15 for Fig.14 Schematic diagram of the cross section after packaging. DETAILED DESCRIPTION

[0050] Embodiment 1

[0051] like Figures 2 to 5As shown, this embodiment provides a fluid storage bag with wireless pressure monitoring, which includes a fluid storage bag shell 1, a ventricular catheter interface 2, a flexible membrane 3, and a wireless pressure sensor 4. The fluid storage bag shell 1 is formed with a fluid storage cavity 11 for storing cerebrospinal fluid, and a pumping window 12 is opened on the top wall of the fluid storage bag shell 1 facing the patient's scalp. The ventricular catheter interface 2 is arranged in the fluid storage bag shell 1 and connected to the fluid storage cavity 11. The flexible membrane 3 is sealed and covered on the pumping window 12. The wireless pressure sensor 4 includes a sensor body 41 and an antenna 42. The wireless pressure sensor 4 is arranged in the fluid storage bag 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 storage capsule with wireless pressure monitoring provided in this embodiment uses the high-frequency industrial, scientific and medical frequency band (ISMband, such as 915MHz or 2.4GHz). The wireless pressure sensor based on radio frequency excitation does not need to use an inductive coil for coupling, which greatly reduces the volume of the external receiver and the fluid storage capsule, so that the fluid storage capsule can be miniaturized and can be better implanted under the scalp of patients with limited space. After minimally invasive implantation, scalp sutures can be performed to effectively avoid the risks caused by percutaneous infection. Furthermore, excitation based on the radio frequency band also makes it unnecessary to set up a power supply in the sensor to further reduce the volume 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), and changes in the surrounding environment (such as temperature, pressure, brain oxygen saturation and other parameters) change the resonant frequency of the sensor and the frequency of the echo signal. The external receiver receives the echo signal sent by the wireless pressure sensor, and calculates parameters such as temperature, pressure, brain oxygen saturation and so on according to 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 frequency band (ISMband, for example 915MHz) or the RFID frequency band (865MHz). Compared with the traditional LC inductively coupled pressure sensor 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, the surface acoustic wave resonator (SAW) and the film bulk acoustic wave resonator (FBAR) will have a higher quality factor Q, usually around 3000, which is much higher than the quality factor of the LC resonator (the quality factor of the LC resonator 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]

[0056] Based on this relationship, it can be obtained that: the higher the quality factor Q, the smaller the frequency resolution δf will be, that is, the higher the frequency accuracy. Therefore, compared with the traditional MEMS sensor based on LC resonator, the liquid storage bag with wireless pressure monitoring provided in this embodiment will have a higher frequency response sensitivity, and it has a very high monitoring capability for small pressure changes. At the same time, the improvement of the quality factor Q can also significantly reduce the resonance bandwidth and make 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 resonance response, with small frequency drift and higher linearity. The accuracy of the intracranial pressure sensor currently used in clinical practice (such as a MEMS sensor based on an LC resonator) is just 2mmHg, which just meets the requirements, while the high Q value wireless pressure sensor based on a surface acoustic wave resonator (SAW) provided in this embodiment can reach a sensitivity of 1mmHg; the range of intracranial pressure is relatively low (usually 7-15mmHg), and this accuracy improvement is of significant significance for diagnosis, treatment and disease management.

[0057] However, the present invention does not impose any limitation on the specific type of wireless pressure sensor and the way in which 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 limitation on this. In other embodiments, the fluid reservoir shell can also be made of a biocompatible polymer with a relatively high hardness (such as polyetheretherketone PEEK, polyaryletherketone PAEK or polytetrafluoroethylene PTFE); or a biocompatible ceramic (such as aluminum oxide or zirconium oxide).

[0058] In the present 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 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.

[0059] In this embodiment, the wireless pressure monitoring fluid storage bag further 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 arranged on the bottom wall of the fluid storage bag housing 1, and the ventricular catheter 5 is detachably connected to the ventricular catheter interface 2. Figure 4FIG. 1 is a schematic diagram of the structure after the ventricular catheter 5 is disassembled. This configuration allows the fluid reservoir shell 1 and the ventricular catheter interface 2 to be replaced or sold as an integral part; 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 disposed on the side wall of the fluid reservoir shell, such as Figure 6 and Figure 7 shown.

[0060] like Figure 3 As shown, the reservoir with wireless pressure monitoring is located between the scalp 100 and the skull 200. The diameter of the skull burr hole 300 is usually about 2.7 mm, and the ventricular catheter 5 is implanted into the anterior horn 400 of the ventricle through the skull burr hole 300 on the skull. Afterwards, the scalp 100 is sutured to close the implantation point, reducing percutaneous infection. The anterior horn 400 of the ventricle is connected to the reservoir 11 through the drainage port 51 on the ventricular catheter 5, and cerebrospinal fluid and medication can be extracted through the reservoir. Specifically, the flexible membrane 3 can achieve a self-closing seal. When the intracranial pressure of the patient is too high, the cerebrospinal fluid in the reservoir can be extracted by piercing the flexible membrane 3 with a needle to reduce the intracranial pressure; in addition, the drug can be injected into the reservoir 11 through a needle, and the drug then penetrates into the patient's ventricle through the ventricular catheter interface 2 and the drainage port 51 on the ventricular catheter 5 to achieve treatment. In this embodiment, the material of the ventricular catheter interface 2 is the same as that of the reservoir shell 1, and is made of a biocompatible metal material; specifically, it can be titanium or stainless steel. However, the present invention does not make any limitation to this. In other embodiments, the material of the ventricular catheter interface can also be different from that of the reservoir shell, and a biocompatible polymer with relatively high hardness, such as polypropylene, can be used.

[0061] In this embodiment, the volume of the wireless pressure sensor 4 is less than or equal to 10*3*1mm 3 In the wireless pressure sensor provided by the present invention, the antenna 42 is made of a biocompatible metal wire with a very thin diameter 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, a maximum cross-section diameter of 15mm to 25mm, and a height of 5mm to 10mm, and the space occupancy rate in the liquid storage capsule shell 1 is less than 5.9%. This space occupancy ratio is much smaller than the space occupancy rate of traditional MEMS sensors in the same liquid storage capsule shell, thereby making the liquid storage cavity 11 have a larger liquid storage space.

[0062] 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 make the flexible membrane 3 concave into the liquid storage chamber 11, thereby increasing the pressure in the liquid storage chamber 11, so that the cerebrospinal fluid in the liquid storage chamber 11 and the ventricular catheter 5 can flush the drainage port 51 of the ventricular catheter 5, thereby achieving the 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. Figure 2 As shown, 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 limit the shape of the ventricular catheter drainage port, which can be square, oval, long strip and other shapes.

[0063] Preferably, the inner diameter of the ventricular catheter 5 is generally about 1.3 mm, and the outer diameter is about 2.5 mm; the length of the ventricular catheter 5 can be trimmed as needed. The ventricular catheter 5 is usually made of a biocompatible polymer, such as silicone, silica gel or natural rubber, and the circular drainage hole 51 is placed in the lateral ventricle to drain the hydrocephalus from the ventricle. However, the present invention is not limited to this.

[0064] Specifically, the flexible membrane 3 is a flat flexible elastic membrane, and the overall thickness of the flexible membrane can be basically the same. When extracting cerebrospinal fluid and injecting drugs, a 25-gauge or smaller needle can be used. However, the present invention does not make any limitation to this. In other embodiments, in order to increase the number of needle penetrations that can be used, the overall thickness of the flexible membrane can also be set thicker, such as about 4 mm or even thicker. However, the present invention does not make any limitation to this. In other embodiments, the flexible membrane may include a needle puncture area located in the middle area and a pressing area located on the periphery of the needle puncture area for producing membrane deformation, and the thickness of the needle puncture area is greater than the thickness of the pressing area. The thick needle puncture area can increase the number of needle penetrations and extend the service life of the liquid storage capsule, while the thinner pressing area can facilitate the pressing of the flexible membrane to flush the ventricular catheter. In other embodiments, the flexible middle area can also be set thin to form a pressing area, while the edge area is thicker to form a needle puncture area. The present invention does not make any limitation to the shape of the flexible membrane. In other embodiments, it may also be a curved surface that is raised toward the patient's scalp to facilitate pressing.

[0065] In this embodiment, the flexible membrane 3 is a silicone membrane. However, the present invention does not limit this. In other embodiments, the flexible membrane can also be any one of natural rubber, silicone membrane or other biocompatible elastic flexible membrane.

[0066] This embodiment is described by taking the liquid storage capsule housing 1 and the flexible membrane 3 as different materials. However, the present invention does not make any limitation to this. Figure 8 As shown, both the reservoir shell 1 and the flexible membrane 3 can be made of flexible membrane and the two are integrally formed or bonded to the bottom of the reservoir shell. The flexible reservoir shell 1 will be more conducive to pressing to flush the ventricular catheter. At this time, the flexible membrane 3 is still used to extract cerebrospinal fluid or inject drugs. The wall thickness at the flexible membrane 3 can be basically the same as the wall thickness of the reservoir shell; or, the wall thickness at the flexible membrane 3 is greater than the wall thickness of the reservoir shell 1 to increase the number of needle penetrations and extend the service life of the reservoir. In this embodiment, the reservoir shell 1 and the flexible membrane 3 are both silicone. However, the present invention does not make any limitation to this. In other embodiments, both can also be natural rubber, silicone, or other biocompatible flexible materials.

[0067] In this embodiment, the sensor body 41 is disposed on the inner wall of the liquid storage capsule housing 1; specifically, it is disposed on the inner bottom wall of the liquid storage capsule housing 1. In order to prevent the sensor body 3 from being damaged due to excessive force when the needle pierces the flexible membrane, the liquid storage capsule housing 1 also has a protective portion extending to the bottom of the flexible membrane 3 and opposite to the sensor body 41, and the protective portion blocks the needle piercing the flexible membrane 3 to protect the sensor body 41. However, the present invention is not limited to this. In other embodiments, the sensor body may be disposed on the inner bottom wall of the liquid storage capsule housing at the periphery of the projection surface of the flexible membrane; or, the sensor body may also be disposed on the inner side wall of the liquid storage capsule housing.

[0068] Furthermore, to prevent the needle from piercing the inner bottom wall of the fluid storage bag shell 1 made of a biocompatible polymer, in this embodiment, the fluid storage bag with wireless pressure monitoring also includes a puncture-proof portion 6 arranged on the inner bottom wall of the fluid storage bag shell 1, and the puncture-proof portion 6 blocks the needle to prevent the needle from damaging the inner bottom wall of the fluid storage bag 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 a 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 a polypropylene material.

[0069] The arrangement of the sensor body 41 in the space of the liquid storage chamber 11 not only optimizes the design of the wireless pressure sensor 4 and improves its performance, but also makes the wireless pressure sensor and the antenna closer to the skin surface, reduces electromagnetic wave loss, and can obtain better data transmission effect. In addition, in this design, the liquid storage capsule housing 1 can also be used as part of the sensor antenna, or an antenna structure can be made on the bottom of the liquid storage capsule housing.

[0070] In this embodiment, the antenna 42 is distributed in the fluid reservoir shell 1 where the sensor body 41 is located. Specifically, the fluid reservoir shell 1 where the sensor body 41 is located is a non-metallic biocompatible polymer or biocompatible ceramic, and the antenna 42 is laid on the inner surface of the fluid reservoir shell 1 where the sensor body 1 is located, such as the inner bottom wall and / or the inner side wall. However, the present invention does not impose any limitation on this. In other embodiments, the antenna may also be laid on the inner and outer surfaces of the fluid reservoir shell where the sensor body is located; or the outer surface of the fluid reservoir shell; or, the antenna is embedded in the fluid reservoir shell where the sensor body is located. Alternatively, the fluid reservoir shell serves as a part of the antenna. In other embodiments, when the fluid reservoir shell has a stab-proof portion, the sensor body may also be disposed on the stab-proof portion, and the antenna may be arranged on the stab-proof portion and / or the fluid reservoir shell, and the form of the antenna may also be set as needed. Figures 9A to 9G Any of .

[0071] like Fig. 9A As shown, in this embodiment, the antenna 42 is a circular metal antenna formed on the inner bottom wall of the liquid storage capsule shell 1 or on the puncture-proof portion. Usually, the bottom of the liquid storage capsule shell 1 is a disk with a diameter of 15 mm to 25 mm, and the material of the liquid storage capsule shell 1 is a biocompatible polymer (such as polyetheretherketone PEEK, polyaryletherketone PAEK or polytetrafluoroethylene PTFE); or a biocompatible ceramic (such as aluminum oxide or zirconium oxide). Fig. 9A and 9B The loop antenna or the bent loop antenna is made at the bottom of the liquid storage capsule housing 1. The shape of the antenna matches the size and shape of the bottom of the liquid storage capsule housing 1, and the liquid storage capsule space can be reasonably utilized. For example, the loop antenna or the bent loop antenna is embedded in the inner bottom wall of the liquid storage capsule housing 1 using a metal wire, or is made on the inner bottom wall of the liquid storage capsule housing 1 by electroplating.

[0072] for Fig. 9A The circumference of the loop antenna can be calculated using the following formula:

[0073] C=n·λ eff

[0074] Wherein, C: the circumference of the loop antenna, which is usually an integer multiple or fractional multiple of the working wavelength to achieve resonance; n: resonant mode (usually 1 is selected, i.e., 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).

[0075] In this embodiment, the working frequency f of the antenna 42 is selected to be 915 MHz or 865 MHz. As for the effective dielectric constant, since the upper surface of the antenna 42 is in contact with the cerebrospinal fluid, the dielectric constant of the cerebrospinal fluid in this frequency band is about 68; and the lower surface of the antenna 42 is in contact with the bottom of the reservoir shell 1. When the reservoir shell 1 is a biocompatible polymer, the dielectric constant of the lower surface of the antenna 42 is about 3, and when the reservoir shell 1 is a ceramic, the dielectric constant of the lower surface of the antenna 42 is about 10, so the weighted average formula is used to estimate the effective dielectric constant. After calculation by the above formula, it can be obtained that: when the working frequency is 915 MHz, the antenna diameter is about 17 mm, and when the working frequency is 865 MHz, the antenna diameter is about 18 mm. At this time, the antenna diameter just matches the bottom diameter (15 mm to 25 mm) of the reservoir shell 1. Further, for a small-sized reservoir for children, a bent loop antenna (9B) can be used to modulate the antenna 42 to the corresponding working frequency.

[0076] However, the present invention does not impose any limitation on this. In other embodiments, the antenna may also be a wave ring (such as Fig. 9B as shown), equal-width spirals (as shown Fig. 9C As shown), unequal line width spiral (such as Fig.9D As shown), polygonal patch type (as shown Fig.9E as shown) or circular patch type (as Fig.9F It can also be any one or more combinations of straight lines, broken lines, and arcs; for example, Figure 9G In FIG. 4 , the antenna 42 includes a straight line 421 and an arc 422; Figure 9H In the figure, the antenna 42 includes a rectangular fold line 423 and a wavy arc line 424; the complex antenna structure can enhance the antenna radiation efficiency, but its processing complexity will be relatively higher. Figure 9C to Figure 9H The structure shown is that the antenna 42 is laid on the outer surface of the liquid storage capsule housing 1 where the sensor body 41 is located and / or embedded in the liquid storage capsule housing 1 where the sensor body 41 is located; at this time, the liquid storage capsule housing 1 has a wire hole 13, and the two ends of the antenna 42 are fed to the sensor body 41 through the wire hole 13. Among them, Fig. 9C and Fig.9D It is the antenna structure on the outer surface side of the liquid capsule housing 1. Due to the viewing angle, the sensor body is not shown in this figure.

[0077] Although the present embodiment is described by taking the liquid reservoir shell 1 as a non-metallic biocompatible polymer or biocompatible ceramic as an example, the present invention does not impose any limitation on this. In other embodiments, the liquid reservoir shell where the sensor body is located can also be made of a biocompatible metal material; in this case, the liquid reservoir shell will form a polarization of the antenna. In this case, the liquid reservoir shell serves as a part of the antenna to further simplify the setting of the antenna.

[0078] In this embodiment, the liquid storage capsule housing 1 is an integrated structure. However, the present invention does not limit this. In other embodiments, the liquid storage capsule housing may also be a split structure, which includes an upper shell and a lower shell that are sealed and connected, and the upper shell and the lower shell may be bonded or welded.

[0079] 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 on 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.

[0080] Specifically, for patients with acute brain trauma: after the reservoir 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, the scalp and the flexible membrane 3 can be pierced with a needle to extract cerebrospinal fluid to achieve the purpose of reducing intracranial pressure. According to clinical needs and the intracranial pressure data provided by the reservoir 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 method intracranial pressure monitoring and discharge of cerebrospinal fluid. The reservoir 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 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.

[0081] 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, and to guide the extraction of cerebrospinal fluid to release intracranial pressure; a needle can also be used to pierce the scalp and flexible membrane 3 to extract cerebrospinal fluid, and tests can be performed to determine bleeding and infection. Drugs are injected through the flexible membrane to achieve therapeutic functions. The reservoir with wireless pressure monitoring is suitable for long-term implantation. It can be retained in the patient's body after the patient is discharged from the hospital, and intracranial pressure can be monitored regularly, cerebrospinal fluid can be extracted to reduce intracranial pressure, tests and medication can be performed, and the ventricular catheter 5 can be flushed by pressing the flexible membrane 3. It is used for postoperative monitoring, rehabilitation and nursing of patients with tumors and cerebral hemorrhage.

[0082] Embodiment 2

[0083] This embodiment is basically the same as the first embodiment and its variations, except that: in this embodiment, Fig.10As shown, the ventricular catheter interface 2 is arranged on the side wall of the fluid storage bag housing 1, and the fluid storage bag with wireless pressure monitoring also includes a peritoneal / atrial shunt tube interface 7 which is arranged on the other side wall of the fluid storage bag housing 1 opposite to the ventricular catheter interface 2 and connected to the fluid storage cavity 11. However, the present invention does not make any limitation to this. In other embodiments, such as Fig.13 As shown, the ventricular catheter interface 2 is arranged at the bottom of the fluid storage bag shell 1, and the abdominal cavity / atrial shunt tube interface 7 is arranged on the side wall of the fluid storage bag shell 1.

[0084] Further, such as Fig.11 As shown, in this embodiment, the abdominal / atrial shunt tube interface 7 is detachably connected to the abdominal / atrial shunt tube 8. The arrangement of the abdominal / atrial shunt tube interface 7 and the abdominal / atrial shunt tube 8 can drain the cerebrospinal fluid in the fluid storage cavity 11 to the patient's abdominal cavity or atrium. Furthermore, the abdominal / atrial shunt tube 8 also has 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 flow, and when the intracranial pressure is low, the opening of the flow control valve can be adjusted to control the intracranial pressure, so that it can be well applied to patients who need to implant an abdominal / atrial shunt tube.

[0085] However, for patients who are uncertain whether to implant a ventriculoperitoneal / atrial shunt or when the implantation conditions are not mature, it is necessary to monitor the intracranial pressure. Fig.12 As shown, the fluid storage bag with wireless pressure monitoring also includes a blocking end cap 9 detachably arranged on the abdominal / atrial shunt tube interface 7. The detachable arrangement of the abdominal / atrial shunt tube 8 and the blocking end cap 9 allows the two to be replaced at different stages of the patient. Specifically, the fluid storage bag with wireless pressure monitoring having the 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 an abdominal / atrial shunt tube 8, surgery is performed to remove the blocking end cap 9 and install the abdominal / atrial shunt tube 8 to drain the cerebrospinal fluid to the abdominal cavity or atrium to reduce intracranial pressure, such as Fig.11 shown.

[0086] Specifically, for patients with congenital hydrocephalus, normal pressure hydrocephalus or those who need to implant a ventriculoperitoneal / atrial shunt, when the patient has intracranial infection, bleeding or other symptoms and does not have the ability to implant a shunt, the prior art is to implant an ordinary fluid reservoir, inject drugs through the fluid reservoir to control infection or other symptoms, and control 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 implanting 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.

[0087] In addition, when the peritoneal / atrial shunt tube interface 7 is connected to the peritoneal / atrial shunt tube 8, the fluid storage bag 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 is automatically closed, and the cerebrospinal fluid in the fluid storage cavity will flush toward the ventricular catheter 5 to improve the flushing effect.

[0088] Although this embodiment is described by taking congenital hydrocephalus, normal pressure hydrocephalus or patients who need to implant ventriculoperitoneal / atrial shunt as examples, the present invention does not make any limitation to this. The fluid storage capsule with wireless pressure monitoring provided in this embodiment can also be applied to other patients who need to monitor and reduce intracranial pressure, such as the acute brain trauma patients, brain tumor or cerebral hemorrhage patients, and lumbar peritoneal shunt patients in the first embodiment.

[0089] The materials of the liquid reservoir shell 1, the ventricular catheter interface 2 and the abdominal cavity / atrial shunt tube interface 7 can be the same or different, and all three can be any one of biocompatible metals or polymers. When they are made of the same material, the liquid reservoir shell 1, the ventricular catheter interface 2 and the abdominal cavity / atrial shunt tube interface 7 can be processed as a whole, or connected by bonding or welding.

[0090] As for the specific structures of the fluid storage bag 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, this embodiment is the same as the first embodiment and will not be described in detail here.

[0091] Furthermore, since the fluid reservoir is a long-term implantable device, in order to ensure the long-term airtightness of the device, the present embodiment uses quartz-quartz bonding to package the surface acoustic wave resonator or thin film acoustic bulk wave resonator in the sensor body 41. Specifically, the surface acoustic wave resonator is used as an example below. Fig.14 As shown, a surface acoustic wave resonator 54 is fabricated on a quartz wafer 52 and the quartz wafer 52 is thinned to less than 100 μm. 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 may also introduce another surface acoustic wave resonator 53, which is fabricated on another thicker quartz wafer 51, and its thickness is usually more than 200 μm. The two quartz wafers have the same cutting angle and properties, so 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, 2 MHz), 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 does not make any limitation to this. In other embodiments, the pressure sensor body 41 may also have only one surface acoustic wave resonator.

[0092] Regarding 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 forms 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.

[0093] The specific working principle is as follows: the external host emits electromagnetic waves, which are coupled through the external antenna and the antenna 42 of the wireless pressure sensor to excite the surface acoustic wave resonators 53 and 54 in the pressure sensor body 41. When the pressure in the liquid storage chamber 11 changes, the quartz crystal 52 is pushed to deform, changing the frequency of the surface acoustic wave resonator 54. The echo signal of the resonator is returned to the external host through the sensor antenna 42 and the external antenna. The external host calculates the pressure in the liquid storage chamber 11 by detecting the change in the frequency of the resonator return signal.

[0094] 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.

[0095] In addition, the symptoms caused by ventricular catheter blockage (such as headache, abnormal urination and abnormal gait) are similar to those caused by other diseases; the existing fluid storage capsule cannot determine whether the ventricular catheter is blocked. The fluid storage capsule with wireless pressure monitoring provided by the present invention can determine whether the ventricular catheter is blocked by monitoring the intracranial pressure, thereby avoiding unnecessary catheter replacement surgery and saving medical resources.

[0096] The present invention is improved on the basis of the existing fluid storage capsule, and adds additional functions besides maintaining the original functions of medication and extracting cerebrospinal fluid.

[0097] 1. Integrate the wireless pressure sensor into the reservoir to realize the intracranial pressure monitoring function. After the device is implanted, the scalp is sutured to reduce the risk of percutaneous infection caused by conventional intracranial pressure monitoring and cerebrospinal fluid catheters.

[0098] 2. When the conditions for cerebrospinal fluid catheter implantation are not mature (for example, there is intracranial bleeding, infection or other symptoms), it can be used as a temporary cerebrospinal fluid drainage device and drug delivery. It can also replace the cerebrospinal fluid catheter to play the same function and be used in and outside the hospital. The pressure data provided by the device can guide the time and amount of cerebrospinal fluid drainage.

[0099] 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.

[0100] 4. By pressing the reservoir regularly, the purpose of flushing the ventricular catheter is achieved, and the catheter blockage caused by blood clots, choroid plexus, brain tumor tissue, cerebrospinal fluid deposits, etc. can be reduced. A valve can be set 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 leading to the peritoneal / atrial shunt tube is automatically closed, and the cerebrospinal fluid in the reservoir will rush to the ventricular catheter to improve the flushing effect.

[0101] 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.

[0102] 6. It can determine whether the cerebrospinal fluid catheter is blocked and avoid unnecessary catheter replacement surgery.

[0103] Although the present invention has been disclosed as above by the preferred embodiment, it is not intended to limit the present invention. Anyone familiar with this technology can 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 based on the scope of protection required by the claims.

Claims

1. A liquid storage bag with wireless pressure monitoring, characterized in that: include: The liquid storage capsule shell is formed with a liquid storage cavity for storing cerebrospinal fluid and a pumping window is provided on the top wall of the liquid storage capsule shell facing the patient's scalp; A ventricular catheter interface is arranged on the liquid storage bag shell and communicated with the liquid storage cavity; A flexible membrane seals the injection window; A wireless pressure sensor comprises a sensor body and an antenna. The wireless pressure sensor is arranged in a fluid storage bag shell and contacts the fluid storage cavity to collect the patient's intracranial pressure signal and transmit it to an external receiver. The wireless pressure sensor is a sensor based on a surface acoustic wave resonator or a thin film acoustic bulk wave resonator.

2. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: The liquid storage capsule shell is an integrated structure; or, the liquid storage capsule shell includes an upper shell and a lower shell that are separated and sealed, and the upper shell and the lower shell are connected by bonding or welding.

3. The liquid storage bag 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*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.

4. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: The fluid storage bag with wireless pressure monitoring also includes a ventricular catheter, one end of which is connected to the ventricular catheter interface and the other end of which is implanted in the anterior horn of the patient's ventricle. 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. The ventricular catheter interface is arranged on the bottom wall or side wall of the fluid storage bag shell.

5. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: The flexible membrane is any flexible elastic membrane of natural rubber, silicone membrane or silica gel membrane. The flexible membrane on the fluid storage bag is squeezed by external force and sinks into the fluid storage cavity, increasing the pressure in the fluid storage cavity so that the cerebrospinal fluid in the ventricular catheter can flush the drainage port of the ventricular catheter.

6. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: The flexible membrane is a flat membrane or a curved membrane with a middle portion protruding toward the patient's scalp; the thickness of the flexible membrane is substantially uniform; or, the flexible membrane includes a needle puncture area located in the middle region and a pressing area located outside the needle puncture area for producing membrane deformation, and the thickness of the needle puncture area is greater than the thickness of the pressing area.

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

8. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: The liquid storage bag with wireless pressure monitoring also includes a puncture-proof portion arranged on the inner bottom wall of the liquid storage bag shell, and the puncture-proof portion is made of biocompatible metal or ceramic or a biocompatible polymer with a hardness higher than that of the liquid storage bag shell to prevent the needle from piercing the inner bottom wall of the liquid storage bag shell. The antenna is distributed on the puncture-proof portion or the puncture-proof portion serves as a part of the antenna.

9. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: The sensor body is arranged on the inner bottom wall or the puncture-proof part of the liquid storage capsule shell. The liquid storage capsule shell has a protective part extending to the bottom of the flexible membrane and opposite to the sensor body. The protective part blocks the needle that punctures the flexible membrane to prevent the sensor body from being punctured.

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

11. The liquid storage bag with wireless pressure monitoring according to claim 7, characterized in that: The antenna is any one of a circular ring, a wavy ring, an equal-width spiral, an unequal-width spiral, a polygonal patch or a circular patch; or, the antenna is any one or more combinations of a straight line, a broken line, and an arc.

12. The liquid storage bag with wireless pressure monitoring according to claim 1, characterized in that: 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 blocking end cap or a peritoneal / atrial shunt tube connected to the patient's abdominal cavity.

13. The liquid storage bag with wireless pressure monitoring according to claim 12, characterized in that: The fluid storage bag with wireless pressure monitoring also includes a valve arranged 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 is automatically closed, and the cerebrospinal fluid in the fluid storage bag will rush to the ventricular catheter. The shape and volume of the fluid storage bag are optimized to improve the flushing effect and prevent excessive pressure from damaging the ventricles and brain tissue.

14. The liquid storage bag with wireless pressure monitoring according to claim 13, characterized in that: The materials of the 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, biocompatible polymers or biocompatible ceramics.

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