Disclosure of Invention
The invention provides a liquid storage bag with wireless pressure monitoring for overcoming the defects of the prior art.
In order to achieve the above purpose, the present invention provides a liquid reservoir with wireless pressure monitoring. It comprises a liquid storage bag shell, a ventricular catheter interface, a flexible membrane and a wireless pressure sensor. The reservoir shell is formed with the liquid storage chamber that is used for storing cerebrospinal fluid and the reservoir shell is offered on the roof that faces the patient scalp and is taken out the notes window. The ventricular catheter interface is arranged on the liquid storage bag shell and communicated with the liquid storage cavity. The flexible film sealing cover is sealed on the pumping and injecting window. The wireless pressure sensor comprises a sensor body and an antenna, and is arranged in the liquid storage bag shell and contacts the liquid storage cavity so as to collect intracranial pressure signals of a patient and transmit the intracranial pressure signals to an external receiver. The wireless pressure sensor is a sensor based on a surface acoustic wave resonator or a film acoustic wave resonator.
According to one embodiment of the invention, the liquid storage bag shell is of an integrated structure, or comprises an upper shell and a lower shell which are connected in a split type and sealed manner, and the upper shell and the lower shell are connected in an adhesive or welding manner.
According to an embodiment of the invention, the volume of the wireless pressure sensor is less than or equal to 10×3×1mm3, the cross section of the liquid storage bag shell is circular, the maximum diameter of the cross section is 15 mm-25 mm, and the height of the liquid storage bag shell is 5 mm-10 mm.
According to an embodiment of the present invention, the liquid storage bag with wireless pressure monitoring further comprises a ventricle catheter, wherein one end of the ventricle catheter is connected to the ventricle catheter interface and the other end of the ventricle catheter is implanted into the anterior horn of the ventricle of the patient, and the ventricle catheter is connected to the ventricle catheter interface in a split type or connected with the ventricle catheter interface in an integrated manner.
According to an embodiment of the invention, the ventricular catheter interface is disposed at a bottom wall or a side wall of the reservoir housing.
According to one embodiment of the invention, the flexible membrane is a flexible elastic membrane, the flexible membrane on the liquid storage bag is extruded by external force and then is sunken into the liquid storage cavity, so that the pressure in the liquid storage cavity is increased to enable cerebrospinal fluid in the ventricular catheter to wash the ventricular catheter drainage port.
According to an embodiment of the present invention, the flexible film is a planar film or a curved film with a middle portion protruding toward the scalp of the patient.
According to an embodiment of the invention, the thickness of the flexible membrane is substantially uniform, or the flexible membrane comprises a needle penetration zone in the central region and a pressing zone at the periphery of the needle penetration zone for producing membrane deformation, the thickness of the needle penetration zone being greater than the thickness of the pressing zone.
According to an embodiment of the present invention, the flexible film is any one of natural rubber, silicone film or silicone film.
According to an embodiment of the present invention, the reservoir housing is a biocompatible polymer, and the reservoir with wireless pressure monitoring further includes a puncture preventing portion disposed on an inner bottom wall of the reservoir housing, wherein the puncture preventing portion is made of a biocompatible metal or a biocompatible polymer having a hardness higher than that of the reservoir housing, so as to prevent the needle from piercing the inner bottom wall of the reservoir housing.
According to an embodiment of the invention, the stab-resistant portion is made of a biocompatible metal material/biocompatible polymer having a hardness higher than the hardness of the reservoir housing and is part of the antenna.
According to an embodiment of the invention, the sensor body is disposed on an inner wall of the reservoir housing, and the antenna is distributed on the reservoir housing where the sensor body is located or the reservoir housing is used as a part of the antenna.
According to an embodiment of the invention, the reservoir housing where the sensor body is located is made of a biocompatible metallic material to form one polarization of the antenna.
According to an embodiment of the present invention, the reservoir housing where the sensor body is located is a biocompatible polymer or a biocompatible ceramic, and the reservoir housing is part of the antenna.
According to an embodiment of the invention, the reservoir housing where the sensor body is located is made of biocompatible polymer or biocompatible ceramic, and the antenna is laid on the inner surface and/or the outer surface of the reservoir housing where the sensor body is located, or the antenna is embedded in the reservoir housing where the sensor body is located.
According to an embodiment of the 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 is provided with a wire through hole, and two ends of the antenna are fed to the sensor body through the wire through hole.
According to an embodiment of the present invention, the antenna is any one of a circular ring shape, a wavy ring shape, an equal-line-width spiral shape, an unequal-line-width spiral shape, a polygonal patch shape, or a circular patch shape;
or the antenna is any one or a combination of a plurality of straight lines, broken lines and arcs.
According to an embodiment of the invention, the sensor body is disposed on an inner side wall or an inner bottom wall of the reservoir housing.
According to an embodiment of the invention, the sensor body is arranged on the inner bottom wall of the liquid storage bag shell and is positioned on the periphery of the projection surface of the flexible film;
or the sensor body is arranged on the inner bottom wall of the liquid storage bag shell, the liquid storage bag shell is provided with a protection part which extends to the bottom of the flexible film and is opposite to the sensor body, and the protection part blocks the needle penetrating through the flexible film so as to protect the sensor body.
According to an embodiment of the invention, the reservoir with wireless pressure monitoring further comprises an abdominal cavity/atrial shunt tube interface which is arranged on the side wall of the reservoir shell and is communicated with the reservoir cavity, and the abdominal cavity/atrial shunt tube interface is detachably connected with a plugging end cap or connected to an abdominal cavity/atrial shunt tube of a patient.
According to the embodiment of the invention, the abdominal cavity/atrium shunt tube interface is detachably connected with the abdominal cavity/atrium shunt tube, the liquid storage bag with wireless pressure monitoring further comprises a valve arranged on the abdominal cavity/atrium shunt tube interface or the abdominal cavity/atrium shunt tube, when the flexible membrane is extruded to flush the ventricle catheter, the valve is automatically closed, cerebrospinal fluid in the liquid storage bag is flushed to the ventricle catheter, and the flushing effect is improved.
According to an embodiment of the present invention, the materials of the reservoir housing, the ventricular catheter interface, and the abdominal/atrial shunt interface, which are the same or different, may be any of biocompatible metals or biocompatible polymers.
In summary, after the liquid storage bag with wireless pressure monitoring is implanted under the scalp of a patient, the implantation point can be closed through scalp suture, so that an infection path is cut off, the infection risk is reduced, and long-time monitoring is realized. At the same time, the risk of safety and data loss by the patient, especially a child, due to the unplugging or breaking of the wire of the wired monitoring device is avoided. The wireless monitoring function greatly improves the convenience of the patient in transferring, carrying and free movement. Furthermore, compared with the existing wired and wireless cranium pressure monitoring products, the sensor technology adopted by the invention has higher precision, and solves the problems of accuracy and drift. Compared with a wireless product based on an LC resonance technology, the wireless pressure sensor provided by the invention has the advantages that the volume miniaturization of the wireless pressure sensor is realized, and the support is provided for the miniaturization design of the liquid storage bag, so that the wireless pressure sensor is more suitable for being implanted under the scalp. If the reservoir size is maintained substantially the same as in the prior art, the miniaturized sensor can increase the reservoir volume, thereby expelling more cerebrospinal fluid into the ventricular catheter when the flexible membrane is pressed, significantly improving the flushing effect. In addition, the external host and the antenna also realize smaller size, and the use process has higher usability and comfort and can also meet the requirement of continuous monitoring of patients for a long time.
The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments, as illustrated in the accompanying drawings.
Detailed Description
Example 1
As shown in fig. 2 to 5, the present embodiment provides a liquid reservoir with wireless pressure monitoring, which includes a reservoir housing 1, a ventricular catheter interface 2, a flexible membrane 3, and a wireless pressure sensor 4. The reservoir housing 1 is formed with a reservoir 11 for storing cerebrospinal fluid and a pumping and injecting window 12 is provided on a top wall of the reservoir housing 1 facing the scalp of the patient. The ventricular catheter interface 2 is arranged on the liquid storage bag shell 1 and is communicated with the liquid storage cavity 11. The flexible membrane 3 is sealed and sealed with the pumping and injecting window 12. The wireless pressure sensor 4 comprises a sensor body 41 and an antenna 42, and the wireless pressure sensor 4 is arranged in the liquid storage bag shell 1 and contacts the liquid storage cavity 11 so as to collect intracranial pressure signals of a patient and transmit the intracranial pressure signals to an external receiver.
Unlike existing wireless pressure sensors based on inductive coupling, the reservoir with wireless pressure monitoring provided in this embodiment uses the high-band industrial, scientific and medical band (ISMband, e.g., 915MHz or 2.4 GHz). The wireless pressure sensor based on radio frequency excitation does not need to be coupled by adopting an inductance coil, so that the volumes of an external receiver and a liquid storage bag are greatly reduced, the liquid storage bag can be designed in a miniaturized manner, and the wireless pressure sensor can be implanted under the scalp of a patient with limited space better. Scalp suturing can be performed after minimally invasive implantation to effectively avoid the risk of percutaneous infection. Furthermore, the excitation based on the radio frequency band also enables no power supply to be arranged in the sensor so as to further reduce the volume of the wireless pressure sensor.
Specifically, the pressure sensor provided by the invention is a sensor based on a surface acoustic wave resonator (SAW) or a film acoustic wave resonator (FBAR), and changes the resonance frequency of the sensor and the frequency of an echo signal due to the change of the surrounding environment (such as temperature, pressure, brain oxygen saturation and other parameters). The external receiver receives the echo signal sent by the wireless pressure sensor, and calculates parameters such as temperature, pressure, brain oxygen saturation and the like according to the frequency of the echo signal. Specifically, the present embodiment applies a pressure sensor based on a surface acoustic wave resonator (SAW) or a film acoustic wave resonator (FBAR) to a reservoir in a high frequency band, such as an RFID band (865 MHz) for industrial, scientific and medical bands (ISMband, e.g., 915 MHz). Compared with the traditional LC inductance coupling type pressure sensor with the working frequency band of 40-400MHz, the high frequency band does not need a large inductance coil, so that the sizes of the wireless pressure sensor 4 and an external host machine can be smaller. Further, surface acoustic wave resonators (SAW) and film bulk acoustic wave resonators (FBAR) in the high frequency band will have a higher quality factor Q, typically around 3000, which is much higher than that of LC resonators (quality factor Q <300 of LC resonators).
Specifically, the following relationship exists among the frequency resolution δf, the resonant frequency f0, the quality factor Q, and the signal-to-noise ratio SNR:
Based on this relationship, it is possible to obtain that the higher the quality factor Q, the smaller the frequency resolution δf will be, i.e. the higher the frequency accuracy. Therefore, compared with the traditional MEMS sensor based on the LC resonator, the liquid storage bag with wireless pressure monitoring provided by the embodiment has higher frequency response sensitivity and extremely high monitoring capability on tiny pressure change. Meanwhile, the improvement of the quality factor Q can also obviously reduce the resonance bandwidth to enable the system noise to be far smaller than the signal strength, and further improve the signal-to-noise ratio. Furthermore, the high quality factor Q can also provide more stable resonance response, small frequency drift and higher linearity. The accuracy of the currently clinically used intracranial pressure sensor (such as an MEMS sensor based on an LC resonator) is 2mmHg which just meets the requirement, but the sensitivity of the high Q value wireless pressure sensor based on the surface acoustic wave resonator (SAW) provided by the embodiment can reach 1mmHg, the range of intracranial pressure is lower (usually 7-15 mmHg), and the accuracy improvement has obvious significance on diagnosis, treatment and disease management.
However, the invention is not limited in any way to the specific type of wireless pressure sensor and the manner in which it transmits the pressure signal. Other wireless pressure sensors that do not require inductive coupling are within the scope of the present invention. In this embodiment, the reservoir housing 1 is made of a biocompatible metal material, specifically, titanium or stainless steel. However, the present invention is not limited in any way thereto. In other embodiments, the reservoir housing may be made of a biocompatible polymer having a relatively high hardness (e.g., polyetheretherketone PEEK, polyaryletherketone PAEK, or polytetrafluoroethylene PTFE), or a biocompatible ceramic (e.g., alumina or zirconia).
In this embodiment, the cross section of the reservoir housing 1 is circular, the maximum diameter of the cross section is 15 mm-25 mm, and the height of the reservoir housing 1 is 5 mm-10 mm. Specifically, the size of the reservoir housing 1 may be designed to a variety of different sizes depending on the size of the cranium of different types of patients, such as adults, children, and infants. Preferably, the reservoir housing 1 may be provided with a maximum cross-sectional diameter of about 15mm and a height of about 8mm. However, the present invention is not limited in any way thereto. In other embodiments, the cross section of the reservoir housing is circular and the maximum diameter of the cross section may be other values within 10mm to 35mm, and the height of the reservoir housing may be other values within 4mm to 15 mm.
In this embodiment, the wireless pressure monitoring reservoir further comprises a ventricular catheter 5, one end of the ventricular catheter 5 is connected to the ventricular catheter interface 2 and the other end is implanted in the anterior ventricle of the patient. Specifically, the ventricular catheter interface 2 is disposed at the bottom wall of the reservoir housing 1, the ventricular catheter 5 is detachably connected to the ventricular catheter interface 2, and fig. 4 is a schematic diagram of the structure after the ventricular catheter 5 is detached. This arrangement allows the reservoir housing 1 and the ventricular catheter hub 2 to be replaced or sold as a single piece, as well as the ventricular catheter 5 as a separate component. However, the present invention is not limited in any way thereto. In other embodiments, the ventricular catheter may also be integrally connected to the ventricular catheter interface. In addition, in other embodiments, the ventricular catheter interface may be provided on a side wall of the reservoir housing, as shown in fig. 6 and 7.
As shown in fig. 3, a reservoir with wireless pressure monitoring is located between the scalp 100 and the skull 200. The burr hole 300 is typically around 2.7mm in diameter and the ventricular catheter 5 is implanted through the burr hole 300 in the skull into the anterior ventricular angle 400. Thereafter, the scalp 100 is sutured to close the implantation site, reducing percutaneous infection. The anterior ventricular angle 400 is connected with the liquid storage cavity 11 through the drainage port 51 on the ventricular catheter 5, and cerebrospinal fluid can be extracted and used through the liquid storage cavity. Specifically, the flexible membrane 3 can realize self-closing sealing, when the intracranial pressure of a patient is too high, the needle can be used for puncturing the flexible membrane 3 to extract cerebrospinal fluid in the liquid storage cavity so as to realize pressure reduction of the intracranial pressure, in addition, the medicine can be injected into the liquid storage cavity 11 through the needle, and then the medicine permeates into the ventricle of the patient through the ventricle catheter interface 2 and the drainage port 51 on the ventricle catheter 5 so as to realize treatment. In this embodiment, the ventricular catheter interface 2 is made of the same material as the reservoir housing 1, and is made of a biocompatible metal material, specifically titanium or stainless steel. However, the present invention is not limited in any way thereto. In other embodiments, the ventricular catheter interface may be formed of a biocompatible polymer having a relatively high durometer, such as a polypropylene material, as opposed to the reservoir housing.
In the present embodiment, the volume of the wireless pressure sensor 4 is less than or equal to 10×3×1mm3, in the wireless pressure sensor provided by the present invention, the antenna 42 is made of a biocompatible wire with a very thin diameter or a very thin metal sheet, and compared with the volume of the sensor body 41, the volume of the antenna 42 is very small and can be almost ignored, so the volume of the wireless pressure sensor 4 is the volume of the sensor body 41. The wireless pressure sensor with small volume reduces the volume of the liquid storage cavity occupied by the wireless pressure sensor. Specifically, the wireless pressure sensor 4 provided in this embodiment has a circular cross section, the maximum diameter of the cross section is 15 mm-25 mm, the space occupation ratio in the liquid storage bag housing 1 with the height of 5 mm-10 mm is less than 5.9%, and the space occupation ratio is far less than the space occupation ratio of the traditional MEMS sensor in the same liquid storage bag housing, so that the liquid storage cavity 11 has a larger liquid storage space.
When in use, the flexible membrane 3 on the liquid storage bag shell 1 can be forced to enable the flexible membrane 3 to be sunken into the liquid storage cavity 11, so that the pressure in the liquid storage cavity 11 is increased, cerebrospinal fluid in the liquid storage cavity 11 and the ventricular catheter 5 is flushed out of the drainage port 51 of the ventricular catheter 5, and further the ventricular catheter 5 is flushed out, so that the blockage of the ventricular catheter is effectively avoided, and unnecessary catheter replacement operation is avoided. Further, the blockage of the ventricular catheter 5 can be determined by the rebound time of the flexible membrane 3. As shown in fig. 2, the ventricular catheter drainage port 51 is a plurality of circular drainage holes formed on the leading end of the ventricular catheter 5. However, the shape of the drainage port of the ventricular catheter is not limited in the invention, and the drainage port can be square, elliptic, strip-shaped and the like.
Preferably, the ventricular catheter 5 is also provided with an inner diameter of about 1.3mm and an outer diameter of about 2.5mm, and the length of the ventricular catheter 5 may be trimmed as desired. Ventricular catheter 5 is typically made of a biocompatible polymer, such as silicone, silicone gel or natural rubber, and circular drainage holes 51 are placed in the lateral ventricle for drainage of hydrocephalus from the ventricle. However, the present invention is not limited in any way thereto.
In particular, the flexible membrane 3 is a planar flexible elastic membrane, and the overall thickness of the flexible membrane may be substantially uniform, and a needle of 25-gauge or less may be used in the extraction of cerebrospinal fluid and the injection of drugs. However, the present invention is not limited in any way thereto. In other embodiments, the overall thickness of the flexible membrane may be set thicker, such as about 4mm or even thicker, in order to increase the number of needle penetrations that may be used. However, the present invention is not limited in any way thereto. In other embodiments, the flexible membrane may include a needle penetration region at the central region and a pressing region at the outer periphery of the needle penetration region for generating membrane deformation, the thickness of the needle penetration region being greater than the thickness of the pressing region. A thick needle penetration zone may increase the number of needle penetrations to extend the life of the reservoir, while a thinner compression zone may facilitate compression of the flexible membrane to flush the ventricular catheter. In other embodiments, the flexible middle region may be thin to form the compression region and the edge region thicker to form the needle penetration region. The shape of the flexible film is not limited in any way. In other embodiments, the device may also be curved with a convex portion toward the scalp of the patient to facilitate pressing.
In the present embodiment, the flexible film 3 is a silicone film. However, the present invention is not limited in any way thereto. In other embodiments, the flexible membrane may be any of natural rubber, silicone membrane, or other biocompatible, resilient flexible membrane.
The present embodiment is described taking the reservoir housing 1 and the flexible membrane 3 as examples of different materials. However, the present invention is not limited in any way thereto. In other embodiments, as shown in fig. 8, both the reservoir housing 1 and the flexible membrane 3 may be made of flexible membranes and both are integrally formed or bonded together with the bottom of the reservoir housing, the flexible reservoir housing 1 will be more advantageous for pressing to flush the ventricular catheter. At this point, the flexible membrane 3 still has the function of withdrawing cerebrospinal fluid or infusing a drug. The wall thickness of the flexible membrane 3 can be basically consistent with the wall thickness of the liquid storage bag shell, or the wall thickness of the flexible membrane 3 is larger than the wall thickness of the liquid storage bag shell 1 so as to increase the penetration frequency of the needle head and prolong the service life of the liquid storage bag. In this embodiment, both the reservoir housing 1 and the flexible membrane 3 are silicone. However, the present invention is not limited in any way thereto. In other embodiments, both may be natural rubber, silicone, or other biocompatible flexible materials.
In the present embodiment, the sensor body 41 is provided on the inner wall of the reservoir housing 1, specifically, on the inner bottom wall of the reservoir housing 1. And in order to avoid the damage to the sensor body 3 caused by excessive force when the needle pierces the flexible membrane, the reservoir housing 1 is further provided with a protection part extending to the bottom of the flexible membrane 3 and opposite to the sensor body 41, and the protection part blocks the needle piercing the flexible membrane 3 to protect the sensor body 41. However, the present invention is not limited in any way thereto. In other embodiments, the sensor body may be disposed on an inner bottom wall of the reservoir housing around the projection surface of the flexible film, or may be disposed on an inner side wall of the reservoir housing.
Further, the needle is prevented from piercing the inner bottom wall of the reservoir housing 1 made of the biocompatible polymer, and in this embodiment, the reservoir with wireless pressure monitoring further includes a puncture preventing portion 6 disposed on the inner bottom wall of the reservoir housing 1, where the puncture preventing portion 6 blocks the needle to prevent the needle from damaging the inner bottom wall of the reservoir housing 1. Specifically, the anti-penetration part 6 may be made of biocompatible metal material, such as orthopedic stainless steel, nickel-titanium alloy, and the like, and the anti-penetration part 6 may also be used as a part of the antenna to simplify the antenna structure. However, the present invention is not limited in any way thereto. In other embodiments, the stab-resistant portion may be made of a biocompatible polymer having a relatively high hardness, such as a polypropylene material.
The arrangement of the sensor body 41 based on the space in the liquid storage cavity 11 not only optimizes the design of the wireless pressure sensor 4 and improves the performance of the wireless pressure sensor, but also enables the wireless pressure sensor and the antenna to be closer to the skin surface, so that the electromagnetic wave loss is smaller, and better data transmission effect can be obtained. Furthermore, the reservoir housing 1 may also be part of the sensor antenna in this design, or the antenna may be constructed on the bottom of the reservoir housing.
In the present embodiment, the antennas 42 are distributed in the reservoir housing 1 where the sensor body 41 is located. Specifically, the reservoir housing 1 where the sensor body 41 is located is a non-metallic biocompatible polymer or biocompatible ceramic, and the antenna 42 is laid on an inner surface, such as an inner bottom wall and/or an inner side wall, of the reservoir housing 1 where the sensor body 1 is located. However, the present invention is not limited in any way thereto. In other embodiments, the antenna may be laid on the inner surface and the outer surface of the reservoir housing where the sensor body is located, or the outer surface of the reservoir housing, or the antenna may be embedded in the reservoir housing where the sensor body is located. Or alternatively the reservoir housing may be part of the antenna. In other embodiments, when the reservoir housing has an anti-piercing portion, the sensor body may also be disposed on the anti-piercing portion, and the antenna may be disposed on the anti-piercing portion and/or the reservoir housing, and the antenna may be configured as any one of fig. 9A to 9G as desired.
As shown in fig. 9A, in the present embodiment, the antenna 42 is a circular metal antenna formed on the inner bottom wall of the reservoir housing 1 or on the puncture preventing portion. Typically, the bottom of the reservoir housing 1 is a disc with a diameter of 15 mm-25 mm, and the material of the reservoir housing 1 is a biocompatible polymer (such as polyetheretherketone PEEK, polyaryletherketone PAEK, or polytetrafluoroethylene PTFE), or a biocompatible ceramic (such as alumina or zirconia). The loop antenna or the bending loop antenna shown in fig. 9A and 9B is arranged at the bottom of the liquid storage bag shell 1, and the shape of the antenna is matched with the size and the shape of the bottom of the liquid storage bag shell 1, so that the space of the liquid storage bag can be reasonably utilized. For example, the loop antenna or the bent loop antenna is inlaid on the inner bottom wall of the reservoir housing 1 by using metal wires or is formed on the inner bottom wall of the reservoir housing 1 by electroplating.
For the loop antenna of fig. 9A, the circumference can be calculated using the following formula:
C=n·λeff
Wherein C is the circumference of the loop antenna, which is typically an integer or fractional multiple of the operating wavelength to achieve resonance, n is the resonant mode (typically 1 is selected, i.e., fundamental mode); An effective wavelength in the medium; Free space wavelength, c: speed of light (about 3 x 108 m/s), f: antenna operating frequency, εeff: effective dielectric constant (dielectric constant in contact with cerebrospinal fluid and dielectric constant in contact with polymer at the bottom of reservoir housing 1 calculated using weighted average).
In this embodiment, the operating frequency f of the antenna 42 is 915MHz or 865MHz. For effective permittivity, the upper surface of the antenna 42 is in contact with cerebrospinal fluid, and the permittivity of cerebrospinal fluid in the frequency band is about 68, while the lower surface of the antenna 42 is in contact with the bottom of the reservoir housing 1, and the permittivity of the lower surface of the antenna 42 is about 3 when the reservoir housing 1 is a biocompatible polymer, and about 10 when the reservoir housing 1 is a ceramic, so that the effective permittivity is estimated using a weighted average formula. The antenna diameter was found to be about 17mm at 915MHz and about 18mm at 865MHz. At this time, the diameter of the antenna is just matched with the bottom diameter (15 mm-25 mm) of the reservoir housing 1. Further, for small size reservoirs for children, a meander loop antenna (9B) may be used to modulate the antenna 42 to a corresponding operating frequency.
However, the present invention is not limited in any way thereto. In other embodiments, the antenna may be any of a wavy loop (as shown in fig. 9B), an equal-linewidth spiral (as shown in fig. 9C), an unequal-linewidth spiral (as shown in fig. 9D), a polygonal patch (as shown in fig. 9E), or a circular patch (as shown in fig. 9F). Any one or more of straight lines, broken lines and curved lines are also possible, for example, in fig. 9G, the antenna 42 includes straight lines 421 and curved lines 422, in fig. 9H, the antenna 42 includes rectangular broken lines 423 and curved lines 424, and the complex antenna structure can enhance the radiation efficiency of the antenna, but the relative complexity of processing is also higher. Fig. 9C-9H show structures in which antennas 42 are distributed on the outer surface of the reservoir housing 1 where the sensor body 41 is located and/or embedded in the reservoir housing 1 where the sensor body 41 is located, and at this time, the reservoir housing 1 is provided with a wire through hole 13, and two ends of the antennas 42 are fed to the sensor body 41 through the wire through hole 13. Fig. 9C and 9D show the antenna structure on the outer surface side of the liquid crystal bag housing 1, and the sensor body is not shown due to the view angle.
Although this embodiment is described with the reservoir housing 1 being a non-metallic biocompatible polymer or biocompatible ceramic as an example. However, the present invention is not limited in any way thereto. In other embodiments, the reservoir housing where the sensor body is located may also be made of a biocompatible metal material, where the reservoir housing will form one polarization of the antenna. At this time, the reservoir housing is used as a part of the antenna to further simplify the arrangement of the antenna.
In this embodiment, the reservoir housing 1 is of an integral structure. However, the present invention is not limited in any way thereto. In other embodiments, the reservoir housing may also be a split structure comprising an upper housing and a lower housing that are sealingly connected, and the upper housing and the lower housing may be bonded or welded.
The liquid storage bag with wireless pressure monitoring provided by the embodiment can be implanted into patients such as acute brain trauma patients, brain tumor or cerebral hemorrhage patients and the like to realize wireless monitoring and management of intracranial pressure. The present invention provides a reservoir with wireless pressure monitoring for use in both types of patients with implantation as will be described. However, the present invention is not limited in any way thereto. The reservoir with wireless pressure monitoring provided in this embodiment can be implanted in all patients who need to monitor and manage intracranial pressure.
Specifically, for acute brain trauma patients, after the liquid storage bag with wireless pressure monitoring is implanted, the scalp is sutured, the implantation point is closed, and the infection path is cut off. The cranium pressure is monitored in a wireless mode, so that the monitoring function of the implantation method is realized. When the cranium pressure of the patient is too high, the scalp and the flexible membrane 3 can be pierced by a needle to extract cerebrospinal fluid, thereby achieving the purpose of reducing the cranium pressure. According to clinical needs and intracranial pressure data provided by a liquid storage bag with wireless pressure monitoring, cerebrospinal fluid can be extracted for multiple times, and a needle head can be fixed through an additional device to continuously discharge the cerebrospinal fluid so as to realize the functions of catheter-based intracranial pressure monitoring and cerebrospinal fluid discharge. The liquid storage bag with wireless pressure monitoring provided by the invention can realize craniocerebral pressure monitoring and control craniocerebral pressure by discharging cerebrospinal fluid, and simultaneously control infection risk. In addition, can realize carrying out the longer monitoring in the ward, wireless function makes things convenient for the patient to move freely, also avoids patient especially children to pull out or damage the wire of wired monitoring product.
After craniotomy, the cerebral tumor or cerebral hemorrhage patient is implanted with a liquid storage bag with wireless pressure monitoring and the scalp is sutured. Whether the intracranial pressure is too high, bleeding, infection or other postoperative complications exist can be judged through craniocerebral pressure monitoring, the cerebrospinal fluid is guided to be extracted and released, and the scalp and the flexible membrane 3 can be pierced by a needle to extract the cerebrospinal fluid for testing to judge the bleeding and the infection. The medicine is injected through the flexible membrane to realize the treatment function. The reservoir with wireless pressure monitoring is suitable for long-term implantation, can be kept in the patient after the patient is discharged, periodically monitors the cranium pressure, extracts cerebrospinal fluid to reduce cranium pressure, tests and administration, and washes the ventricular catheter 5 by pressing the flexible membrane 3 for postoperative monitoring, rehabilitation and nursing of tumor and cerebral hemorrhage patients.
Example two
The difference between this embodiment and the first embodiment is that in this embodiment, as shown in fig. 10, the ventricular catheter interface 2 is disposed on a side wall of the reservoir housing 1, and the reservoir with wireless pressure monitoring further includes an abdominal cavity/atrial shunt interface 7 disposed on another side wall of the reservoir housing 1 opposite to the ventricular catheter interface 2 and communicating with the reservoir 11. However, the present invention is not limited in any way thereto. In other embodiments, as shown in fig. 13, the ventricular catheter interface 2 is disposed at the bottom of the reservoir housing 1, and the abdominal/atrial shunt interface 7 is disposed at the side wall of the reservoir housing 1.
Further, as shown in fig. 11, in this embodiment, the abdominal/atrial shunt 8 is detachably connected to the abdominal/atrial shunt interface 7. The arrangement of the abdominal/atrial shunt interface 7 and the abdominal/atrial shunt 8 can drain cerebrospinal fluid in the reservoir 11 to the patient's abdominal or atrium. Furthermore, the abdominal cavity/atrium shunt tube 8 is also provided with a flow control valve with an adjustable opening, the wireless pressure sensor 4 can also provide guidance for adjusting the flow control valve, for example, when the intracranial pressure is higher, a doctor can increase the opening of the flow control valve to improve the shunt quantity, and when the intracranial pressure is lower, the doctor can adjust the opening of the flow control valve to control the intracranial pressure, so that the device can be well applied to patients needing to implant the abdominal cavity/atrium shunt tube.
However, for patients who are not certain of the need to implant ventricular abdominal/atrial shunts or when the implantation conditions are not mature, intracranial pressure needs to be monitored. To meet the use requirement of this type of patient, in this embodiment, as shown in fig. 12, the reservoir with wireless pressure monitoring further includes a blocking end cap 9 detachably disposed on the abdominal cavity/atrial shunt interface 7. The removable arrangement of the abdominal/atrial shunt 8 and the occlusion cap 9 allows for replacement of both during different phases of the patient. Specifically, a reservoir with wireless pressure monitoring with a blocking end cap 9 is initially implanted to enable intracranial pressure monitoring, flushing of the ventricular catheter 5, administration, and extraction and detection of cerebrospinal fluid. When the patient needs to implant the abdominal/atrial shunt 8, the patient is operated to remove the cap 9 and install the abdominal/atrial shunt 8, draining cerebrospinal fluid to the abdominal or atrial to reduce intracranial pressure, as shown in fig. 11.
In particular, for congenital hydrocephalus, normal pressure hydrocephalus, or patients requiring implantation of ventricular abdominal/atrial shunts, in cases where the patient has infection, bleeding, or other symptoms intracranially without the implanted shunt, the prior art is to implant a common reservoir, inject a drug through the reservoir to control the infection or other symptoms, and withdraw cerebrospinal fluid to control the intracranial pressure. However, the existing common liquid storage bag can not provide cranium pressure data, and can not provide accurate basis for the extraction time and quantity of cerebrospinal fluid. The liquid storage bag with wireless pressure monitoring can accurately provide the cranium pressure data of the patient in real time, provide accurate basis for the extraction time and the quantity of cerebrospinal fluid, and realize the flushing of the ventricular catheter 5 to avoid the blockage thereof. When the patient meets the conditions for implantation of the ventricular abdominal/atrial shunt, the cap 9 is removed and the abdominal/atrial shunt 8 is directly connected to the abdominal/atrial shunt port 7 to shunt cerebrospinal fluid into the abdominal or atrial.
In addition, when the abdominal/atrial shunt port 7 is connected to the abdominal/atrial shunt 8, the reservoir with wireless pressure monitoring may also include a valve disposed on the abdominal/atrial shunt port 7 or the abdominal/atrial shunt 8. When the flexible membrane 3 is pressed to flush the ventricular catheter 5, the valve leading to the abdominal/atrial shunt is automatically closed, so that the cerebrospinal fluid in the reservoir cavity is flushed towards the ventricular catheter 5 to improve the flushing effect.
Although this embodiment is described with respect to congenital hydrocephalus, normal pressure hydrocephalus, or patients requiring implantation of ventricular and peritoneal/atrial shunts. However, the present invention is not limited thereto. The liquid storage bag with wireless pressure monitoring provided by the embodiment can be also suitable for other patients needing to monitor and reduce intracranial pressure, such as acute cerebral trauma patients, brain tumor or cerebral hemorrhage patients in embodiment one, and patients with lumbar cistern abdominal cavity shunt operation and the like.
The materials of the reservoir housing 1, the ventricular catheter interface 2 and the abdominal/atrial shunt interface 7 may be the same or different, and all of them may be any biocompatible metal or polymer. When the materials are the same, the reservoir housing 1, the ventricular catheter interface 2 and the abdominal/atrial shunt interface 7 may be integrally formed or bonded or welded together.
The specific structure and possible implementation manner of the sensor body 41 and the antenna 42 in the reservoir housing 1, the ventricular catheter interface 2, the flexible membrane 3, and the wireless pressure sensor 4 are the same as those of the first embodiment, and are not described herein.
Further, since the reservoir belongs to a long-term implanted device, the surface acoustic wave resonator or the film acoustic wave resonator in the sensor body 41 is encapsulated in a quartz-quartz bonding manner to ensure the long-term air tightness of the device. Specifically, a surface acoustic wave resonator is exemplified below, and as shown in fig. 14, a surface acoustic wave resonator 54 is fabricated on a quartz wafer 52 and the quartz wafer 52 is thinned to 100 μm or less. To eliminate pressure sensor drift problems caused by environmental temperature changes around the saw resonator and aging, the sensor body 41 may also incorporate another saw resonator 53, the other saw resonator 53 being fabricated on another thicker quartz wafer 51, typically over 200 μm thick. The two quartz wafers have the same chamfer and attribute, so that the resonance frequencies of the two surface acoustic wave resonators are changed simultaneously due to factors such as ambient temperature change and aging, namely, the difference value of the two resonance frequencies is kept unchanged (for example, 2 MHz), and the pressure sensor drift problem caused by factors such as ambient temperature change and aging of the surface acoustic wave resonators is eliminated. However, the present invention is not limited in any way thereto. In other embodiments, only one SAW resonator may be provided in the pressure sensor body 41.
For the packaging mode of the saw resonator, the present embodiment is bonded by the quartz wafer 52-the quartz wafer 57 having the cavity-the other quartz wafer 51. However, the present invention is not limited in any way thereto. In other embodiments, the bonding may also be performed using a quartz wafer 52-an intermediate layer (glass or metal forming the cavity) -another quartz wafer 51. After packaging, an airtight cavity 58 is formed around the bonding wires around the two saw resonators, and the leads 55,56 at the two ends of the saw resonator are connected to the antenna 42 of the wireless pressure sensor by bonding wires or die. The invention is not limited in this regard, and in other embodiments leads may be routed to the edge or bottom of the pressure sensor via through a via-wafer (TWV), a via-glass (TGV), or a routing layer (RDL) and then bonded to the pressure sensor antenna pins.
The specific working principle is that an external host emits electromagnetic waves, and the acoustic surface wave resonators 53 and 54 in the pressure sensor body 41 are excited by coupling the external antenna with the antenna 42 of the wireless pressure sensor. When the pressure in the liquid storage cavity 11 changes, the quartz wafer 52 is pushed to deform, and the frequency of the SAW resonator 54 is changed. The echo signal of the resonator is returned to the external host computer through the sensor antenna 42 and the external antenna. The external host calculates the pressure in the reservoir 11 by detecting the frequency change of the resonator return signal.
In summary, after the liquid storage bag with wireless pressure monitoring is implanted under the scalp of a patient, the scalp is sutured, and the implantation point is closed to cut off the infection path so as to realize long-time monitoring. The wireless monitoring function greatly facilitates the free movement of the patient, and avoids the risk that the patient, especially children, pulls out or breaks the wire of the wired monitoring device. Further, the small-volume wireless pressure sensor provides conditions for miniaturized design of the reservoir, so that it can be well implanted under the scalp of a patient. Or when the size of the liquid storage bag is basically the same as that of the prior art, the miniaturized wireless pressure sensor also enables the liquid storage cavity to have larger volume, and at the moment, more cerebrospinal fluid is discharged into the ventricle catheter from the liquid storage cavity when the flexible membrane is pressed, so that the effect of flushing the ventricle catheter is enhanced.
In addition, the symptoms caused by the blockage of the ventricular catheter (such as headache, inability to urinate normally and abnormal gait) are similar to those caused by other diseases, and the existing liquid storage bag can not judge whether the ventricular catheter is blocked or not. The liquid storage bag with wireless pressure monitoring can judge whether the ventricle catheter is blocked or not through monitoring the intracranial pressure, so that unnecessary catheter replacement operation is avoided, and medical resources are saved.
The invention improves on the basis of the existing liquid storage bag, and adds additional functions besides the original functions of medication and cerebrospinal fluid extraction.
1. The wireless pressure sensor is integrated into the liquid storage bag, so that the cranium pressure monitoring function is realized. After the device is implanted, the scalp is sutured, and the risk of percutaneous infection caused by conventional craniocerebral pressure monitoring and spinal fluid catheters is reduced.
2. When the implantation condition of the spinal fluid catheter is immature (such as hemorrhage, infection or other symptoms exist in the cranium), the spinal fluid catheter can be used as a temporary cerebrospinal fluid drainage device and drug delivery, and can also replace the spinal fluid catheter to play the same role, and can be used in hospitals and outside hospitals. The pressure data provided by the device may guide the timing and amount of cerebrospinal fluid drainage.
3. The device may be implanted for a long period of time, with a conventional cerebrospinal fluid catheter attached, draining excess cerebrospinal fluid to the abdominal cavity/atrium.
4. By periodically pressing the reservoir, the aim of flushing the ventricular catheter is achieved, and catheter blockage caused by blood clots, choroid plexus, brain tumor tissue, cerebrospinal fluid deposit and the like is reduced. The abdominal/atrial shunt interface or the abdominal/atrial shunt may be provided with a valve. When the flexible membrane is extruded to flush the ventricular catheter, the valve leading to the abdominal cavity/atrium shunt is automatically closed, so that the cerebrospinal fluid in the liquid storage cavity is flushed towards the ventricular catheter to improve the flushing effect.
5. The pressure data output by the device can be used for adjusting a cerebrospinal fluid conduit valve, avoiding excessive or insufficient release of cerebrospinal fluid and maintaining normal intracranial pressure.
6. Can judge whether the cerebrospinal fluid duct is blocked or not, and avoid unnecessary duct replacement operation.
Although the invention has been described with reference to the preferred embodiments, it should be understood that the invention is not limited thereto, but rather may be modified and varied by those skilled in the art without departing from the spirit and scope of the invention.