Dual monitoring biliary tract stent capable of monitoring biliary tract wall pressure and bile flow

Abstract

The invention provides a biliary tract stent capable of monitoring biliary tract wall pressure and bile flow, which comprises a biliary tract stent, the first pressure sensor unit and the second pressure sensor unit are used for monitoring the pressure change of the inner wall of the biliary tract of a patient in real time, and the flow sensor unit is used for monitoring the flow and the flow speed of bile in the biliary tract of the patient in real time. Each of the first pressure sensor unit and the second pressure sensor unit comprises a pressure sensor; the system has the following beneficial effects that the pressure change of the inner wall of the biliary tract of a patient can be monitored in real time through the pressure sensor, and the flow and flow velocity of bile in the biliary tract of the patient can be monitored in real time through the flow sensor in the flow sensor unit; in addition, the pressure sensor and the flow sensor can transmit collected information to the microprocessor unit or terminal equipment through the Bluetooth module, so that a doctor can know complicated pathological changes in the biliary tract of a patient and relevant characteristics of bile flow in time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical device treatment, and particularly to a dual-monitoring biliary stent capable of monitoring biliary wall pressure and bile flow rate. Background Art

[0002] Biliary diseases have long been a major challenge in the global medical community, with high incidence and mortality rates. In China, due to the insidious early symptoms and the low public awareness of prevention and early screening, many patients are diagnosed at the middle or late stage, which increases the treatment difficulty and significantly reduces the survival rate. The complex anatomical structure of the biliary system further adds to the challenges of diagnosis and treatment. Biliary stents play an important role in the treatment of various diseases such as biliary cancer, primary sclerosing cholangitis, and biliary stricture after liver transplantation, and can effectively relieve problems such as biliary stricture and cholestasis. However, existing biliary stents have many deficiencies in clinical applications and are difficult to meet the growing clinical and research needs. There is an urgent need for breakthroughs through technological innovation.

[0003] Although existing biliary stents have alleviated problems such as biliary stricture and cholestasis to a certain extent, they are still difficult to monitor the characteristics related to bile flow in real time and cannot comprehensively reflect the complex pathological changes in the patient's biliary tract. This limitation is particularly prominent in disease management and treatment evaluation. For example, after biliary surgery, patients need to insert a T-tube to drain bile, and clinicians can only judge the bile flow rate by checking the T-tube drainage volume in a drainage bag for a period of time. This not only affects the timeliness of clinical decision-making but may also delay the best treatment opportunity. Therefore, it is particularly necessary to design an intelligent biliary stent that can monitor the characteristics of bile flow in real time and adapt to different pathological conditions, which can not only provide personalized treatment plans for patients but also contribute to the update of biliary disease diagnosis and treatment technologies and further enhance the innovation of clinical research. Summary of the Invention

[0004] In view of the above-mentioned disadvantages of the prior art, the purpose of the present invention is to provide a dual-monitoring biliary stent capable of monitoring biliary wall pressure and bile flow rate, so as to solve the problems that existing biliary stents are difficult to monitor the characteristics related to bile flow in real time and cannot comprehensively reflect the complex pathological changes in the patient's biliary tract.

[0005] To achieve the above object and other related objects, the present invention provides the following technical solutions:

[0006] A dual - monitoring biliary stent capable of monitoring biliary wall pressure and bile flow, including a biliary stent in the shape of a braided mesh cylinder. The biliary stent is provided with a first pressure sensor unit and a second pressure sensor unit for real - time monitoring of the pressure changes of the inner wall of the patient's biliary tract and a flow sensor unit for real - time monitoring of the flow rate and velocity of bile in the patient's biliary tract. The first pressure sensor unit, the flow sensor unit, and the second pressure sensor unit are evenly installed on the biliary stent at intervals along the length direction of the biliary stent. Among them, both the first pressure sensor unit and the second pressure sensor unit include a pressure sensor, a first Bluetooth module for transmitting the biliary inner wall information collected by the pressure sensor, and a first wireless power supply module for supplying power to the pressure sensor. The first wireless power supply module includes an energy storage battery and a wireless charging coil connected to the energy storage battery.

[0007] In an embodiment of the present invention, the biliary stent is a nickel - titanium alloy frame, the thickness of the biliary stent is 0.3 - 0.5 mm, and a protective layer made of polytetrafluoroethylene is coated on the surface of the nickel - titanium alloy frame.

[0008] In an embodiment of the present invention, the first pressure sensor unit and the second pressure sensor unit form a pressure distribution network for accurately measuring the pressure of the biliary wall at different positions, and the pressure sensor is a MEMS pressure sensor. The diameter of the pressure sensor is 1 - 2 mm and the thickness is about 0.1 mm.

[0009] In an embodiment of the present invention, the flow sensor unit includes a flow sensor, a second Bluetooth module for transmitting the biliary information collected by the flow sensor, and a second wireless power supply module for supplying power to the flow sensor. The second wireless power supply module also includes an energy storage battery and a wireless charging coil connected to the energy storage battery.

[0010] In an embodiment of the present invention, the flow sensor is a thermal flow sensor, the width of the flow sensor is 2 - 3 mm, and the thickness is less than 50 μm.

[0011] In an embodiment of the present invention, the biliary stent may also be provided with a micro - processor unit for collecting, processing the information collected by each sensor in real - time, and transmitting the processed information to a display screen for display. The micro - processor unit, the first pressure sensor unit, the flow sensor unit, and the second pressure sensor unit are evenly installed on the biliary stent at intervals along the length direction of the biliary stent, and the micro - processor unit is installed on the side of the end of the biliary stent where the bile inflow port is located.

[0012] In an embodiment of the present invention, the microprocessor unit, the first pressure sensor unit, the flow sensor unit, and the second pressure sensor unit can be installed on the biliary stent by soldering or buckling, and the first pressure sensor unit, the flow sensor unit, and the second pressure sensor unit can be connected to the microprocessor unit or to an external terminal device.

[0013] In an embodiment of the present invention, the microprocessor unit includes a microprocessor and a third wireless power supply module for supplying power to the microprocessor. The microprocessor integrates a data acquisition module, a data processing module, a wireless transmission module, and a low-power Bluetooth chip. The third wireless power supply module also includes a storage battery and a wireless charging coil connected to the storage battery.

[0014] In an embodiment of the present invention, the microprocessor is a SoC micro-integrated chip. The length of the SoC micro-integrated chip is about 4 mm, the width is about 3 mm, and the thickness is about 0.5 mm.

[0015] In an embodiment of the present invention, the storage battery is a flexible solid-state lithium-ion battery. The length of the storage battery is about 4 mm, the width is about 4 mm, and the thickness is about 0.2 mm. The wireless charging coil provides energy through electromagnetic induction technology. The width of the wireless charging coil is about 1 mm, and the thickness is about 0.2 mm.

[0016] As described above, a dual-monitoring biliary stent capable of monitoring biliary wall pressure and bile flow of the present invention has the following beneficial effects: The pressure sensors in the first pressure sensor unit and the second pressure sensor unit of the present invention can real-time monitor the pressure changes of the inner wall of the patient's biliary tract. Moreover, the first pressure sensor unit and the second pressure sensor unit can form a pressure distribution network to accurately measure the pressure of the biliary wall at different positions. The flow sensor in the flow sensor unit of the present invention can real-time monitor the flow rate and velocity of bile in the patient's biliary tract. And the pressure sensor and the flow sensor can transmit the collected information to the microprocessor unit or the terminal device through the Bluetooth module, facilitating doctors to timely understand the complex pathological changes and bile flow-related characteristics in the patient's biliary tract. In addition, the microprocessor unit can collect, process the information real-time collected by each sensor and transmit the processed information to a display screen for display, thus solving the problems that the existing biliary stents are difficult to real-time monitor the related characteristics of bile flow and cannot comprehensively reflect the complex pathological changes in the patient's biliary tract. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a three-dimensional schematic diagram of a dual-monitoring biliary stent capable of monitoring biliary wall pressure and bile flow in the first embodiment of the present invention;

[0018] Figure 2 It is a three-dimensional schematic diagram of a dual-monitoring biliary stent that can monitor biliary wall pressure and bile flow in the second embodiment of the present invention;

[0019] Figure 3 It is a three-dimensional schematic diagram of the components included in the first pressure sensor unit of the present invention;

[0020] Figure 4 It is a three-dimensional schematic diagram of the components included in the flow sensor unit of the present invention;

[0021] Figure 5 It is a three-dimensional schematic diagram of the components included in the microprocessor unit of the present invention;

[0022] Figure 6 It is a schematic diagram of the wireless charging coil of the present invention;

[0023] Figure 7 It is a three-dimensional schematic diagram of the brazing sheet formed during brazing in the present invention;

[0024] Figure 8 It is a three-dimensional schematic diagram of the buckle of the present invention.

[0025] Description of Component Labels

[0026] 1. Biliary stent; 2. First pressure sensor unit; 201. Pressure sensor; 202. First Bluetooth module; 203. First wireless power supply module; 3. Flow sensor unit; 301. Flow sensor; 302. Second Bluetooth module; 303. Second wireless power supply module; 4. Second pressure sensor unit; 5. Microprocessor unit; 501. Microprocessor; 502. Third wireless power supply module; 6. Energy storage battery; 7. Wireless charging coil; 8. Brazing sheet; 9. Buckle. Specific Embodiments

[0027] The following specific embodiments illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. It should be noted that, without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0028] The first embodiment of the present invention relates to a dual-monitoring biliary stent that can monitor biliary wall pressure and bile flow. For details, please refer to Figure 1, for the long-term treatment and detection of long-term and recurrent diseases such as biliary stricture where bile cannot flow normally, including a biliary stent 1 in the shape of a braided mesh cylinder. The biliary stent 1 is a nickel-titanium alloy frame used to support the patency of the biliary tract. When the biliary stent 1 is not deployed, its length is 1 - 2 mm, and when deployed, its length is 8 - 10 mm. Moreover, nickel-titanium alloy (Nitinol) has biocompatibility, corrosion resistance, and shape memory properties; the thickness of the biliary stent 1 is 0.3 - 0.5 mm to ensure the minimum impact of the stent on bile flow; and a protective layer made of polytetrafluoroethylene is coated on the surface of the nickel-titanium alloy frame to prevent bile corrosion and adhesion.

[0029] The biliary stent 1 is provided with a first pressure sensor unit 2 and a second pressure sensor unit 4 for real-time monitoring of the pressure changes in the inner wall of the patient's biliary tract and a flow sensor unit 3 for real-time monitoring of the flow rate and velocity of bile in the patient's biliary tract. The first pressure sensor unit 2, the flow sensor unit 3, and the second pressure sensor unit 4 are evenly installed on the biliary stent 1 at intervals along the length direction of the biliary stent 1; among them, the first pressure sensor unit 2, the flow sensor unit 3, and the second pressure sensor unit 4 can be installed on the biliary stent 1 by soldering or by means of a buckle 9, and after soldering is completed, a solder joint 8 will be formed between the biliary stent 1 and the sensor unit.

[0030] As Figure 3 and Figure 4 shown, both the first pressure sensor unit 2 and the second pressure sensor unit 4 include a pressure sensor 201, a first Bluetooth module 202 for transmitting the information of the inner wall of the biliary tract collected by the pressure sensor 201, and a first wireless power supply module 203 for supplying power to the pressure sensor 201. The first pressure sensor unit 2 and the second pressure sensor unit 4 form a pressure distribution network for accurately measuring the pressure magnitude of the biliary wall at different positions, and the pressure sensor 201 is a MEMS pressure sensor. The MEMS pressure sensor detects the pressure changes in the inner wall of the biliary tract through a piezoresistive film. Moreover, the diameter of the pressure sensor 201 is 1 - 2 mm and the thickness is about 0.1 mm; the flow sensor unit 3 includes a flow sensor 301, a second Bluetooth module 302 for transmitting the biliary information collected by the flow sensor 301, and a second wireless power supply module 303 for supplying power to the flow sensor 301. The flow sensor 301 is a thermal flow sensor. When the fluid flows, the thermal flow sensor measures the flow rate and flow of bile based on the heat transfer equation. Moreover, the width of the flow sensor 301 is 2 - 3 mm and the thickness is less than 50 μm.

[0031] Among them, the first wireless power supply module 203 and the second wireless power supply module 303 both include a storage battery 6 and a wireless charging coil 7 connected to the storage battery 6; the storage battery 6 is a flexible solid-state lithium-ion battery, with a length of about 4 mm, a width of about 4 mm, and a thickness of about 0.2 mm. The storage battery is closely connected to the wireless charging coil 7, facilitating fast power supply while avoiding interference with the sensor working area; the wireless charging coil 7 provides energy through electromagnetic induction technology, with a width of about 1 mm and a thickness of about 0.2 mm. For details, please refer to Figure 3 , Figure 4 and Figure 6 .

[0032] Specifically, when installing the sensor unit, the first pressure sensor unit 2 and the second pressure sensor unit 4 are installed on the outer surface of the biliary stent 1 by soldering or using a buckle 9, and the wireless charging coils 7 in the first pressure sensor unit 2 and the second pressure sensor unit 4 will be in close contact with the stent wall; the flow sensor unit 3 is installed on the inner surface of the biliary stent 1 by soldering or using a buckle 9, and the wireless charging coil 7 in the flow sensor unit 3 will be in close contact with the stent wall. For details, please refer to Figure 7 and Figure 8 ;

[0033] Also, when using the biliary stent 1, the first pressure sensor unit 2, the second pressure sensor unit 4, and the flow sensor unit 3 can directly transmit the collected information to the terminal device in the doctor's office through the Bluetooth module. The terminal device processes the collected information and then displays it on its display screen; the first pressure sensor unit 2, the second pressure sensor unit 4, and the flow sensor unit 3 can also transmit the collected information to the microprocessor unit 5 in the following text through the Bluetooth module. The microprocessor unit 5 will process the collected information and then transmit the processed information to a small display screen through the Bluetooth module for display. This small display screen can be hung on the patient's hospital bed.

[0034] More specifically, the present invention includes a biliary stent 1. Inside the main body mesh structure of the biliary stent 1, a pressure sensor 201, a flow sensor 301, a wireless charging coil 7, and a power supply device (battery) are encapsulated and fixed. A data processing chip may also be encapsulated and fixed inside the main body mesh structure of the biliary stent 1. By implanting the biliary stent 1 into the patient's biliary tract and activating the power supply, real-time monitoring of the internal fluid of the biliary tract can be performed at different frequencies. Each sensor can directly transmit the collected information to a mobile device outside the body through a Bluetooth module, or transmit it to a microprocessor 501 through the Bluetooth module. After the microprocessor 501 processes the collected data, it is displayed on a display screen outside the body through the Bluetooth module, so that the condition data can be monitored. When the battery power is low, it can be charged by an external radio charging device. The wireless charging coil 7 can charge the battery inside the stent based on a skin distance of 3 - 5 cm from the radio transmitter during later use.

[0035] The second embodiment of the present invention relates to a dual-monitoring biliary stent capable of monitoring biliary wall pressure and bile flow. Specifically, please refer to Figure 2 , and a microprocessor unit 5 for collecting, processing the information collected by each sensor in real time and transmitting the processed information to a display screen for display may also be provided on the biliary stent 1. The microprocessor unit 5, the first pressure sensor unit 2, the flow sensor unit 3, and the second pressure sensor unit 4 are evenly spaced along the length direction of the biliary stent 1 and installed on the biliary stent 1, and the microprocessor unit 5 is installed on the side of the end of the biliary stent 1 where the bile inflow port is located. Among them, the microprocessor unit 5 is also installed on the biliary stent 1 by soldering or a buckle 9.

[0036] As Figure 5 shown, the microprocessor unit 5 includes a microprocessor 501 and a third wireless power supply module 502 for supplying power to the microprocessor 501. The microprocessor 501 integrates a data acquisition module, a data processing module, a wireless transmission module, and a low-power Bluetooth chip. The third wireless power supply module 502 also includes a storage battery 6 and a wireless charging coil 7 connected to the storage battery 6. Among them, the microprocessor 501 is a SoC micro-integrated chip, and the length of the SoC micro-integrated chip is about 4 mm, the width is about 3 mm, and the thickness is about 0.5 mm.

[0037] Specifically, the microprocessor 501 collects the information collected by the first pressure sensor unit 2, the flow sensor unit 3, and the second pressure sensor unit 4 through the Bluetooth module, then the microprocessor 501 processes the information collected by the sensors, and then transmits the processed information to a small display screen for display through the Bluetooth module. The small display screen can be hung on the patient's hospital bed for doctors to view during ward rounds.

[0038] In summary, the pressure sensors 201 in the first pressure sensor unit 2 and the second pressure sensor unit 4 of the present invention can monitor the pressure changes of the inner wall of the patient's biliary tract in real time. Moreover, the first pressure sensor unit 2 and the second pressure sensor unit 4 can form a pressure distribution network to accurately measure the pressure magnitudes of the biliary tract walls at different positions. The flow sensor 301 in the flow sensor unit 3 of the present invention can monitor the flow rate and velocity of bile in the patient's biliary tract in real time. And the pressure sensor 201 and the flow sensor 301 can transmit the collected information to the microprocessor unit 5 or the terminal device through the Bluetooth module, facilitating doctors to timely understand the complex pathological changes in the patient's biliary tract and the related characteristics of bile flow. Additionally, the microprocessor unit 5 can collect, process the information collected by each sensor in real time, and transmit the processed information to the display screen for display, thus solving the problem that the existing biliary stent 1 is difficult to monitor the related characteristics of bile flow in real time and cannot comprehensively reflect the complex pathological changes in the patient's biliary tract.

[0039] The above embodiments are only illustrative of the principles and effects of the present invention and are not intended to limit the present invention. All equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow, characterized in that: The invention comprises a biliary stent (1) in the shape of a woven mesh cylinder, wherein the biliary stent (1) is provided with a first pressure sensor unit (2) and a second pressure sensor unit (4) for real-time monitoring of pressure changes on the inner wall of the patient's bile duct, and a flow sensor unit (3) for real-time monitoring of the flow rate and flow rate of bile in the patient's bile duct, wherein the first pressure sensor unit (2), the flow sensor unit (3) and the second pressure sensor unit (4) are evenly spaced and installed on the biliary stent (1) along the length direction of the biliary stent (1); The first pressure sensor unit (2) and the second pressure sensor unit (4) both comprise a pressure sensor (201), a first Bluetooth module (202) for transmitting bile duct inner wall information collected by the pressure sensor (201), and a first wireless power supply module (203) for providing power to the pressure sensor (201), wherein the first wireless power supply module (203) comprises an energy storage battery (6) and a wireless charging coil (7) connected to the energy storage battery (6).

2. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 1, characterized in that: The biliary stent (1) is a nickel-titanium alloy frame, the thickness of the biliary stent (1) is 0.3-0.5 mm, and a protective layer made of polytetrafluoroethylene is coated on the surface of the nickel-titanium alloy frame.

3. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 1, characterized in that: The first pressure sensor unit (2) and the second pressure sensor unit (4) form a pressure distribution network for accurately measuring the pressure magnitude of the bile duct wall at different positions, and the pressure sensor (201) is a MEMS pressure sensor. The pressure sensor (201) has a diameter of 1 to 2 mm and a thickness of approximately 0.1 mm.

4. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 1, characterized in that: The flow sensor unit (3) comprises a flow sensor (301), a second Bluetooth module (302) for transmitting bile duct information collected by the flow sensor (301), and a second wireless power supply module (303) for providing power to the flow sensor (301), wherein the second wireless power supply module (303) also comprises a power storage battery (6) and a wireless charging coil (7) connected to the energy storage battery (6).

5. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 4, characterized in that: The flow sensor (301) is a thermal flow sensor, and the width of the flow sensor (301) is 2 to 3 mm and the thickness is less than 50 μm.

6. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 4, characterized in that: The biliary stent (1) may also be provided with a microprocessor unit (5) for collecting and processing information collected by each sensor in real time and transmitting the processed information to a display screen for display; the microprocessor unit (5), the first pressure sensor unit (2), the flow sensor unit (3) and the second pressure sensor unit (4) are evenly spaced and installed on the biliary stent (1) along the length direction of the biliary stent (1); and the microprocessor unit (5) is installed on the side of the biliary stent (1) at the end of the bile inlet.

7. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 6, characterized in that: The microprocessor unit (5), the first pressure sensor unit (2), the flow sensor unit (3) and the second pressure sensor unit (4) can be installed on the biliary stent (1) by means of soldering or snap-fitting (9), and the first pressure sensor unit (2), the flow sensor unit (3) and the second pressure sensor unit (4) can be connected to the microprocessor unit (5) and can also be connected to an external terminal device.

8. The dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 6, characterized in that: The microprocessor unit (5) comprises a microprocessor (501) and a third wireless power supply module (502) for providing power to the microprocessor (501); a data acquisition module, a data processing module, a wireless transmission module and a low-power Bluetooth chip are integrated in the microprocessor (501); the third wireless power supply module (502) also comprises an energy storage battery (6) and a wireless charging coil (7) connected to the energy storage battery (6).

9. A dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 8, characterized in that: The microprocessor (501) is a SoC micro integrated chip, and the length of the SoC micro integrated chip is about 4 mm, the width is about 3 mm, and the thickness is about 0.5 mm.

10. The dual monitoring biliary stent capable of monitoring bile duct wall pressure and bile flow according to claim 8, characterized in that: The energy storage battery (6) is a flexible solid-state lithium-ion battery. The energy storage battery (6) has a length of approximately 4 mm, a width of approximately 4 mm, and a thickness of approximately 0.2 mm. The wireless charging coil (7) provides energy through electromagnetic induction technology. The wireless charging coil (7) has a width of approximately 1 mm and a thickness of approximately 0.2 mm.

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