Novel anti-reflux integrated biliary stent for bile flow monitoring

Abstract

The invention provides a novel anti-reflux integrated biliary tract stent for bile flow monitoring, which comprises a biliary tract stent in the shape of a woven mesh cylinder, and a flexible covering film is arranged in the biliary tract stent. A flow sensor unit for monitoring the flow and the flow velocity of bile in the biliary tract of a patient in real time and an anti-reflux assembly are mounted in the flexible covering film; wherein the anti-reflux assembly comprises an anti-reflux membrane flap, a plurality of through holes are formed in the anti-reflux membrane flap, and a plurality of anti-reflux flexible parts are arranged in the through holes; the biliary tract bile flow monitoring system has the advantages that a flow sensor in the flow sensor unit can monitor the flow and the flow speed of bile in the biliary tract of a patient in real time, the flow sensor can transmit collected information to an in-vitro terminal device through a Bluetooth module, and therefore the bile flow related characteristics can be monitored in real time; and bile in the biliary tract is prevented from entering the biliary tract stent and flowing back into the biliary tract through the anti-reflux flap and the anti-reflux flexible piece.

Description

Technical Field

[0001] The present invention relates to the technical field of medical device treatment, and particularly to a novel anti-reflux integrated biliary stent for bile flow monitoring. Background Art

[0002] Biliary diseases are a major long-term challenge in the global medical field, with their incidence and fatality rates remaining at relatively high levels. In China, due to the lack of obvious early symptoms and insufficient public attention to early prevention and screening for biliary diseases, most patients are diagnosed at the middle and late stages, significantly increasing the treatment difficulty and severely affecting the survival rate. The biliary system has a complex anatomical structure, posing many problems for the diagnosis and treatment of diseases. In the treatment of various biliary diseases, such as biliary cancer, primary sclerosing cholangitis, and biliary stricture after liver transplantation, biliary stents play an indispensable role and can effectively relieve biliary stricture and improve cholestasis. However, the current biliary stents on the market have many limitations and are difficult to fully meet the growing needs of clinical practice and clinical research, and further innovation and breakthroughs are required.

[0003] Although the existing biliary stents can solve some problems in the treatment of biliary diseases to a certain extent, they cannot monitor the relevant characteristics of bile flow in real time, and there is also a serious problem of reflux in the existing biliary stents. The limitations of the existing stents are particularly obvious in disease management and treatment evaluation. Taking patients after biliary surgery as an example, a T-tube is usually inserted for bile drainage, and doctors can only indirectly judge the drainage situation by observing the amount of bile in the drainage bag. This method is not only inefficient but also may lead to a lag in clinical decision-making and even miss the best treatment opportunity. Therefore, it is particularly important to develop an intelligent biliary stent that can monitor the characteristics of bile flow in real time. This innovative design can not only provide more accurate personalized treatment for patients but also promote the progress of biliary disease diagnosis and treatment technology. 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 novel anti-reflux integrated biliary stent for bile flow monitoring, which is used to solve the problems that the existing biliary stents cannot monitor the relevant characteristics of bile flow in real time and there is also a serious problem of reflux in the existing biliary stents.

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

[0006] A novel anti-reflux integrated biliary stent for bile flow monitoring, comprising a biliary stent in the shape of a braided mesh cylinder, a flexible film is arranged inside the biliary stent, and a flow sensor unit for real-time monitoring of the bile flow rate and velocity in the patient's biliary tract and an anti-reflux component located on the side of the flow sensor unit are installed inside the flexible film; wherein, the anti-reflux component includes an anti-reflux membrane flap, a plurality of through holes are opened in the anti-reflux membrane flap, and the plurality of through holes are arranged at equal intervals along the height direction of the anti-reflux membrane flap in the anti-reflux membrane flap, and a plurality of anti-reflux flexible members are arranged in the through holes.

[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, a plurality of mounting holes are opened at the middle position of the flexible film, and the plurality of mounting holes are arranged at equal intervals along the circumferential direction of the flexible film in the flexible film, and a binding band for mounting the flexible film on the biliary stent is penetrated in the mounting holes.

[0009] In an embodiment of the present invention, the flow sensor unit includes a flow sensor, a PH sensor for real-time monitoring of the acidity and alkalinity of bile in the patient's biliary tract, a Bluetooth module for transmitting the biliary tract information collected by the sensor, and a wireless power supply module for supplying power to the sensor. The wireless power supply module includes a storage battery and a wireless charging coil connected to the 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, the thickness is less than 50 μm, and the length and width of the PH sensor are both about 5 mm.

[0011] 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, the thickness is about 0.2 mm, the wireless charging coil provides energy through electromagnetic induction technology, and the width of the wireless charging coil is about 1 mm and the thickness is about 0.2 mm.

[0012] In an embodiment of the present invention, the flexible film and the anti-reflux membrane flap can be made of silicone rubber film, and the flexible film and the anti-reflux membrane flap can also be made of polytetrafluoroethylene film.

[0013] In an embodiment of the present invention, the port of the through hole facing the bile inlet of the biliary stent is the inlet, the port of the through hole opposite to the bile inlet of the biliary stent is the outlet, and the diameter of the inlet of the through hole is larger than the diameter of the outlet of the through hole.

[0014] As described above, a novel anti-reflux integrated biliary stent for bile flow monitoring of the present invention has the following beneficial effects: The flow sensor in the flow sensor unit of the present invention can monitor the flow rate and velocity of bile in the patient's biliary tract in real time, and the flow sensor can transmit the collected information to an external terminal device through a Bluetooth module, so that doctors can timely understand the relevant characteristics of bile flow in the patient's biliary tract; moreover, the anti-reflux bile can be blocked by the anti-reflux membrane flap and the anti-reflux flexible member, which can prevent the bile in the biliary tract from flowing back into the biliary stent and then into the biliary tract. At the same time, the diameter of the inlet of the anti-reflux membrane flap is larger than that of the outlet, which can further avoid the backflow of liquids such as bile and improve the treatment efficiency of the biliary stent, solving the problems that the existing biliary stents cannot monitor the relevant characteristics of bile flow in real time and have serious reflux. Description of the Drawings

[0015] Figure 1 Stereoscopic schematic diagram of the novel anti-reflux integrated biliary stent for bile flow monitoring disclosed in the embodiment of the present invention;

[0016] Figure 2 Stereoscopic schematic diagram of the flexible coating film in the novel anti-reflux integrated biliary stent for bile flow monitoring disclosed in the embodiment of the present invention;

[0017] Figure 3 Cross-sectional schematic diagram of the flexible coating film in the novel anti-reflux integrated biliary stent for bile flow monitoring disclosed in the embodiment of the present invention;

[0018] Figure 4 For the novel anti-reflux integrated biliary stent for bile flow monitoring disclosed in the embodiment of the present invention Figure 1 Enlarged schematic diagram at A;

[0019] Figure 5 Stereoscopic schematic diagram of the components included in the flow sensor unit in the novel anti-reflux integrated biliary stent for bile flow monitoring disclosed in the embodiment of the present invention;

[0020] Figure 6 Schematic diagram of the wireless charging coil in the novel anti-reflux integrated biliary stent for bile flow monitoring disclosed in the embodiment of the present invention.

[0021] Explanation of Component Labels

[0022] 1. Biliary stent; 2. Flexible film; 3. Mounting hole; 4. Flow sensor unit; 401. Flow sensor; 402. PH sensor; 403. Bluetooth module; 404. Wireless power supply module; 5. Anti-reflux component; 501. Anti-reflux membrane flap; 502. Through hole; 503. Anti-reflux flexible part; 6. Inlet; 7. Outlet; 8. Binding strap; 9. Energy storage battery; 10. Wireless charging coil. Detailed implementation mode

[0023] 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.

[0024] Please refer to Figure 1 , the present invention provides a novel anti-reflux integrated biliary stent for bile flow monitoring, which is used for the long-term treatment and detection of long-term and recurrent diseases such as biliary stricture where bile cannot flow normally. It includes a biliary stent 1 in the shape of a braided mesh cylinder. The biliary stent 1 is a nickel-titanium alloy frame, which is used to support the patency of the bile duct. 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 characteristics; 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.

[0025] As Figure 2 and Figure 4 shown, a flexible film 2 is provided inside the biliary stent 1. Both ends of the flexible film 2 are installed on both ends of the biliary stent 1. In actual applications, the installation method can be an adhesive method or other methods. A number of mounting holes 3 are provided at the middle position of the flexible film 2. The number of mounting holes 3 is evenly arranged along the circumferential direction of the flexible film 2 inside the flexible film 2. A binding strap 8 for installing the flexible film 2 on the biliary stent 1 is passed through the mounting holes 3. Among them, the flexible film 2 can be made of a silicone rubber film or a polytetrafluoroethylene film; it should also be noted that when specifically installing the flexible film 2, according to the final installation firmness, mounting holes 3 can also be provided at other positions of the flexible film 2, and the flexible film 2 is tied to the inner side wall of the biliary stent 1 by passing the binding strap 8 through the mounting holes 3.

[0026] As Figure 3 , Figure 5 and Figure 6As shown, a flow sensor unit 4 for real-time monitoring of the flow rate and velocity of bile in the patient's biliary tract and an anti-reflux component 5 located on the side of the flow sensor unit 4 are installed inside the flexible film 2; the flow sensor unit 4 includes a flow sensor 401, a PH sensor 402 for real-time monitoring of the pH value of bile in the patient's biliary tract, a Bluetooth module 403 for transmitting the biliary tract information collected by the sensor, and a wireless power supply module 404 for supplying power to the sensor. The wireless power supply module 404 includes a storage battery 9 and a wireless charging coil 10 connected to the storage battery 9;

[0027] Among them, the flow sensor 401 is a thermal flow sensor. When the fluid flows, the thermal flow sensor measures the flow velocity and flow rate of bile based on the heat transfer equation. The width of the flow sensor 401 is 2 - 3 mm, and the thickness is less than 50 μm. The length and width of the PH sensor 402 are both about 5 mm; also, the storage battery 9 is a flexible solid-state lithium-ion battery. The length of the storage battery 9 is about 4 mm, the width is about 4 mm, and the thickness is about 0.2 mm. The storage battery 9 is closely connected to the wireless charging coil 10, which is convenient for quick power supply and avoids interfering with the working area of the sensor; the wireless charging coil 10 provides energy through electromagnetic induction technology. The width of the wireless charging coil 10 is about 1 mm, and the thickness is about 0.2 mm.

[0028] As Figure 3 shown, the anti-reflux component 5 includes an anti-reflux membrane flap 501. A plurality of through holes 502 are formed in the anti-reflux membrane flap 501. The plurality of through holes 502 are evenly arranged along the height direction of the anti-reflux membrane flap 501 inside the anti-reflux membrane flap 501, and a plurality of anti-reflux flexible members 503 are provided in the through holes 502. The port of the through hole 502 facing the bile inlet of the biliary stent 1 is the inlet 6, and the port of the through hole 502 opposite to the bile inlet of the biliary stent 1 is the outlet 7. The diameter of the inlet 6 of the through hole 502 is larger than the diameter of the outlet 7 of the through hole 502. Among them, the anti-reflux membrane flap 501 can be made of silicone rubber membrane, and the anti-reflux membrane flap 501 can also be made of polytetrafluoroethylene membrane; it should be noted that the anti-reflux flexible member 503 is conductive when bile flows forward into the biliary stent 1, but will block the bile when bile refluxes. Therefore, the refluxed bile can be blocked by the anti-reflux membrane flap and the anti-reflux flexible member, preventing the bile in the biliary tract from flowing back into the biliary tract through the biliary stent.

[0029] Specifically, the present invention includes a biliary stent 1. A flexible film 2 is encapsulated within the main body mesh structure of the biliary stent 1. A flow sensor 401 is installed on the inner surface of the flexible film 2. By implanting the biliary stent 1 into the patient's biliary tract and activating the power supply, real-time monitoring of the fluid within the biliary tract can be performed at different frequencies. Each flow sensor 401 and pH sensor 402 can directly transmit the collected information to a mobile device outside the body through a Bluetooth module 403. The mobile device displays the detected flow rate, flow velocity, and pH value on a display screen, thereby enabling monitoring of the disease condition data. When the battery power is low, it can be charged through an external radio charging device. During later use, the wireless charging coil 10 can charge the battery inside the stent based on a radio transmitter through a skin distance of 3 - 5 cm.

[0030] In summary, the flow sensor 401 within the flow sensor unit 4 of the present invention can real-time monitor the flow rate and flow velocity of bile within the patient's biliary tract, and the flow sensor 401 can transmit the collected information to a terminal device outside the body through the Bluetooth module 403, thereby facilitating doctors to timely understand the relevant characteristics of bile flow within the patient's biliary tract. Additionally, the anti-reflux membrane flap 501 and the anti-reflux flexible member 503 can block the refluxed bile, preventing the bile in the biliary tract from flowing back into the biliary stent 1 and into the biliary tract. At the same time, the diameter of the inlet 6 of the anti-reflux membrane flap 501 is larger than that of the outlet 7, which can further avoid the backflow of liquids such as bile and improve the treatment efficiency of the biliary stent 1, solving the problems that the existing biliary stent 1 cannot real-time monitor the relevant characteristics of bile flow and has serious reflux.

[0031] The above embodiments are merely 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 shall still be covered by the claims of the present invention.

Claims

1. A novel anti-reflux integrated biliary stent for bile flow monitoring, characterized by: The invention comprises a biliary stent (1) in the shape of a woven mesh cylinder, wherein a flexible covering film (2) is provided inside the biliary stent (1), and a flow sensor unit (4) for real-time monitoring of the flow rate and flow rate of bile in the patient's bile duct and an anti-reflux component (5) located on the side of the flow sensor unit (4) are installed inside the flexible covering film (2); The anti-reflux component (5) comprises an anti-reflux membrane flap (501), a plurality of through holes (502) are provided in the anti-reflux membrane flap (501), the plurality of through holes (502) are evenly spaced in the anti-reflux membrane flap (501) along the height direction of the anti-reflux membrane flap (501), and a plurality of anti-reflux flexible parts (503) are provided in the through holes (502).

2. According to claim 1, a novel anti-reflux integrated biliary stent for bile flow monitoring is 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. According to claim 1, a novel anti-reflux integrated biliary stent for bile flow monitoring is characterized in that: A plurality of mounting holes (3) are provided at a middle position of the flexible covering (2), and the plurality of mounting holes (3) are evenly spaced in the flexible covering (2) along the circumference of the flexible covering (2), and a binding band (8) for mounting the flexible covering (2) on the biliary stent (1) is passed through the mounting holes (3).

4. According to claim 1, a novel anti-reflux integrated biliary stent for bile flow monitoring is characterized by: The flow sensor unit (4) comprises a flow sensor (401), a pH sensor (402) for real-time monitoring of the acidity and alkalinity of bile in the patient's bile duct, a Bluetooth module (403) for transmitting bile duct information collected by the sensor, and a wireless power supply module (404) for providing power to the sensor, wherein the wireless power supply module (404) comprises an energy storage battery (9) and a wireless charging coil (10) connected to the energy storage battery (9).

5. According to claim 4, a novel anti-reflux integrated biliary stent for bile flow monitoring is characterized in that: The flow sensor (401) is a thermal flow sensor, the width of the flow sensor (401) is 2-3 mm and the thickness is less than 50 μm, and the length and width of the pH sensor (402) are both approximately 5 mm.

6. The novel anti-reflux integrated biliary stent for bile flow monitoring according to claim 4 is characterized in that: The energy storage battery (9) is a flexible solid-state lithium-ion battery. The energy storage battery (9) 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 (10) provides energy through electromagnetic induction technology. The wireless charging coil (10) has a width of approximately 1 mm and a thickness of approximately 0.2 mm.

7. The novel anti-reflux integrated biliary stent for bile flow monitoring according to claim 1, characterized in that: The flexible covering membrane (2) and the anti-reflux membrane flap (501) can be made of a silicone rubber membrane, and the flexible covering membrane (2) and the anti-reflux membrane flap (501) can also be made of a polytetrafluoroethylene membrane.

8. The novel anti-reflux integrated biliary stent for bile flow monitoring according to claim 1, characterized in that: The end of the through hole (502) facing the bile inlet of the biliary stent (1) is the inlet (6), and the end of the through hole (502) opposite to the bile inlet of the biliary stent (1) is the outlet (7), and the diameter of the inlet (6) of the through hole (502) is greater than the diameter of the outlet (7) of the through hole (502).

Images