Anti-reflux enteral nutrition infusion pipeline and early warning mechanism

Abstract

The anti-reflux enteral nutrition infusion pipeline comprises a double-cavity catheter, a plurality of Luer tapers are arranged at the tail end of the double-cavity catheter, a nose fixing fin is arranged on the outer side of the double-cavity catheter, the double-cavity catheter is provided with an anti-reflux mechanism at the junction of the stomach bottom and the upper section of the stomach body, and the double-cavity catheter comprises an outer tube and an inner tube. A one-way valve is arranged between the end of the outer pipe and the end of the inner pipe, the direction is set to enable the inner pipe to flow to the outer pipe, the anti-backflow mechanism comprises a driving part, a feedback part, an early warning part, an outer sealing part and an inner blocking part, the feedback part comprises a gas storage ring fixedly connected to the outer side of the double-cavity catheter, and a movable channel is formed between the gas storage ring and the outer pipe; and an isolating ring is fixedly connected into the movable channel. According to the invention, the beneficial effects of double-path anti-reflux plugging and real-time visual early warning when the intragastric pressure is abnormal are realized, the risk of reflux aspiration of gastric contents is effectively avoided, then the reflux path is bidirectionally blocked, and the clinical safety of enteral nutrition infusion is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an anti-reflux enteral nutrition infusion pipeline and an early warning mechanism. Background Technology

[0002] Enteral nutrition support is a core clinical treatment for patients who are unable to eat orally due to swallowing dysfunction, critical illness, traumatic brain injury, postoperative fasting after gastrointestinal surgery, or impaired consciousness. Nasoenteric nutrition infusion tubing is a key medical device for implementing enteral nutrition support. It is inserted into the patient's body through the nasal cavity to deliver enteral nutrition solution directly into the patient's intestines. While providing the patient with the necessary nutrients and maintaining normal physiological metabolism, it reduces stimulation to the patient's gastrointestinal function. It is widely used in many clinical departments such as intensive care unit, gastroenterology, neurology, and general surgery, and is the mainstream implementation vehicle for clinical enteral nutrition therapy.

[0003] Most existing enteral nutrition infusion tubing uses a single-lumen or double-lumen tubing structure. Basic anti-reflux design is achieved by setting a one-way valve at the infusion interface of the tubing. In clinical use, after the tubing is inserted into the target position through the patient's nasal cavity, the nutrient solution is infused into the patient's intestine through the inner lumen of the tubing using an external infusion device. The one-way valve's one-way conduction characteristic restricts the backflow of the medium in the tubing, thereby achieving a basic anti-reflux effect.

[0004] However, such devices are difficult to simultaneously achieve physical blockage of the esophageal reflux path and the infusion tubing when the patient's gastric pressure rises abnormally. They cannot completely block the bidirectional reflux path of gastric contents at the physical level, and are very prone to gastric contents reflux and aspiration events due to a sudden increase in gastric pressure, which has significant safety defects in clinical application. Summary of the Invention

[0005] The purpose of this invention is to provide an anti-reflux enteral nutrition infusion pipeline and an early warning mechanism, which aims to improve the problem in the prior art of simultaneously achieving physical blockage of the dual paths of the esophageal reflux path and the infusion pipeline when the patient's gastric pressure rises abnormally.

[0006] The objective of this invention is achieved through the following technical solution: an anti-reflux enteral nutrition infusion pipeline and an early warning mechanism, comprising a double-lumen catheter, wherein the end of the double-lumen catheter is provided with multiple Luer connectors, a nasal fixation wing is provided on the outer side of the double-lumen catheter, and an anti-reflux mechanism is provided at the junction of the gastric fundus and the upper part of the gastric body of the double-lumen catheter.

[0007] The dual-lumen conduit includes an outer tube and an inner tube. A one-way valve is provided between the ends of the outer tube and the inner tube, and the direction is set so that the flow is from the inner tube to the outer tube. The anti-backflow mechanism includes a driving component, a feedback component, an early warning component, an outer sealing component, and an inner plugging component.

[0008] The feedback device includes an air storage ring fixedly connected to the outside of the double-lumen conduit. An active channel is provided between the air storage ring and the outer tube, and an isolation ring is fixedly connected inside the active channel. A piston is slidably connected inside the active channel. One end of the piston is fixedly connected to the isolation ring, and the isolation ring is slidably connected inside the buried wire plate. An isolation post is fixedly connected to the inner side of the isolation ring, and a conductive fork is fixedly connected to the other end of the isolation post.

[0009] As a further description of the above technical solution:

[0010] The driving component includes a sensing ring slidably connected to the outside of the outer tube, a plurality of pressure sensing membranes are provided inside the sensing ring, a plurality of transmission rods are fixedly connected to the bottom of the sensing ring, a pressure ring is fixedly connected to the bottom of the transmission rods and the pressure ring is slidably connected to the inside of the gas storage ring, and a plurality of magnetic blocks are provided on the inner side of the pressure ring.

[0011] As a further description of the above technical solution:

[0012] The warning device includes a buried wire plate installed inside the outer and inner pipes. The buried wire plate is equipped with a two-color wire. The section of the two-color wire inside the isolation ring is disconnected and a metal connector is provided at the disconnection point. A lamp tube is installed on the outside of the buried wire plate and is electrically connected to the two-color wire.

[0013] As a further description of the above technical solution:

[0014] The outer sealing component includes an inflatable bladder disposed on the outside of the gas storage ring, with a gas channel opened between the inflatable bladder and the gas storage ring, and a sealing wing provided on the outside of the inflatable bladder.

[0015] As a further description of the above technical solution:

[0016] The inner plug includes a magnetic ring that is slidably connected to the inner side of the inner tube. The magnetic ring attracts the magnetic block. A sealing cone is fixedly connected to the middle of the magnetic ring. A support ring is also fixedly connected to the inner side of the inner tube. The inner shape of the support ring is adapted to the outer shape of the sealing cone.

[0017] As a further description of the above technical solution:

[0018] The number of Luer connectors is three, namely a main infusion Luer connector, a sampling Luer connector, and a flushing Luer connector. The end of the sampling Luer connector is connected to the cavity between the outer tube and the inner tube, and the end of the flushing Luer connector is connected to the cavity between the outer tube and the inner tube and the main input channel in the inner tube.

[0019] As a further description of the above technical solution:

[0020] The Luer connector includes a nutrient solution input interface, the front end of which is tapered, and a threaded lock is provided on the outer side of the end. A silicone cap is provided on the top of the nutrient solution input interface, and a duckbill valve is provided at the output end of the nutrient solution input interface.

[0021] As a further description of the above technical solution:

[0022] The outer side of the dual-lumen catheter is provided with two sets of positioning and imaging rings, which are respectively located on the outer side of the gas storage ring and at the distal infusion port.

[0023] Compared with the prior art, the advantages of the present invention are as follows:

[0024] 1. The pressure-sensing diaphragm of the driving component deforms under pressure, causing the sensing ring to slide along the outer tube. The transmission rod drives the pressure ring to move down within the gas storage ring, compressing the gas. Simultaneously, the inflation bladder inflates, causing the sealing vanes to expand and adhere to the stomach wall, thus sealing the peripheral reflux channel. At the same time, the magnetic block on the pressure ring, through magnetic attraction, causes the magnetic ring in the inner tube to move down, causing the sealing cone to adhere to the support ring and seal the infusion channel. Combined with the one-way valve, it blocks the reverse flow of the medium, achieving the beneficial effect of physical anti-reflux sealing of the esophageal end and the infusion channel in case of abnormal gastric pressure. Furthermore, by blocking the reflux path in both directions, it effectively avoids the risk of aspiration of gastric contents and improves the clinical safety of enteral nutrition infusion.

[0025] 2. By changing the air pressure within the gas storage ring, the piston slides directionally along the active channel. Through the isolation ring and isolation stake, the conductive fork moves synchronously, switching the conduction circuit of the dual-color wire. This, combined with the metal connector within the embedded plate, completes the circuit switching between normal and abnormal states. It also drives the lamp, electrically connected to the dual-color wire, to switch from green to red, achieving the beneficial effect of real-time monitoring and visual early warning of abnormal gastric pressure. It can intuitively display the pipeline operation status and reflux risk to medical staff, facilitating rapid risk identification and timely intervention, further reducing the probability of adverse events such as clinical reflux aspiration. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the main body of an embodiment of an anti-reflux enteral nutrition infusion pipeline and early warning mechanism proposed in this invention;

[0027] Figure 2 This is a schematic diagram of the Luer connector of an anti-backflow enteral nutrition delivery pipeline and early warning mechanism proposed in this invention.

[0028] Figure 3 This is a schematic diagram of the structure of the early warning component of the anti-backflow enteral nutrition infusion pipeline and early warning mechanism proposed in this invention;

[0029] Figure 4This is a schematic diagram of the anti-reflux mechanism of the anti-reflux enteral nutrition infusion pipeline and early warning mechanism proposed in this invention;

[0030] Figure 5 This is a schematic diagram of the internal plug of an anti-backflow enteral nutrition delivery pipeline and early warning mechanism proposed in this invention;

[0031] Figure 6 This is a schematic diagram of the drive component of an anti-backflow enteral nutrition infusion pipeline and early warning mechanism proposed in this invention;

[0032] Figure 7 This is a schematic diagram of the feedback element of an anti-backflow enteral nutrition delivery pipeline and early warning mechanism proposed in this invention;

[0033] Figure 8 for Figure 7 Enlarged view of point A in the image.

[0034] Labeling Explanation: 1. Double-lumen catheter; 101. Inner tube; 102. Outer tube; 2. Luer connector; 201. Nutrient solution inlet; 202. Threaded locking; 203. Silicone end cap; 204. Duckbill valve; 3. Nasal fixation flap; 4. Anti-reflux mechanism; 41. Drive component; 411. Sensing ring; 412. Pressure sensing diaphragm; 413. Transmission rod; 414. Pressure ring; 415. Magnetic block; 42. Feedback component; 421. Gas storage ring; 422. Positioning and imaging ring; 423. Piston; 424. Isolation ring; 425. Isolation post; 426. Conductive fork; 43. Warning component; 431. Embedded wire plate; 432. Two-color wire; 433. Metal connector; 434. Lamp tube; 44. Outer seal; 441. Inflatable bladder; 442. Sealing wing; 45. Inner plug; 451. Magnetic ring; 452. Sealing cone; 453. Support ring. Detailed Implementation

[0035] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0036] like Figures 1 to 8The diagram shown is an embodiment of an anti-reflux enteral nutrition infusion pipeline and early warning mechanism provided by the present invention. The pipeline includes a double-lumen catheter 1, which enables multi-lumen media delivery for enteral nutrition infusion, sampling, and flushing operations. It provides a stable mounting platform for each functional component, constructing independent double-layered flow channels to ensure the orderly conduct of various clinical procedures. The end of the double-lumen catheter 1 is equipped with multiple Luer connectors 2, which enable standardized connection between the infusion pipeline and external operating equipment, providing a connection for nutrient solution infusion, gastric fluid sampling, and pipeline flushing. The corresponding connection interface ensures stable and sealed communication between external equipment and the pipeline cavity. The nasal fixation wing 3 is provided on the outside of the double-lumen catheter 1. The nasal fixation wing 3 realizes the external limitation and fixation of the double-lumen catheter 1 in the patient's nasal cavity, effectively limiting the displacement and slippage of the catheter during use and ensuring the stability of the catheter body's insertion position. The double-lumen catheter 1 is provided with an anti-reflux mechanism 4 at the junction of the gastric fundus and the upper part of the gastric body. The anti-reflux mechanism 4 realizes physical blockage of the reflux path and visual warning of risks when the gastric pressure is abnormal. It prevents the risk of gastric contents reflux and aspiration from multiple dimensions and greatly improves the clinical safety of enteral nutrition infusion.

[0037] There are three Luer connectors 2, namely, main infusion Luer connector 2, sampling Luer connector 2, and flushing Luer connector 2. The main infusion Luer connector 2 connects to the dedicated channel for enteral nutrition infusion, providing a standardized connection interface for the nutrient solution to enter the main input channel of the inner tube 101, ensuring the independent controllability of the nutrient solution infusion pathway. The sampling Luer connector 2 connects to the dedicated channel for gastric fluid sampling, providing an independent sampling pathway for the cavity between the outer tube 102 and the inner tube 101, ensuring that the sampling operation does not interfere with the normal operation of the main infusion pathway. The end of the sampling Luer connector 2 connects to the cavity between the outer tube 102 and the inner tube 101. The flushing Luer connector 2 connects to the dedicated channel for pipeline flushing, and can simultaneously connect the cavity between the outer tube 102 and the inner tube 101 and the main input channel of the inner tube 101, ensuring comprehensive coverage of the entire pipeline flushing operation. The end of the flushing Luer connector 2 connects to the cavity between the outer tube 102 and the inner tube 101 and the main input channel inside the inner tube 101.

[0038] The Luer connector 2 includes a nutrient solution inlet 201, which enables the connection and adaptation of external equipment pipelines and infusion pipelines. The tapered structure at the front end ensures a tight seal during the connection process, providing a stable transition connection channel for media flow. The tapered front end of the nutrient solution inlet 201 is equipped with a threaded locking buckle 202 on the outer side of the end. The threaded locking buckle 202 achieves a locking connection between the external equipment and the Luer connector 2, enhancing the connection strength and stability of the connection point and preventing pipeline detachment and media leakage during operation. A silicone end cap 203 is provided at the top of the nutrient solution inlet 201, providing end sealing when the Luer connector 2 is not in use, isolating the external environment from the internal pipeline cavity and effectively preventing contaminants from entering the pipeline and causing cavity contamination. A duckbill valve 204 is provided at the output end of the nutrient solution inlet 201. The duckbill valve 204 automatically opens the passage during connection and automatically closes the passage during disconnection, preventing backflow of media within the pipeline and avoiding external contaminants from entering the pipeline.

[0039] The dual-lumen catheter 1 includes an outer tube 102 and an inner tube 101. The inner tube 101 serves as the main channel for delivering enteral nutrition solution, providing a dedicated flow path for the solution from the external infusion end to the target location in the intestine. It is the core carrier for nutrient solution infusion. The outer tube 102, in conjunction with the inner tube 101, forms an independent annular cavity, providing an independent channel for sampling and flushing operations. It also provides a stable mounting base for the components of the anti-reflux mechanism 4. A one-way valve is installed between the ends of the outer tube 102 and the inner tube 101. The one-way valve restricts the flow of the medium in one direction, allowing only the medium in the inner tube 101 to flow into the cavity between the outer tube 102 and the inner tube 101, blocking the reverse flow of the medium and preventing gastric reflux from entering the main infusion channel of the inner tube 101. The direction is set from the inner tube 101 to the outer tube 102. The anti-reflux mechanism 4 includes a drive component 41, a feedback component 42, a warning component 43, an outer sealing component 44, and an inner plugging component 45. The driving component 41 realizes real-time sensing and power conversion of gastric pressure changes, converting gastric pressure signals into mechanical actions to provide triggering power for the blocking and early warning actions of the anti-reflux mechanism 4. The feedback component 42 realizes the transmission of air pressure and displacement conversion of the driving component 41's actions, converting air pressure changes into mechanical displacement to provide stable action support for the switching of the early warning circuit. The early warning component 43 realizes the visual prompt of abnormal gastric pressure, intuitively displaying the pipeline operation status and reflux risk through light color switching, providing real-time risk warning signals for medical staff. The outer sealing component 44 realizes the external physical blockage of the gastric reflux path, blocking the reflux channel of gastric contents towards the esophagus by expanding the structure to fit the gastric wall, thus building an anti-reflux barrier from the outside. The inner blocking component 45 realizes the internal blockage of the infusion main channel, closing the infusion passage of the inner tube 101 when the pressure is abnormal, blocking the reverse flow path of refluxed material through the infusion channel, thus building an anti-reflux barrier from the inside.

[0040] Feedback component 42 includes a gas storage ring 421 fixedly connected to the outside of the double-lumen conduit 1. The gas storage ring 421 stores compressed gas and transmits air pressure, providing stable air pressure power for the operation of subsequent components. It is the core carrier of air pressure transmission. A movable channel is provided between the gas storage ring 421 and the outer tube 102. The movable channel realizes the directional sliding limit of the piston 423, provides dedicated movement space for the displacement of the piston 423, and ensures that the piston 423 moves stably along a preset path. An isolation ring 424 is fixedly connected inside the movable channel. The isolation ring 424 realizes spatial separation and displacement transmission inside the movable channel, drives the corresponding components to complete synchronous displacement, and isolates the medium interference between different cavities. The movable channel is slidably connected to... Piston 423 converts air pressure changes into mechanical displacement. Driven by air pressure, it completes directional sliding, providing displacement power for subsequent electrical circuit switching. One end of piston 423 is fixedly connected to isolation ring 424, which is slidably connected inside the buried plate 431. Isolation post 425 is fixedly connected to the inner side of isolation ring 424. Isolation post 425 realizes the fixed connection and transmission between isolation ring 424 and conductive fork 426, ensuring the synchronicity and stability of displacement transmission. The other end of isolation post 425 is fixedly connected to conductive fork 426, which realizes the on / off switching of electrical circuits. It completes the switching of different warning circuits through position changes and is the core execution component for warning signal switching.

[0041] The driving component 41 includes a sensing ring 411 slidably connected to the outside of the outer tube 102. The sensing ring 411 secures the pressure sensing diaphragm 412, provides a supporting foundation for the deformation of the pressure sensing diaphragm 412, and simultaneously drives the transmission components to complete synchronous displacement. Multiple pressure sensing diaphragms 412 are disposed inside the sensing ring 411. The pressure sensing diaphragms 412 realize real-time sensing of changes in gastric pressure, converting these changes into mechanical deformation, and providing a trigger signal for the overall movement of the driving component 41. Multiple transmission rods 413 are fixedly connected to the bottom of the sensing ring 411, and the transmission rods 413 realize the connection between the sensing ring 411 and the pressure ring 414. The displacement transmission between the sensing ring 411 synchronously transmits the sliding displacement of the sensing ring 411 to the pressure ring 414, ensuring the synchronicity of power transmission. The bottom of the transmission rod 413 is fixedly connected to the pressure ring 414, and the pressure ring 414 is slidably connected inside the gas storage ring 421. The pressure ring 414 compresses the gas inside the gas storage ring 421. By changing the volume of the closed space inside the gas storage ring 421 through sliding displacement, high-pressure gas is generated to drive subsequent actions. Multiple magnetic blocks 415 are provided on the inner side of the pressure ring 414. The magnetic blocks 415 realize the output of magnetic attraction power, and provide non-contact power transmission for the sealing action of the inner plug 45 through magnetic attraction.

[0042] The warning component 43 includes a buried wire plate 431 installed inside the outer pipe 102 and the inner pipe 101. The buried wire plate 431 realizes the installation, fixation and protection of electrical circuits, provides a stable installation carrier for wires and conductive components, and isolates the interference of the medium in the cavity to the electrical circuit. The buried wire plate 431 is equipped with a dual-color wire 432, which realizes the transmission of warning current. Through the independent dual-circuit design, it provides a corresponding conductive path for the different light colors of the lamp tube 434. The section of the dual-color wire 432 located inside the isolation ring 424 is disconnected and the disconnected part is equipped with a metal connector 433. The metal connector 433 realizes the conductive connection of the disconnected part of the electrical circuit and works with the conductive fork 426 to complete the circuit on and off control. It is the core docking component for switching electrical circuits. The lamp tube 434 is installed on the outside of the buried wire plate 431 and is electrically connected to the dual-color wire 432. The lamp tube 434 realizes the visual display of the pipeline operation status. Through the switching of different light colors, it intuitively displays the normal operation status and backflow risk warning status of the pipeline.

[0043] The outer sealing element 44 includes an inflatable bladder 441 disposed outside the gas storage ring 421. The inflatable bladder 441 realizes the conversion of air pressure into volume deformation. By inflating, it drives the sealing vane 442 to complete the expansion action, providing deformation support for the sealing action of the sealing vane 442. A gas channel is opened between the inflatable bladder 441 and the gas storage ring 421. The gas channel realizes the gas flow between the gas storage ring 421 and the inflatable bladder 441, providing a dedicated path for high-pressure gas to enter the inflatable bladder 441, ensuring the smooth transmission of air pressure. The sealing vane 442 is disposed on the outer side of the inflatable bladder 441. The sealing vane 442 achieves close sealing with the stomach wall. After the inflatable bladder 441 inflates and expands, it comes into close contact with the stomach wall, blocking the external reflux channel of the stomach contents and constructing an external anti-reflux barrier.

[0044] The inner plug 45 includes a magnetic ring 451 slidably connected to the inner side of the inner tube 101. The magnetic ring 451 receives and transmits magnetic attraction power, and the sealing cone 452 is driven by the magnetic attraction to complete synchronous displacement, providing displacement power for the sealing action. The magnetism of the magnetic ring 451 is attracted to the magnetism of the magnetic block 415. The sealing cone 452 is fixedly connected to the middle of the magnetic ring 451. The sealing cone 452 seals the main input channel of the inner tube 101. By fitting with the support ring 453, the infusion passage is closed, blocking the bidirectional flow of the medium and constructing an internal anti-backflow barrier. The support ring 453 is also fixedly connected to the inner side of the inner tube 101. The support ring 453 fits and fits with the sealing cone 452, providing a sealing docking reference surface for the sealing cone 452, ensuring the complete closure of the passage of the inner tube 101 under the sealing state. The inner shape of the support ring 453 is adapted to the outer shape of the sealing cone 452.

[0045] Two sets of positioning imaging rings 422 are provided on the outside of the double-lumen catheter 1. The positioning imaging rings 422 realize the visualization positioning of the catheter body. Under the imaging equipment, the insertion depth of the catheter and the position of the anti-backflow mechanism 4 are clearly displayed, ensuring that the catheter is accurately inserted into the target position. The two sets of positioning imaging rings 422 are respectively set on the outside of the gas storage ring 421 and at the distal infusion port.

[0046] Working principle: The double-lumen catheter 1 is inserted into the patient's body through the nasal cavity. External fixation of the catheter is achieved through the nasal fixation flap 3 on the outer side of the double-lumen catheter 1. Using the imaging effect of the two sets of positioning imaging rings 422 on the outer side of the double-lumen catheter 1, the insertion depth of the catheter is adjusted, and the anti-reflux mechanism 4 on the double-lumen catheter 1 is precisely positioned at the junction of the gastric fundus and the upper part of the gastric body. Simultaneously, it is confirmed that the distal infusion port of the catheter has reached the target infusion position, completing the internal positioning and external fixation of the entire conduit, ensuring the inner tube 10 of the double-lumen catheter 1 is securely in place. 1. The cavity corresponding to the outer tube 102 is kept in an initial unobstructed state. All Luer connectors 2 are in a closed state. The drive component 41, feedback component 42, warning component 43, outer sealing component 44 and inner plug component 45 of the anti-backflow mechanism 4 are all in the initial standby position. At this time, the green light wire in the dual-color wire 432 is engaged with one of the conductive forks 426. The current is transmitted through the green light wire in the closed dual-color wire 432 to the lamp tube 434 outside the buried wire plate 431, so that the lamp tube 434 is energized and lit up and displays a green light.

[0047] According to clinical operation requirements, select the corresponding Luer connector 2 for docking operation. The three Luer connectors 2 are the main infusion Luer connector 2, the sampling Luer connector 2, and the flushing Luer connector 2. When performing the corresponding operation, first open the silicone end cap 203 of the selected Luer connector 2, and dock the corresponding operation device with the nutrient solution input interface 201 of the Luer connector 2. Complete the docking and locking of the device and the interface through the threaded lock 202 on the outer side of the interface end. During the docking process, the device pipeline pushes open the duckbill valve 204 at the output end of the nutrient solution input interface 201, so that the channel of the operation device is connected with the corresponding cavity of the double lumen catheter 1. After docking the sampling Luer connector 2, the sampling channel is connected with the cavity between the outer tube 102 and the inner tube 101. After docking the flushing Luer connector 2, the flushing channel is connected to the cavity between the outer tube 102 and the inner tube 101 and the main input channel in the inner tube 101. After docking the main infusion Luer connector 2, the infusion channel is connected with the main input channel in the inner tube 101, completing the channel preparation work for the corresponding operation.

[0048] After completing the connection and channel preparation of the main infusion Luer connector 2, the enteral nutrition infusion device is started. The nutrient solution enters the main input channel of the inner tube 101 through the main infusion Luer connector 2, and is continuously delivered along the lumen of the inner tube 101 to the distal end of the catheter. Finally, it enters the patient's intestine through the infusion port at the distal end of the catheter, completing the infusion supply of enteral nutrition. During this process, the one-way valve between the ends of the inner tube 101 and the outer tube 102 maintains a fixed flow direction restriction, allowing only the medium in the inner tube 101 to flow to the space between the outer tube 102 and the inner tube 101. The cavity and reverse flow of the medium are blocked by the one-way valve. At the same time, all components of the anti-backflow mechanism 4 are in the initial standby state. The sensing ring 411 is in the initial position outside the outer tube 102, the pressure ring 414 is in the initial position inside the gas storage ring 421, the piston 423 is in the initial position inside the active channel, the inflation bladder 441 is in the uninflated contracted state, the magnetic ring 451 and the sealing cone 452 are in the position away from the support ring 453, and the main input channel of the inner tube 101 remains completely unobstructed, ensuring the continuous and normal infusion of nutrient solution.

[0049] When the patient's gastric pressure rises abnormally and exceeds the set trigger threshold, the increased gastric pressure directly acts on the pressure sensing membrane 412 inside the sensing ring 411 of the drive component 41. The pressure sensing membrane 412 deforms under pressure, causing the sensing ring 411 to slide downward along the outer side of the outer tube 102. During the sliding process of the sensing ring 411, multiple transmission rods 413 fixedly connected to its bottom drive the pressure ring 414 to slide downward synchronously along the inside of the gas storage ring 421. When the pressure ring 414 slides downward, it compresses the sealed gas inside the gas storage ring 421, causing the gas pressure inside the gas storage ring 421 to rise synchronously. At the same time, multiple magnetic blocks 415 inside the pressure ring 414 move downward synchronously with the pressure ring 414, completing the triggering of the overall action of the anti-reflux mechanism 4, and providing corresponding power and trigger signals for subsequent anti-reflux blocking and early warning actions.

[0050] As the pressure inside the gas storage ring 421 continues to rise due to the compression action of the pressure ring 414, the high-pressure gas inside the gas storage ring 421 enters the air bladder 441 of the outer sealing member 44 quickly through the gas channel between the gas storage ring 421 and the air bladder 441, causing the air bladder 441 to quickly inflate. During the inflation process of the air bladder 441, the sealing wing 442 on its outer side expands outward synchronously. After expansion, the sealing wing 442 fits tightly against the patient's stomach wall, forming an outer sealing structure at the junction of the gastric fundus and the upper part of the gastric body, blocking the reflux channel of high-pressure contents in the stomach towards the esophagus, and completing the outer sealing action to prevent reflux.

[0051] As the internal pressure of the gas storage ring 421 increases, high-pressure gas simultaneously enters the movable channel between the gas storage ring 421 and the outer tube 102, pushing the piston 423 in the movable channel to slide inward along the channel. During the sliding process of the piston 423, the isolation ring 424 at its end moves synchronously. The isolation ring 424 drives the conductive fork 426 at its end to move, thereby causing the green light circuit in the dual-color wire 432 to disconnect from the conductive fork 426, while the red light circuit connects to another conductive fork 426. This causes the entire light strip to switch from a green light circuit to a red light circuit, thus displaying a red warning state and completing the triggering and visual prompting of the backflow warning signal.

[0052] As the pressure ring 414 moves the magnetic block 415 downward, the magnetic attraction of the magnetic block 415 acts synchronously on the magnetic ring 451 inside the inner tube 101, causing the magnetic ring 451 to slide downward along the inner side of the inner tube 101. During the sliding of the magnetic ring 451, the sealing cone 452 fixedly connected in its middle moves downward synchronously, causing the sealing cone 452 to continuously approach the support ring 453. When the sealing cone 452 moves to the set sealing position, the outer cone surface of the sealing cone 452 completely fits the inner mating surface of the support ring 453, completely sealing the main input channel of the inner tube 101 and blocking the infusion channel of the nutrient solution. At the same time, in conjunction with the one-way valve between the inner tube 101 and the outer tube 102, it prevents the high-pressure contents in the stomach from flowing back into the infusion device outside the body through the infusion channel, thus completing the internal channel sealing action to prevent backflow.

[0053] During the device reset phase after pressure recovery, when the abnormal pressure in the patient's stomach decreases and returns to the normal pressure range, the pressure acting on the pressure sensing membrane 412 disappears. The sensing ring 411, transmission rod 413, and pressure ring 414 slide upwards and reset under the pressure of the gas inside the gas storage ring 421, returning to their initial standby position. After the pressure ring 414 resets, the gas pressure inside the gas storage ring 421 returns to its initial state. The gas inside the inflation bladder 441 flows back into the gas storage ring 421 through the gas channel. The inflation bladder 441 and the sealing wing 442 contract and reset synchronously, releasing the outer sealing structure inside the stomach. Simultaneously, the piston 42 in the moving channel... 3. As the air pressure decreases, the device returns to its initial position, causing the isolation ring 424, isolation post 425, and conductive fork 426 to reset synchronously. The red light conductive circuit of the dual-color wire 432 is disconnected, while the green light conductive circuit is open, causing the lamp tube 434 to switch to the green light state and canceling the backflow warning. At the same time, the magnetic block 415 resets synchronously with the pressure ring 414, and the magnetic attraction to the magnetic ring 451 disappears. The magnetic ring 451 and the sealing cone 452 return to their initial positions, and the sealing cone 452 separates from the support ring 453. The main input channel of the inner tube 101 is restored to unobstructed flow, and the entire device returns to its initial standby state, ready to continue normal enteral nutrition infusion operations.

[0054] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention. In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0055] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," "setting," and "forming" should be interpreted broadly; for example, they can refer to fixed connections or settings, detachable connections or settings, or integrated structures; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium, or internal connections between two components; those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0056] In the description of this invention, references to terms such as “embodiment,” “specific example,” or “practical application” indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment or example of the invention; the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example, and the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0057] The above embodiments are only used to illustrate the technical solutions of the present invention. Those skilled in the art should understand that the above embodiments do not limit the present invention in any way. All technical solutions obtained by equivalent substitution or equivalent transformation fall within the protection scope of the present invention.

Claims

1. A reflux-preventing enteral nutrition infusion pipeline and early warning mechanism, comprising a double-lumen catheter (1), characterized in that: The end of the double-lumen catheter (1) is provided with multiple Luer connectors (2), the outside of the double-lumen catheter (1) is provided with a nasal fixing wing (3), and the double-lumen catheter (1) is provided with an anti-reflux mechanism (4) at the junction of the gastric fundus and the upper part of the gastric body. The double-lumen conduit (1) includes an outer tube (102) and an inner tube (101). A one-way valve is provided between the ends of the outer tube (102) and the inner tube (101), and the direction is set so that the inner tube (101) flows to the outer tube (102). The anti-backflow mechanism (4) includes a drive component (41), a feedback component (42), an early warning component (43), an outer sealing component (44), and an inner plug component (45). The feedback device (42) includes a gas storage ring (421) fixedly connected to the outside of the double-lumen conduit (1). An active channel is provided between the gas storage ring (421) and the outer tube (102). An isolation ring (424) is fixedly connected inside the active channel. A piston (423) is slidably connected inside the active channel. One end of the piston (423) is fixedly connected to the isolation ring (424). The isolation ring (424) is slidably connected inside the buried wire plate (431). An isolation post (425) is fixedly connected to the inner side of the isolation ring (424). A conductive fork (426) is fixedly connected to the other end of the isolation post (425).

2. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 1, characterized in that: The driving component (41) includes a sensing ring (411) slidably connected to the outside of the outer tube (102). Multiple pressure sensing membranes (412) are provided inside the sensing ring (411). Multiple transmission rods (413) are fixedly connected to the bottom of the sensing ring (411). A pressure ring (414) is fixedly connected to the bottom of the transmission rod (413) and is slidably connected to the inside of the gas storage ring (421). Multiple magnetic blocks (415) are provided on the inner side of the pressure ring (414).

3. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 1, characterized in that: The warning device (43) includes a buried wire plate (431) installed inside the outer tube (102) and the inner tube (101). The buried wire plate (431) is equipped with a two-color wire (432). The section of the two-color wire (432) inside the isolation ring (424) is disconnected and a metal connector (433) is provided at the disconnection point. A lamp tube (434) is installed on the outside of the buried wire plate (431) and the lamp tube (434) is electrically connected to the two-color wire (432).

4. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 1, characterized in that: The outer sealing element (44) includes an inflatable bladder (441) disposed outside the air storage ring (421), a gas channel is provided between the inflatable bladder (441) and the air storage ring (421), and a sealing wing (442) is provided on the outside of the inflatable bladder (441).

5. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 2, characterized in that: The inner plug (45) includes a magnetic ring (451) slidably connected to the inner side of the inner tube (101). The magnetism of the magnetic ring (451) attracts the magnetism of the magnetic block (415). A sealing cone (452) is fixedly connected to the middle of the magnetic ring (451). A support ring (453) is also fixedly connected to the inner side of the inner tube (101), and the inner shape of the support ring (453) is adapted to the outer shape of the sealing cone (452).

6. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 1, characterized in that: The number of Luer connectors (2) is three, namely, main infusion Luer connector (2), sampling Luer connector (2) and flushing Luer connector (2). The end of the sampling Luer connector (2) is connected to the cavity between the outer tube (102) and the inner tube (101). The end of the flushing Luer connector (2) is connected to the cavity between the outer tube (102) and the inner tube (101) and the main input channel in the inner tube (101).

7. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 1, characterized in that: The Luer connector (2) includes a nutrient solution input interface (201), and the front end of the nutrient solution input interface (201) is conical, with a threaded lock (202) on the outer side of the end, and a silicone cap (203) on the top of the nutrient solution input interface (201), and a duckbill valve (204) on the output end of the nutrient solution input interface (201).

8. The anti-reflux enteral nutrition infusion pipeline and early warning mechanism according to claim 1, characterized in that: The double-lumen catheter (1) is provided with two sets of positioning imaging rings (422) on the outside. The two sets of positioning imaging rings (422) are respectively located on the outside of the gas storage ring (421) and at the distal infusion port.

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