An enteral feeding infusion flow rate monitor with automatic tube flushing

Abstract

This invention relates to an enteral nutrition infusion flow rate monitor with an automatic flushing tube, comprising at least: a monitoring module for real-time monitoring of gastric antrum parameters; and a flow rate control component for graded adjustment of the enteral nutrition infusion flow rate. The flow rate monitor also includes a control mechanism, the flow rate control component and the monitoring module being electrically connected to the control mechanism. The control mechanism is capable of controlling the flow rate control component to adjust the enteral nutrition infusion flow rate based at least on the cross-sectional area of ​​the gastric antrum monitored by the monitoring module.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an enteral nutrition infusion flow rate monitor with an automatic flushing tube. Background Technology

[0002] Enteral nutrition refers to a nutritional support method that provides metabolically necessary nutrients and other nutrients through the gastrointestinal tract. Nutritional therapy is the material basis for patient recovery. Enteral nutrition provides patients with the daily required nutrients such as protein, lipids, carbohydrates, vitamins, minerals, trace elements, and dietary fiber in the most physiological way, providing comprehensive and balanced nutritional and energy support, protecting intestinal function, and promoting patient recovery.

[0003] When choosing the type of enteral nutrition, factors such as the continuity of the patient's gastrointestinal anatomy, the integrity of its function, the expected duration of enteral nutrition administration, and the possibility of aspiration need to be considered. Enteral nutrition can be categorized into oral nutritional supplementation and tube feeding based on the type of infusion. Oral nutritional supplementation is the preferred method of enteral nutrition, suitable for those who can eat orally but whose intake is insufficient. It is also the safest, most economical, and physiologically sound method of enteral nutrition support. When patients have nutritional risks / malnutrition, supplementing their diet with oral nutritional supplements can improve their nutritional status without affecting their food intake. Oral nutritional supplements can reduce nutritional risks and postoperative complications in bedridden patients. Oral nutritional supplements with higher protein content can reduce the risk of pressure ulcers.

[0004] If oral nutrition supplementation is insufficient or persistently inadequate, tube feeding should be considered. The advantage of tube feeding is that it ensures a uniform infusion of nutrients, fully utilizing the digestive and absorptive functions of the gastrointestinal tract. Common tube feeding routes include nasogastric tubes and tubes inserted through a gastrostomy.

[0005] Existing technology, such as patent document CN104721949B, discloses a closed-loop intelligent enteral nutrition infusion system based on small intestinal lumen pressure. This system includes an enteral nutrition solution infusion tube, an intestinal lumen pressure measuring tube, a nutrient solution infusion pump, and an intestinal lumen pressure signal processing system. The lower port of the intestinal lumen pressure measuring tube is equipped with a pressure sensor. The nutrient solution infusion pump infuses enteral nutrition solution through the upper port of the enteral nutrition solution infusion tube. The intestinal lumen pressure signal processing system processes the intestinal lumen pressure signal collected by the pressure sensor and transmits the processing result to a flow control module. The flow control module adaptively controls the nutrient solution infusion pump based on the processing result and the actual flow rate of the nutrient solution fed back by the flow feedback module.

[0006] Chinese patent CN204593825U discloses an enteral nutrition heating and insulation device, comprising a heating bag for heating enteral nutrition solution bags and an insulation sleeve for wrapping the enteral nutrition pump tubing. The heating bag has an adjustable-size infusion tube connector channel to accommodate various enteral nutrition solution bags. An electric heating wire is coiled inside the outer wall of the heating bag, with the wire extending out to form a plug for connecting to a power source. This enteral nutrition heating and insulation device consists of two parts: a heating bag and an insulation sleeve. The adjustable-size infusion tube connector channel inside the heating bag accommodates different enteral nutrition solution bags. In use, the enteral nutrition solution bag is placed into the infusion tube connector channel of the heating bag. The enteral nutrition pump tubing, extending from the bottom of the bag, passes through the insulation sleeve. The enteral nutrition solution is heated inside the heating bag and then drawn out through the infusion tube. This design keeps the heating bag away from the patient to prevent burns, and the insulation sleeve prevents the heated enteral nutrition solution from cooling down.

[0007] The aforementioned technologies propose regulating the infusion rate of enteral nutrition solutions based on intestinal pressure, particularly using a pressure signal processing system to control the infusion rate and thus avoid intolerance symptoms such as nausea, vomiting, abdominal distension, and diarrhea. However, methods that rely on measuring pressure to indicate the likelihood of feeding intolerance often fail to provide timely and effective assessments of tolerance. Different populations exhibit varying pressure levels corresponding to different levels of tolerance, and the factors influencing intestinal pressure changes are complex. For example, external pressure or gases produced during digestion can alter intestinal pressure. Therefore, there is an urgent need for an effective method for controlling enteral nutrition infusion to prevent feeding intolerance.

[0008] Furthermore, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the inventors studied a large number of documents and patents when making this invention, but due to space limitations, not all details and contents were listed in detail. However, this does not mean that the present invention does not possess the features of these prior art. On the contrary, the present invention already possesses all the features of the prior art, and the applicant reserves the right to add relevant prior art to the background art. Summary of the Invention

[0009] To address at least some of the shortcomings of the prior art, this application provides an enteral nutrition infusion rate monitoring device with an automatic flushing tube, comprising at least: a first monitoring module for real-time monitoring of gastric antrum parameters; and a flow rate control component for graded adjustment of the enteral nutrition infusion rate. The flow rate monitoring device also includes a control mechanism, with the flow rate control component and monitoring module electrically connected to the control mechanism. The control mechanism is capable of adjusting the enteral nutrition infusion rate based on the gastric antrum cross-sectional area monitored by the monitoring module. This invention can adjust the nutrient solution infusion rate based on the gastric antrum cross-sectional area measured by the first monitoring module to reduce the probability of feeding intolerance. Furthermore, the electrical connection between the monitoring and control devices results in high control efficiency. When an abnormal gastric antrum area is detected, the nutrient solution infusion rate can be automatically adjusted immediately according to pre-programmed parameters, reducing the time lost during manual detection, judgment, and adjustment.

[0010] Preferably, the device further includes an infusion tube connector for connection to the infusion tube input end. The infusion tube connector is a cylindrical structure with an internal channel. The blades of the flow rate control component are disposed inside the internal channel of the infusion tube connector. The blades can rotate under the drive of the drive end to change the area projected onto the axial direction of the internal channel of the infusion tube connector. This invention controls the flow rate of the nutrient solution flowing through the tube by changing the area projected onto the internal channel of the infusion tube connector. The drive end, partially disposed outside the infusion tube connector, controls the state of the blades, avoiding contamination of the nutrient solution during infusion caused by directly adjusting the blades.

[0011] Preferably, the drive end is electrically connected to the control unit. The drive end, in response to an electrical signal from the control mechanism, adjusts the state of the blades within the infusion pipe connector based on its own rotation angle to adjust the infusion rate of the nutrient solution flowing through the infusion pipe connector. Connecting the drive end to the control circuit electrically allows for more precise rotation of the drive end to change the state of the blades, reducing errors caused by manual adjustment.

[0012] Preferably, the control mechanism includes at least a processor, a timing component, and a storage device. The processor, timing component, and storage device are electrically connected via a printed circuit board. The storage device can provide the flow rate monitor with data processed by the processor to guide the control process of the control mechanism. This invention can store all electronic operating information and use it to guide subsequent infusion parameter control. It can also pre-program the processor to control nutrient solution infusion parameters, enabling the invention to automatically control infusion parameters and reduce the workload of the user.

[0013] Preferably, the flow rate monitor further includes a metering component for measuring the infusion volume of the nutrient solution. The metering component is electrically connected to a control mechanism, which can determine the infusion rate of the nutrient solution based on the infusion volume and time data from the timing component. This invention can control the nutrient solution flow to a pre-set flow rate when controlling the infusion rate based on the cross-sectional area of ​​the gastric antrum measured by the first monitoring module.

[0014] Preferably, the flow rate monitor further includes a second monitoring module electrically connected to the control mechanism. The second monitoring module monitors the digestive state of the intestine and transmits corresponding electrical signals to the control module. The control module, based on the electrical signals, controls the flow rate control component to adjust the infusion rate of the nutrient solution so that the intestine remains in a state of partial saturation. This invention can adjust the infusion rate to be lower than the digestive rate after detection, keeping the intestine in a semi-starved state to maintain digestive activity and reduce digestive function damage caused by prolonged enteral nutrition infusion rates.

[0015] Preferably, the flow rate monitor further includes a flow rate monitor housing, which comprises a first half-shell and a second half-shell that can be joined to form a shellfish-like structure. The first and second half-shells are hinged along their edges so that the flow rate monitor housing can be rotated open or closed along the edges. An infusion tube connector extends orthogonally from the base of the second half-shell, and the internal channel of the infusion tube connector communicates with the internal space of the flow rate monitor housing. When not in use, the entire invention can be closed to a sealed shell shape, thus preventing contamination of the intestinal environment and the internal environment of the flow rate monitor from external environmental pollution. Furthermore, the infusion tube connector can cooperate to connect the flow rate monitor housing to the infusion tube and maintain a fixed connection. The connector maintains an interference-sealed connection based on its own structure, reducing contamination during feeding.

[0016] Preferably, when the flow rate monitor housing is in the closed position, a plug is provided at the position of the corresponding channel of the infusion tube connector in the first half-shell. The plug can be inserted into the channel of the infusion tube connector and form an interference seal with the channel when the first half-shell is in the closed position. This invention prevents intestinal fluid from flowing back along the infusion tube by providing a plug at the input end of the infusion tube when no nutrient solution is being infused. This allows the invention to be semi-permanently attached to the infusion tube and further prevents contamination inside the feeding tube.

[0017] Preferably, the first half-shell is a sealed structure with an internal cavity for housing a control mechanism that controls electronic operation. The outer surface of the first half-shell also has a user input device capable of pre-programming and changing control parameters of the control mechanism. The user input device is electrically connected to the control mechanism. This invention introduces a user input device to pre-set or adjust infusion parameters, ensuring that the infusion parameters can be individually controlled, greatly increasing the applicability of the invention.

[0018] Preferably, the flow rate monitor also includes a display electrically connected to the control mechanism, which can output the physical parameters of the nutrient solution during infusion in a visual manner.

[0019] The present invention has at least the following advantages:

[0020] (1) The present invention combines the change of gastric antrum cross-sectional area to indicate the graded control of nutrient solution infusion rate, which greatly reduces enteral feeding intolerance caused by nutrient solution infusion rate.

[0021] (2) The present invention introduces a second monitoring module to detect the digestion rate of different patients and then indicates that the infusion rate of the nutrient solution is adjusted to the state of unsaturated digestion in the intestine, thereby ensuring that the patient's autonomous digestive function will not be weakened due to long-term enteral nutrition infusion.

[0022] (3) By setting a plug at the infusion tube input end, the present invention can prevent intestinal fluid from flowing back along the infusion tube when no nutrient solution is being infused, so that the present invention does not require frequent plugging and disassembling.

[0023] (4) By setting up a variety of monitoring devices and displays, the present invention displays the infusion parameters of the nutrient solution in a visual manner, which makes it easy to understand the various parameters of the nutrient solution intuitively;

[0024] (5) The present invention is equipped with an alarm device, which can issue a warning to the outside world in the form of sound and light alarm when the actual infusion parameters deviate from the preset infusion parameters. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the main structure of the present invention;

[0026] Figure 2 This is a schematic diagram of the connections between the various electronic components of the present invention.

[0027] List of reference numerals

[0028] 11: First monitoring module; 12: Second monitoring module; 13: Flow rate monitor housing; 19: Hinge; 15: First half-shell; 17: Second half-shell; 21: First radial lug; 23: First bottom surface; 25: First groove; 27: First circumferential wall; 28: Locking port; 29: Infusion pipe connector; 31: First flange protrusion; 32: Second flange protrusion; 33: Infusion pipe connector inner channel; 35: Liquid inlet; 37: Liquid outlet; 39: Second radial lug; 41: Second bottom surface; 43: Second circumferential wall; 45: Plug; 47: Locking tongue; 63: Control mechanism; 65: Processor; 67: Timing component; 69: Storage component; 71: Metering component; 73: Pressure sensor; 75: Display component; 66: Flow rate control component; 77: User input component; 79: Alarm component; 81: Temperature measurement component. Detailed Implementation

[0029] The present invention will now be described in detail with reference to the accompanying drawings.

[0030] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] In the description of this invention, it should be understood that if terms such as "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, it is only for the convenience of describing this invention and simplifying the description, and does 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, and therefore should not be construed as a limitation of this invention.

[0032] Figure 1 A schematic diagram of the main structure of the enteral nutrition infusion flow monitor with an automatic flushing tubing is shown. For ease of description, the term "flow monitor" will be used to refer to the enteral nutrition infusion flow monitor with an automatic flushing tubing in the following text. The output of the flow monitor can be directly connected to the enteral infusion tubing.

[0033] The flow rate monitor includes a flow rate monitor housing 13. The flow rate monitor housing 13 has a shell-like structure. The flow rate monitor housing 13 includes a first half-shell 15 and a second half-shell 17 that are pivotally connected via a hinge 19, and the first half-shell 15 and the second half-shell 17 can be rotated open or closed about the hinge 19. The second half-shell 17 is a one-piece structure. Preferably, the second half-shell 17 can be manufactured using conventional injection molding technology.

[0034] The second half-shell 17 includes a first radial lug 21 located radially outward and a first bottom surface 23 defined by the first radial lug 21. The first radial lug 21 is a cylindrical structure with both ends connected, and the cross-section of the first radial lug 21 in at least the horizontal direction is quasi-annular, with at least a portion of the annular protrusion of the first radial lug 21 for hinged connection with the first half-shell 15. Preferably, the first radial lug 21 and the first bottom surface 23 are integrally formed.

[0035] The first bottom surface 23 and the inner annular wall of the first radial lug 21 form a first groove 25. A first circumferential wall 27 is also formed around the first groove 25. A locking opening 28 that does not completely penetrate the outer wall is provided on the periphery of the first circumferential wall 27. The locking opening 28 is used to lockably hold the first half-shell 15 in its closed position, that is, to hold it in the connected closed position with the second half-shell 17, which will be described in further detail below.

[0036] According to a preferred embodiment, the flow rate monitor further includes a cylindrical infusion tube connector 29, which is used to connect the internal space of the flow rate monitor to a conduit for transporting enteral nutrition solution. Figure 1The infusion tube connector 29 extends orthogonally from the first bottom surface 23. The infusion tube connector 29 is sized and shaped to allow insertion into the open end of a silicone tube (e.g., the proximal end of an implanted gastrostomy feeding tube or the input end of a Y-port). Preferably, the infusion tube connector 29 includes outwardly projecting first flange protrusions 31 and second flange protrusions 32 spaced along its length. The first flange protrusions 31 and second flange protrusions 32 are identical in shape, both being inverted conical structures with a continuously increasing cross-sectional area from the infusion tube connector 29 to the end connecting with the first bottom surface 23. The first flange protrusions 31 and second flange protrusions 32 allow the infusion tube connector 29 to be inserted into the inner surface of the silicone tube and held in this position. In this way, the first flange protrusions 31 and second flange protrusions 32 can secure the infusion tube connector 29 of the flow monitor within the silicone tube. The infusion tube connector 29 is a cylindrical body with an internal cylindrical infusion tube connector channel 33. The infusion tube connector internal channel 33 extends through the first half-shell 15 along the axis of the infusion tube connector 29 to form a liquid inlet 35 and a liquid outlet 37. The infusion tube connector internal channel 33 is used to connect the first groove 25 to the silicone tube connected during use to transfer nutrient solution.

[0037] According to a preferred embodiment, at least a portion of the infusion pipe connector 29, excluding the locations of the first flange protrusion 31 and the second flange protrusion 32, is configured as a flow rate control assembly 66. The flow rate control assembly 66 includes a valve body. A sealing sleeve is provided inside the valve body. A butterfly plate is installed inside the sealing sleeve. Mounting holes are provided on the butterfly plate, the sealing sleeve, and the valve body. A valve stem is inserted into the mounting holes. The bottom end of the valve stem is a fixed end, and the top end of the valve stem is a power transmission end. The butterfly plate includes a plate frame and a plate core. The plate frame and the plate core are arranged coaxially, and multiple angle-adjustable blades are provided between the plate frame and the plate core. The blades are evenly distributed in a circular array with the central axis of the plate core as the center line. In use, the angle of the blades can be adjusted by simply rotating the power end, thereby controlling the flow rate of the nutrient solution. See CN205978496U for details. Preferably, the power transmission end can be an electric transmission end, which is electrically connected to the control mechanism 63 so that the flow rate control component 66 can control the infusion flow rate of the nutrient solution under the instruction of the control mechanism.

[0038] According to a preferred embodiment, the first half-shell 15 is preferably an integral component manufactured using conventional injection molding techniques. The structure of the first half-shell 15 is similar to that of the second half-shell 17. The first half-shell 15 includes a generally flat second radial lug 39 and a generally flat second bottom surface 41. A second circumferential wall 43 protrudes from the second bottom surface 41. As the first half-shell 15 pivots to its closed position, the protruding second circumferential wall 43 can be nested within the first groove 25. The periphery of the second circumferential wall 43 frictionally engages with the inner surface of the first circumferential wall 27. The friction between the second circumferential wall 43 and the first circumferential wall 27 allows the first half-shell 15 to remain closed until a large force is applied when the connection between the first half-shell 15 and the second half-shell 17 is in the closed position. A plug 45 protrudes vertically from the second bottom surface 41. As the first half-shell 15 pivots to the closed position, the plug 45 is interference-fitted into the infusion tube connector inner channel 33, and the plug 45 can achieve a sealing fit with the infusion tube connector inner channel 33. With the first half-shell 15 pivotally closed, gastric or intestinal contents from the patient's body cannot flow out through the silicone tube from the infusion tube connector channel 33.

[0039] According to a preferred embodiment, the first half-shell 15 is provided with a latch 47 for releasably securing the first half-shell 15 in its closed position. The latch 47 is sized to protrude into a locking slot 28 in the second half-shell 17 when the first half-shell 15 is in the closed position, so that the first half-shell 15 and the second half-shell 17 are held in the closed position by the latch 47 and the locking slot 28. When it is necessary to open the first half-shell 15 and the second half-shell 17, simply pressing the edge of the first half-shell 15 above the latch 47 unlocks the latch 47 from the locking slot 28, thereby adjusting the first half-shell 15 to the open position.

[0040] According to a preferred embodiment, the first half-shell 15 is a sealed structure with an internal enclosed cavity, the size and shape of which are suitable for accommodating a control mechanism 63 responsible for managing all electronic operations of the flow rate monitor. The control mechanism 63 includes a processor 65, a timing component 67, and a storage component 69. The processor 65, timing component 67, and storage component 69 are electrically connected via a common printed circuit board (not shown). The processor 65 is an application-specific integrated circuit (ASIC) that serves as the central processing unit of the flow rate monitor. Specifically, the processor 65 is responsible for monitoring the main operations required by the flow rate monitor during use, such as calculations and task management. The timing component 67 is electrically connected to the processor 65 and provides the flow rate monitor with time monitoring capabilities. Specifically, the timing component 67 can be used to obtain feeding times or plan the interval between feedings. The storage component 69 is electrically connected to the processor 65 and provides the flow rate monitor with the ability to retain data processed by the processor 65, which can be used for later retrieval. Preferably, the processed data can be stored in a database for later comparison and retrieval or to provide instructions for subsequent operations. The metering component 71 is electrically connected to the control mechanism 63 and provides the flow monitor with the ability to monitor the amount of fluid delivered to the patient at the final end. The metering component 71 is preferably in the form of a metal disc or plastic sheet, which is fixedly connected to the second half-shell 17 within the infusion tube connector inner channel 33. The metering component 71 preferably includes a pressure-sensitive material disposed on the inner wall of the infusion tube connector inner channel 33, its size limited to allow placement within the infusion tube connector inner channel 33. The pressure-sensitive material is electrically connected to the control mechanism 63 such that fluid passing through the infusion tube connector inner channel 33 is sequentially detected by the pressure-sensitive resistor of the metering component 71. In response to detecting fluid passing through the infusion tube connector inner channel 33, the metering component 71 can transmit an electrical signal to the control mechanism 63, which determines the dispensing volume of fluid and its final delivery to the patient—a crucial aspect of enteral nutrition infusion. Preferably, the control mechanism 63 can derive the fluid delivery rate from the data of the metering component 71 combined with the timing component 67 to guide the user in controlling the fluid flow rate. The pressure sensor 73 is electrically connected to the control mechanism 63 and provides the flow rate monitor with the ability to determine whether the first half-shell 15 is in the closed position. Specifically, the pressure sensor 73 can provide an electrical signal to the control mechanism 63 to indicate the start (first half-shell 15 in the open position) or end (first half-shell 15 in the closed position) of a specific feed cycle. The pressure sensor 72 is preferably in the form of a pressure-sensitive material. The pressure sensor is disposed on at least a portion of the circumference of the second circumferential wall 43, a position that ensures the pressure sensor can only be contacted when the first half-shell 15 is in the closed position.Only when the first half-shell 15 is closed does the pressure-sensitive material of the pressure sensor 72 contact the inner wall of the first circumferential wall 27 to transmit the electrical signal indicating that the flow rate monitor is in the closed state to the control mechanism 63. Furthermore, the pressure sensor can also be mounted on the first radial lug 21 of the second half-shell 17 or on the second bottom surface 41 of the first half-shell 15. The display assembly 75 is electrically connected to the control mechanism 63 and presents the relevant data collected in the storage device in a visual manner. The display assembly 75 is referred to herein as an LED liquid crystal display capable of displaying numerical and / or alphanumeric characters. Preferably, the display assembly 75 is designed to provide a running digital counter (e.g., a type common in digital watches or digital stopwatches) capable of displaying the elapsed time. The display assembly 75 is mounted within the first half-shell 17 in such a way that it is aligned within a transparent window formed in the second radial lug 39, making the display assembly 75 externally visible. At least two user input components 77 are mounted in the first half-shell 15, each user input component 77 at least partially protruding into and positioned through a corresponding opening formed in the second radial lug 39. Each user input component 77 is referred herein as an externally accessible control button for primary operation of the flow monitor. Specifically, pressing each user input component 77 closes a corresponding disconnect switch in a control mechanism 63, which in turn transmits an electrical signal to a processor 65. In this way, the user input component 77 can be used to start / stop the timing component, reset the timing component, and / or scroll through the operation menu that can be performed by the flow monitor. An alarm component 79 is electrically connected to the control mechanism 63. The alarm component 79 represents any visual or auditory indicator that can be activated by the control mechanism 63. In this case, if there is a deviation from the written feeding plan (e.g., the patient's nutrient solution is used up or the feeding cycle exceeds a preset time threshold), the control mechanism 63 can control the alarm component 79 to sound an alarm. The temperature measuring component 81 is disposed inside the infusion tube connector 29 and electrically connected to the control mechanism 63. It displays the temperature of the nutrient solution fluid visually on the display component 75. In this way, the temperature measuring component 81 can be used to measure the fluid temperature to indicate the control of the nutrient solution fluid temperature. Preferably, when the control mechanism 63 receives a zero flow rate from the metering component 71 while the first half-shell 15 and the second half-shell 17 are open, indicating that the nutrient solution fluid delivery is complete, the control mechanism 63 controls the alarm component 79 to issue an alarm signal to remind that the nutrient solution infusion is complete. Simultaneously, the control mechanism 63 sends an electrical signal to the flow rate control component 66 to adjust the blades to the closed position. Preferably, the user input component 77 is also used to input the patient's gastric antrum cross-sectional area to match the infusion flow rate level during feeding, i.e., matching the patient's gastric antrum cross-sectional area according to a preset flow rate gradient level to control the infusion rate, which will be described in further detail below.

[0041] According to a preferred embodiment, the flow rate monitor further includes a first monitoring module 11 for real-time measurement of gastric antrum parameters. In this document, the first monitoring module 11 can be a bedside ultrasound measurement device. The patient is in a semi-recumbent position (upper body elevated 30°), and the ultrasound probe is placed in the midline of the upper abdomen below the xiphoid process. The monitoring module obtains the gastric antrum cross-sectional area using the superior mesenteric vein, abdominal aorta, and left lobe of the liver as landmarks. The first monitoring module 11 is electrically connected to a control mechanism 63 and transmits the gastric antrum cross-sectional area (CAS) to the control mechanism 63 in real time. The control mechanism 63 controls the flow rate control component 66 based on the gastric antrum cross-sectional area and its degree of change to adjust the nutrient solution infusion rate, thereby preventing feeding intolerance. The flow rate control component 66 can control the infusion rate to a gradient rate matching the corresponding gastric antrum cross-sectional area. The first monitoring module 11 detects that the gastric antrum cross-sectional area has not reached the minimum area of ​​7.0 cm² required for feeding intolerance. 2 When the difference between the minimum area and the control unit 63 exceeds 20%, a first signal is sent to the control unit 63. The control unit 63 controls the flow rate control component 66 to match the normal nutrient solution infusion rate. That is, at this time, the control module 63 determines that there is no situation where the nutrient solution infusion rate is too high, leading to intolerance, based on the pre-programmed gastric antrum cross-sectional area for feeding tolerance and the real-time gastric antrum cross-sectional area transmitted by the first monitoring module 11. Preferably, when the control module 63 determines that feeding intolerance will not occur, in order to reduce the intra-abdominal pressure of the patient, the flow rate control component 66 adjusts the normal nutrient solution infusion rate to 55 mL / h. Among them, when the first monitoring module 11 detects that the difference between the gastric antrum cross-sectional area and the minimum area for feeding intolerance is less than 20%, it sends different gradient electrical signals to the control unit 63 based on the data gradient of the percentage of the difference area to the minimum area. The data gradient can be divided into: first gradient (1%~3%), second gradient (4%~10%), and third gradient (11%~19%). When the control mechanism 63 receives different gradient electrical signals, it controls the flow rate control component 66 to map the corresponding nutrient solution infusion rate. The nutrient solution infusion rate, in conjunction with the data gradient, can be divided into: a first rate (50 mL / h), a second rate (45 mL / h), and a third rate (40 mL / h). The first, second, and third rates correspond to the angles between the blades in the flow rate control component and the axis of the channel 33 in the infusion tube connector, respectively. The first, second, and third angles increase sequentially, and the angles are greater than 0 degrees and less than 90 degrees. When the real-time gastric antrum cross-sectional area is greater than the preset minimum cross-sectional area of ​​7.0 cm²... 2When the control mechanism 63 determines that the patient is about to experience or has already experienced feeding intolerance, it will stop the infusion of nutrient solution and activate the alarm component 79 to issue an audible / visual alarm to prompt the user to take action. That is, as the patient's real-time gastric antrum cross-sectional area gradually increases, the flow rate monitor continuously adjusts and reduces the nutrient solution infusion rate to prevent feeding intolerance. The closer the real-time monitored gastric antrum cross-sectional area is to the minimum area, the higher the likelihood of feeding intolerance, thus requiring a reduction in the nutrient solution infusion rate to prevent it. When introducing the initial minimum area, the control mechanism 63 can also introduce adjustment parameters based on the patient's age via the user input component 77, so that the influence of different gastric antrum cross-sectional areas in patients of different ages can be eliminated when determining the minimum area for feeding intolerance and when calculating the minimum area. Preferably, the flow rate monitor can also input the gastric antrum cross-sectional area value into the control mechanism 63 via the user input component 77 to match the corresponding nutrient solution infusion rate.

[0042] According to a preferred embodiment, to prevent the intestinal digestive function from weakening due to prolonged digestion of saturated nutrient solution during long-term enteral nutrition infusion, the control mechanism 63 can adjust the infusion rate to be lower than the intestinal digestion rate, ensuring that the intestine remains in a state of incomplete digestion during the digestion of the nutrient solution, thereby maintaining the intestinal digestive capacity. Specifically, the second monitoring module 12 is used to visually display whether there is an accumulation of nutrient solution awaiting digestion during the nutrient solution infusion process, combined with multiple gradient reductions in the nutrient solution infusion rate to test the enteral nutrition digestion rate. That is, when the nutrient solution infusion rate is gradient reduced until the volume of nutrient solution in the intestine does not change, the enteral nutrition infusion rate is essentially the same as the intestinal digestion rate. The control mechanism 63 records the intestinal digestion rate and uses it to guide the subsequent enteral nutrition infusion rate. Having obtained the patient's enteral nutrition digestion rate through experiments, the control mechanism 63 infuses the nutrient solution at an infusion rate lower than the digestion rate, ensuring that the intestine remains in a state of incomplete digestion during the digestion and absorption of the nutrient solution, thereby maintaining the digestive activity of the intestine. An infusion rate lower than the digestion rate can be any value between 50% and 90% of the intestinal digestion rate. At this infusion rate, intestinal digestion remains in a state of incomplete saturation while ensuring basic nutrient intake.

[0043] According to a preferred embodiment, the control mechanism 63 preferably receives power from a power source 83 disposed within a first half-shell 15 on the flow monitor housing 13. The power source 83 may be in the form of one or more replaceable AA batteries, which are removably mounted in an associated battery compartment and accessible through a removable cover. Preferably, it is understood that any power source capable of providing a suitable direct current (DC) voltage can be used to power the control mechanism 63.

[0044] The flow monitor can be used to monitor the administration of enteral nutrition solution to an enteral nutrition infusion tube implanted in a patient in the following manner. Since the first half-shell 15 can be lockably positioned in its closed position, the flow monitor can be permanently connected to the proximal end of the opening of the enteral nutrition infusion tube implanted in the patient. By inserting the infusion tube connector 29 into the open end of the enteral nutrition infusion tube, the flow monitor is fixedly connected to the infusion tube via the first flange protrusion 31 and the second flange protrusion 32 on the infusion tube connector 29. With the infusion tube connector 29 inserted into the open end of the infusion tube, the longitudinal extension hole defined by the infusion tube directly communicates with the internal channel of the flow monitor's infusion tube connector. After connecting the flow monitor to the infusion tube in the above manner, the party responsible for administering enteral nutrition solution to the patient (hereinafter referred to as the administering party) can use the user input device to operate the control mechanism 63 to control the infusion time, infusion fluid volume, infusion rate, etc. In this way, the administering party can start an operational counter that indicates the time elapsed since the last feeding. Potentially, the control mechanism 63 can be programmed such that once the running counter reaches a specific value, the alarm component 79 will be activated to indicate that the next feeding cycle has been reached. Once the administerer determines that the feeding period has been reached, i.e., that enteral nutrition solution needs to be delivered to the patient immediately, the tab 57 of the actuating member 51 is pressed down, thereby unlocking the first half-shell 15 and the second half-shell 17. As the first half-shell 15 and the second half-shell 17 are unlocked, the first half-shell 15 pivots to its open position. Notably, once the first half-shell 15 is pivoted open, the pressure sensor 73 sends a signal to the control mechanism 63 indicating that the first half-shell 15 has been pivoted open. Nutritional solution can then be delivered into the enteral nutrition infusion tube through the channel 33 inside the infusion tube connector, and the monitoring device on the flow monitor will also monitor and control the infusion parameters of the nutritional solution in real time. To administer nutrient solution to a patient, an infusion device with a flow rate monitor is installed in the liquid inlet 35 of the infusion tubing connector channel 33. The nutrient solution fluid is then delivered into the infusion tubing through the infusion tubing connector channel using any conventional drip delivery technique (e.g., using a rotary peristaltic pump). As the fluid passes through the infusion tubing connector channel 33, the metering component 71 detects the fluid flow and, in response, transmits an electrical signal to the control mechanism 63. Preferably, the user presets the required fluid volume and rate of infusion using the input component 77. The control mechanism 63 records the infused fluid volume via the metering component 71 and controls the fluid flow rate via the flow rate control component 76 when the preset fluid volume is reached. In addition, the display component 75 visually displays the following types of data related to the fluid: the rate at which fluid is delivered to the patient, the cumulative fluid volume, the fluid temperature, and the fluid delivered to the patient (which can be manually or automatically reset after each feeding period) and / or the elapsed time of a specific feeding period.Preferably, data is provided on the display component 75 to assist the administrator in delivering fluid to the patient according to the doctor-prescribed guidelines. Furthermore, if historical analysis is required, the data is stored in the memory component 69. Additionally, the control mechanism 63 can be programmed to activate the alarm component 79 when any accumulated data deviates substantially from the doctor-prescribed guidelines. Once the feeding period ends, the administerer withdraws the adapter for the feeding device from the liquid inlet 35 of the infusion tube connector channel 33 and pivots the first half-shell 15 closed. As the first half-shell 15 is pivotally closed, the locking tongue 47 eventually extends into the locking port 28 to secure the first half-shell 15 in its closed position. With the first half-shell 15 pivotally closed, the plug 45 forms a sealing fit within the infusion tube connector channel 33. In this way, the plug 45 prevents unwanted substances from entering the patient through the implanted infusion tube. Simultaneously, the plug 45 also serves to prevent the patient's gastric contents from draining out through the liquid inlet 35 of the infusion tube connector channel 33. Preferably, the feeding adapter is further equipped with a flushing tube for flushing the infusion tube connector channel 33 and the infusion tube. The control mechanism 63 is electrically connected to the adapter. After the nutrient solution infusion in the adapter is completed, the flushing solution is switched to flush the infusion tube connector channel 33 and the infusion tube to prevent blockage of the infusion tube and the infusion tube connector channel 33 due to solidification of the remaining nutrient solution. Specifically, the control mechanism 63 is programmed to automatically switch to flushing solution to flush the infusion tube connector channel 33 and the remaining nutrient solution in the infusion tube if no response is received within 3 minutes of the feeding end alarm component 79 being activated. The flushing solution, such as physiological saline, should not have any effect on the human body.

[0045] It should be noted that the specific embodiments described above are exemplary, and those skilled in the art can devise various solutions inspired by the disclosure of this invention. These solutions all fall within the scope of this invention and its protection. Those skilled in the art should understand that this specification and its accompanying drawings are illustrative and not intended to limit the scope of the claims. The scope of protection of this invention is defined by the claims and their equivalents.

Claims

1. An enteral nutrition infusion flow rate monitor with an automatic flushing tube, comprising: The first monitoring module is used for real-time monitoring of the gastric antrum area parameters of the stomach. The second monitoring module is used to monitor the digestive status of the intestines and transmit corresponding electrical signals to the control mechanism. A flow rate control component for classifying and regulating the flow rate of enteral nutrition infusion; A control mechanism that is electrically connected to the first monitoring module, the second monitoring module, and the flow rate control component, respectively; The key feature is that the control mechanism adjusts the flow rate of enteral nutrition infusion based on the cross-sectional area of ​​the gastric antrum and its changes monitored by the first monitoring module, and adjusts the infusion rate of the nutrient solution based on the electrical signal transmitted by the second monitoring module, so that the intestine is always in a state of incomplete saturation. The flow rate monitor also includes an infusion tube connector for connection to the infusion tube input end. The infusion tube connector is a cylindrical structure with an internal channel. The blades of the flow rate control component are disposed inside the internal channel of the infusion tube connector. The blades rotate under the drive of a drive end partially disposed on the outside of the infusion tube connector to change the area projected onto the axial direction of the internal channel of the infusion tube connector. The flow rate control component controls the enteral nutrition infusion rate to match the gradient rate of the corresponding gastric antrum cross-sectional area. When the first monitoring module detects that the gastric antrum cross-sectional area has not reached the minimum area for feeding intolerance and the difference between the gastric antrum cross-sectional area and the minimum area exceeds 20%, it sends a first signal to the control mechanism. The control mechanism controls the flow rate control component to match the normal nutrient solution infusion rate. When the first monitoring module detects that the difference between the gastric antrum cross-sectional area and the minimum area for feeding intolerance is less than 20%, it sends different gradient electrical signals to the control mechanism based on the data gradient of the percentage of the difference area to the minimum area. When the control mechanism receives different gradient electrical signals, it controls the flow rate control component to map the corresponding nutrient solution infusion rate.

2. The flow velocity monitoring instrument according to claim 1, characterized in that, The drive end of the flow rate control component (66) is electrically connected to the control mechanism (63). The drive end is able to adjust the state of the blade in the channel (33) of the infusion pipe joint based on its own rotation angle in response to the electrical signal of the control mechanism (63) so as to adjust the infusion rate of the nutrient solution flowing through the channel (33) of the infusion pipe joint.

3. The flow velocity monitoring instrument according to claim 1, characterized in that, The control mechanism (63) includes at least a processor (65), a timing component (67), and a storage component (69). The processor (65), the timing component (67), and the storage component (69) are electrically connected via a printed circuit board. The storage component (69) is capable of providing the flow rate monitor with data processed by the processor (65) to guide the control process of the control mechanism (63).

4. The flow velocity monitoring instrument according to claim 3, characterized in that, The flow rate monitor also includes a metering component (71) for measuring the infusion volume of the nutrient solution fluid. The metering component (71) is electrically connected to the control mechanism (63). The control mechanism (63) can determine the infusion rate of the nutrient solution fluid based on the infusion volume and the time data of the timing component (67), so that when the infusion rate of the nutrient solution fluid is controlled based on the cross-sectional area of ​​the gastric antrum measured by the first monitoring module (11), the nutrient solution fluid can be controlled to a pre-set flow rate.

5. The flow velocity monitoring instrument according to claim 1, characterized in that, The flow rate monitor also includes a flow rate monitor housing (13), which includes a first half-shell (15) and a second half-shell (17) that can be spliced ​​together to form a shell-like structure. The first half-shell (15) and the second half-shell (17) are hinged along the edge so that the flow rate monitor housing (13) can be rotated open or closed along the edge. The infusion tube connector (29) extends orthogonally from the first bottom surface (23) of the second half-shell (17), and the infusion tube connector internal channel (33) of the infusion tube connector (29) is connected to the internal space of the flow rate monitor housing (13).

6. The flow rate monitor according to claim 5, characterized in that, When the flow rate monitor housing (13) is in the closed position, the first half-shell (15) is provided with a plug (45) at the position corresponding to the inner channel (33) of the infusion tube connector. The plug (45) can be inserted into the inner channel (33) of the infusion tube connector and make an interference seal with the inner channel (33) of the infusion tube connector when the first half-shell (15) is in the closed position.

7. The flow velocity monitor according to claim 6, characterized in that, The first half-shell (15) is a sealed structure with an internal cavity structure for housing the control mechanism (63) that controls the electronic operation. The outer surface of the first half-shell (15) is also provided with a user input component (77) that can pre-program and change the control parameters of the control mechanism (63). The user input component (77) is electrically connected to the control mechanism (63).

8. The flow velocity monitoring instrument according to claim 1, characterized in that, The flow rate monitor also includes a display component (75) electrically connected to the control mechanism (63), which is capable of visually outputting the physical parameters during nutrient solution infusion.

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