An infusion system and method based on carrier liquid synchronous boosting combined with anti-push injection

Abstract

The application provides an infusion system and method based on carrier liquid synchronous boosting combined with anti-push injection, which comprises: a drug liquid infusion branch for infusing vasoactive drugs; a carrier liquid infusion branch for infusing carrier liquid; an infusion channel; a confluence cavity, which is in communication with the drug liquid infusion branch, the carrier liquid infusion branch and the infusion channel respectively; an on-off mechanism, which is arranged at any position where the drug liquid infusion branch is in communication with the confluence cavity, and is used for opening and closing the flow of vasoactive drugs in the drug liquid infusion branch; a detection unit, which is configured to carry liquid information of the carrier liquid; a synchronous control unit, which is in signal connection with the detection unit and the on-off mechanism, and is in communication connection with infusion execution elements of the drug liquid infusion branch and the carrier liquid infusion branch respectively. The vasoactive drug delivery speed is accelerated by using the carrier liquid, the abnormality of the carrier liquid infusion state can be actively detected, and the drug liquid infusion branch can be timely blocked to prevent the risk of non-intended push injection when the abnormality occurs.

Description

Technical Field

[0001] This application relates to the field of medical device and drug infusion control technology, and in particular to an infusion system and method based on carrier fluid synchronous propulsion combined with anti-push injection. Background Technology

[0002] In the treatment of critical illnesses such as septic shock, cardiogenic shock, and severe trauma, the continuous and precise infusion of vasoactive drugs such as norepinephrine, epinephrine, dopamine, dobutamine, and vasopressin is crucial for maintaining hemodynamic stability. Clinically, these drugs are usually infused continuously and slowly via a microinfusion pump through a central venous catheter and its extension tubing. However, the infusion pathway formed by the central venous catheter, its extension tubing, and multi-connectors contains a non-negligible equivalent dead space volume. When vasoactive drugs are propelled at extremely low flow rates, the drug solution moves slowly within the dead space, which clinically manifests as delayed onset of action, sluggish rate adjustment response, and may even require manual flushing or empirically increasing the flow rate.

[0003] Meanwhile, to reduce the impact of dead space retention, in clinical practice, vasoactive drug infusion lines are often connected in parallel to carrier fluid (e.g., 0.9% sodium chloride injection or balanced crystalloid solution) infusion lines. The higher flow rate of the carrier fluid helps to propel the drug in the dead space, thus shortening the onset of action. However, this parallel connection introduces new safety risks: when carrier fluid infusion suddenly stops due to pump failure, depletion of the infusion bag, tubing kinks, or tubing clamping, the microinfusion pump continues to infuse at a very low rate, causing the drug to accumulate continuously in the dead space. Consequently, the moment the carrier fluid pathway is restored, the accumulated drug is instantaneously pushed into the patient's body by the carrier flow, resulting in an unexpected injection, potentially leading to severe fluctuations in blood pressure, arrhythmias, or even cardiac arrest. Summary of the Invention

[0004] To address the aforementioned problems, one objective of this invention is to provide an infusion system based on a carrier fluid-based synchronous booster combined with anti-pumping technology. This system utilizes the carrier fluid to shorten the onset of action caused by drug dead space retention, while simultaneously shutting off drug infusion when abnormal carrier fluid infusion occurs, thereby reducing the risk of unexpected pumping. A second objective of this invention is to provide a synchronous control method for infusion systems.

[0005] To achieve one of the objectives, in a first aspect, the present invention provides an infusion system based on carrier fluid synchronous propulsion combined with anti-push injection, the system comprising: The drug infusion branch is configured to infuse vasoactive drugs with preset drug parameters; The carrier fluid delivery branch is configured to deliver the carrier fluid with preset carrier fluid parameters; Infusion pathway, used to connect to the infusion object; The confluence cavity is connected to the drug infusion branch, the carrier fluid infusion branch, and the infusion pathway, respectively, so that the vasoactive drug and the carrier fluid are combined in the confluence cavity and then output to the infusion target along the infusion pathway. A switching mechanism is provided at any position where the drug infusion branch connects to the confluence cavity, and is used to switch the flow of the vasoactive drug in the drug infusion branch; A detection unit is disposed on the carrier liquid infusion branch and configured to acquire the carrier liquid loading information in the carrier liquid infusion branch; The synchronous control unit is signal-connected to the detection unit and the on / off mechanism, and is communicatively connected to the respective infusion execution elements of the drug infusion branch and the carrier liquid infusion branch. The synchronization control unit is used for at least: When the carrier fluid information transmitted by the detection unit is received, and the carrier fluid infusion branch is determined to meet the abnormal infusion conditions based on the carrier fluid information, the on / off mechanism is controlled to block the drug infusion branch and / or the infusion execution element of the drug infusion branch is controlled to suspend operation, so as to simultaneously suspend the infusion of the vasoactive drug.

[0006] Optionally, the inlet of the drug infusion branch is connected to a syringe, and a micro-injection pump is provided on the drug infusion branch; and / or, the inlet of the carrier fluid infusion branch is connected to an infusion bag, and an infusion pump is provided on the carrier fluid infusion branch. The micro-injection pump and the infusion pump are respectively the infusion execution elements.

[0007] Optionally, the confluence cavity has a first inlet, a second inlet, and an outlet; the drug infusion branch and the carrier liquid infusion branch are respectively connected to the first inlet and the second inlet; and the infusion passage is connected to the outlet. The first and second inlets of the confluence cavity are each equipped with an anti-backflow valve; The confluence cavity is provided with an identifier on its body to indicate the equivalent dead cavity volume of the infusion pathway. The identifier includes at least one of a barcode, an RFID tag, or a preset model code.

[0008] Optionally, the switching mechanism includes any one of an electrically controlled clamp valve, a pipe clamp, and a solenoid valve.

[0009] Optionally, the synchronization control unit is further configured to: When the carrier fluid information meets the first preset recovery condition, the carrier fluid flow rate is increased from the initial value to the target value in a step-incremental or linear manner within a preset time to gradually restore the carrier fluid flow rate. When the fluid carrier information meets the second preset recovery condition, the infusion of the vasoactive drug is resumed.

[0010] Optionally, the preset fluid loading parameters include maintenance flow rate; the synchronization control unit is further configured to: The carrier fluid infusion branch is controlled to continuously output the carrier fluid at the maintenance flow rate to form a continuous driving flow within the infusion passage; In response to any one of the following operations: starting or adjusting the rate of the vasoactive drug, replacing the vasoactive drug, replacing the syringe, or changing the infusion pathway, the carrier fluid flow rate is switched from the maintenance flow rate to a preset flushing flow rate and maintained for a preset flushing time to perform a quantitative flush before returning to the maintenance flow rate.

[0011] To achieve the second objective, in a second aspect, the present invention provides a synchronization control method for an infusion system as provided in the first aspect of the present invention, the technical solution of which is: The methods include: The drug infusion branch is controlled to infuse vasoactive drugs with preset drug parameters, and the carrier fluid infusion branch is controlled to output carrier fluid with preset carrier fluid parameters, so as to use the carrier fluid to propel the vasoactive drugs within the infusion pathway. Receive the carrier fluid information transmitted by the detection unit, and determine whether the carrier fluid infusion branch meets the abnormal infusion conditions based on the carrier fluid information; If so, the control switch mechanism blocks the drug infusion branch and / or controls the infusion execution element of the drug infusion branch to stop operating, so as to simultaneously stop the infusion of the vasoactive drug.

[0012] Optionally, the carrier fluid information includes at least one of the carrier fluid flow rate, carrier fluid pressure, and infusion pump operating parameters; The step of determining whether the carrier fluid infusion branch meets abnormal infusion conditions based on the carrier fluid information includes: When any one of the following conditions is met: the carrier fluid flow rate is lower than a preset flow rate threshold, the carrier fluid pressure exceeds a preset pressure threshold, or the infusion pump stops operating, the carrier fluid infusion branch is determined to meet the abnormal infusion condition.

[0013] Optionally, the preset fluid loading parameters include the maintenance flow rate, and the method further includes: The carrier fluid infusion branch is controlled to continuously output the carrier fluid at the maintenance flow rate to form a continuous driving flow within the infusion passage; In response to any of the following operations: starting or adjusting the rate of the vasoactive drug, replacing the vasoactive drug, replacing the syringe, or changing the infusion pathway, the carrier fluid flow rate is switched from the maintenance flow rate to a preset flushing flow rate and maintained for a preset flushing time to perform a quantitative flush before returning to the maintenance flow rate.

[0014] Optionally, the method further includes: When the carrier fluid information meets the first preset recovery condition, the carrier fluid flow rate is increased from the initial value to the target value in a step-incremental or linear manner within a preset time to gradually restore the carrier fluid flow rate. When the fluid carrier information meets the second preset recovery condition, the infusion of the vasoactive drug is resumed; The second preset recovery condition includes: the cumulative volume of the carrier liquid running at the preset flushing flow rate or the maintenance flow rate reaches the preset flushing volume, and the pressure of the carrier liquid remains stable within a preset time.

[0015] Compared with the prior art, this application has the following advantages: The system provided in this application combines the drug solution and carrier fluid in a confluence cavity, allowing them to share a single infusion pathway into the patient. During normal operation, the carrier fluid continuously provides propulsion for the drug solution, eliminating the need for the drug to rely solely on its extremely low flow rate to pass through the dead space, thus solving the clinical problem of delayed onset of action caused by low-flow-rate drugs. Furthermore, by installing an on / off mechanism controlled by a synchronous control unit between the drug infusion branch and the confluence cavity, and by setting up a detection unit on the carrier fluid infusion branch to continuously collect carrier fluid information, the synchronous control unit can detect and actively trigger an interlock in real time when the carrier fluid flow rate suddenly drops or stops due to pump failure, pipeline blockage, or fluid depletion. This physically blocks the drug infusion branch and / or pauses the drug infusion execution element, preventing drug accumulation in the dead space during carrier fluid interruption. Therefore, when the carrier fluid is subsequently restored, there will be no unexpected injection caused by the instantaneous injection of drug accumulated in the dead space into the patient's body, systematically reducing the safety risks during clinical infusion.

[0016] The method described above has the same advantages over existing technologies as the system described above, and will not be repeated here. Attached Figure Description

[0017] To more clearly illustrate the technical solution of this application, the drawings used in the description of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1This is a structural diagram of the infusion system based on a carrier liquid synchronous boosting combined with anti-push injection system according to an embodiment of this application; Figure 2 This is an electrical connection diagram of the infusion system based on a carrier liquid synchronous boosting combined with anti-push injection system according to an embodiment of this application; Figure 3 This is a flowchart illustrating the steps of a synchronization control method for an infusion system according to an embodiment of this application.

[0019] Explanation of reference numerals in the attached figures: 1. Carrier fluid infusion branch; 11. Infusion bag; 12. Infusion pump; 2. Drug infusion branch; 21. Syringe; 22. Micro-infusion pump; 3. Infusion passage; 4. Combination chamber; 41. First inlet; 42. Second inlet; 43. Outlet; 5. On / off mechanism; 6. Marking; 7. Anti-backflow valve. Detailed Implementation

[0020] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0021] It should be noted that before describing the technical solution of this application in detail, the current state of the prior art and its limitations will be further explained in order to facilitate understanding of the improvements made by the technical solution of this application compared with the prior art.

[0022] In existing technologies, some have proposed solutions to shorten the onset time of drug delivery using carrier fluid and to automatically flush away tubing residues. However, these solutions only focus on drug delivery accuracy when switching fluids during normal infusion procedures and do not address safety protection in scenarios involving abnormal interruptions in carrier fluid delivery. Others have proposed delivery curve prediction and visualization based on multiple drug pumps and carrier fluid pumps. If the carrier fluid flow rate changes, the model calculates that the actual drug arrival rate deviates from the target value, and the system automatically adjusts the drug pump rate to compensate for this deviation. This approach not only fails to prevent unintended bolus delivery but may also exacerbate drug accumulation in the dead space by increasing the drug pump rate during carrier fluid interruptions, thereby increasing the bolus risk when the carrier fluid is restored.

[0023] It is evident that there is currently no effective solution in the field to address the risk of unintended injections. Therefore, a structured solution compatible with existing infusion pumps and central venous access is needed. This solution should be able to shorten the onset delay caused by dead space retention using the carrier fluid without altering clinical dosing principles, and should also proactively trigger safety interlock protection in the event of abnormal interruption, resumption, or rate change of the carrier fluid, thereby systematically reducing the risk of unintended injections.

[0024] To enable those skilled in the art to more clearly understand the technical solution of the present invention, the following definitions are provided for several technical terms used in this specification: In the description of this application, "vasoactive drugs" include, but are not limited to, drugs that require continuous and precise infusion via micro-injection, such as norepinephrine, epinephrine, dopamine, dobutamine, vasopressin, and sodium nitroprusside.

[0025] "Carrier fluid" includes, but is not limited to, commonly used clinical crystalloid or colloidal solutions such as 0.9% sodium chloride injection, sodium lactate Ringer's injection, sodium acetate Ringer's injection, and compound electrolyte injection. It should be noted that the main function of the carrier fluid is to provide continuous propulsion for the drug in the dead space within infusion pathway 3. Its chemical composition only needs to be clinically compatible with the patient's condition; this application does not limit the specific chemical composition of the carrier fluid.

[0026] "Equivalent dead space volume" refers to the effective internal volume contained in the infusion pathway 3 from the point where the vasoactive drug and carrier fluid meet, along the infusion pathway 3 into the patient's body (e.g., the tip of the central venous catheter). The equivalent dead space volume can be obtained from the tubing model preset value, the factory parameters stored in the barcode or RFID (Radio Frequency Identification) tag, or through actual measurement via a calibration procedure.

[0027] "Maintenance flow rate" refers to the minimum flow rate at which the carrier fluid is continuously infused under normal operating conditions, in order to maintain continuous driving flow within the pathway.

[0028] "Preset flushing velocity" refers to the carrier fluid flow rate that is increased when a specific event (such as drug start-up, speed adjustment, or drug change) is triggered, in order to shorten the steady-state establishment time and quickly replace the dead space volume to shorten the steady-state establishment time.

[0029] "Unintended injection" refers to the phenomenon where, due to changes in carrier fluid flow rate, removal of tubing blockage, replacement of syringe 21, or resumption of carrier fluid infusion, the drug solution accumulated in the dead space of the infusion pathway 3 is instantaneously pushed into the patient's body, resulting in the amount of drug delivered per unit time exceeding the preset range.

[0030] To overcome or at least partially solve the above problems, one or more embodiments of this application will be further described below with reference to specific examples.

[0031] Reference Figure 1 As shown, Figure 1 This is a diagram illustrating the overall structural composition of the infusion system based on carrier fluid synchronous propulsion combined with anti-push injection, as shown in this invention. Figure 1As shown, this invention provides an infusion system based on carrier fluid synchronous boosting combined with anti-push injection. The system includes: a drug infusion branch 2 configured to infuse vasoactive drugs with preset drug parameters; a carrier fluid infusion branch 1 configured to infuse a carrier fluid with preset carrier fluid parameters; an infusion passage 3 for connecting to the infusion target; a confluence chamber 4 connected to the drug infusion branch 2, the carrier fluid infusion branch 1, and the infusion passage 3, respectively, so that the vasoactive drug and the carrier fluid merge in the confluence chamber 4 and are then output to the infusion target along the infusion passage 3; and a switching mechanism 5 disposed at any position connecting the drug infusion branch 2 and the confluence chamber 4, for switching the drug infusion branch 2 on and off. The flow of vasoactive drugs; a detection unit, located on the carrier fluid infusion branch 1, configured to acquire the carrier fluid information in the carrier fluid infusion branch 1; a synchronization control unit, signal-connected to the detection unit and the on / off mechanism 5 respectively, and communicatively connected to the infusion execution elements of the drug infusion branch 2 and the carrier fluid infusion branch 1 respectively; the synchronization control unit is at least used to: receive the carrier fluid information transmitted by the detection unit, and when it is determined based on the carrier fluid infusion branch 1 that abnormal infusion conditions are met, control the on / off mechanism 5 to block the drug infusion branch 2 and / or control the infusion execution elements of the drug infusion branch 2 to suspend operation, so as to synchronously suspend the infusion of vasoactive drugs.

[0032] Specifically, drug infusion branch 2 is configured to deliver vasoactive drugs according to preset drug solution parameters. Carrier fluid infusion branch 1 is configured to deliver carrier fluid according to preset carrier fluid parameters (e.g., carrier fluid type, maintenance flow rate). The two branches operate independently and do not interfere with each other's flow rate settings. The preset drug solution parameters include, but are not limited to, drug concentration, drug rate, and drug pressure. The preset carrier fluid parameters include, but are not limited to, carrier fluid type, maintenance flow rate, carrier fluid pressure, and carrier fluid flow rate.

[0033] The confluence chamber 4 is connected to the drug infusion branch 2, the carrier fluid infusion branch 1, and the infusion pathway 3. Drug infusion branch 2 injects the drug and carrier fluid into the confluence chamber 4, and the two fluids mix within the confluence chamber 4 before being delivered to the patient along the same infusion pathway 3. The confluence chamber 4 is preferably located closer to the patient than the other two branches to minimize the dead space between the confluence point and the patient. In one specific implementation, the volume of the confluence chamber 4 is less than 0.1 mL.

[0034] In some embodiments, the infusion pathway 3 includes a central venous catheter and its extension tubing, with an equivalent dead space volume of 0.5-5 mL.

[0035] The on / off mechanism 5 is located on the passage connecting the drug infusion branch 2 and the confluence cavity 4, that is, at any position before the drug enters the confluence cavity 4 from the drug infusion branch 2. For example, it can be located on the drug infusion branch 2, or at the first inlet 41 connecting the confluence cavity 4 and the drug infusion branch 2. Under normal operating conditions, the on / off mechanism 5 is in the open state, and the drug infusion branch 2 remains open; when the synchronous control unit issues a blocking command, the on / off mechanism 5 switches from the open state to the closed state, physically blocking the flow of drug in the drug infusion branch 2 to the confluence cavity 4 and the infusion passage 3.

[0036] The detection unit is located on carrier fluid infusion branch 1 and is configured to acquire carrier fluid information. The types and acquisition methods of carrier fluid information are detailed below.

[0037] like Figure 2 As shown, Figure 2 The connection path of the synchronization control unit is shown. The synchronization control unit is signal-connected to the detection unit and the on / off mechanism 5, and communicatively connected to the respective infusion actuators of the drug infusion branch 2 and the carrier fluid infusion branch 1. The infusion actuator refers to the power device that drives the fluid flow in the branch, such as the micro-injection pump 22 on the drug infusion branch 2, more specifically, the stepper motor on the micro-injection pump 22; or the infusion pump 12 on the carrier fluid infusion branch 1, more specifically, the peristaltic mechanism of the infusion pump 12. The synchronization control unit receives carrier fluid information transmitted by the detection unit, including carrier fluid flow rate, carrier fluid pressure, and operating parameters of the infusion pump 12, and determines whether there is an abnormality in carrier fluid infusion based on the carrier fluid information. It then generates a blocking or restoring command and sends it to the on / off mechanism 5. The on / off mechanism 5 executes the corresponding switching operation according to the blocking / restoring command.

[0038] Thus, in this embodiment, the drug solution and carrier solution are combined in the confluence cavity 4 and enter the patient through a single infusion pathway 3. During normal operation, the carrier solution continuously provides propulsion for the drug solution, eliminating the need for the drug solution to rely solely on its extremely low flow rate to pass through the dead space, thereby solving the clinical problem of delayed onset of action due to low-flow-rate drugs. Furthermore, by setting up an on / off mechanism 5 controlled by a synchronous control unit between the drug solution infusion branch 2 and the confluence cavity 4, and by installing a detection unit on the carrier solution infusion branch 1 to continuously collect carrier solution information, the synchronous control unit can detect and actively trigger an interlock in real time when the carrier solution flow rate suddenly drops or stops due to pump failure, pipeline blockage, or fluid depletion. This physically blocks the drug solution infusion branch 2 and / or pauses the drug solution infusion execution element, preventing drug accumulation in the dead space during carrier solution interruptions. Therefore, when the carrier solution is subsequently restored, there will be no unexpected injection caused by the instantaneous injection of drug solution accumulated in the dead space into the patient's body, systematically reducing the safety risks during clinical infusion.

[0039] This embodiment is used to illustrate the judgment mechanism for abnormal infusion conditions: The carrier fluid information includes at least one of the following: carrier fluid flow rate, carrier fluid pressure, and operating parameters of the infusion pump 12. Correspondingly, the detection unit includes a flow sensor, a pressure sensor, and a pump-side sensor. When any one of the following conditions is met—carrier fluid flow rate below a preset flow rate threshold, carrier fluid pressure exceeding a preset pressure threshold, or infusion pump 12 stopping operation—the carrier fluid infusion branch 1 is determined to meet abnormal infusion conditions.

[0040] Specifically, the carrier fluid flow rate can be acquired in real time by a flow sensor. A preset flow threshold is set based on the clinical maintenance flow rate; for example, when the maintenance flow rate is 40 mL / h, the preset flow threshold can be set to 10 mL / h (i.e., 25% of the maintenance flow rate). When the carrier fluid flow rate is lower than the preset flow threshold, it indicates that the carrier fluid supply may be significantly reduced due to depletion of the infusion bag 11, tubing kinking, or other reasons. The carrier fluid pressure can be acquired in real time by a pressure sensor. The preset pressure threshold is divided into an upper limit threshold and a lower limit threshold. Exceeding the upper limit threshold indicates downstream tubing blockage (e.g., tubing clamping, tubing kinking, thrombosis), resulting in an abnormally high pressure; exceeding the lower limit threshold indicates tubing disconnection or leakage. The operating parameters of the infusion pump 12 include its running / stop status, alarm status, and motor speed, which are directly obtained from the operating status detection interface or communication interface of the infusion pump 12. Therefore, when the carrier fluid stops flowing or its flow rate drops sharply due to pump failure, pipeline kinking, or solution depletion, the drug delivery branch 2 continues to deliver the drug at a very low flow rate, leading to drug accumulation in the dead space. By setting multiple anomaly detection conditions covering flow rate, pressure, and pump operating status, the detection sensitivity and coverage for different types of carrier fluid anomalies are significantly improved.

[0041] Furthermore, the inlet of the drug infusion branch 2 is connected to a syringe 21, which contains a prepared vasoactive drug. A micro-infusion pump 22 is installed on the drug infusion branch 2. The micro-infusion pump 22 drives the piston of the syringe 21 to slowly advance at a preset rate, thereby delivering the vasoactive drug with preset drug parameters. The infusion rate range of the micro-infusion pump 22 is typically 0.1-10 mL / h, suitable for precise micro-infusion of vasoactive drugs. The inlet of the carrier fluid infusion branch 1 is connected to an infusion bag 11 (or infusion bottle), which contains a carrier fluid (e.g., 0.9% sodium chloride injection). An infusion pump 12 is installed on the carrier fluid infusion branch 1. The infusion pump 12 squeezes the tubing at a preset rate, thereby delivering the carrier fluid with preset carrier parameters. The infusion rate range of the infusion pump 12 is typically 5-200 mL / h, preferably 10-100 mL / h, suitable for providing sufficient driving flow rate for the carrier fluid without introducing excessive fluid load.

[0042] The micro-injection pump 22 and the infusion pump 12 are each an infusion actuator for their respective branches and are independently controlled by the communication connection of the synchronization control unit. When the synchronization control unit determines that the drug infusion needs to be paused, it sends a blocking command to the on / off mechanism 5 to physically block the drug infusion branch 2, and / or sends a pause command to the micro-injection pump 22 to stop its advance. The micro-injection pump 22 and the infusion pump 12 independently drive the drug and carrier fluid, respectively. The synchronization control unit performs independent communication control on the micro-injection pump 22 and the infusion pump 12, realizing a completely decoupled architecture for the two pumps. Thus, in the event of abnormal carrier fluid infusion, only the drug infusion branch 2 is paused while maintaining the controllability of the carrier fluid pump, or when the carrier fluid is restored, the infusion pump 12 is controlled to adjust the flow rate according to a ramp strategy without immediately starting the micro-injection pump 22.

[0043] More specifically, the confluence chamber 4 has a first inlet 41, a second inlet 42, and an outlet 43, forming a low dead space Y-type connector. The drug infusion branch 2 is connected to the first inlet 41, the carrier fluid infusion branch 1 is connected to the second inlet 42, and the infusion passage 3 communicates with the outlet 43. The drug and carrier fluid enter the confluence chamber 4 through the first inlet 41 and the second inlet 42 respectively, mix within the chamber, and are then uniformly output from the outlet 43. Anti-backflow valves 7 are provided at both the first inlet 41 and the second inlet 42. The anti-backflow valve 7 has a one-way flow structure, allowing fluid to flow only from the corresponding inlet into the confluence chamber 4 and preventing fluid from flowing back from the confluence chamber 4 to the inlet branch. In some embodiments, the anti-backflow valve 7 may also be located on the corresponding branch. The anti-backflow valve 7 in this embodiment solves the pressure difference backflow problem in the dual-channel confluence architecture. For example, when the micro-injection pump 22 infuses at an extremely low flow rate while the infusion pump 12 infuses at a higher flow rate, the local static pressure on the drug inlet side of the confluence chamber 4 may be lower than that on the carrier liquid inlet side, which may cause the carrier liquid to flow back into the drug infusion branch 2, resulting in a decrease in infusion accuracy.

[0044] Preferably, the manifold 4 is provided with a label 6 to indicate the equivalent dead space volume of the infusion pathway 3. The label 6 is at least one of a barcode, RFID tag, or preset model code. In practical use, the operator brings the label 6 of the manifold 4 close to the reading device (e.g., barcode scanner, RFID reader / writer) of the synchronization control unit, and the synchronization control unit automatically obtains the equivalent dead space volume parameter for that batch. Alternatively, the clinician selects the model code of the manifold 4 during system initialization, and the system retrieves the corresponding equivalent dead space volume parameter from a preset database. This avoids errors caused by manual measurement or input of tubing length and volume parameters, and eliminates the need for recalibration each time the tubing is replaced.

[0045] Thus, by installing anti-backflow valves 7 at the dual inlets of the confluence chamber 4, reverse flow of fluid in either branch due to pressure difference is effectively prevented, ensuring the independence and controllability of drug concentration and preventing contamination from carrier fluid backflow. Simultaneously, the inclusion of an equivalent dead space volume indicator 6 on the confluence chamber 4 allows the synchronization control unit to automatically identify the equivalent dead space volume parameter of the current infusion pathway 3, reducing safety risks caused by parameter misrecording.

[0046] In some embodiments, the on / off mechanism 5 includes any one of an electrically controlled clamp valve, a pipe clamp, and a solenoid valve. Specifically, in this embodiment, the electrically controlled clamp valve uses an electromagnet or motor to drive the clamping jaws to squeeze the flexible drug delivery branch 2 from the outside, causing the pipe wall to adhere and block the inner cavity. The pipe clamp is a locking mechanism controlled by an electrical signal to clamp the pipe; it is typically a spring-loaded normally closed structure that clamps the pipe by default when power is off and releases the pipe to restore flow when power is applied. The solenoid valve is located in the drug delivery branch 2 and uses electromagnetic force to drive the valve core to open and close the fluid passage.

[0047] Therefore, the above-mentioned switching mechanism 5 can apply pressure to the flexible drug infusion branch 2 pipeline to achieve physical blocking, and the switching action is not constrained by the operating state of the micro-infusion pump 22. When the micro-infusion pump 22 itself has an electrical fault, the switching mechanism 5 can still independently complete the blocking of the drug infusion branch 2, providing redundant safety protection at the hardware level.

[0048] This embodiment illustrates the implementation method for abnormal recovery of the carrier fluid.

[0049] After determining that the carrier fluid infusion branch 1 meets the abnormal infusion conditions and performs interlocking shutdown, the synchronous control unit continues to monitor the carrier fluid information through the detection unit to determine whether the abnormality has been ruled out by clinical personnel. Specifically, when the synchronous control unit determines that the carrier fluid infusion branch 1 meets the first preset recovery condition based on carrier fluid flow rate returning to the normal range, carrier fluid pressure returning to the normal range, or infusion pump 12 resuming operation, the synchronous control unit controls the carrier fluid infusion branch 1 to gradually restore the carrier fluid flow rate using a preset ramp strategy. For example, the preset ramp strategy can be to increase the carrier fluid flow rate from the initial value to the target value (e.g., maintain flow rate) linearly within a preset time. Another example is that the preset ramp strategy can be a step-by-step increase, increasing the preset flow rate (5 mL / h every 10 seconds) every preset time until the target value is reached.

[0050] It should be noted that the preset flow rate change rate and recovery time of the ramp strategy can be individually adjusted according to the equivalent dead space volume and drug concentration of infusion pathway 3. For example, when the equivalent dead space volume is large or the drug concentration is high, a slower ramp recovery rate and a longer recovery time can be set to further reduce the injection amplitude. Correspondingly, when the equivalent dead space volume is small or the drug concentration is low, a faster recovery rate can be set.

[0051] Furthermore, once the carrier fluid flow rate stabilizes, the synchronous control unit continues to monitor the carrier fluid information to determine whether the second preset recovery condition is met. The second preset recovery condition includes carrier fluid pressure stabilization information, which indicates that the carrier fluid pressure remains stable within a preset time. Stable pressure indicates that there are no residual abnormalities such as blockages, kinks, or clamping within the infusion pathway 3, and the pathway can safely support the resumption of drug infusion. Once the second preset recovery condition is met, the synchronous control unit sends a recovery command to the infusion execution element (micro-infusion pump 22) of the drug infusion branch 2, causing it to resume infusion of the vasoactive drug at a preset rate; simultaneously, the synchronous control unit sends a release command to the on / off mechanism 5, switching it from the off state back to the on state.

[0052] Thus, by limiting the sudden increase in carrier fluid flow rate per unit time through the ramp control strategy, the instantaneous thrust on the residual drug in the dead space when the carrier fluid jumps directly from zero flow rate to the target flow rate is avoided, further reducing the unexpected injection of drug in the dead space during the carrier fluid recovery process. Drug infusion is only resumed after the carrier fluid has recovered to a stable state, avoiding the possibility of hastily resuming drug infusion before carrier fluid infusion branch 1 is fully operational, further ensuring the safety of drug delivery recovery.

[0053] In the maintenance phase of normal infusion, the synchronous control unit controls the carrier fluid infusion branch 1 to maintain a continuous flow rate of carrier fluid. The maintenance flow rate is typically set to a moderate, constant value, such as 5-60 mL / h, within which sufficient driving force can be provided to continuously propel the drug from the dead space to the patient without introducing excessive fluid load. The synchronous control unit also monitors and responds to any of the following clinical operational events: starting the microinfusion pump 22 (from pump off to pump on), adjusting the rate of vasoactive drugs (increasing or decreasing the rate of the microinfusion pump 22), changing vasoactive drugs (e.g., replacing norepinephrine with dopamine), changing syringe 21 (replacing syringe 21 with a full syringe after it is emptied), or changing the infusion route 3 (e.g., changing the central venous catheter or extension tubing). When any of the above events is triggered, the synchronous control unit executes a quantitative flushing procedure: switching the carrier fluid flow rate from the maintenance flow rate to a preset flushing flow rate, maintaining the preset flushing time, and then automatically reverting to the maintenance flow rate. The product of the preset flushing velocity and the preset flushing time equals the flushing volume. The principle for setting this flushing volume is that it is sufficient to complete a full replacement of the dead cavity volume.

[0054] As a specific explanation of this embodiment, the equivalent dead cavity volume Vdead is pre-inputted or identified, and the flushing volume Vflush = k × Vdead is set, where k is a coefficient of 1.0-3.0, preferably 1.2-2.0; a preset flushing flow rate Qflush (e.g., 30-200 mL / h) and a maintenance flow rate Qkeep (e.g., 5-60 mL / h) are set. The flushing time Tflush = Vflush / Qflush.

[0055] For example, assuming the equivalent dead space volume of infusion pathway 3 is 2 mL, and for ease of calculation (K = 1), with a maintenance flow rate of 40 mL / h (approximately 0.667 mL / min), relying solely on the maintenance flow rate for natural propagation, completing one volume replacement of the dead space requires approximately 2 mL ÷ 0.667 mL / min ≈ 3.0 min. However, if flushing is performed at a preset flow rate of 150 mL / h (approximately 2.5 mL / min), completing the same volume replacement requires only approximately 2 mL ÷ 2.5 mL / min ≈ 0.8 min. It can be seen that the time to reach steady-state delivery after drug initiation is shortened from approximately 3 minutes to less than 1 minute. For critically ill patients requiring rapid upregulation of vasoactive drugs to achieve blood pressure targets, the onset time is reduced to less than a quarter of the original, which has significant clinical implications.

[0056] By triggering quantitative flushing during events such as drug initiation, rate adjustment, and drug change, the dead space concentration disturbances generated during these clinical procedures can be completely replaced in one go at a higher preset flushing flow rate before the slow maintenance flow rate has been fully eliminated. This not only shortens the time to reach steady-state delivery but also defines the flushing end point through clear flushing start and end times, preventing over-flushing or under-flushing due to forgetfulness or inconsistent clinical experience, thus improving the standardization and safety of the operation.

[0057] As an explanation of this embodiment, the response of the synchronization control unit to the aforementioned clinical operation events can be achieved through one or more of the following methods: For starting or adjusting the rate of a vasoactive drug, the synchronization control unit receives status change or rate change events actively reported by the pump via a communication connection with the micro-infusion pump 22. For changing a vasoactive drug or changing the infusion pathway 3, the operator selects the corresponding operation command on the operation interface of the synchronization control unit (e.g., pressing the "Drug Change Confirmation" or "Infusion Pathway 3 Change" button), and the synchronization control unit triggers a quantitative flush accordingly. For changing the syringe 21, the synchronization control unit can receive pump door opening / closing events and / or syringe 21 emptying alarm events reported by the micro-infusion pump 22, automatically determining that the syringe 21 replacement operation has occurred.

[0058] During the resumption of drug infusion, if the flushing volume meets the target but the tubing pressure continues to fluctuate, resuming drug infusion at this time may cause a further increase in pressure, triggering a secondary anomaly. If the carrier fluid pressure reading remains normal but the flushing volume does not meet the target, resuming drug infusion at this time may cause residual old concentration drug in the dead space to be reintroduced into the patient, resulting in concentration errors. In conjunction with the above embodiments, the second preset resumption condition also includes the cumulative volume of the carrier fluid running at a preset flushing flow rate or maintenance flow rate reaching the preset flushing volume. Therefore, the second preset resumption condition includes two steady-state conditions. The first steady-state condition is that the cumulative volume of the carrier fluid running at the preset flushing flow rate or maintenance flow rate reaches the preset flushing volume. The preset flushing volume should not be less than the equivalent dead space volume of infusion passage 3 to ensure that residual drug in the dead space has been fully emptied. The second steady-state condition is that the carrier fluid pressure remains stable within a preset time. When both steady-state conditions are met simultaneously, a start command is sent to the micro-injection pump 22 of the drug infusion branch 2, and a release command is sent to the on / off mechanism 5. This verifies from both volume and pressure dimensions that the infusion pathway 3 has been restored to a normal and safe operating state, eliminating the possibility of erroneous restoration of drug infusion.

[0059] It should be noted that although this application describes the central venous microinfusion of vasoactive drugs as the main application scenario, the system and method of this application are also applicable to other clinical drug infusion scenarios via infusion pathway 3 at low flow rates and sensitive to push delays and / or unexpected pushes, such as insulin infusion, sedative drug infusion, and chemotherapy drug infusion.

[0060] It should also be noted that the function of the "synchronization control unit" in this application can be implemented by an independent embedded controller, a main control module integrated with an existing infusion pump, or a software module running on a monitor or central monitoring station. This application does not limit the specific hardware implementation of the synchronization control unit.

[0061] Secondly, embodiments of the present invention also provide a synchronous control method for an infusion system, applied to the infusion system based on carrier fluid synchronous propulsion combined with anti-push infusion provided in the first aspect of the present invention. This method is executed in the synchronous control unit, correspondingly implementing the interlocking logic executed by the synchronous control unit in the system of the first aspect, integrating continuous carrier fluid monitoring, anomaly detection, drug solution pause and recovery, and quantitative flushing into a closed-loop control link. Correspondingly, please refer to... Figure 3 As shown, Figure 3 This is a flowchart illustrating the steps of a synchronization control method for an infusion system, which includes the following steps: S1. Control the drug infusion branch 2 to infuse vasoactive drugs with preset drug parameters, and control the carrier fluid infusion branch 1 to output carrier fluid with preset carrier fluid parameters, so as to use the carrier fluid to propel vasoactive drugs within the infusion pathway 3. S2. Receive carrier liquid information transmitted by the detection unit; the carrier liquid information includes at least one of the carrier liquid flow rate, carrier liquid pressure, and operating parameters of the infusion pump 12; S3. When any one of the following conditions is met: the carrier fluid flow rate is lower than the preset flow rate threshold, the carrier fluid pressure exceeds the preset pressure threshold, or the infusion pump 12 stops running, the carrier fluid infusion branch 1 is determined to meet the abnormal infusion condition. S4. If so, the control switch 5 blocks the drug infusion branch 2 and / or controls the infusion actuator of the drug infusion branch 2 to stop operating, so as to simultaneously stop the infusion of vasoactive drugs.

[0062] Furthermore, the method also includes: S5. Control the carrier liquid infusion branch 1 to maintain the flow rate and continuously output the carrier liquid, so as to form a continuous driving flow in the infusion passage 3; S6. In response to starting or adjusting the rate of the vasoactive drug, changing the vasoactive drug, changing the syringe 21, or changing the infusion pathway 3, the carrier fluid flow rate is switched from the maintenance flow rate to the preset flushing flow rate and maintained for the preset flushing time, so as to perform quantitative flushing and then return to the maintenance flow rate.

[0063] Furthermore, the method also includes: S7. When the carrier fluid information meets the first preset recovery condition, the carrier fluid flow rate is increased from the initial value to the target value in a step-by-step or linear manner within a preset time to gradually restore the carrier fluid flow rate. S8. When the carrier fluid information meets the second preset recovery condition, the infusion of the vasoactive drug is resumed; wherein, the second preset recovery condition includes: the cumulative volume of the carrier fluid running at the preset flushing flow rate or maintenance flow rate reaches the preset flushing volume, and the carrier fluid pressure remains stable within a preset time.

[0064] It should be noted that, for the method embodiments, the embodiments of this application are not limited to the described order of actions, because according to the embodiments of this application, some steps may be performed in other orders or simultaneously.

[0065] The above method embodiments are basically similar to the system embodiments, so the description is relatively simple. For relevant details, please refer to the description of the system embodiments.

[0066] In summary, compared with the prior art, this application has at least the following technical effects: (1) By combining the carrier fluid and the vasoactive drug in the same infusion pathway 3 through the confluence cavity 4, the drug delivery is propelled by the carrier fluid, reducing the dead space propulsion time of low-flow-rate drugs from tens of minutes to several minutes.

[0067] (2) By combining the carrier fluid information collected by the detection unit with the abnormal judgment logic of the synchronous control unit, the three types of abnormalities, namely abnormal carrier fluid flow, abnormal carrier fluid pressure and abnormal infusion pump 12, are monitored and automatically identified in real time. The physical blocking and / or suspension of drug infusion execution element are performed by the on / off mechanism 5 to prevent drug accumulation in the dead space during abnormal interruption of carrier fluid, thus systematically eliminating the risk of unexpected injection when carrier fluid is restored.

[0068] (3) By implementing a ramp strategy (step-by-step or linear-by-step) during the carrier fluid recovery phase, the instantaneous rate of change of the carrier fluid flow rate is limited, and the flow recovery is transformed from a step-by-step change to a controlled gradual change, which significantly reduces the amplitude of the change in the carrier fluid flow rate and its instantaneous pushing force on the drug in the dead space.

[0069] (4) By setting dual pre-verification conditions (accumulated flushing volume meets the standard and pressure is stable) before resuming drug infusion, the drug interlock protection is released only after the infusion pathway 3 has returned to normal in both volume and pressure dimensions, thus eliminating the risk of premature release of the interlock due to a single condition delay or misjudgment.

[0070] (5) By triggering quantitative flushing at a preset flushing flow rate when events such as drug initiation, speed adjustment, drug change and consumable replacement occur, the preset flushing volume is clearly defined to complete the rapid replacement of the dead cavity volume, reducing the steady-state delivery establishment time from tens of minutes depending on the maintenance flow rate to tens of seconds depending on the preset flushing flow rate, while eliminating the non-standard problems caused by inconsistent manual flushing operations.

[0071] (6) By using the independent drive architecture of the micro-injection pump 22 and the infusion pump 12 and the independent physical control of the on / off mechanism 5, dual redundant safety protection of electrical stop and physical blockage is realized, so that when any protection path fails, the other path can still independently stop the drug infusion.

[0072] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0073] It should also be noted that, in this document, the terms "upper," "lower," "left," "right," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the invention and simplifying the description, 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, and therefore should not be construed as a limitation of the invention. Furthermore, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor should they be construed as indicating or implying relative importance. Moreover, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements, but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device.

[0074] The above provides a detailed description of an infusion system and method based on carrier fluid synchronous propulsion combined with anti-push injection, as provided in this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand this application, and the content of this specification should not be construed as limiting this application. Furthermore, those skilled in the art will recognize that various modifications may be made to the specific implementation methods and application scope based on this application. It is neither necessary nor possible to exhaustively list all implementation methods here, but obvious variations or modifications derived therefrom are still within the protection scope of this application.

Claims

1. An infusion system based on carrier fluid synchronous propulsion combined with anti-push injection, characterized in that, The system includes: The drug infusion branch is configured to infuse vasoactive drugs with preset drug parameters; The carrier fluid delivery branch is configured to deliver the carrier fluid with preset carrier fluid parameters; Infusion pathway, used to connect to the infusion object; The confluence cavity is connected to the drug infusion branch, the carrier fluid infusion branch, and the infusion pathway, respectively, so that the vasoactive drug and the carrier fluid are combined in the confluence cavity and then output to the infusion target along the infusion pathway. A switching mechanism is provided at any position where the drug infusion branch connects to the confluence cavity, and is used to switch the flow of the vasoactive drug in the drug infusion branch; A detection unit is disposed on the carrier liquid infusion branch and configured to acquire the carrier liquid loading information in the carrier liquid infusion branch; The synchronous control unit is signal-connected to the detection unit and the on / off mechanism, and is communicatively connected to the respective infusion execution elements of the drug infusion branch and the carrier liquid infusion branch. The synchronization control unit is used for at least: When the carrier fluid information transmitted by the detection unit is received, and the carrier fluid infusion branch is determined to meet the abnormal infusion conditions based on the carrier fluid information, the on / off mechanism is controlled to block the drug infusion branch and / or the infusion execution element of the drug infusion branch is controlled to suspend operation, so as to simultaneously suspend the infusion of the vasoactive drug.

2. The infusion system based on carrier fluid synchronous boosting combined with anti-push injection according to claim 1, characterized in that, The inlet of the drug infusion branch is connected to a syringe, and a micro-injection pump is provided on the drug infusion branch; and / or, the inlet of the carrier fluid infusion branch is connected to an infusion bag, and an infusion pump is provided on the carrier fluid infusion branch. The micro-injection pump and the infusion pump are respectively the infusion execution elements.

3. The infusion system based on carrier fluid synchronous propulsion combined with anti-push injection according to claim 1, characterized in that, The confluence cavity has a first inlet, a second inlet, and an outlet. The drug infusion branch and the carrier liquid infusion branch are respectively connected to the first inlet and the second inlet. The infusion passage is connected to the outlet. The first and second inlets of the confluence cavity are each equipped with an anti-backflow valve; The confluence cavity is provided with an identifier on its body to indicate the equivalent dead cavity volume of the infusion pathway. The identifier includes at least one of a barcode, an RFID tag, or a preset model code.

4. The infusion system based on carrier fluid synchronous propulsion combined with anti-push injection according to claim 1, characterized in that, The switching mechanism includes any one of an electrically controlled clamp valve, a pipeline clamp, and a solenoid valve.

5. The infusion system based on carrier fluid synchronous propulsion combined with anti-push injection according to claim 1, characterized in that, The synchronization control unit is also used for: When the carrier fluid information meets the first preset recovery condition, the carrier fluid flow rate is increased from the initial value to the target value in a step-incremental or linear manner within a preset time to gradually restore the carrier fluid flow rate. When the fluid carrier information meets the second preset recovery condition, the infusion of the vasoactive drug is resumed.

6. The infusion system based on carrier fluid synchronous boosting combined with anti-push injection according to claim 2, characterized in that, The preset fluid parameters include the maintenance flow rate; the synchronization control unit is also used for: The carrier fluid infusion branch is controlled to continuously output the carrier fluid at the maintenance flow rate to form a continuous driving flow within the infusion passage; In response to any one of the following operations: starting or adjusting the rate of the vasoactive drug, replacing the vasoactive drug, replacing the syringe, or changing the infusion pathway, the carrier fluid flow rate is switched from the maintenance flow rate to a preset flushing flow rate and maintained for a preset flushing time to perform a quantitative flush before returning to the maintenance flow rate.

7. A synchronization control method for an infusion system as described in any one of claims 1-6, characterized in that the method... include: The drug infusion branch is controlled to infuse vasoactive drugs with preset drug parameters, and the carrier fluid infusion branch is controlled to output carrier fluid with preset carrier fluid parameters, so as to use the carrier fluid to propel the vasoactive drugs within the infusion pathway. Receive the carrier fluid information transmitted by the detection unit, and determine whether the carrier fluid infusion branch meets the abnormal infusion conditions based on the carrier fluid information; If so, the control switch mechanism blocks the drug infusion branch and / or controls the infusion execution element of the drug infusion branch to stop operating, so as to simultaneously stop the infusion of the vasoactive drug.

8. A synchronization control method for an infusion system according to claim 7, characterized in that, The carrier fluid information includes at least one of the carrier fluid flow rate, carrier fluid pressure, and infusion pump operating parameters; The step of determining whether the carrier fluid infusion branch meets abnormal infusion conditions based on the carrier fluid information includes: When any one of the following conditions is met: the carrier fluid flow rate is lower than a preset flow rate threshold, the carrier fluid pressure exceeds a preset pressure threshold, or the infusion pump stops operating, the carrier fluid infusion branch is determined to meet the abnormal infusion condition.

9. A synchronization control method for an infusion system according to claim 7, characterized in that, The preset fluid parameters include the maintenance flow rate, and the method further includes: The carrier fluid infusion branch is controlled to continuously output the carrier fluid at the maintenance flow rate; In response to any of the following operations: starting or adjusting the rate of the vasoactive drug, replacing the vasoactive drug, replacing the syringe, or changing the infusion pathway, the carrier fluid flow rate is switched from the maintenance flow rate to a preset flushing flow rate and maintained for a preset flushing time to perform a quantitative flush before returning to the maintenance flow rate.

10. A synchronization control method for an infusion system according to claim 9, characterized in that, The method further includes: When the carrier fluid information meets the first preset recovery condition, the carrier fluid flow rate is increased from the initial value to the target value in a step-incremental or linear manner within a preset time to gradually restore the carrier fluid flow rate. When the fluid carrier information meets the second preset recovery condition, the infusion of the vasoactive drug is resumed; The second preset recovery condition includes: the cumulative volume of the carrier liquid running at the preset flushing flow rate or the maintenance flow rate reaches the preset flushing volume, and the carrier liquid pressure remains stable within a preset time.

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