Safety protection device, infusion equipment, infusion system and working method

Abstract

The present invention relates to a safety protection device, an infusion device, an infusion system and a working method; the infusion system comprises an infusion drive device, an infusion device and a safety protection device, the safety protection device is connected to the infusion device, the infusion device is detachably connected to the infusion drive device, and the anti-self-flow locking mechanism of the safety protection device can switch between a locked state and an unlocked state; the anti-self-flow locking mechanism in the locked state closes the infusion pipeline of the infusion device; the anti-self-flow locking mechanism in the unlocked state opens the infusion pipeline; when the connection between the infusion device and the infusion drive device is normal, the anti-self-flow locking mechanism switches from the locked state to the unlocked state; when the connection between the infusion device and the infusion drive device is abnormal, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or remains in the locked state; with such a configuration, the infusion pipeline can be cut off in time when an abnormal connection occurs between the infusion drive device and the infusion device, thereby ensuring the safety of infusion.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a safety protection device, an infusion device, an infusion system and a working method. Background Art

[0002] Portable electronic infusion devices are among the most commonly used products in the medical field. They typically consist of an infusion driver and a disposable infusion device, enabling continuous or intermittent infusion of medications. They are widely used in daily infusions, anesthesia, analgesia, chemotherapy, and other medical treatments. Infusion devices are required to operate safely and efficiently, including the ability to monitor the infusion process, typically with detection and alarm functions for blockages, bubbles, improper clamping, device failure, and battery level.

[0003] Although current portable electronic infusion devices have various detection and alarm functions that can monitor the operating status of the infusion device in real time, safety hazards still exist. Specifically, if the disposable infusion device and the infusion driver become loose or detach during the infusion process, the infusion driver will issue an alarm and prompt message similar to a clamp failure or incomplete installation. However, because the infusion driver fails to automatically close the disposable infusion device, even though the infusion line is equipped with an infusion clamp, the time delay between the alarm and the response process often leads to spontaneous leakage of the disposable infusion device or blood backflow. In severe cases, excessive infusion of the drug solution may endanger the patient's life and health.

[0004] Therefore, there is an urgent need for a safety protection device, infusion equipment and infusion system that can quickly cut off the infusion pipeline when an abnormal connection event occurs. Summary of the Invention

[0005] The purpose of the present invention is to provide a safety protection device, an infusion device, an infusion system and a working method to solve the problem that the existing infusion device cannot automatically and quickly cut off the infusion line when an abnormal connection event occurs.

[0006] To achieve at least one of the above-mentioned purposes, the present invention provides a safety protection device, which includes an anti-self-flow locking mechanism for connecting to an infusion device and an infusion drive device, and the anti-self-flow locking mechanism can switch between a locked state and an unlocked state; the anti-self-flow locking mechanism in the locked state is used to close the infusion pipeline of the infusion device, and the anti-self-flow locking mechanism in the unlocked state is used to open the infusion pipeline; the anti-self-flow locking mechanism is configured to switch from the locked state to the unlocked state when the connection between the infusion device and the infusion drive device is normal; the anti-self-flow locking mechanism is also configured to switch from the unlocked state to the locked state or maintain the locked state when the connection between the infusion device and the infusion drive device is abnormal.

[0007] Optionally, the anti-self-flow locking mechanism is configured to switch from the locked state to the unlocked state when the pressure applied by the infusion drive device increases or is generated, and to switch from the unlocked state to the locked state when the pressure applied by the infusion drive device decreases or is eliminated.

[0008] Optionally, the anti-self-flow locking mechanism is configured to maintain the locked state or switch to the locked state when the pressure applied by the infusion drive device is less than a preset value, and to switch from the locked state to the unlocked state when the pressure applied by the infusion drive device is greater than a preset value.

[0009] Optionally, the anti-self-flow locking mechanism includes an elastic structure and a pressing structure connected to each other;

[0010] The elastic structure is configured to be in a pre-tightened state under normal conditions and to apply an elastic force to the pressing structure, so that the pressing structure presses against the infusion line after receiving the elastic force applied by the elastic structure, thereby closing the infusion line;

[0011] The pressure-resistance structure is configured to remove the pressure on the infusion line when the pressure applied by the infusion drive device increases or is generated, so as to open the infusion line;

[0012] The pressing structure is further configured to press against the infusion line again when the pressure applied by the infusion drive device is reduced or eliminated, so as to close the infusion line.

[0013] Optionally, the anti-self-flow locking mechanism further includes a rotating shaft, the elastic structure includes a torsion spring, the torsion spring is sleeved on the rotating shaft, and the pressing structure can rotate around the rotating shaft;

[0014] The torsion spring is configured to be in a pre-tightened state under normal conditions and to apply an elastic force to the force-bearing end of the pressing structure, so that the pressing structure rotates in a first direction around the rotating shaft under the action of the elastic force until the pressing end of the pressing structure presses against the infusion pipeline;

[0015] The pressure-resisting structure is configured to rotate around the rotating shaft in a second direction opposite to the first direction when the infusion drive device applies a pressure opposite to the elastic force to the force-receiving end of the pressure-resisting structure until the pressure on the infusion pipeline is removed.

[0016] Optionally, the pressure structure includes a pressure plate and a pressure strip, the pressure strip is a cylindrical structure and is fixed on the pressure plate, the pressure strip is used to directly press against the infusion pipeline, the pressure plate is a flat plate structure and is rotatably connected to the infusion device through the rotating shaft.

[0017] Optionally, the anti-self-flow locking mechanism further includes a fixing plate, the fixing plate is used to be connected to the infusion device, and the pressing structure is rotatably connected to the fixing plate via the rotating shaft.

[0018] Optionally, a first vertical distance from the force action line of the force-bearing end of the pressing structure to the rotation axis is greater than a second vertical distance from the force action line of the pressing end of the pressing structure to the rotation axis.

[0019] Optionally, a ratio of the second vertical distance to the first vertical distance is 0.5.

[0020] To achieve the above-mentioned object, the present invention further provides an infusion device, which includes an infusion device and any one of the safety protection devices described above, wherein the safety protection device is connected to the infusion device.

[0021] Optionally, the infusion device is detachably connected to the safety protection device.

[0022] Optionally, the infusion device has a mounting surface at the top, the safety protection device is fixedly arranged on the mounting surface, and an infusion pipeline and a guide column are arranged on the mounting surface, the safety protection device has a positioning hole, and the guide column is connected to the positioning hole by interference fit.

[0023] To achieve the above objectives, the present invention also provides an infusion system, which includes an infusion device, an infusion drive device and any one of the safety protection devices described, wherein the safety protection device is connected to the infusion device, and the infusion device is detachably connected to the infusion drive device.

[0024] Optionally, the infusion drive device is fixedly connected to the infusion device by a snap buckle.

[0025] To achieve the above-mentioned object, the present invention further provides a working method of an infusion system, wherein the infusion system includes an infusion drive device, an infusion device, and a safety protection device, wherein the safety protection device includes an anti-self-flow locking mechanism capable of switching between a locked state and an unlocked state. The working method comprises:

[0026] Before the infusion drive device is connected to the infusion device, the infusion pipeline of the infusion device is closed by the anti-self-flow locking mechanism;

[0027] When or after the infusion drive device is connected to the infusion device, obtaining a connection state between the infusion device and the infusion drive device, and selectively switching the anti-self-flow locking mechanism between a locked state and an unlocked state according to the connection state; and

[0028] When the connection state is a normal connection, the anti-self-flow locking mechanism switches from the locked state to the unlocked state, and opens the infusion pipeline;

[0029] When the connection state is an abnormal connection, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or maintains the locked state, and closes the infusion pipeline.

[0030] Optionally, when the connection state is a normal connection, the anti-self-flow locking mechanism switches from the locked state to the unlocked state, including:

[0031] The anti-self-flow locking mechanism is configured to switch from the locked state to the unlocked state when the pressure applied by the infusion drive device increases or is generated;

[0032] When the connection state is abnormal, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or maintains the locked state, including:

[0033] When the pressure applied by the infusion drive device to the anti-self-flow locking mechanism is reduced or eliminated, the anti-self-flow locking mechanism switches from the unlocked state to the locked state.

[0034] The safety protection device, infusion equipment, infusion system, and working method provided by the present invention have at least one of the following advantages:

[0035] First, the anti-self-flow locking mechanism provided by the safety protection device can promptly and quickly cut off the infusion line when an abnormal connection occurs between the infusion drive device and the infusion device, preventing the flow of liquid medicine into the patient's body and blood backflow, thereby ensuring the safety of infusion. Moreover, the safety protection device is installed between the mounting contact surface of the infusion device and the infusion drive device, and can be installed and used in a small space. In addition, the anti-self-flow locking mechanism is small in size and light in weight, does not require complex circuit parts, and does not require a power supply system, so it is low in cost and easy to implement.

[0036] Second, the infusion drive device applies pressure to the safety protection device to trigger the safety protection device to open and close the infusion line. This can quickly respond to abnormal connections between the infusion drive device and the infusion device. The fast response speed allows for faster processing of abnormal connections and better ensures infusion safety.

[0037] Third, the anti-self-flow locking mechanism uses the elastic force provided by the elastic structure to compress the infusion line to achieve the effect of stopping flow. Since the elastic structure can compensate for the adverse effects caused by installation and manufacturing tolerances, it not only makes the safety protection device respond faster, but also can evenly and firmly compress the infusion line, reducing damage to the infusion line and ensuring more reliable cutting off of the infusion line;

[0038] Fourth, the anti-self-flow locking mechanism uses a torsion spring and compresses the infusion pipeline according to the principle of leverage, so that when the infusion drive device and the infusion device are installed, only a small force is needed to overcome the installation resistance, so that the infusion drive device and the infusion device can be installed in place, meeting the hardware requirements of normal infusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0040] Figure 1 A schematic diagram of the overall structure of an infusion system provided by a preferred embodiment of the present invention, wherein the infusion drive device and the infusion device have been assembled;

[0041] Figure 2 A schematic structural diagram of an infusion drive device provided in a preferred embodiment of the present invention, illustrating the working surface of the infusion drive device in contact with the anti-self-flow locking mechanism when the infusion drive device is installed with the infusion device;

[0042] Figure 3 A schematic diagram of the overall structure of an infusion device provided in a preferred embodiment of the present invention;

[0043] Figure 4 An enlarged view of the installation of a safety protection device provided in a preferred embodiment of the present invention;

[0044] Figure 5a A schematic structural diagram of a safety protection device provided by a preferred embodiment of the present invention in a locked state at a first viewing angle;

[0045] Figure 5b A schematic structural diagram of a safety protection device provided by a preferred embodiment of the present invention in a locked state at a second viewing angle;

[0046] Figure 6a A front view of an infusion device provided in a preferred embodiment of the present invention;

[0047] Figure 6b for Figure 6a A magnified partial cross-sectional view of the infusion device at position a;

[0048] Figure 7 A schematic structural diagram of a safety protection device in an unlocked state provided by a preferred embodiment of the present invention;

[0049] Figure 8 A mechanical principle diagram of a safety protection device provided in a preferred embodiment of the present invention.

[0050] [Description of reference numerals is as follows]:

[0051] 1-infusion device; 11-mounting surface; 12-guide column; 2-infusion drive device; 3-safety protection device; 31-torsion spring; 32-pressure plate; 33-rotating shaft; 34-pressure strip; 35-fixing plate; 351-positioning hole; 4-infusion pipeline; 5-liquid stop clamp; F1-first force; F2-second force; C-force-bearing end; A-pressing end; B-fulcrum; D-center of the rotating shaft. DETAILED DESCRIPTION

[0052] To make the content of the present invention more clear and understandable, the present invention is further described below in conjunction with the accompanying drawings. Of course, the present invention is not limited to this specific embodiment, and general replacements known to those skilled in the art are also covered within the scope of protection of the present invention.

[0053] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms "a", "said" and "the" used in this application are also intended to include the plural forms, unless the context clearly indicates otherwise. It should be understood that similar words such as "a" or "an" do not indicate a quantity limitation, but rather indicate the presence of at least one; "plurality" indicates a quantity of two or more. Similar words such as "include" or "comprises" mean that the elements or objects appearing before "include" or "comprises" cover the elements or objects listed after "include" or "comprises" and their equivalents, and do not exclude other elements or objects. Secondly, the present invention is described in detail using schematic diagrams, but these schematic diagrams are only for the convenience of detailing examples of the present invention and should not be used as limitations of the present invention.

[0054] The present invention mainly relates to an infusion system, which includes a detachably connected infusion drive device and an infusion device. The infusion drive device is used to control the infusion process of the infusion device to accurately control the infusion volume or infusion flow rate, ensure that the drug can be administered evenly at a specified speed, and the drug volume accurately and safely enters the patient's body, thereby ensuring the accuracy and safety of the infusion and improving the user experience. The infusion drive device is usually a reusable device. The infusion drive device disclosed in the present invention is further an electronic infusion pump. The infusion device is used to store liquid medicine, such as liquid medicine or injectable liquid medicine stored in advance. The liquid medicine stored on the infusion device reaches the patient's body through the infusion line, and the infusion drive device achieves the purpose of controlling the infusion process by acting on the infusion line. The infusion device is usually a disposable product (i.e., consumables). The infusion device disclosed in the present invention further has its own infusion line, which is generally connected to a medicine bag on the infusion device. The medicine bag is arranged in the medicine box of the infusion device and stores the liquid medicine.

[0055] The infusion system disclosed in the present invention is preferably constructed as a portable electronic infusion system to realize intelligent infusion, such as monitoring the infusion status of the drug solution and controlling the infusion rate and infusion time. For example, various data of the infused drug solution are collected and calculated by a controller. After the judgment result is finally obtained, it is fed back to the infusion pump, and the infusion rate is automatically adjusted by the infusion pump. Furthermore, the status of the infused drug solution can also be displayed, such as the current amount of drug solution infused, the remaining amount of drug solution to be infused, the infusion rate, the remaining infusion time, the infusion time, and other information.

[0056] The infusion drive device disclosed in the present invention is detachably connected to the infusion device, and the method of detachable connection is not limited. For example, a relatively convenient and simple snap connection is usually selected to achieve rapid disassembly and assembly between the infusion drive device and the infusion device.

[0057] In order to solve the problem of abnormal connection between the existing infusion device and the infusion drive device, such as loosening or falling off, during the infusion process, the infusion system disclosed in the present invention also includes a safety protection device, which is connected to the infusion device. The safety protection device can promptly detect abnormal connection between the infusion device and the infusion drive device, and automatically and promptly close the infusion line after detecting the abnormal connection, preventing the drug solution from flowing into the patient's body and preventing blood backflow, thereby effectively ensuring the safety of the infusion. Since the safety protection device disclosed in the present invention can promptly respond to abnormal connection events, the speed and efficiency of abnormal event processing are improved, and the reliability and safety of the infusion are better guaranteed.

[0058] The present invention will be further described below with reference to the accompanying drawings and preferred embodiments. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

[0059] Please refer to Figures 1 to 3 A preferred embodiment of the present invention provides an infusion system comprising an infusion device 1 and an infusion drive device 2; the infusion drive device 2 is detachably secured to the infusion device 1, preferably with a snap-fit ​​connection. Specifically, the infusion system further comprises a safety protection device 3, comprising an anti-self-flow locking mechanism for connecting to the infusion device 1 and the infusion drive device 2. The anti-self-flow locking mechanism is detachably or non-detachably connected to the infusion device 1, such as by any one or more mechanical structural connections, such as gluing, riveting, welding, screwing, snap-fitting, or interference fit.

[0060] The anti-self-flow locking mechanism has a locked state and an unlocked state. When the anti-self-flow locking mechanism is in the locked state, it can close (cut off) the infusion line 4, preventing the flow of liquid medicine into the patient's body or blood backflow. When the anti-self-flow locking mechanism is in the unlocked state, it can open the infusion line 4, allowing the liquid medicine to flow out of the infusion device 1 and initiating infusion. Specifically, when the connection between the infusion device 1 and the infusion drive device 2 is normal, the anti-self-flow locking mechanism switches from the locked state to the unlocked state. However, when the connection between the infusion device 1 and the infusion drive device 2 is abnormal, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or remains in the locked state. Preferably, the locking state is a normally closed state; the "normally closed state" means that under normal circumstances, the anti-self-flow locking mechanism is in a state of closing the infusion pipeline 4. When the anti-self-flow locking mechanism is in normal state, it is in a static state when the anti-self-flow locking mechanism is not subject to external force. This state usually corresponds to the situation where the infusion drive device 2 is not clamped on the infusion device 1. Then, when the infusion drive device 2 is clamped on the infusion device 1 and the connection is normal, the anti-self-flow locking mechanism is triggered and switched to the unlocked state. However, when the infusion drive device 2 is clamped on the infusion device 1 and the connection is abnormal, the anti-self-flow locking mechanism will switch to the locked state again or continue to maintain the locked state.

[0061] After applying the above infusion system, when the connection between the infusion drive device 2 and the infusion device 1 is abnormal, the safety protection device 3 can be quickly triggered, resulting in a fast response and the ability to quickly cut off the infusion line 4, ensuring the safety of the infusion. It should also be understood that when the infusion drive device 2 and the infusion device 1 are assembled and infusion has not yet begun, if the infusion drive device 2 and the infusion device 1 are not properly clamped or installed, the safety protection device 3 will not be triggered and will remain in a locked state. Therefore, with respect to the infusion device alone, it also has a second function: after the infusion device is filled with liquid medicine, the anti-self-flow locking device will automatically close the infusion line and prevent the liquid medicine from flowing out.

[0062] This embodiment does not impose any particular limitation on the specific structure of the safety protection device 3. As long as the safety protection device 3 can promptly respond to a normal connection between the infusion drive device 2 and the infusion device 1 and open the infusion line 4, and can also promptly respond to an abnormal connection between the infusion drive device 2 and the infusion device 1 and close the infusion line 4, once a connection abnormality occurs, the safety protection device 3 can be quickly triggered.

[0063] As an example, the anti-self-flow locking mechanism includes a sensor and a valve that are communicatively connected. The sensor is used to detect the connection status between the infusion drive device 2 and the infusion device 1, so that the valve selectively closes or opens the infusion line 4 according to the connection status. If the sensor detects that the connection between the infusion drive device 2 and the infusion device 1 is normal, the valve opens the infusion line 4; conversely, when the sensor detects that the connection between the infusion drive device 2 and the infusion device 1 is abnormal, the valve closes the infusion line 4. The specific type of the sensor is not limited, and a pressure sensor or a displacement sensor can be used for detection. The valve is arranged on the infusion line 4, for example, at a position on the infusion line 4 close to the liquid outflow outlet on the infusion device 2 or at other positions. The type of valve is not limited and can be selected as needed. A valve with higher control accuracy, such as an electric valve, is preferred.

[0064] As another example, the anti-self-flow locking mechanism is a purely mechanical component. Specifically, when the anti-self-flow locking mechanism is subjected to an increase or generation of pressure applied by the infusion drive device 2, it switches from a locked state to an unlocked state, and when the anti-self-flow locking mechanism is subjected to a reduction or elimination of the pressure applied by the infusion drive device 2, it switches from an unlocked state to a locked state. The reduction or elimination of the pressure applied by the infusion drive device 2 here can be understood as meaning that when the infusion drive device 2 and the infusion device 1 are not clamped in place or not installed in place, the pressure applied by the infusion drive device 2 on the anti-self-flow locking mechanism is smaller, or even reduced to zero. This method triggers the anti-self-flow locking mechanism to open or close the infusion line 4 by applying pressure to the anti-self-flow locking mechanism by the infusion drive device 2. This allows for a quick response to abnormal connections between the infusion drive device 2 and the infusion device 1, with a fast response speed and high response accuracy. This allows for faster processing of abnormal connections and better guarantees infusion safety.

[0065] Furthermore, the anti-self-flow locking mechanism remains locked or switches to a locked state when the pressure applied by the infusion drive unit 2 is less than a preset value, and switches from the locked state to the unlocked state when the pressure applied by the infusion drive unit 2 exceeds a preset value. In other words, the anti-self-flow locking mechanism can only open the infusion line 4 when the pressure applied by the infusion drive unit 2 is sufficiently high, further ensuring the safety of the infusion. The pressure value required to open the infusion line 4 can be set according to actual needs and is not required by this application.

[0066] In a preferred embodiment, the anti-self-flow locking mechanism includes an elastic structure and a pressure-resisting structure connected to each other; the elastic structure is configured to be in a pre-tightened state under normal conditions and to apply an elastic force to the pressure-resisting structure, so that the pressure-resisting structure, after being subjected to the elastic force applied by the elastic structure, presses against the infusion line 4, thereby closing the infusion line 4 after being subjected to a sufficiently large pressure applied by the pressure-resisting structure. In addition, when the pressure-resisting structure is subjected to the pressure applied by the infusion drive device 2, it removes the pressure applied to the infusion line 4 from the infusion line 4, thereby opening the infusion line 4. At this time, the pressure applied by the pressure-resisting structure to the infusion line 4 is reduced or eliminated, allowing the infusion line 4 to be opened. In addition, when the pressure applied by the infusion drive device 2 is reduced or eliminated, the pressure-resisting structure can again press against the infusion line 4, thereby reclosing the infusion line 4. In a preferred embodiment, the pressure-resisting structure can again press against the infusion line 4 after the pressure applied by the infusion drive device 2 is less than the elastic force applied by the elastic structure.

[0067] This embodiment does not limit the structure of the elastic structure, and it can be an elastic element of a coil spring, torsion spring, spring sheet, or other structure. The structure (including shape and / or size) of the said pressing structure is also not limited, and includes but is not limited to structures such as pressure strips and pressure blocks. The provision of the elastic structure facilitates the use of elastic force to compress the infusion line 4 to achieve the effect of stopping flow. The flow stopping effect is good and the structure is simple. In addition, the elastic structure can compensate for the adverse effects of installation and manufacturing tolerances, not only making the safety protection device respond faster, but also being able to evenly and firmly compress the infusion line 4, reducing damage to the infusion line 4, and ensuring more reliable cutting of the infusion line 4.

[0068] Please refer to Figure 4 , and combined with Figure 5a and Figure 5b In one embodiment, the elastic structure includes a torsion spring 31, the pressing structure includes a pressure plate 32, and the anti-self-flow locking mechanism further includes a rotating shaft 33. The pressure plate 32 is rotatable about the rotating shaft 33, and the torsion spring 31 is sleeved on the rotating shaft 33. The torsion spring 31 is normally in a pre-tensioned state. Under the action of the torsion spring 31, the force-bearing end C of the pressure plate 32 is propped upward by one leg of the torsion spring 31, and the pressing end A of the pressure plate 32 is pressed against the infusion line 4. After the pressure plate 32 presses against the infusion line 4, the infusion device 1 is locked. More specifically, when the force-bearing end C of the pressure plate 32 is subjected to the first force F1 (i.e., elastic force) of the torsion spring 31, the pressure plate 32 rotates counterclockwise (first direction) around the rotation axis 33, for example, as viewed from a direction perpendicular to the direction shown in the figure, until the pressing end A of the pressure plate 32 generates a second force F2 on the infusion line 4. The magnitude of the second force F2 can be determined based on the magnitude of the first force F1, the length of the power arm, and the length of the resistance arm. The magnitude of the second force F2 is sufficient to stop the flow of the infusion line 4.

[0069] For more details, refer to Figure 6a and Figure 6b , the surface of the infusion line 4 is depressed after being subjected to the pressure of the pressure plate 32 until the internal infusion channel is blocked. Conversely, when the pressure plate 32 is subjected to a pressure in the opposite direction of the first force F1 applied to its force-bearing end C by the infusion drive device 2, it rotates clockwise (in the second direction) around the rotation axis 33 until it is separated from the infusion line 4 or no longer presses the infusion line 4. The setting of the torsion spring 31 can provide sufficient torque to ensure flow cessation, and it is also convenient to compress the infusion line 4 according to the principle of leverage. Only a small force is needed to overcome the installation resistance between the infusion device 1 and the infusion drive device 2, ensuring that the infusion drive device 2 and the infusion device 1 are installed in place to meet normal infusion needs.

[0070] Return Reference Figure 4 、 Figure 5a and Figure 5b In one exemplary embodiment, the pressure structure further includes a pressure strip 34, which is fixedly disposed on the side of the pressure plate 32 facing the infusion line 4. That is, the pressure strip 34 is disposed between the infusion line 4 and the pressure plate 32. The pressure strip 34 is used to directly press against the infusion line 4. Because the pressure strip 34 is smaller than the pressure plate 32, it can be configured as an elongated structure. More preferably, the pressure strip 34 is a cylindrical structure, which facilitates avoiding existing structures on the mounting surface 11 of the infusion device 1. Moreover, the cylinder can press against the infusion line 4 through line contact, resulting in a better pressure effect and less likely to shift. More preferably, the pressure strip 34 is perpendicular to the infusion line 4 when pressing against the infusion line 4, thereby further ensuring a more stable flow-stopping effect. Of course, in other embodiments, the pressure strip 34 can be eliminated and the pressure plate 32 can directly press against the infusion line 4. The pressure plate 32 is preferably a flat plate structure and is rotatably connected to the infusion device 1 via a rotating shaft 33. The flat plate structure has a large contact area and a good compression effect, which can reduce damage to the infusion pipeline 4.

[0071] In one embodiment, the anti-self-flow locking mechanism further includes a fixing plate 35 for fixedly connecting to the infusion device 1, preferably detachably connecting thereto. The pressing plate 32 and the fixing plate 35 are connected by a rotating shaft 33, allowing the pressing plate 32 to rotate relative to the fixing plate 35. Optionally, the fixing plate 35 is connected to the infusion device 1 by an interference fit.

[0072] refer to Figure 4 The infusion device 1 has a top mounting surface 11, on which the anti-self-flow locking mechanism is fixedly mounted. The mounting surface 11 is provided with an infusion line 4 and is also used to assemble the infusion drive device 2. Optionally, a protruding guide column 12 is further provided on the mounting surface 11; Figure 5aAs shown, the fixing plate 35 is provided with a through-hole 351. The locating hole 351 on the pressing plate 35 is installed along the guide post 12 and fixed to the mounting surface 11 of the infusion device 1. The guide post 12 and the locating hole 351 are connected by an interference fit. The number of guide posts 12 is preferably two, and the two guide posts 12 are connected by an interference fit with a corresponding locating hole 351.

[0073] refer to Figure 2-4 The infusion drive device 2 has a working surface (where the label b is located). When the infusion drive device 2 is locked and installed with the infusion device 1, the working surface is also in contact with the pressure plate 32 and exerts a downward force on the pressure plate 32. Under the connection of the rotating shaft 33, the pressing end A of the pressure plate 32 begins to rotate, and the pressure strip 34 leaves the infusion pipeline 4, opening the infusion pipeline 4, so that the anti-self-flow locking mechanism is changed from a locked state to an unlocked state to perform the infusion task.

[0074] refer to Figure 8 In a preferred embodiment, the first vertical distance L1 between the force action line of the force-bearing end C of the pressure plate 32 and the rotating shaft 33 is greater than the second vertical distance L2 between the force action line of the pressing end A of the pressure plate 32 and the rotating shaft 33. With such a structure, the infusion line 4 can be opened with a smaller force, and the installation resistance between the infusion drive device 2 and the infusion device 1 can be overcome. Among them, the force action line of the force-bearing end C of the pressure plate 32 is the force action line of the first force F1, and the force action line of the pressing end A of the pressure plate 32 is the force action line of the second force F2. In view of the limitation of the space size of the pump head and the medicine box, preferably, the ratio of the second vertical distance L2 to the first vertical distance L1 is 0.5. More specifically, based on the principle of leverage, the length of the power arm CB of the pressure plate 32 is greater than the length of the resistance arm AB. The lengths of the power arm CB and resistance arm AB are proportional, allowing the infusion drive device 2 to trigger the pressure plate 32 with a force far less than that required to compress the infusion line 4. This does not affect the installation of the infusion drive device 2 and the infusion device 1, while also making it easier to open the infusion line 4. Where B is the fulcrum of the lever, and D is the center of the rotating shaft 33.

[0075] In a specific embodiment, an infusion line 4 with an outer diameter of 4.0 mm and an inner diameter of 2.4 mm is used as a test object, a flow-stopping operation is performed on the infusion line 4, and a pressure strip 34 with a diameter of 1 mm is used to stop the flow of the infusion line 4. At this time, the length L of the force arm AD of the pressure on the infusion line 4 can be set to 6 mm, and after experimental measurement, it is found that a pressure of approximately 3 N can stop the flow of the infusion line 4. Therefore, a target torque of 18 N.mm is required to stop the flow of the infusion line 4.

[0076] Furthermore, based on the required target torque of 18 N.mm, the required specifications of the torsion spring 31 can be inferred. Specifically, the calculation process of the torsion spring torque is as follows:

[0077] According to the torsion spring torque formula and moment of inertia formula The torsion spring torque can be derived as:

[0078]

[0079] Where: T is the torque of the torsion spring, E is the elastic modulus of the torsion spring; θ is the angle of the torsion spring; d is the wire diameter of the torsion spring; n is the number of effective turns of the torsion spring; and D is the inner diameter of the torsion spring.

[0080] When E = 2250 N / mm, θ = 0.667 rad, d = 1.2 mm, n = 2, and D = 1.2 mm, and according to equation (1), the torsion spring torque T ≈ 20.26 N.mm can be obtained. Therefore, the torque provided by the torsion spring 31 is greater than the required target torque of 18 N.mm, and the torsion spring 31 can meet the flow stopping requirement.

[0081] When the torsion spring torque is known, the required pressure of the flow-stopping infusion line can be obtained based on the length L of the force arm AD. Figure 8 Under the action of the second force F2, the pressure plate 32 will rotate along the center point D of the rotating shaft, so that the pressure strip 34 at the pressing end A presses the infusion pipeline 4. If the AB length and the BD distance are known, the AD distance can be obtained. The AD distance is the length L of the force arm for the pressing end A of the pressure plate 32 to apply pressure to the infusion pipeline 4, which can be 6.045mm. Then, according to the torque formula T=F*L, when the torque T=20.26Nmm of the torsion spring 31 is known, it can be known that the force F≈3.35N, which is greater than 3N and can meet the flow-stopping requirements.

[0082] Next, the working principle of the infusion system proposed by the present invention will be further explained in conjunction with the preferred embodiments.

[0083] First, the medical staff fills the medicine bag of the infusion device 1 with a fixed amount of liquid medicine. Then, the safety protection device 3 is aligned with the positioning hole 351 along the guide column 12, and the safety protection device 3 is pressed downward to fix the safety protection device 3 on the mounting surface 11 of the infusion device 1. At this time, the safety protection device 3 is subjected to the torsion force of the torsion spring 31, so that the pressure strip 34 automatically presses against the infusion line 4 to block it and prevent the liquid medicine from flowing out. Therefore, there is no need to manually press the liquid stop clamp 5 to close the infusion line 4.

[0084] Next, the medical staff sets the infusion task (such as infusion time, infusion amount, infusion rate, etc.) on the infusion drive device 2; after setting the infusion task, the infusion drive device 2 is snap-fitted to the infusion device 1. When the infusion drive device 2 and the infusion device 1 are installed, Figure 2The working surface of the infusion drive device 2 shown contacts the force-bearing end C of the pressure plate 32 of the safety protection device 3 and applies a downward pressing force. Based on the principle of leverage, the pressure strip 34 leaves the extrusion surface of the infusion line 4, thereby opening the infusion line 4. At the same time, due to the principle of leverage, the length of the power arm BC is greater than the length of the resistance arm AB, so that the force for opening the infusion line 4 is much smaller than the force for closing the infusion line 4, thereby reducing or eliminating the resistance when the infusion drive device 2 and the infusion device 1 are installed.

[0085] After the infusion drive device 2 and the infusion device 1 are installed in place, the medical staff completes the exhaust and connects the infusion line 4 to the human body with a puncture needle, and then starts the infusion task and begins the infusion.

[0086] During the normal infusion process, if the fixing buckle on one side of the infusion drive device 2 is suddenly loosened due to various external reasons, the working surface of the infusion drive device 2 will leave the pressure plate 32 of the safety protection device 3, and the pressure plate 32 will be separated from the force applied by the infusion drive device 2. The pressure strip 34 will also follow the pressure plate 32 under the torsion of the torsion spring 31 to re-tighten the infusion line 4 and close the infusion line, avoiding the problem of failing to close the infusion line 4 in time, resulting in over-injection of medicine without knowing how much extra medicine is infused, thereby reducing the risk of threatening the patient's life and health.

[0087] While there are commercially available infusion driver alarms, the infusion driver 2 only issues an alarm indicating a misalignment. Until medical personnel arrive to address the alarm, the infusion driver 2 remains unable to monitor the infused medication volume. The solution provided by the present invention immediately closes the infusion line 4 when the infusion driver 2 issues a misalignment alarm. This ensures that the infusion medication volume recorded by the infusion driver 2 is consistent with the actual amount delivered to the patient, significantly improving the accuracy and safety of infused medication volume. Adapting the solution provided by the present invention to existing alarm measures further ensures the continuity and monitorability of infused medication volume.

[0088] Furthermore, this embodiment also provides an infusion device, including an infusion device 1 and a safety protection device 3, wherein the safety protection device 3 is connected to the infusion device 1, and preferably the safety protection device 3 is detachably connected to the infusion device 1, such as an interference fit connection.

[0089] In this embodiment, the infusion drive device 2, the safety protection device 3 and the infusion device 1 are three independent components that can be assembled and then disassembled. In a preferred embodiment, the infusion drive device 2 can detect an abnormal connection between it and the infusion device 1 and issue an alarm.

[0090] Furthermore, this embodiment also provides a working method of an infusion system, comprising:

[0091] Before the infusion drive device 2 is connected to the infusion device 1, the infusion line 4 is closed by the anti-self-flow locking mechanism;

[0092] When or after the infusion drive device 2 is connected to the infusion device 1, obtaining the connection state between the infusion device 1 and the infusion drive device 2, and selectively switching the anti-self-flow locking mechanism between the locked state and the unlocked state according to the connection state; and

[0093] When the connection state is normal, the anti-self-flow locking mechanism switches from the locked state to the unlocked state, and the infusion pipeline 4 is opened;

[0094] When the connection state is an abnormal connection, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or maintains the locked state, and closes the infusion pipeline 4.

[0095] Furthermore, in the working method, when the connection state is a normal connection, the anti-self-flow locking mechanism switches from a locked state to an unlocked state, including:

[0096] When the pressure applied by the infusion drive device 2 to the anti-self-flow locking mechanism increases or is generated, it switches from the locked state to the unlocked state.

[0097] Furthermore, when the connection state is an abnormal connection, the anti-self-flow locking mechanism switches from an unlocked state to a locked state or maintains a locked state, including:

[0098] When the pressure applied by the infusion drive device 2 to the anti-self-flow locking mechanism is reduced or eliminated, the anti-self-flow locking mechanism switches from the unlocked state to the locked state.

[0099] In summary, the present invention can solve the problem of preferentially closing the infusion line when an abnormal connection occurs between the infusion drive device and the infusion device, preventing the drug solution from flowing into the patient's body or blood from flowing back, reducing the risk of endangering the patient's life safety and avoiding the problem of medical staff being unable to arrive in time to deal with the abnormal connection. In addition, the present invention utilizes the principle of torsion spring and lever to achieve the purpose of overcoming the installation resistance to open the infusion line with only a small force, while ensuring the good clamping of the infusion drive device and the infusion device, thus ensuring the hardware requirements for normal infusion. In addition, the anti-self-flow locking mechanism disclosed in the present invention is installed between the mounting contact surface of the infusion device and the infusion drive device, which can be installed and used in a small space. The anti-self-flow locking mechanism is small in size, light in weight, does not require complex circuit parts, does not require a power supply system, is low in cost, and is easy to implement. It automatically closes before infusion, automatically opens during infusion, and automatically closes in the event of an abnormal connection (such as an alarm). After the infusion drive device detects and alarms, it builds another safety guarantee platform, protecting the safe use of patients and effectively improving the safety of infusion.

[0100] It should be understood that the above description is only a preferred embodiment of the present invention and does not constitute any formal or substantial limitation to the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the present invention.

Claims

1. An infusion device, characterized in that: The invention comprises an infusion device and a safety protection device, wherein the safety protection device comprises an anti-self-flow locking mechanism, wherein the anti-self-flow locking mechanism can be switched between a locked state and an unlocked state. The anti-self-flow locking mechanism in the locked state is used to close the infusion pipeline, and the anti-self-flow locking mechanism in the unlocked state is used to open the infusion pipeline. The infusion device has a top mounting surface, the anti-self-flow locking mechanism is fixedly mounted on the mounting surface, and the mounting surface is also used to assemble the infusion drive device; the infusion pipeline and the guide column are arranged on the mounting surface; The anti-self-flow locking mechanism includes a rotating shaft, a torsion spring, a pressure plate, and a fixed plate; the fixed plate is provided with a through positioning hole, and is installed along the guide column through the positioning hole and is detachably fixed to the mounting surface; the pressure plate and the fixed plate are connected by the rotating shaft so that the pressure plate can rotate around the rotating shaft; the torsion spring is sleeved on the rotating shaft; The anti-self-flow locking mechanism is in a locked state under normal conditions, and the torsion spring is in a pre-tightened state. The force-bearing end of the pressure plate rotates in a first direction about the rotating shaft under the action of the torsion spring, so that the pressing end of the pressure plate is pressed against the infusion pipeline; a first vertical distance from the force-bearing end to the rotating shaft is greater than a second vertical distance from the pressing end to the rotating shaft; When the connection between the infusion device and the infusion drive device is normal, the force-bearing end of the pressure plate is rotated in the second direction about the rotation axis after receiving the pressure applied by the infusion drive device, until the infusion line is opened, so that the anti-self-flow locking mechanism switches from the locked state to the unlocked state; When the connection between the infusion device and the infusion drive device is abnormal, the pressure plate is pressed against the infusion pipeline again after the pressure applied by the infusion drive device is reduced or eliminated, so that the anti-self-flow locking mechanism switches from the unlocked state to the locked state or maintains the locked state.

2. The infusion device according to claim 1, characterized in that The anti-self-flow locking mechanism is configured to switch from the locked state to the unlocked state when the pressure applied by the infusion drive device increases or is generated, and the anti-self-flow locking mechanism is configured to switch from the unlocked state to the locked state when the pressure applied by the infusion drive device decreases or is eliminated.

3. The infusion device according to claim 2, characterized in that: The anti-self-flow locking mechanism is configured to maintain the locked state or switch to the locked state when the pressure applied by the infusion drive device is less than a preset value, and to switch from the locked state to the unlocked state when the pressure applied by the infusion drive device is greater than a preset value.

4. The infusion device according to any one of claims 1 to 3, characterized in that: The anti-self-flow locking mechanism also includes a pressure strip, which is a cylindrical structure and is fixed to the pressure plate. The pressure strip is used to directly press against the infusion pipeline. The pressure plate is a flat plate structure and is rotatably connected to the infusion device through the rotating shaft.

5. The infusion device according to any one of claims 1 to 3, characterized in that: A ratio of the second vertical distance to the first vertical distance is 0.

5.

6. An infusion system, characterized in that: The invention comprises an infusion drive device and an infusion apparatus as described in any one of claims 1 to 5, wherein the infusion drive device is detachably mounted on the mounting surface of the infusion device, and the infusion drive device has a working surface. When the infusion drive device is locked and mounted with the infusion device, the working surface contacts the pressure plate to drive the pressure plate to rotate around the rotating shaft to open the infusion pipeline.

7. The infusion system according to claim 6, characterized in that: The infusion drive device is fixedly connected with the infusion device by a buckle.

8. A method for operating an infusion system, performed based on the infusion system according to claim 6 or 7, characterized in that: The working method comprises: Before the infusion drive device is connected to the infusion device, the infusion pipeline of the infusion device is closed by the anti-self-flow locking mechanism; When or after the infusion drive device is connected to the infusion device, obtaining a connection state between the infusion device and the infusion drive device, and selectively switching the anti-self-flow locking mechanism between a locked state and an unlocked state according to the connection state; and When the connection state is a normal connection, the anti-self-flow locking mechanism switches from the locked state to the unlocked state, and opens the infusion pipeline; When the connection state is an abnormal connection, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or maintains the locked state, and closes the infusion pipeline.

9. The operating method of the infusion system according to claim 8, characterized in that: When the connection state is a normal connection, the anti-self-flow locking mechanism switches from the locked state to the unlocked state, including: The anti-self-flow locking mechanism is configured to switch from the locked state to the unlocked state when the pressure applied by the infusion drive device increases or is generated; When the connection state is abnormal, the anti-self-flow locking mechanism switches from the unlocked state to the locked state or maintains the locked state, including: When the pressure applied by the infusion drive device to the anti-self-flow locking mechanism is reduced or eliminated, the anti-self-flow locking mechanism switches from the unlocked state to the locked state.

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