Disposable multi-fluid channel lead device for examination and research of hypobaric substances

Abstract

The present invention provides a disposable multi-fluid path lead device for the purpose of checking and researching pressure-boosting substances. The device is composed of a base, a rotary core, a lock nut, a protective cap, a tube body, and a fixed plate. The lock nut, the tube body, the base and the fixed plate are made of polycarbonate (PC) or polyurethane (PU) materials, and the protective cap and the rotary core are made of polyethylene (PE) materials. Except that the lock nut port is a standard Luer connector (male head), the other connection ports are all standard Luer conical connectors (female head). The actual torque of the rotary core rotation is less than 1.0Nm. It is sterilized with ethylene oxide, sterile and pyrogen-free, and is for disposable use. Each set of the lead device subject interface is equipped with a rotary cap. In addition to the main body, it also contains 3 Luer connector one-way check valves and 3 Luer connector extension tubes (length 40cm). When using the lead device for experiments, the test sample, standard product, and push solution do not need to be plugged in and out for liquid aspiration. By rotating the position of the rotary core, different liquid paths are selected, and no bubbles are generated between pushing and aspirating liquid.

Description

Technical Field

[0001] The invention belongs to the technical field of drug inspection, and is used for continuous switching of multiple liquid paths for drug administration by femoral vein artery cannulation for checking blood pressure-boosting and blood pressure-reducing substances in drug inspection. Background Art

[0002] Existing technical conditions: Inspection of blood pressure-boosting and blood pressure-lowering substances. The femoral vein administration method has different doses of standard and test solutions. During the injection process, the intravenous cannula connection port is frequently plugged in and out, resulting in a sudden increase in the risk of injecting air into the animal. And after each injection, the syringe needs to be removed to absorb the next injection of the drug solution. Frequent operations greatly reduce the experimental stability and efficiency.

[0003] The inspection of pressor and hypotensive substances includes three stages: laboratory animal sensitivity review, inspection, and laboratory animal sensitivity verification. Calculated based on the inspection of a batch of samples, the inspection of hypotensive substances requires 13-16 injections, and the inspection of pressor substances requires 10-13 injections after the standard dosage is accurately found. After each injection of the standard / test sample, a certain amount of sodium chloride injection is injected to flush the drug solution into the animal. After the experimental animal surgery is completed, the stable time available for experimental operation is limited (animal anesthesia effect, secretion production, etc.), and any external interference factors may affect the blood pressure of the experimental animal and even cause the experiment to be interrupted. Under such conditions, frequent plugging and unplugging of syringes to switch solutions not only affects the experimental efficiency, but also has a significant impact on the accuracy of the experimental results and the stability of the experimental process. Due to the gradual strengthening of the concept of experimental animal welfare at home and abroad, and the rapid rise of the 3R (reduction, optimization, and substitution) principle, animal experiments mostly use centralized experiments to complete drug inspections to improve the efficiency of experimental animals and reduce the investment in quantity. Therefore, in the inspection of multiple batches of samples, the impact of existing technical conditions on experimental efficiency will be more obvious. Summary of the invention

[0004] In view of the above defects or deficiencies in the prior art, the present invention is based on the practical perspective of experimental operation and intends to solve the problem of low efficiency and large error caused by frequent alternating injection of standard solutions and test solutions of various concentrations when administering drugs through the femoral vein during the inspection of pressor and hypotensive substances. A disposable multi-fluid-path lead device for the inspection and research of pressor and hypotensive substances is provided.

[0005] Its main technical solution is: a disposable multi-liquid-path guide device for the purpose of inspection and research of pressure-boosting substances, including a fixed plate, a base and a tube body, wherein the base is fixedly arranged below the tube body, and the base is detachably fixedly connected to the top of the fixed plate, and is characterized in that: three branches are cross-arranged on both sides of the tube body, a lock nut is fixedly arranged on the head of the tube body, and a rotary core for controlling the internal circulation of the tube body is arranged above the tube body, and the rotary cores correspond to the three branches respectively, and corresponding interfaces are arranged at the three branches and the lock nut port.

[0006] Furthermore, each set of lead device main body interface is equipped with a screw cap.

[0007] Furthermore, the lock nut, the tube body, the base and the fixing plate are all made of polycarbonate (PC) or polyurethane (PU) materials, and the rotary cap and the rotary core are made of polyethylene (PE) material.

[0008] Furthermore, the locking female port is a standard Luer connector (male head), and the remaining connection ports are standard Luer conical connectors (female heads).

[0009] Furthermore, the rotating torque of the rotating core is less than 1.0 Nm. The device is sterilized by ethylene oxide and is sterile and pyrogen-free.

[0010] Furthermore, the joints of the three branches are respectively provided with a Luer connector one-way check valve and a Luer connector extension tube.

[0011] A method for using a disposable multi-fluid path lead device for the purpose of testing and researching hypobaric substances, comprising the following cycle steps:

[0012] (1) Injection of standard solution: insert the Luer connector extension tube of the head branch of the three branches into the standard container, and use a syringe to inject the standard solution into the device branch by pressure difference;

[0013] (2) Flush the standard solution: insert the Luer connector extension tube of the tail branch of the three branches into the standard container, and use a syringe to inject the sodium chloride solution into the device branch by pressure difference;

[0014] (3) Injection of the test solution: insert the Luer connector extension tube of the middle branch of the three branches into the standard container, and use a syringe to inject the test solution into the device branch by pressure difference;

[0015] (4) Flush the test solution: Insert the Luer connector extension tube of the tail branch of the three branches into the standard container, and use a syringe to inject the sodium chloride solution into the device branch using the pressure difference.

[0016] The beneficial effects of the present invention are:

[0017] 1. When using the lead device for the experiment, there is no need to plug in or unplug the test sample, standard sample, and push solution to aspirate the liquid.

[0018] 2. Select different liquid paths by rotating the core position.

[0019] 3. No bubbles will be generated between pushing and aspirating liquid, and there are no other steps.

[0020] 4. Improve experimental efficiency and reduce the input and use of experimental animals during the limited laboratory time of animals, in line with the 3R principle. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Other features, objects and advantages of the present application will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0022] Figure 1 It is a schematic diagram of the main structure of the device of the present invention;

[0023] Figure 2 This is a top view of the working principle of the device of the present invention;

[0024] Among them: 1. Fixed plate; 2. Base; 3. Pipe body; 4. Branch; 5. Lock nut; 6. Rotary core; 7. Check valve; 8. Extension tube; 9. Standard solution; 10. Test solution; 11. Sodium chloride solution. DETAILED DESCRIPTION

[0025] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the relevant invention, rather than to limit the invention. It is also necessary to explain that, for ease of description, only the parts related to the invention are shown in the accompanying drawings.

[0026] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0027] Example:

[0028] The disposable multi-fluid path lead device is composed of a base, a rotary core, a lock nut, a rotary cap, a tube body, and a fixed plate. The base is fixedly arranged below the tube body, and the base is detachably fixedly connected to the top of the fixed plate. It is characterized in that three branches are arranged on both sides of the tube body in sequence, a lock nut is fixedly arranged at the head of the tube body, and a rotary core for controlling the internal circulation of the tube body is arranged above the tube body. The rotary cores correspond to the three branches respectively, and the three branches and the lock nut port are provided with corresponding interfaces. Each set of the main interface of the lead device is equipped with a rotary cap, wherein the lock nut, the tube body, the base and the fixed plate are made of polycarbonate (PC) or polyurethane (PU) materials, and the rotary cap and the rotary core are made of polyethylene (PE) materials. Except for the lock nut port, which is a standard Luer connector (male head), the other connection ports are standard Luer conical connectors (female head). The actual torque of the rotary core rotation is less than 1.0Nm. It is sterilized with ethylene oxide, sterile and pyrogen-free, and is for disposable use. Each set of the main interface of the lead device is equipped with a rotary cap. In addition to the main body, it also contains 3 Luer connector one-way check valves and 3 Luer connector extension tubes (length 40cm), but does not include a syringe.

[0029] As shown in the figure, the method for using the disposable multi-fluid path guide device includes the following cycle steps:

[0030] (1) Injection of standard solution: insert the Luer connector extension tube of the head branch of the three branches into the standard container, and use a syringe to inject the standard solution into the device branch by pressure difference;

[0031] (2) Flush the standard solution: insert the Luer connector extension tube of the tail branch of the three branches into the standard container, and use a syringe to inject the sodium chloride solution into the device branch by pressure difference;

[0032] (3) Injection of the test solution: insert the Luer connector extension tube of the middle branch of the three branches into the standard container, and use a syringe to inject the test solution into the device branch by pressure difference;

[0033] (4) Flush the test solution: Insert the Luer connector extension tube of the tail branch of the three branches into the standard container, and use a syringe to inject the sodium chloride solution into the device branch using the pressure difference.

[0034] The device to be invented by the present invention solves the following problems based on the existing technical conditions:

[0035] 1. Eliminate the risk of injecting air into the animal due to frequent insertion and removal of the syringe.

[0036] The syringe can complete the cycle process from aspiration to pushing of liquid without plugging in or out. The washing process can wash the liquid accurately according to the volume, and no bubbles are generated during the injection cycle.

[0037] 2. Solve the experimental errors caused by different liquid pushing speeds due to human factors.

[0038] Under existing technical conditions, the manual advancement speed of the solution depends on the operator's experience and feeling, and it is difficult to achieve completely consistent advancement speed each time. The uneven advancement speed leads to errors in blood measurement values.

[0039] The device can not only retain the traditional manual liquid pushing function, but also use the automatic liquid pushing function. The automatic liquid pushing function requires the syringe to be connected to an electric syringe pump. By setting the injection speed and pushing distance of the electric syringe pump, the effect of precise control of liquid pushing can be achieved. Compared with manual liquid pushing, the error caused by the pushing speed will be greatly reduced.

[0040] 3. Reduce the cycle time of liquid aspiration, liquid pushing and exhaust, greatly improving the experimental efficiency and success rate.

[0041] The prior art takes about 4 minutes to complete a cycle injection (excluding the waiting time for pressure fluctuation recovery after injection). The steps are: ⑴ Aspirate the reference solution in a test tube → ⑵ Exhaust → ⑶ Fill the syringe to the exact volume → ⑷ Insert the arterial cannula connector and inject → ⑸ Remove the syringe → ⑹ Aspirate the residual solution at the connection port → ⑺ Aspirate the test solution in a test tube → ⑻ Exhaust → ⑼ Fill the connection port with the solution to be injected to isolate the air → ⑽ Fill the syringe to the exact volume → ⑾ Insert the arterial cannula connector and inject → ⑿ Remove the syringe.

[0042] After the device connects each liquid, it takes about 40 seconds to manually complete a cycle injection (excluding the waiting time for pressure fluctuation recovery after injection). The injection cycle steps of the present invention are: ① select the reference substance / test solution through the liquid circuit switch and accurately aspirate the liquid according to the injection volume → ② switch the liquid circuit to complete the liquid push → ③ switch the liquid circuit to sodium chloride injection to complete the liquid aspiration → ④ switch the liquid circuit to complete the liquid push.

[0043] During the cyclic injection process, the device of the present invention does not require steps such as exhausting, emptying / filling the connection port, and constant volume. Within the limited stable experimental time of experimental animals, the experimental efficiency and experimental stability are greatly improved, the workload of operators is reduced, and operator operation errors are reduced.

[0044] The above description is only a preferred embodiment of the present application and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present application is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the present application.

Claims

1. A disposable multi-fluid-path lead device for the purpose of examining and studying hypobaric substances, comprising a fixing plate (1), a base (2) and a tube body (3), wherein the base (2) is fixedly arranged below the tube body (3), and the base (2) is detachably fixedly connected to the top of the fixing plate (1), characterized in that: Three branches (4) are arranged crosswise on both sides of the tube body (3); a lock nut (5) is fixedly arranged at the head of the tube body (3); a swivel core (6) for controlling the internal flow of the tube body is arranged above the tube body (3); the swivel core (6) corresponds to the three branches (4) respectively; the three branches (4) and the ports of the lock nut (5) are all provided with corresponding interfaces; and the joints of the three branches are respectively provided with a Luer connector one-way check valve (7) and a Luer connector extension tube (8).

2. A disposable multi-fluid-path lead device for the purpose of testing and researching hypobaric substances according to claim 1, characterized in that: Each set of lead device main body interface is equipped with a screw cap.

3. A disposable multi-fluid-path lead device for the purpose of testing and researching hypobaric substances according to claim 2, characterized in that: The lock nut (5), the tube body (3), the base (2) and the fixing plate (1) are all made of polycarbonate or polyurethane materials, and the rotary cap and the rotary core (6) are made of polyethylene materials.

4. A disposable multi-fluid-path lead device for the purpose of testing and researching hypobaric substances according to claim 1, characterized in that: The lock nut port is a standard Luer connector, and the other connection ports are standard Luer cone connectors.

5. A disposable multi-fluid-path lead device for the purpose of testing and researching hypobaric substances according to claim 1, characterized in that: The rotating core (6) has a rotational torque of less than 1.0 Nm and is sterilized using ethylene oxide, making it sterile and pyrogen-free.

6. The method for using the disposable multi-fluid path lead device for the purpose of testing and researching hypobaric substances according to claim 1, characterized in that: The cycle includes the following steps: (1) Injection of standard solution: insert the Luer connector extension tube of the head branch of the three branches into the standard container, and use a syringe to inject the standard solution into the device branch by pressure difference; (2) Flush the standard solution: insert the Luer connector extension tube of the tail branch of the three branches into the standard container, and use a syringe to inject the sodium chloride solution into the device branch by pressure difference; (3) Injection of the test solution: insert the Luer connector extension tube of the middle branch of the three branches into the standard container, and use a syringe to inject the test solution into the device branch by pressure difference; (4) Flush the test solution: Insert the Luer connector extension tube of the tail branch of the three branches into the standard container, and use a syringe to inject the sodium chloride solution into the device branch using the pressure difference.

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