A closed drug compounding and transfer system

Abstract

The application discloses a closed medicine preparation and transfer system, which comprises a three-way reversing valve, two puncture devices, two buckling support plates, two elastic bellows, two bottle cap clamping devices and an exhaust assembly. The bottle cap clamping device clamps a medicine bottle, the buckling support plate is buckled with the bottle cap clamping device through a convex post and a clamping groove, and the elastic bellows surrounds a puncture film and forms a closed buffer space during puncture. The exhaust assembly comprises two exhaust pipes and an air bag, which are respectively connected with the side wall of the puncture device and the two ends of the air bag, and is used for buffering the gas production pressure during medicine preparation. When the convex post is buckled with the clamping groove, the lower end edge of the liquid outlet hole of the puncture device is flush with the inner surface of the bottle cap of the medicine bottle, so that the residual medicine liquid is minimized. The application realizes full-closed puncture, system pressure balance and precise dose control, and can be directly switched to infusion through the three-way valve, and is suitable for safe preparation of dangerous medicines, especially biological medicines.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a closed-loop drug preparation and transfer system (CSTD) for the safe preparation of hazardous drugs. It is particularly suitable for the closed-loop preparation, transfer, and direct infusion of vials of lyophilized powder for injection with infusion bags / bottles, and is especially designed for the pressure buffering of gas-generating drugs during the preparation process and for ensuring the dosage accuracy of biological drugs. Background Technology

[0002] In clinical medicine, the spillage of drug aerosols, droplets, or vapors during the preparation of hazardous drugs such as chemotherapy and antiviral drugs can pose serious health hazards to healthcare workers. To reduce exposure to hazardous drugs, hospitals typically use closed-system drug delivery devices (CSTD) for drug preparation.

[0003] The existing CSTD products and technical solutions have the following main shortcomings:

[0004] First, the pressure balancing mechanism is inadequate. Existing CSTDs all use syringe adapters to connect sequentially to vial adapters and infusion / injection connectors, with the puncture needle concealed and a self-sealing membrane at the connection point preventing drug leakage. While these CSTDs employ some pressure balancing measures, the structure for achieving system pressure balance is complex, the operating cost is high, and drug leakage and foreign matter contamination cannot be completely prevented. Especially during the preparation of certain gas-producing drugs (such as the carbon dioxide produced when sodium bicarbonate is mixed with acidic drugs), the internal gas pressure rises sharply, and existing devices lack effective pressure relief and buffering mechanisms, making drug spillage highly likely.

[0005] Secondly, there is a risk of drug leakage at the moment of puncture. With existing CSTD (Cyclic Subsistence Tunneling Device), the high-pressure gas inside the vial may carry drug particles and leak out along the puncture path at the moment the needle pierces the vial stopper, causing contamination. Although existing technologies employ self-sealing membranes and other methods, they fail to fundamentally solve the sealing problem at the moment of puncture.

[0006] Third, the medication preparation process is complex and the equipment is scattered. Existing CSTDs typically require multiple components to be connected sequentially, making the operation cumbersome. After medication preparation, the vial must be removed from the device before connecting the infusion set for infusion, increasing the number of operational steps and the risk of contamination.

[0007] Fourth, residual medication affects dosage accuracy. The current CSTD (Cyclic Substance Treatment Device) needle length is poorly designed and lacks a precise depth-limiting mechanism. Healthcare professionals often struggle to control the puncture force during connection, and the needle tip frequently fails to reach the lowest point of the vial (the dome), resulting in some medication residue remaining inside and causing dosage errors. For expensive biological drugs such as monoclonal antibodies and vaccines, which require extremely precise dosage, this residue-induced underdosage can directly impact efficacy and even pose medication safety risks.

[0008] Fifth, biopharmaceuticals are susceptible to shock damage during preparation. Biopharmaceuticals (such as monoclonal antibodies and vaccines) are sensitive to shock and vibration. Existing CSTDs often require repeated pumping and dispensing of the syringe during preparation, generating impact forces and pressure fluctuations, which may affect the stability and efficacy of the drug.

[0009] To address the aforementioned shortcomings, there is an urgent need for a CSTD that is simple in structure, has good airtightness, can effectively balance system pressure, avoid puncture leakage, ensure dosage accuracy, and is suitable for the safe preparation of biopharmaceuticals. Summary of the Invention

[0010] In view of the above-mentioned defects or improvement needs of the existing technology, the present invention provides a closed drug preparation and transfer system, which aims to solve the technical problems of existing CSTDs in drug preparation process, such as drug spillage due to pressure difference, leakage of drug carried by gas at the moment of puncture, complex drug preparation process, drug residue affecting dosage accuracy, and susceptibility to impact damage during the preparation of biological drugs.

[0011] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0012] A closed-loop drug preparation and transfer system, comprising:

[0013] A three-way reversing valve has a first port, a second port, a third port, and a knob for controlling the on / off state between the ports. The first port is used to connect to an infusion tube.

[0014] The puncture device assembly includes a first puncture device and a second puncture device, wherein the first puncture device is connected to the third port of a three-way directional valve, and the second puncture device is connected to the second port of the three-way directional valve.

[0015] Two snap-fit ​​support plates, each being a cylindrical structure with one end open and the other end closed by a bottom plate, with an annular protrusion on its inner sidewall near the opening. The first puncture tool and the second puncture tool are integrally formed with the two snap-fit ​​support plates.

[0016] Two flexible corrugated cylinders, one end of each flexible corrugated cylinder is coaxially fixed to the inner wall of the bottom plate of the corresponding fastening support plate;

[0017] Two bottle cap clips are cylindrical structures with one end open and the other end closed by a base plate. The edge of the open end of the side wall is rolled inward to secure the bottle cap. A puncture membrane is provided in the center of the base plate. An annular groove that matches and engages with the boss is provided on the outer side wall near the base plate. The outer diameter of the side wall of the bottle cap clip is matched with the inner diameter of the side wall of the fastening support plate. The other end of each elastic corrugated cylinder is coaxially fixed on the outer wall of the base plate of the corresponding bottle cap clip and surrounds the outer periphery of the puncture membrane.

[0018] The exhaust assembly includes two exhaust pipes and an airbag. One end of each of the two exhaust pipes is connected to the side wall of the first puncture device and the second puncture device, respectively, and the other end of each of the two exhaust pipes is connected to both ends of the airbag, respectively.

[0019] The annular protrusion and annular groove are configured such that when the annular protrusion and annular groove are engaged, the tip of the puncture device passes through the puncture membrane in sequence and is inserted into the medicine bottle, and the lowest edge of the liquid outlet on the side wall of the puncture device is flush with the inner surface of the bottle cap.

[0020] Furthermore, a silicon cap is also connected to the first interface, and the infusion tube is detachably connected to the first interface through the silicon cap; the silicon cap is an elastic seal, and its interior is provided with a slit that automatically closes when the infusion tube connector is pulled out, so as to maintain positive pressure sealing of the system.

[0021] Furthermore, the inner diameter of the side wall of the bottle cap clip matches the outer diameter of the bottle cap of the medicine bottle, and the inside of the bottle cap clip is also provided with a double annular sealing ring for tight contact with the outer wall of the bottle cap.

[0022] Furthermore, the elastic corrugated cylinder is made of medical-grade elastic material, and its axial compression stroke is not less than the stroke of the puncture tip piercing the puncture membrane and entering the inside of the medicine bottle. The elastic corrugated cylinder is used to provide axial guiding force and reverse elastic bias force during puncture, and to form a sealed buffer space around the puncture path on the outer periphery of the puncture device.

[0023] Compared with the prior art, the beneficial effects of the present invention are:

[0024] 1. This invention provides a dedicated buffer and pressure relief channel for gases generated during drug preparation (especially gases generated by the reaction of gas-producing drugs) by setting up independent exhaust components (exhaust pipe and air bag), effectively preventing drug leakage caused by increased internal system pressure. Simultaneously, through multiple seals of the elastic corrugated cylinder and puncture membrane, as well as the locking seal between the support plate and the bottle cap, a fully sealed environment is constructed, fundamentally solving the problem of drug leakage during puncture and drug preparation.

[0025] 2. This invention integrates the functions of connecting medicine bottles, preparing medicine solutions, and administering infusions into one unit. By switching the three-way reversing valve, the system can directly switch from the medicine preparation state to the infusion state without disassembling any parts, which simplifies the operation process, reduces the risk of contamination in intermediate links, and improves work efficiency.

[0026] 3. When the protrusion of the fastening support plate of this invention engages with the slot of the bottle cap clip, the puncture depth is precisely controlled, ensuring that the lowest edge of the outlet hole on the side wall of the puncturist is flush with the inner surface of the bottle cap. This design ensures that the tip of the puncturist can approach the dome of the bottle bottom to the maximum extent, allowing the liquid to flow out completely through the outlet hole under gravity, reducing the residual amount of liquid in the bottle to near zero. This fundamentally solves the dosage deviation problem caused by insufficient puncture depth and is of outstanding significance for ensuring the accuracy of drug administration for biological products.

[0027] 4. The drug preparation process of this invention mainly utilizes gravity to transfer the drug solution between different medicine bottles, eliminating the need for repeated pumping and pushing of the syringe. This avoids damage to the active ingredients of biological drugs (such as proteins, antibodies, etc.) caused by mechanical impact and drastic pressure fluctuations, effectively ensuring the safety and efficacy of the drug.

[0028] 5. The three-way reversing valve of the present invention can be connected to a common syringe. By rotating the knob, the opening and closing of the passage and the flow rate can be precisely controlled, and the ratio of drug to saline can be precisely controlled, thereby achieving precise drug dispensing.

[0029] 6. Compared with the complex pressure balancing mechanism in the prior art, the exhaust assembly of the present invention has a simple and reliable structure, and the overall system has fewer components, making it easy to manufacture and assemble, which helps to reduce production costs and clinical use costs. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the structure of the present invention;

[0031] Figure 2 This is a schematic diagram of the connecting vial structure of the present invention;

[0032] Figure 3 This is a schematic diagram of the structure during drug preparation according to the present invention;

[0033] In the diagram: 1. Three-way reversing valve; 11. First port; 12. Second port; 13. Third port; 2. Puncture device assembly; 21. First puncture device; 22. Second puncture device; 3. Silicon cap; 4. Infusion tubing; 5. Fastening support plate; 51. Boss; 6. Elastic corrugated cylinder; 7. Bottle cap clip; 71. Slot; 72. Puncture membrane; 8. Exhaust assembly; 81. Exhaust pipe; 82. Airbag; 91. Medicine bottle one; 92. Medicine bottle two. Detailed Implementation

[0034] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0035] like Figure 1-3As shown, the closed-loop drug preparation and transfer system of the present invention mainly includes a three-way reversing valve 1, a puncture device assembly, a first puncture device 21 and a second puncture device 22, two identical fastening support plates 5, two identical elastic corrugated cylinders 6, two identical bottle cap clips 7, and an exhaust assembly 8.

[0036] The three-way reversing valve 1 is a medical-grade plug valve, which has a first port 11, a second port 12 and a third port 13. The first port 11 is used to connect to the infusion line. Preferably, it is detachably connected to the infusion line 4 through a silicon cap 3. The silicon cap 3 is an elastic seal with an automatically closing slit inside. It opens when the connector of the infusion line 4 is inserted and automatically closes when it is pulled out to maintain the system seal. The knob is used to selectively connect any two ports or close all ports.

[0037] Both the first puncture device 21 and the second puncture device 22 are hollow puncture needles, and their tail ends, i.e., the ends away from the needle tip, are respectively fixedly connected to and connected to the third port 13 and the second port 12 of the three-way reversing valve 1. A branch pipe interface for connecting to the exhaust pipe 81 is opened on the middle side wall of the puncture device.

[0038] The fastening support plate 5 and the bottle cap clip 7 together constitute the sealing connection unit of the medicine bottle. The first puncture device 21 and the second puncture device 22 are integrally formed with the two fastening support plates 5, respectively. The fastening support plate 5 is a cylindrical structure made of medical rigid plastic, with one end open and the other end closed by a bottom plate. An annular boss 51 is integrally formed on the upper part of the inner side wall of the fastening support plate 5 near the open end.

[0039] The bottle cap clip 7 is also a cylindrical structure made of medical-grade rigid plastic, open at one end and closed at the other by a base plate. The edge of the open end of its side wall is designed as an inwardly curled constriction, allowing it to elastically deform and secure the bottle cap. A puncture membrane 72 is fixedly fixed to the center of the base plate through a central opening. An annular groove 71, matching the shape of the annular protrusion 51, is formed on the outer side wall of the bottle cap clip 7 near the base plate. The outer diameter of the side wall of the bottle cap clip 7 is slightly smaller than or equal to the inner diameter of the side wall of the fastening support plate 5, allowing the bottle cap clip 7 to be inserted into the fastening support plate 5 and secured by the annular protrusion 51 engaging the annular groove 71.

[0040] The elastic corrugated tube 6 is made of medical-grade elastic material and is in the shape of an axially expandable corrugated tube. One end is coaxially and fixedly sealed to the inner wall of the base plate of the fastening support plate 5; the other end is coaxially and fixedly sealed to the outer wall of the base plate of the bottle cap clip 7 and surrounds the outer periphery of the puncture membrane 72.

[0041] The exhaust assembly 8 includes two exhaust pipes 81 and an airbag 82. One end of each exhaust pipe 81 is fixed and connected to the side wall branch port of the first trocar 21 and the second trocar 22, respectively. The other ends of each exhaust pipe 81 are fixed and connected to both ends of the airbag 82. The airbag 82 is a flexible, inflatable medical bag used to contain the gas discharged from the medicine bottle.

[0042] When medical staff press the medicine bottle to make the protrusion 51 engage with the slot 71, the tip of the puncture device is located at a safe distance above the bottom of the bottle, and the lowest edge of the liquid outlet is located on the horizontal surface of the inner surface of the bottle cap, thus ensuring that the liquid can be completely discharged through the liquid outlet under the action of gravity, without any residual dead corners.

[0043] The operation process of this invention is as follows:

[0044] 1. Assembly and puncture:

[0045] The medical staff first insert the caps of vials 91 (e.g., lyophilized powder for injection) and 92 (e.g., injectable solvents) into the open ends of the two cap retainers 7. As the open ends of the cap retainers 7 contract inward, they securely lock the neck of the cap, while the sealing ring inside the cap retainers 7 fits tightly against the outer wall of the cap, forming the first seal.

[0046] Subsequently, medical staff used internal pressure to compress the medicine bottle, overcoming the elasticity of the corrugated cylinder 6. The bottle cap clip 7 moved relative to the fastening support plate 5 towards the bottom plate. During this process, the tip of the puncture device 2 pierced the puncture membrane 72 and finally pierced the rubber stopper of the medicine bottle cap, entering the bottle. When a "click" sound is heard, it indicates that the annular protrusion 51 is engaged in the annular groove 71, and the two are locked. At this time, the lowest edge of the liquid outlet on the side wall of the puncture device 2 is flush with the inner surface of the bottle cap. Both medicine bottles are sealed and connected to the corresponding interface of the three-way reversing valve 1 through the puncture device 2. The entire puncture process is completed in a sealed space composed of components such as the corrugated cylinder 6, effectively preventing any particles or aerosols that may be generated at the moment of puncture from leaking out.

[0047] 2. Dispensing medication:

[0048] After assembly, rotate the knob of the three-way reversing valve 1 to connect the second port 12 and the third port 13, that is, to connect the first puncture device 21 and the second puncture device 22. Medical personnel hold the system, placing the second vial 92 containing solvent at the top and the first vial 91 containing drug powder at the bottom. Under gravity, the solvent in the second vial 92 flows through the second puncture device 22, the three-way reversing valve 1, and the first puncture device 21 into the first vial 91 below, dissolving or suspending the drug powder.

[0049] If gas is generated during the drug preparation process, such as when certain drugs dissolve and gas is produced, the pressure inside the bottle will increase. The gas can enter the air bladder 82 through the branch tube interface on the side wall of the puncture device 2 and the exhaust pipe 81. The air bladder 82 will then expand, effectively buffering the internal pressure of the system and preventing the drug solution from overflowing from the connection gap due to the pressure increase.

[0050] 3. Recirculation and mixing of the drug solution:

[0051] After all the solvent has flowed into vial 91, the two vials can be inverted so that vial 91 is on top and vial 92 is on the bottom. This allows the dissolved medicine to flow back into vial 92 under gravity. If necessary, the vials can be inverted several times to ensure thorough mixing. The entire mixing process involves gentle gravitational flow without violent impact, which helps preserve the activity of the biological drugs.

[0052] 4. Direct infusion:

[0053] After the medication is prepared and mixed thoroughly, no parts need to be disassembled. Hang the second vial (92) on the infusion stand. Insert the connecting end of the infusion tubing (4) into the silica cap (3), establishing communication with the first interface (11). Rotate the knob of the three-way reversing valve (1) to connect the first interface (11) with the second interface (12) (i.e., connect the infusion tubing (4) to the second puncture device (22) connected to the second vial (92). At this point, the finished medication in the second vial (92) can be directly infused into the patient through the second puncture device (22), the three-way reversing valve (1), the silica cap (3), and the infusion tubing (4). By rotating the knob, the opening and closing of the access route and the flow rate can be precisely controlled, achieving accurate drug delivery.

[0054] 5. End operation:

[0055] After the infusion is completed, close the knob of the three-way reversing valve 1, disconnect the infusion tubing 4 from the silica cap 3, and the silica cap 3 will automatically seal to prevent leakage. Finally, dispose of the entire system, along with the used medicine bottle, as medical waste according to regulations, without the need for cumbersome disassembly and sorting.

[0056] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A closed-loop drug preparation and transfer system, characterized in that, include: A three-way reversing valve (1) has a first port (11), a second port (12), a third port (13) and a knob for controlling the opening and closing of the ports. The first port (11) is used to connect to an infusion tube (4). The puncture device assembly (2) includes a first puncture device (21) and a second puncture device (22), wherein the first puncture device (21) is connected to the third port (13) of the three-way directional valve (1) and the second puncture device (22) is connected to the second port (12) of the three-way directional valve (1). Two snap-fit ​​support plates (5), the snap-fit ​​support plates (5) are cylindrical structures with one end open and the other end closed by the bottom plate, and an annular protrusion (51) is provided on the inner side wall near the opening. The first puncture tool (21) and the second puncture tool (22) are integrally formed with the two snap-fit ​​support plates (5). Two elastic corrugated cylinders (6), one end of each elastic corrugated cylinder (6) is coaxially fixed on the inner wall of the bottom plate of the corresponding fastening support plate (5); Two bottle cap clips (7), the bottle cap clips (7) are cylindrical structures with one end open and the other end closed by the bottom plate. The edge of the open end of the side wall is rolled inward to secure the bottle cap. A puncture membrane (72) is provided in the center of the bottom plate. An annular groove (71) that matches and engages with the boss (51) is provided on the outer side wall near the bottom plate. The outer diameter of the side wall of the bottle cap clips (7) matches the inner diameter of the side wall of the fastening support plate (5). The other end of each elastic corrugated cylinder (6) is coaxially fixed on the outer wall of the bottom plate of the corresponding bottle cap clips (7) and surrounds the outer periphery of the puncture membrane (72). The exhaust assembly (8) includes two exhaust pipes (81) and an airbag (82). One end of each of the two exhaust pipes (81) is connected to the side wall of the first puncture device (21) and the second puncture device (22), respectively, and the other end of each of the two exhaust pipes (81) is connected to both ends of the airbag (82). The annular protrusion (51) and the annular groove (71) are configured such that when the annular protrusion (51) and the annular groove (71) are engaged, the tip of the puncture device (2) passes through the puncture membrane (72) in sequence and is inserted into the medicine bottle, and the lowest edge of the liquid outlet on the side wall of the puncture device (2) is flush with the inner surface of the bottle cap.

2. The system according to claim 1, characterized in that, A silicon cap (3) is also connected to the first interface (11). The infusion tube (4) is detachably connected to the first interface (11) through the silicon cap (3). The silicon cap (3) is an elastic seal, and its interior is provided with a slit that automatically closes when the infusion tube connector is pulled out, so as to maintain the positive pressure seal of the system.

3. The system according to claim 1, characterized in that, The inner diameter of the side wall of the bottle cap clip (7) matches the outer diameter of the bottle cap of the medicine bottle, and the inside of the bottle cap clip (7) is also provided with a double annular sealing ring for tight fit with the outer wall of the bottle cap.

4. The system according to claim 1, characterized in that, The elastic corrugated cylinder (6) is made of medical grade elastic material. Its axial compression stroke is not less than the stroke of the tip of the puncture device (2) piercing the puncture membrane (72) and entering the inside of the medicine bottle. The elastic corrugated cylinder (6) is used to provide axial guiding force and reverse elastic bias force during puncture, and to form a closed buffer space around the puncture path on the outer periphery of the puncture device (2).

Images