Drug infusion leak observation device

Abstract

The application discloses a medicine infusion leakage observation device, and belongs to the technical field of intravenous infusion instruments. The device comprises an observation cylinder, the bottom of the observation cylinder is sealingly fixed with a bottom plate, and the lateral wall of the observation cylinder is provided with scale lines; a first color developing layer for height indication is arranged on the inner wall of the observation cylinder, a second color developing layer for receiving and developing leakage is arranged on the bottom plate, the first color developing layer and the second color developing layer are both irreversibly color changed when meeting medicine liquid; a through hole is formed in the center of the bottom plate, a sealing sleeve is sealingly connected in the through hole, and a sealing reinforcing member for enhancing sealing is sleeved in the sealing sleeve. The scheme of the application solves the problems of the existing medical fluid infusion equipment in interface cooperation stability, leakage identification reliability, use safety and the like, improves the early identification and quantitative observation ability of fluid leakage, and improves the structural stability and the overall safety, controllability and use convenience of the infusion process.

Description

Technical Field

[0001] This invention relates to the field of intravenous infusion device technology, specifically to a drug infusion leakage observation device. Background Technology

[0002] Currently, in clinical drug infusions, such as intravenous infusions of chemotherapy drugs, highly active drugs, and controlled substances, conventional infusion tubing using infusion bags and bottle stopper puncture devices is employed. For example... Figure 1 As shown, the infusion bag outlet is equipped with a rubber stopper. The bottle stopper puncture device establishes a drug flow path by puncturing the rubber stopper, realizing the delivery of drugs to the patient's blood vessels. In actual use, when the bottle stopper punctures the rubber stopper, factors such as deviation of the puncture angle, insufficient puncture depth, elastic retraction of the rubber stopper, the patient turning over or moving and pulling the infusion tubing, and the tubing's own weight pulling may cause micro-gaps between the bottle stopper puncture device and the rubber stopper. Medication can slowly seep out through this gap. Initially, the leakage is minimal and scattered, making it difficult for medical staff to detect immediately. It is usually only noticed when the leakage has accumulated to a considerable extent, resulting in a delay in detection. Furthermore, for cytotoxic, irritating, or corrosive medications such as chemotherapy drugs, this directly poses an occupational exposure risk to medical staff, contaminates the treatment environment, and increases infection control and disinfection costs. More importantly, the leaked medication cannot be measured, meaning the actual amount entering the patient's body is less than the prescribed amount, leading to insufficient drug infusion. This affects the effectiveness of chemotherapy, the stability of blood drug concentrations, and the overall treatment plan. The inability to accurately determine the leakage volume makes it difficult for medical staff to judge whether and how much fluid replacement is needed. Currently, there are technologies related to infusion set leakage, such as the delivery device for introducing fluid into a patient disclosed in existing patent US20210093779A1. This delivery device has a base with a bottom surface for connecting to the patient's skin and a sleeve extending from the bottom surface for penetrating the patient's skin. The fluid supply conduit has a first lumen connected to a cannula for supplying fluid to the cannula, wherein the fluid contains an active agent and a stabilizer. The catheter has a second lumen with an open end for capturing and removing any leakage of fluid from the infusion site. The second lumen has a leak detector containing a color change that reacts with the stabilizer and provides a visual indication to the patient via the catheter. The leak detector is spaced apart from the infusion site and oriented in a position visible to the patient through the catheter. Similarly, US9326686B2 discloses a device configured to assist in the diagnosis of at least one of infiltration and extravasation in animal tissue based on a first and second electromagnetic extinction detected by a sensor. However, existing technologies are relatively expensive and have room for improvement in terms of ease of use. Summary of the Invention

[0003] The purpose of this invention is to provide a drug infusion leakage observation device, which solves the shortcomings of existing medical fluid infusion equipment in terms of interface fit stability, leakage identification reliability, and usage safety. The device of this invention improves the early identification and quantitative observation capability of fluid leakage, and enhances the structural stability and overall safety, controllability and ease of use of the infusion process.

[0004] To solve the above-mentioned technical problems, the present invention specifically provides the following technical solution: Drug infusion leak monitoring device, including, The observation tube has a sealed base plate at the bottom. The observation tube is a transparent, rigid, hollow cylinder. Based on the structure of the observation tube being a transparent, rigid, hollow cylinder with a sealed base plate at the bottom, it can fully surround and seal the liquid seeping from the stopper puncture site. The observation tube has graduation lines on its side wall. These graduation lines are for graded measurement and are used to estimate the leakage level by two stages. In this way, the leakage level can be estimated whether the infusion leakage is collected in a horizontal or non-horizontal state.

[0005] The inner wall of the observation cylinder is equipped with a first color-developing layer for height indication, and the bottom plate is equipped with a second color-developing layer for receiving and developing color upon leakage. Both the first and second color-developing layers irreversibly change color upon contact with the medication. A tiny amount of leakage can trigger immediate color development, solving the problem that leakage at the infusion interface is small, scattered, and lacks visual indication, making it difficult to detect early. This enables immediate visual warning of leakage.

[0006] The base plate has a through hole in the center, and a sealing kit is sealed inside the through hole to prevent the leakage of the fluid collected in the observation tube from seeping out through the assembly gap, further improving the sealing and protection effect. The sealing kit is fitted with a sealing reinforcement for enhancing the seal. The sealing reinforcement can adapt to the deformation under pressure after the bottle stopper trocar is inserted, and can tightly fit the outer wall of the trocar to form a multi-layer sealing structure. It can not only adapt to bottle stopper trocars of different diameters and ensure the sealing reliability under different consumable usage scenarios, but also form a flexible coaxial guide and radial limit for the bottle stopper trocar, helping to reduce the angular deviation during puncture and reduce the risk of micro-gap caused by tilted fit. At the same time, the double sealing structure of the sealing reinforcement and the sealing kit can offset the loosening effect caused by external forces such as patient movement, tube traction, and self-weight, and maintain the stable fit between the bottle stopper trocar and the rubber stopper.

[0007] According to one embodiment of the present invention, the first color-developing layer is an annular humidity-sensitive color-changing indicator strip arranged at intervals along the height direction of the inner wall of the observation cylinder. The annular humidity-sensitive color-changing indicator strip corresponds one-to-one with the scale interval of the scale line. When the leakage liquid level rises to the corresponding scale height, the first color-developing layer changes color synchronously. Medical staff can intuitively understand the leakage level without closely observing the liquid level.

[0008] According to one embodiment of the present invention, the sealing kit includes a hollow sealing sleeve body, which is fitted into the through hole of the base plate. At least two sealing rings are embedded in the outer wall of the sealing sleeve body. The outer wall of the sealing rings is tightly fitted with the inner wall of the through hole of the base plate to form a radial seal. This tight fit between the outer wall of the sealing rings and the inner wall of the through hole of the base plate forms multiple radial seals, which can effectively prevent the liquid medicine collected inside the observation tube from leaking outward from the assembly gap between the sealing sleeve body and the base plate.

[0009] According to one embodiment of the present invention, a sealing plate is fixedly connected to the bottom of the sealing sleeve by a connecting plate. A sealing strip is provided on the outer ring of the sealing plate to reliably seal the bottom of the central through hole of the bottom plate, preventing leakage from flowing out from the bottom of the through hole and ensuring that a completely closed leakage collection space is formed inside the observation tube, ensuring that all leaked medicine is confined within the observation tube. The bottom end of the sealing sleeve is provided with a first adhesive layer for puncture by a bottle stopper puncturer. After the puncturer punctures the first adhesive layer, the first adhesive layer is used to wrap the outer wall of the puncturer to form a seal, further improving the sealing reliability of the puncture position.

[0010] According to one embodiment of the present invention, the connecting plate is any one of an arc-shaped strip, a vertical straight strip, or an inclined straight strip. One end of the connecting plate is fixedly connected to the bottom of the sealing sleeve, and the other end is fixedly connected to the surface of the sealing plate. During the insertion of the bottle stopper piercing device and the application of external force, the connecting plate of the arc-shaped strip, the vertical straight strip, or the inclined straight strip can resist radial torque and lateral force by relying on its own arc-shaped anti-bending structure, thus suppressing relative rotation, radial offset, or angular deflection between the sealing sleeve and the sealing plate.

[0011] According to one embodiment of the present invention, the bottom of the sealing plate is provided with an extension post, and the extension post is coaxially formed with the sealing plate to provide a passage for the bottle stopper piercing device to pass through. Through the integrated coaxial forming structure of the extension post and the sealing plate, a stable and continuous lower section guide support is provided for the bottle stopper piercing device, and its movement direction is constrained and limited from the initial stage of piercing device insertion.

[0012] According to one embodiment of the present invention, the sealing reinforcement includes a sealing sleeve, the outer wall of which is provided with multiple layers of annular sealing rings. After being compressed and deformed, the sealing sleeve fits against the outer wall of the bottle stopper puncturer. The sealing reinforcement adopts a structure of a sealing sleeve with elastic deformation capability and multiple layers of annular sealing rings. During the tilting insertion of the bottle stopper puncturer, the sealing reinforcement will generate corresponding radial compression deformation and circumferential fitting deformation as the posture of the puncturer adjusts, always tightly wrapping the outer wall of the bottle stopper puncturer with an elastic surface, filling any possible tiny radial gaps.

[0013] According to one embodiment of the present invention, a connector is connected below the sealing kit. The connector includes a base, and a second adhesive layer that can move up and down is provided inside the base. A spring is provided inside the base, with one end of the spring abutting against the second adhesive layer and the other end abutting against a protruding ring on the inner wall of the base. One end of the spring stably abuts against the second adhesive layer, and the other end abuts against the protruding ring, providing a constant upward elastic thrust to the second adhesive layer. When the bottle stopper piercing device passes through the second adhesive layer, the second adhesive layer continues to push the bottle stopper piercing device upward under the action of the spring, so that the head of the bottle stopper piercing device always remains in close contact with the rubber stopper. This counteracts the downward pull of the tubing, its own weight, and the loosening tendency caused by external shaking, reducing leakage due to micro-gap caused by loose fit. At the same time, the second adhesive layer can float up and down inside the base, which can adapt to the assembly height and small displacement of the bottle stopper piercing device, ensuring that the pushing force is stable and reliable, and preventing damage to the rubber stopper or piercing device due to rigid tightening.

[0014] According to one embodiment of the present invention, the second color developing layer is a thin sheet structure that is fully covered on the base plate, and its volume has been pre-deducted when the scale line is calibrated to ensure accurate measurement of leakage.

[0015] According to one embodiment of the present invention, the first color-developing layer is an irreversible moisture-sensitive color-changing ink or a medical color-changing nonwoven fabric, and the second color-developing layer is a cobalt-free color-changing silicone sheet or a medical absorbent color-changing nonwoven fabric. Attached Figure Description

[0016] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0017] Figure 1 A schematic diagram of the connection scheme between existing infusion bags, rubber stoppers, and bottle stopper puncture devices for drug infusion. Figure 2 This is a schematic diagram of the drug infusion leakage observation device of the present invention; Figure 3 This is a schematic diagram of the connection scheme between the observation cylinder and the sealing kit of the present invention; Figure 4 This is a schematic diagram of the internal structure of the observation tube of the present invention; Figure 5 This is a schematic diagram illustrating the connection scheme of the sealing reinforcement, sealing kit, and connector of the present invention; Figure 6 This is a schematic diagram of the sealing reinforcement solution of the present invention; Figure 7 This is a schematic diagram of the connection scheme between the sealing kit and the connector of the present invention; Figure 8 This is a schematic diagram of the internal structure of the connector of the present invention; Figure 9 This is a schematic diagram of the first connection scheme between the sealing kit and the sealing plate of the present invention; Figure 10 This is a schematic diagram of a second connection scheme between the sealing kit and the sealing plate of the present invention; Figure 11 This is a schematic diagram of the third connection scheme between the sealing kit and the sealing plate of the present invention.

[0018] Explanation of reference numerals in the attached drawings: 10. Rubber stopper; 20. Observation tube; 21. First color developing layer; 22. Second color developing layer; 23. Base plate; 24. Scale line; 30. Sealing kit; 31. Sealing sleeve; 32. Sealing ring; 33. Connecting plate; 34. First adhesive layer; 35. Reinforcing plate; 40. Connector; 41. Base; 42. Second adhesive layer; 43. Convex ring; 44. Spring; 50. Sealing reinforcement; 51. Sealing rubber ring; 52. Extension body; 53. Sealing sleeve; 60. Sealing plate; 61. Extension column. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] The concepts involved in this application will first be described with reference to the accompanying drawings. It should be noted that the following descriptions of various concepts are only for the purpose of making the content of this application easier to understand and do not constitute a limitation on the scope of protection of this application; furthermore, the embodiments and features in the embodiments of this application can be combined with each other unless otherwise specified. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0021] Example 1: As shown in the attached figure Figure 1As shown, during chemotherapy drug infusion, the bottle stopper puncturer passes through the rubber stopper 10 on the infusion bag containing the drug to facilitate intravenous infusion. Leakage may occur due to various reasons, such as angle issues when puncturing the rubber stopper, accidental pulling of the infusion tubing by the patient, or slow separation or displacement of the bottle stopper puncturer from the rubber stopper 10 caused by the weight of the infusion tubing. Leakage of consumables like infusion sets / bags is also a common problem, leading to chemotherapy drug leakage. In the early stages, leakage is often subtle and difficult to detect visually. It is usually only discovered when leakage has accumulated to a significant amount. The most direct problem is that the actual infusion dose of chemotherapy drugs is insufficient, failing to guarantee the expected treatment effect and affecting the patient's treatment. Furthermore, the exact amount of leaked chemotherapy drugs is uncertain, posing a risk of environmental pollution, occupational exposure for medical staff, and environmental safety risks. In addition, drug leakage can easily cause dissatisfaction and questioning from patients and their families, potentially leading to medical disputes.

[0022] To address the above situation, this embodiment proposes a drug infusion leakage observation device, see attached document. Figures 2-4 As shown, the drug infusion leakage observation device of the present invention includes an observation cylinder 20, which is a transparent, rigid, hollow cylinder. A base plate 23 is sealed and fixed to the bottom of the observation cylinder 20 to collect the leakage. Furthermore, scale lines 24 are printed on the side wall of the observation cylinder 20. These scale lines are for graded measurement and are used to estimate the leakage level. This allows the leakage level to be estimated whether the infusion leakage is collected in a horizontal or non-horizontal state. A first color-developing layer 21 and a second color-developing layer 22 are sequentially attached to the inner wall of the observation cylinder 20 from top to bottom. Specifically… The first color-changing layer 21 is a ring-shaped color-changing indicator band along the inner wall of the container, with graduations such as 0.5mL, 1mL, and 2mL. The corresponding layer changes color when the liquid level reaches a certain height, allowing for rapid visual reading without needing to look closely at the liquid surface. The number of first color-changing layers 21 is unlimited, and the preferred material is irreversible moisture-sensitive ink printing or narrow strip color-changing non-woven fabric. The second color-changing layer 22 is a cobalt-free color-changing silicone sheet / medical color-changing non-woven fabric fully covered on the base plate 23, with a thickness of 0.2–0.5mm. For this measurement method, the thickness of the bottom material needs to be pre-deducted from the scale calibration to avoid affecting the reading.

[0023] Both color-developing layers are made of water-absorbing and color-changing materials, which change color immediately upon contact with the liquid, enabling visual observation of leakage. The water-absorbing and color-changing materials used in this implementation include, but are not limited to: cobalt-free color-changing silica gel, medical water-sensitive color-changing non-woven fabric / absorbent paper, super absorbent resin color-changing film, and irreversible moisture-sensitive color-changing ink.

[0024] This invention utilizes the structure of the observation cylinder 20, which is a transparent, rigid, hollow cylinder with a sealed bottom plate 23. This structure allows for the complete containment and sealing of medication leaking from the stopper puncture site. Simultaneously, the second color-developing layer 22 on the bottom plate 23 is made of a material that irreversibly changes color upon contact with medication. Even a small amount of leakage triggers immediate color development, solving the problem of small, dispersed leaks at the infusion interface that are difficult to detect early due to lack of visual warning. This provides immediate visual warning of leakage. Combined with the first color-developing layer 21 arranged along the height of the inner wall of the observation cylinder 20, it forms a one-to-one corresponding layered color indication with the graduations on the scale 24. When the leaking liquid level rises to the corresponding graduation height, the first color-developing layer 21 changes color synchronously. Medical personnel can quickly understand the leakage level without close observation of the liquid level, avoiding the shortcomings of easy misreading. Furthermore, the second color-developing layer 22 uses an ultra-thin sheet structure, and its volume is pre-deducted when calibrating the scale 24. Its primary function is for immediate color-developing warning of leakage, and its minute volume changes do not significantly affect the leakage. The leakage level is affected by the central through-hole of the base plate 23, which forms a sealed fit with the sealing kit 30. The sealing ring on the outer wall of the sealing kit 30 can fit tightly with the inner wall of the through-hole to form a radial seal, preventing leakage collected in the observation cylinder 20 from seeping out through the assembly gap, further improving the sealing and protection effect. The sealing reinforcement 50 inside the sealing kit 30 has multiple layers of annular sealing rubber rings on its outer wall. After the bottle stopper puncture device is inserted, it undergoes adaptive deformation under pressure, which can fit tightly with the outer wall of the puncture device to form a multi-layer sealing structure. This not only adapts to bottle stopper puncture devices of different diameters and ensures the sealing reliability under different consumable usage scenarios, but also forms a flexible coaxial guide and radial limit for the bottle stopper puncture device, helping to reduce the angle deviation that occurs during puncture and reduce the risk of micro-gap caused by tilted fit. At the same time, the double sealing structure of the sealing reinforcement 50 and the sealing kit 30 counteracts the loosening effect caused by external forces such as patient movement, tubing traction, and self-weight drooping, maintaining a stable fit between the bottle stopper puncture device and the rubber stopper.

[0025] See Figure 3 as well as Figure 5 As shown, the base plate 23 has a through hole in its center, through which a sealing kit 30 is detachably connected to achieve assembly and sealing between the observation tube 20 and the bottle stopper puncture device. The sealing kit 30 includes a sealing sleeve 31, preferably made of medical-grade liquid silica gel. The sealing sleeve 31 is a hollow sleeve structure, fitted into the through hole of the base plate 23. Multiple sealing rings 32 are embedded in the outer wall of the sealing sleeve 31, preferably made of medical-grade butyl rubber. The inner wall of the sealing rings 32 is tightly fitted with the inner wall of the through hole of the base plate 23 to form a seal. The bottom of the sealing sleeve 31 is connected to a circular sealing plate 60 coaxial with it via a connecting plate 33. The outer ring of the sealing plate 60 has a sealing strip. The sealing plate 60 can block the bottom of the central through hole of the base plate 23. Figure 7As shown, the bottom of the hollow sleeve of the sealing sleeve 31 has a first adhesive layer 34 that seals its bottom opening, and a reinforcing plate 35 is provided between the bottom of the sealing sleeve 31 and the connecting plate 33. See Figure 9 As shown, the bottom of the sealing plate 60 has an extension post 61 with a rotating structure. Both the extension post 61 and the center of the sealing plate 60 have passages allowing a bottle stopper piercing device to pass through. The bottom of the extension post 61 is connected to the base 41. Further details can be found in... Figure 9 The connecting plate 33 shown has multiple arc-shaped structures, with one end connected to the bottom of the sealing sleeve 31 and the other end connected to the surface of the sealing plate 60.

[0026] See Figure 5 , Figure 6 As shown, a sealing reinforcement 50 is tightly fitted inside the hollow sleeve of the sealing sleeve 31. The sealing reinforcement 50 includes a sealing sleeve 53, which is tightly fitted inside the sealing sleeve 31. The inner and outer walls of the sealing sleeve 53 have annular sealing strip structures stacked one on top of the other. In use, the sealing sleeve 53 forms a seal between the sealing sleeve 31 and the bottle stopper puncture device. The sealing sleeve 53 can deform under pressure in either direction. The sealing sleeve 53 has a sealing ring 51 with an annular plane and an extension body 52 extending downward from the bottom. The extension body 52 wraps around and fits against the outer wall of the sealing sleeve 53. The sealing sleeve 53 and the sealing ring 51 are preferably made of highly elastic medical natural rubber.

[0027] The sealing sleeve 31 of this invention adopts a hollow sleeve structure and is fitted into the through hole of the base plate 23. Multiple sealing rings 32 are embedded in the outer wall of the sealing sleeve 31, ensuring a tight fit between the outer wall of the sealing rings 32 and the inner wall of the through hole of the base plate 23, forming multiple radial seals. This effectively prevents the leakage of the medicine collected inside the observation tube 20 from the assembly gap between the sealing sleeve 31 and the base plate 23, avoiding the risk of medicine leakage and environmental pollution. Simultaneously, the detachable connection allows the sealing kit 30 to be assembled and disassembled, facilitating production assembly, clinical use, and adaptation to different sizes of bottle stopper puncture devices, improving the device's versatility and ease of use. The bottom of the sealing sleeve 31 is connected to the same... The circular sealing plate 60 with a sealing strip on its outer ring can reliably seal the bottom of the central through hole of the base plate 23, preventing leakage from flowing out from the bottom of the through hole and ensuring that the observation tube 20 has a completely closed leakage collection space. This ensures that all leaked medicine is confined within the observation tube 20. After the puncture device breaks through the first adhesive layer 34, the first adhesive layer 34 wraps around the outer wall of the puncture device to form a seal, further improving the sealing reliability of the puncture position. The reinforcing plate 35 between the bottom of the sealing sleeve 31 and the connecting plate 33 can enhance the connection strength between the sealing sleeve 31 and the connecting plate 33, preventing loosening, deformation or even breakage of the connection under external pulling force.

[0028] In this embodiment, the sealing sleeve 31 is fitted into the through hole of the base plate 23 and radially positioned and fastened by multiple sealing rings 32, ensuring that the central axis of the sealing sleeve 31 coincides with the central axis of the observation cylinder 20. The bottom of the sealing sleeve 31 is fixedly connected to the sealing plate 60 via a connecting plate 33 and a reinforcing plate 35. Both the connecting plate 33 and the reinforcing plate 35 are symmetrically arranged with respect to the central axis of the sealing sleeve 31, ensuring that the sealing plate 60 and the sealing sleeve 31 remain coaxial. The extension post 61 at the bottom of the sealing plate 60 is also coaxially formed with the sealing plate 60. The extension post 61 and the interior of the sealing plate 60 have a passage for the bottle stopper piercing device to pass through. The axis of this passage is aligned with the sealing sleeve. The axes of 31 coincide, and the sealing reinforcement 50 is tightly fitted inside the sealing sleeve 31, with its central axis aligned with the axis of the sealing sleeve 31. This forms a continuous constraint channel from the sealing sleeve 31 to the sealing plate 60, the extension post 61, and the sealing reinforcement 50. When the bottle stopper puncturer is inserted, regardless of whether the puncturer is initially tilted, it passes through the extension post 61, the sealing plate 60, the sealing reinforcement 50, and the sealing sleeve 31 in sequence. Through coaxial constraint, the bottle stopper puncturer is flexibly guided and radially limited, which helps to straighten the puncture posture, reduce the angular deviation that occurs during puncture, and reduce the probability of micro-gaps caused by tilted fit.

[0029] Because the sealing reinforcement 50 adopts a structure of a sealing sleeve 53 with elastic deformation capability and a multi-layer annular sealing ring 51, during the tilting insertion of the bottle stopper piercing device, the sealing reinforcement 50 will generate corresponding radial compression deformation and circumferential fitting deformation with the posture adjustment of the piercing device, always tightly wrapping the outer wall of the bottle stopper piercing device with an elastic surface, filling the small radial gaps that may occur during the piercing process. At the same time, multiple sealing rings 32 form multiple radial static seals between the sealing sleeve 31 and the base plate 23. This sealing structure is not affected by the piercing action of the piercing device, and always maintains a tight fit between the outer wall of the sealing sleeve 31 and the inner wall of the through hole of the base plate 23, blocking the leakage path. The sealing plate 60 is provided with a sealing strip on the outer ring and forms a seal at the bottom of the central through hole of the base plate 23. Its sealing fit is a static end face seal, which is not affected by the dynamic interference of the piercing device posture.

[0030] See Figure 8As shown, the connector 40 includes a base 41, which is a rotating structure with a hollow cylindrical structure inside. The hollow cylindrical structure of the base 41 extends through both ends. A second adhesive layer 42 capable of vertical displacement is provided inside the hollow cylindrical structure. An integrally formed protruding ring 43 is provided on the inner wall of the bottom outlet of the base 41. A limiting protruding ring is also provided inside the base 41. There is a gap between the limiting protruding ring and the protruding ring 43. The limiting protruding ring is placed above the second adhesive layer 42 to limit the upward movement distance of the puncture device. A spring 44 is provided inside the base 41. One end of the spring 44 is connected to the bottom surface of the second adhesive layer 42, and the other end is connected to the protruding ring 43. The inner diameter of the spring 44 is greater than or equal to the inner diameter of the protruding ring 43. One end of the spring 44 is stably abutted against the second adhesive layer 42, and the other end abuts against the convex ring 43, providing a constant upward elastic thrust to the second adhesive layer 42. After the bottle stopper piercing device passes through the second adhesive layer 42, the second adhesive layer 42 continues to push the bottle stopper piercing device upward under the action of the spring 44, so that the head of the bottle stopper piercing device always remains in close contact with the rubber stopper 10, which counteracts the downward pull of the pipeline, its own weight, and the loosening tendency caused by external shaking, and reduces leakage due to micro-gap caused by loose fit. At the same time, the second adhesive layer 42 can float up and down inside the base 41, which can adapt to the assembly height and small displacement of the bottle stopper piercing device, ensuring that the pushing force is stable and reliable, and will not cause damage to the rubber stopper 10 or the piercing device due to rigid tightening.

[0031] Instructions for using the drug infusion leak observation device: This device is a pre-assembled design. Before production or clinical use, the various components of the bottle stopper puncture device and the drug infusion leakage observation device, such as the first adhesive layer 34 and the second adhesive layer 42, have been pre-assembled. In clinical use, the pre-assembled device can be directly connected to the rubber stopper of the infusion bag.

[0032] Example 2: See Figure 10 As shown, the difference between this embodiment and Embodiment 1 is that the connecting plate 33 is a straight strip structure, with one end vertically connected to the bottom of the sealing sleeve 31 and the other end vertically connected to the surface of the sealing plate 60. During the insertion of the bottle stopper piercing device and the application of external force, the vertical straight strip connecting plate 33 can resist radial torque and lateral force by relying on its own arc-shaped anti-bending structure, thus suppressing relative rotation, radial offset, or angular deflection between the sealing sleeve 31 and the sealing plate 60.

[0033] Example 3: See Figure 11As shown, the difference between this embodiment and Embodiment 1 is that the connecting plate 33 is a straight strip structure, with one end inclinedly connected to the bottom of the sealing sleeve 31 and the other end inclinedly connected to the surface of the sealing plate 60. During the insertion of the bottle stopper piercing device and the application of external force, the inclined straight strip connecting plate 33 can resist radial torque and lateral force by relying on its own arc-shaped anti-bending structure, thus suppressing relative rotation, radial offset, or angular deflection between the sealing sleeve 31 and the sealing plate 60.

[0034] It should also be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. Unless otherwise expressly specified and limited, the terms "installed," "connected," "linked," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication between two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0035] The embodiments and / or implementation methods described above are merely preferred embodiments and / or implementation methods for implementing the technology of the present invention, and are not intended to limit the implementation methods of the technology of the present invention in any way. Any person skilled in the art can make some modifications or alterations to other equivalent embodiments without departing from the scope of the technical means disclosed in the content of the present invention, but they should still be regarded as the technology or embodiments that are substantially the same as the present invention.

[0036] This document uses specific examples to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the methods and core ideas of this application. The above descriptions are only preferred embodiments of this application. It should be noted that due to the limitations of written expression, while there are objectively infinite specific structures, those skilled in the art can make several improvements, modifications, or changes without departing from the principles of this application, and can also combine the above technical features in an appropriate manner. These improvements, modifications, changes, or combinations, or the direct application of the inventive concept and technical solution to other situations without modification, should all be considered within the scope of protection of this application.

Claims

1. A drug infusion leakage observation device, including, An observation tube (20) is provided with a bottom plate (23) sealed and fixed at the bottom, and a scale line (24) is provided on the side wall of the observation tube (20). Its features are, The inner wall of the observation tube (20) is provided with a first color-developing layer (21) for height indication, and the bottom plate (23) is provided with a second color-developing layer (22) for receiving leakage and developing color. Both the first color-developing layer (21) and the second color-developing layer (22) irreversibly change color when exposed to the medicine. The base plate (23) has a through hole in the center, and a sealing kit (30) is sealed and connected inside the through hole. A sealing reinforcement (50) for enhancing the seal is fitted inside the sealing kit (30).

2. The drug infusion leakage observation device according to claim 1, characterized in that, The first color-developing layer (21) is an annular humidity-sensitive color-changing indicator strip arranged at intervals along the height direction of the inner wall of the observation tube (20), and the annular humidity-sensitive color-changing indicator strip corresponds one-to-one with the scale interval of the scale line (24).

3. The drug infusion leakage observation device according to claim 1, characterized in that, The sealing kit (30) includes a hollow sealing sleeve (31), and at least two sealing rings (32) are embedded on the outer wall of the sealing sleeve (31). The outer wall of the sealing rings (32) is tightly fitted with the inner wall of the through hole of the base plate (23) to form a radial seal.

4. The drug infusion leakage observation device according to claim 3, characterized in that, The bottom of the sealing sleeve (31) is fixedly connected to a sealing plate (60) via a connecting plate (33), and the bottom end of the sealing sleeve (31) is provided with a first adhesive layer (34) for being punctured by a bottle stopper puncturer.

5. The drug infusion leakage observation device according to claim 4, characterized in that, The connecting plate (33) is any one of an arc-shaped strip, a vertical straight strip, or an inclined straight strip. One end of the connecting plate (33) is fixedly connected to the bottom of the sealing sleeve (31), and the other end is fixedly connected to the surface of the sealing plate (60).

6. The drug infusion leakage observation device according to claim 4, characterized in that, The bottom of the sealing plate (60) is provided with an extension post (61), and the extension post (61) is coaxial with the sealing plate (60) to provide a passage for the bottle stopper piercing device to pass through.

7. The drug infusion leakage observation device according to claim 1, characterized in that, The sealing reinforcement (50) includes a sealing sleeve (53), the outer wall of which is provided with multiple layers of annular sealing rings (51), and the sealing sleeve (53) fits against the outer wall of the bottle stopper puncturer after being deformed by pressure.

8. The drug infusion leakage observation device according to claim 1, characterized in that, The sealing kit (30) is connected to a connector (40) below it. The connector (40) includes a base (41) and a second adhesive layer (42) that can move up and down inside the base (41).

9. The drug infusion leakage observation device according to claim 1, characterized in that, The second color layer (22) is a thin sheet structure that is fully covered on the base plate (23).

10. The drug infusion leakage observation device according to claim 1, characterized in that, The first color-developing layer (21) is an irreversible moisture-sensitive color-changing ink or medical color-changing non-woven fabric, and the second color-developing layer (22) is a cobalt-free color-changing silicone sheet or medical water-absorbing color-changing non-woven fabric.

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