Closed transfer medicine dispenser and application thereof in preparing and transferring medicines
Technical Field
The invention belongs to the field of preparation and transfer devices of medicaments, and particularly relates to a closed transfer medicament dispenser.
Background
Chemotherapeutic drugs for treating cancer can cause serious harm to healthy people, especially to medical workers who are exposed to the chemotherapeutic drugs for a long time in the process of preparation and transportation. The data published by the american BD company indicate that the hazardous drug exposure in the medical environment is carcinogenic, damages internal organs and organs, DNA damage due to genotoxicity, reproductive problems due to biotoxicity, abortion and teratogenesis. The data show that the cancer incidence of pharmacists and nurses is increased by 3-10 times compared with the general population and the risk of infertility, abortion and the like is increased by 2-5 times due to long-term contact with dangerous drugs.
In this regard, some developed countries have begun to employ isolation systems such as bio-cabinets to prevent or reduce the risk of hazardous drug exposure. However, studies have confirmed that even when these systems are used to formulate and deliver chemotherapeutic agents, large amounts of chemotherapeutic agents are still detected in the ground, gloves, air, and respiratory gases of humans. In recent years, a closed drug preparation and transfer system (CSTD) is developed in the United states, which claims to reduce the pollution of 50-80% of chemotherapeutic drugs, but the CSTD consists of three subsystems, has a very complex structure and a complex use mode, requires replacement of accessories for many times in the use process, causes leakage risks to still exist, has high cost, is difficult for patients to bear, and cannot be popularized and applied in various regions on a large scale.
It is reported that nearly 2.6 billion bottles of chemotherapy drugs are used annually in our country. The chemotherapy medicine can enter human body through skin, digestive tract and respiratory tract. The health of about 1000 million medical workers is affected by long-term exposure in the process of preparation and transportation of chemotherapeutic drugs. Although the hazards of these drugs are known, no practical and generalizable special protective equipment and measures exist in China.
Disclosure of Invention
In view of the deficiencies and needs in the art, it is an object of the present invention to provide a closed transfer dispenser. When the medicine dispenser is used for preparing and transferring medicines, the medicine dispenser can be completed in a nearly totally closed condition, the medicines are effectively prevented from being leaked and volatilized, and the medicine dispenser is simple in structure, convenient and safe to use and low in cost.
The invention discloses a closed transfer medicine dispenser, which comprises an injection piece, a sealing piece and a protection piece, and is characterized in that:
the injection piece consists of an injector, a needle seat and a dispensing needle, wherein the needle seat is fixedly connected with the injector through a joint on the injector, and the dispensing needle is fixedly connected on the needle seat;
the dispensing needle is of a double-layer columnar structure and is provided with an inner column channel and a side ring channel, wherein one channel is used as a transfusion channel and is communicated with the cavity of the needle seat, and the other channel is used as an exhaust channel and is communicated with a transom arranged on the side surface of the needle seat;
a water-resistant film is arranged in the transom window;
the closed part is made of elastic materials and sequentially comprises a closed tube, a folding tube and an air bag from front to back, wherein the front end of the folding tube is fixedly connected with the rear end of the closed tube, the rear end of the folding tube is fixedly connected to the front end surface of the air bag, a through hole for a dispensing needle to pass through is arranged on the front end surface of the air bag, and an opening is arranged at the rear end of the air bag;
the closed tube and the folding tube are coaxially arranged with the dispensing needle, and the dispensing needle exposed out of the needle seat is shielded inside; wherein, the closed tube tightly wraps the front end part of the dispensing needle and seals the transfusion passage port and the exhaust passage port;
the air bag is sleeved outside the needle seat, the front end face of the air bag is arranged by being attached to the front end face of the needle seat, and the opening end of the rear end of the air bag is hermetically connected with the front end face of the injector;
the protection piece comprises a first sheath and a second sheath;
the first sheath is sleeved outside the closed pipe, the front end face of the first sheath is closed, and a through hole for a dispensing needle to pass through is formed in the center of the end face;
the two ends of the second sheath are both of an open structure, the rear end of the second sheath is sleeved at the front end of the injector and is fixedly connected with the injector, and the front end of the second sheath is sleeved at the rear end of the first sheath in a non-fixed connection manner;
the first sheath is axially slidable within the second sheath.
In the present invention, unless otherwise stated, the front end refers to the end of the dispensing needle pointed at, and the rear end refers to the opposite end.
The injection member in which the needle holder is fixedly connected to the syringe and the dispensing needle is fixedly connected to the needle holder is well known to those skilled in the art.
In a preferred embodiment, the inner column channel of the dispensing needle is a vent channel, the side ring channel is a transfusion channel, and the inner column channel is longer than the side ring channel.
Suitably, the liquid outlet port (i.e., the liquid feeding passage port) of the liquid feeding passage is provided on the side of the front end of the side ring passage, and the gas discharge port (i.e., the gas discharge passage port) of the gas discharge passage is provided on the side of the front end of the inner column passage. The arrangement of the passage opening at the side part is helpful for realizing the wrapping sealing of the closed tube to the passage opening under the non-operation state, thereby ensuring that the medicament cannot leak to the atmosphere through the passage opening. If the passage opening is arranged at the front-end needle point of the dispensing needle, the risk that the sealed tube cannot fully wrap the sealed passage opening exists.
The liquid outlet hole is arranged at the rear end of the exhaust hole, and the purpose is to fit the operation habit of medical personnel in the process of preparing the medicament. When the medical staff operates, the medicament bottle filled with the liquid medicament is usually inverted, the needle point of the dispensing needle is upwards inserted into the medicament bottle, and the liquid outlet hole is positioned below the dispensing needle, so that the liquid medicament is favorably and fully sucked. If the liquid outlet hole is arranged too far forward, the liquid medicine at the bottle mouth can not be smoothly sucked, so that the medicine is wasted or the operation risk is promoted due to secondary operation.
The side surface of the needle seat is provided with a transom window communicated with the exhaust passage, and a water-blocking film is arranged in the transom window, so that only gas but not liquid can pass through the passage.
The closing member is made of elastic material and comprises a closing tube, a folding tube and an air bag.
In a preferred embodiment, the inner diameter of the containment tube is smaller than the outer diameter of the dispensing needle. Under the elastic force of the elastic material, the front end part of the dispensing needle can be tightly wrapped by the closed tube, and the infusion channel port and the exhaust channel port are sealed inside. Therefore, the medicament in the dispensing device can be effectively prevented from leaking to the atmosphere through the passage port in the process of dispensing and transferring. More preferably, the containment tube has a smaller inner diameter near the front end port to further enhance sealing performance.
The folding tube is an elastic component in the closed transfer dispensing device and is positioned at the rear end of the closed tube. Under the non-operation state, the folding tube naturally extends, and supports the sealed tube by relying on the front end surface of the needle seat. During operation (namely under a pressed state), the folding tube is axially compressed, and the front end part of the dispensing needle including the infusion channel port and the exhaust channel port can penetrate out of the first sheath through the front port of the sealing tube and the through hole in the center of the front end face of the first sheath and enter the medicament bottle.
As the elastic member, in addition to the folding tube, a spring may be additionally provided along the folding tube to further enhance the supporting force and the resilient force. Suitably, in the non-operative condition, the additional spring is naturally extended, with the two ends being connected to the rear end of the front member and the front end of the rear member, respectively. As a preferred embodiment, the spring is arranged outside the folded tube coaxially with the dispensing needle to avoid potential metal contamination risks when arranged inside the folded tube.
The air bag is sleeved outside the needle seat to shield the needle seat integrally. The air bag is arranged to ensure that the air pressure in the medicine bottle is consistent with the outside in the medicine dispensing process, so that the problem that the negative pressure in the bottle causes the difficulty in sucking the medicine liquid when the medicine liquid is sucked is avoided, or the medicine liquid and/or the medicine gas are sprayed out from a needle hole of the bottle mouth when the needle is pulled due to the high pressure in the bottle when the medicine is injected. When the air bag is used, the air bag is communicated with the interior of the medicine bottle through the air window and the exhaust channel, and the medicine bottle is ensured to keep constant internal and external pressure at any time in the liquid injection or liquid absorption process through self deformation.
In order to further ensure the air tightness of the air bag, the joint parts of the front end surface of the air bag and the front end surface of the needle seat are preferably fixed and hermetically connected with each other in a pressing way, an adhesion way and the like. In a preferred embodiment, a connecting seat is arranged on the front end face of the injector, and the opening end of the air bag is fixedly and hermetically connected with the connecting seat in a pressing, bonding, screwing and other modes.
The closed tube, the folding tube and the air bag are made of elastic materials, are independent from each other (namely, the materials can be the same or different), and are preferably made of any one of rubber, silica gel and synthetic rubber. Suitable elastic materials should meet the relevant standards for medical materials, as will be readily known and established by those skilled in the art.
In a preferred embodiment, the closing tube, the folding tube and the balloon of the closing member are of an integral construction.
As another alternative preferred embodiment, the closing tube, the folding tube and the air bag are respectively of independent structures, and the closing member is formed by fixedly connecting the three. Optionally, at this time, a spring may be used instead of the folded tube to perform the same function, or a spring may be added along the folded tube to further enhance the supporting force and the resilient force.
The protector includes a first sheath and a second sheath. The first sheath is able to slide axially within the second sheath as the folded tube and/or spring compresses and expands.
In a preferred embodiment, the inner diameter of the first sheath is smaller than the outer diameter of the obturation tube, and the fixed connection between the two is realized by interference fit.
Preferably, the rear end of the second sheath is fixedly connected with the front end of the syringe in a screwing, clamping and other modes. Preferably, the second sheath is provided with at least one vent hole communicating with the atmosphere to ensure that the interior of the balloon is constantly isobaric to the external environment.
Optionally, the protector further comprises a cap. In a standby state, the protective cap is sleeved at the front end of the second sheath to avoid misoperation and potential pollution risk of the first sheath.
With a full understanding of the construction of the closed transfer dispenser described above in this invention, it will be readily apparent to those skilled in the art how to use it to dispense and transfer a medicament.
In general, the use process may include the following steps:
1) aligning and attaching the front end face of the first sheath with the bottle mouth of the medicament bottle A, and extruding along the axial direction of the dispensing needle to enable the front end part of the dispensing needle to penetrate through the sealed tube and the first sheath and penetrate into the medicament bottle A;
2) pulling the piston of the injector to suck the liquid medicine; in the link, as the liquid medicine is sucked, the air pressure in the medicine bottle A is reduced, and part of air in the air bag enters the medicine bottle A through the exhaust passage, so that the inside and the outside of the medicine bottle A are in equal pressure;
3) after the liquid medicine is sucked, gradually removing the axial pressure applied to the first sheath, simultaneously slowly pulling out the dispensing needle until the folding tube and/or the spring are reset, tightly wrapping the front end part of the dispensing needle by the closed tube, and sealing the liquid outlet hole and the exhaust hole;
4) similar to the step 1), aligning and attaching the front end face of the first sheath with the bottle mouth of the medicament bottle B, and extruding along the axial direction of the dispensing needle to enable the front end part of the dispensing needle to penetrate through the sealed tube and the first sheath and penetrate into the medicament bottle B;
5) pushing the piston of the injector to inject the liquid medicine into the medicine bottle B; in the link, along with the injection of the liquid medicine, the air pressure in the medicine bottle B is increased, and part of the air is discharged into the air bag through the exhaust passage, so that the inside and the outside of the medicine bottle B are in equal pressure;
6) after the liquid medicine is injected, the axial pressure applied to the first sheath is gradually removed, the dispensing needle is slowly pulled out at the same time until the folding tube and/or the spring are reset, the front end part of the dispensing needle is tightly wrapped by the closed tube again, and the liquid outlet hole and the exhaust hole are sealed inside.
By the method, the purposes of preparing mixed medicaments, transferring prepared liquid medicaments into infusion bottles or indwelling needles and the like can be achieved.
Compared with the prior art, the invention has the following beneficial effects:
1) by using the closed type transfer medicine dispensing device, the liquid outlet hole and the exhaust hole of the medicine dispensing needle are nearly not contacted with the external air, the full sealing of the medicine dispensing process can be realized to the maximum extent, and the leakage and volatilization of the medicine are effectively prevented;
2) in the process of dispensing, the pressure in the medicament bottle is constantly equal to the external pressure, so that the difficulty in sucking the liquid medicament is avoided, or the liquid medicament or the exhaust gas is sprayed out of a bottle opening needle hole due to overhigh pressure in the bottle at the moment of needle pulling;
3) the product has simple and compact structure, convenient and safe use and low cost, and is beneficial to large-scale popularization and application.
Drawings
FIG. 1 is a schematic structural diagram of a closed transfer dispenser in an embodiment;
FIG. 2 is a schematic structural view of the front end portion of the dispensing needle in the embodiment;
FIG. 3 is a schematic view of the structure of a closure in an embodiment;
FIG. 4 is a representative pictorial view of the closed transfer dispenser of the present invention;
fig. 5 is a diagram showing a test result in the embodiment using the three-way uv analyzer.
Detailed Description
The present invention will be described in further detail with reference to the following examples and drawings, but the present invention should not be construed as being limited to the scope of the present invention.
Examples
As shown in fig. 1, the closed transfer dispenser includes an injector, a closure, and a protector.
The injection piece consists of an injector 1, a needle base 2 and a dispensing needle 3. The needle base 2 is fixedly connected with the injector 1 through a joint 11 on the injector 1, and the dispensing needle 3 is fixedly connected on the needle base 2.
The dispensing needle 3 is a double-layer column structure having an inner column channel and a side ring channel, and the inner column channel is slightly longer than the side ring channel (as shown in fig. 2). Wherein, the side ring channel is a transfusion channel 31 which is communicated with the cavity of the needle seat 2, and the inner column channel is an exhaust channel 32. The liquid outlet hole 311 of the liquid feeding channel 31 is positioned at the front end side of the side ring channel, and the air outlet hole 321 of the air outlet channel 32 is positioned at the front end side of the inner column channel.
The side of the needle seat 2 is provided with a transom 21 communicated with the exhaust passage 32, and a water-resisting film 22 is arranged in the transom 21.
The closing member 4 is made of silicon rubber (brand: C6-165; manufactured by DPS Electronic company), and includes a closing tube 41, a folding tube 42, and an air bag 43 in this order from front to rear. As shown in fig. 3, the closing tube 41, the folding tube 42, and the balloon 43 are integrally formed. Wherein the front end of the folding tube 42 is connected with the rear end of the closed tube 41, and the rear end of the folding tube 42 is connected with the front end surface of the air bag 43; the front end face of the air bag 43 is provided with a through hole for the dispensing needle 3 to pass through, and the rear end is provided with an opening.
The sealing tube 41 and the folding tube 42 are arranged coaxially with the dispensing needle 3 and shield the dispensing needle 3 exposed from the needle holder 2. Wherein, the inner diameter of the sealed tube 41 is smaller than the outer diameter of the dispensing needle 3, and under the elastic force of the silicon rubber, the sealed tube 41 tightly wraps the front end part of the dispensing needle 3 and seals the liquid outlet 311 and the exhaust hole 321. The inner diameter of the front end port of the containment tube 41 is smaller than the inner diameter of the other portions to further enhance the sealing performance.
The folding tube 42 naturally extends and supports the airtight tube 41 by relying on the front end surface of the needle seat 2.
The air bag 43 is sleeved outside the needle seat 2 to shield the needle seat 2. Wherein, the part of the front end surface of the air bag 43, which is positioned at the periphery of the through hole and is jointed with the front end surface of the needle seat 2, is fixedly and hermetically connected with the front end surface of the needle seat 2 in a bonding way; the open end of the rear end is fixedly and hermetically connected with a connecting seat 12 arranged on the front end surface of the injector 1 in a bonding mode.
The protector 5 includes a first sheath 51, a second sheath 52, and a cap 53.
The front end face of the first sheath 51 is closed, and a through hole 511 for the dispensing needle 3 to pass through is arranged at the center of the end face, and the through hole is sleeved outside the sealed tube 41 and shields the sealed tube 41. The inner diameter of the first sheath 51 is smaller than the outer diameter of the obturation tube 41, and the fixed connection between the two is realized through interference fit.
Both ends of the second sheath 52 are open structure. Wherein, the inner surface of the back end is provided with internal threads (not shown in the figure), and the second sheath 52 is fixedly connected with the injector 1 in a screwing way by matching with external threads (not shown in the figure) arranged on the outer surface of the front end of the injector 1; the front end is fitted over the rear end of the first sheath 51 in a non-fixed connection. The first sheath 51 is able to slide axially within the second sheath 52 as the collapsed and expanded collapsed tube 42.
The second sheath 52 is also provided with a vent 521 which communicates with the atmosphere. A cap 53 is fitted over the front end of the second sheath 52.
Application examples
The performance advantages of the closed transfer dispenser of the present invention over the prior art have been described in detail above. In order to further verify the technical effect, the practical product is used for carrying out application experiments and is compared with the existing product.
1. Site of experiment
Product research and development laboratory of Zhanjiang Jianliyuan medical supplies GmbH.
2. Test object
A closed transfer dispenser as shown in fig. 4 was used as the experimental sample, syringe format 60 mL. The closed transfer medicine dispenser has a structure as shown in fig. 1, and a spring is provided outside the folding tube coaxially with the dispensing needle to further enhance the supporting force and the resilient force. In the figure, fig. 4a is a sample object diagram in a standby state, and fig. 4b is a sample object diagram with a part of the components detached (to show the internal structure more clearly).
A conventional dispensing needle (i.e., a conventional syringe, gauge: 20mL) commonly used in the art was used as a comparative sample.
3. Experimental methods
3.1 use of the test samples
1) 20mL of a 10g/L aqueous solution of fluorescein sodium was added to a vial (specification: 40mL), sealing by an aluminum cap chlorinated butyl rubber plug, and marking as a penicillin bottle A; filling 10mL of purified water into another penicillin bottle (specification: 40mL), sealing with an aluminum cap chlorinated butyl rubber plug, and marking as a penicillin bottle B; and (5) standby.
2) Removing a protective cap of the closed transfer dispensing device, aligning and attaching the front end face of a first protective sleeve of the protective cap with the bottle opening of the penicillin bottle A, wrapping the attaching part with qualitative filter paper, and then extruding along the axial direction of a dispensing needle to enable the front end part of the dispensing needle to penetrate through the sealed tube and the first protective sleeve and penetrate into the penicillin bottle; the plunger of the syringe is then pulled and 10mL of the sodium fluorescein solution is aspirated.
3) After the sucking is finished, gradually removing the axial pressure, simultaneously slowly pulling out the dispensing needle until the folding tube and the spring reset, tightly wrapping the front end part of the dispensing needle by the closed tube, and sealing the liquid outlet hole and the exhaust hole; and then, finishing the attaching state of the closed type transferring and dispensing device and the penicillin bottle mouth, and taking down the qualitative filter paper.
4) Aligning and attaching the front end face of a first sheath of the closed transfer dispensing device filled with the fluorescein sodium solution with the bottle opening of the penicillin bottle B, wrapping the attaching part with qualitative filter paper taken down in the step 3) again, and then extruding along the axial direction of the dispensing needle to enable the front end part of the dispensing needle to penetrate through the sealed tube and the first sheath and penetrate into the penicillin bottle; then the piston of the syringe is pushed to inject the sodium fluorescein solution into the penicillin bottle B.
5) After the injection is finished, gradually removing the axial pressure, and simultaneously slowly pulling out the dispensing needle until the folding tube and the spring reset, tightly wrapping the front end part of the dispensing needle by the closed tube, and sealing the liquid outlet hole and the exhaust hole; and then, finishing the attaching state of the closed type transferring and dispensing device and the penicillin bottle mouth, and taking down the qualitative filter paper.
6) A three-way ultraviolet analyzer (model: ZF-1) the removed qualitative filter paper was examined. The specific method comprises the following steps: and (3) placing the qualitative filter paper taken down in the step 5) on an operation table of a three-purpose ultraviolet analyzer, starting the device to enable ultraviolet light to irradiate the qualitative filter paper, and observing whether fluorescent spots appear on the qualitative filter paper.
3.2 use of comparative sample
1) Referring to step 1) in 3.1, preparing a penicillin bottle A and a penicillin bottle B for later use.
2) Aligning the needle point of an injection needle of a common injector (namely a common dispensing needle) to the bottle opening of the penicillin bottle A, wrapping the bottle opening of the penicillin bottle and the injection needle of the common injector by qualitative filter paper, and then extruding along the axial direction of the injector to ensure that the injection needle penetrates into the penicillin bottle; the plunger of the syringe is then pulled and 10mL of the sodium fluorescein solution is aspirated.
3) After the aspiration, the needle was slowly withdrawn and the qualitative filter paper was removed.
4) Aligning the needle point of the injection needle of the common injector filled with the sodium fluorescein solution to the bottle opening of the penicillin bottle B, wrapping the bottle opening of the penicillin bottle and the injection needle of the common injector by using the qualitative filter paper taken out in the step 3), and then extruding along the axial direction of the injector to ensure that the injection needle penetrates into the penicillin bottle; then the piston of the syringe is pushed to inject the sodium fluorescein solution into the penicillin bottle B.
5) After the injection was completed, the injection needle was slowly withdrawn, and the qualitative filter paper was removed.
6) See step 6) in fig. 3.1), the removed qualitative filter paper is tested.
4. Results of the experiment
The results of the measurement using the three-way ultraviolet analyzer are shown in fig. 5. Wherein, fig. 5a shows the detection result of the closed transfer dispensing apparatus to which the present invention is applied, and fig. 5b shows the detection result of the common dispensing needle to which the present invention is applied. It can be seen that:
(1) by using the closed transfer dispensing device, no fluorescent spot appears on the finally obtained qualitative filter paper, and the bottle mouth of the penicillin bottle B is very clean, which indicates that no solution leaks in the using process;
(2) by using a common dispensing needle, yellow-green fluorescent spots with obvious and large range appear on the finally obtained qualitative filter paper, and the bottle mouth of the penicillin bottle B also has obvious fluorescence at the periphery of the needle hole, which indicates that a larger solution leakage problem exists in the using process. The leakage is mainly caused by the fact that the pressure in the bottle is too high when the needle is withdrawn, and solution is sprayed and gas is discharged from a needle hole of the bottle mouth.
The figures also show the situation of the closed transfer medicine dispenser and the common medicine dispensing needle on the three-purpose ultraviolet analyzer after use. It can be seen that the closed transfer dispenser of the present invention does not exhibit any fluorescence in appearance. When the closed type transfer medicine dispensing device is used, the liquid outlet hole and the exhaust hole of the medicine dispensing needle are nearly not contacted with the external air, the preparation and transfer processes are totally closed, and the leakage and volatilization of the solution are effectively prevented. When a common dispensing needle is seen, the needle tip of the injection needle is exposed, obvious yellow-green fluorescence is displayed, liquid medicine is easy to leak and volatilize from the needle tip, and hidden danger of accidental injury of personnel exists.
Furthermore, the closed transfer dispenser of the present invention and the conventional dispensing needle also show differences in operation. When the closed type transfer medicine dispenser is used, the solution is very smoothly sucked and injected because the inner and outer equal pressure of the penicillin bottle can be ensured; when a common dispensing needle is used for sucking and injecting the solution, the force is gradually increased to overcome the internal and external pressure difference of the penicillin bottle, and the operation difficulty is obviously improved.
The foregoing description is only exemplary of the invention. From the above, those skilled in the art can make various changes and modifications without departing from the technical idea of the present invention. The protection scope of the present invention is not limited to the above-mentioned embodiments, but is subject to the scope defined by the claims.