CN105232330A - Medicine mixer, hard double connectors and infusion soft bag - Google Patents
Medicine mixer, hard double connectors and infusion soft bag Download PDFInfo
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- CN105232330A CN105232330A CN201510781506.5A CN201510781506A CN105232330A CN 105232330 A CN105232330 A CN 105232330A CN 201510781506 A CN201510781506 A CN 201510781506A CN 105232330 A CN105232330 A CN 105232330A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
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Abstract
The invention provides a medicine mixer. The medicine mixer comprises a base, a medicine mixing channel, a diaphragm in the medicine mixing channel, a medicine mixing cup and a cross needle, wherein the base, the medicine mixing channel, the diaphragm and the medicine mixing cup are integrally formed; the medicine mixing cup comprises cup walls and a cup bottom; the cross needle is arranged in the medicine mixing cup. The medicine mixer is characterized in that the cross needle comprises a needle plate, an upper needle and a lower needle, which are integrally formed; the upper and lower needles are provided with hollow channels communicated with each other; the lower end of the medicine mixing channel passes through the base and the upper end passes through the cup bottom; a sealing rubber plug is arranged in the medicine mixing channel between the diaphragm and the cup bottom; balanced by the needle plate, the cross needle keeps a basically upright status in the medicine mixing cup. The medicine mixer also comprises a sealing membrane, wherein the sealing membrane is connected on the rim of the medicine mixing cup by way of pressure welding; the sealing membrane is an easy-to-tear membrane which can still keep basically flat after undergoing moist heat terminal sterilization. The invention also discloses hard double connectors and an infusion soft bag.
Description
Technical field
The present invention relates to a kind of medicine mixer, particularly a kind of medicine mixer with mixed medicine glass.。
Background technology
When using the injectable powder of cillin bottle splendid attire, lyophilized injectable powder or aqueous injection, needing by syringe the liquid medicine in transfusion flexible bag or water for injection to be extracted out to inject in cillin bottle, repeating above-mentioned work, until there are enough medicinal liquids in cillin bottle; And then cillin bottle shaken repeatedly until medicament mix homogeneously in bottle, then with syringe cillin bottle inner liquid medicine extracted out and inject transfusion flexible bag, so repeatedly, until the medicinal liquid in bottle is exhausted.
First, above-mentioned mixed medicine operating process is more time-consuming, effort, take consumptive material as syringe, more seriously, in above-mentioned mixed medicine process, be very easy to the air Injection of outside in cillin bottle and transfusion flexible bag, there is very many various dust, pathogenic bacteria under generic condition in air, enter human body again after being mixed into liquid medicine injection, very serious malpractice can be brought.
Secondly, traditional dosing mode, is first make up a prescription to inject again, is pumped in transfusion flexible bag by the medicine in cillin bottle in advance, then the transfusion flexible bag preparing medicine is brought to ward to patient fluid infusion.After having joined medicine, vacant cillin bottle has been placed, and what medicine what patient protected medical personnel not know to join in transfusion flexible bag completely is, does not possess trackability.Slightly do not note going wrong once medical personnel in dosing, medicinal liquid mismatch is wrong, and consequence is by hardly imaginable.
Again, for the medicine that some are special, such as need the medicine of namely joining namely, traditional dispensing method is very inconvenient, and the various medicine mixer structures disclosed before this patent, not can solve this problem.
Finally, the various medicine mixer structures disclosed before making the present invention, the problem of Drug leakage after always failing to solve mixed medicine.For the needs to higher medical service level, in the urgent need to a kind of easy to use, safe, reliable, without the infusion products of potential safety hazard.
In addition, medicine mixer is welded on transfusion flexible bag, and after transfusion flexible bag fill, need to carry out high temperature sterilize to transfusion flexible bag entirety, high temperature sterilize environment is generally the high temperature of 115-121 degree Celsius, sterilization time 30-15 minute, and sterilization pressure is 0.15MPa.Although medicine mixer and transfusion flexible bag material polypropylene used can withstand the temperature of 120 degrees Celsius, but inevitably soften, add the high pressure of 0.15MPa, being equivalent to the pressure that every square centimeter bears 150N---this is fatal for the mixed medicine glass being in sealing state.First-selection, mixed medicine glass and diaphragm seal are at the temperature of 120 degrees Celsius, and mechanical strength can decrease; Secondly, the pressure of every square centimeter of 150N, directly can cause that the cup of mixed medicine glass is out of shape, diaphragm seal is stretched, and occurs fold, and sealing is destroyed, and causes mixed medicine glass structure completely damaged and cannot use.
Before making the present invention, the medicine mixer of sealed mixed medicine cup structure, its terminal sterilization is the individual obstacle being difficult to overcome; And mixed medicine glass blow-by, can not ensure again to meet sterility requirements when using, no matter be consider from policies and regulations or from actual security standpoint, the terminal sterilization of transfusion flexible bag is all must and be very necessary.
Summary of the invention
Based on the problems referred to above, the present invention proposes a kind of easy to use reliable and without the transfusion flexible bag of potential safety hazard and associated medicine mixer, interface.
The medicine mixer that the present invention proposes, comprise the barrier film in integrated pedestal, mixed medicine passage and mixed medicine passage and mixed medicine glass, cross needle, described mixed medicine glass is formed by the bottom of wall of cup and cup, and described cross needle is positioned at described mixed medicine glass, it is characterized in that:
Described cross needle is by integrated needle plate and possess the upper pin of hollow channel and lower pin is formed, and the hollow channel of described upper pin and lower pin communicates with each other;
Described mixed medicine passage lower end is through described pedestal, and upper end is through at the bottom of described cup;
Seal rubber plug is provided with in mixed medicine passage between at the bottom of described barrier film and described cup;
Under the balance of described needle plate, described cross needle keeps basic erectility in described mixed medicine glass;
Described medicine mixer also comprises diaphragm seal, and described diaphragm seal is connected to the rim of a cup of described mixed medicine glass in the mode of pressure welding, forms sealing to described mixed medicine glass;
Described diaphragm seal is easily tore film.
Medicine mixer as above, is characterized in that:
Described diaphragm seal is breathability easily tore film.
Medicine mixer as above, is characterized in that:
The air penetrability of described diaphragm seal is 5% to 35%.
Medicine mixer as above, is characterized in that:
Described diaphragm seal upper surface metal-plated membrane layer.
As above arbitrary described medicine mixer, is characterized in that:
Also comprise a cover plate;
Described cover plate is positioned at described rim of a cup edge, and is covered by described diaphragm seal.
Medicine mixer as above, is characterized in that:
Described cover plate is polygon, and center is provided with a hole, and the needle point of described upper pin is positioned at described hole but does not pass described hole.
As above arbitrary described medicine mixer, is characterized in that:
Described mixed medicine glass, before being sealed by described diaphragm seal, pre-installs a certain amount of liquid.
Medicine mixer as above, is characterized in that:
Described liquid be can under high temperature sterilize environment the liquid of rapid vaporization.
As above arbitrary described medicine mixer, is characterized in that:
The described certain quantity of fluid of prepackage is vaporized formed gas under high temperature sterilize environment, and the inside and outside air pressure of described mixed medicine glass can be allowed in a basic balance.
As above arbitrary described medicine mixer, is characterized in that:
The inwall of described wall of cup is provided with restriction protrusion, after described cross needle is installed into described mixed medicine glass, can not be removed between described needle plate is limited at the bottom of described restriction protrusion and described cup by described restriction protrusion.
Medicine mixer as above, is characterized in that:
Described restriction protrusion is elastic card claw, the inwall week of wall of cup described in described elastic card claw upper end edge is along being evenly arranged and fixing, described elastic card claw lower end is free end, and described elastic card claw from fixing described upper end to described lower end freely in the centroclinal structure of described mixed medicine glass;
Described needle plate at the bottom of described lower end and described cup between.
Medicine mixer as above, is characterized in that:
Described restriction protrusion is elastic clamp seat, described elastic clamp seat comprises a snap ring, elastic card claw is provided with on the downside of described snap ring, snap ring described in described elastic card claw upper end edge is evenly arranged and fixes, described elastic card claw lower end is free end, and described elastic card claw from fixing described upper end to described lower end freely in the centroclinal structure of described mixed medicine glass;
Described needle plate is installed under the described elastic card claw in described mixed medicine glass;
The inwall of described wall of cup is provided with position limiting structure, and described elastic clamp seat is installed in described mixed medicine glass and is limited by described position limiting structure.
Medicine mixer as above, is characterized in that:
Described elastic clamp seat has integrated base plate, support column, described snap ring and described elastic card claw, and described base plate periphery is provided with support column and supports fixing to described snap ring formation;
Described base plate is provided with centre bore, and described lower pin is formed through described centre bore thus to described crosspointer and locates;
Described needle plate is between described base plate and described elastic card claw.
As above arbitrary described medicine mixer, is characterized in that:
Distance at the bottom of described barrier film upper surface and described cup between upper surface and the consistency of thickness of described plug.
Medicine mixer as above, is characterized in that:
Described barrier film upper surface is provided with bulge loop or groove, and described plug lower surface correspondence position is provided with groove or bulge loop;
Described barrier film is chimeric each other with groove by bulge loop with described plug
As above arbitrary described medicine mixer, is characterized in that:
Described plug central area is provided with paracentesis area, and described paracentesis area is thinner than marginal zone.
As above arbitrary described medicine mixer, is characterized in that:
Described mixed medicine passage lower end, is provided with foldable handle, and is sealed by the lower end of described foldable handle to described mixed medicine passage.
The invention allows for a kind of medicine mixer with reinforcement structure, it is characterized in that: comprise as above arbitrary described medicine mixer;
On the described wall of cup of described mixed medicine glass, be provided with reinforcing rib structure to strengthen the comprcssive strength of described wall of cup.
Medicine mixer as above, is characterized in that:
Described reinforcement to be arranged on inside described wall of cup along the vertical direction and/or horizontal direction one is arranged.
The invention allows for a kind of hard double nip with medicine mixer, comprise as above arbitrary described medicine mixer, it is characterized in that:
Relative to the opposite side of described mixed medicine passage on the described pedestal of described medicine mixer, be provided with an infusion channel;
Described infusion channel is provided with interface.
With a transfusion flexible bag for hard double nip, it is characterized in that:
Described hard double nip is hard double nip as above.
With a transfusion flexible bag for medicine mixer, it is characterized in that: described medicine mixer is as above arbitrary described medicine mixer;
Described medicine mixer is bonded together by described pedestal and described soft bag.
Transfusion flexible bag as above, is characterized in that:
Also comprise an infusion connector, described infusion connector is arranged on on the transfusion flexible bag of described medicine mixer homonymy, or is arranged on the transfusion flexible bag of the opposite side relative with described medicine mixer.
As above arbitrary described transfusion flexible bag, is characterized in that:
What described transfusion flexible bag adopted is non-PVC multi-layer co-extruded film;
What described integrated pedestal and mixed medicine glass, barrier film adopted is medical polypropylene material, preferably polypropylene R530C material;
Described cross needle, described restriction protrusion are polypropylene material, preferably polypropylene P17 material.
Accompanying drawing explanation
Fig. 1 cross needle
Fig. 2 pedestal and mixed medicine glass sectional view
Fig. 3 elastic clamp seat
The mixed medicine glass of Fig. 4 deck one
Fig. 5 is provided with the mixed medicine glass of elastic clamp seat
Fig. 6 plug top view/plan view
Fig. 7 cross needle schematic diagram (outlet is located at syringe needle side-walls)
Fig. 8 cross needle three dimensional structure schematic diagram (outlet is located at syringe needle side-walls)
The cross needle schematic diagram of Fig. 9 band coating film
Figure 10 coating film is by the cross needle schematic diagram compressed
Figure 11 cover plate
Figure 12 strengthens the mixed medicine glass of structure
Figure 13 assembles the band foldable handle medicine mixer of cillin bottle
The transfusion flexible bag of Figure 14 band medicine mixer
Specific implementation method
Description of reference numerals: 1 transfusion flexible bag, 2 pedestals, 3 mixed medicine glasses, 3-1 wall of cup, at the bottom of 3-2 cup, 3-3 reinforcement, 4 elastic clamp seats, 4-1 elastic card claw, 4-2 annular projection, 4-3 centre bore, 4-4 support column, 4-5 base plate, 4-6 snap ring, 5 cross needles/crosspointer, 5-1 needle plate, the upper pin of 5-2, pin under 5-3,5-4 side opening, 5-5 needle point, 6 plugs, 6-1 paracentesis area, 6-2,6-3, groove/bulge loop, 7 mixed medicine passage, 8 barrier films, 9 cillin bottles, 10 foldable handles, 11 infusion channel, 12 cover plates, 12-1 through hole, 12-2 reinforcement, 13 diaphragm seals
Specific implementation method
Below, in conjunction with Figure of description, the present invention is further detailed.
As shown in Figure 1, cross needle 5, comprise integrated hollow upper pin 5 ?2 and lower pin 5 ?3 and needle plate 5 that upper pin and lower pin are combined as a whole ?1, upper pin 5 ?2, lower pin 5 ?3 heads be provided with needle point 5 ?5.
For cross needle 5, the outlet of the hollow channel of upper pin 5 ?4, can be opened in described upper pin 5 ?2 syringe needle sidewall on, as figure 7 ?shown in 8; Same, the outlet of the hollow channel of described lower pin, be opened in described lower pin 5 ?3 syringe needle sidewall on (not shown).Setting like this is that the edge of outlet forms directly cutting to stopper and produces a large amount of chips in order to avoid upper pin, lower pin are when puncturing plug, bottle stopper.By being arranged on the sidewall of syringe needle by outlet, needle point directly thrusts in plug, can not form direct dissection, reduces the generation of chip.
Or, as figure 9 ?shown in 10, upper pin is coated with one deck elastic contraction film, and elastic contraction film is compressed after piercing, is deposited in around puncturing hole, thus can effectively prevent medicinal liquid along puncturing hole gap leakage out.It is evident that, lower pin equally can coated one deck elastic contraction film, to solve seepage to appear in medicinal liquid problem along the gap of puncturing hole.
Pedestal as shown in Figure 2 and mixed medicine glass sectional view, comprise pedestal 2, mixed medicine glass 3, barrier film 8 and mixed medicine passage 7, and the above-mentioned medicine mixer body construction be made up of pedestal 2, mixed medicine glass 3, barrier film 8 and mixed medicine passage 7 is formed in integrated mode.
Plug 6 is placed in mixed medicine passage, is positioned on barrier film 8.
Be understandable that, the infusion channel 11 shown in Fig. 2, can be one-body molded together with above-mentioned medicine mixer body construction, also can adopt other infusion connector when soft bag bag.
Mixed medicine passage 7 through pedestal 2 upwards extends straight-through to mix at the bottom of the cup of medicine glass 33 ?2, the effect of barrier film 8 is that isolated medicinal liquid contacts with the direct of plug, accomplish the sealing completely before using, any position of the mixed medicine passage under plug 6 can be arranged in theory, but consider if barrier film 8 position is too low, cause the lower pin 5 of cross needle 5 ?3 long, so preferably barrier film 8 to be positioned under plug 6 and to be close to the lower surface of plug 6.
Plug 6 is placed in mixed medicine passage, on barrier film.The effect of plug be ensure lower pin 5 ?3 after puncture plug 6 with barrier film 8, medicinal liquid from barrier film 8 and lower pin 5 ?flow out gap between 3 outer walls after be unlikely to ooze out mixed medicine passage, that is, the external diameter of plug 6 and the internal diameter of mixed medicine passage match, and make plug 6 and mixed medicine passage close contact.
For elastic clamp seat 4 as shown in Figure 3, comprise a snap ring 4 ?6, be provided with on the downside of described snap ring elastic card claw 4 ?1, described elastic card 4 ?snap ring described in 1 upper end edge to be evenly arranged and fixing, described elastic card claw 4 ?1 lower end be free end, and described elastic card claw from fixing described upper end to described lower end freely in the centroclinal structure of described mixed medicine glass.Described elastic clamp seat have integrated base plate 4 ?5, support column 4 ?4, snap ring 4 ?6 and elastic card claw 4 ?1, described base plate 4 ?5 peripheries be provided with support column 4 ?4 to described snap ring 4 ?6 formed support fixing.
Described base plate 4 ?5 be provided with centre bore 4 ?3, described lower pin 5 ?3 through described centre bore, location is formed to described crosspointer.Around being provided with circle annular projection 4 ?2 around centre bore 4 ?3, after elastic clamp seat 4 is installed in mixed medicine glass, annular projection 4 ?2 on elastic clamp seat 4 can form a squeezing action to plug.
Described wall of cup 3 ?1 inwall on be provided with restriction protrusion (not shown), described elastic clamp seat 4 is installed in described mixed medicine glass and is limited by described restriction protrusion.
For the relation between cross needle 5, elastic clamp seat 4, mixed medicine glass 3, preferably independently elastic clamp seat 4 as shown in Figure 3, cross needle 5 be placed in elastic card claw 4 ?1 and base plate 4 ?between 5.
After the assembling of cross needle 5, elastic clamp seat 4 and mixed medicine glass, as shown in Figure 5, a preferred scheme is, at the bottom of plug 6 upper surface and cup 3 ?2 upper surfaces substantially flush with or slightly higher than upper surface, thus, the lower surface of elastic clamp seat 4 as shown in Figure 3, just can form a squeezing action to the upper surface of plug 6.
As a preferred technical scheme, barrier film 8 to be positioned under plug 6 and to be close to the lower surface of plug 6, can better prevent medicinal liquid from after lower needle-penetration barrier film, infiltrating mixed medicine passage.Especially, plug be as described in Figure 6 provided with on the surface by bulge loop or groove 6 ?2,6 ?3 thinner paracentesis areas limited 6 ?1, relative with the bulge loop on plug or groove, the corresponding position of barrier film 8 upper surface is also provided with groove or bulge loop.It is evident that, the bulge loop on plug or groove and the groove on barrier film 8 or bulge loop mutually chimeric, thus reach the object better preventing Drug leakage.
Be provided with plug 6 and the barrier film 8 of mutually chimeric groove or bulge loop, after elastic clamp seat 4 pairs of plugs 6 form a squeezing action, the seepage of medicinal liquid after mixed medicine can being stopped completely.
Described wall of cup 3 ?1 inwall on be provided with restriction protrusion (not shown), described elastic clamp seat 4 is installed in described mixed medicine glass and is limited by described restriction protrusion, thus makes elastic clamp seat 4 can not skid off mixed medicine glass after placing.Especially, at medicine mixer as described in Figure 5, lower pin 5 ?3 complete the puncture to plug 6 and barrier film 8 after, the complete limited structure of elastic clamp seat limited.In addition, the confined position of elastic clamp seat 4, make the bottom of elastic clamp seat 4 to contact at the bottom of the cup of described mixed medicine glass 33 ?2.In the plan of establishment of preferred plug 6, annular projection bottom elastic clamp seat 44 ?2 can form extruding to plug 6.
Be installed on the crosspointer 5 among elastic clamp seat 4, needle plate 5 ?1 of crosspointer 5 is between elastic card claw 4 ?1 and base plate 4 ?5, and after being provided with, lower pin 5 ?3 does not pierce through plug 6.
Certainly, also be understandable that, before the use, lower pin 5 ?3 parts thrust in plug 6 or the plug 6 that punctures completely, or an aperture is preset at plug 6 center, hole diameter than lower pin 5 ?3 little, make lower pin 5 ?3 insert apertures in plug 6 and through after plug 6, lower pin 5 ?3 pairs of plugs 6 can not form dissection, thus can effectively avoid lower pin 5 ?3 form the pollution that micro-bits cause medicinal liquid when puncturing plug 6.And, due to hole diameter than lower pin 5 ?3 external diameter little, plug 6 still can be close to lower pin 5 ?3 thus avoid leakage.
Certainly, before using after medicine mixer assembling, cross needle 5 is just placed in mixed medicine glass 3, does not form the puncture to barrier film 8, can not puncture or puncture partly to plug 6, or puncture completely as shown in Figure 5.Tearing diaphragm seal 13, taking off dividing plate 12, inserting cillin bottle 9, as shown in figure 13, pushed away downwards by cillin bottle 9, the bottleneck of cillin bottle 9 be pushed into elastic card claw 4 ?under 1.Now the upper pin of cross needle 5 and lower pin complete puncture to the bottle stopper of plug, barrier film and cillin bottle respectively, simultaneously cross needle 5 completely limit by the position limiting structure on mixed medicine glass inwall, the bottleneck of cillin bottle 9 by elastic card claw 4 ?1 block and can not exit.
By above-mentioned setting, can to make up a prescription safely, easily and efficiently, dosing, completely solve the secondary pollution problem in link of making up a prescription.Simultaneously also can ensure that transfusion can be reviewed because be fixed to mixed medicine glass 3 from cillin bottle 9 docking, by elastic card claw 4 ?1 block after, cillin bottle 9 just can not nondestructively take out.That is, from making up a prescription, complete to transfusion, until reclaim link, can trace back to added, which kind of medicine what inject is.
And a class is needed to the medicine of special preservation, for example need namely to join i.e. note type, may also there are some inconveniences in above-mentioned medicine mixer because the medicine of cillin bottle fill must be taken to ward, then cillin bottle is docked with medicine mixer, then making up a prescription in ward uses at once.
Namely joining demand namely to meet medical personnel more easily, on the basis of said structure, having set up foldable handle 10, as shown in figure 13.
Foldable handle 10 is set in mixed medicine passage lower end, as shown in fig. 13 that, cillin bottle 9 and the elastic clamp seat 4 in mixed medicine glass 3 is completed after docking and puncturing, bring to pharmacy, before transfusion, break disconnected foldable handle 10, get through mixed medicine passage, dispensing site can be completed, onsite application.
About shape and the structure of pedestal 2, after medicine mixer, infusion channel or band medicine mixer and the hard double nip of infusion channel are welded on soft bag, the transfusion flexible bag of band medicine mixer is as shown in figure 14 in storage, transport and use procedure, the damage that pedestal welding position causes transfusion flexible bag, foundation design is dumb-bell shape or ship shape, as shown in the pedestal 2 in Fig. 2, and the lower end of mixed medicine passage 7, infusion channel 11 is concordant with the lower end of pedestal 2.Uniform welding lines on the surrounding sidewall of pedestal 2, can well ensure to be in the welding process of transfusion flexible bag like this, even pedestal 2 also well can fuse welding with soft bag 2 at a lower temperature.And, the pedestal of ship shape or dumb-bell shape, streamlined good, improve the mechanical property of welding not to the utmost, and there is no sharp angle, the combination of hard double nip and transfusion flexible bag 2 can be made more level and smooth, not fragile soft bag.
For elastic clamp seat 4 another design in mixed medicine glass 3, as shown in Figure 4, adopt the restriction protrusion 4 be directly fixed on mixed medicine glass inwall to replace the elastic clamp seat 4 in embodiment 1.Restriction protrusion 4 preferably elastic card claw; More preferably, as the elastic card claw of restriction protrusion 4 and described mixed medicine glass 3 one-body molded.Inwall week of wall of cup described in elastic card claw upper end edge, described elastic card claw lower end was free end along to be evenly arranged and fixing, and described elastic card claw 4 from fixing described upper end to described lower end freely in the centroclinal structure of described mixed medicine glass.Namely to adopt as shown in Figure 4 direct arranges the elastic clamp seat structure that elastic card claw 4 replaces as shown in Figure 3 in mixed medicine glass, the needle plate of cross needle 5 is still at the bottom of the lower end and cup of elastic card claw 4 between 3 ?2, as for other structure and aforementioned structure just the same, do not repeat them here.
For the selection of medicine mixer and transfusion flexible bag material, what transfusion flexible bag adopted is the non-PVC multi-layer co-extruded film generally used at present, comprises the PP TYPE of three layers, five layers.
And medicine mixer, then what adopt is and the good medical polypropylene material of the transfusion flexible bag non-PVC material compatibility, pedestal, mixed medicine glass, cover plate preferably polypropylene R530C material; And cross needle, card, consider its puncture and mechanical property, the P17 material preferably in pp material system.
Described cross needle, described restriction protrusion are polypropylene material, preferably polypropylene P17 material
Finally, hermetically-sealed construction medicine mixer key a bit---the terminal sterilization of sealed mixed medicine device after being welded on soft bag.Consider from the angle of policies and regulations and actual injection safety at present, all drug packagings, before fill is dispatched from the factory, must carry out terminal sterilization, or adopt injection Sterility Assurance technique.
At present, the Sterility Assurance technique of injection mainly contains two kinds:
1. terminal sterilization technique: on the basis controlling microbial contamination amount, after medicine embedding, degerming by moist heat sterilization mode.In general, this method cost is low, and sterility assurance level is high, is suitable for the sterilizing of bulk capacity injection and small-volume injection.
2. sterile production technique: under sterile system environment, by aseptic filtration method or aseptic manipulation, for the purpose of preventing pollution, eliminates and causes the various probabilities polluted to ensure aseptic level.In general, because the requirement of this method to environmental system is high, and the factor affecting sterile working is many and make sterility assurance level lower than terminal sterilization technique.Sterile production technique is generally suitable for injectable powder, also can be suitable for clinical needs but can not carry out the small-volume injection of terminal sterilization.Thus, terminal sterilization technique and sterile production technique have different system requirements, different degerming methods and different Sterility Assurance results
For infusion solutions, cost exquisite sensitivity, so, the terminal sterilization in infusion solutions, only may adopt low cost and moist heat sterilization technique efficiently---sterilising conditions is generally under the steam of the high temperature of 115 ?121 degrees Celsius, 0.15MPa pressure, keeps 30 ?15 minutes.
Although medicine mixer and transfusion flexible bag, be all the polypropylene material of ability 120 celsius temperature selected, but, the medicine mixer under sealing state, at such high temperatures, its mechanical performance can reduce, and is very easy to be out of shape under the pressure of 0.15MPa; And diaphragm seal also can occur distortion, fold losing sealing effectiveness at this temperature and pressure.
We have carried out from 2011 to 2014 reaching the experiment of up to a hundred times in 4 years, finally set about from multiple angle, determine solution.
First, for the structure of mixed medicine glass, as shown in figure 12, the Lower Half of cup be provided with reinforcement 3 ?3.The setting of reinforcement is the wall of cup to mixed medicine glass, and preferential is carry out in wall of cup Lower Half.
Reinforcement can be arranged on inside wall of cup and/or the vertical bar integrated with mixed medicine glass of equally distributed projection in outside, or horizontal stripe, or crisscross network structure.Preferably along the equally distributed perpendicular list structure of Lower Half inside wall of cup; At the bottom of more preferably the vertical bar of projection to extend to glass from Lower Half inside wall of cup, most preferably the thickness of vertical bar projection is level and smooth gradually from top to bottom increases continuously.
Be provided with the mixed medicine glass of reinforcement, suitable degree improves the mechanical resistance of cup.Experiment is compared, and does not arrange the mixed medicine glass of reinforcement, and after the employing wet heating sterilization process, circular mixed medicine glass cup, is compressed into square, can not uses completely.
After being provided with reinforcement, after wet heating sterilization process, circular mixed medicine glass cup, has slight compression, does not substantially affect normal using function.
Secondly, for diaphragm seal 13, itself is a very thin easily tore film just, is convenient to the effect of tearing when playing the sealing of mixed medicine glass 3 and use.Diaphragm seal 13 is more weaker than the cup of mixed medicine glass 3, because diaphragm seal 13 itself is the thin film of one deck micron dimension thickness, holds the pressure that can't stand 0.15MPa in wet heating sterilization process.
To this, have passed through a large amount of experiments, find, under diaphragm seal 13, install a cover plate 12 as shown in figure 11 additional, diaphragm seal 13 covers cover plate 12, makes cover plate 12 pairs of diaphragm seals 13 form effective support, prevents diaphragm seal 13 when sterilizing by compression.It is step-like interior along upper that cover plate 12 is then shelved on described mixed medicine glass rim of a cup, make the upper surface of the cover plate being arranged on rim of a cup place concordant with rim of a cup or a little less than described rim of a cup, and the setting like this of cover plate 12, can not impact the sealing technology of diaphragm seal 13 pressure welding at described wall of cup upper end face.
For the shape of cover plate, with the circle that the shape of mixed medicine glass rim of a cup is mated substantially, the shape of preferred cover plate 12 is cross sections is polygon, for example (,) pentagon, hexagon, octagon, 12 distortion.Take out eaily when the benefit of polygonal cover plate 12 1 aspect is and uses; And cover plate 12 is set to that polygonal in addition one is beyond thought act on below can mention.
In addition, in order to strengthen the comprcssive strength of cover plate, preferably cover plate 12 and cross needle are coaxially arranged, the needle point of upper pin 5 ?5 just formed to cover plate central and to cover plate and supporting.More have preferably, cover plate 12 center be provided with a through hole 12 ?1, through hole 12 ?1 internal diameter be less than pin 5 ?2 external diameter, upper pin 5 ?2 needle point 5 ?5 parts be positioned at through hole but can not described through hole be passed, namely needle point 5 ?5 going up pin 5 ?2 embeds in through hole 13 ?1 of cover plate 12, thus makes the support effect of pin 5 ?2 pairs of cover plates more remarkable.
Meanwhile, consider the huge downward pressure that cover plate 12 bears, except design upper pin 5 ?except the formation of 2 pairs of cover plates 12 supports, also carried out strengthening arranging to cover plate 12, the reinforcement 12 radially arranged with ring-type as shown in figure 11 ?2, enhance the mechanical strength of cover plate 12.
The diaphragm seal 13 of pressure welding and rim of a cup upper end, sticking in cover plate 12 upper surface tightly, makes diaphragm seal 13 substantially not need to bear high pressure, alleviates the phenomenon that diaphragm seal 13 is out of shape fold greatly.
And for fold, because diaphragm seal 13 is too thin, slightly pressure will cause the appearance of fold, have a strong impact on the visual effect of product.
Through contrast experiment repeatedly, plate the thin metal film of one deck at diaphragm seal 13 upper surface, effectively can alleviate the problem of diaphragm seal fold.
The sealed mixed medicine device of setting like this, although also substantially can normally use after withstanding the high temperature and high pressure of wet heating sterilization process, but the profile as product is still difficult to remain on good state, consider from the angle of infusion products, remain underproof product.
After structurally above-mentioned design having been carried out to medicine mixer, can only using function being ensured, in order to thoroughly solve the terminal sterilization problem of sealed mixed medicine device, also having needed to solve from root---the inside and outside air pressure balance of mixed medicine glass when wet heating sterilizing of sealing.
After mixed medicine glass has been assembled, install cover plate 12 and diaphragm seal 13 additional to before its sealing, in cup, pre-installed a certain amount of liquid, and then install cover plate additional, sealing.
The sealed mixed medicine cup of contained liquid, when carrying out terminal sterilization with transfusion flexible bag, liquid fast vaporizing under high temperature, thus the air pressure inside and outside cup that allows that can be very fast reaches a balance.
For preloaded with liquid, preferably thermal capacity is less, the liquid that saturated vapor pressure is higher.We have studied various liquid at 120 degrees Celsius, the state under 0.15MPa, comprise the harmless liquid that water, ethanol etc. are conventional, all can meet our demand.Consider cost and safety, preferably preloaded with liquid is water.
As for vital pre-installation of water V
0, can be confirmed by following equation:
PV=nRT, external and internal pressure when wherein P is wet heating sterilizing is poor, and V is mixed medicine glass volume, and n is the molal quantity of preloaded with liquid/water, and R is gas constant, absolute temperature when T is wet heating sterilizing.
V
0=n*M/ ρ, wherein M is the molal weight of fluid/water, and ρ is the density of fluid/water.
Can well the inner and outer air pressure of balanced seal medicine mixer when terminal sterilization according to above-mentioned equation.
Balancing inner and outer air pressure in the mode of preloaded with liquid, is a ratio more preferably solution.
But, said method can solve the problem of air pressure balance, then in actual use, still there is certain problem, the most typically, there is water droplet or liquid after cooling in the finished product transfusion flexible bag that sterilizing is in mixed medicine glass, very affect perception, and such product usually also not too can by hospital and patient accept.
On this basis, a more preferred scheme is, we have studied the diaphragm seal with certain air permeability based on pp material system especially, ensure after vaporizing liquid, sufficient gas exchange is carried out by gas-permeable seal film and outside, like this after sterilizing completes, in mixed medicine glass, residual liquid can not be there is.
The air penetrability of gas-permeable seal film, through long many experiments, 5% ?35% air penetrability, be highly preferred.
For the medicine mixer adopting the gas-permeable seal film of our research to seal, after wet heating high temperature sterilize, mixed medicine glass does not have a bit distortion, and diaphragm seal is also as before smooth, does not have fold to occur.
Certainly, a modified model scheme is, at not preloaded with liquid, directly adopting the gas-permeable seal film with appropriate air permeability to carry out sealed mixed medicine device, through our many experiments, is also feasible.
It should be noted that: the only unrestricted technical scheme of the present invention in order to explanation above, although with reference to above-described embodiment to invention has been detailed description, those of ordinary skill in the art is to be understood that: still can modify to the present invention or equivalent replacement, and do not depart from any modification or partial replacement of the spirit and scope of the present invention, all should be encompassed in the middle of right of the present invention.
Claims (10)
1. a medicine mixer, comprise the barrier film in integrated pedestal, mixed medicine passage and mixed medicine passage and mixed medicine glass, cross needle, described mixed medicine glass is formed by the bottom of wall of cup and cup, and described cross needle is positioned at described mixed medicine glass, it is characterized in that:
Described cross needle is by integrated needle plate and possess the upper pin of hollow channel and lower pin is formed, and the hollow channel of described upper pin and lower pin communicates with each other;
Described mixed medicine passage lower end is through described pedestal, and upper end is through at the bottom of described cup;
Seal rubber plug is provided with in mixed medicine passage between at the bottom of described barrier film and described cup;
Under the balance of described needle plate, described cross needle keeps basic erectility in described mixed medicine glass;
Described medicine mixer also comprises diaphragm seal, and described diaphragm seal is connected to the rim of a cup of described mixed medicine glass in the mode of pressure welding, forms sealing to described mixed medicine glass;
Described diaphragm seal still can keep substantially smooth easily tore film after wet heating terminal sterilization.
2. medicine mixer as claimed in claim 1, is characterized in that:
Described diaphragm seal is breathability easily tore film;
The air penetrability of described diaphragm seal is 5% to 35%.
3. medicine mixer as claimed in claim 2, is characterized in that:
Described diaphragm seal upper surface metal-plated membrane layer.
4. as claim 1 ?3 arbitrary as described in medicine mixer, it is characterized in that:
Also comprise a cover plate;
Described cover plate is positioned at described rim of a cup edge, and is covered by described diaphragm seal;
Described cover plate is polygon, and center is provided with a hole, and the needle point of described upper pin is positioned at described hole but does not pass described hole.
5. as claim 1 ?4 arbitrary as described in medicine mixer, it is characterized in that:
Described mixed medicine glass, before being sealed by described diaphragm seal, pre-installs a certain amount of liquid;
Described liquid be can under wet heating sterilized environment the liquid of rapid vaporization;
The gas formed after vaporization allows the inside and outside air pressure of described mixed medicine glass reach in a basic balance.
6. as claim 1 ?5 arbitrary as described in medicine mixer, it is characterized in that:
Described mixed medicine passage lower end, is provided with foldable handle, and is sealed by the lower end of described foldable handle to described mixed medicine passage.
7. have and strengthen the medicine mixer of structure, it is characterized in that: comprise as arbitrary in claim 1 ?16 as described in medicine mixer;
On the described wall of cup of described mixed medicine glass, be provided with reinforcing rib structure to strengthen the comprcssive strength of described wall of cup;
Described reinforcement to be arranged on inside described wall of cup along the vertical direction and/or horizontal direction one is arranged.
8. the hard double nip with medicine mixer, comprise as arbitrary in claim 1 ?7 as described in medicine mixer, it is characterized in that:
Relative to the opposite side of described mixed medicine passage on the described pedestal of described medicine mixer, be provided with an infusion channel;
Described infusion channel is provided with interface.
9. a transfusion flexible bag, is characterized in that:
Described transfusion flexible bag comprises hard double nip as claimed in claim 8;
Or comprise as claim 1 ?7 arbitrary as described in medicine mixer;
Described hard double nip or medicine mixer are bonded together by described pedestal and described transfusion flexible bag.
10. transfusion flexible bag as claimed in claim 9, is characterized in that:
What described transfusion flexible bag adopted is non-PVC multi-layer co-extruded film;
What described integrated pedestal and mixed medicine glass, barrier film adopted is medical polypropylene material, preferably polypropylene R530C material;
Described cross needle, described restriction protrusion are polypropylene material, preferably polypropylene P17 material.
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510781506.5A CN105232330B (en) | 2015-11-13 | 2015-11-13 | Medicine mixer, hard double nip and transfusion flexible bag |
| US15/776,073 US20200253827A1 (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual-port member, and soft infusion bag |
| CA3004927A CA3004927C (en) | 2015-11-13 | 2016-11-13 | Medication mixer, dual hard ports, and soft intravenous bag |
| EP16863698.3A EP3375427B1 (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual-port member, and soft infusion bag |
| PCT/CN2016/105564 WO2017080522A1 (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual-port member, and soft infusion bag |
| KR1020187014837A KR102119990B1 (en) | 2015-11-13 | 2016-11-13 | Chemical mixing mixer, rigid dual pot and soft bag for fluids |
| JP2018544393A JP2018535071A (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual interface and infusion softback |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510781506.5A CN105232330B (en) | 2015-11-13 | 2015-11-13 | Medicine mixer, hard double nip and transfusion flexible bag |
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| Publication Number | Publication Date |
|---|---|
| CN105232330A true CN105232330A (en) | 2016-01-13 |
| CN105232330B CN105232330B (en) | 2019-11-26 |
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ID=55030344
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| CN201510781506.5A Active CN105232330B (en) | 2015-11-13 | 2015-11-13 | Medicine mixer, hard double nip and transfusion flexible bag |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106074160A (en) * | 2016-07-18 | 2016-11-09 | 湖南懿科药用包装材料科技有限公司 | The infusion vessel dispenser that can the most directly join and infusion vessel |
| WO2017080522A1 (en) * | 2015-11-13 | 2017-05-18 | 重庆莱美药业股份有限公司 | Drug mixer, hard dual-port member, and soft infusion bag |
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|---|---|---|---|---|
| CN2897247Y (en) * | 2006-04-08 | 2007-05-09 | 浙江永宁制药厂 | Lid-rotary dosaging diluent infusion bag without needle |
| CN102499888A (en) * | 2011-11-11 | 2012-06-20 | 重庆莱美药业股份有限公司 | Integrally formed medicine mixing joint |
| CN203107704U (en) * | 2013-02-25 | 2013-08-07 | 四川科伦药物研究有限公司 | Seal cover for infusion container |
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2015
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2897247Y (en) * | 2006-04-08 | 2007-05-09 | 浙江永宁制药厂 | Lid-rotary dosaging diluent infusion bag without needle |
| CN102499888A (en) * | 2011-11-11 | 2012-06-20 | 重庆莱美药业股份有限公司 | Integrally formed medicine mixing joint |
| CN203107704U (en) * | 2013-02-25 | 2013-08-07 | 四川科伦药物研究有限公司 | Seal cover for infusion container |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017080522A1 (en) * | 2015-11-13 | 2017-05-18 | 重庆莱美药业股份有限公司 | Drug mixer, hard dual-port member, and soft infusion bag |
| CN106074160A (en) * | 2016-07-18 | 2016-11-09 | 湖南懿科药用包装材料科技有限公司 | The infusion vessel dispenser that can the most directly join and infusion vessel |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105232330B (en) | 2019-11-26 |
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