CN105232329B - Medicine mixer, hard double nip and transfusion flexible bag - Google Patents
Medicine mixer, hard double nip and transfusion flexible bag Download PDFInfo
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- CN105232329B CN105232329B CN201510780465.8A CN201510780465A CN105232329B CN 105232329 B CN105232329 B CN 105232329B CN 201510780465 A CN201510780465 A CN 201510780465A CN 105232329 B CN105232329 B CN 105232329B
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- medicine
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- mixed medicine
- mixer
- cup
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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
-
- 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
- A61J1/10—Bag-type containers
-
- 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
-
- 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
- A61J1/1406—Septums, pierceable membranes
Abstract
A kind of medicine mixer, including the diaphragm and mixed medicine glass in integrally formed pedestal, mixed medicine channel and mixed medicine channel, cross needle, it is interior and by integrally formed needle plate and have hollow channel and the upper needle to communicate with each other and knit stitch are constituted that cross needle is located at the mixed medicine glass；It is also integrally formed on needle plate to be provided with support column, snap ring and elastic card claw, wherein the support column setting is fixed in the needle plate periphery with forming support to the snap ring；Elastic card claw is arranged on the downside of snap ring and the upper end edge snap ring of elastic card claw is evenly arranged and fixes, and the elastic card claw is in the mixed medicine glass center incline structure from fixed upper end to free lower end；The mixed medicine channel lower end passes through the pedestal, and upper end passes through the bottom of a cup；Rubber plug is equipped in mixed medicine channel between the diaphragm and the bottom of a cup；Mixed medicine glass is sealed with sealing film, and sealing film is that substantially smooth easily tore film is still able to maintain after wet heating terminal sterilization.
Description
Technical field
The present invention relates to a kind of medicine mixer, in particular to a kind of band mixes the medicine mixer of medicine glass.
Background technique
In the powder-injection, freeze drying powder injection or liquid drugs injection contained using cillin bottle, need to be infused by syringe soft
In liquid medicine or water for injection extraction injection cillin bottle in bag, above-mentioned work is repeated, until there are enough medical fluids in cillin bottle；So
Cillin bottle is shaken repeatedly again afterwards until the medicament in bottle is uniformly mixed, then with syringe that medical fluid extraction injection in cillin bottle is defeated
In liquid soft bag, repeatedly, until the medical fluid in bottle is exhausted.
Firstly, above-mentioned mixed medicine operating process it is relatively time-consuming, it is laborious, take consumptive material such as syringe, more seriously, upper
During stating mixed medicine, it is very easy to for the air of outside being injected into cillin bottle and transfusion flexible bag, under general condition in air
In the presence of very more various dust, germ, human body is entered back into after being mixed into liquid medicine injection, malpractice very serious can be brought.
Secondly, traditional matches liquid mode, it is first to make up a prescription to inject again, the medicine in cillin bottle is pumped to transfusion flexible bag in advance
In, then the transfusion flexible bag for preparing medicine brought to ward to patient fluid infusion.After having matched medicine, vacant cillin bottle is placed on one side,
Patient protects medical staff not know that medicine matched in transfusion flexible bag is completely, does not have trackability.Once medical care people
Member does not pay attention to slightly going wrong when matching liquid, and by medical fluid with mistake is misused, consequence will be hardly imaginable.
Again, it for some special drugs, for example needs i.e. with drug i.e., traditional dispensing method is very not
Just, the various medicine mixer structures and before this patent disclosed, not can solve the problem.
Finally, the various medicine mixer structures disclosed before making the present invention, Drug leakage after mixed medicine not can solve always
Problem.For the needs to higher medical service level, there is an urgent need to it is a kind of it is easy to use, safe and reliable, without security risk
Infusion products.
In addition, medicine mixer is welded on transfusion flexible bag, after transfusion flexible bag is filling, need it is whole to transfusion flexible bag into
Row high-temperature sterilization, high-temperature sterilization environment are usually 115-121 degrees Celsius of high temperature, and sterilization time 30-15 minutes, sterilization pressure was
0.15MPa.Although material polypropylene used in medicine mixer and transfusion flexible bag can withstand 120 degrees Celsius of temperature,
Inevitably softening, along with the high pressure of 0.15MPa, be equivalent to the pressure every square centimeter for bearing 150N --- this is right
It is fatal for the mixed medicine glass in sealing state.First choice, mix medicine glass and seal film 120 degrees Celsius at a temperature of, machine
Tool intensity can decrease；Secondly, the pressure of 150N every square centimeter, can directly result in cup body deformation, the sealing film of mixed medicine glass
It is stretched, fold occurs, leakproofness is destroyed, and mixed medicine glass structure is caused to be damaged and be not available completely.
Before making the present invention, the medicine mixer of sealed mixed medicine cup structure, terminal sterilization are to be difficult to the obstacle overcome；And
Mixed medicine glass blow-by, and cannot be guaranteed to meet sterility requirements when using, whether from policies and regulations or from practical safety angle
Degree considers that the terminal sterilization of transfusion flexible bag, being all must and be very necessary.
Summary of the invention
Based on the above issues, the invention proposes a kind of easy to use reliable and transfusion flexible bag without security risk and therewith
Relevant medicine mixer, interface.
Medicine mixer proposed by the present invention, including in integrally formed pedestal, mixed medicine channel and mixed medicine channel diaphragm and
Mixed medicine glass, cross needle, the mixed medicine glass are made of wall of cup and bottom of a cup, and the cross needle is located in the mixed medicine glass, and feature exists
In:
The cross needle is by integrally formed needle plate and has the upper needle of hollow channel and knit stitch is constituted, the upper needle and
The hollow channel of knit stitch communicates with each other；
It is also integrally formed on the needle plate to be provided with support column, snap ring and elastic card claw, wherein the support column is set
It sets and is fixed in the needle plate periphery with forming support to the snap ring；
The elastic card claw is arranged on the downside of the snap ring and snap ring described in the upper end edge of the elastic card claw is evenly arranged
And it is fixed, the elastic card claw lower end is free end, and the elastic card claw is from the fixed upper end to the free lower end
In to the mixed medicine glass center incline structure；
The mixed medicine channel lower end passes through the pedestal, and upper end passes through the bottom of a cup；
Rubber plug is equipped in mixed medicine channel between the diaphragm and the bottom of a cup；
The medicine mixer further includes sealing film, and the sealing film is connected to the rim of a cup of the mixed medicine glass in a manner of pressure welding,
Sealing is formed to the mixed medicine glass；
The sealing film is easily tore film；
The sealing film is that substantially smooth easily tore film is still kept after wet heating terminal sterilization.
Medicine mixer as described above, it is characterised in that:
The sealing film is ventilated membrane.
Medicine mixer as described above, it is characterised in that:
The air penetrability of the sealing film is 5% to 35%.
Medicine mixer as described above, it is characterised in that:
Sealing film upper surface metal-plated membrane layer.
As above any medicine mixer, it is characterised in that:
It further include a cover board；
The cover board is located at edge in the rim of a cup, and is covered by the sealing film.
Medicine mixer as described above, it is characterised in that:
The cover board is in polygon, and center is equipped with a hole, and the needle point of the upper needle is located in the hole but is not passed through institute
State hole.
As above any medicine mixer, it is characterised in that:
The mixed medicine glass pre-installs a certain amount of liquid before by sealing film sealing.
Medicine mixer as described above, it is characterised in that:
The liquid be can under high-temperature sterilization environment rapid vaporization liquid.
As above any medicine mixer, it is characterised in that:
The certain quantity of fluid of prepackage vaporizes under high-temperature sterilization environment and is formed by gas, can allow the mixed medicine glass
Inside and outside air pressure is in a basic balance.
As above any medicine mixer, it is characterised in that:
Position limiting structure is provided on the inner wall of the wall of cup, after the cross needle is installed into the mixed medicine glass, the limit
The needle plate is limited between the position limiting structure and the bottom of a cup and cannot be removed by structure.
As above any medicine mixer, it is characterised in that:
The distance between the diaphragm upper surface and the bottom of a cup upper surface are almost the same with the thickness of the rubber plug.
Medicine mixer as described above, it is characterised in that:
The diaphragm upper surface is provided with bulge loop or groove, and corresponding position setting in the rubber plug lower surface is fluted or convex
Ring；
The diaphragm is chimeric each other with groove by bulge loop with the rubber plug.
As above any medicine mixer, it is characterised in that:
The rubber plug central area is equipped with paracentesis area, and the paracentesis area is thinner than marginal zone.
As above any medicine mixer, it is characterised in that:
The mixed medicine channel lower end, is provided with foldable handle, and by the foldable handle to the lower end in the mixed medicine channel into
Row sealing.
As above any medicine mixer, it is characterised in that:
The outlet of the hollow channel of the upper needle is provided on the syringe needle side wall of the upper needle；
And/or；
The outlet of the hollow channel of the knit stitch is provided on the syringe needle side wall of the knit stitch.
As above any medicine mixer, it is characterised in that:
The upper needle is coated with one layer of elastic contraction film；
And/or；
The knit stitch is coated with one layer of elastic contraction film.
The invention also provides a kind of medicine mixers with reinforcement structure, it is characterised in that: including as above any described
Medicine mixer；
On the wall of cup of the mixed medicine glass, reinforcing rib structure is provided with to enhance the compression strength of the wall of cup.
Medicine mixer as described above, it is characterised in that:
The reinforcing rib is arranged on the inside of the wall of cup along the vertical direction and/or horizontal direction is integrally arranged.
A kind of hard double nip with medicine mixer, including as above any medicine mixer, it is characterised in that:
The other side on the pedestal of the medicine mixer relative to the mixed medicine channel is equipped with an infusion channel；
Interface is provided in the infusion channel.
A kind of transfusion flexible bag of the hard double nip of band, it is characterised in that:
The hard double nip is hard double nip as described above；
The hard double nip is bonded together by the pedestal and the transfusion flexible bag.
A kind of transfusion flexible bag with medicine mixer, it is characterised in that: the medicine mixer is any medicine mixer as above；
The medicine mixer is bonded together by the pedestal and the transfusion flexible bag.
Transfusion flexible bag as described above, it is characterised in that:
It further include an infusion connector, the infusion connector is arranged on the transfusion flexible bag ipsilateral with the medicine mixer, or
It is arranged on the transfusion flexible bag of the other side opposite with the medicine mixer.
As above any transfusion flexible bag, it is characterised in that:
The transfusion flexible bag is using non-PVC multi-layer co-extruded film；
The integrally formed pedestal and mixed medicine glass, diaphragm are using medical polypropylene material, preferably polypropylene
R530C material；
The cross needle, the restriction protrusion are polypropylene material, preferably polypropylene P17 material.
Detailed description of the invention
Cross needle of the Fig. 1 with card body
Fig. 2 pedestal and mixed medicine glass sectional view
Medicine mixer after Fig. 3 puncture
Fig. 4 rubber plug top view/plan view
Fig. 5 cross needle schematic diagram (outlet is located at syringe needle side-walls)
Fig. 6 cross needle three dimensional structure diagram (outlet is located at syringe needle side-walls)
Cross needle schematic diagram of the Fig. 7 with coating film
The compressed cross needle schematic diagram of Fig. 8 coating film
Fig. 9 cover board
The mixed medicine glass of Figure 10 reinforcement structure
Figure 11 assembles the band foldable handle medicine mixer of cillin bottle
Transfusion flexible bag of the Figure 12 with medicine mixer
Specific implementation method
Description of symbols: 1 transfusion flexible bag, 2 pedestals, 3 mixed medicine glasses, 3-1 wall of cup, 3-2 bottom of a cup, 3-3 reinforcing rib, 4-1 bullet
Property claw, 4-2 snap ring, 4-4 support column, 5 cross needles, 5-1 needle plate, the upper needle of 5-2,5-3 knit stitch, 5-4 side opening, 5-5 needle point, 6 glue
Plug, the paracentesis area 6-1,6-2,6-3, groove/bulge loop, 7 mixed medicine channels, 8 diaphragms, 9 cillin bottles, 10 foldable handles, 11 infusion channels, 12
Cover board, 12-1 through-hole, 12-2 reinforcing rib, 13 sealing films
Specific implementation method
In the following, the present invention is further detailed in conjunction with Figure of description.
As shown in Figure 1, the cross needle 5 with deck, cross needle is by 5 integrally formed needle plate 5-1 and has hollow channel
Upper needle 5-2 and knit stitch 5-3 constitute, the hollow channel of the upper needle 5-2 and knit stitch 5-3 communicates with each other.
It is also integrally formed on the needle plate 5-1 to be provided with support column 4-3, snap ring 4-2 and elastic card claw 4-1, wherein
The support column 4-3 setting is fixed in the periphery the needle plate 5-1 with forming support to the snap ring 4-2.
Snap ring described in the elastic card claw 4-1 upper end edge is evenly arranged and fixes, and the lower end the elastic card claw 4-1 is freely
End, and the elastic card claw 4-1 is in the mixed medicine glass center bevelled junction from the fixed upper end to the free lower end
Structure.Elastic card claw 4-1 have it is multiple, preferably 3 or 4.
For the structure of upper the needle 5-2 and knit stitch 5-3 of cross needle 5, remove outside syringe needle 5-5 structure as shown in Figure 1, upper needle
Hollow channel outlet 5-4, can be provided on the syringe needle side wall of the upper needle 5-2, as shown in Figure 5,6；Likewise, described
The outlet of the hollow channel of knit stitch is provided with (not shown) on the syringe needle side wall of the knit stitch 5-3.So set, being to keep away
Exempt from upper needle, knit stitch when puncturing rubber plug, bottle stopper, the edge of outlet forms directly cutting to plug and generates a large amount of clast.It is logical
It crosses and outlet is arranged on the side wall of syringe needle, needle point is directly pierced into rubber plug, not will form direct dissection, is reduced clast
It generates.
Or as shown in fig. 7, upper needle is coated with one layer of elastic contraction film, elastic contraction film is compressed after piercing,
It is deposited in around puncturing hole, as shown in figure 8, so as to effectively prevent medical fluid to come out along the gap leakage of puncturing hole.It is aobvious and easy
See, knit stitch can equally coat one layer of elastic contraction film, to solve the problems, such as that medical fluid is leaked along the gap of puncturing hole.
Pedestal and mixed medicine glass sectional view as shown in Figure 2, including pedestal 2 mix medicine glass 3, diaphragm 8 and mixed medicine channel 7, on
It states and is formed in a manner of integrally formed by the medicine mixer body construction that pedestal 2, mixed medicine glass 3, diaphragm 8 and mixed medicine channel 7 are constituted.
Rubber plug 6 is placed in mixed medicine channel, is located on diaphragm 8.
Cross needle 5 with deck is placed in mixed medicine glass 3, as shown in figure 3, being placed in ten with deck in mixed medicine glass 3
Word needle 5, is pushed to bottom of a cup, to complete puncture to rubber plug 6 and diaphragm 8.
For the medicine mixer being completed, i.e., by the cross needle 5 with deck, after being placed in mixed medicine glass 3, just to mixed medicine glass
Be sealed, sealing is generally adopted by sealing film 13, or easily tear sealing film, in a manner of pressure welding to mixed medicine glass rim of a cup into
Row sealing；Alternatively, first placing a cover board 12 in rim of a cup, then sealed on it with sealing film, the mixed medicine glass weldering after sealing
It connects on transfusion flexible bag, forms the transfusion flexible bag with medicine mixer, as shown in figure 12.After terminal sterilization, i.e., for medical staff
It uses.
It is understood that infusion channel 11 shown in Fig. 3, it can be with the setting of medicine mixer side by side on the base 2, just
As shown in Figure 1.Infusion channel can also be individually welded on transfusion flexible bag 1 by another pedestal, and it is soft to be set to infusion
Other positions of bag 1 and the ipsilateral perhaps opposite other side of medicine mixer or transfusion flexible bag 1, for those skilled in the art
For, it is obviously to be arranged.
Mixed medicine channel 7 passes through the bottom of a cup 3-2 that pedestal 2 upwardly extends straight-through mixed medicine glass 3, and the effect of diaphragm 8 is isolation medical fluid
With directly contacting for rubber plug, accomplish to be fully sealed using preceding, can theoretically be located at appointing in the mixed medicine channel under rubber plug 6
What position, but in view of causing the knit stitch 5-3 of cross needle 5 too long if 8 position of diaphragm is too low, so preferably
Diaphragm 8 is located under rubber plug 6 and is close to the lower surface of rubber plug 6.
Rubber plug 6 is placed in mixed medicine channel, on diaphragm.The effect of rubber plug be guarantee knit stitch 5-3 puncture rubber plug 6 with every
After film 8, medical fluid is unlikely to ooze out mixed medicine channel after flowing out in the gap between diaphragm 8 and knit stitch 5-3 outer wall, that is,
It says, the outer diameter of rubber plug 6 and the internal diameter in mixed medicine channel match, so that rubber plug 6 and mixed medicine channel are in close contact.
Preferably, 6 upper surface of rubber plug and the upper surface bottom of a cup 3-2 are substantially flush or slightly above upper surface, in this way, such as
The lower surface of elastic clamp seat 4 shown in Fig. 3, pushes down the upper surface of rubber plug 6.
As a preferred technical solution, diaphragm 8 is located under rubber plug 6 and is close to the lower surface of rubber plug 6, as Fig. 2,
Shown in 3, it can preferably prevent medical fluid from penetrating into mixed medicine channel after lower needle-penetration diaphragm.Especially, rubber plug as shown in Figure 4,
The relatively thin paracentesis area 6-1 limited by bulge loop or groove 6-2,6-3 is equipped on rubber plug surface, with the bulge loop or groove on rubber plug
Opposite, the corresponding position in 8 upper surface of diaphragm also is provided with groove or bulge loop.It is readily apparent that the bulge loop or recessed on rubber plug
Slot on diaphragm 8 groove or bulge loop it is mutually chimeric, to achieve the purpose that preferably to prevent Drug leakage.
It is provided with the rubber plug 6 and diaphragm 8 of mutually chimeric groove or bulge loop, needle plate 5-1 forms an extruding to rubber plug 6 and makees
With rear, the leakage of medical fluid after mixed medicine can be prevented completely.
It is further preferred that it is provided with a circle annular projection at root of the lower surface of needle plate 5-1 around knit stitch 5-3,
After the cross needle 5 with deck is installed in mixed medicine glass, the annular projection of needle plate 5-1 is stronger crowded to rubber plug formation one
Pressure effect, forms better seal.
Position limiting structure (not shown) is provided on the inner wall of the wall of cup 3-1, the cross needle 5 with deck is installed on institute
It states in mixed medicine glass 3 and is limited by the position limiting structure, especially, completed in knit stitch 5-3 as described in Figure 3 to rubber plug 6 and diaphragm 8
Puncture after, cross needle 5 is limited structure completely and is limited.
Certainly, medicine mixer assembly after before use, cross needle 5 only be placed in mixed medicine glass 3, do not formed to diaphragm 8
Puncture, rubber plug 6 can not be punctured or partial puncture or completely puncture, as long as not to diaphragm 8 puncture, do not influence
The use of medicine mixer.Sealing film 13 is being torn, partition 12 is being removed, is inserted into cillin bottle 9, it is as shown in figure 11, downward by cillin bottle 9
It pushes away, the bottleneck of cillin bottle 9 is pushed under elastic card claw 4-1.The upper needle of cross needle 5 and knit stitch are respectively to rubber plug, diaphragm at this time
And the bottle stopper of cillin bottle is completed to puncture, while cross needle 5 is limited by the position limiting structure mixed on medicine glass inner wall completely, cillin bottle
9 bottleneck is blocked and cannot be exited by elastic card claw 4-1.
By above-mentioned setting, it can conveniently, safely, efficiently make up a prescription, dosing, completely solve in the secondary of link of making up a prescription
Pollution problem.It also can guarantee that infusion is traceable simultaneously, because being fixed on mixed medicine glass 3 from the docking of cillin bottle 9, by elastic card claw 4-
After 1 blocks, cillin bottle 9 nondestructive cannot be taken out.That is, completed from making up a prescription to infusion, until recycling link,
Can trace back to added, which kind of drug injected is.
And for a kind of drug for needing special preservation, it for example needs i.e. with i.e. note type, above-mentioned medicine mixer may be also
There are some inconveniences, because the filling drug of cillin bottle must be taken to ward, then cillin bottle are docked with medicine mixer, so
It makes up a prescription in ward and uses at once afterwards.
Match the needs of using to more easily meet medical staff, on the basis of above structure, is additionally arranged easy to break
Handle 10, as shown in figure 11.
Foldable handle 10 is set in mixed medicine channel lower end, as shown in figure 11, by the elasticity in cillin bottle 9 and mixed medicine glass 3
After deck 4 is completed docking and punctured, band to pharmacy breaks disconnected foldable handle 10 before infusion, gets through mixed medicine channel, scene can be completed
It makes up a prescription, scene uses.
About the shape and structure of pedestal 2, in order to avoid medicine mixer, infusion channel or with medicine mixer and infusion channel
After hard double nip is welded in soft bag, as shown in figure 12, in storage, transport and use process, pedestal welding position pair
It being damaged caused by transfusion flexible bag, pedestal is designed as dumb-bell shape or ship shape, as shown in the pedestal 2 in Fig. 2, and mixed medicine channel 7, infusion
The lower end in channel 11 is concordant with the lower end of pedestal 2.Lines is uniformly welded on the surrounding side wall of pedestal 2, can be guaranteed well in this way
It is in the welding process of transfusion flexible bag, even pedestal 2 also can be with the fusion welding well of soft bag 2 at a lower temperature.
Moreover, the pedestal of ship shape or dumb-bell shape, streamlined good, the mechanical property of welding is improved not to the utmost, and not sharp angle,
The combination of hard double nip and transfusion flexible bag 2 can be made smoother, be hardly damaged soft bag.
Selection for medicine mixer and transfusion flexible bag material, transfusion flexible bag is using the non-PVC being commonly used
PP TYPE, the PP TYPE including three layers, five layers.
And medicine mixer, then using with the good medical polypropylene material of transfusion flexible bag non-PVC material compatibility, base
Seat, mixed medicine glass, cover board are preferably polypropylene R530C material；And cross needle, card body, it is contemplated that its puncture and mechanical spy
Property, preferably the P17 material in pp material system.
The cross needle, the restriction protrusion are polypropylene material, preferably polypropylene P17 material
Finally, sealing structure medicine mixer it is crucial a bit --- end of the sealed mixed medicine device after being welded in soft bag
End sterilizing.At present from the point of view of policies and regulations and actual injection safety, all Key works Drug packings, in filling factory
Before, it is necessary to terminal sterilization is carried out, or uses injection Sterility Assurance technique.
Currently, there are mainly two types of the Sterility Assurance techniques of injection:
1. terminal sterilization technique: on the basis of controlling microbial contamination amount, after drug encapsulating, by moist heat sterilization side
Formula degerming.In general, this method is at low cost, and sterility assurance level is high, is suitable for high-capacity injection and small-volume injection
Sterilizing.
2. sterile production technique: under sterile system environment, by aseptic filtration method or aseptic manipulation, to prevent from polluting
For the purpose of, eliminating causes the various possibilities of pollution to guarantee sterile level.Typically, since this method is to environmental system
It is required that it is high, and the factor for influencing sterile working makes sterility assurance level lower than terminal sterilization technique more.Sterile production technique
It is generally applicable to powder-injection, can also be suitable for the clinical small-volume injection needed but not can be carried out terminal sterilization.Terminal as a result,
Sterilization process and sterile production technique have different system requirements, different degerming methods and different Sterility Assurance results
It is cost exquisite sensitivity for being infused greatly, so, the terminal sterilization in big infusion is only possible to use
Low cost and efficient moist heat sterilization technique --- sterilising conditions are usually high temperature at 115-121 degrees Celsius, 0.15MPa pressure
Steam under, keep 30-15 minutes.
It is all the polypropylene material for 120 celsius temperature of ability selected although medicine mixer and transfusion flexible bag, however,
Medicine mixer under sealing state, at such high temperatures, mechanical performance can reduce, and be very easy to the pressure in 0.15MPa
Lower deformation；And deformation, fold can be occurred at this temperature and pressure by sealing film also, lose sealing effect.
We year have carried out experiments of up to a hundred times up to 4 years from 2011 to 2014, finally set about from multiple angles, really
Solution is determined.
Firstly, for the structure of mixed medicine glass, as shown in Figure 10, reinforcing rib 3-3 is provided in the lower half of cup body.Reinforcing rib
Setting be wall of cup to mixed medicine glass, preferential is carried out in wall of cup lower half.
Reinforcing rib can be being integrally formed with mixed medicine glass for the equally distributed protrusion that wall of cup inside and or outside is arranged in
Vertical bar perhaps horizontal stripe or criss-cross reticular structure.Preferably along the equally distributed vertical bar in lower half on the inside of wall of cup
Shape structure；More preferably the vertical bar of protrusion extends to bottom of a cup, the most preferably thickness of vertical bar protrusion from lower half on the inside of wall of cup
Degree is gradually smooth from top to bottom to be increased continuously.
Mixed medicine glass provided with reinforcing rib, improves the mechanical resistance of cup body in comparable degree.Experiment is compared, and is not had
There is the mixed medicine glass of setting reinforcing rib, after using wet heating sterilization process, circular mixed medicine glass cup body has been compressed into side
Shape cannot use completely.
After being provided with reinforcing rib, after wet heating sterilization process, circular mixed medicine glass cup body has slight pressure
Contracting has no substantial effect on and normally uses function.
Secondly, itself is a very thin easily tore film, plays the sealing and use to mixed medicine glass 3 for sealing film 13
When convenient for the effect torn.It is more weaker than the cup body of mixed medicine glass 3 to seal film 13, because sealing film 13 itself is one layer of micron
The film of magnitude thickness cannot withstand the pressure of 0.15MPa in wet heating sterilization process.
In this regard, have passed through a large amount of experiment, it is found that install a cover board 12 as shown in Figure 9 additional under sealing film 13, it is close
Sealer 13 covers cover board 12, so that 12 pairs of sealing films 13 of cover board form effective support, prevents sealing film 13 from being pressed in sterilizing
Compression deformation.And to be then shelved on the mixed medicine glass rim of a cup step-like interior along upper for cover board 12, so that the cover board being arranged at rim of a cup is upper
Surface is concordant with rim of a cup or slightly below described rim of a cup, and cover board 12 so set, to sealing 13 pressure welding of film on the wall of cup
The sealing technology of end surfaces will not impact.
The substantially matched circle of shape of shape and mixed medicine glass rim of a cup for cover board, the shape of preferred cover board 12 are
Cross section is in polygon, for example pentagon, hexagon, octagon, 12 deformations.The benefit of 12 one side of cover board of polygon is
It is eaily taken out when use；And unexpected act on of other one that cover board 12 is set as polygon can mention below
It arrives.
In addition, preferably cover board 12 and cross needle is coaxially disposed, the needle point of upper needle in order to enhance the compression strength of cover board
5-5 face cover plate central simultaneously forms support to cover board.More have preferably, 12 center of cover board is equipped with a through-hole 12-1, through-hole 12-
1 internal diameter is less than the outer diameter of upper needle 5-2, and the part needle point 5-5 of upper needle 5-2 is located in through-hole but cannot pass through the through-hole, i.e., on
In the through-hole 13-1 of the needle point 5-5 insertion cover board 12 of needle 5-2, so that upper needle 5-2 is more significant to the support effect of cover board.
At the same time, it is contemplated that the huge downward pressure that cover board 12 is born, in addition to designing upper needle 5-2 to cover board 12
It is outer to form support, also cover board 12 has been carried out to reinforce setting, the reinforcing rib 12- of radial and cyclic annular setting as shown in Figure 9
2, enhance the mechanical strength of cover board 12.
The sealing film 13 of pressure welding and rim of a cup upper end, tightly be pasted on 12 upper surface of cover board so that sealing film 13 substantially
It does not need to bear high pressure, greatly alleviates the phenomenon that sealing film 13 deforms fold.
And for fold, since sealing film 13 is too thin, the slightly pressure appearance that will lead to fold seriously affects product
Visual effect.
By multiple comparative experiments, one layer of thin metal film is plated in sealing 13 upper surface of film, can effectively be alleviated close
The problem of sealer fold.
The sealed mixed medicine device of such setting, although also substantially can after withstanding the high temperature and high pressure of wet heating sterilization process
Normal use, however, the shape as product is still difficult to keep in good state, from the viewpoint of infusion products,
It is still underproof product.
After having carried out above-mentioned design to medicine mixer in structure, it can only guarantee using function, in order to thoroughly solve to seal
Interior outer gas of the mixed medicine glass of the terminal sterilization problem of medicine mixer, it is also necessary to be solved from root --- sealing when wet heating sterilizes
Flatten weighing apparatus.
After mixed medicine glass is completed, before installation cover board 12 seals it with sealing film 13, one is pre-installed into cup body
Then quantitative liquid installs cover board additional again, sealing.
The sealed mixed medicine cup of contained liquid, when carrying out terminal sterilization with transfusion flexible bag, the quick vapour of liquid under high temperature
Change, allows the air pressure inside and outside cup body to reach a balance so as to cracking.
For preloaded with liquid, preferably thermal capacity is smaller, the higher liquid of saturated vapor pressure.We have studied various liquid
The common harmless liquids such as the body state under 120 degrees Celsius, 0.15MPa, including water, ethyl alcohol, are able to satisfy our demand.
In view of cost and safety, preferably preloaded with liquid is water.
As for vital pre- installation of water V0, it can be confirmed by following equation:
PV=nRT, wherein P is internal and external pressure difference when wet heating sterilizes, and V is mixed medicine glass volume, and n is preloaded with liquid/water
Molal quantity, R is gas constant, and T is absolute temperature when wet heating sterilizes.
V0=n*M/ ρ, wherein M is the molal weight of fluid/water, and ρ is the density of fluid/water.
It can be very good inner and outer air pressure of the balanced seal medicine mixer in terminal sterilization according to above-mentioned equation.
Inner and outer air pressure is balanced in a manner of preloaded with liquid, is one than more preferably solution.
However, the above method is able to solve the problem of air pressure balance, then in actual use, certain ask is still remained
Topic, most typically, sterilize the finished product transfusion flexible bag being over, and there are water droplet or liquid in mixed medicine glass after cooling, very
Perception is influenced, and such product is generally also not likely to be received by hospital and patient.
On this basis, a more preferably scheme is that we especially have studied having centainly based on pp material system
The sealing film of gas permeability guarantees after liquid vaporizes, and can carry out sufficient gas exchanges by gas-permeable seal film and outside, this
Sample is after sterilizing is completed, and there is no residual liquids in mixed medicine glass.
The air penetrability of gas-permeable seal film, by prolonged many experiments, 5%-35% air penetrability is preferred
's.
The medicine mixer sealed for the gas-permeable seal film studied using us is mixed after wet heating high-temperature sterilization
The not a bit deformation of medicine glass, sealing film is also smooth as before, occurs without fold.
Certainly, a modified scheme is, in not preloaded with liquid, to directly adopt the gas-permeable seal with appropriate air permeability
Film carrys out sealed mixed medicine device, by our many experiments and feasible.
It should be understood that being only used to illustrate and not limit the technical solutions of the present invention above, although referring to above-mentioned implementation
Example describes the invention in detail, those skilled in the art should understand that: the present invention can still be repaired
Change or equivalent replacement should all cover in this hair without departing from the spirit or scope of the invention, or any substitutions
In bright scope of the claims.
Claims (24)
1. a kind of medicine mixer, including the diaphragm and mixed medicine glass in integrally formed pedestal, mixed medicine channel and mixed medicine channel, ten
Word needle, the mixed medicine glass are made of wall of cup and bottom of a cup, and the cross needle is located in the mixed medicine glass, it is characterised in that:
The cross needle is by integrally formed needle plate and has the upper needle of hollow channel and knit stitch is constituted, the upper needle and knit stitch
Hollow channel communicate with each other；
It is also integrally formed on the needle plate to be provided with support column, snap ring and elastic card claw, wherein the support column setting exists
The needle plate periphery is fixed with forming support to the snap ring；
The elastic card claw is arranged on the downside of the snap ring and snap ring described in the upper end edge of the elastic card claw is evenly arranged and solid
Fixed, the elastic card claw lower end is free end, the elastic card claw from the fixed upper end to the free lower end be in
The mixed medicine glass center incline structure；
The mixed medicine channel lower end passes through the pedestal, and upper end passes through the bottom of a cup；
Rubber plug is equipped in mixed medicine channel between the diaphragm and the bottom of a cup；
The medicine mixer further includes sealing film, and the sealing film is connected to the rim of a cup of the mixed medicine glass in a manner of pressure welding, to institute
It states mixed medicine glass and forms sealing；
The sealing film is that substantially smooth easily tore film is still kept after wet heating terminal sterilization, and the sealing film is gas permeability
Easily tore film.
2. medicine mixer as described in claim 1, it is characterised in that:
The air penetrability of the sealing film is 5% to 35%.
3. medicine mixer as claimed in claim 2, it is characterised in that:
Sealing film upper surface metal-plated membrane layer.
4. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
It further include a cover board；
The cover board is located at edge in the rim of a cup, and is covered by the sealing film.
5. medicine mixer as claimed in claim 4, it is characterised in that: the cover board is in polygon, and center is equipped with a hole, described
The needle point of upper needle is located in the hole but is not passed through the hole.
6. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
The mixed medicine glass pre-installs a certain amount of liquid before by sealing film sealing.
7. medicine mixer as claimed in claim 6, it is characterised in that:
The liquid be can under high-temperature sterilization environment rapid vaporization liquid.
8. medicine mixer as claimed in claim 7, it is characterised in that:
The certain quantity of fluid of prepackage vaporizes under high-temperature sterilization environment is formed by gas, and the mixed medicine glass can be allowed inside and outside
Air pressure is in a basic balance.
9. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
Position limiting structure is provided on the inner wall of the wall of cup, after the cross needle is installed into the mixed medicine glass, the position limiting structure
The needle plate is limited between the position limiting structure and the bottom of a cup and cannot be removed.
10. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
The distance between the diaphragm upper surface and the bottom of a cup upper surface are almost the same with the thickness of the rubber plug.
11. medicine mixer as claimed in claim 10, it is characterised in that:
The diaphragm upper surface is provided with bulge loop or groove, and fluted or bulge loop is arranged in rubber plug lower surface corresponding position；
The diaphragm is chimeric each other with groove by bulge loop with the rubber plug.
12. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
The rubber plug central area is equipped with paracentesis area, and the paracentesis area is thinner than marginal zone.
13. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
The mixed medicine channel lower end is provided with foldable handle, and close by lower end progress of the foldable handle to the mixed medicine channel
Envelope.
14. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
The outlet of the hollow channel of the upper needle is provided on the syringe needle side wall of the upper needle；
And/or；
The outlet of the hollow channel of the knit stitch is provided on the syringe needle side wall of the knit stitch.
15. medicine mixer a method according to any one of claims 1-3, it is characterised in that:
The upper needle is coated with one layer of elastic contraction film；
And/or；
The knit stitch is coated with one layer of elastic contraction film.
16. a kind of medicine mixer with reinforcement structure, it is characterised in that: including the mixed medicine as described in claim 1-15 is any
Device；
On the wall of cup of the mixed medicine glass, reinforcing rib structure is provided with to enhance the compression strength of the wall of cup.
17. medicine mixer as claimed in claim 16, it is characterised in that:
The reinforcing rib is arranged on the inside of the wall of cup along the vertical direction and/or horizontal direction is integrally arranged.
18. a kind of hard double nip with medicine mixer, including the medicine mixer as described in claim 1-17 is any, it is characterised in that:
The other side on the pedestal of the medicine mixer relative to the mixed medicine channel is equipped with an infusion channel；
Interface is provided in the infusion channel.
19. a kind of transfusion flexible bag of the hard double nip of band, it is characterised in that:
The hard double nip is hard double nip as claimed in claim 18；
The hard double nip is bonded together by the pedestal and the transfusion flexible bag.
20. a kind of transfusion flexible bag with medicine mixer, it is characterised in that: the medicine mixer is as described in claim 1-17 is any
Medicine mixer；
The medicine mixer is bonded together by the pedestal and the transfusion flexible bag.
21. transfusion flexible bag as claimed in claim 20, it is characterised in that:
It further include an infusion connector, the infusion connector is arranged on the transfusion flexible bag ipsilateral with the medicine mixer, or setting
On the transfusion flexible bag of the other side opposite with the medicine mixer.
22. the transfusion flexible bag as described in claim 19-21 is any, it is characterised in that:
The transfusion flexible bag is using non-PVC multi-layer co-extruded film；
The integrally formed pedestal and mixed medicine glass, diaphragm are using medical polypropylene material；
The cross needle is polypropylene material.
23. transfusion flexible bag as claimed in claim 22, it is characterised in that:
The integrally formed pedestal and mixed medicine glass, diaphragm are using polypropylene R530C material.
24. transfusion flexible bag as claimed in claim 22, it is characterised in that:
The cross needle is polypropylene P17 material.
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510780465.8A CN105232329B (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 |
| PCT/CN2016/105564 WO2017080522A1 (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual-port member, and soft infusion bag |
| EP16863698.3A EP3375427B1 (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual-port member, and soft infusion bag |
| JP2018544393A JP2018535071A (en) | 2015-11-13 | 2016-11-13 | Drug mixer, hard dual interface and infusion softback |
| KR1020187014837A KR102119990B1 (en) | 2015-11-13 | 2016-11-13 | Chemical mixing mixer, rigid dual pot and soft bag for fluids |
| CA3004927A CA3004927C (en) | 2015-11-13 | 2016-11-13 | Medication mixer, dual hard ports, and soft intravenous bag |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510780465.8A CN105232329B (en) | 2015-11-13 | 2015-11-13 | Medicine mixer, hard double nip and transfusion flexible bag |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105232329A CN105232329A (en) | 2016-01-13 |
| CN105232329B true CN105232329B (en) | 2019-02-22 |
Family
ID=55030343
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510780465.8A Active CN105232329B (en) | 2015-11-13 | 2015-11-13 | Medicine mixer, hard double nip and transfusion flexible bag |
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| Country | Link |
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| CN (1) | CN105232329B (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2018535071A (en) * | 2015-11-13 | 2018-11-29 | 重慶莱美薬業股▲ふん▼有限公司Ｃｈｏｎｇｑｉｎｇ Ｌｕｍｍｙ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． | Drug mixer, hard dual interface and infusion softback |
| CN106178155B (en) * | 2016-07-18 | 2019-05-17 | 湖南懿科药用包装材料科技有限公司 | The infusion container interface and infusion vessel repeatedly directly matched can be carried out to multi-form |
| CN106726558B (en) * | 2016-12-21 | 2024-02-02 | 湖南乐福地医药包材科技有限公司 | Pull ring combined cover for infusion container and infusion container |
| CN110812225A (en) * | 2019-11-15 | 2020-02-21 | 湖南乐福地医药包材科技有限公司 | Medicine mixer capable of tracking powder injection source |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN203252919U (en) * | 2013-05-21 | 2013-10-30 | 重庆莱美医疗器械有限公司 | Hard dual connector with medicine mixing cup |
Family Cites Families (1)
| 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 |
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2015
- 2015-11-13 CN CN201510780465.8A patent/CN105232329B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN203252919U (en) * | 2013-05-21 | 2013-10-30 | 重庆莱美医疗器械有限公司 | Hard dual connector with medicine mixing cup |
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| CN105232329A (en) | 2016-01-13 |
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