WO2017080522A1 - 混药器、硬双接口及输液软袋 - Google Patents

混药器、硬双接口及输液软袋 Download PDF

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Publication number
WO2017080522A1
WO2017080522A1 PCT/CN2016/105564 CN2016105564W WO2017080522A1 WO 2017080522 A1 WO2017080522 A1 WO 2017080522A1 CN 2016105564 W CN2016105564 W CN 2016105564W WO 2017080522 A1 WO2017080522 A1 WO 2017080522A1
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WO
WIPO (PCT)
Prior art keywords
cup
needle
mixing
wall
drug
Prior art date
Application number
PCT/CN2016/105564
Other languages
English (en)
French (fr)
Inventor
邱宇
李科
Original Assignee
重庆莱美药业股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201510781506.5A external-priority patent/CN105232330B/zh
Priority claimed from CN201510781507.XA external-priority patent/CN105232331B/zh
Priority claimed from CN201510780465.8A external-priority patent/CN105232329B/zh
Application filed by 重庆莱美药业股份有限公司 filed Critical 重庆莱美药业股份有限公司
Priority to JP2018544393A priority Critical patent/JP2018535071A/ja
Priority to CA3004927A priority patent/CA3004927C/en
Priority to EP16863698.3A priority patent/EP3375427B1/en
Priority to US15/776,073 priority patent/US20200253827A1/en
Priority to KR1020187014837A priority patent/KR102119990B1/ko
Publication of WO2017080522A1 publication Critical patent/WO2017080522A1/zh

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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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • 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
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    • 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
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    • A61J1/1406—Septums, pierceable membranes
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    • 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
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
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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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
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    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals

Definitions

  • the invention relates to a medicine mixer, in particular to a medicine mixer with a mixing cup, a hard double interface and an infusion soft bag.
  • the syrup or water for injection in the infusion soft bag needs to be pumped out into the vial via a syringe, and the above work is repeated until there is enough liquid in the vial; Then, the vial is repeatedly shaken until the medicine in the bottle is evenly mixed, and then the liquid medicine in the vial is pumped out into the soft bag of the infusion, and repeated until the liquid in the bottle is exhausted.
  • the above-mentioned mixed drug operation process is relatively time consuming, laborious, and consumables such as a syringe. More seriously, in the above mixed drug process, it is very easy to inject the outside air into the vial and the infusion soft bag under normal conditions. There are a lot of dust and germs in the air, and they will enter the human body after being mixed with the injection liquid, which will bring about a very serious medical accident.
  • the traditional method of liquid dispensing is to first re-inject the medicine, and then pump the medicine in the vial to the infusion soft bag, and then bring the infusion soft bag with the medicine to the patient to infusion. After the medicine is finished, the vacant vials are placed on one side, and the patient protection medical staff is completely unaware of what medicine is contained in the infusion soft bag and is not traceable. Once the medical staff pays little attention to the mistakes during the dosing, the mismatching of the liquid is wrong, and the consequences will be unimaginable.
  • the drug mixture is welded on the infusion soft bag.
  • the high temperature sterilization environment is generally a high temperature of 115-121 degrees Celsius, and the sterilization time is 30- The sterilization pressure was 0.15 MPa for 15 minutes.
  • the material used in the blender and the infusion soft bag can withstand temperatures of 120 degrees Celsius, it will inevitably soften, plus a high pressure of 0.15 MPa, which is equivalent to a pressure of 150 N per square centimeter - this is In the case of a sealed mixed cup, it is fatal.
  • the mechanical strength of the mixing cup and the sealing film will decrease at 120 °C.
  • the pressure of 150 N per square centimeter will directly cause the cup of the mixing cup to deform, the sealing film to be stretched, and wrinkles appear. The seal is broken, causing the mixed cup structure to be completely damaged and unusable.
  • the terminal sterilizing of the mixed drug cup structure was an insurmountable obstacle; and the mixed cup was not sealed, and it was not guaranteed to meet the sterility requirements at the time of use, whether from policies and regulations. From the perspective of practical safety, terminal sterilization of infusion soft bags is necessary and necessary.
  • the object of the present invention is to provide an infusion soft bag which is convenient and reliable and has no safety hazard, and a mixer and an interface therewith.
  • a mixing device comprising a base, a mixing channel, a diaphragm and a mixing cup in the mixing channel, a base, a mixing channel, a diaphragm in the mixing channel, and a mixing
  • the medicine cup is integrally formed;
  • the mixed medicine cup is composed of a cup wall and a cup bottom; and a cross needle is arranged, the cross needle is located in the mixing medicine cup, and the cross needle is composed of an integrally formed needle board and an upper needle and a lower needle having a hollow passage, The hollow passages of the needle and the lower needle are in communication with each other; and the support plate, the snap ring and the elastic claw are integrally formed on the needle plate, wherein the support column is disposed on the outer circumference of the needle plate to form and support the snap ring; the elastic claw Set in The lower end of the snap ring and the upper end of the elastic claw are evenly arranged and fixed along the snap ring, and the lower end of the elastic claw is
  • the mixing device further comprises a sealing film, and the sealing film is pressure-welded to the cup mouth of the mixing cup The sealing film is sealed; the sealing film is an easy-to-tear film which remains substantially flat after being sterilized by the wet heat method.
  • a limited protrusion is disposed on the inner wall of the cup wall, and after the cross pin is installed into the mixing cup, the limiting protrusion defines the needle plate between the limiting protrusion and the cup bottom and cannot be taken out.
  • a mixing device comprising an integrally formed base, a mixing channel and a mixing cup, a cross pin, the mixing cup is composed of a cup wall and a cup bottom;
  • the integrally formed needle plate and the upper needle and the lower needle having a hollow passage, the hollow passages of the upper needle and the lower needle communicate with each other; the lower end of the mixed medicine passage passes through the base, and the upper end passes through the bottom of the cup, at the base and the bottom of the cup
  • the needle plate is defined between the limiting protrusion and the cup bottom and cannot be taken out; the distance between the upper surface of the cup bottom and the lower surface of the diaphragm is smaller than
  • the limiting protrusion is an elastic claw, and the upper end of the elastic claw is evenly arranged and fixed along the inner wall circumference of the cup wall, the lower end of the elastic claw is a free end, and the elastic claw is from the fixed upper end to the free end toward the mixing cup
  • the center is inclined; the needle plate is located between the lower end and the bottom of the cup.
  • a mixing device comprising an integrally formed base, a mixing channel and a mixing cup, a cross pin, the mixing cup is composed of a cup wall and a cup bottom, and the cross pin is composed of
  • the integrally formed needle plate and the upper needle and the lower needle having a hollow passage, the hollow passages of the upper needle and the lower needle communicate with each other;
  • the lower end of the mixed medicine passage passes through the base, and the upper end passes through the bottom of the cup, at the base and the bottom of the cup a diaphragm is arranged in the mixed mixing passage, and a rubber plug is arranged in the mixing passage between the diaphragm and the bottom of the cup;
  • an elastic card seat is included;
  • the elastic card seat includes a snap ring, and the elastic ring is arranged on the lower side of the snap ring The upper end of the elastic claw is evenly arranged and fixed along the snap ring, the lower end of the elastic claw is a free end, and the elastic claw is from the
  • the elastic card holder has an integrally formed bottom plate, a support column, a snap ring and an elastic claw, and the outer periphery of the bottom plate is provided with a support column for supporting and fixing the snap ring; the bottom plate is provided with a center hole, and the lower needle passes through the center hole to the cross pin The positioning is formed; the needle plate is located between the bottom plate and the elastic jaws.
  • a central portion of the lower surface of the bottom plate is provided with an annular protrusion, and the area defined by the annular protrusion completely overlaps the central hole and is disposed coaxially with the mixing passage; the bottom plate is pressed against the bottom of the cup by the annular protrusion.
  • the central region of the rubber plug is provided with a puncture zone, and the puncture zone is thinner than the edge zone; the central region of the lower surface of the needle plate is provided with an annular protrusion, and the puncture zone coincides with the area defined by the annular protrusion or is located in the area defined by the annular protrusion.
  • a mixing device having a reinforcing structure, comprising a mixing device; a cup wall of the mixing cup, provided with a reinforcing rib structure to enhance the compressive strength of the cup wall;
  • the ribs are disposed integrally inside the cup wall in the up and down direction and/or the horizontal direction.
  • a cover plate is disposed, the cover plate is located in the mouth of the cup, and is covered by the sealing film.
  • cup mouth is provided with a stepped inner edge along the wall of the cup, and the cover plate rests on the inner edge; the upper surface of the cover plate is flush with the cup mouth or slightly lower than the cup mouth;
  • the sealing film is hot pressed against the upper end surface of the cup wall to form a seal to the cup opening.
  • the cover plate has a polygonal shape and a hole is formed in the center, and the needle tip of the upper needle is located in the hole but does not pass through the hole.
  • the sealing film is a gas permeable and easy to tear film; the air permeability of the sealing film is 5% to 35%;
  • the upper surface of the sealing film is plated with a metal film layer.
  • the liquid is a liquid which can be rapidly vaporized in a moist heat sterilization environment.
  • the lower end of the mixed drug channel is provided with an easy folding handle, and the lowering of the mixed drug passage through the easy folding handle The end is sealed.
  • the upper surface of the diaphragm is provided with a convex ring or a groove
  • the lower surface of the rubber plug is provided with a groove or a convex ring at a corresponding position; the diaphragm and the rubber plug are fitted to each other through the convex ring and the groove.
  • outlet of the hollow passage of the upper needle is opened on the side wall of the needle tip of the upper needle; and/or the outlet of the hollow passage of the lower needle is opened on the side wall of the needle tip of the lower needle.
  • the upper needle is coated with an elastic shrink film; and/or; the lower needle is covered with an elastic shrink film.
  • a hard dual interface with a drug mixture comprising a mixing device, on the base of the mixing device, with an infusion channel on the other side of the mixing channel An interface is provided on the infusion channel.
  • an infusion soft bag comprising a drug mixture; or comprising the aforementioned hard dual interface; the drug mixture or the hard double interface is coupled to the soft bag through the base .
  • an infusion interface is provided, and the infusion interface is disposed on the infusion soft bag on the same side as the drug mixture, or on the infusion soft bag on the other side opposite to the drug mixture.
  • the infusion soft bag is a non-PVC multi-layer co-extruded film
  • the base, the mixing cup and the diaphragm are made of medical polypropylene material, preferably polypropylene R530C material;
  • cross pin, the limiting protrusion and the limiting structure are polypropylene materials, preferably polypropylene P17 material.
  • Figure 1 is a cross-sectional view of the susceptor and the mixing cup
  • Figure 2 is a top view of the rubber plug
  • Figure 3 is a cross-sectional view of the elastic card holder
  • Figure 4 is a cross pin
  • Figure 5 is a cross pin opened on the side of the through hole
  • Figure 6 is a perspective view of a cross pin opened on the side of the through hole
  • Figure 7 is a cross pin coated with an elastic stretchable film
  • Figure 8 is a cross pin compressed by a stretchable film
  • Figure 9 is a mixture of the elastic card holder and the cross pin
  • Figure 10 is an integrated structural view of a cross pin and an elastic card holder
  • Figure 11 is a structural view of a mixer equipped with an integrated elastic card holder
  • Figure 12 is a cross-sectional view of the mixing cup with the elastic jaws
  • Figure 13 is a mixer equipped with a cross pin
  • Figure 14 is a structural view of the vial after being loaded into the mixing device
  • Figure 15 is a mixer with easy folding handle
  • Figure 16 is an infusion soft bag with a drug mixture
  • Figure 17 is a reinforced structural mixing cup
  • Figure 18 is a reinforcing structural cover
  • Figure 19 is a cross pin with a card holder
  • Figure 20 shows the drug mixture after puncture.
  • a cross-sectional view of the susceptor 2 and the mixing cup 3 shown in FIG. 1 includes a susceptor 2, a mixing cup 3, a rubber stopper 6, a mixing passage 7, a diaphragm 8, and an infusion channel 11, and the mixing cup 3 is covered by a cup wall.
  • the 3-1 and the cup bottom 3-2 are configured; the above-mentioned mixer body structure composed of the susceptor 2, the mixing cup 3, the diaphragm 8 and the mixing passage 7 is integrally formed.
  • the rubber stopper 6 is placed in the mixing passage 7 above the diaphragm 8.
  • a cross pin 5 is further included, and the cross pin 5 is located in the mixing cup 3.
  • the structure of the cross pin 5 is as shown in FIG. 4-8, and the cross pin 5 includes a needle plate 5-1 and an upper needle 5-2. , the lower needle 5-3 and the needle tip 5-5, wherein the upper needle 5-2 and the lower needle 5-3 are integrally formed, and the needle plate 5-1 combines the upper needle 5-2 and the lower needle 5-3 into one body,
  • the heads of the needle 5-2 and the lower needle 5-3 are provided with a needle tip 5-5.
  • the structure of the upper needle 5-2 and the lower needle 5-3 of the cross pin 5 except for the structure of the needle tip 5-5 as shown in Fig.
  • the side hole 5-4 of the hollow passage of the upper needle 5-2 can be opened.
  • the side hole 5-4 of the hollow passage of the lower needle 5-3 is opened on the side wall of the needle tip of the lower needle 5-3 ( Not shown).
  • the arrangement is such that when the upper needle 5-2 and the lower needle 5-3 are puncture the rubber stopper 6 and the stopper, the edge of the side hole 5-4 directly cuts the plug to generate a large amount of debris.
  • the upper needle 5-2 is covered with an elastic shrink film, and after the puncture, the elastic shrink film is compressed and accumulated around the puncture hole, as shown in FIG. 8, thereby effectively preventing the liquid medicine along The gap of the puncture hole leaked out.
  • the lower needle 5-3 can also be coated with an elastic shrink film to solve the problem of leakage of the liquid along the puncture hole.
  • the mixing passage 7 extends upward through the base 2 and passes through the bottom 3-2 of the mixing cup 3.
  • the function of the diaphragm 8 is to isolate the direct contact between the liquid and the rubber plug 6, so that the complete sealing before use can theoretically Any position in the mixing passage 7 below the rubber stopper 6, but considering that if the position of the diaphragm 8 is too low, the lower needle 5-3 of the cross needle 5 is too long, it is preferable that the diaphragm 8 is located at the rubber stopper 6. Under And it is in close contact with the lower surface of the rubber stopper 6.
  • the rubber stopper 6 is placed in the mixing passage 7 above the diaphragm 8.
  • the function of the rubber stopper 6 is to ensure that after the lower needle 5-3 is punctured from the rubber stopper 6 and the diaphragm 8, the liquid medicine flows out from the gap between the diaphragm 8 and the outer wall of the lower needle 5-3, and does not ooze out the mixed medicine passage 7, That is, the outer diameter of the rubber stopper 6 is matched with the inner diameter of the mixing passage 7, so that the rubber stopper 6 is in close contact with the mixing passage 7.
  • the upper surface of the rubber stopper 6 is substantially flush with the upper surface of the cup bottom 3-2 or slightly higher than the upper surface, so that the lower surface of the elastic cartridge 4 as shown in FIG. 3 is pressed against the rubber stopper 6.
  • the diaphragm 8 is located under the rubber plug 6 and is in close contact with the lower surface of the rubber plug 6, as shown in FIG. 1, which can better prevent the liquid medicine from penetrating after the lower needle 5-3 pierces the diaphragm 8.
  • the rubber plug 6 shown in FIG. 2 is provided with a thin puncture zone 6-1 defined by the convex ring 6-2 or the groove 6-3 on the surface of the rubber plug 6, and the rubber plug 6
  • the convex ring 6-2 or the groove 6-3 is opposite to each other, and the corresponding position of the upper surface of the diaphragm 8 is also provided with a groove 6-3 or a convex ring 6-2.
  • the convex ring 6-2 or the groove 6-3 on the rubber plug 6 and the groove 6-3 or the convex ring 6-2 on the diaphragm 8 are fitted to each other, thereby achieving better prevention of leakage of the liquid.
  • the collar may be 6-3 and the groove is 6-2.
  • the rubber plug 6 and the diaphragm 8 are provided with the groove 6-3 or the convex ring 6-2 which are fitted to each other, and the needle plate 5-1 forms a pressing action on the rubber stopper 6, and can completely eliminate the liquid medicine after the mixing. leakage.
  • a circular ring protrusion is provided around the lower surface of the needle plate 5-1 around the root of the lower needle 5-3, and the needle plate 5 is mounted in the mixing cup after the needle holder 5 is mounted in the mixing cup.
  • the annular protrusion of -1 forms a relatively strong pressing action on the rubber plug, resulting in a better seal.
  • the infusion channel 11 shown in FIG. 1 can be integrally formed with the above-mentioned mixer body structure, and is arranged side by side with the drug mixture on the base 2, as shown in FIG. It is also possible to use an additional infusion port when making a soft bag. For example, it can be separately welded to the infusion soft bag 1 by another base 2, and disposed on the same side of the infusion soft bag 1 and the opposite side of the mixed drug, or other parts of the infusion soft bag 1, for the field. For the technician, it is an obvious setting.
  • the hybrid device further includes an elastic card holder 4, preferably a separate elastic card holder 4 as shown in FIG. 3, and the cross pin 5 is placed between the elastic claw 4-1 and the bottom plate 4-5, and the specific structure is as shown in FIG.
  • the elastic card The seat 4 includes a snap ring 4-6, and the lower side of the snap ring 4-6 is provided with an elastic claw 4-1, and the upper end of the elastic claw 4-1 is evenly arranged and fixed along the snap ring 4-6, and the elastic claw 4-
  • the lower end of the 1 is a free end, and the elastic claw 4-1 is inclined from the fixed upper end to the free end toward the center of the mixing cup 3.
  • the elastic card holder 4 has an integrally formed bottom plate 4-5, a support column 4-4, a snap ring 4-6 and an elastic claw 4-1.
  • the bottom plate 4-5 is provided with a support column 4-4 to the snap ring 4-6. The support is fixed.
  • the bottom plate 4-5 is provided with a center hole 4-3 through which the lower needle 5-3 passes to thereby position the cross pin.
  • a ring-shaped annular protrusion 4-2 is disposed around the center hole 4-3, and the area defined by the annular protrusion 4-2 completely overlaps with the center hole 4-3, and is disposed coaxially with the mixing channel 7; the bottom plate 4-5 passes the The annular projection 4-2 abuts against the cup bottom 3-2.
  • the needle 5-1 is mounted below the elastic jaws 4-1 in the mixing cup 3, above the bottom plate 4-5.
  • the cross pin 5 includes an integrally formed hollow upper needle 5-2 and a lower needle 5-3, and a needle plate 5-1 in which the upper needle 5-2 and the lower needle 5-3 are integrated, the upper needle 5-2,
  • the lower needle 5-3 is provided with a needle tip 5-5.
  • the mixing cup 3 and the base 2 are integrally formed, and the elastic card holder 4 is placed in the mixing cup 3.
  • the cross pin 5 is snapped into the elastic card holder 4.
  • a limited structure (not shown) is provided on the wall of the cup, and the cross pin 5 with the cartridge is installed in the mixing cup 3 and is limited by the stopper structure, in particular, the lower needle 5-3 completes the rubber stopper 6 and the diaphragm. After the puncture of 8, the cross pin is completely limited by the limit structure.
  • the elastic card holder 4 After the elastic card holder 4 is placed in the mixing cup 3, it is restrained by a limiting structure (not shown) provided on the inner wall of the cup wall 3-1, so that the elastic card holder 4 is placed after being placed Will not slip out of the mixing cup 3. In addition, the position of the elastic card holder 4 is restricted so that the bottom of the elastic card holder 4 can contact the cup bottom 3-2 of the mixing cup 3. In the arrangement of the preferred rubber plug 6, the annular projection 4-2 at the bottom of the elastic cartridge 4 can form a compression of the rubber stopper 6.
  • the cross pin 5 installed in the elastic card holder 4, the needle plate 5-1 of the cross pin 5 is located between the elastic claw 4-1 and the bottom plate 4-5. After the setting is completed, the lower needle 5-3 does not pierce the glue. Plug 6.
  • the lower needle 5-3 partially penetrates the rubber stopper 6 before use, or the rubber stopper 6 is completely pierced as shown in Fig. 9, or more preferably the rubber stopper 6 is preset at the center.
  • One small hole forms the annular rubber plug 6, and the lower needle 5-3 pierces the rubber stopper 6 through the small hole, which is a feasible solution.
  • the diameter of the center hole of the rubber plug 6 is smaller than that of the lower needle 5-3, so that the lower needle 5-3 is inserted into the small hole in the rubber plug 6 and passes through the rubber stopper 6, and the lower needle 5- 3 pairs of rubber plugs 6 will not form a cutting action, thereby effectively avoiding the contamination caused by the formation of micro-chips by the lower needles 5-3 when the rubber plugs 6 are punctured.
  • the rubber stopper 6 can still abut the lower needle 5-3 to avoid leakage.
  • the cross pin 5 is only placed in the mixing cup 3, and does not form a puncture of the diaphragm 8.
  • the rubber plug 6 can be puncture or partial puncture, or completely puncture, as long as it is not correct. Penetration of the septum 8 does not affect the use of the drug mixture.
  • the upper needle 5-2 and the lower needle 5-3 of the cross needle 5 respectively puncture the stoppers of the rubber stopper 6, the diaphragm 8, and the vial 9, and the cross needle 5 is completely restricted by the inner wall of the mixing cup 3.
  • the protrusion, that is, the elastic claw 4-1, is restricted, and the neck of the vial 9 is caught by the elastic claw 4-1 and cannot be withdrawn.
  • the vial 9 is inserted into the mixing cup 3, and the cap of the vial 9 is pressed into the elastic holder 4, so that the free end of the elastic jaw 4-1 is located in Xilin.
  • the bottle neck of the bottle 9 is stuck at the neck of the bottle, so that the jam of the vial 9 cannot be withdrawn from the mixing cup 3.
  • the cap of the vial 9 is pierced by the upper needle 5-2, and the cap pushes down the needle plate 5-1, thereby pushing the lower needle 5-3 to pierce the rubber stopper 6, and then piercing the diaphragm 8, so that the mixing
  • the drug channel 7 is in communication with the vial 9 via the cross pin 5.
  • the inner diameter of the snap ring 4-6 of the elastic card holder 4 is substantially the same as the outer diameter of the vial 9 or slightly larger than the outer diameter of the vial 9.
  • the thickness of the cap of the vial 9 should be substantially the same as the distance between the free end of the elastic jaw 4-1 and the bottom plate 4-5, so that The vial 9 is just caught between the free end of the elastic jaw 4-1 and the bottom plate 4-5 by the cap and cannot move up and down.
  • the distance between the free end of the elastic claw 4-1 to the bottom plate 4-5 is slightly larger than the thickness of the cap, and does not significantly affect the docking of the vial 9. And fixed.
  • the elastic card holder 4 and the mixing cup 3 as shown in FIG. 9, a preferred solution is that the upper surface of the rubber plug 6 is substantially flush with the upper surface of the cup bottom 3-2 or slightly higher than the upper surface.
  • the lower surface of the elastic cartridge 4 as shown in FIG. 3 can form a pressing action on the upper surface of the rubber stopper 6.
  • the elastic card holder 4 shown in FIG. 3 is placed in the mixing cup 3, and the cross pin 5 shown in FIGS. 4 to 8 is placed in the elastic card holder 4, thereby forming a mixing device as shown in FIG.
  • the cover 12 is placed at the cup mouth of the mixing cup 3, and then the sealing film 13 is covered to seal the mixed cup 3.
  • the mixer is combined with the infusion channel 11 disposed side by side on the base 2 to form a hard dual interface.
  • the mixing device and the infusion soft bag 1 are joined together by welding to form an infusion soft bag 1 with a drug mixture, as shown in FIG.
  • the drug mixture is connected to the infusion soft bag 1 through the base 2.
  • the infusion channel 11 can be arranged side by side with the mixer on the base 2, as shown in FIG.
  • the infusion channel 11 can also be separately welded to the infusion soft bag 1 through another base 2, and disposed on the same side of the infusion soft bag 1 and the opposite side of the drug mixture, or other parts of the infusion soft bag 1, for It will be obvious to those skilled in the art that the settings are obvious.
  • the sealed mixed cup 3 generally adopts an easy tear film, and is preferably a pp easy tear film, preferably a pp easy tear film with a certain gas permeability.
  • the easy-to-peel film is directly pressed into the mouth of the cup of the mixing cup, and the tear-off film can be directly peeled off during use.
  • the infusion soft bag 1 Since the infusion soft bag 1 is filled, it is sealed and then subjected to high temperature sterilization. If the mixed cup 3 is not sealed, the infusion soft bag 1 with the drug mixture after sterilization is still exposed to the external environment due to the puncture cross pin 5 in the mixing cup 3, which is inevitable when transported. It will be polluted and its sterility is still not guaranteed.
  • the sealed mixing cup 3 after sealing is a cup body of a mixed medicine cup 3 composed of a medical polymer material in a high temperature and high pressure environment, and an easy tear film material for sealing the mixed medicine cup 3, Softening and shrinking; there is a large pressure difference between the inside and the outside of the closed cup 3. Under the action of high pressure, the mixed cup 3 and the easy tear film will be deformed. After cooling, the cup 3 will be easily torn. The membrane is completely crushed, destroying the structure of the mixer and causing the mixer to be completely unusable.
  • the bead 33-1 to the cup wall 3-1 of the mixing cup 3, preferably in the lower half of the cup wall 3-1, as shown in FIG.
  • the reinforcing ribs 3-3 may be vertical strips integrally formed with the mixing cup 3, or horizontal strips, or criss-crossed web structures, which are uniformly distributed on the inner side and/or the outer side of the cup wall 3-1. Preference is given to a vertical strip-like structure uniformly distributed along the lower half of the inner side of the cup wall 3-1; more preferably the raised vertical strip extends from the lower inner half of the cup wall 3-1 to the bottom 3-2, most preferably It is the continuous increase of the thickness of the vertical protrusion from the top to the bottom.
  • the provision of the reinforcing ribs 3-3 on the cup wall 3-1 can basically solve the problem that the mixed medicine cup 3 is not deformed by pressing during the sterilization process, but there is also a sealing film 13 for sealing the mixed medicine cup 3 which is compressed and deformed during sterilization. The problem.
  • a cover plate 12 as shown in FIG. 18 is further disposed at the 3 cups of the mixing cup, and the sealing film 13 covers the cover plate 12, so that the cover plate 12 forms an effective support for the sealing film 13 to prevent sealing.
  • the film 13 is compressively deformed upon sterilization.
  • a stepped inner edge is provided along the cup wall 3-1 at the cup opening, and the cover plate 12 rests on the stepped inner edge such that the upper surface of the cover plate 12 disposed at the cup opening is flush with or slightly lower than the cup opening
  • the cup mouth does not affect the sealing process of the sealing film 13 by hot pressing on the upper end surface of the cup wall 3-1.
  • a preferred cover 12 is disposed coaxially with the cross pin 5, and the tip 5-5 of the upper needle 5-2 is centered on the cover 12.
  • the shape of the cover plate 12 is designed to be a polygonal shape with a hole in the middle.
  • the preferred design can balance the air pressure inside and outside the mixing cup 3 more quickly, thereby In the wet heat sterilization process, the performance is even better - the sealing film 13 is flat as before, and the mixed cup 3 is not deformed at all. This is because the polygonal and intermediate perforated cover plate 12 can increase the gas exchange speed under the cover plate 12 and the upper portion of the cover plate 12, and the air pressure in the mixing cup 3 can be made faster. Balance, let the balance of the mixing cup 3 inside and outside.
  • the infusion can be traced back, because the vial 9 is docked and fixed to the mixing cup 3, and after being caught by the elastic claw 4-1, the vial 9 cannot be removed non-destructively. That is to say, from the dispensing, to the completion of the infusion, to the recycling process, it can be traced back to what kind of medicine is added and injected.
  • the above-mentioned drug mixture may still have some inconvenience, because the medicine filled in the vial 9 must be brought to the ward, and then the vial 9 docked with the drug mixture, and then used in the ward immediately.
  • an easy folding handle 10 is added, as shown in FIG.
  • An easy-folding handle 10 is arranged at the lower end of the mixing channel 7, and as shown in FIG. 15, the vial 9 is docked and punctured with the elastic card holder 4 in the mixing cup 3, and then taken to the pharmacy, and cut off before the infusion. Easy to fold the handle 10, open the mixed drug channel 7, you can complete the on-site dispensing, on-site use.
  • the base 2 in order to prevent the hybrid device, the infusion channel 11 or the hard dual interface with the drug mixture and the infusion channel 11 from being welded on the soft bag, the base 2 is stored, transported and used. Damage to the infusion soft bag 1 caused by the welded portion, the base 2 is designed as a dumbbell or a boat, as shown by the base 2 in FIG. 1, and the lower end of the mixed passage 7 and the infusion passage 11 is flat with the lower end of the base 2. Qi.
  • the welding pattern is uniformly distributed on the side walls of the base 2, so that the welding of the infusion soft bag 1 can be well ensured, and the base 2 can be excellent with the infusion soft bag 1 even at a lower temperature. Fusion welding.
  • the boat-shaped or dumbbell-shaped base 2 has a streamlined shape, which improves the mechanical properties of the welding, and has no sharp angle, so that the combination of the hard double interface and the infusion soft bag 1 is smoother and the soft bag is not easily damaged.
  • the infusion soft bag 1 is a commonly used non-PVC multilayer co-extruded film, including a three-layer, five-layer multi-layer co-extruded film.
  • the drug mixture is made of a medical polypropylene material which is compatible with the infusion soft bag 1 non-PVC material, the base 2, the mixing cup 3, the cover plate 12 is preferably a polypropylene R530C material; and the cross Needle 5.
  • the card body in view of its puncture and mechanical properties, is preferably a P17 material in the pp material system.
  • the cross pin 5, the limiting protrusion and the limiting structure are polypropylene materials, preferably polypropylene P17 material
  • the terminal is sterilized after the seal is welded to the soft bag.
  • all pharmaceutical packaging must be terminally sterilized before injection, or an injection sterility assurance process.
  • Terminal sterilization process On the basis of controlling the amount of microbial contamination, after the drug is potted, it is sterilized by moist heat sterilization. In general, the method is low in cost and high in sterility assurance, and is suitable for sterilization of large-volume injections and small-volume injections.
  • Aseptic production process In the aseptic system environment, through the sterilization filtration method or the aseptic operation method, in order to prevent pollution, various possibilities of pollution are eliminated to ensure the sterility level. In general, the sterility assurance level is lower than the terminal sterilization process due to the high requirements of the method for the environmental system and the factors affecting the aseptic operation.
  • the aseptic production process is generally suitable for powder injections, and can also be suitable for small-volume injections that are clinically necessary but cannot be terminally sterilized. Thus, the terminal sterilization process and the aseptic production process have different system requirements, different sterilization methods and different sterility assurance results.
  • the drug mixture and the infusion soft bag 1 are all selected polypropylene materials capable of withstanding high temperatures of 120 degrees Celsius, the mechanical properties of the drug mixture in a sealed state at such a high temperature are lowered, and it is very easy to be 0.15.
  • the deformation of the pressure of MPa is deformed; and the sealing film 13 is deformed and wrinkled at this temperature and pressure, and the sealing effect is lost.
  • a reinforcement is provided in the lower half of the cup.
  • Tendon 3-3 The setting of the rib 3-3 is performed on the cup wall 3-1 of the mixing cup 3, preferably in the lower half of the cup wall 3-1.
  • the reinforcing ribs 3-3 may be vertical strips integrally formed with the mixing cup 3, or horizontal strips, or criss-crossed web structures, which are uniformly distributed on the inner side and/or the outer side of the cup wall 3-1. Preference is given to a vertical strip-like structure uniformly distributed along the lower half of the inner side of the cup wall 3-1; more preferably the raised vertical strip extends from the lower inner half of the cup wall 3-1 to the bottom 3-2, most preferably It is the continuous increase of the thickness of the vertical protrusion from the top to the bottom.
  • the mixing cup 3 provided with the reinforcing ribs 3-3 improves the mechanical pressure resistance of the cup to a considerable extent.
  • the mixing cup 3 of the reinforcing rib 3-3 was not provided, and after the wet heat sterilization process, the round mixed cup body was compressed into a square shape and could not be used at all.
  • the round mixed cup body After the rib 3-3 is set, after the wet heat sterilization process, the round mixed cup body has a slight compression, which basically does not affect the normal use function.
  • the sealing film 13 is only a very thin and easy-to-peel film, which serves to seal the mixed cup 3 and facilitate tearing when used.
  • the sealing film 13 is weaker than the cup of the mixing cup 3 because the sealing film 13 itself is only a film of a micron order thickness and cannot withstand a pressure of 0.15 MPa in the wet heat sterilization process.
  • a cover plate 12 as shown in FIG. 13 was attached under the sealing film 13, and the sealing film 13 covered the cover plate 12, so that the cover plate 12 formed an effective support for the sealing film 13.
  • the sealing film 13 is prevented from being compressed and deformed upon sterilization.
  • the cover 12 is placed on the stepped inner edge of the cup of the mixing cup, so that the upper surface of the cover 12 disposed at the mouth of the cup is flush with or slightly lower than the mouth of the cup, and the cover 12 is It is provided that the sealing process of the sealing film 13 on the upper end surface of the cup wall 3-1 is not affected.
  • the shape of the preferred cover plate 12 is polygonal in cross section, such as a pentagon, a hexagon, an octagon, and ten. Two variants.
  • the advantage of the polygonal cover 12 on the one hand is that it is easier to remove when used; and another unexpected effect of the cover 12 being polygonal is mentioned below.
  • the cover 12 is coaxial with the cross pin 5. It is provided that the tip 5-5 of the upper needle 5-2 faces the center of the cover 12 and supports the cover 12. More preferably, the cover 12 is centrally provided with a through hole 12-1. The inner diameter of the through hole 12-1 is smaller than the outer diameter of the upper needle 5-2, and the needle tip 5-5 of the upper needle 5-2 is located at the through hole 12. -1 but not through the through hole 12-1, that is, the needle tip 5-5 of the upper needle 5-2 is inserted into the through hole 12-1 of the cover 12, so that the support effect of the upper needle 5-2 on the cover 12 More significant.
  • the cover 12 is also reinforced, as shown in FIG.
  • the cover stiffener 12-2 which is radially and annularly disposed, enhances the mechanical strength of the cover 12.
  • the pressure-welding and sealing film 13 at the upper end of the cup mouth is tightly applied to the upper surface of the cover plate 12, so that the sealing film 13 does not need to be subjected to high pressure substantially, and the phenomenon of deformation and wrinkles of the sealing film 13 is greatly alleviated.
  • a thin metal film is plated on the surface of the sealing film 13, which can effectively alleviate the problem of wrinkles of the sealing film 13.
  • the sealed drug mixture thus set can basically be used normally even after being subjected to the high temperature and high pressure of the moist heat sterilization process, however, the shape of the product is still difficult to maintain in a good state, from the viewpoint of the infusion product. , still a product that is not qualified.
  • the function can only be guaranteed.
  • it is also necessary to solve the problem from the root - the sealed mixture cup 3 is in the wet heat method. The internal and external air pressure balance of bacteria.
  • the liquid-filled sealed mixing cup 3 is rapidly vaporized at a high temperature when the terminal is sterilized with the infusion soft bag 1, so that the pressure inside and outside the cup can be quickly balanced.
  • pre-fill liquid a liquid having a small heat capacity and a high saturated vapor pressure is preferred.
  • it is preferred to pre-fill liquid It is water.
  • PV nRT, where P is the internal and external pressure difference during wet heat sterilization, V is the volume of the mixing cup 3, n is the number of moles of prefilled liquid/water, R is the gas constant, and T is the absolute time during the wet heat sterilization temperature.
  • V 0 n * M / ⁇ , where M is the molar mass of liquid / water and ⁇ is the density of liquid / water.
  • the internal and external air pressure of the sealed mixture at the time of terminal sterilization can be well balanced.
  • the above method can solve the problem of air pressure balance, and then in practical use, there are still certain problems, most typically, the finished product infusion soft bag 1 is sterilized, and water droplets or liquid are present in the mixing cup 3 after cooling. It is very influential, and such products are often not accepted by hospitals and patients.
  • a more preferable solution is that we have specially studied a sealing film 13 having a certain gas permeability based on the pp material system, and ensuring that a sufficient gas can be passed through the gas permeable sealing film 13 and the outside after the liquid is vaporized. Exchange, so that after the sterilization is completed, there is no residual liquid in the mixing cup 3.
  • the gas permeability of the gas permeable sealing film 13 is most preferably 5% to 35% of the air permeability after a long period of time.
  • the cross pin 5 with the card holder is placed in the mixing cup 3, and the mixed medicine cup 3 is sealed.
  • the sealing film 13 is generally used for sealing, or the sealing film is easy to tear.
  • 3 cups of the mixing cup are sealed by pressure welding; or a cover 12 is placed on the cup mouth, and then sealed with a sealing film 13 thereon, and the sealed mixing cup 3 is welded to the infusion soft bag.
  • an infusion soft bag 1 with a drug mixture is formed, as shown in FIG. After terminal sterilization, it can be used by medical personnel.
  • the limit directly fixed to the inner wall of the mixing cup 3 is adopted.
  • a protrusion is used instead of the elastic card holder 4 in Embodiment 1.
  • a limiting protrusion (not shown) is disposed on the inner wall of the cup wall 3-1, and the cross pin 5 with the card seat is installed in the mixing cup 3 to be restrained by the limiting protrusion, in particular, as shown in FIG. After the lower needle 5-3 completes the puncture of the rubber stopper 6 and the diaphragm 8, the cross needle 5 is completely restricted by the restriction projection.
  • the limiting projection is preferably an elastic claw 4-1; more preferably, the elastic claw 4-1 as a limiting projection is integrally formed with the mixing cup 3.
  • the upper end of the elastic claw 4-1 is evenly arranged and fixed along the inner wall periphery of the cup wall 3-1, the lower end of the elastic claw 4-1 is a free end, and the elastic claws 4-14 are mixed from the fixed upper end to the free end.
  • the tilting structure of the center of the medicine cup 3 is as shown in FIG.
  • the limiting protrusion limits the needle plate 5-1 of the cross pin 5 to the limiting protrusion. Can not be taken out between the cup bottom 3-2.
  • Fig. 13 shows a state in which the cross pin 5 has pierced the rubber stopper 6 without piercing the diaphragm 8.
  • the cross pin 5 and the elastic card holder 4 are directly fixed, preferably.
  • the cross pin 5 is integrally formed with the elastic card holder 4.
  • the elastic card holder 4 includes a snap ring 4-6.
  • the lower side of the snap ring 4-6 is provided with an elastic claw 4-1, and the upper end of the elastic claw 4-1 is along the snap ring.
  • 4-6 is evenly arranged and fixed, the lower end of the elastic claw 4-1 is a free end, and the elastic claw 4-1 is inclined from the fixed upper end to the free end toward the center of the mixing cup 3.
  • the elastic card holder 4 has an integrally formed bottom plate 4-5, a support column 4-4, a snap ring 4-6 and an elastic claw 4-1.
  • the bottom plate 4-5 is provided with a support column 4-4 to the snap ring 4-6. The support is fixed.
  • a ring-shaped annular protrusion 4-2 is provided at the root of the lower needle 5-3.
  • the annular protrusion 4-2 on the elastic card holder 4 can form a squeeze on the rubber plug 6. Pressure effect.
  • the elastic cartridge 4 Prior to use, the elastic cartridge 4 is mounted in the mixing cup 3 and is restrained by the cup wall 3-1 when it is pushed to the bottom 3-2 of the cup. As shown in Fig. 11, when the elastic card holder 4 with the cross pin 5 is pushed to the cup bottom 3-2, the lower needle 5-3 forms a puncture for both the rubber stopper 6 and the diaphragm 8. of course,
  • a support post 4-3, a snap ring 4-6, and an elastic claw 4-1 are integrally formed on the needle plate 5-1, and the support post 4-3 is disposed on the needle plate 5- 1 The outer circumference is supported and fixed to the snap ring 4-6.
  • the upper end of the elastic claw 4-1 is evenly arranged and fixed along the snap ring, the lower end of the elastic claw is a free end, and the elastic claw 4-1 is inclined from the fixed upper end to the free lower end toward the center of the mixing cup.
  • a limiting protrusion is disposed on an inner wall of the cup wall, and after the cross needle is installed into the mixing cup, the limiting protrusion defines the needle board between the limiting protrusion and the bottom of the cup and cannot be take out.
  • the limiting projection here is preferably an elastic jaw.
  • the cross pin 5 with the card holder is placed in the mixing cup 3, as shown in Fig. 20, the cross pin 5 with the card seat placed in the mixing cup 3 is pushed to the cup bottom 3-2, thereby The plug 6 and the septum 8 complete the puncture.

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Abstract

一种混药器、硬双接口及输液软袋，包括一体成型的基座（2）、混药通道（7）和混药杯（3），十字针（5），混药杯（3）由杯壁（3-1）和杯底（3-2）构成；十字针（5）由一体成型的针板（5-1）以及具备中空通道的上针（5-2）和下针（5-3）构成，上针（5-2）和下针（5-3）的中空通道彼此连通；混药通道（7）下端穿过基座（2），上端穿过杯底（3-2），在基座（2）与杯底（3-2）之间的混药通道（7）内设有隔膜（8），在隔膜（8）和杯底（3-2）之间的混药通道（7）内设有胶塞（6）；杯壁（3-1）的内壁上设置有限位突起，十字针（5）安装进混药杯（3）后，限位突起将针板（5-1）限定在限位突起和杯底（3-2）之间而不能被取出；杯底（3-2）上表面与隔膜（8）下表面之间的距离小于下针（5-3）的长度；混药器还包括密封膜（13），密封膜（13）以压焊的方式连接在混药杯（3）的杯口，对混药杯（3）形成密封；密封膜（13）是经湿热法终端灭菌后依然保持基本平整的易撕膜。

Description

混药器、硬双接口及输液软袋 技术领域
本发明涉及一种混药器，特别涉及一种带混药杯的混药器、硬双接口和输液软袋。
背景技术
在使用西林瓶盛装粉针剂、冻干粉针剂或水针剂时，需要通过注射器将输液软袋中的药水或注射用水抽出注入西林瓶内，重复上述工作，直到西林瓶内有足够的药液；然后再将西林瓶反复摇动直到瓶内的药剂混合均匀，再用注射器将西林瓶内药液抽出注入输液软袋中，如此反复，直到瓶内的药液被抽完为止。
首先，上述的混药操作过程比较费时、费力、费耗材如注射器，更为严重的是，在上述混药过程中，非常容易将外面的空气注入到西林瓶以及输液软袋中，一般条件下空气中存在非常多的各种尘埃、病菌，混入注射药液后再进入人体，会带来非常严重的医疗事故。
其次，传统的配液方式，是先配药再注射，事先将西林瓶中的药抽吸至输液软袋中，再将配好药的输液软袋带至病房给患者输液。在配完药后，空置的西林瓶被放置一边，患者保护医护人员完全不知道输液软袋中所配的是什么药，不具备可追溯性。一旦医护人员在配液时稍不注意出现差错，将药液配错用错，后果将不堪设想。
再次，对于一些特殊的药物，譬如需要即配即用的药物，传统的配药方式非常不便，而且在本专利之前披露的各种混药器结构，并未能很好的解决该问题。
最后，在本专利之前披露的各种混药器结构，一直未能解决混药之后药液渗漏的问题。
出于对更高的医疗服务水平的需要，迫切需要一种使用便捷、安全、可靠、无安全隐患的输液产品。
另外，混药器焊接在输液软袋上，在输液软袋灌装完毕后，需要对输液软袋整体进行高温灭菌，高温灭菌环境一般是115-121摄氏度的高温，灭菌时间30-15分钟，灭菌压力是0.15MPa。虽然混药器以及输液软袋所用的材料聚丙烯能够经受住120摄氏度的温度，但是不可避免的会软化，再加上0.15MPa的高压，相当于每平方厘米承受了150N的压力——这对于处于密封状态的混药杯而言，是致命的。首选，混药杯和密封膜在120摄氏度的温度下，机械强度会有所降低；其次，每平方厘米150N的压力，会直接导致混药杯的杯体变形、密封膜被拉伸，出现褶皱，密封性被破坏，导致混药杯结构完全被损坏而无法使用。
在本发明之前，密封混药杯结构的混药器，其终端灭菌，是个难以克服的障碍；而混药杯不密封，又不能保证满足使用时的无菌要求，不论是从政策法规还是从实际安全角度考虑，输液软袋的终端灭菌，都是必须而且是十分必要的。
发明内容
本发明的目的是提出一种使用便捷可靠且无安全隐患的输液软袋及与之相关的混药器、接口。
根据本发明实施例的一个方面，提供一种混药器，包括基座、混药通道、混药通道内的隔膜和混药杯，基座、混药通道、混药通道内的隔膜和混药杯一体成型；混药杯由杯壁和杯底构成；还包括十字针，十字针位于混药杯内，十字针由一体成型的针板以及具备中空通道的上针和下针构成，上针和下针的中空通道彼此连通；在针板上还一体成型的设置有支撑柱、卡环和弹性卡爪，其中，支撑柱设置在针板外周以对卡环形成支撑固定；弹性卡爪设置在 卡环下侧且弹性卡爪的上端沿卡环均匀布置且固定，弹性卡爪下端为自由端，弹性卡爪从固定的上端到自由端呈向混药杯中心倾斜结构；混药通道下端穿过基座，上端穿过杯底；在隔膜和杯底之间的混药通道内设有胶塞；混药器还包括密封膜，密封膜以压焊的方式连接在混药杯的杯口，对混药杯形成密封；密封膜是经湿热法终端灭菌后依然保持基本平整的易撕膜。
进一步，杯壁的内壁上设置有限位突起，十字针安装进混药杯后，限位突起将针板限定在限位突起和杯底之间而不能被取出。
根据本发明实施例的另一个方面，还提供一种混药器，包括一体成型的基座、混药通道和混药杯，十字针，混药杯由杯壁和杯底构成；十字针由一体成型的针板以及具备中空通道的上针和下针构成，上针和下针的中空通道彼此连通；混药通道下端穿过基座，上端穿过杯底，在基座与杯底之间的混药通道内设有隔膜，在隔膜和杯底之间的混药通道内设有胶塞；杯壁的内壁上设置有限位突起，十字针安装进混药杯后，限位突起将针板限定在限位突起和杯底之间而不能被取出；杯底上表面与隔膜下表面之间的距离小于下针的长度；混药器还包括密封膜，密封膜以压焊的方式连接在混药杯的杯口，对混药杯形成密封；密封膜是经湿热法终端灭菌后依然保持基本平整的易撕膜。
进一步，限位突起为弹性卡爪，弹性卡爪上端沿杯壁的内壁周沿均匀布置且固定，弹性卡爪下端为自由端，且弹性卡爪从固定的上端到自由端呈向混药杯中心倾斜结构；针板位于下端和杯底之间。
根据本发明实施例的另一个方面，还提供一种混药器，包括一体成型的基座、混药通道和混药杯，十字针，混药杯由杯壁和杯底构成，十字针由一体成型的针板以及具备中空通道的上针和下针构成，上针和下针的中空通道彼此连通；混药通道下端穿过基座，上端穿过杯底，在基座与杯底之间的混药通道内设有隔膜，在隔膜和杯底之间的混药通道内设有胶塞；还包括弹性卡座，弹性卡座包括一卡环，卡环下侧设置有弹性卡爪，弹性卡爪上端沿卡环均匀布置且固定，弹性卡爪下端为自由端，且弹性卡爪从固定的上端到自 由端呈向混药杯中心倾斜结构；针板安装于混药杯内的弹性卡爪之下；杯壁的内壁上设置有限位结构，弹性卡座安装于混药杯内而被限位结构限制；杯底上表面与隔膜下表面之间的距离小于下针的长度；混药器还包括密封膜，密封膜以压焊的方式连接在混药杯的杯口，对混药杯形成密封；密封膜是经湿热法终端灭菌后依然保持基本平整的易撕膜。
进一步，弹性卡座具有一体成型的底板、支撑柱、卡环和弹性卡爪，底板外周设置有支撑柱对卡环形成支撑固定；底板设有中心孔，下针穿过中心孔从而对十字针形成定位；针板位于底板和弹性卡爪之间。
进一步，底板下表面的中心区域设置有一环形突起，环形突起限定的区域与中心孔完全重叠，且与混药通道同轴设置；底板通过环形突起贴紧杯底。
进一步，胶塞的中心区域设有穿刺区，穿刺区比边缘区薄；针板下表面的中心区域设置有一环形突起，穿刺区与环形突起限定的区域重合或位于环形突起限定的区域内。
根据本发明实施例的又一方面，还提供一种具有加强结构的混药器，包括混药器；混药杯的杯壁上，设置有加强筋结构以增强杯壁的抗压强度；加强筋设置在杯壁内侧沿上下方向和/或水平方向一体布置。
进一步，还包括一盖板，盖板位于杯口内，且被密封膜覆盖。
进一步，杯口处沿杯壁设有台阶状内沿，盖板搁置在内沿上；盖板上表面与杯口平齐或略低于杯口；
密封膜热压在杯壁上端表面，从而对杯口形成密封。
进一步，盖板呈多边形，且中心设有一孔，上针的针尖位于孔内但不穿过孔。
进一步，密封膜是透气性易撕膜；密封膜的透气率是5％到35％；
进一步，密封膜上表面镀有金属膜层。
进一步，混药杯在被密封膜密封之前，预装一定量的液体，用于使混药杯内、外气压达到基本平衡；液体是能在湿热法灭菌环境下迅速汽化的液体。
进一步，混药通道下端，设置有易折柄，并通过易折柄对混药通道的下 端进行密封。
进一步，隔膜上表面设置有凸环或凹槽，胶塞下表面对应位置设置有凹槽或凸环；隔膜与胶塞通过凸环与凹槽彼此嵌合。
进一步，上针的中空通道的出口，开设在上针的针尖侧壁上；和/或；下针的中空通道的出口，开设在下针的针尖侧壁上。
进一步，上针包覆有一层弹性收缩膜；和/或；下针包覆有一层弹性收缩膜。
根据本发明实施例的又一方面，还提供一种带混药器的硬双接口，包括混药器，在混药器的基座上相对于混药通道的另一侧，设有一输液通道；输液通道上设置有接口。
根据本发明实施例的又一方面，还提供一种输液软袋，输液软袋包括混药器；或者包括前述的硬双接口；混药器或硬双接口通过基座与软袋接合在一起。
进一步，还包括一输液接口，输液接口设置在与混药器同侧的输液软袋上，或者设置在与混药器相对的另一侧的输液软袋上。
进一步，输液软袋采用的是非PVC多层共挤膜；
进一步，基座、混药杯及隔膜采用的是医用聚丙烯材料，优选的是聚丙烯R530C材料；
进一步，十字针、限位突起和限位结构为聚丙烯材料，优选的是聚丙烯P17材料。
附图说明
图1为基座及混药杯截面图；
图2为胶塞顶视图；
图3为弹性卡座截面图；
图4为十字针；
图5为通孔侧开的十字针；
图6为通孔侧开的十字针立体图；
图7为包覆有弹性可伸缩膜的十字针；
图8为可伸缩膜压缩后的十字针；
图9为安装弹性卡座及十字针后的混药器；
图10为十字针与弹性卡座一体化结构图；
图11为安装有一体化弹性卡座的混药器结构图；
图12为内设弹性卡爪的混药杯截面图；
图13为安装有十字针的混药器；
图14为西林瓶装进混药器后的结构图；
图15为带易折柄的混药器
图16为带混药器的输液软袋；
图17为加强结构混药杯；
图18为加强结构盖板；
图19为带卡座的十字针；
图20为穿刺后的混药器。
附图标记说明：
1.输液软袋，2.基座,3.混药杯，3-1.杯壁,3-2.杯底，3-3.加强筋,4.弹性卡座，4-1.弹性卡爪，4-2.环形突起，4-3.中心孔，4-4.支撑柱，4-5.底板，4-6.卡环，5.十字针，5-1.针板，5-2.上针，5-3.下针，5-4.侧孔，5-5.针尖、6.胶塞，6-1.穿刺区，6-2.凸环，6-3.凹槽，7.混药通道，8.隔膜，9.西林瓶，10.易折柄，11.输液通道，12.盖板，12-1.通孔，12-2.盖板加强筋，13.密封膜。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明了，下面结合具体实施方式并参照附图，对本发明进一步详细说明。应该理解，这些描述只是示例性的，而并非要限制本发明的范围。此外，在以下说明中，省略了对公知结 构和技术的描述，以避免不必要地混淆本发明的概念。
第一实施例
下面，结合说明书附图，对本发明进行进一步的说明。
如图1所示的基座2及混药杯3截面图，包括基座2、混药杯3、胶塞6、混药通道7、隔膜8和输液通道11，混药杯3由杯壁3-1和杯底3-2构成；上述由基座2、混药杯3、隔膜8及混药通道7构成的混药器本体结构以一体成型的方式形成。
胶塞6安放于混药通道7中，位于隔膜8之上。
如图11所示，还包括十字针5，十字针5位于混药杯3内，十字针5的结构如图4-8所示，十字针5包括针板5-1、上针5-2、下针5-3和针尖5-5，其中，上针5-2和下针5-3一体成型，针板5-1将上针5-2和下针5-3结合为一体，上针5-2和下针5-3的头部设置有针尖5-5。对于十字针5的上针5-2和下针5-3的结构，除去如图5所示的针尖5-5结构外，上针5-2的中空通道的侧孔5-4，可以开设在上针5-2的针尖侧壁上，如图5、6所示；同样的，下针5-3的中空通道的侧孔5-4，开设在下针5-3的针尖侧壁上(未示出)。如此设置，是为了避免上针5-2、下针5-3在穿刺胶塞6、瓶塞时，侧孔5-4的边缘对塞子形成直接切割而产生大量的碎屑。通过将侧孔5-4设置在针尖的侧壁上，针尖5-5直接刺入胶塞6中，不会形成直接切割作用，降低碎屑的产生。
又或者，如图7所示，上针5-2包覆有一层弹性收缩膜，在穿刺后弹性收缩膜受到压缩，堆积在穿刺孔周围，如图8所示，从而可以有效防止药液沿穿刺孔的缝隙渗漏出来。显而易见的是，下针5-3同样可以包覆一层弹性收缩膜，以解决药液沿穿刺孔的缝隙出现渗漏的问题。
混药通道7穿过基座2向上延伸直通混药杯3的杯底3-2，隔膜8的作用是隔绝药液与胶塞6的直接接触，做到使用前的完全密封，理论上可以位于胶塞6之下的混药通道7中的任何位置，不过考虑到如果隔膜8位置过低的话，导致十字针5的下针5-3过长，故而优选的是隔膜8位于胶塞6之下 且紧贴着胶塞6的下表面。
胶塞6安放在混药通道7中，隔膜8之上。胶塞6的作用是保证下针5-3在穿刺胶塞6与隔膜8之后，药液从隔膜8与下针5-3外壁之间的缝隙中流出后不至于渗出混药通道7，也就是说，胶塞6的外径与混药通道7的内径相匹配，使得胶塞6与混药通道7紧密接触。
优选的是，胶塞6上表面与杯底3-2上表面基本平齐或略高于上表面，如此一来，如图3所示的弹性卡座4的下表面，压住胶塞6的上表面。
作为一个优选的技术方案，隔膜8位于胶塞6之下且紧贴着胶塞6的下表面，如图1所示，可以更好的防止药液在下针5-3刺穿隔膜8后渗入混药通道7。尤其是，如图2所示的胶塞6，在胶塞6表面上设有由凸环6-2或凹槽6-3限定的较薄的穿刺区6-1，与胶塞6上的凸环6-2或凹槽6-3相对的是，隔膜8上表面相应的位置也设有凹槽6-3或凸环6-2。显而易见的是，胶塞6上的凸环6-2或凹槽6-3与隔膜8上的凹槽6-3或凸环6-2相互嵌合，从而达到更好的防止药液渗漏的目的。可选地，凸环也可以是6-3，凹槽为6-2。
设置有相互嵌合的凹槽6-3或凸环6-2的胶塞6与隔膜8，针板5-1对胶塞6形成一个挤压作用后，能够完全杜绝混药之后药液的渗漏。
更为优选的是，在针板5-1的下表面环绕下针5-3的根部处，设置有一圈环形突起，带卡座的的十字针5安装于混药杯中之后，针板5-1的环形突起对胶塞形成一个比较强的挤压作用，形成更好的密封。
可以理解的是，图1中所示的输液通道11，可以和上述混药器本体结构一起一体成型，与混药器并排设置在基座2上，正如图1所示。也可以在软袋制袋时采用另外的输液接口。例如可以通过另外一个基座2单独的焊接在输液软袋1上，设置于输液软袋1与混药器同侧或者相对的另一侧，或者输液软袋1的其他部位，对于本领域的技术人员而言，均是显而易见的设置。
混药器还包括弹性卡座4，优选的是如图3所示的独立的弹性卡座4，十字针5安放于弹性卡爪4-1与底板4-5之间，具体结构如图3所示，弹性卡 座4，包括一卡环4-6，卡环4-6下侧设置有弹性卡爪4-1，弹性卡爪4-1上端沿卡环4-6均匀布置且固定，弹性卡爪4-1下端为自由端，且弹性卡爪4-1从固定的上端到自由端呈向混药杯3中心倾斜结构。弹性卡座4具有一体成型的底板4-5、支撑柱4-4、卡环4-6和弹性卡爪4-1，底板4-5外周设置有支撑柱4-4对卡环4-6形成支撑固定。
底板4-5设有中心孔4-3，下针5-3穿过中心孔4-3从而对十字针形成定位。环绕中心孔4-3周围设置有一圈环形突起4-2，环形突起4-2限定的区域与中心孔4-3完全重叠，且与混药通道7同轴设置；底板4-5通过所述环形突起4-2贴紧所述杯底3-2。在弹性卡座4安装于混药杯3中之后，弹性卡座4上的环形突起4-2能对胶塞6形成一个挤压作用。
如图4‐8的十字针5，其针板5-1安装于混药杯3内的弹性卡爪4-1之下，底板4-5之上。十字针5包括一体成型的中空的上针5-2和下针5-3、以及将上针5-2和下针5-3结合为一体的针板5-1，上针5-2、下针5-3头部设置有针尖5-5。
对于十字针5、弹性卡座4以及混药杯3、基座2的组合，如图11所示，混药杯3及基座2一体成型，而弹性卡座4安放于混药杯3之中，十字针5卡设在弹性卡座4中。
杯壁上设置有限位结构(未示出)，带卡座的十字针5安装于混药杯3内而被限位结构所限制，尤其是，在下针5-3完成对胶塞6和隔膜8的穿刺后，十字针完全被限位结构所限制。
具体而言，弹性卡座4安放于混药杯3中后，被设置于杯壁3-1的内壁上的限位结构(未示出)限制住，从而使得弹性卡座4在安放好之后不会滑出混药杯3。另外，弹性卡座4被限制的位置，使得弹性卡座4的底部能接触混药杯3的杯底3-2。在优选的胶塞6的设置方案中，弹性卡座4底部的环形突起4-2能对胶塞6形成挤压。
安装于弹性卡座4之中的十字针5，十字针5的针板5-1位于弹性卡爪4-1和底板4-5之间，设置完成之后，下针5-3不刺穿胶塞6。
当然，也可以理解的是，在使用之前，下针5-3部分刺入胶塞6中，或者如图9所示对胶塞6完全穿刺，或者更为优选的是胶塞6中心预设一个小孔，形成环形胶塞6，下针5-3通过小孔穿刺胶塞6，均是可行的方案。在设计成环形胶塞6时，胶塞6中心小孔直径比下针5-3小，使得下针5-3插入胶塞6中的小孔并穿过胶塞6后，下针5-3对胶塞6不会形成切割作用，从而能有效避免下针5-3在穿刺胶塞6时形成微屑对药液造成的污染。而且，由于小孔直径比下针5-3的外径小，胶塞6依然能紧贴下针5-3从而避免漏液。
当然，在混药器装配后使用前，十字针5只是安放于混药杯3中，并不形成对隔膜8的穿刺，对胶塞6可以不穿刺或部分的穿刺、或者完全穿刺，只要不对隔膜8穿刺，均不影响混药器的使用。在撕开密封膜13，取下隔板12，插入西林瓶9，如图14所示，通过西林瓶9向下推，西林瓶9的瓶颈被推入弹性卡爪4-1之下。此时十字针5的上针5-2和下针5-3分别对胶塞6、隔膜8以及西林瓶9的瓶塞完成穿刺，同时十字针5完全被混药杯3内壁上的限位突起，即弹性卡爪4-1所限制，西林瓶9的瓶颈被弹性卡爪4-1所卡住而不能退出。
至于使用的状态，如图14、15所示，西林瓶9插入混药杯3中，西林瓶9的瓶盖被压进弹性卡座4内，使得弹性卡爪4-1的自由端位于西林瓶9的瓶颈处并卡在瓶颈处，从而对西林瓶9卡死不能从混药杯3中退出。
同时，西林瓶9的瓶盖被上针5-2刺穿，瓶盖向下推压针板5-1，从而推动下针5-3刺穿胶塞6、继而刺穿隔膜8，使得混药通道7通过十字针5而与西林瓶9连通。
显而易见的是，弹性卡座4的卡环4-6内径与西林瓶9外径基本一致，或略大于西林瓶9外径。而为了更好的固定限制住西林瓶9，使得西林瓶9不滑动，西林瓶9的瓶盖厚度应该与弹性卡爪4-1的自由端到底板4-5之间的距离基本一致，使得西林瓶9刚好通过瓶盖卡在弹性卡爪4-1的自由端与底板4-5之间，且不能上下移动。
当然，可以理解的是，出于加工容差等的考虑，弹性卡爪4-1的自由端到底板4-5之间的距离略大于瓶盖厚度，也不会显著影响西林瓶9的对接和固定。
十字针5、弹性卡座4以及混药杯3组装之后，如图9所示，一个优选的方案是，胶塞6上表面与杯底3-2上表面基本平齐或略高于上表面，如此一来，如图3所示的弹性卡座4的下表面，就能对胶塞6的上表面形成一个挤压作用。
如图3所示的弹性卡座4安放于混药杯3中，如图4至图8所示的十字针5安放于弹性卡座4中，从而形成如图9所示的混药器，在弹性卡座4和十字针5安装完毕后，在混药杯3的杯口位置安放有盖板12，然后覆盖密封膜13对混药杯3进行密封。
如图1所示，混药器与并排设置于基座2的输液通道11一起，构成硬双接口。
将混药器与输液软袋1通过焊接的方式接在一起，构成带混药器的输液软袋1，如图16所示。混药器通过基座2与输液软袋1接1合在一起。可以理解的是，输液通道11可以与混药器并排的设置在基座2上，正如图1所示。输液通道11也可以通过另外一个基座2单独的焊接在输液软袋1上，设置于输液软袋1与混药器同侧或者相对的另一侧，或者输液软袋1的其他部位，对于本领域的技术人员而言，均是显而易见的设置。
最后，为了保证输液软袋1在使用时的安全无菌，需要对混药杯3进行密封。密封混药杯3一般采用易撕膜，比较优选的是pp易撕膜，优选的是带有一定透气性的pp易撕膜。将易撕膜直接压合在混药杯3杯口处，使用时直接撕掉易撕膜即可。
因为在输液软袋1灌装之后，进行封口，然后进行高温灭菌。如果不对混药杯3进行密封的话，灭菌之后带混药器的输液软袋1，由于混药杯3中带有穿刺的十字针5依然暴露在外部环境中，运输使用时必可避免的会被污染，依然不能保证其无菌性。
而密封之后的混药杯3，在灭菌时，由于是在高温高压环境下，由医用聚合物材料构成的混药杯3的杯体，以及密封混药杯3的易撕膜材料，会变软收缩；混药杯3封闭的内部和外部，存在一个比较大的压力差，在高压的作用下，混药杯3和易撕膜均会变形，冷却后会混药杯3和易撕膜完全被压坏，从而破坏了混药器结构，导致混药器完全不能使用。
为了解决上述问题，比较优选的做法是对混药杯3的杯壁3-1，优先的是在杯壁3-1下半部，设置加强筋3-3，如图17所示。
加强筋3-3可以是设置在杯壁3-1内侧和/或外侧的均匀分布的突起的与混药杯3一体成型的竖条，或者横条，或者纵横交错的网状结构。优选的是沿杯壁3-1内侧下半部均匀分布的竖条状结构；更优选的是突起的竖条从杯壁3-1内侧下半部延伸至杯底3-2，最优选的是竖条突起的厚度从上到下逐渐平滑的连续增加。
在杯壁3-1上设置加强筋3-3基本上可以解决灭菌过程中混药杯3不被压变形，但是还存在着密封混药杯3的密封膜13在灭菌时被压缩变形的问题。
为了解决这一问题，在混药杯3杯口处还设置有一如图18所示的盖板12，密封膜13覆盖盖板12，使得盖板12对密封膜13形成有效的支撑，防止密封膜13在灭菌时被压缩变形。在杯口处沿杯壁3-1设有台阶状内沿，盖板12搁置在台阶状内沿上，使得设置在杯口处的盖板12的上表面与杯口平齐或略低于杯口，对密封膜13热压在杯壁3-1上端表面的密封工艺不会造成影响。
对于盖板12的设置，优选的盖板12与十字针5同轴设置，上针5-2的针尖5-5正对盖板12中心。
而优选设计的盖板12形状——多边形且中间带孔的结构，实验表明，在采用了气压平衡手段后，这种优选设计，能更快的让混药杯3内外的气压达到平衡，从而在湿热法灭菌工艺中，表现更为出色——密封膜13平整如初，混药杯3没有丝毫变形。这是因为多边形且中间带孔的盖板12，能加大盖板12之下和盖板12之上区域的气体交换速度，能更快的让混药杯3内的气压 均衡，让混药杯3内外其他平衡。
通过上述设置，可以安全、方便、快捷的配药、加药，完全解决了在配药环节的二次污染问题。同时也能保证输液可追溯，因为从西林瓶9对接固定到混药杯3上，被弹性卡爪4-1卡住后，西林瓶9就不能非破坏性的取出。也就是说，从配药，到输液完成，直至回收环节，都能追溯到所加、所注射的是何种药物。
而对于一类需要特殊保存的药物，譬如说需要即配即注型的，上述混药器可能还存在一些不便之处，因为必须把西林瓶9灌装的药物带到病房，再将西林瓶9与混药器对接、然后在病房配药当即使用。
为了更方便的满足医护人员即配即用的需求，在上述结构的基础上，增设了易折柄10，如图15所示。
在混药通道7下端设置易折柄10，在如图15所示的，将西林瓶9与混药杯3中的弹性卡座4完成对接和穿刺后，带至药房，在输液前掰断易折柄10，打通混药通道7，即可完成现场配药，现场使用。
关于基座2的形状及结构，为了避免混药器、输液通道11或者带混药器及输液通道11的硬双接口焊接在软袋上之后，在储存、运输以及使用过程中，基座2焊接部位对输液软袋1造成的损坏，基座2设计为哑铃形或船形，如图1中的基座2所示，且混药通道7、输液通道11的下端与基座2的下端平齐。基座2的四周侧壁上均布焊接纹路，这样能很好的保证在于输液软袋1的焊接过程中，即使是在较低的温度下基座2也能和输液软袋1很好的熔合焊接。而且，船形或哑铃形的基座2，流线型好，不尽改善了焊接的力学性能，而且没有锋锐的角度，可以使硬双接口与输液软袋1的结合更平滑，不易损坏软袋。
对于混药器以及输液软袋1材料的选择，输液软袋1采用的是目前普遍使用的非PVC多层共挤膜，包括三层、五层的多层共挤膜。
而混药器，则采用的是和输液软袋1非PVC材料相容性很好的医用聚丙烯材料，基座2、混药杯3、盖板12优选的是聚丙烯R530C材料；而十字针 5、卡体，考虑到其穿刺性以及机械特性，优选的是pp材料系中的P17材料。
十字针5、限位突起和限位结构为聚丙烯材料，优选的是聚丙烯P17材料
最后，在密封结构的混药器关键的一点——密封混药器在焊接到软袋上之后的终端灭菌。目前从政策法规以及实际注射安全的角度考虑，所有的药品包装，在灌装出厂之前，必须进行终端灭菌，或者是采用注射剂无菌保证工艺。
目前，注射剂的无菌保证工艺主要有两种：
1.终端灭菌工艺：在控制微生物污染量的基础上，在药品灌封后，通过湿热灭菌方式除菌。一般来说，本方法成本低，无菌保证水平高，适宜于大容量注射剂和小容量注射剂的灭菌。
2.无菌生产工艺：在无菌系统环境下，通过除菌过滤法或无菌操作法，以防止污染为目的，消除导致污染的各种可能性来保证无菌水平。一般来说，由于本方法对环境系统的要求高，且影响无菌操作的因素多而使得无菌保证水平比终端灭菌工艺低。无菌生产工艺一般适宜于粉针剂，亦可适宜于临床需要但不能进行终端灭菌的小容量注射剂。由此，终端灭菌工艺和无菌生产工艺具有不同的系统要求、不同的除菌方法和不同的无菌保证结果
对于大输液而言，是成本极度敏感性的，故而，大输液中的终端灭菌，只可能采用低成本且高效的湿热灭菌工艺——灭菌条件一般是在115‐121摄氏度的高温、0.15MPa压力的蒸汽下，保持30‐15分钟。
虽然混药器以及输液软袋1，都是选用的能耐120摄氏度高温的聚丙烯材料，然而，密封状态下的混药器，在如此高的温度下，其机械性能会降低，非常容易在0.15MPa的压强下变形；而密封膜13也会在这个温度和压强下出现变形、褶皱，失去密封效果。
我们从2011年到2014年进行了长达四年上百次的实验，最终从多个角度着手，确定了解决方案。
首先，对于混药杯3的结构，如图17所示，在杯体的下半部设置了加强 筋3-3。加强筋3-3的设置是对混药杯3的杯壁3-1，优先的是在杯壁3-1下半部来进行。
加强筋3-3可以是设置在杯壁3-1内侧和/或外侧的均匀分布的突起的与混药杯3一体成型的竖条，或者横条，或者纵横交错的网状结构。优选的是沿杯壁3-1内侧下半部均匀分布的竖条状结构；更优选的是突起的竖条从杯壁3-1内侧下半部延伸至杯底3-2，最优选的是竖条突起的厚度从上到下逐渐平滑的连续增加。
设置了加强筋3-3的混药杯3，在相当的程度上提高了杯体的机械抗压性。实验比较，没有设置加强筋3-3的混药杯3，在采用湿热法灭菌工艺之后，圆形的混药杯杯体，被压缩成了方形，完全不能使用。
在设置了加强筋3-3之后，经过湿热法灭菌工艺之后，圆形的混药杯杯体，有轻微的压缩，基本上不影响正常的使用功能。
其次，对于密封膜13，本身只是一个很薄的易撕膜，起到对混药杯3的密封和使用时便于撕开的效果。密封膜13比混药杯3的杯体更为薄弱，因为密封膜13本身只是一层微米量级厚度的薄膜，承受不了湿热法灭菌工艺中0.15MPa的压强。
对此，经过了大量的实验，发现，在密封膜13之下加装一个如图13所示的盖板12，密封膜13覆盖盖板12，使得盖板12对密封膜13形成有效的支撑，防止密封膜13在灭菌时被压缩变形。而盖板12则搁置在混药杯3杯口台阶状内沿上，使得设置在杯口处的盖板12的上表面与杯口平齐或略低于杯口，而盖板12的如此设置，对密封膜13压焊在杯壁3-1上端表面的密封工艺不会造成影响。
对于盖板12的形状，和混药杯3的杯口的形状基本匹配的圆形，优选的盖板12的形状是横截面呈多边形，譬如五边形、六边形、八边形、十二变形。多边形的盖板12一方面的好处是使用时比较方便的取出；而盖板12设置为多边形的另外的一个意想不到的作用在下面会提到。
此外，为了增强盖板12的抗压强度，优选的是盖板12与十字针5同轴 设置，上针5-2的针尖5-5正对盖板12中心并对盖板12形成支撑。更有优选的是，盖板12中心设有一通孔12-1，通孔12-1的内径小于上针5-2的外径，上针5-2的针尖5-5部分位于通孔12-1内但不能穿过通孔12-1，即上针5-2的针尖5-5嵌入盖板12的通孔12-1中，从而使得上针5-2对盖板12的支撑效果更为显著。
与此同时，考虑到盖板12所承受的巨大的向下压力，除了设计上针5-2对盖板12的形成支撑外，还对盖板12进行了加强设置，如图18所示的呈放射状和环状设置的盖板加强筋12-2，增强了盖板12的机械强度。
压焊与杯口上端的密封膜13，紧紧的贴敷于盖板12上表面，使得密封膜13基本上不需要承受高的压力，极大的缓解了密封膜13变形褶皱的现象。
而对于褶皱，由于密封膜13太薄，稍有压力就会导致褶皱的出现，严重影响产品的视觉效果。
经过多次的对比实验，在密封膜13上表面镀一层薄的金属膜，可以有效的缓解密封膜13褶皱的问题。
如此设置的密封混药器，虽然经受住湿热法灭菌工艺的高温和高压后还基本上能正常使用，然而，作为产品的外形依然难以保持在很好的状态，从输液产品的角度来考虑，仍然是不合格的产品。
在结构上对混药器进行了上述设计之后，只能保证使用功能，为了彻底解决密封混药器的终端灭菌问题，还需要从根部上解决——密封的混药杯3在湿热法灭菌时的内外气压平衡。
在混药杯3组装完成之后，加装盖板12和密封膜13对其密封之前，向杯体内预装一定量的液体，然后再加装盖板12，密封。
内装液体的密封混药杯3，在随输液软袋1一起进行终端灭菌时，高温下液体快速汽化，从而可以很快的让杯体内外的气压达到一个平衡。
对于预装液体，优选的是热容量较小，饱和蒸汽压较高的液体。我们研究了各种液体在120摄氏度，0.15MPa下的状态，包括水、乙醇等常用的无害液体，均能满足我们的需求。考虑到成本以及安全性，优选的是预装液体 是水。
至于至关重要的预装水量V0，可以通过以下方程来确认：
PV＝nRT，其中P为湿热法灭菌时的内外压力差，V为混药杯3容积，n为预装液体/水的摩尔数，R为气体常数，T为湿热法灭菌时的绝对温度。
V0＝n*M/ρ，其中M即为液体/水的摩尔质量，ρ为液体/水的密度。
根据上述方程可以很好的平衡密封混药器在终端灭菌时的内外气压。
以预装液体的方式来平衡内外气压，是一个比较优选的解决方案。
然而，上述方法能够解决气压平衡的问题，然后在实际使用中，依然存在一定的问题，最为典型的是，灭菌完了的成品输液软袋1，冷却后在混药杯3内存在水滴或液体，非常的影响观感，而且这样的产品通常也不太会被医院和患者所接受。
在此基础上，一个更为优选的方案是，我们特别研究了基于pp材料系的具有一定透气性的密封膜13，保证在液体汽化后，能通过透气性密封膜13和外面进行充分的气体交换，这样在灭菌完成之后，混药杯3内不会存在残留的液体。
透气性密封膜13的透气率，经过长时间的多次实验，5％‐35％透气率，是最为优选的。
对于采用我们研究的透气性密封膜13来密封的混药器，经过湿热法高温灭菌后，混药杯3没有丝毫的变形，密封膜13也光滑如初，没有褶皱出现。
当然，一个改进型方案是，在不预装液体，直接采用具有合适透气率的透气性密封膜13来密封混药器，经过我们的多次实验，也是可行的。
对于组装完成的混药器，即将带卡座的十字针5，安放于混药杯3中后，就对混药杯3进行密封，密封一般采用的是密封膜13，或者是易撕密封膜，以压焊的方式对混药杯3杯口进行密封；或者，在杯口先安放一盖板12，再在其上用密封膜13予以密封，密封之后的混药杯3焊接在输液软袋1上，形成带混药器的输液软袋1，如图16所示。经终端灭菌后，即可供医护人员使用。
第二实施例
在上述实施例1的基础上，对于第一实施例中的弹性卡座4的设置方式，在如图12所示的在实施例2中，采用直接固定于混药杯3内壁上的限位突起来代替实施例1中的弹性卡座4。具体是在杯壁3-1的内壁上设置有限位突起(未示出)，带卡座的十字针5安装于混药杯3内而被限位突起限制，尤其是，在如图5的下针5-3完成对胶塞6和隔膜8的穿刺后，十字针5完全被限位突起所限制。限位突起优选的是弹性卡爪4-1；更为优选的是，作为限位突起的弹性卡爪4-1与混药杯3一体成型。弹性卡爪4-1上端沿杯壁3-1的内壁周沿均匀布置且固定，弹性卡爪4-1下端为自由端，且弹性卡爪4-14从固定的上端到自由端呈向混药杯3中心倾斜结构，如图12所示。
在使用如图4‐8所示的十字针5安装进带限位突起的混药杯3之后，如图13所示，限位突起将十字针5的针板5-1限定在限位突起和杯底3-2之间而不能被取出。图13所示的是十字针5已经刺穿了胶塞6而尚未刺穿隔膜8的状态。
显而易见的是，杯底3-2上表面与隔膜8下表面之间的距离小于下针5-3的长度。
对于混药器的其他结构，具有和实施例1一样的设置。
第三实施例
在上述实施例1的基础上，对于第一实施例中的弹性卡座4的设置方式，在如图10所示的在实施例3中，将十字针5与弹性卡座4直接固定，优选的是十字针5与弹性卡座4一体成型。
和实施例1中的弹性卡座4一样，弹性卡座4包括一卡环4-6，卡环4-6下侧设置有弹性卡爪4-1，弹性卡爪4-1上端沿卡环4-6均匀布置且固定，弹性卡爪4-1下端为自由端，且弹性卡爪4-1从固定的上端到自由端呈向混药杯3中心倾斜结构。弹性卡座4具有一体成型的底板4-5、支撑柱4-4、卡环4-6和弹性卡爪4-1，底板4-5外周设置有支撑柱4-4对卡环4-6形成支撑固定。
所不同的是取消了底板4-5上的中心孔4-3，十字针5一体成型的直接固定在底板4-5上。上针5-2与下针5-3的结构依然如图4‐8所示的结构一样，上针5-2和下针5-3的中空通道穿过弹性卡座4的底板4-5的中心并彼此连通。
在下针5-3的根部，设置有一圈环形突起4-2，在弹性卡座4安装于混药杯3中之后，弹性卡座4上的环形突起4-2能对胶塞6形成一个挤压作用。在使用前，弹性卡座4安装在混药杯3中且在被推压至杯底3-2时，被杯壁3-1限制而不能取出。如图11所示，带十字针5的弹性卡座4被推至杯底3-2时，下针5-3对胶塞6和隔膜8均形成穿刺。当然，
或者，如图19所示，在针板5-1上一体成型的设置有支撑柱4-3、卡环4-6和弹性卡爪4-1，支撑柱4-3设置在针板5-1外周以对卡环4-6形成支撑固定。
弹性卡爪4-1上端沿卡环均匀布置且固定，弹性卡爪的下端为自由端，且弹性卡爪4-1从固定的上端到自由的下端呈向混药杯中心倾斜结构。弹性卡爪4-1有多个，优选的是3个或4个。
杯壁的内壁上设置有限位突起，所述十字针安装进所述混药杯后，所述限位突起将所述针板限定在所述限位突起和所述杯底之间而不能被取出。此处的限位突起优选的为弹性卡爪。
带卡座的十字针5，安放于混药杯3中，如图20所示，安放于混药杯3中的带卡座的十字针5，被推至杯底3-2，从而对胶塞6及隔膜8完成了穿刺。
对于混药器的其他结构，具有和实施例1一样的设置。
应当理解的是，本发明的上述具体实施方式仅仅用于示例性说明或解释本发明的原理，而不构成对本发明的限制。因此，在不偏离本发明的精神和范围的情况下所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。此外，本发明所附权利要求旨在涵盖落入所附权利要求范围和边界、或者这种范围和边界的等同形式内的全部变化和修改例。

Claims (25)

  1. 一种混药器，包括基座、混药通道、混药通道内的隔膜和混药杯，所述基座、混药通道、混药通道内的隔膜和混药杯一体成型；所述混药杯由杯壁和杯底构成；还包括十字针，所述十字针位于所述混药杯内，其特征在于：
    所述十字针由一体成型的针板以及具备中空通道的上针和下针构成，所述上针和下针的中空通道彼此连通；
    在所述针板上还一体成型的设置有支撑柱、卡环和弹性卡爪，其中，所述支撑柱设置在所述针板外周以对所述卡环形成支撑固定；
    所述弹性卡爪设置在所述卡环下侧且所述弹性卡爪的上端沿所述卡环均匀布置且固定，所述弹性卡爪下端为自由端，所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构；
    所述混药通道下端穿过所述基座，上端穿过所述杯底；
    在所述隔膜和所述杯底之间的混药通道内设有胶塞；
    所述混药器还包括密封膜，所述密封膜以压焊的方式连接在所述混药杯的杯口，对所述混药杯形成密封；
    所述密封膜是经湿热法终端灭菌后依然保持基本平整的易撕膜。
  2. 如权利要求1所述的混药器，其特征在于，所述杯壁的内壁上设置有限位突起，所述十字针安装进所述混药杯后，所述限位突起将所述针板限定在所述限位突起和所述杯底之间而不能被取出。
  3. 一种混药器，包括一体成型的基座、混药通道和混药杯，十字针，所述混药杯由杯壁和杯底构成；
    所述十字针由一体成型的针板以及具备中空通道的上针和下针构成，所述上针和下针的中空通道彼此连通；
    其特征在于：
    所述混药通道下端穿过所述基座，上端穿过所述杯底，在所述基座与所述杯底之间的所述混药通道内设有隔膜，在所述隔膜和所述杯底之间的 混药通道内设有胶塞；
    所述杯壁的内壁上设置有限位突起，所述十字针安装进所述混药杯后，所述限位突起将所述针板限定在所述限位突起和所述杯底之间而不能被取出；
    所述杯底上表面与所述隔膜下表面之间的距离小于所述下针的长度；
    所述混药器还包括密封膜，所述密封膜以压焊的方式连接在所述混药杯的杯口，对所述混药杯形成密封；
    所述密封膜是经湿热法终端灭菌后依然保持基本平整的易撕膜。
  4. 如权利要求3所述的混药器，其特征在于：
    所述限位突起为弹性卡爪，所述弹性卡爪上端沿所述杯壁的内壁周沿均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构；
    所述针板位于所述下端和所述杯底之间。
  5. 一种混药器，包括一体成型的基座、混药通道和混药杯，十字针，所述混药杯由杯壁和杯底构成；
    所述十字针由一体成型的针板以及具备中空通道的上针和下针构成，所述上针和下针的中空通道彼此连通；
    其特征在于：
    所述混药通道下端穿过所述基座，上端穿过所述杯底，在所述基座与所述杯底之间的所述混药通道内设有隔膜，在所述隔膜和所述杯底之间的混药通道内设有胶塞；
    还包括弹性卡座，所述弹性卡座包括一卡环，所述卡环下侧设置有弹性卡爪，所述弹性卡爪上端沿所述卡环均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构；
    所述针板安装于所述混药杯内的所述弹性卡爪之下；
    所述杯壁的内壁上设置有限位结构，所述弹性卡座安装于所述混药杯 内而被所述限位结构限制；
    所述杯底上表面与所述隔膜下表面之间的距离小于所述下针的长度；
    所述混药器还包括密封膜，所述密封膜以压焊的方式连接在所述混药杯的杯口，对所述混药杯形成密封；
    所述密封膜是经湿热法终端灭菌后依然保持基本平整的易撕膜。
  6. 如权利要求5所述的混药器，其特征在于：
    所述弹性卡座具有一体成型的底板、支撑柱、所述卡环和所述弹性卡爪，所述底板外周设置有支撑柱对所述卡环形成支撑固定；
    所述底板设有中心孔，所述下针穿过所述中心孔从而对所述十字针形成定位；
    所述针板位于所述底板和所述弹性卡爪之间。
  7. 如权利要求6所述的混药器，其特征在于：
    所述底板下表面的中心区域设置有一环形突起，所述环形突起限定的区域与所述中心孔完全重叠，且与所述混药通道同轴设置；
    所述底板通过所述环形突起贴紧所述杯底。
  8. 一种具有加强结构的混药器，其特征在于：包括如权利要求1-7任一所述的混药器；
    所述混药杯的所述杯壁上，设置有加强筋结构以增强所述杯壁的抗压强度；
    所述加强筋设置在所述杯壁内侧沿上下方向和/或水平方向一体布置。
  9. 如权利要求8所述的混药器，其特征在于：
    所述胶塞的中心区域设有穿刺区，所述穿刺区比边缘区薄；
    所述针板下表面的中心区域设置有一环形突起，所述穿刺区与所述环形突起限定的区域重合或位于所述环形突起限定的区域内。
  10. 如权利要求8所述的混药器，其特征在于：
    还包括一盖板，所述盖板位于所述杯口内，且被所述密封膜覆盖。
  11. 如权利要求10所述的混药器，其特征在于：
    所述杯口处沿所述杯壁设有台阶状内沿，所述盖板搁置在所述内沿上；
    所述盖板上表面与所述杯口平齐或略低于所述杯口；
    所述密封膜热压在所述杯壁上端表面，从而对所述杯口形成密封。
  12. 如权利要求10所述的混药器，其特征在于：
    所述盖板呈多边形，且中心设有一孔，所述上针的针尖位于所述孔内但不穿过所述孔。
  13. 如权利要求8-12中任一项所述的混药器，其特征在于：
    所述密封膜是透气性易撕膜；
    所述密封膜的透气率是5％到35％；
  14. 如权利要求13所述的混药器，其特征在于：
    所述密封膜上表面镀有金属膜层。
  15. 如权利要求8-12中任一项所述的混药器，其特征在于：
    所述混药杯在被所述密封膜密封之前，预装一定量的液体，用于使所述混药杯内、外气压达到基本平衡；
    所述液体是能在湿热法灭菌环境下迅速汽化的液体。
  16. 如权利要求8-12中任一项所述的混药器，其特征在于：
    所述混药通道下端，设置有易折柄，并通过所述易折柄对所述混药通道的下端进行密封。
  17. 如权利要求8所述的混药器，其特征在于：
    所述隔膜上表面设置有凸环或凹槽，所述胶塞下表面对应位置设置有凹槽或凸环；
    所述隔膜与所述胶塞通过凸环与凹槽彼此嵌合。
  18. 如权利要求8所述的混药器，其特征在于：
    所述上针的中空通道的出口，开设在所述上针的针尖侧壁上；
    和/或；
    所述下针的中空通道的出口，开设在所述下针的针尖侧壁上。
  19. 如权利要求8所述的混药器，其特征在于：
    所述上针包覆有一层弹性收缩膜；
    和/或；
    所述下针包覆有一层弹性收缩膜。
  20. 一种带混药器的硬双接口，包括如权利要求1-19任一所述的混药器，其特征在于：
    在所述混药器的所述基座上相对于所述混药通道的另一侧，设有一输液通道；
    所述输液通道上设置有接口。
  21. 一种输液软袋，其特征在于：所述输液软袋包括如权利要求1-19任一所述的混药器；
    或者包括如权利要求20所述的硬双接口；
    所述混药器或所述硬双接口通过所述基座与所述软袋接合在一起。
  22. 如权利要求21所述的输液软袋，其特征在于：
    还包括一输液接口，所述输液接口设置在与所述混药器同侧的输液软袋上，或者设置在与所述混药器相对的另一侧的输液软袋上。
  23. 如权利要求21或22所述的输液软袋，其特征在于：
    所述输液软袋采用的是非PVC多层共挤膜。
  24. 如权利要求21或22所述的输液软袋，其特征在于：所述基座、混药杯及隔膜采用的是医用聚丙烯材料，优选的是聚丙烯R530C材料。
  25. 如权利要求21或22所述的输液软袋，其特征在于：所述十字针、所述限位突起和所述限位结构为聚丙烯材料，优选的是聚丙烯P17材料。
PCT/CN2016/105564 2015-11-13 2016-11-13 混药器、硬双接口及输液软袋 WO2017080522A1 (zh)

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JP2018544393A JP2018535071A (ja) 2015-11-13 2016-11-13 薬物ミキサー、ハードデュアルインターフェースおよび輸液ソフトバック
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
US15/776,073 US20200253827A1 (en) 2015-11-13 2016-11-13 Drug mixer, hard dual-port member, and soft infusion bag
KR1020187014837A KR102119990B1 (ko) 2015-11-13 2016-11-13 약품 혼합 믹서기, 경질 듀얼 포트 및 수액용 소프트 백

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CN201510780465.8A CN105232329B (zh) 2015-11-13 2015-11-13 混药器、硬双接口及输液软袋
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