WO2018024092A1 - 一种密闭式流体转移装置及一种密闭式流体转移方法 - Google Patents

一种密闭式流体转移装置及一种密闭式流体转移方法 Download PDF

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Publication number
WO2018024092A1
WO2018024092A1 PCT/CN2017/093142 CN2017093142W WO2018024092A1 WO 2018024092 A1 WO2018024092 A1 WO 2018024092A1 CN 2017093142 W CN2017093142 W CN 2017093142W WO 2018024092 A1 WO2018024092 A1 WO 2018024092A1
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WO
WIPO (PCT)
Prior art keywords
container
fluid
fluid conduit
transfer device
fixing seat
Prior art date
Application number
PCT/CN2017/093142
Other languages
English (en)
French (fr)
Inventor
赵继龙
王强
孙首禹
Original Assignee
山东新华安得医疗用品有限公司
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 CN201620840014.9U external-priority patent/CN206304132U/zh
Priority claimed from CN201610630585.4A external-priority patent/CN106176221B/zh
Application filed by 山东新华安得医疗用品有限公司 filed Critical 山东新华安得医疗用品有限公司
Priority to DE112017003170.2T priority Critical patent/DE112017003170B4/de
Priority to US15/763,444 priority patent/US10463573B2/en
Publication of WO2018024092A1 publication Critical patent/WO2018024092A1/zh

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Classifications

    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/50—Mixing liquids with solids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/712—Feed mechanisms for feeding fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/71745—Feed mechanisms characterised by the means for feeding the components to the mixer using pneumatic pressure, overpressure, gas or air pressure in a closed receptacle or circuit system
    • 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
    • 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
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/2065—Connecting means having aligning and guiding means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions

Definitions

  • the present invention relates to the field of fluid formulation, and more particularly to a closed fluid transfer device and a closed fluid transfer method.
  • Dispensers involved in the preparation and management of hazardous fluids are susceptible to exposure to hazardous fluids and dangerous fluid vapors that can diffuse into the surrounding environment.
  • hazardous fluid refers to any injectable material that can cause health hazards by contact with the material or the vapor of the material.
  • Illustrative and non-limiting examples of such fluids include, but are not limited to, cytotoxins, antiviral drugs, chemotherapeutic fluids, antibiotics, and radiopharmaceuticals, such as herceptin, cisplatinum, fluorouracil, Leucovorin, taxol, metatroxat, gemzar hydrochloride for injection, cyclophosphamide, cytoxan, and cyclophosphamide injection (neosar), Or a combination of the liquid, solid or gaseous states of the fluids listed above.
  • cytotoxins such as cytotoxins, antiviral drugs, chemotherapeutic fluids, antibiotics, and radiopharmaceuticals, such as herceptin, cisplatinum, fluorouracil, Leucovorin, taxol, metatroxat, gemzar hydrochloride for injection, cyclophosphamide, cytoxan, and cyclophosphamide injection (neosar), Or a
  • the hazardous fluid in liquid or powder form is contained in a vial (first container) and is typically prepared in a separate room by a dispensing personnel provided with protective clothing, a mask and a laminar flow safety cabinet, utilized by the dispensing personnel
  • a syringe with a cannula, ie a hollow injection needle, is provided to deliver hazardous fluid from the vial (first container) and the hazardous fluid is added to the corresponding solution.
  • hazardous fluids are toxic, direct physical contact with hazardous fluids or even small amounts of dangerous fluid vapors exposed to the air can cause damage to the human body, increasing the risk of physical illness such as skin cancer, leukemia, liver damage, deformities, Abortion and premature birth.
  • locations where hazardous fluids are exposed to the air are readily available, including containers containing hazardous fluids, such as vials, bottles, syringes, and IV bags, which are subject to overpressure and cause danger.
  • the fluid is exposed to contaminated air. Residual fluid solutions on the tip of the needle, on the vial or in the intravenous bag seal may also result in exposure of the hazardous fluid.
  • a fluid dispensing device that avoids exposure of hazardous fluids to the air during hazardous fluid formulation or direct contact of the hazardous fluid with the human body, such that the hazardous fluids are internally sealed within the dispensing device to complete the fluid assembly process.
  • the internal preparation of the hazardous fluid is completed under the environment to avoid direct contact between the dangerous fluid and the air or the human body, and to prevent the medical staff from being stabbed by the needle.
  • the present application provides a closed fluid transfer device comprising a first container puncturing device, a second container puncturing device and a fluid transfer device, the fluid transfer device comprising a first container puncturing device An adapter, a second container piercing adapter, and a pressure supply device, the first container piercing adapter including a seal holder, a guide casing, a first fluid conduit, and a second fluid conduit, the first seal being mounted in the seal holder
  • the guide casing is disposed outside the seal fixing seat, the lower portion of the guide casing is provided with a pipe fixing seat, and the pipe fixing seat is provided with the first fluid pipe and the second fluid pipe, a tail of the first fluid conduit is in communication with one end of the third fluid conduit, the other end of the third fluid conduit is in communication with the pressure supply, and a tail of the second fluid conduit is passed through the fourth fluid conduit and the second
  • the container piercing adapter is in communication, and the second container piercing adapter is in communication, and the second container pierc
  • the first container puncturing device is disposed at one end of the first container mouth and has a second sealing member at the other end;
  • the sealing member is fixed When the distance between the bottom surface of the seat and the bottom surface of the guiding jacket is a second distance, the fluid outlet of the first fluid conduit and the fluid outlet of the second fluid conduit are both located inside the first sealing member; the bottom surface of the sealing member is fixed When the distance between the bottom surfaces of the guiding jacket is a third distance, the fluid outlet of the first fluid conduit and the fluid outlet of the second fluid conduit pass through the second seal into the interior of the first container puncturing device,
  • the first container piercing adapter is in communication with the first container piercer.
  • both the fluid outlet of the first fluid conduit and the fluid outlet of the second fluid conduit expose the conduit mount.
  • the seal holder is provided with a guide hole through which the second fluid conduit and the first fluid conduit enter the inside of the seal holder.
  • the first container puncturing device has a fifth fluid conduit and a sixth fluid conduit, and one ends of the fifth fluid conduit and the sixth fluid conduit extend into the first container, the fifth fluid The other end of the conduit and the sixth fluid conduit extend to the second seal.
  • the guiding jacket is provided with a limiting hole and a limiting arm
  • the root of the limiting arm is fixedly disposed at the bottom of the limiting hole and the end of the limiting arm is suspended
  • the limiting arm is The inner side of the end has a first protrusion
  • the first container piercing end is provided with a second protrusion
  • the first container piercer end can protrude into the seal fixing seat, the first protrusion In contact with the second protrusion, the second protrusion presses the first protrusion to the outside.
  • the seal fixing seat comprises a bottom surface of the seal fixing seat and a side wall of the seal fixing seat, the sealing member a third recess matching the first protrusion is disposed on the sidewall of the fixing seat, and the third recess generates a first plane facing downward on the sidewall of the seal fixing seat, the first protrusion Having a second plane opposite the first plane, the projection of the first plane having an overlap with the projection of the second plane when the first protrusion is not pressed outward.
  • the pressure supply device provides a required positive or negative pressure during operation of the closed fluid transfer device.
  • the upper side wall of the seal fixing seat is provided with an upper limit bayonet and a lower limit bayonet.
  • the limit The upper end faces of the holes are in contact to limit downward and upward movement of the seal holder relative to the guide sleeve, respectively.
  • the upper limit bayonet is in contact with the upper end surface of the limiting hole, and the fluid of the first fluid conduit Both the outlet and the fluid outlet of the second fluid conduit are located inside the first seal.
  • the guiding jacket is provided with a first recess
  • the side wall of the sealing member is provided with a movable member mounting hole
  • the movable member mounting hole is provided with a movable member
  • the first container puncturing device The other end has a second recess.
  • a movable member sliding groove is disposed below the first recess.
  • the movable member locks the first container puncturing device.
  • the second fluid conduit is at least one, and the first fluid conduit is at least one.
  • a lower portion of the guiding jacket is provided with a mounting hole of the pipe fixing seat, or the guiding jacket and the pipe fixing seat are integrally formed.
  • first fluid conduit and the second fluid conduit are mounted on the conduit mount or the first fluid conduit and the second fluid conduit are integrally formed with the conduit mount.
  • the invention also provides a closed fluid transfer method for the above closed fluid transfer device, comprising:
  • the first container is coupled to the first container trocar adapter of the fluid transfer device by a first container puncturing device; the second container is coupled to the second container trocar adapter of the fluid transfer device by a second container puncturing device; the first container is punctured
  • the adapter is connected to the second trocar adapter through a conduit, and the first container trocar adapter is connected to the pressure providing device;
  • the liquid in the first container When the first container is filled with liquid, the liquid in the first container is placed under the action of gravity at a position away from the mouth of the first container, while the liquid in the second container is in gravity Away away from the second
  • the pressure supply device provides a negative pressure
  • the gas in the second container is transferred into the first container through the second container puncturing device, the fluid transfer device and the first container puncturing device, while the first container is in the first container
  • the gas enters the pressure providing device, and the liquid in the second container enters the first container under the action of the negative pressure to form a mixed solution, and the first container is inverted so that the mixed solution in the first container is moved to the gravity
  • the pressure supply device provides a positive pressure, so that the mixed solution in the first container reaches the second container through the first container puncturing device, the fluid transfer device and the second container puncturing device, thereby achieving liquid tight transfer ;
  • the solid powder in the first container is placed under the action of gravity at a position away from the mouth of the first container, while the liquid in the second container is under the action of gravity
  • the position of the mouth of the second container at which time the pressure supply device provides a negative pressure, the gas in the first container enters the pressure supply device, and the liquid in the second container enters the first container under the action of the negative pressure, and shakes at this time
  • the first container after mixing the powder in the first container with the liquid, inverting the first container such that the mixed liquid in the first container is moved by gravity to the mouth of the first container, and the pressure supply device provides positive pressure.
  • the mixture in the first container is passed through the first container puncturing device, the fluid transfer device and the second container puncturing device into the second container to achieve a hermetic transfer of the liquid.
  • the present invention discloses the following technical effects:
  • the pressure supply device provides a negative pressure
  • the gas in the first container and the second container is sucked out through the first fluid conduit connected to the pressure supply device, and a negative pressure is generated in the first container and the second container
  • the second container is inverted, and the liquid in the second container is close to the mouth of the device, and the liquid in the second container passes through the second container piercer, the second container piercing adapter, the catheter, the fourth fluid pipe, the second fluid pipe, and
  • the fifth fluid conduit enters the first container and mixes with the liquid in the first container to form a mixed solution
  • the pressure supply device provides a positive pressure, so that the gas in the pressure supply device enters the first container, and the mixed solution in the first container Returning to the second container under the pressure
  • a fluid conduit sucks out the gas in the first container, a negative pressure is generated in the first container and the second container, and the liquid in the second container enters the first container under the action of the negative pressure, so that the solid powder in the first container Mix well with the liquid in the second container.
  • the pressure supply device Since the pressure supply device is only in communication with the first fluid conduit through the third fluid conduit, and the first fluid conduit only allows air to enter and exit (or because the pressure supply device is filled with air in a sealed state, the liquid cannot enter under the action of air pressure) ), the pressure supply device does not enter the mixed solution, Therefore, the mixed solution is left in the inner wall surface of the pressure supply device, and the residual mixed solution exposes the air or directly contacts the human body, causing air pollution or injury to the human body;
  • the fluid outlet of the first fluid conduit and the fluid outlet of the second fluid conduit are always in a closed state during the use of the fluid transfer operation: the distance between the bottom surface of the seal holder and the bottom surface of the guide jacket is a first distance When the fluid outlet of the first fluid conduit and the fluid outlet of the second fluid conduit are both located outside the first seal, when the product is subjected to a sterilization/sterilization procedure, such that the bottom surface of the seal holder and the bottom surface of the guide sleeve When the distance between the first distance is sufficient, the device is fully disinfected/sterilized, and the residual disinfecting/sterilizing medium is analyzed; when the distance between the bottom surface of the sealing member and the bottom surface of the guiding jacket is the second distance, the fluid outlet of the first fluid conduit And the fluid outlet of the second fluid conduit is completely isolated from the outside of the first seal; when the distance between the bottom surface of the seal holder and the bottom surface of the guide jacket is a third distance, the fluid outlet of the first fluid conduit and the second The fluid outlet of the
  • first container puncturing device of the present invention and the first container puncturing adapter are matched with the movable member mounted on the sealing member fixing seat of the first container adapter through the second recess provided in the first container puncturing device.
  • the first container puncturing device and the first container puncturing adapter are locked tightly.
  • the present invention uses the movable member to lock the first container puncturing device, and the movable member can be rolled when the first container puncturing device is pulled out outward. The operator only needs to overcome the small frictional resistance to separate the first container piercer from the first container piercing adapter.
  • Figure 1 is a schematic view showing the overall structure of a closed fluid transfer device
  • Figure 2 is a schematic view showing the assembly of the first container puncturing device and the first container;
  • Figure 3 is a schematic view showing the axial structure of the seal fixing seat
  • Figure 4 is a schematic view showing the axial structure of the guide casing
  • Figure 5 is a partial cross-sectional view of the first container puncture adapter
  • the present application provides a closed fluid transfer device comprising a first container piercer 7, a second container piercer 6 and a fluid transfer device, the fluid transfer device comprising a first container piercing adapter 3 a second container piercing adapter 5 comprising a seal holder 11, a guide casing 18, a first fluid conduit 24 and a second fluid conduit 25, said seal holder A first sealing member 26 is disposed in the first sealing member 26, and the guiding outer casing 18 is disposed outside the sealing member fixing seat 11.
  • the lower portion of the guiding outer casing 18 is provided with a pipe fixing seat 31, and the pipe fixing seat 31 is provided with a first fluid conduit 24 and a second fluid conduit 25, the tail of the first fluid conduit 24 is in communication with one end of the third fluid conduit 30, and the other end of the third fluid conduit 30 is in communication with the pressure supply device 4.
  • the tail of the second fluid conduit 25 communicates with the second container piercing adapter 5 via a fourth fluid conduit 29, and the second container piercing adapter 5 is in communication with the second container piercer 6;
  • the first container puncturing device 7 is disposed at one end of the first container 1 and has a second sealing member 10 at the other end;
  • the fluid outlet of the first fluid conduit 24 and the fluid outlet of the second fluid conduit 25 are both located in the first seal 26 when the distance between the bottom surface 32 of the seal holder and the bottom surface 33 of the guide sleeve is a first distance. External; when the distance between the bottom surface 32 of the seal fixing seat and the bottom surface 33 of the guide casing is a second distance, the fluid of the first fluid conduit 24 is out
  • the port and the fluid outlet of the second fluid conduit 25 are both located inside the first sealing member 26; the first fluid conduit 24 when the distance between the bottom surface 32 of the seal holder and the bottom surface 33 of the guide sleeve is a third distance a fluid outlet and a fluid outlet of the second fluid conduit 25 through the second seal 10 into the interior of the first container piercer 7, the first container piercing adapter 3 and the first container piercing The device 7 is connected.
  • first distance, the second distance and the third distance are not a unique specific value as long as the fluid outlet of the first fluid conduit 24 and the second fluid conduit 25 are ensured at the first distance
  • the fluid outlets are both located outside the lower end of the first seal member 26; at the second distance, the fluid outlet of the first fluid conduit 24 and the fluid outlet of the second fluid conduit 25 are both located inside the first seal member 26; At a third distance, the fluid outlet of the first fluid conduit 24 and the fluid outlet of the second fluid conduit 25 pass through the second seal 10 into the interior of the first container piercer 7 at a third distance
  • the value is zero, that is, the seal holder bottom surface 32 is in close contact with the guide jacket bottom surface 33 at the third distance.
  • the first sealing member 26 and the second sealing member 10 are in a close fitting state to ensure that the fluid outlet is entered from the inside of the first sealing member 26.
  • the second seal 10 is kept in a sealed state during the internal process.
  • the second container puncture adapter 5 After the second container puncture adapter 5 is in communication with the second container puncture device 6, the second container puncture adapter 5 and the second container puncture device 6 form a sealing structure, and the second container puncture adapter 5 is
  • the second container piercing adapter 5 and the second container piercing device 6 are respectively provided with a seal structure (which may be a third seal member and a fourth seal member, respectively) at a position where the second container piercing device 6 is connected. To ensure the sealing performance of the joint.
  • the distance between the bottom surface 32 of the seal holder and the bottom surface 33 of the guide sleeve is a first distance.
  • the bottom surface and the guide of the seal holder are guided.
  • the distance between the bottom surfaces of the outer casing is the first distance, the device is conveniently disinfected/sterilized, and the residual disinfecting/sterilizing medium is analyzed;
  • the distance between the bottom surface 32 of the seal fixing seat and the bottom surface 33 of the guide casing can only be restored to the second distance due to the existence of the limiting structure, that is, the first fluid conduit 24
  • the fluid outlet and the fluid outlet of the second fluid conduit 25 are both in a state inside the first seal 26 to ensure that the fluid outlet and the residual fluid remaining inside the fluid conduit are not exposed to the sealed fluid transfer device after use.
  • the initial state between the bottom surface 32 of the seal fixing seat and the bottom surface 33 of the guide casing in the closed fluid transfer device disclosed in the present invention is: the bottom surface 32 of the seal fixing seat and the bottom surface 33 of the guide casing. The distance between the first distance or the second distance.
  • the fluid outlet of the first fluid conduit 24 and the fluid outlet of the second fluid conduit 25 both expose the conduit mount 31.
  • the fluid outlet of the first fluid conduit 24 and the fluid outlet of the second fluid conduit 25 are at least one, and both expose the upper surface of the conduit holder 31, and the fluid outlet of the first fluid conduit 24
  • the distance between the fluid outlet of the second fluid conduit 25 and the conduit mount 31 is determined according to actual needs to meet the purpose of internal fluid transfer.
  • the seal holder 11 is provided with a guide hole 17 through which the second fluid conduit 25 and the first fluid conduit 24 enter the seal holder. internal.
  • the guide hole 17 is a through hole disposed on the bottom surface 32 of the seal fixing seat, and the second fluid conduit 25 and the first fluid conduit 24 enter the seal fixing seat 11 through the guide hole 17 .
  • the interior enters the first seal 26.
  • the first container puncturing device 7 has a fifth fluid conduit and a sixth fluid conduit, and one ends of the fifth fluid conduit and the sixth fluid conduit extend into the first container The other ends of the fifth fluid conduit and the sixth fluid conduit both extend to the second seal 10.
  • the one or more of the first fluid conduit 24 and the second fluid conduit 25 pass through the second seal 10 into the fifth fluid conduit and the sixth fluid conduit, respectively, to achieve rapid, closed movement of the fluid.
  • the guiding sleeve 18 is provided with a limiting hole 21 and a limiting arm 19, and the root of the limiting arm 19 is fixedly disposed at the bottom of the limiting hole 21 and the limiting arm 19
  • the end of the end of the limiting arm 19 has a first protrusion
  • the end of the first container puncturing device 7 is provided with a second protrusion 8
  • the end of the first container puncturing device 7 can be extended.
  • the first protrusion is in contact with the second protrusion 8, and the second protrusion 8 presses the first protrusion to the outside.
  • the positional relationship of the second protrusion 8 with respect to the second sealing member 10 is: the second protrusion 8 is at an upper portion of the second sealing member 10, and the second protrusion 8 is The second sealing member 10 is closer to the mouth of the first container 1; the limiting arm 19 is an elastic limiting arm.
  • the seal fixing seat includes a seal fixing seat bottom surface 32 and a seal fixing seat side wall 27, and the seal fixing seat side wall 27 is disposed on the first protrusion a matching third recess 16 that creates a downwardly facing first plane 15 on the seal holder side wall 27, the first projection having a first surface opposite the first plane 15
  • the projection of the first plane 15 and the second plane 20 when the first protrusion is not pressed outward The projection has an overlapping area to ensure that the seal holder 11 does not smoothly move in the guide casing 18 when the first projection is not pressed to the outside force; the first projection is not When pressed to the outside, the projection of the first plane 15 does not have an overlapping area with the projection of the second plane 20, and the seal holder 11 can smoothly move in the guide casing 18.
  • the inner wall of the guiding sleeve is provided with a plurality of guiding protrusions 28, and the sealing member fixing side wall 27 of the sealing member fixing seat is provided with the guiding protrusions 28 Corresponding guide chutes.
  • the pressure supply device 4 provides the required positive or negative pressure during operation of the closed fluid transfer device.
  • the pressure supply device 4 has a strong sealing performance, so that the gas absorbed by the pressure supply device 4 can be well stored, forming a strong air pressure, and capable of providing a required positive or negative pressure. It is ensured that the dangerous fluid does not enter the pressure supply device 4.
  • the seal holder side wall 27 is provided with an upper limit bayonet 13 and a lower limit bayonet 14.
  • the upper limit bayonet 13 and the lower limit bayonet 14 on the side wall 27 of the seal fixing seat are for limiting the sealing seat, and correspondingly, the upper limit bayonet 13 and the lower limit
  • the bayonet 14 can also be disposed on the side wall of the guide casing 18, and a limiting recess corresponding to the upper limit bayonet 13 and the lower limit bayonet 14 is disposed on the seal fixing seat side wall 27.
  • the upper limit bayonet 13 and the lower limit bayonet 14 respectively and the guide An upper end surface of the outer casing and an upper end surface of the limiting hole 21 are in contact to restrict downward movement of the seal fixing seat relative to the guiding outer casing, respectively.
  • the upper limit bayonet 13 contacts the upper end surface of the limiting hole 21
  • the fluid outlet of the first fluid conduit 24 and the fluid outlet of the second fluid conduit 25 are both located inside the first seal.
  • the guiding sleeve is provided with a first recess 22, and the sealing member sidewall 27 is provided with a movable member mounting hole, and the movable member mounting hole is provided with a movable member 12,
  • the other end of the first container piercer 7 has a second recess 9.
  • the radial angle of the movable member mounting hole on the side wall 27 of the seal holder coincides with the radial angle of the first recess 22 on the guide sleeve.
  • a movable member sliding groove 23 is disposed under the first recess 22 .
  • the movable member 12 locks the first container puncturing device 7.
  • the second fluid conduit 25 is at least one, and the first fluid conduit 24 is at least one.
  • the lower portion of the guiding jacket is provided with a mounting hole of the pipe fixing seat 31, or the guiding jacket and the pipe fixing seat 31 are integrally formed.
  • first fluid conduit 24 and the second fluid conduit 25 are mounted on the conduit mount 31, or the first fluid conduit 24 and the second fluid conduit 25 are
  • the pipe fixing seat 31 is an integrally formed structure.
  • the invention also provides a closed fluid transfer method for the above closed fluid transfer device, comprising:
  • the first container is coupled to the first container puncturing device 7 of the fluid transfer device via a first container puncturing device 7;
  • the second container is coupled to the second container puncturing device 6 adapter of the fluid transfer device via a second container puncturing device 6;
  • a first container puncturing device 7 adapter is coupled to the second trocar adapter through a conduit, and a first container puncturing device 7 adapter is coupled to the pressure supply device 4;
  • the liquid in the first container When the first container is filled with liquid, the liquid in the first container is placed under the action of gravity at a position away from the mouth of the first container, while the liquid in the second container is in gravity Under the action of being at a position away from the mouth of the second container, the pressure supply device 4 provides a negative pressure, and the gas in the second container is transferred through the second container puncturing device 6, the fluid transfer device and the first container puncturing device 7.
  • the liquid in the second container enters the first container under the action of the negative pressure to form a mixed solution, and the first container is inverted to make the first
  • the mixed solution in the container is moved by gravity to the mouth of the first container, and the pressure supply device 4 provides a positive pressure to pass the mixed solution in the first container through the first container puncturing device 7, the fluid transfer device and the second
  • the container piercer 6 reaches the second container to achieve a closed transfer of the liquid;
  • the solid powder in the first container is placed under the action of gravity at a position away from the mouth of the first container, while the liquid in the second container is under the action of gravity
  • the position of the mouth of the second container, at which time the pressure supply device 4 provides a negative pressure the gas in the first container enters the pressure supply device 4, and the liquid in the second container enters the first container under the action of the negative pressure.
  • the powder in the first container is mixed with the liquid, and the first container is inverted so that the mixed liquid in the first container is moved by gravity to the position of the mouth of the first container, and the pressure supply device 4 A positive pressure is provided such that the mixed liquid in the first container reaches the second container through the first container puncturing device 7, the fluid transfer device, and the second container puncturing device 6, thereby achieving a hermetic transfer of the liquid.

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Abstract

一种密闭式流体转移装置及一种密闭式流体转移方法，包括第一容器穿刺器（7）、第二容器穿刺器（6）和流体转移器，流体转移器包括第一容器穿刺适配器（3）、第二容器穿刺适配器（5）和压力供给装置（4），第一容器穿刺适配器（3）包括密封件固定座（11）、导向外套（18）、管道固定座（31）、第一流体管道（24）和第二流体管道（25）；密封件固定座（11）与第一容器穿刺器（7）相连接时，第一密封件（26）与第二密封件（10）先紧密连接起来，第一流体管道（24）和第二流体管道（25）穿过两密封件与第一容器（1）相连通；在第一次使用之后第一流体管道（24）和第二流体管道（25）始终处于不与外界接触状态；第二容器（2）中的流体与第一容器（1）中的流体采用内部传送的方式，不与外部空气相接触，避免危险流体与空气或者人体的直接接触。

Description

一种密闭式流体转移装置及一种密闭式流体转移方法 技术领域
本发明涉及流体配制领域，特别是涉及一种密闭式流体转移装置及一种密闭式流体转移方法。
背景技术
涉及危险流体配制和管理的配药人员，容易受到暴露到空气中的危险流体及危险流体蒸汽的伤害，这些危险流体蒸汽可扩散到周围环境。在此，“危险流体”是指任意的可注射材料，与该材料或该材料的蒸汽的接触可导致健康危害。这样的流体的示例性和非限制性例子包括但不限于，细胞毒素、抗病毒药、化疗流体、抗生素和放射药剂，例如赫赛汀(herceptin)、顺铂(cisplatinum)、氟尿嘧啶(fluorouracil)、亚叶酸(leucovorin)、紫杉醇(taxol)、麦特索克特(metatroxat)、注射用盐酸吉西他滨(gemzar)、环磷酰胺(cyclophosphamide)、环磷酰胺(cytoxan)和环磷酰胺注射剂(neosar)，或上述列举流体的液态、固态或气态的组合。
其中，液体或粉末形式的危险流体容纳在管形瓶(第一容器)中，并通常由被提供了保护性衣物、口罩和层流安全柜的配药人员在单独的房间中准备，配药人员利用设置有插管的针筒，即中空注射针，从管形瓶(第一容器)中传送危险流体，危险流体被添加至相应的溶液中。
由于危险流体是有毒的，与危险流体直接进行身体接触或即使暴露至空气中的微小量危险流体蒸汽都会对人体造成损伤，增加引起身体病痛的风险，诸如皮肤癌、白血病、肝损伤、畸形、流产和早产。在传统的危险流体配药过程中，容易产生危险流体暴露至空气中的位置包括，盛放危险流体的容器——诸如管形瓶、瓶子、针筒和静脉注射袋——经历过压而导致危险流体暴露污染空气。针尖上的、管形瓶上的或静脉注射袋密封部的流体溶液残留也可以导致暴露危险流体。因此，需要提供一种避免危险流体配制过程中危险流体易暴露至空气中或危险流体与人体直接接触的流体配制装置，使得危险流体实现在配药装置的内部密闭完成流体的配备过程。
发明内容
本发明的目的是提供一种密闭环境下，实现流体内部转换的一种密闭式流体转移装置及一种密闭式流体转移方法，以解决上述现有技术存在的问题，使危险流体能够在全密闭 的环境下完成危险流体的内部配制，避免危险流体与空气或者人体的直接接触，同时防止医护人员被针刺伤。
为实现上述目的，本发明提供了如下方案：本申请提供一种密闭式流体转移装置，包括第一容器穿刺器、第二容器穿刺器和流体转移器，所述流体转移器包括第一容器穿刺适配器、第二容器穿刺适配器和压力供给装置，所述第一容器穿刺适配器包括密封件固定座、导向外套、第一流体管道和第二流体管道，所述密封件固定座内安装有第一密封件，所述导向外套设在所述密封件固定座外部，所述导向外套的下部设置有管道固定座，所述管道固定座上设置有所述第一流体管道和第二流体管道，所述第一流体管道的尾部与第三流体管道的一端连通，所述第三流体管道的另一端与所述压力供给装置连通，所述第二流体管道的尾部经第四流体管道与所述第二容器穿刺适配器连通，所述第二容器穿刺适配器与所述第二容器穿刺器连通；
所述第一容器穿刺器一端设置在第一容器口部，另一端具有第二密封件；
密封件固定座底面与导向外套底面之间距离为第一距离时，所述第一流体管道的流体出口和所述第二流体管道的流体出口均位于所述第一密封件外部；密封件固定座底面与导向外套底面之间距离为第二距离时，所述第一流体管道的流体出口和所述第二流体管道的流体出口均位于所述第一密封件内部；密封件固定座底面与导向外套底面之间距离为第三距离时，所述第一流体管道的流体出口和所述第二流体管道的流体出口穿过所述第二密封件进入所述第一容器穿刺器的内部，所述第一容器穿刺适配器与所述第一容器穿刺器连通。
优选的，所述第一流体管道的流体出口和所述第二流体管道的流体出口均露出所述管道固定座。
优选的，所述密封件固定座设置有导向孔，所述第二流体管道和所述第一流体管道通过所述导向孔进入所述密封件固定座的内部。
优选的，所述第一容器穿刺器中具有第五流体管道和第六流体管道，所述第五流体管道和第六流体管道的一端均延伸至所述第一容器内，所述第五流体管道和第六流体管道的另一端均延伸至所述第二密封件处。
优选的，所述导向外套上设置有限位孔及限位臂，所述限位臂的根部固定设置在所述限位孔底部且所述限位臂的端部悬空，所述限位臂的端部的内侧具有第一凸起，所述第一容器穿刺器末端设置有第二凸起，所述第一容器穿刺器末端可伸入所述密封件固定座内，所述第一凸起与所述第二凸起接触，所述第二凸起将所述第一凸起压向外侧。
优选的，所述密封件固定座包括密封件固定座底面和密封件固定座侧壁，所述密封件 固定座侧壁上设置有与所述第一凸起相匹配的第三凹陷，所述第三凹陷在所述密封件固定座侧壁上生成朝向下方的第一平面，所述第一凸起具有与所述第一平面相对的第二平面，所述第一凸起未被压向外侧时，所述第一平面的投影与所述第二平面的投影具有重叠区域。
优选的，所述压力供给装置在所述密闭式流体转移装置工作过程中提供所需要的正压或负压。
优选的，所述密封件固定座侧壁上设置有上限位卡口和下限位卡口。
优选的，所述密封件固定座底面与所述导向外套底面之间距离为第一距离时，所述上限位卡口和下限位卡口分别与所述导向外套的上端面、所述限位孔的上端面接触，以分别限制所述密封件固定座相对于所述导向外套的向下、向上运动。
优选的，所述密封件固定座底面与所述导向外套底面之间距离为第二距离时，所述上限位卡口与所述限位孔的上端面接触，所述第一流体管道的流体出口和所述第二流体管道的流体出口均位于所述第一密封件内部。
优选的，所述导向外套上设置有第一凹陷，所述密封件固定座侧壁上设置有活动件安装孔，所述活动件安装孔内放置有活动件，所述第一容器穿刺器的所述另一端具有第二凹陷。
优选的，所述第一凹陷下方设置有活动件滑动槽。
优选的，密封件固定座底面与导向外套底面之间距离为第三距离时，所述活动件将所述第一容器穿刺器锁紧。
优选的，所述第二流体管道至少为1个，所述第一流体管道至少为1个。
优选的，所述导向外套的下部设置有所述管道固定座的安装孔，或者所述导向外套与所述管道固定座为一体成型结构。
优选的，所述第一流体管道和所述第二流体管道安装在所述管道固定座上或者所述第一流体管道和所述第二流体管道与所述管道固定座为一体成型结构。
本发明还提供了一种上述密闭式流体转移装置的密闭式流体转移方法，包括：
第一容器通过第一容器穿刺器与流体转移器的第一容器穿刺器适配器连接；第二容器通过第二容器穿刺器与流体转移器的第二容器穿刺器适配器连接；所述第一容器穿刺器适配器与所述第二穿刺器适配器通过导管相连接，第一容器穿刺器适配器与压力提供装置连接；
当所述第一容器中装有液体时，使所述第一容器内的液体在重力的作用下处于远离所述第一容器的器口位置，同时使所述第二容器内的液体在重力的作用下处于远离所述第二 容器的器口位置，此时压力供给装置提供负压，第二容器内的气体通过第二容器穿刺器、流体转移器和第一容器穿刺器转移至第一容器内，同时第一容器内的气体进入压力提供装置内，第二容器中的液体在负压的作用下进入第一容器中形成混合溶液，此时将第一容器倒置使得第一容器内的混合溶液在重力的作用下移至第一容器的器口位置，压力供给装置提供正压，使第一容器内的混合溶液通过第一容器穿刺器、流体转移器和第二容器穿刺器到达第二容器内，实现液体的密闭转移；
当所述第一容器中装有固体粉末时，使第一容器内的固体粉末在重力的作用下处于远离第一容器的器口位置，同时使第二容器内的液体在重力的作用下处于第二容器的器口位置，此时压力供给装置提供负压，第一容器内的气体进入压力供给装置内，第二容器内的液体在负压的作用下进入第一容器内，此时晃动第一容器，使第一容器内的粉末与液体混合后，将第一容器倒置使得第一容器内的混合液在重力的作用下移至第一容器的器口位置，压力供给装置提供正压，使得第一容器内的混合液通过第一容器穿刺器、流体转移器和第二容器穿刺器到达第二容器内，实现液体的密闭转移。
根据本发明提供的具体实施例，本发明公开了以下技术效果：
本发明提供的一种密闭式流体转移装置中第一容器中存放有液体时，将第一容器中的液体远离第一容器的器口位置，与此同时使第二容器内的液体远离第二容器的器口位置，压力供给装置提供负压，通过与压力供给装置相连接的第一流体管道将第一容器和第二容器中的气体吸出，第一容器和第二容器中产生负压，此时将第二容器倒置第二容器内的液体靠近器口位置，第二容器中的液体依次通过第二容器穿刺器、第二容器穿刺适配器、导管、第四流体管道、第二流体管道和第五流体管道进入第一容器中与第一容器中的液体相混合形成混合溶液，压力供给装置提供正压，使得压力供给装置中的气体进入到第一容器中，第一容器中的混合溶液在气体的压力下回流到第二容器中，重复上述对压力供给装置的操作步骤，使得第一容器中的流体与第二容器中的流体充分混合；相应的当第一容器中存放有固体粉末时，将第一容器中的固体粉末远离第一容器的器口位置，压力供给装置提供负压，通过与压力供给装置相连接的第一流体管道将第一容器中的气体吸出，第一容器和第二容器中产生负压，第二容器内的液体在负压的作用下进入第一容器内，使得第一容器中的固体粉末与第二容器中的液体充分混合。由于压力供给装置通过第三流体管道仅与第一流体管道相连通，且第一流体管道仅允许空气进入和排出(或由于密封状态下压力供给装置中充满空气，在气压的作用下液体不能进入)，压力供给装置中不会进入混合溶液， 从而避免了压力供给装置内壁表面中残留有混合溶液，残留的混合溶液暴露空气或者与人体直接接触，造成的对空气污染或者对人体伤害的问题；
另外，本发明在使用过程中除了进行流体转移工作时第一流体管道的流体出口和第二流体管道的流体出口始终处于密闭状态：密封件固定座底面与导向外套底面之间距离为第一距离时，第一流体管道的流体出口和第二流体管道的流体出口均位于第一密封件外部，当产品经过一个消毒/灭菌程序后，使得当密封件固定座的底面与导向外套的底面之间距离为第一距离时，方便装置充分消毒/灭菌，残留的消毒/灭菌介质解析；密封件固定座底面与导向外套底面之间距离为第二距离时，第一流体管道的流体出口和第二流体管道的流体出口均位于所述第一密封件内部完全与外部隔离；密封件固定座底面与导向外套底面之间距离为第三距离时，第一流体管道的流体出口和第二流体管道的流体出口穿过第二密封件进入第一容器穿刺器的内部，使得第一容器穿刺适配器与第一容器穿刺器连通；由于本装置中具有限位结构，在第一流体管道的流体出口和第二流体管道的流体出口在开始使用以后不会暴露在外界空气中，即在密闭式流体转移装置使用之后密封件固定座底面与导向外套底面之间距离只能恢复到第二位置，避免了第二流体管道的流体出口位置有可能残留的流体混合溶液暴露在空气中对空气造成污染，间接的对人体造成伤害的问题。
再者，本发明中的第一容器穿刺器与第一容器穿刺适配器之间，通过设在第一容器穿刺器的第二凹陷与第一容器适配器中密封件固定座上安装的活动件相配合，使得第一容器穿刺器和第一容器穿刺适配器之间相锁紧，本发明采用活动件锁紧第一容器穿刺器的方式，在第一容器穿刺器向外拔出时由于活动件可以滚动，操作人员仅需克服较小的摩擦阻力即可将第一容器穿刺器与第一容器穿刺适配器分离。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1为密闭式流体转移装置的整体结构示意图；
图2为第一容器穿刺器和第一容器的装配示意图；
图3为密封件固定座的轴向结构示意图；
图4为导向外套的轴向结构示意图；
图5为第一容器穿刺适配器的局部剖视图；
其中，1-第一容器、2-第二容器、3-第一容器穿刺适配器、4-压力供给装置、5-第二容器穿刺适配器、6-第二容器穿刺器、7-第一容器穿刺器、8-第二凸起、9-第二凹陷、10-第二密封件、11-密封件固定座、12-活动件、13-上限位卡口、14-下限位卡口、15-第一平面、16-第三凹陷、17-导向孔、18-导向外套、19-限位臂、20-第二平面、21-限位孔、22-第一凹陷、23-活动件滑动槽、24-第一流体管道、25-第二流体管道、26-第一密封件、27-密封件固定座侧壁、28-导向凸起、29-第四流体管道、30-第三流体管道、31-管道固定座、32-密封件固定座底面、33-导向外套底面。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的目的是提供一种密闭环境下，实现流体内部转换的一种密闭式流体转移装置及一种密闭式流体转移方法，以解决上述现有技术存在的问题，使危险流体能够在全密闭的环境下完成危险流体的内部配制，避免危险流体与空气或者人体的直接接触。
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图和具体实施方式对本发明作进一步详细的说明。
如图1-6所示，本申请提供一种密闭式流体转移装置，包括第一容器穿刺器7、第二容器穿刺器6和流体转移器，所述流体转移器包括第一容器穿刺适配器3、第二容器穿刺适配器5和压力供给装置4，所述第一容器穿刺适配器3包括密封件固定座11、导向外套18、第一流体管道24和第二流体管道25，所述密封件固定座11内安装有第一密封件26，所述导向外套18设在所述密封件固定座11外部，所述导向外套18的下部设置有管道固定座31，所述管道固定座31上设置有所述第一流体管道24和第二流体管道25，所述第一流体管道24的尾部与第三流体管道30的一端连通，所述第三流体管道30的另一端与所述压力供给装置4连通，所述第二流体管道25的尾部经第四流体管道29与所述第二容器穿刺适配器5连通，所述第二容器穿刺适配器5与所述第二容器穿刺器6连通；
所述第一容器穿刺器7一端设置在第一容器1口部，另一端具有第二密封件10；
密封件固定座底面32与导向外套底面33之间距离为第一距离时，所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均位于所述第一密封件26外部；密封件固定座底面32与导向外套底面33之间距离为第二距离时，所述第一流体管道24的流体出 口和所述第二流体管道25的流体出口均位于所述第一密封件26内部；密封件固定座底面32与导向外套底面33之间距离为第三距离时，所述第一流体管道24的流体出口和所述第二流体管道25的流体出口穿过所述第二密封件10进入所述第一容器穿刺器7的内部，所述第一容器穿刺适配器3与所述第一容器穿刺器7连通。
其中，所述第一距离、第二距离和第三距离并不是一个唯一的具体数值，只要能够保证在第一距离时所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均位于所述第一密封件26下端外部；第二距离时所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均位于所述第一密封件26内部；第三距离时所述第一流体管道24的流体出口和所述第二流体管道25的流体出口穿过所述第二密封件10进入所述第一容器穿刺器7的内部，第三距离的优选值为零，即第三距离时所述密封件固定座底面32与导向外套底面33紧密贴合。
所述密封件固定座底面32与导向外套底面33之间距离处于第二距离和第三距离之间时，即所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均由第一密封件26内部进入第二密封件10内部时，所述第一密封件26与所述第二密封件10处于紧密贴合状态，以保证流体出口由第一密封件26内部进入第二密封件10内部过程中保持密闭状态。
所述第二容器穿刺适配器5与所述第二容器穿刺器6连通后，所述第二容器穿刺适配器5与所述第二容器穿刺器6形成密封结构，在所述第二容器穿刺适配器5与所述第二容器穿刺器6连接处所述第二容器穿刺适配器5与所述第二容器穿刺器6上均设置有密封件结构(可以分别为第三密封件、第四密封件)，以保证连接处的密封性能。
在所述密闭式流体转移装置使用之前密封件固定座底面32与导向外套底面33之间距离为第一距离，当产品经过一个消毒/灭菌程序后，使得当密封件固定座的底面与导向外套的底面之间距离为第一距离时，方便装置充分消毒/灭菌，残留的消毒/灭菌介质解析；
在所述密闭式流体转移装置使用之后，由于限位结构的存在，密封件固定座底面32与导向外套底面33之间的距离只能恢复为第二距离，即所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均处于第一密封件26内部的状态，以保证所述密闭式流体转移装置使用之后流体出口及流体管道内部处残留的危险流体不会暴露至空气中或者直接与人体相接触，相应的本发明公开的密闭式流体转移装置中密封件固定座底面32与导向外套底面33之间的初始状态为：密封件固定座底面32与导向外套底面33之间的距离为第一距离或者第二距离。
作为一种优选的实施方式，所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均露出所述管道固定座31。
其中，所述第一流体管道24的流体出口和所述第二流体管道25的流体出口至少为一个，且均露出所述管道固定座31的上表面，所述第一流体管道24的流体出口和所述第二流体管道25的流体出口与所述管道固定座31之间的距离根据实际需要确定，以满足流体内部转移的目的。
作为一种优选的实施方式，所述密封件固定座11设置有导向孔17，所述第二流体管道25和所述第一流体管道24通过所述导向孔17进入所述密封件固定座的内部。
其中，所述导向孔17为设置在密封件固定座底面32上的通孔，所述第二流体管道25和所述第一流体管道24通过所述导向孔17进入所述密封件固定座11的内部，进而进入所述第一密封件26。
作为一种优选的实施方式，所述第一容器穿刺器7中具有第五流体管道和第六流体管道，所述第五流体管道和第六流体管道的一端均延伸至所述第一容器内，所述第五流体管道和第六流体管道的另一端均延伸至所述第二密封件10处。
其中，一个或多个所述第一流体管道24和所述第二流体管道25穿过所述第二密封件10分别进入第五流体管道和第六流体管道，以实现流体的快速、密闭移动。
作为一种优选的实施方式，所述导向外套18上设置有限位孔21及限位臂19，所述限位臂19的根部固定设置在所述限位孔21底部且所述限位臂19的端部悬空，所述限位臂19的端部的内侧具有第一凸起，所述第一容器穿刺器7末端设置有第二凸起8，所述第一容器穿刺器7末端可伸入所述密封件固定座11内，所述第一凸起与所述第二凸起8接触，所述第二凸起8将所述第一凸起压向外侧。
其中，所述第二凸起8相对于所述第二密封件10的位置关系为：所述第二凸起8在所述第二密封件10的上部，所述第二凸起8比所述第二密封件10更靠近所述第一容器1的口部；所述限位臂19为弹性限位臂。
作为一种优选的实施方式，所述密封件固定座包括密封件固定座底面32和密封件固定座侧壁27，所述密封件固定座侧壁27上设置有与所述第一凸起相匹配的第三凹陷16，所述第三凹陷16在所述密封件固定座侧壁27上生成朝向下方的第一平面15，所述第一凸起具有与所述第一平面15相对的第二平面20，所述第一凸起未被压向外侧时，所述第一平面15的投影与所述第二平面20的投影具有重叠区域。
其中，在所述第一凸起未被压向外侧时，所述第一平面15的投影与所述第二平面20 的投影具有重叠区域，以保证在所述第一凸起未受压向外侧力时所述密封件固定座11不能顺利的在所述导向外套18中运动；在所述第一凸起未被压向外侧时，所述第一平面15的投影与所述第二平面20的投影不具有重叠区域，所述密封件固定座11能顺利的在所述导向外套18中运动。
作为一种优选的实施方式，所述导向外套的内壁上设置有多个导向凸起28，所述密封件固定座的所述密封件固定座侧壁27上设置有与所述导向凸起28相对应的导向滑槽。
作为一种优选的实施方式，所述压力供给装置4在所述密闭式流体转移装置工作过程中提供所需要的正压或负压。
其中，所述压力供给装置4具有较强的密封性能，使得所述压力供给装置4吸收的气体能够很好的存储，形成较强的气压，在提供所需要的正压或负压的同时能够保证危险流体不进入压力供给装置4中。
作为一种优选的实施方式，所述密封件固定座侧壁27上设置有上限位卡口13和下限位卡口14。
其中，所述密封件固定座侧壁27上的上限位卡口13和下限位卡口14是为了完成对密封件固定座的限位作用，相应的，所述上限位卡口13和下限位卡口14还可以设置在所述导向外套18的侧壁上，并在所述密封件固定座侧壁27上设置与上限位卡口13和下限位卡口14相对应的限位凹陷。
作为一种优选的实施方式，所述密封件固定座底面32与所述导向外套底面33之间距离为第一距离时，所述上限位卡口13和下限位卡口14分别与所述导向外套的上端面、所述限位孔21的上端面接触，以分别限制所述密封件固定座相对于所述导向外套的向下、向上运动。
作为一种优选的实施方式，所述密封件固定座底面32与所述导向外套底面33之间距离为第二距离时，所述上限位卡口13与所述限位孔21的上端面接触，所述第一流体管道24的流体出口和所述第二流体管道25的流体出口均位于所述第一密封件内部。
作为一种优选的实施方式，所述导向外套上设置有第一凹陷22，所述密封件固定座侧壁27上设置有活动件安装孔，所述活动件安装孔内放置有活动件12，所述第一容器穿刺器7的所述另一端具有第二凹陷9。
其中，所述活动件安装孔在所述密封件固定座侧壁27上的径向角度与所述第一凹陷22在所述导向外套上的径向角度一致。
作为一种优选的实施方式，所述第一凹陷22下方设置有活动件滑动槽23。
作为一种优选的实施方式，密封件固定座底面32与导向外套底面33之间距离为第三距离时，所述活动件12将所述第一容器穿刺器7锁紧。
作为一种优选的实施方式，所述第二流体管道25至少为一个，所述第一流体管道24至少为一个。
作为一种优选的实施方式，所述导向外套的下部设置有所述管道固定座31的安装孔，或者所述导向外套与所述管道固定座31为一体成型结构。
作为一种优选的实施方式，所述第一流体管道24和所述第二流体管道25安装在所述管道固定座31上，或者所述第一流体管道24和所述第二流体管道25与所述管道固定座31为一体成型结构。
本发明还提供了一种上述密闭式流体转移装置的密闭式流体转移方法，包括：
第一容器通过第一容器穿刺器7与流体转移器的第一容器穿刺器7适配器连接；第二容器通过第二容器穿刺器6与流体转移器的第二容器穿刺器6适配器连接；所述第一容器穿刺器7适配器与所述第二穿刺器适配器通过导管相连接，第一容器穿刺器7适配器与压力供给装置4连接；
当所述第一容器中装有液体时，使所述第一容器内的液体在重力的作用下处于远离所述第一容器的器口位置，同时使所述第二容器内的液体在重力的作用下处于远离所述第二容器的器口位置，此时压力供给装置4提供负压，第二容器内的气体通过第二容器穿刺器6、流体转移器和第一容器穿刺器7转移至第一容器内，同时第一容器内的气体进入压力提供装置内，第二容器中的液体在负压的作用下进入第一容器中形成混合溶液，此时将第一容器倒置使得第一容器内的混合溶液在重力的作用下移至第一容器的器口位置，压力供给装置4提供正压，使第一容器内的混合溶液通过第一容器穿刺器7、流体转移器和第二容器穿刺器6到达第二容器内，实现液体的密闭转移；
当所述第一容器中装有固体粉末时，使第一容器内的固体粉末在重力的作用下处于远离第一容器的器口位置，同时使第二容器内的液体在重力的作用下处于第二容器的器口位置，此时压力供给装置4提供负压，第一容器内的气体进入压力供给装置4内，第二容器内的液体在负压的作用下进入第一容器内，此时晃动第一容器，使第一容器内的粉末与液体混合后，将第一容器倒置使得第一容器内的混合液在重力的作用下移至第一容器的器口位置，压力供给装置4提供正压，使得第一容器内的混合液通过第一容器穿刺器7、流体转移器和第二容器穿刺器6到达第二容器内，实现液体的密闭转移。

Claims (17)

  1. 一种密闭式流体转移装置，其特征在于，包括第一容器穿刺器、第二容器穿刺器和流体转移器，所述流体转移器包括第一容器穿刺适配器、第二容器穿刺适配器和压力供给装置，所述第一容器穿刺适配器包括密封件固定座、导向外套、第一流体管道和第二流体管道，所述密封件固定座内安装有第一密封件，所述导向外套设在所述密封件固定座外部，所述导向外套的下部设置有管道固定座，所述管道固定座上设置有所述第一流体管道和第二流体管道，所述第一流体管道的尾部与第三流体管道的一端连通，所述第三流体管道的另一端与所述压力供给装置连通，所述第二流体管道的尾部经第四流体管道与所述第二容器穿刺适配器连通，所述第二容器穿刺适配器与所述第二容器穿刺器连通；
    所述第一容器穿刺器一端设置在第一容器口部，另一端具有第二密封件；
    密封件固定座底面与导向外套底面之间距离为第一距离时，所述第一流体管道的流体出口和所述第二流体管道的流体出口均位于所述第一密封件外部；密封件固定座底面与导向外套底面之间距离为第二距离时，所述第一流体管道的流体出口和所述第二流体管道的流体出口均位于所述第一密封件内部；密封件固定座底面与导向外套底面之间距离为第三距离时，所述第一流体管道的流体出口和所述第二流体管道的流体出口穿过所述第二密封件进入所述第一容器穿刺器的内部，所述第一容器穿刺适配器与所述第一容器穿刺器连通。
  2. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述第一流体管道的流体出口和所述第二流体管道的流体出口均露出所述管道固定座。
  3. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述密封件固定座设置有导向孔，所述第二流体管道和所述第一流体管道通过所述导向孔进入所述密封件固定座的内部。
  4. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述第一容器穿刺器中具有第五流体管道和第六流体管道，所述第五流体管道和第六流体管道的一端均延伸至所述第一容器内，所述第五流体管道和第六流体管道的另一端均延伸至所述第二密封件处。
  5. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述导向外套上设置有限位孔及限位臂，所述限位臂的根部固定设置在所述限位孔底部且所述限位臂的端部悬空，所述限位臂的端部的内侧具有第一凸起，所述第一容器穿刺器末端设置有第二凸起，所述第一容器穿刺器末端可伸入所述密封件固定座内，所述第一凸起与所述第二凸起接触，所述第二凸起将所述第一凸起压向外侧。
  6. 根据权利要求5所述的一种密闭式流体转移装置，其特征在于，所述密封件固定 座包括密封件固定座底面和密封件固定座侧壁，所述密封件固定座侧壁上设置有与所述第一凸起相匹配的第三凹陷，所述第三凹陷在所述密封件固定座侧壁上生成朝向下方的第一平面，所述第一凸起具有与所述第一平面相对的第二平面，所述第一凸起未被压向外侧时，所述第一平面的投影与所述第二平面的投影具有重叠区域。
  7. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述压力供给装置在所述密闭式流体转移装置工作过程中提供所需要的正压或负压。
  8. 根据权利要求6所述的一种密闭式流体转移装置，其特征在于，所述密封件固定座侧壁上设置有上限位卡口和下限位卡口。
  9. 根据权利要求8所述的一种密闭式流体转移装置，其特征在于，所述密封件固定座底面与所述导向外套底面之间距离为第一距离时，所述上限位卡口和下限位卡口分别与所述导向外套的上端面、所述限位孔的上端面接触，以分别限制所述密封件固定座相对于所述导向外套的向下、向上运动。
  10. 根据权利要求8所述的一种密闭式流体转移装置，其特征在于，所述密封件固定座底面与所述导向外套底面之间距离为第二距离时，所述上限位卡口与所述限位孔的上端面接触，所述第一流体管道的流体出口和所述第二流体管道的流体出口均位于所述第一密封件内部。
  11. 根据权利要求6所述的一种密闭式流体转移装置，其特征在于，所述导向外套上设置有第一凹陷，所述密封件固定座侧壁上设置有活动件安装孔，所述活动件安装孔内放置有活动件，所述第一容器穿刺器的所述另一端具有第二凹陷。
  12. 根据权利要求11所述的一种密闭式流体转移装置，其特征在于，所述第一凹陷下方设置有活动件滑动槽。
  13. 根据权利要求11所述的一种密闭式流体转移装置，其特征在于，密封件固定座底面与导向外套底面之间距离为第三距离时，所述活动件将所述第一容器穿刺器锁紧。
  14. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述第二流体管道至少为1个，所述第一流体管道至少为1个。
  15. 根据权利要求1所述的一种密闭式流体转移装置，其特征在于，所述导向外套的下部设置有所述管道固定座的安装孔，或者所述导向外套与所述管道固定座为一体成型结构。
  16. 根据权利要求1或15所述的一种密闭式流体转移装置，其特征在于，所述第一流体管道和所述第二流体管道安装在所述管道固定座上，或者所述第一流体管道和所述第二 流体管道与所述管道固定座为一体成型结构。
  17. 一种密闭式流体转移方法，其特征在于，包括：
    第一容器通过第一容器穿刺器与流体转移器的第一容器穿刺器适配器连接；第二容器通过第二容器穿刺器与流体转移器的第二容器穿刺器适配器连接；所述第一容器穿刺器适配器与所述第二穿刺器适配器通过导管相连接，第一容器穿刺器适配器与压力提供装置连接；
    当所述第一容器中装有液体时，使所述第一容器内的液体在重力的作用下处于远离所述第一容器的器口位置，同时使所述第二容器内的液体在重力的作用下处于远离所述第二容器的器口位置，此时压力供给装置提供负压，第二容器内的气体通过第二容器穿刺器、流体转移器和第一容器穿刺器转移至第一容器内，同时第一容器内的气体进入压力提供装置内，第二容器中的液体在负压的作用下进入第一容器中形成混合溶液，此时将第一容器倒置使得第一容器内的混合溶液在重力的作用下移至第一容器的器口位置，压力供给装置提供正压，使第一容器内的混合溶液通过第一容器穿刺器、流体转移器和第二容器穿刺器到达第二容器内，实现液体的密闭转移；
    当所述第一容器中装有固体粉末时，使第一容器内的固体粉末在重力的作用下处于远离第一容器的器口位置，同时使第二容器内的液体在重力的作用下处于第二容器的器口位置，此时压力供给装置提供负压，第一容器内的气体进入压力供给装置内，第二容器内的液体在负压的作用下进入第一容器内，此时晃动第一容器，使第一容器内的粉末与液体混合后，将第一容器倒置使得第一容器内的混合液在重力的作用下移至第一容器的器口位置，压力供给装置提供正压，使得第一容器内的混合液通过第一容器穿刺器、流体转移器和第二容器穿刺器到达第二容器内，实现液体的密闭转移。
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