WO2021099519A1 - Appareil de transfert de fluide médical - Google Patents

Appareil de transfert de fluide médical Download PDF

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Publication number
WO2021099519A1
WO2021099519A1 PCT/EP2020/082780 EP2020082780W WO2021099519A1 WO 2021099519 A1 WO2021099519 A1 WO 2021099519A1 EP 2020082780 W EP2020082780 W EP 2020082780W WO 2021099519 A1 WO2021099519 A1 WO 2021099519A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid container
transfer device
fluid transfer
fluid
medical fluid
Prior art date
Application number
PCT/EP2020/082780
Other languages
German (de)
English (en)
Inventor
Karl Martin Berg
Nathanael Fischer
Florin Kopp
Varaprasad SIKHILE
Jürgen Fuchs
Original Assignee
B. Braun Melsungen Ag
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
Application filed by B. Braun Melsungen Ag filed Critical B. Braun Melsungen Ag
Priority to EP20811560.0A priority Critical patent/EP4061306A1/fr
Publication of WO2021099519A1 publication Critical patent/WO2021099519A1/fr

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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
    • A61J1/2003—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
    • A61J1/201—Piercing means having one piercing end
    • 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
    • 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
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • the invention relates to a medical fluid transfer device for the fluid-tight transfer of a health-endangering drug liquid, comprising a first connector section which has a first passage and is provided for fluid-tight connection to a medical syringe, a second connector section which has a second passage and for fluid-tight connection with a medical liquid container is provided, a fluid channel extending between the first passage and the second passage which - in a ready-to-use state in which the syringe and the liquid container are connected to the respective connector section - allows a fluid-conducting transfer of the medicament liquid between the syringe and the liquid container , and having a volume-variable compensation volume which - in the ready-to-use state - is connected to the liquid container in a fluid-conducting manner, and which is set up to accommodate a volume of gas displaced from the liquid container during the transfer of the medicament liquid.
  • Such a medical fluid transfer device is generally known in the field of medical technology and can also be referred to as a transfer system or closed system transfer device (CSTD).
  • CSTD transfer system or closed system transfer device
  • Such fluid transfer devices are intended for use in the preparation of ready-to-use CMR medicament liquids (Cancerogen Mutagen Reprotoxic) which are hazardous to health due to their carcinogenic, mutagenic and fertility-endangering properties.
  • the known fluid transfer device is intended to enable the medication liquid to be transferred in a fluid-tight manner between the syringe and the liquid container.
  • the known medical fluid transfer device has a first connector section with a first passage and a second connector section with a second passage.
  • the first connector section is provided for fluid-tight connection to a medical syringe.
  • the second connector section is provided for fluid-tight connection to a medical fluid container.
  • the first The passage and the second passage are connected to one another in a fluid-conducting manner by means of a fluid channel. In a ready-to-use state, in which the syringe and the liquid container are connected to the respective connector section, the medicament liquid can thus be transferred between the syringe and the liquid container.
  • the known fluid transfer device provides a volume-variable compensating volume which, in the ready-to-use state, is connected to the liquid container in a fluid-conducting manner.
  • the compensating volume is used to accommodate a gas volume displaced from the liquid container during the transfer of the medicament liquid.
  • the first connector section and the second connector section are designed in the form of an adapter which is pushed onto an opening on the neck of the liquid container.
  • the compensation volume is designed in the form of an elastic bladder protruding laterally from the adapter.
  • the object of the invention is to provide a medical fluid transfer device of the type mentioned at the outset which enables improved application safety and at the same time has the simplest possible structure.
  • a housing arrangement is provided with a receiving space, the liquid container - in the ready-to-use state - being arranged in the receiving space and enclosed in a fluid-tight manner by the housing arrangement.
  • the solution according to the invention counteracts unwanted damage to the liquid container, associated leaks and possible contamination of the environment with the health-endangering drug liquid.
  • the housing arrangement is provided according to the invention.
  • the housing arrangement forms a kind of solid protective cover or container for the liquid container to be received. Since the liquid container in the ready-to-use state is enclosed in a fluid-tight manner by the housing arrangement, contamination of the surroundings is effectively avoided even if the liquid container is destroyed, for example by the fluid transfer device falling or falling.
  • the housing arrangement provided according to the invention prevents medical personnel from touching the liquid container when handling the fluid transfer device and thereby coming into contact with the drug liquid which is hazardous to health.
  • the housing arrangement can be designed in one or more parts.
  • the housing arrangement has a dimensionally stable design, which can be achieved by means of a corresponding choice of material and / or a corresponding dimensioning of the housing arrangement.
  • the housing arrangement is preferably made of dimensionally stable plastic.
  • the receiving space In the ready-to-use state, the receiving space is sealed off in a fluid-tight manner. To bring in the liquid container, the receiving space can be opened and / or is accessible from the outside.
  • the housing arrangement can in particular have an opening that is closed in a fluid-tight manner in the ready-to-use state.
  • the housing arrangement can have housing parts which can be separated from one another and which, in the ready-to-use state, are joined together in a fluid-tight manner to delimit the receiving space.
  • the housing arrangement can serve as a supporting structure for further components and / or sections of the fluid transfer device.
  • the first connector section, the second connector section, the fluid channel and / or the compensating volume can be arranged on the housing arrangement or integrated into the housing arrangement, although this is not mandatory.
  • the first connector section can in particular have a Luer or other medical fluid connection which is set up for a fluid-tight connection to a complementary Luer or fluid connection of the medical syringe.
  • the first passage can, in particular, extend through the first connector section in the form of a lumen or a channel. Depending on the direction of flow of the medicament liquid during the transfer, the first passage can function as an inlet or as an outlet of the fluid transfer device.
  • the second connector section can in particular have a piercing spike which is designed to pierce a section of the medical fluid container provided for this purpose.
  • the second connector section can in particular have a threaded or plug-in section which is designed for a fluid-tight connection with a complementary threaded or plug-in section of the liquid container.
  • the second connector section can have at least one, preferably two, cannulas for insertion into a section of the liquid container provided for this purpose.
  • the insertion mandrel and / or the at least one cannula can in particular be made of plastic, metal or carbon.
  • the second passage can, in particular, extend through the second connector section in the form of a lumen or a channel. Depending on the direction of flow of the medicament liquid during the transfer, the second passage can function as an inlet or as an outlet of the fluid transfer device.
  • the fluid channel forms a fluid-conducting connection between the first passage and the second passage.
  • the health-endangering medication liquid can thus pass from the medical syringe via the first passage into the fluid channel and from there via the second passage into the liquid container, or vice versa.
  • a volume of gas displaced from the medical liquid container is received in a fluid-tight manner in the compensation volume.
  • the compensating volume in the ready-to-use state is connected to the liquid container in a fluid-conducting manner.
  • the compensation volume can in particular be formed by means of an elastic element and / or be separated from a remaining volume of the fluid transfer device.
  • the liquid container to be accommodated in the receiving space can in particular be a bottle, a vial or the like.
  • the liquid container is preferably made from a dimensionally stable plastic or from glass.
  • Such liquid containers are generally known in the field of medical technology for storing and transporting medicament liquids and can also be referred to as vials.
  • a length and / or a diameter of the receiving space is matched to a length and / or a diameter of the liquid container to be received, so that the liquid container - in the ready-to-use state - is positively fixed in the housing arrangement.
  • the form-fitting fixation of the liquid container enables even better protection against damage to be achieved. This is because in the event of an unintentional toppling or falling of the fluid transfer device with the liquid container located therein, the latter is firmly held in the receiving space. In this way, an uncontrolled impact of the liquid container on an inner wall of the receiving space can be avoided.
  • the liquid container can be fixed positively in the axial direction on opposing wall sections of the housing arrangement.
  • the liquid container can be fixed in a corresponding manner in the radial direction.
  • the first connector section and / or the second connector section are integrated into the housing arrangement.
  • the first connector section and / or the second connector section are fixedly, preferably non-detachably, connected to the housing arrangement and / or formed thereon.
  • the housing arrangement is made of plastic
  • the first connector section and / or the second connector section can be molded onto the housing arrangement at least in sections, preferably completely, and / or formed in one piece with it.
  • the first connector section and / or the second connector section can be manufactured separately from the housing arrangement and then firmly joined to the housing arrangement.
  • the first connector section and the second connector section are formed on a removal spike integrated into the housing arrangement.
  • a removal spike is sold by B. Braun Melsungen AG under the name Mini-Spike.
  • the first connector section is preferably designed in the form of a Luer lock connection, but this is not mandatory.
  • the second connector section is designed in the form of a piercing spike.
  • the removal spike also includes the fluid channel extending between the first connector section and the second connector section.
  • the removal spike can in particular have a ventilation channel which serves for the fluid-conducting connection of the liquid container to the compensation volume.
  • the ventilation channel is preferably extended through the piercing spike.
  • the removal spike is preferably manufactured separately from the housing arrangement and then integrated into the housing arrangement by means of a, preferably non-detachable, joint connection.
  • the compensation volume is integrated into the housing arrangement.
  • a further simplified structure of the fluid transfer device can hereby be achieved.
  • the compensation volume is firmly enclosed by the housing arrangement. This can also counteract unintentional damage and any leaks in the compensation volume. With this embodiment of the invention, an even better application security can be achieved.
  • the housing arrangement also functions as a solid protective cover for the compensating volume.
  • an elastic functional element arranged in the housing arrangement is provided, by means of which the compensating volume is separated from the remaining volume of the housing arrangement in a fluid-tight and variable-volume manner.
  • the elastic functional element can in particular be designed in the form of a membrane, a bladder, a balloon, an elastic fluid channel section or the like.
  • the elastic element can enclose the compensation volume completely in a fluid-tight manner. This is the case, for example, when the elastic functional element is designed in the form of a bladder or a balloon.
  • the elastic functional element can only delimit the compensation volume in sections. This is the case, for example, with a design in the form of a membrane.
  • the housing arrangement also serves as a protective cover for the elastic functional element.
  • a gas filter element for filtering the gas volume displaced from the liquid container is integrated into the housing arrangement.
  • the gas filter element can be used to filter and / or separate toxic components from the gas volume. This makes it possible to achieve an even better application security.
  • the gas filter element is particularly advantageous when the displaced gas volume flows into the compensation volume via the receiving space. Because then it is avoided that toxic components accumulate on the outside of the liquid container. Such deposits could contaminate medical personnel if the liquid container were to be removed from the receiving space.
  • the gas filter element preferably has bacteria-proof equipment. As a result of the bacteria-proof equipment, it can be avoided that germs are carried in when the gas flow is directed into the liquid container and that the medication liquid is contaminated as a result.
  • the gas filter element also preferably has a hydrophobic finish. By means of the hydrophobic equipment, an unwanted inflow of the medicament liquid into the housing arrangement can be avoided, which can be advantageous in particular in the event of incorrect operation of the fluid transfer device. Such an incorrect operation can occur, for example, when the medicament liquid is transferred into the liquid container when the fluid transfer device is arranged overhead.
  • the housing arrangement is formed from a plastic that is transparent to view, at least in the area of the receiving space.
  • the recording space can be seen from the outside by the medical staff. This enables an improved visual control of the processes within the recording room.
  • any leaks in the liquid container can be seen directly from the outside.
  • information applied to the liquid container for example in the form of a label, can be read from the outside. This makes it possible to achieve an even better application security.
  • the housing arrangement has at least one upper housing part and one lower housing part, the upper housing part and the lower housing part being joined together in a fluid-tight manner to form the receiving space.
  • the housing arrangement is accordingly designed in at least two parts.
  • the upper housing part and the lower housing part are preferably detachably joined together in a fluid-tight manner, so that the receiving space for receiving the liquid container can be released by releasing the joint between the upper housing part and the lower housing part.
  • a joint connection between the upper housing part and the lower housing part preferably a non-positive and / or positive joining connection is provided.
  • the joint connection can in particular be a latching, plug-in and / or screw connection.
  • a particularly reliable sealing of the receiving space can be achieved if a separate sealing element, for example in the form of an O-ring, is arranged between the upper housing part and the lower housing part.
  • first connector section and the second connector section are integrated into the upper part of the housing.
  • This embodiment of the invention is particularly advantageous when the first connector section and the second connector section are formed on a removal spike.
  • the compensation volume is integrated into the lower part of the housing.
  • an adjusting device assigned to the upper housing part and / or the lower housing part is provided, by means of which at least one dimension of the receiving space can be adapted to accommodate liquid containers of different sizes.
  • the dimensions of the receiving space to be adapted can in particular be an axial length, a width, a depth or a diameter.
  • the adjustable dimension is preferably the axial length of the receiving space.
  • the adjusting device can in particular have a screw or latching mechanism, by means of which the upper housing part and the lower housing part can be moved relative to one another in order to adapt the dimensions and can be fixed to one another in different positions.
  • the adjusting device can have a sliding guide formed between the upper housing part and the lower housing part, which allows relative sliding mobility between the upper housing part and the lower housing part in the axial direction and thus an adjustment of the axial length of the receiving space. For example, a distance between opposing wall sections of the receiving space - depending on the size of the liquid container to be received - can be reduced and / or increased by means of the adjusting device.
  • the upper housing part and the lower housing part can be moved towards and / or away from one another. This is a particularly advantageous embodiment of the invention.
  • the adjustment device is a latching device with a latching geometry arranged on the upper housing part and one on the lower housing part arranged counter-locking geometry, wherein the locking geometry and the counter-locking geometry can be fixed to one another in different locking positions.
  • the upper housing part and the lower housing part are preferably joined together in a fluid-tight manner by means of the latching device.
  • the latching device can have a particularly advantageous multiple function, since in addition to the adaptation of the receiving space, the actual fluid-tight connection between the upper housing part and the lower housing part can also be effected by means of the latching device.
  • a separate sealing element can be assigned to the latching device.
  • the liquid container in particular in the form of a bottle, a vial or a vial, is arranged in the receiving space and is enclosed in a fluid-tight manner by the housing arrangement. Accordingly, in this embodiment of the invention, the liquid container is part of the fluid transfer device. In this embodiment, the liquid container is not only arranged in the housing arrangement in the ready-to-use state, but rather already in a delivery state of the fluid transfer device. As a result, the liquid container is protected from external influences and in particular damage in a particularly simple and effective manner while it is being transported. In this way, possible contamination of the environment is counteracted on the transport route.
  • the liquid container is preferably filled with the drug liquid which is hazardous to health.
  • a fixing device is provided by means of which the liquid container - in the ready-to-use state - is fixed relative to the housing arrangement in the receiving space, the fixing device having a base body which is supported on the housing arrangement and an elastic spring structure connected to the base body has, which acts to fix the liquid container in an elastically resilient manner on an outer diameter of the liquid container.
  • the fixing device is used to fix and / or radially center the liquid container within the receiving space. In this way, a further improved protection against damage to the liquid container and / or an improved positioning of the liquid container relative to the housing arrangement and thus in particular the second connector section can be achieved.
  • the fixing device In the ready-to-use state, the fixing device is arranged together with the liquid container in the receiving space.
  • the fixing device can, for example, first be connected to the liquid container and then introduced into the receiving space together with the latter.
  • the fixing device can first be connected to the housing arrangement and then the liquid container can be connected to the fixing device.
  • the base body preferably acts in the radial direction and / or more axially Direction form-fitting together with the housing arrangement.
  • a non-positive and / or material connection can be formed between the base body and the housing arrangement.
  • the elastic spring structure preferably has an elastically resilient effect in the radial direction on the outer diameter of the liquid container.
  • the outer diameter of the liquid container can also be referred to as the outer circumferential surface.
  • the elastic spring structure preferably acts on a section of the liquid container which is lower in the axial direction of the receiving space and faces away from the second connector section. This section of the liquid container can also be referred to as the bottom section.
  • the base body and the elastic spring structure are preferably designed in one piece, particularly preferably as a plastic injection-molded component. Alternatively, the base body and the elastic spring structure can be designed separately and then connected to one another in a form-fitting, force-fitting and / or material fit.
  • the elastic spring structure is designed to fix liquid containers of different sizes and each designed as a vial with outside diameters of different sizes.
  • Vials are generally known in the medical field as liquid containers for medical liquids and usually have an opening which is typically closed with a septum or an injection stopper that can be pierced with a needle. Vials are also known as “piercing injection vials” or “injection vials”. Vials are manufactured and used in different sizes and usually comply with the ISO 8362-1 and ISO 8536-1 standards. The diameter of the neck of the vials of different sizes is 13 mm, 20 mm, 28 mm and 32 mm (each within certain tolerances).
  • the elastic spring structure is elastically spring-movable to different extents relative to the base body. Depending on the size of the vial, the reaction forces between the spring structure and the outer diameter can vary.
  • the base body has a receiving recess which is designed to receive a bottom section of the liquid container, the elastic spring structure being supported at one end in the radial direction on an inner contour of the receiving recess and at the other end having an elastically resilient effect on the outer diameter of the bottom section in the radial direction .
  • the receiving recess is preferred cylindrically designed and dimensioned to accommodate the different sized vials. To put it simply, the vial for fixing is introduced into the receiving recess with the base section first in the axial direction and fixed in the radial direction by means of the elastic spring structure.
  • the receiving recess is designed to accommodate differently sized outer diameters in the area of the bottom section and in particular allows receiving differently sized bottom sections which, according to the standard, correspond to different neck diameters in the range from 13 to 32 mm.
  • the elastic spring structure has at least one leaf spring element which is curved longitudinally in the radial direction between a first end, which acts on the outer diameter of the liquid container, and a second end, which is supported on the base body.
  • the elastic spring structure is set up to fix vials of different sizes, the at least one leaf spring element for receiving the vials of different sizes deflects elastically to different degrees in the radial direction inwards and / or outwards.
  • the at least one leaf spring element is preferably designed in one piece with the base body.
  • the at least one leaf spring element has an upper flat side and an axially opposite lower flat side, the upper flat side forming a sliding contour for the bottom portion of the vial starting from the second end in the direction of the first end and radially inward is inclined axially downward. Due to the above-described inclination of the upper flat side, the leaf spring element can be elastically deflected in the radial direction under the axial action of the bottom section on the sliding contour. In this case, due to its inclination, the sliding contour generates a radial force component under the axial action of the base section which deflects the at least one leaf spring element correspondingly radially.
  • This refinement of the invention enables the vial to be connected to the fixing device with comparatively little manual effort and nevertheless to be reliably fixed.
  • the elastic spring structure has exactly three leaf spring elements, which are arranged offset from one another by 120 ° in the circumferential direction. This achieves a particularly reliable fixation and, at the same time, a particularly advantageous centering of the vial.
  • the three leaf spring elements preferably have an identical shape.
  • FIG. 1 shows a schematic perspective illustration of an embodiment of a medical fluid transfer device according to the invention, a medical liquid container being arranged in a housing arrangement of the fluid transfer device,
  • FIG. 2 shows the fluid transfer device according to FIG. 2 in a schematic longitudinal sectional illustration
  • FIG. 3 shows the longitudinal section according to FIG. 2 in an exploded view
  • FIG. 4 in a perspective, slightly rotated, schematic longitudinal sectional illustration of a further embodiment of a medical fluid transfer device according to the invention, a further medical liquid container in a housing arrangement in FIG.
  • FIG. 11 shows a schematic exploded view of a further embodiment of a fluid transfer device according to the invention with a fixing device
  • FIG. 12 shows the medical fluid transfer device according to FIG. 11 in an assembled state of the housing arrangement, a medical liquid container being received in the housing arrangement and fixed by means of the fixing device
  • FIG. 13 shows the fixing device of the medical fluid transfer device according to FIGS. 11 and 12 in a perspective detailed representation
  • FIGS. 13 and 14 shows a schematic top view of the fixing device according to FIGS. 13 and
  • FIGS. 13 and 14 shows a partially cut-away longitudinal section of the fixing device according to FIGS. 13 and 14.
  • a medical fluid transfer device 1 is provided for the fluid-tightly sealed transfer of a health-endangering drug liquid between a medical liquid container 2 and a medical syringe not shown in any further drawing.
  • the liquid container 2 is not part of the fluid transfer device 1.
  • the fluid transfer device can instead have a liquid container.
  • the drug liquid to be transferred is a so-called CMR drug liquid, which is classified as hazardous to health due to its carcinogenic, mutagenic and reproductive properties.
  • the ready-to-use preparation of such a health-endangering medicament liquid it is fed to the liquid container 2 or removed from it by means of the syringe.
  • the fluid transfer device 1 By means of the fluid transfer device 1, a contamination of the surroundings by the medicament liquid is to be avoided in particular.
  • the fluid transfer device 1 allows a fluid-tight or airtight or hermetically sealed transfer of the medicament liquid. In this case, in particular, an escape of air contaminated with the medicament liquid from the liquid container 2 into the environment is to be avoided.
  • the medical fluid transfer device 1 has a first connector section 3 with a first passage 4 and a second connector section 5 with a second passage 6.
  • the first connector section 3 is provided for a fluid-tight connection with the said medical syringe.
  • the second connector section 5 is provided for fluid-tight connection to the medical liquid container 2.
  • the first connector section is designed in the form of a Luer lock connection 3, but this is not mandatory.
  • the first connector section 3 can, for example, be in the form of another in the field of medical technology known fluid coupling be formed.
  • the first connector section 3 is connected in a basically known manner to a complementary connector section of the medical syringe, so that a fluid-tight transfer of the medicament liquid between the syringe and the first passage is ensured.
  • the second connector section is designed in the form of a piercing spike 5, the second passage extending through the piercing spike 5 in the form of a lumen 6.
  • the second connector section 5 can instead be designed in particular as a screw or plug-in section.
  • the design of the second connector section as a piercing spike 5 is not mandatory.
  • the piercing spike 5 is inserted in a basically known manner into a section of the liquid container provided for this purpose. As a result, the medicament liquid can be transferred between the liquid container and the second passage 6.
  • the medical liquid container 2 is designed in the form of a vial made of plastic or glass.
  • vials are generally known in the field of medical technology for storing and transporting medical liquids and can also be referred to as vials.
  • the liquid container 2 has a stopper 7, which closes an unspecified frontal opening of the liquid container 2 in a fluid-tight manner in a basically known manner and is set up for piercing by means of the piercing spike 5.
  • a fluid channel 8 extends between the first passage 4 and the second passage 6.
  • the fluid channel 8 connects the first connector section 3 and the second connector section 5 to one another in a fluid-conducting manner, so that the medication liquid, starting from the syringe, can pass through the first passage 4 into the fluid channel 8 and from there via the second passage 6 into the liquid container 2. Conversely, starting from the liquid container 2, the medicament liquid can pass through the second passage 6 into the fluid channel 8 and from there via the first passage 4 into the medical syringe.
  • the fluid transfer device 1 provides a compensating volume 9 of variable volume.
  • the compensating volume 9 is connected in a fluid-conducting manner to the liquid container 2 in a manner which will be described in more detail.
  • the compensation volume is used for the environment Airtight receptacle of a gas volume displaced from the liquid container 2 during the transfer of the medicament liquid.
  • the fluid transfer device 1 has a housing arrangement 10 with a receiving space 11.
  • the receiving space 11 is provided for receiving the liquid container 2.
  • the housing arrangement 10 encloses the liquid container 2 in a fluid-tight manner. Accordingly, the housing arrangement 10 forms a solid protective cover and / or a type of container for the liquid container 2. In this way, the risk of damage to the liquid container 2 in the event of a fall or tipping or other external mechanical influences can be minimized.
  • the housing arrangement 10 can be opened in a manner which will be described in more detail.
  • the liquid container 2 can be introduced into the receiving space 11.
  • the receiving space 11 can then again be closed in a fluid-tight manner.
  • an unspecified axial length of the receiving space 11 is matched to an axial length of the liquid container 2, so that it is positively fixed in the housing arrangement 10 in the accommodated state.
  • the axial dimension of the receiving space 11 is matched to a container size of the liquid container 2, so that it is secured against undesired slipping in the housing arrangement 10 in the received state. If the fluid transfer device 1 with the liquid container 2 located therein falls over or falls down, the latter is thereby protected against damage in a further improved manner.
  • the housing arrangement 10 is made of dimensionally stable plastic, but this is not mandatory. In an embodiment not shown, the housing arrangement 10 can instead be made of metal or some other dimensionally stable material.
  • the housing arrangement 10 in the present case is made of a plastic K that is transparent to view in the area of the receiving space 11.
  • the receiving space 11 can be viewed in a simple manner from the outside when the housing arrangement 10 is closed.
  • both the first connector section 3, the second connector section 5 and the compensating volume 9 are integrated into the housing arrangement 10 in a manner which will be described in more detail.
  • such a design is not mandatory.
  • the compensation volume 9 can be arranged, for example, away from the housing arrangement and connected to the housing arrangement 10 and the liquid container 2 located therein by means of a corresponding fluid-conducting connection. The same can apply to the first connector section 3 and the first passage 4 located thereon.
  • the connector sections 3, 5 and the compensating volume 9 By integrating the connector sections 3, 5 and the compensating volume 9, a particularly compact design is achieved.
  • the said components and / or sections are protected from damage in an improved manner as a result of the integration.
  • the first connector section 3 and the second connector section 5 are formed on a removal spike 12 integrated into the housing arrangement 10.
  • Removal spikes are generally known as such in the field of medical technology.
  • B. Braun Melsungen AG sells a removal spike under the name Mini-Spike.
  • the removal spike 12 is a separate component which is arranged in sections within the housing arrangement 10 and is firmly connected to it.
  • the first connector section 4 protrudes from the housing arrangement 10 at the end.
  • the connector sections 3, 5 can be formed in one piece on the housing arrangement 10.
  • an elastic functional element 13 can also be seen, which is assigned to the compensation volume 9.
  • the elastic functional element 13 is integrated into the housing arrangement 10 and ensures, in a manner which will be described in more detail below, a design of the compensating volume that is variable in volume and a fluid-tight absorption of gas displaced from the liquid container 2.
  • the elastic functional element is a membrane 13, which is fixed on its outer circumference in a fluid-tight manner on a housing wall of the housing arrangement 10, which is not designated in any more detail.
  • the compensation volume 9 is connected to the liquid container 2 in a fluid-conducting manner via the receiving space 11 and a ventilation duct 14 connected to the receiving space 11 in a fluid-conducting manner.
  • the ventilation channel 14 is assigned to the second connector section 5. More precisely, the ventilation channel 14 is present on the piercing spike 5 of the Removal spikes 12 are formed and connected to the receiving space 11 in a fluid-conducting manner via an outlet opening 15 arranged on the removal spike 12.
  • a gas filter element 16 is provided in the present case.
  • the gas filter element 16 is provided for filtering the gas volume displaced from the liquid container 2 and is integrated into the housing arrangement 10.
  • a gas filter element 16 does not necessarily have to be provided.
  • the gas filter element 16 is designed as a component of the removal spike 12 and is fixed to it.
  • the liquid container 2 is first arranged in the receiving space 11 and the housing arrangement 10 is joined together in a fluid-tight manner in a manner which will be described in more detail to close the receiving space 11.
  • the piercing spike 5 is pierced in the axial direction A through the stopper 7 of the liquid container 2, so that a fluid-conducting connection is formed between the liquid container 2 and the second passage 6.
  • a medical syringe filled with the medicament liquid is connected to the first connector section 3 in a fluid-tight manner in the manner described above.
  • the medical syringe is manually operated in a generally known manner, so that the medicament liquid is injected via the first passage 4 into the fluid channel 8 and from there via the second passage 6 into the liquid container 2.
  • the injected medicament liquid displaces a volume of gas from the liquid container 2.
  • the gas volume passes via the ventilation channel 14 through the outlet opening 15 of the removal spike 12. From there, the gas volume passes through the gas filter element 16 and into the receiving space in a manner not shown in the drawing 11.
  • the gas volume is filtered by means of the gas filter element 16.
  • the gas volume passes through a passage opening 17 formed on the housing arrangement 10 into the compensating volume 9.
  • the elastic functional element 13 arches downwards in the axial direction A in relation to the plane of the drawing in FIG Compensation volume to accommodate the gas volume is increased.
  • the downward bulging state of the elastic functional element 13 is illustrated by the dashed line 18 in FIG. 2.
  • the gas volume remains hermetically in the compensation volume 9 or the Enclosed housing assembly 10, so that contamination of the environment with toxic components of the drug liquid is avoided.
  • the fluid transfer device 1 To remove medicament liquid from the liquid container 2, the fluid transfer device 1 is usually oriented against the earth's gravity vector g, so that the first connector section 3 is rotated by approximately 180 ° with respect to the plane of the drawing in FIG. 2. By manually pulling up the syringe, the medicament liquid is sucked into the fluid channel 8 via the second passage 6 and from there passes through the first passage 4 into the syringe. The negative pressure caused by this in the liquid container 2 is compensated for by a subsequent flow of a volume of gas through the ventilation channel 14.
  • the equalizing gas volume is sucked from the equalizing volume 9 via the passage 17 into the receiving space 11 and from there via the gas filter element 16 and the outlet opening 15 into the ventilation channel 14 and from there into the liquid container 2 in the axial direction A upwards, which should be made clear by means of a dashed line 18 '.
  • the housing arrangement 10 is designed in several parts in the present case, but this is not mandatory.
  • the housing arrangement 10 has an upper housing part 19 and a lower housing part 20, the upper housing part 19 and the lower housing part 20 being joined together in a fluid-tight manner to form the receiving space 11.
  • the upper housing part 19 in the present case has a bell-shaped or hood-shaped shape.
  • the upper housing part 19 has a hollow cylindrical shaft section 21 and a dome section 22 which is formed in one piece on the shaft section 21 and is arched in the manner of a dome.
  • the removal spike 12 is arranged in the dome section 22, the first connector section 3 protruding from the dome section 22 at the end in the axial direction A.
  • the entire upper housing part 19 is made of the transparent plastic K, but this is not mandatory.
  • the lower housing part 20 has a base-like basic shape and to this extent can also be referred to as a base.
  • the lower housing part 20 is provided with a planar support surface 23, which is provided for setting up the fluid transfer device 1 on a table surface or the like.
  • the lower housing part 20 also has a receiving section 24 on which the liquid container 2 is supported in the ready-to-use state.
  • the compensation volume 9 is together with the elastic functional element 13 in the Housing lower part 20 integrated.
  • the passage opening 17 is arranged on the lower housing part 20 and extends through the receiving section 24.
  • the upper housing part 19 and the lower housing part 20 are in the present case connected to one another in a form-fitting manner by means of a latching device 25.
  • the latching device 25 has a plurality of latching hooks 26 which are arranged at a distance from one another in the circumferential direction and which are formed on the lower housing part 20.
  • the latching hooks 26 cooperate with an annular shoulder 27 arranged on the upper housing part 19.
  • a sealing element 28 is also provided in the present case (FIG. 3).
  • the sealing element is designed in the form of an O-ring 28.
  • the liquid container 2 is placed on the receiving section 24 of the lower housing part 20.
  • the upper housing part 19 is aligned coaxially with the lower housing part 20 and is joined to the lower housing part 20 in the axial direction A.
  • the latching hooks 26 engage behind the annular shoulder 27 in a form-fitting manner and the sealing element 28 rests in a fluid-tight manner on an inner wall of the shaft section 21, which is not designated in any more detail.
  • the joining connection effected in this way is embodied in the present case in a non-detachable manner, so that the upper housing part 19 and the lower housing part 20 cannot be separated from one another in a non-destructive manner.
  • FIGS. 4 to 15 essentially correspond to the embodiment described above with reference to FIGS. 1 to 3. To avoid repetition, reference is therefore made to the disclosure relating to the embodiment according to FIGS. 1 to 3. Only the essential differences between the embodiments according to FIGS. 4 to 15 are discussed below. Functionally and / or structurally identical sections and parts of the embodiments according to FIGS. 4 to 15 are provided with the same reference numerals with the addition of lowercase letters.
  • the fluid transfer device 1a according to FIGS. 4 to 10 differs essentially from the fluid transfer device 1 by an adjustment device V.
  • the adjustment device V is assigned to the upper housing part 19a and the lower housing part 20a and allows the receiving space 11a to be adapted to accommodate liquid containers 2, 102 of different sizes , 202, which can be seen from FIGS. 5 to 7.
  • the adjustment device is a locking device V with a locking geometry R arranged on the upper housing part 19a and a counter-locking geometry R ′ arranged on the lower housing part 20a.
  • the latching geometry R and the counter-latching geometry R ' can be fixed to one another in different latching positions, as is illustrated with reference to FIGS. 8 to 10.
  • a design of the adjustment device as a latching device V is not mandatory, however.
  • the adjustment device can be designed, for example, in the form of a screw device, by means of which the upper housing part and the lower housing part can be screwed together to different extents in order to adapt the receiving space.
  • the latching geometry R is in the present case formed by a wave-shaped profiled and hollow cylindrical shaft section 21a of the upper housing part 19a.
  • the counter-locking geometry is an annular shoulder R ‘, which is arranged at one end of the lower housing part 20a.
  • the annular shoulder R protrudes outward in the radial direction from the lower housing part 20a.
  • the upper housing part 19a can be snapped onto the lower housing part 20a in different positions in the axial direction A.
  • the fluid transfer device 1b according to FIGS. 11 and 12 differs essentially in a fixing device 50 from the fluid transfer device 1 according to FIGS. 1 to 3 and the fluid transfer device 1a according to FIGS. 4 to 10.
  • the fixing device 50 is used to fix the liquid container 302 inside of the receiving space 11b.
  • the liquid container 302 is centered in relation to the second connector section 5b. In the configuration that can be seen with reference to FIG. 12, the fixing device 50 is received together with the liquid container 302 in the receiving space 11b.
  • the fixing device 50 has a base body 51 and an elastic spring structure F.
  • the elastic spring structure F is designed in a manner that will be described in more detail and is connected to the base body 51.
  • the base body 51 is connected to the housing arrangement 10b and, for this purpose, interacts with the upper housing part 19b and / or the lower housing part 20b in a non-positive, positive and / or material fit.
  • an outer circumferential surface 511 of the base body 51 interacts in a form-fitting manner with an inner contour, not designated in any more detail, of the upper housing part 19b.
  • the base body 51 has a cylindrical annular wall 512 which extends in the axial direction A and which is closed at one end in the axial direction by means of an end wall 513.
  • the base body 51 has a cup-shaped and / or pot-shaped shape.
  • the ring wall 512 delimits a receiving recess 514, which is designed to receive a bottom section 302 ‘of the liquid container 302.
  • the bottom section 302 is arranged on the underside of the liquid container 302 in the axial direction in relation to the orientation shown in FIG. 12.
  • the liquid container 302 has a neck section 302 ′′.
  • the fixing device 50 acts exclusively on the floor section 302 ‘. An interaction with the neck section 302 ′′ is not provided.
  • the liquid container 302 is again designed as a vial.
  • the elastic spring structure F is arranged within the receiving recess 514 of the base body 51. At one end in the radial direction r, the elastic spring structure F is supported on an inner contour 515 of the annular wall 512. At the other end in the radial direction, the elastic spring structure F acts in an elastically resilient manner on the outer diameter D of the bottom section 302 ‘.
  • the elastic spring structure F and the base body 51 are integrally connected.
  • the fixing device 50 is to be manufactured as a one-piece plastic injection-molded component.
  • the fixing device can be made of metal, in particular in one piece.
  • the elastic spring structure F is relatively movable relative to the base body 51 in the radial direction r.
  • the elastic spring structure F for receiving the bottom section 302 ‘in the receiving recess 514 springs outward in the radial direction r.
  • the elastic spring structure F acts in a spring-preloaded inward radial direction r on the outer diameter D of the bottom section 302 ‘.
  • the elastic spring structure has exactly three leaf spring elements 52, 53, 54. These can also be referred to as first leaf spring element 52, second leaf spring element 53 and third leaf spring element 54.
  • the elastic spring structure F has fewer leaf elements, for example one or two leaf spring elements, or instead more than three leaf spring elements, for example four, five or six leaf spring elements.
  • leaf spring elements 52, 53, 54 have an identical design, so that only the first leaf spring element 52 is referred to in detail below in order to avoid repetition. What has been disclosed in relation to the first leaf spring element 52 also applies accordingly with regard to the second leaf spring element 53 and the third leaf spring element 54.
  • the first leaf spring element 52 is elongated in a curved manner in the radial direction r between a first end 521 and a second end 522.
  • the first end 521 is arranged radially on the inside and, in the configuration shown in FIG. 12, acts on the outer diameter D of the bottom section 302 ‘.
  • the second end 522 is arranged on the outside in the radial direction r and is supported on the base body 51.
  • the first leaf spring element 52 has an upper flat side 523 and a lower flat side 524 opposite in the axial direction A.
  • the lower flat side 524 is oriented parallel to the end wall 514 and separated from it, so that the above-described relative mobility of the first leaf spring element 52 with respect to the base body 51 is ensured.
  • the upper flat side 523 is inclined relative to the lower flat side 524.
  • the upper flat side 523 starting from the second end 522, slopes radially inward in the direction of the first end 521.
  • the first leaf spring element 52 tapers in the radial direction from the outside to the inside.
  • the first leaf spring element 52 has a variable height. This height is variable between a minimum height H1 and a maximum height H2 above the radial longitudinal extent of the first leaf spring element 52 (FIG. 15).
  • the minimum height H1 is in the area of the first end 521.
  • the maximum height H2 is in the area of the second end 522 and in the present case corresponds to the axial extent of the ring wall 512.
  • the upper flat side 513 forms a sliding contour G, which is provided for sliding cooperation with a lower end of the base section 302 '(not designated in more detail).
  • the lower end of the bottom section 302 ' forms the bottom of the liquid container 302. Due to the longitudinal extension of the first leaf spring element 52 curved in the radial direction r and the above-described design of the upper flat side 523 or the sliding contour G, the first leaf spring element 52 deviates outward in the radial direction r off as soon as the liquid container 302 is pressed in the axial direction A from top to bottom and onto the sliding contour G.
  • the elastic spring structure F is set up for fixing vials of different sizes with outside diameters of different sizes.
  • the dashed, drawn diameter D1 has a minimum outer diameter.
  • the diameter D2 drawn in dashed lines symbolizes a maximum diameter of the vial to be fixed.
  • the fixing device 50 is set up for fixing and centering vials of different sizes with different neck diameters of 13, 20, 28 and 32 mm. Such neck diameters are typical of conventional medical vials and follow from the relevant standards.
  • the minimum diameter D1 which can be seen with reference to FIG.
  • the maximum outside diameter D2 is a neck diameter of 32 mm.
  • the leaf spring elements 52, 53, 54 assume approximately the configuration shown in FIG. 14.
  • the leaf spring elements 52, 53, 54 are each bent radially outward so that the respective first end touches or almost touches the inner contour 515 of the base body 51.
  • the fixing device 50 and the liquid container 302 are first connected to one another.
  • the liquid container 302 is introduced into the receiving recess 514 with its bottom section 302 'first in the axial direction. This is done under manual pressure.
  • the bottom contact of the liquid container 302 on the upper flat sides of the leaf spring elements 52, 53, 54 pushes them outward in the radial direction, the bottom of the liquid container 302 sliding relative to the respective sliding contour G.
  • the leaf spring elements 52, 53, 54 are spring-loaded far enough outward in the radial direction r, the bottom section 302 'engages the respective first end 521 in the axial direction A.
  • the fixing device 50 together with the liquid container 302 is placed on an unspecified upper side of the lower housing part 20b and, if necessary, fastened.
  • the upper housing part 19b is slipped in the axial direction over the lower housing part 20b and the liquid container 302 located thereon together with the fixing device 50 and moved downward so that it can slide relative to the lower housing part 20b until the second connector section 5b penetrates the liquid container 302 in the axial direction A. .
  • the sliding displacement of the upper housing part 19b allows the axial length of the receiving space 11b to be adapted to the respective size of the vial.

Landscapes

  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un appareil de transfert de fluide médical pour le transfert étanche aux fluides d'un fluide médicamenteux dangereux pour la santé, ledit appareil comprenant : une première partie de connexion, qui a un premier passage et est conçue pour une connexion étanche aux fluides à une seringue médicale ; une seconde partie de connexion, qui a un second passage et est conçue pour une connexion étanche aux fluides à un réservoir de fluide médical ; un canal de fluide s'étendant entre le premier passage et le second passage, qui, dans un état prêt à être utilisé dans lequel la seringue et le réservoir de fluide sont connectés à la partie de connexion respective, permet un transfert conducteur de fluide du fluide médicamenteux entre la seringue et le réservoir de fluide ; et un volume d'égalisation à volume variable, qui, lorsqu'il est prêt à être utilisé, est relié par conduction fluidique au réservoir de fluide, et qui est conçu pour recevoir un volume de gaz déplacé pendant le transfert du fluide médicamenteux hors du réservoir de fluide. Selon l'invention, une unité de boîtier comportant une chambre de réception est prévue, le réservoir de fluide, lorsqu'il est prêt à être utilisé, étant situé dans la chambre de réception et étant entouré par l'unité de boîtier d'une manière étanche aux fluides. L'invention concerne également une utilisation dans une thérapie de perfusion.
PCT/EP2020/082780 2019-11-20 2020-11-19 Appareil de transfert de fluide médical WO2021099519A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20811560.0A EP4061306A1 (fr) 2019-11-20 2020-11-19 Appareil de transfert de fluide médical

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019217908.8A DE102019217908A1 (de) 2019-11-20 2019-11-20 Medizinische Fluidübertragungsvorrichtung
DE102019217908.8 2019-11-20

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WO2021099519A1 true WO2021099519A1 (fr) 2021-05-27

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140183094A1 (en) * 2011-09-07 2014-07-03 Terumo Kabushiki Kaisha Medical container and method of manufacturing the same
US20160151242A1 (en) * 2011-04-12 2016-06-02 Roche Diagnostics International Ag Connector Device
EP3470142A1 (fr) * 2017-10-11 2019-04-17 Orthogen AG Dispositif doté d'une première chambre permettant de recevoir un liquide biologique
US20190298612A1 (en) * 2018-03-30 2019-10-03 Adienne Pharma & Biotech Sa Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutrirional substances to be administered to patients by infusion or injection

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150320640A1 (en) * 2012-07-02 2015-11-12 Novo Nordisk Healthcare Ag Method of Manufacturing a Medical Device
ES2596519T3 (es) * 2012-07-13 2017-01-10 Becton, Dickinson And Company Ltd. Dispositivo de acceso a un vial médico con sistema de igualación de presión y de transferencia cerrada de medicamentos y método de utilización del mismo
WO2015161047A1 (fr) * 2014-04-16 2015-10-22 Becton Dickinson and Company Limited Dispositif de transfert de fluide avec partie à déplacement axial et en rotation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160151242A1 (en) * 2011-04-12 2016-06-02 Roche Diagnostics International Ag Connector Device
US20140183094A1 (en) * 2011-09-07 2014-07-03 Terumo Kabushiki Kaisha Medical container and method of manufacturing the same
EP3470142A1 (fr) * 2017-10-11 2019-04-17 Orthogen AG Dispositif doté d'une première chambre permettant de recevoir un liquide biologique
US20190298612A1 (en) * 2018-03-30 2019-10-03 Adienne Pharma & Biotech Sa Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutrirional substances to be administered to patients by infusion or injection

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EP4061306A1 (fr) 2022-09-28

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