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EP3250173B1 - Module d'aiguille creuse - Google Patents

Module d'aiguille creuse Download PDF

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Publication number
EP3250173B1
EP3250173B1 EP16703073.3A EP16703073A EP3250173B1 EP 3250173 B1 EP3250173 B1 EP 3250173B1 EP 16703073 A EP16703073 A EP 16703073A EP 3250173 B1 EP3250173 B1 EP 3250173B1
Authority
EP
European Patent Office
Prior art keywords
hollow needle
channel
transfer device
liquid
gas channel
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
EP16703073.3A
Other languages
German (de)
English (en)
Other versions
EP3250173A1 (fr
Inventor
Gero Eichelkraut
Tobias Festel
Frank Skaper
Martin Bayer
Christoph Merhold
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Raumedic AG
Original Assignee
Raumedic AG
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Filing date
Publication date
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Publication of EP3250173A1 publication Critical patent/EP3250173A1/fr
Application granted granted Critical
Publication of EP3250173B1 publication Critical patent/EP3250173B1/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
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • 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
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • 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
    • A61J1/2075—Venting means for external 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
    • 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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the invention relates to a hollow needle assembly for a transfer device for transferring a liquid between a storage container and at least one further utility container according to the preamble of claim 1. Furthermore, the invention relates to a transfer device with such a hollow needle assembly and a set with a such transfer device and a storage container.
  • a generic transfer device is from the US 4,588,403 known.
  • the transfer device is used to introduce a medicament into a utility container by means of a syringe.
  • An adapter has a hollow needle with a fluid channel and a ventilation gas channel. The channels run parallel to each other.
  • the ventilation gas duct is in fluid communication with a ventilation chamber, the bottom of which is again penetrated by a plurality of ventilation openings.
  • a filter covers the ventilation openings.
  • a transfer device is also out of the US 4,743,243 previously known.
  • a transfer device with a hollow needle assembly is known from the WO 2011/088471 A1 , from the WO 2014/152249 A1 , from the WO 98/32411 A1 , from the US 6,209,738 B1 , from the US 6,537,263 B1 , from the US 5,879,345 and from the WO 2012/119225 A1 , The WO 2008/117178 A2 .
  • WO 03/043564 A1 and US 8,480,645 B1 disclose other known transfer devices.
  • needle-separating edges between the liquid channel openings and the gas channel openings prevent or at least largely avoid a liquid transfer between the liquid channel and the gas channel.
  • a blockage of the gas channel with liquid or unwanted entrainment of liquid droplets through the gas channel is then prevented or at least largely avoided.
  • the separating edge can be sharp-edged.
  • liquid emerging from the liquid channel opening desirably detaches from the hollow needle at the separating edge and thus does not enter the region of the gas channel opening.
  • an adverse overflow of liquid into the gas channel is reduced by acting gravity during injection.
  • sharpening cut edges improve a piercing effect of the hollow needle, which is desired in the transfer device, which usually has to penetrate a closure of the storage container.
  • the at least one liquid channel opening can be designed so that it allows an ejection of liquid with the hollow needle radial movement component, so a lateral ejection. This is advantageous when using the hollow needle assembly within a reconstitution device, namely, when the liquid is not to be injected directly into a medicament powder during injection. As a result, an undesirable foaming of the powder is avoided.
  • the at least one liquid channel opening may be laterally offset relative to a central longitudinal axis of the hollow needle. Such a lateral arrangement of the at least one liquid channel opening reduces the risk that when piercing the hollow needle with the channel opening undesirably a component of a closure plug of a storage container is punched out.
  • the liquid channel opening is at least as far removed from a needle tip at the free needle end of the hollow needle as the gas channel opening.
  • Such an arrangement of the channel openings ensures that when returning the liquid from the storage container into the use container, which usually takes place when using the transfer device by holding it "overhead", the gas channel opening comes to lie above the liquid channel opening , which facilitates venting of the storage container.
  • the at least one liquid channel opening may be further from the needle point than the gas channel opening.
  • the hollow needle assembly comprises exactly one gas channel opening. It preferably has at least two liquid channel openings. Exactly one gas channel opening and at least two liquid channel openings have been found to be particularly suitable for reliable execution of the hollow needle assembly.
  • the annulus reduces the likelihood of clogging of the vent gas channel and, in particular, reduces the likelihood that an often-present downstream air filter will be clogged by undesirable fluid entrained in the gas channel.
  • An air filter prevents unwanted foreign bodies and germs from entering the gas channel. Also leakage of liquid drops, if they actually reach the air filter, to the outside is prevented.
  • a direction reversal channel section represents an additional obstacle to possibly entrained liquid drops.
  • an obstacle effect resulting from the reversal of direction for undesirably entrained liquid drops is again increased.
  • An ascent of air flowing out of the storage container when injecting the liquid into the storage container can be forced.
  • inflowing liquid droplets can be additionally distributed or separated by gravity.
  • the hollow needle assembly according to the two aspects described above can also be embodied with other combinations of the features explained above.
  • a transfer device according to claim 2 and a set according to claim 3 correspond to those in, the above with reference to the hollow needle assemblies according to the invention already explained.
  • a device can be used in particular as a reconstitution device.
  • the storage container can then be a powdered drug, which is first mixed with the transfer device in the connection position on the then connected utility container with a solvent and then transferred via the transfer device in the same or another use container in dissolved form for further use
  • the set may also include at least one utility container, for example in the form of a standard syringe.
  • Fig. 1 to 12 Based on Fig. 1 to 12 is a first embodiment of a device 1 for transferring a liquid between a storage container 2 (see. Fig. 6 ) and at least one further storage container 3 (see. Fig. 6 ). All moldings of the transfer device 1 are made of plastic and are designed in particular as injection-molded parts.
  • the transfer device 1 has a sealing portion 4 for the sealing abutment of a base body 5 (see. Fig. 2 ) of the transfer device 1 on the storage container 2.
  • the sealing portion 4 is applied to an elastomeric sealing plug of the storage container 2a, which will be described below.
  • the sealing portion 4 engages around a neck 6 of the storage container 2 (see. Fig. 5 ).
  • An outer locking sleeve 7 of the transfer device 1 is used to secure the sealing portion 4 in its sealing position.
  • Fig. 1 shows the securing sleeve 7 in a transport position of the transfer device 1 prior to placement on the storage container 2.
  • Fig. 6 shows the securing sleeve 7 in a pushed over the sealing portion 4 securing position, engage in the corresponding locking lug of the locking sleeve 7 in locking receptacles 8 of the sealing portion 4 and press this against the neck 6 of the storage container 2 sealing.
  • the transfer device 1 further has a hollow needle assembly 9 with a hollow needle 10 and a surrounding needle sleeve 11.
  • the hollow needle 10 is designed as a plastic hollow needle.
  • the hollow needle 10 may also be designed at least in sections as a steel cannula. Through the hollow needle 10 there is a liquid transfer between the utility container 3 and the storage container 2 and at the same time a ventilation of these containers 2, 3, as will be explained in more detail below.
  • the hollow needle assembly 9 is by means of a gear 12 relative to the main body 5 linearly along a movement axis 13 (see. Fig. 3 ) relocatable.
  • This movement axis 13 extends coaxially to a central longitudinal axis 14 of the transfer device 1.
  • a displacement of the hollow needle assembly 9 takes place between one example in the FIGS. 2 and 3 shown, retracted rest position and one example in the Fig. 5 shown, extended connection position.
  • the hollow needle 10 provides, inter alia, a fluid connection channel between the storage container 2 and the transfer device 1.
  • This liquid channel extends between a free needle end 15 and an opposite connection portion 16 (see. Fig. 5 ).
  • the connecting portion 16 is an integral part of the hollow needle 10.
  • the connecting portion 16 is for sealing the connection of the transfer device 1 with the use container 3 and is designed as a Luer connection.
  • the use container 3 is designed as a standard syringe with a complementary Luer connection.
  • the transfer device 1 may also be connected differently to the utility container 3, for example by way of another embodiment of a conical connection.
  • the needle sleeve 11 is a separate component to the hollow needle 10.
  • the needle sleeve 11 is circumferentially sealed to the hollow needle 10 at two axial positions, namely on the one hand in the region of the connecting portion 16 facing the end of the needle sleeve 11 (see Fig. 3 ) and on the other hand axially spaced at an opposite connecting portion 18. Between these connecting portions 17, 18 axially and between the hollow needle 10 and the needle sleeve 11 radially is an approximately hollow cylindrical annular space 19th
  • the transfer device 1 further has a multi-part rotary actuator 20 which is connected via the gear 12 with the hollow needle assembly 9 in operative connection.
  • the rotary actuator 20 has an annular cover 21 and an actuator base 22 (see, eg FIGS. 2 and 3 ).
  • the rotary actuator 20 is rotatable relative to the main body 5 of the transfer device 1 about the central longitudinal axis 14.
  • the actuator base body 22 is against the base body 5 of the transfer device 1 via a base seal 23 (see, for example Fig. 2 ) sealed. This creates a closed and in particular germ-tight space within the body.
  • the rotary actuator 20 further includes an outer coupling sleeve 24 which is rotatably connected to the actuator base body 22 and can be understood as part of this body 22.
  • the transmission 12 has an axially and about the central longitudinal axis 14 rotatably mounted in the base body 5 of the transfer device 1 driving ring 25. Radially, the driving ring 25 is located between the base body 5 and the needle sleeve 11th
  • the driver ring 25 has an inner driver, which is designed as an internal thread 26 in the embodiment shown.
  • the internal thread 26 interacts with a complementary thread 27, designed as external thread, the needle sleeve 11 for displacing the hollow needle assembly 9 together.
  • the actuating element base body 22 has a plurality, for example three, axial projections 28 (cf., for example, FIG Fig. 3 ), which, as long as a rotationally fixed connection of the actuating element base body 22 with the driving ring 25, engage in associated axial receptacles 29 of the driving ring 25.
  • the axial lugs 28 and the associated axial receptacles 29 are distributed in the circumferential direction about the central longitudinal axis 14.
  • the axial lugs 28 are integral parts of the actuator base body 22nd
  • a rotation of the hollow needle assembly 9 is given relative to the base body 5 to the central longitudinal axis 14.
  • the needle sleeve 11 to the axial ribs 30 complementary axial guide grooves 31 (see, eg Fig. 11a and 12 ).
  • End faces 32 of these inner axial ribs 30 simultaneously represent an axial seat of the driving ring 25 in the main body 5 of the transfer device.
  • the main body 5 of the transfer device 1 has a lift-off driver 33 designed as an external thread.
  • the latter interacts with a counter-lift-off carrier 34, designed as a complementary internal thread, of the coupling sleeve 24 of the rotary actuating element 20.
  • the interaction of the lift-off cam 33 with the counter-lifting-driver 34 leads to a lifting of the rotary actuator 20 from Basic body 5 of the transfer device 1 for relieving the main body seal 23rd
  • Fig. 4 shows by way of example the correspondingly relieved position in which the actuator base body 22 is lifted off the main body 5 axially.
  • the main body seal 23 may be designed as a silicone lamellar seal. Alternatively, the main body seal 23 may be designed as a hard / hard mechanical seal.
  • the drivers 33, 34 are disengaged, so that the entire rotary actuator 20 from the main body 5 of the transfer device 1 is removable.
  • the transfer device 1 additionally has a locking device 35 for locking the hollow needle assembly 9 in the connecting position. This locking is used to ensure the originality of the transfer device 1 by the displacement of the hollow needle assembly 9 is made irreversible in the connection position.
  • the locking device 35 comprises a latching component 36 on the main body 5 of the transfer device 1, which cooperates with a detent counter-component 37 complementary thereto on the outer wall of the hollow needle 10 latching.
  • Fig. 6 shows the transfer device 1 with the hollow needle assembly 9 in the connecting position with removed rotary actuator 20.
  • the connecting portion 16 of the hollow needle assembly 9 is now accessible from above and not covered by the ring cover 21 of the rotary actuator 20. Due to this accessibility of the connecting portion 16, this can be connected to the Luer connector of the utility container 3.
  • the storage container 2 is sealed in the region of its neck 6 by a stopper 38 in the form of an elastomeric sealing plug or a sealing membrane.
  • a stopper 38 in the form of an elastomeric sealing plug or a sealing membrane.
  • the liquid channel 39 already mentioned above in connection with the displacement of the hollow needle assembly 9 opens between the storage container 2 and the transfer device 1 via two liquid channel openings 40, 41 (cf. Fig. 10 ) outwards.
  • the liquid channel 39 serves to transport liquid through the hollow needle 10.
  • a ventilation gas channel 42 also opens out of the hollow needle 10 via a gas channel opening 43.
  • the ventilation gas duct 42 serves to transport gas through the hollow needle assembly 9, namely for venting or venting the storage container 2 or the use container 3.
  • the channel paths of the liquid channel 39 on the one hand and the gas channel 42 on the other hand are separated from each other.
  • the liquid channel 39 on the one hand and the gas channel 42 on the other hand open axially along the hollow needle 10 adjacent to each other and in the circumferential direction about the central longitudinal axis 14 offset from each other.
  • Between each one of the liquid channel openings 40, 41 and the circumferentially adjacent gas channel opening 43 extends in the longitudinal direction of the hollow needle 10 extending needle-separating edge 44, 45.
  • Another, correspondingly extending in the longitudinal direction of the hollow needle 10 needle-separating edge 46 extends between the two liquid channel openings 40 and 41st
  • the two needle-separating edges 44, 45 between the liquid channel openings 40, 41 and the gas channel opening 43 reduces undesirable liquid transfer between the liquid channel 39 and the vent gas channel 42.
  • the needle-separating edges 44 to 46 serve for reduction of piercing forces of the hollow needle 12 in the sealing plug 38 of the storage container 2.
  • the needle-separating edges 44 to 46 have a cutting action when puncture in the sealing plug 38th
  • the liquid channel openings 40, 41 are axially at least as far away from the needle tip at the free needle end 15 as the gas channel opening 43. In the illustrated embodiment (see. Fig. 9 ), the liquid channel openings 40, 41 are axially further away from the needle tip at the free needle end 15 than the gas channel opening 43.
  • a gas flow path through the ventilation gas channel 42 initially runs via a gas channel section 47, which runs parallel to the central longitudinal axis 14 in the hollow needle 10.
  • the gas channel section 47 opens via a passage opening 48 (cf. Fig. 8a / b ) in the annular space 19 between the hollow needle 10 and the needle sleeve 11 from.
  • the annular space 19 thus forms a portion of the ventilation gas channel 42.
  • the needle sleeve 11 has a plurality of needle sleeve passage openings 49. In total, eight such needle sleeve passage openings 49 are arranged evenly distributed around the central longitudinal axis 14 around.
  • the needle sleeve passage openings 49 provide a flow passage of the ventilation gas channel 42 between the annular space 19 and a further annular space 50 in a bottom side, ie the storage container 2 facing, portion of the needle sleeve 11 in this further annular space 50 is an annular disc-shaped filter carrier 51st arranged, which surrounds the hollow needle 10 annular.
  • the filter support 51 carries a likewise annular air filter 52 of the transfer device 1.
  • the transfer device 1 is used as follows: First, the transfer device 1 in the after Fig. 1 present configuration on the neck 6 of the storage container 2, in which an example powdered medicine is present, placed. Subsequently, the seal securing sleeve 7 is pushed over the sealing portion 4. As a result, the transfer device 1 is secured on the neck 6 of the storage container 2, wherein in particular a tamper-evident closure can be ensured. In addition, secured by the sliding of the sealing-securing sleeve 7 on the sealing portion 4 of this sealing portion 4 and seals the transfer device 1 against the storage container 2 from.
  • the rotary actuator 20 is rotated in the direction indicated by arrow symbols 53 on the outside of the ring cover 21 direction of rotation by 360 ° or an even larger angle of rotation.
  • the driving ring 25 which, axially mounted in the base body 5, now also rotates about the central longitudinal axis 14, thereby axially displaced against the base body 5 but not.
  • the driving ring 25 is secured over undercuts in the base body 5.
  • the threads 26, 27 now begins the displacement of the hollow needle assembly 9 relative to the base body 5 in the direction of the movement axis 13, ie to the storage container 2 to.
  • the entire rotary actuator 20 can be removed and the use of container 3, so the standard hypodermic syringe, can be connected via the Luer coupling with the connecting portion 16 of the transfer device 1.
  • container 3 is a matched to the drug in the storage container 2 solvent.
  • this solvent is injected by actuation of a syringe plunger of the use container 3 via the transfer device 1 into the interior of the storage container 2.
  • the solvent flows through the liquid channel 39 in the hollow needle 10 and exits via the two liquid channel openings 40, 41 from the hollow needle 10 into the storage container 2.
  • the arrangement of the liquid channel openings 40, 41 relative to the gas channel opening 43 reduces an overflow of liquid droplets in the gas channel during injection, since the liquid does not flow in the direction of gravity down and thus during injection in the direction of the gas channel.
  • air escapes from the storage container 2 via the gas channel opening 43 through the ventilation gas channel 42 via the gas channel section 47, the passage opening 48, the annular space 19, the needle sleeve passage openings 49, the annular space 50 , the air filter 52 and from there between the needle sleeve 11 and the main body 5 of the transfer device 1 to the outside.
  • a solution of the initially powdered medicament in the solvent is brought about by shaking the assembly from the storage container 2, the transfer device 1 and the utility container 3.
  • the dissolution of the dissolved drug is transferred via the transfer device 1 from the storage container 2 in the use of container 3.
  • the dissolved medicament flows via the liquid channel 39 through the hollow needle 10 to the storage container 2 into the use container 3.
  • This flow of the dissolved medicament into the use container 3 is produced by mounting the use container 3 designed as a syringe.
  • the transfer of the dissolved drug from the storage container 2 in the use of container 3 is usually in over-head position, in which the storage container 2 is disposed above the utility container 3.
  • the liquid channel openings 40, 41 are closer to a residual solution of the dissolved drug, so that a residual emptying of the solution is improved.
  • the gas channel opening 43 is further away from the remainder of the solution in this overhead position than the liquid channel openings 40, 41, so that the gas channel can perform its ventilation function well.
  • air flows through the ventilation gas channel 42 from the environment around the transfer device 1 through the air filter 52 into the storage container 2.
  • the inflowing air is sterile-filtered by the air filter 52.
  • Fig. 13a and 13b show a variant of a hollow needle assembly 54, which can be used instead of the hollow needle assembly 9 in the transfer device 1.
  • an axial channel body 55 is disposed in the annular space 19. This is designed so that a reversal of the direction of the vent gas channel 42 is not, as in the execution of the Fig. 1 to 12 , in the bottom side, the storage container 2 facing region of the annular space 19 takes place, but approximately at an axial height A of about two-thirds of the total axial height of the annular space 19.
  • the axial channel body 55 effectively suppresses unwanted entrainment of liquid along the entire vent gas channel 42.
  • the path of the gas through the gas channel 42 during venting of the storage container 2 is in the Fig. 13a indicated by a directional arrow 55a.
  • the axial channel body 55 is designed as up to a height of two-thirds of the entire axial height of the annular space 19 sealed sub-segment between the hollow needle 10 and the needle sleeve 11.
  • the passage openings 48 are closed so that an ascent of the air flowing out of the storage container 2 is forced upon injection of the liquid into the storage container 2. The air then flows after the rise and the direction reversal through the remaining openings 48 of the unlocked segment.
  • inflowing liquid droplets are additionally distributed or deposited by gravity.
  • FIG. 14 ff. Another embodiment of a transfer device 56, which instead of the transfer device 1 after the Fig. 1 to 13a / b can be used, is described below on the basis of Fig. 14 ff. described. Components and functions corresponding to those described above with reference to FIGS Fig. 1 to 13a / b have already been described, bear the same reference numbers or designations and will not be discussed again in detail.
  • Fig. 14 shows the transfer device 56 after placement on the storage container 2 and before moving the seal securing sleeve. 7
  • Fig. 15 shows the transfer device 56 after moving the seal securing sleeve 7 in the securing position for the sealing portion. 4
  • Fig. 16 shows the transfer device 56 in a transport configuration.
  • this transport configuration is displaced in the securing position seal-securing sleeve 7 between this and a head portion 57 of a pressure-actuating element 58 of the transfer device 56 a removable securing element 59 introduced in the form of a locking half-ring.
  • the securing element 59 is in a circumferential receiving groove 60 (see. Fig. 15 ) of the head portion 57 of the pressure actuator 58 is inserted.
  • the securing element 59 prevents a displacement of the pressure actuating element 58 relative to a base body 61 (cf. Fig. 17 ) of the transfer device 56 in the direction of the storage container 2 to. An unintentional pressure actuation of the pressure actuating element 58 is thus prevented.
  • the hollow needle assembly 62 is apart from an outer geometry of the needle sleeve 11 constructed as the hollow needle assembly 9.
  • the outer geometry of the needle sleeve 11 of the embodiment according to the FIG. 14 ff. Is designed for a pushing movement and thus eg without the thread 27.
  • the design of the hollow needle assembly 62 with respect to the liquid channel and the ventilation gas channel as in the hollow needle assembly 9 in connection with the Fig. 1 to 12 has already been explained.
  • a guide device 64 For axial guidance of the pressure actuator 58 on the base body 61 in the displacement of the hollow needle assembly 62 from the rest position to the connecting position is a guide device 64.
  • the latter has two guide pins 65 which are integrally formed on an inner side of a jacket wall of the pressure-actuating element 58.
  • the guide pins 65 slide in the displacement of the rest position into the connecting position in each case an associated guide groove 66 which is executed in an outer wall of the main body 61 of the transfer device 56.
  • the guide device 64 is designed such that the displacement of the hollow needle assembly 62 from the rest position to the connecting position is irreversible.
  • the two guide grooves 66 each have a sawtooth profiled groove base 67, which in the Fig. 19 in cross-section and in the Fig. 20a / b is shown for one of the two guide grooves 66 in a perspective view.
  • the profiling of saw teeth in groove base 67 is such that the guide pin 65 can slide on the displacement of the pressure actuating element 58 from the rest position into the connecting position on inclined surfaces of the saw teeth. In the connecting position, a sliding back of the guide pin 65 in the guide grooves 66 upwards is not possible, since the guide pins 65 are then blocked by vertical surfaces of the sawtooth profiling.
  • the guide grooves 66 each continue into a guide helix 68.
  • a twisting of the pressure-actuating element 58 from the main body 61 of the transfer device 56 is possible, as indicated by directional arrows 69, 70 in the Fig. 20a / b indicated.
  • the guide pins 65 of the pressure-actuating element 58 slide in each case in one of the two guide spirals 68 on the outside of the main body 61 of the transfer device 56 until the guide pin 65 at the end of the guide spirals 68 out of engagement with the main body 61.
  • the transfer device 56 After removal of the pressure actuator 58, the transfer device 56 is in the instantaneous position, which in the Fig. 21 is shown. In this instantaneous position, the connecting portion 16 of the hollow needle 63 is accessible from above, as described in connection with the transfer device 1 and the Fig. 6 has already been explained.
  • the transfer device 56 is used as follows: After installation, the transfer device 56 is located together with the storage container 2, in which the powdered medicament is kept, first in the in the Fig. 16 shown transport position with inserted securing element 59 before.
  • the securing element 59 is first withdrawn. Then, pressure is applied to an upper end surface of the pressure actuator 58 from above and the pressure actuator 58 along the directional arrow 71 in the Fig. 17 transferred from the rest position to the connection position. In this shift the guide pin 65 rattling over the saw teeth in the groove bases 67 of the guide grooves 66 to the storage container 2 facing the end of the guide grooves 66. Now, the pressure actuator 58 by rotation are turned off from the main body 61 of the transfer device 56 according to the directional arrow 69, so that the pressure-actuating element can be removed from the base body 61. Now, the use of container 3, so the standard syringe, via the Luer connector to the connecting portion 16 are connected. The remaining handling is, as in connection with the execution of the Fig. 1 to 12 described.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
  • Loading And Unloading Of Fuel Tanks Or Ships (AREA)

Claims (3)

  1. Ensemble d'aiguille creuse (9; 54; 62) pour un dispositif de transfert (1; 56) pour transférer un liquide entre un réservoir de stockage (2) et au moins un autre réservoir d'usage (3)
    - avec une aiguille creuse (10),
    - avec une extrémité pointue libre de l'aiguille (15),
    - avec au moins un canal pour liquide (39), débouchant dans la zone de l'extrémité libre de l'aiguille (15) via une ouverture de canal pour liquide (40, 41), pour transporter du liquide à travers de l'aiguille creuse (10), et
    - avec au moins un canal de ventilation pour gaz (42), débouchant dans la zone de l'extrémité libre de l'aiguille (15) via une ouverture de canal pour gaz (43), pour transporter du gaz à travers de l'ensemble d'aiguille creuse (9; 54; 62),
    - les voies de canaux de l'au moins un canal pour liquide (39) d'un part et de l'au moins un canal de ventilation pour gaz (42) d'autre part se déroulant séparément l'un de l'autre,
    - une section du canal de ventilation pour gaz (42) étant configurée par un espace annulaire (19) entre l'aiguille creuse (10) et un manchon entourant celle-ci (11),
    - un filtre à air annulaire (52) étant disposé en aval de l'espace annulaire (19) dans un trajet d'écoulement de gaz à travers du canal de ventilation pour gaz (42), à partir de l'ouverture de canal pour gaz (43) à l'extrémité libre de l'aiguille (15),
    - le trajet d'écoulement de gaz, entre l'ouverture de canal pour gaz (43) à l'extrémité libre de l'aiguille (15) et le filtre à air (52), présentant une section de canal pour inversion de sens (19), dans laquelle un sens principal axial d'écoulement de gaz s'inverse,
    caractérisé en ce que
    dans l'espace annulaire (19) un corps axial de canal (55) est disposé, provoquant un rallongement d'un trajet axial du canal de ventilation pour gaz (42) devant la section de canal pour inversion de sens.
  2. Dispositif de transfert (1; 56) avec un ensemble d'aiguille creuse (9; 54; 62) selon la revendication 1.
  3. Set comprenant un dispositif de transfert selon la revendication 2 et un réservoir de stockage (2).
EP16703073.3A 2015-01-26 2016-01-22 Module d'aiguille creuse Active EP3250173B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015201288.3A DE102015201288B4 (de) 2015-01-26 2015-01-26 Hohlnadel-Baugruppe
PCT/EP2016/051327 WO2016120163A1 (fr) 2015-01-26 2016-01-22 Module d'aiguille creuse

Publications (2)

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EP3250173A1 EP3250173A1 (fr) 2017-12-06
EP3250173B1 true EP3250173B1 (fr) 2019-06-19

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EP16703073.3A Active EP3250173B1 (fr) 2015-01-26 2016-01-22 Module d'aiguille creuse

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US (1) US20170367931A1 (fr)
EP (1) EP3250173B1 (fr)
AR (1) AR103489A1 (fr)
DE (1) DE102015201288B4 (fr)
DK (1) DK3250173T3 (fr)
ES (1) ES2736848T3 (fr)
TW (1) TW201634034A (fr)
WO (1) WO2016120163A1 (fr)

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Publication number Priority date Publication date Assignee Title
DE102017005791B4 (de) * 2017-06-21 2023-08-10 Jan Willem Marinus Mijers Transfervorrichtung zur Fluidübertragung
ES2802484T3 (es) 2017-08-24 2021-01-19 Epic Medical Pte Ltd Adaptador de vial y sistema de transferencia de líquido
CA3101200A1 (fr) * 2018-06-18 2019-12-26 Becton Dickinson and Company Limited Element de percage pour adaptateur de flacon
DE102020210629A1 (de) 2020-08-20 2022-02-24 B. Braun Melsungen Aktiengesellschaft Filtersystem für ein geschlossenes Fluidtransfersystem mit Druckausgleich

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4588403A (en) * 1984-06-01 1986-05-13 American Hospital Supply Corporation Vented syringe adapter assembly

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US4743243A (en) * 1984-01-03 1988-05-10 Vaillancourt Vincent L Needle with vent filter assembly
DE4010202C2 (de) * 1990-03-30 1995-02-16 Roland Wex Vorrichtung zum Entnehmen von Flüssigkeit aus einem Behältnis, insbesondere einer Flasche, bei gleichzeitiger gefilterter Belüftung des Behältnisses
FR2738550B1 (fr) 1995-09-11 1997-11-07 Biodome Dispositif d'obturation d'un recipient lui-meme ferme, ensemble pour dispenser un produit comprenant un tel recipient et un tel dispositif d'obturation
GB9701413D0 (en) 1997-01-24 1997-03-12 Smithkline Beecham Biolog Novel device
US6209738B1 (en) 1998-04-20 2001-04-03 Becton, Dickinson And Company Transfer set for vials and medical containers
FR2783808B1 (fr) 1998-09-24 2000-12-08 Biodome Dispositif de connexion entre un recipient et un contenant et ensemble pret a l'emploi comprenant un tel dispositif
ITMO20010226A1 (it) * 2001-11-22 2003-05-22 Aries Srl Apparato
US8540686B2 (en) * 2005-03-02 2013-09-24 Covidien Ag Blunt tip vial access cannula
GB0705782D0 (en) * 2007-03-26 2007-05-02 Novartis Ag Vial assemblies
US8480645B1 (en) * 2008-08-22 2013-07-09 Sambhu N. Choudhury Multi-dose device for insertion into a vial and method of using the same
WO2011088471A1 (fr) * 2010-01-15 2011-07-21 Bayer Healthcare Llc Dispositif
ES2593266T3 (es) 2011-03-04 2016-12-07 Duoject Medical Systems, Inc. Sistema de transferencia de conexión fácil
US9089474B2 (en) * 2012-07-13 2015-07-28 Becton Dickinson and Company Ltd. Medical vial access device with pressure equalization and closed drug transfer system and method utilizing same
KR20150130423A (ko) 2013-03-14 2015-11-23 바이엘 헬스케어 엘엘씨 전달 세트

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US4588403A (en) * 1984-06-01 1986-05-13 American Hospital Supply Corporation Vented syringe adapter assembly

Also Published As

Publication number Publication date
DE102015201288A1 (de) 2016-07-28
AR103489A1 (es) 2017-05-10
DE102015201288B4 (de) 2017-01-05
TW201634034A (zh) 2016-10-01
WO2016120163A1 (fr) 2016-08-04
DK3250173T3 (da) 2019-09-23
ES2736848T3 (es) 2020-01-08
EP3250173A1 (fr) 2017-12-06
US20170367931A1 (en) 2017-12-28

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