Apparatus for Transferring a Liquid Between a Storage Container and At Least One Further Use Container
20180000690 · 2018-01-04
Inventors
- Gero Eichelkraut (Dresden, DE)
- Tobias Festel (Sparneck, DE)
- Frank Skaper (Leupoldsgrün, DE)
- Martin Bayer (Rödental, DE)
- Christoph Merhold (Hof, DE)
Cpc classification
International classification
Abstract
An apparatus for transferring a liquid between a storage container and at least one further use container has a storage-container sealing portion for leaktight abutment of a main body of the transfer apparatus against the storage container. A hollow-needle assembly has a hollow needle. The hollow-needle assembly can be displaced in a linear manner along a movement axis relative to the main body by means of a gear mechanism between a retracted rest position and an extended connecting position. In the latter, the hollow needle creates a liquid connecting duct between the storage container and the transfer apparatus. A connecting portion serves to connect the transfer apparatus to the use container in a leaktight manner. A rotary-actuation element is operatively connected to the hollow-needle assembly via the gear mechanism. The gear mechanism has a driver ring that is mounted in the main body axially and so as to be rotatable about the movement axis. Said driver ring interacts with a complementary thread of the hollow-needle assembly for the displacement thereof. The driver ring is connected to the rotary-actuation element for conjoint rotation during the displacement. This results in a transfer apparatus having improved operational reliability, in particular when used by inexperienced patients.
Claims
1. An apparatus for transferring a liquid between a storage container and at least one further use container, having a storage-container sealing portion for leaktight abutment of a main body of the transfer apparatus against the storage container; having a hollow-needle assembly with a hollow needle, wherein the hollow-needle assembly is displaceable in a linear manner along a movement axis relative to the main body by means of a gear mechanism between a retracted rest position and an extended connecting position in which the hollow needle creates a liquid connecting duct between the storage container and the transfer apparatus, having a connecting portion for connecting the transfer apparatus to the use container in a leaktight manner, having a rotary-actuation element which is operatively connected to the hollow-needle assembly via the gear mechanism, wherein the gear mechanism has a driver ring that is mounted in the main body axially and so as to be rotatable about the movement axis, said driver ring interacting with a complementary thread of the hollow-needle assembly for the displacement of the hollow-needle assembly, and being connected to the rotary-actuation element for conjoint rotation during the displacement.
2. The apparatus according to claim 1, wherein the driver ring has at least one inner driver which interacts with the complementary thread, embodied as an external thread, of the hollow-needle assembly.
3. The apparatus according to claim 1, comprising at least one axial lug via which the rotary-actuation element interacts with an axial receptacle in the driver ring in order to be connected for conjoint rotation.
4. The apparatus according to claim 1, wherein ribs on the main body, which belong to a device for preventing the hollow-needle assembly from rotating in the main body, simultaneously specify an axial seat of the driver ring.
5. An apparatus for transferring a liquid between a storage container and at least one further use container, having a storage-container sealing portion for leaktight abutment of a main body of the transfer apparatus against the storage container, having a hollow-needle assembly with a hollow needle, wherein the hollow-needle assembly is displaceable in a linear manner along a movement axis relative to the main body by means of a gear mechanism between a retracted rest position and an extended connecting position in which the hollow needle creates a liquid connecting duct between the storage container and the transfer apparatus, having a connecting portion for connecting the transfer apparatus to the use container in a leaktight manner, having a rotary-actuation element which is operatively connected to the hollow-needle assembly via the gear mechanism, having a seal for sealing off the main body from the rotary-actuation element, wherein the main body has a lifting driver which is embodied such that it interacts with a counterpart lifting driver, embodied in a complementary manner, on the rotary-actuation element in order that the rotary-actuation element is lifted off the main body in a manner relieving the seal during the rotary actuation of the rotary-actuation element.
6. The apparatus according to claim 5, wherein at least one of the group comprising the lifting driver and the counterpart lifting driver is embodied as a thread.
7. The apparatus according to claim 6, wherein the lifting driver is embodied as an external thread.
8. The apparatus according to claim 1, comprising a locking device for locking the hollow-needle assembly to the main body in the connecting position.
9. A set made up of a transfer apparatus according to claim 1 and a storage container.
10. A set made up of a storage container and a transfer apparatus according to claim 5.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF AT LEAST ONE PREFERRED EMBODIMENT
[0042] A first embodiment of an apparatus 1 for transferring a liquid between a storage container 2 (cf.
[0043] The transfer apparatus 1 has a sealing portion 4 for leaktight abutment of a main body 5 (cf.
[0044]
[0045] The transfer apparatus 1 furthermore has a hollow-needle assembly 9 with a hollow needle 10 and a needle sleeve 11 surrounding the latter. The hollow needle 10 is embodied as a plastics hollow needle. Alternatively, the hollow needle 10 can also be embodied at least in part as a steel cannula. Liquid is transferred between the use container 3 and the storage container 2 through the hollow needle 10 and at the same time ventilation and venting of these containers 2, 3 takes place, as will be explained in more detail in the following text.
[0046] The hollow-needle assembly 9 is displaceable in a linear manner along a movement axis 13 (cf.
[0047] The hollow-needle assembly 9 is displaced between a retracted rest position, illustrated for example in
[0048] The needle sleeve 11 represents a separate component from the hollow needle 10. The needle sleeve 11 is connected to the hollow needle 10 in a circumferentially leaktight manner in two axial positions, specifically in the region of an end of the needle sleeve 11 that faces the connecting portion 16 (cf. connecting region 17 in
[0049] The transfer apparatus 1 furthermore has a multipart rotary-actuation element 20 which is operatively connected to the hollow-needle assembly 9 via the gear mechanism 12.
[0050] The rotary-actuation element 20 has an annular cover 21 and an actuation-element main body 22 (cf. for example
[0051] The actuation-element main body 22 is sealed off from the main body 5 of the transfer apparatus 1 via a main-body seal 23 (cf. for example
[0052] The rotary-actuation element 20 furthermore includes an external coupling sleeve 24 which is connected to the actuation-element main body 22 for conjoint rotation and can be understood to be a constituent part of this main body 22.
[0053] The gear mechanism 12 has a driver ring 25 that is mounted in the main body 5 of the transfer apparatus 1 axially and so as to be rotatable about the longitudinal centre axis 14. Radially, the driver ring 25 is located between the main body 5 and the needle sleeve 11.
[0054] 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, embodied as an external thread, on the needle sleeve 11 in order to displace the hollow-needle assembly 9.
[0055] During the displacement of the hollow-needle assembly 9 from the rest position into the connecting position, the driver ring 25 is connected to the rotary-actuation element 20 for conjoint rotation. To this end, the actuation-element main body 22 has a plurality of, for example three, axial lugs 28 (cf. for example
[0056] The hollow-needle assembly 9 is prevented from rotating relative to the main body 5 about the longitudinal centre axis 14 via inner axial ribs 30 (cf. for example
[0057] End sides 32 of these inner axial ribs 30 simultaneously represent an axial seat of the driver ring 25 in the main body 5 of the transfer apparatus.
[0058] The main body 5 of the transfer apparatus 1 has a lifting driver 33 embodied as an external thread. Said lifting driver 33 interacts with a counterpart lifting driver 34, embodied as a complementary internal thread, on the coupling sleeve 24 of the rotary-actuation element 20. During the rotary actuation of the rotary-actuation element 20, which brings about the displacement of the hollow-needle assembly 9 from the rest position into the connecting position, the interaction of the lifting driver 33 with the counterpart lifting driver 34 results in the rotary-actuation element 20 being lifted off the main body 5 of the transfer apparatus 1 in order to relieve the main-body seal 23.
[0059] The main-body seal 23 can be embodied as a silicone lamellar seal. Alternatively, the main-body seal 23 can be embodied as a hard/hard end face mechanical seal.
[0060] In the connecting position (cf.
[0061] The transfer apparatus 1 additionally has a locking device 35 for locking the hollow-needle assembly 9 in the connecting position. This locking serves to secure the transfer apparatus 1 in a tamper-evident manner, in that the displacement of the hollow-needle assembly 9 into the connecting position is designed to be irreversible. The locking device 35 comprises a latching component 36 on the main body 5 of the transfer apparatus 1, which interacts in a latching manner with a complementary counter-part latching component 37 on the outer wall of the hollow needle 10.
[0062]
[0063] The storage container 9 is closed in a leaktight manner in the region of its neck 6 by a closure plug 38 in the form of an elastomeric sealing plug or of a sealing membrane. It can be gathered for example from
[0064] In the region of the free needle end 15, the liquid duct 39, already mentioned above in conjunction with the displacement of the hollow-needle assembly 9, between the storage container 2 and the transfer apparatus 1 leads out via two liquid-duct openings 40, 41 (cf.
[0065] In the region of the free needle end 15, an aeration gas duct 42 additionally leads out of the hollow needle 10 via a gas-duct opening 43. The aeration gas duct 42 serves to transport gas through the hollow-needle assembly 9, specifically in order to ventilate or vent the storage container 2 or the use container 3, respectively.
[0066] The duct paths of the liquid duct 39 for the one part and of the gas duct 42 for the other part extend separately from one another. The liquid duct 39 for the one part and the gas duct 42 for the other part lead out adjacently to one another axially along the hollow needle 10 and in a manner offset from one another in the circumferential direction about the longitudinal centre axis 14. A needle separating edge 44, 45 that extends in the longitudinal direction of the hollow needle 10 extends between in each case one of the liquid-duct openings 40, 41 and the adjacent gas-duct opening 43 in the circumferential direction. A further needle separating edge 46 that extends in a corresponding manner in the longitudinal direction of the hollow needle 10 extends between the two liquid-duct openings 40 and 41.
[0067] The two needle separating edges 44, 45 between the liquid-duct openings 40, 41 and the gas-duct opening 43 reduce an undesired transfer of liquid between the liquid duct 39 and the aeration gas duct 42. In addition, the needle separating edges 44 to 46 serve to reduce piercing forces of the hollow needle 12 into the closure plug 38 of the storage container 2. The needle separating edges 44 to 46 have a cutting action during the piercing of the closure plug 38.
[0068] The liquid-duct openings 40, 41 are at least as far away axially from the needle tip at the free needle end 15 as the gas-duct opening 43. In the exemplary embodiment illustrated (cf.
[0069] Starting from the gas-duct opening 43, a gas flow path extends through the aeration gas duct 42 first of all via a gas-duct portion 47 which extends parallel to the longitudinal centre axis 14 in the hollow needle 10. The gas-duct portion 47 leads out into the annular space 19 between the hollow needle 10 and the needle sleeve 11 via a passage opening 48 (cf.
[0070] At the bottom of the annular space 19, the needle sleeve 11 has a plurality of needle-sleeve passage openings 49. A total of eight such needle-sleeve passage openings 49 are arranged in a manner distributed evenly around the longitudinal centre axis 14. The needle-sleeve passage openings 49 represent a flow passage for the aeration gas duct 42 between the annular space 19 and a further annular space 50 in a portion of the needle sleeve 11 at the bottom, i.e. facing the storage container 2. Arranged in this further annular space 50 is a filter carrier 51 which is in the form of an annular disc and annularly surrounds the hollow needle 10. The filter carrier 51 carries a likewise annular air filter 52 of the transfer apparatus 1. In the further flow path of the aeration gas duct 42, after passing through the air filter 52, it is possible for gas to pass between the needle sleeve 11 and the main body 5 of the transfer apparatus 1 and from there to the outer environment.
[0071] In the aeration gas duct 42, a reversal of an axial main gas flow direction takes place between the gas-duct portion 47 and the further gas-duct portion between the needle-sleeve passage openings 49 and the air filter 52 in the region of the annular space 19. Axial flow components in these two gas-duct portions run in a manner precisely opposed to one another. The annular space 19 therefore represents a direction-reversal duct portion of the aeration gas duct 42.
[0072] The transfer apparatus 1 is used as follows:
[0073] First of all, the transfer apparatus 1 is fitted, in the configuration presented in
[0074] Now, the entire rotary-actuation element 20 can be removed and the use container 3, i.e. the standard injection syringe, can be connected to the connecting portion 16 of the transfer apparatus 1 via the Luer coupling. A solvent matched to the medicine in the storage container 2 is present in the use container 3. This solvent is now injected into the interior of the storage container 2 via the transfer apparatus 1 by actuation of a syringe piston of the use container 3. In the process, the solvent flows through the liquid duct 39 in the hollow needle 10 and passes out of the hollow needle 10 into the storage container 2 via the two liquid-duct openings 40, 41. The arrangement of the liquid-duct openings 40, 41 relative to the gas-duct opening 43 reduces an overflow of liquid droplets into the gas duct during injection, since the liquid flows downwards in the direction of gravitational force and thus does not flow in the direction of the gas duct during injection. In a manner corresponding to the volume of the liquid entering the storage container 2, air escapes to the outside from the storage container 2 via the gas-duct opening 43 through the aeration gas duct 42 via the gas-duct portion 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 apparatus 1. The configuration of the free needle end 15 with the needle separating edges 44, 45, the arrangement of the duct openings 40, 41, 43 and the design of the aeration gas duct 42, in particular the reversal of direction in the annular space 19, effectively avoid the situation in which liquid undesirably passes to the outside via the aeration gas duct 42. Liquid droplets that possibly enter the aeration gas duct 42 are dissipated. In particular, the air filter 52 is effectively prevented from becoming clogged with liquid as a result.
[0075] After all of the solvent has been injected into the storage container 2, a solution of the initially pulverulent medicine in the solvent is established by shaking the assembly made up of the storage container 2, the transfer apparatus 1 and the use container 3. After dissolution has taken place, the dissolved medicine is transferred into the use container 3 from the storage container 2 via the transfer apparatus 1. In the process, the dissolved medicine flows into the use container 3 via the liquid duct 39 through the hollow needle 10 to the storage container 2. This flow of the dissolved medicine into the use container 3 is established by filling the use container 3 embodied as a syringe. The transfer of the dissolved medicine from the storage container 2 into the use container 3 generally takes place in an upside-down position, in which the storage container 2 is arranged above the use container 3. In this position, the liquid-duct openings 40, 41 are located closer to a residual solution of the dissolved medicine, such as to improve the emptying of residual solution. Moreover, the gas-duct opening 43 is further away from the residual solution than the liquid-duct openings 40, 41 in this upside-down position, such that the gas duct can readily fulfil its ventilation function. In a manner corresponding to the liquid volume emerging from the storage container 2, air flows into the storage container 2 through the aeration gas duct 42 from the environment around the transfer apparatus 1 through the air filter 52. The air flowing in is filtered sterile by the air filter 52.
[0076] After the syringe piston of the use container 3 has been drawn back fully, the dissolved medicine is present in the interior of the use container and the use container 3 can then be pulled off the connecting portion 16 of the transfer apparatus 1.
[0077]
[0078] In the hollow-needle assembly 54 according to
[0079] The axial-duct body 55 is embodied as a subsegment between the hollow needle 10 and the needle sleeve 11, said subsegment being sealed off up to a height of two thirds of the overall axial height of the annular space 19. In this subsegment, the passage openings 48 are closed, thereby forcing the air flowing out of the storage container 2 to rise during the injection of the liquid into the storage container 2. The air then flows, after rising and reversing direction, through the remaining passage openings 48 in the non-closed segment. During the extended axial rising path of the aeration gas duct 42, liquid droplets flowing in are additionally dissipated or separated via gravitational force.
[0080] A further embodiment of a transfer apparatus 56, which can be used instead of the transfer apparatus 1 according to
[0081]
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[0083]
[0084] With the securing element 59 removed, displacement of a hollow-needle assembly 62 with hollow needle 63 is possible between the rest position shown in FIG. 17 and the connecting position shown in
[0085] The hollow-needle assembly 62 is, apart from an external geometry of the needle sleeve 11, constructed in the same way as the hollow-needle assembly 9. The external geometry of the needle sleeve 11 in the embodiment according to
[0086] For axial guidance of the pressure-actuation element 58 on the main body 61 during the displacement of the hollow-needle assembly 62 from the rest position into the connecting position, a guide device 64 is used. The latter has two guide pins 65 which are integrally formed on an inner side of a lateral wall of the pressure-actuation element 58. The guide pins 65 slide, during the displacement from the rest position into the connecting position, in in each case one associated guide groove 66 which is embodied in an outer wall of the main body 61 of the transfer apparatus 56.
[0087] The guide device 64 is configured such that the displacement of the hollow-needle assembly 62 from the rest position into the connecting position is irreversible.
[0088] The two guide groove 66 each have a groove bottom 67 with a sawtooth profile, said groove bottom 67 being shown in cross section in
[0089] At their ends facing the storage container 2, the guide grooves 66 are each continued by a helical guide 68. Via these helical guides 68, once the connecting position has been reached, it is possible to unscrew the pressure-actuation element 58 from the main body 61 of the transfer apparatus 56, as is indicated by direction arrows 69, 70 in
[0090] Following removal of the pressure-actuation element 58, the transfer apparatus 56 is in the instantaneous position which is shown in
[0091] The transfer apparatus 56 is used as follows:
[0092] Once the assembly has taken place, the transfer apparatus 56, together with the storage container 2, in which the pulverulent medicine is stored, is initially in the transport position shown in
[0093] During use of the transfer apparatus 56, the securing element 59 is first of all pulled off. Then, pressure is exerted from above on an upper end face of the pressure-actuation element 58 and the pressure-actuation element 58 is transferred from the rest position into the connecting position along the direction arrow 71 in