[go: up one dir, main page]

WO2013053935A1 - Compartiment stérile associé à un élément perforateur - Google Patents

Compartiment stérile associé à un élément perforateur Download PDF

Info

Publication number
WO2013053935A1
WO2013053935A1 PCT/EP2012/070364 EP2012070364W WO2013053935A1 WO 2013053935 A1 WO2013053935 A1 WO 2013053935A1 EP 2012070364 W EP2012070364 W EP 2012070364W WO 2013053935 A1 WO2013053935 A1 WO 2013053935A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
vial
cylindrical sleeve
medical container
assembly
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.)
Ceased
Application number
PCT/EP2012/070364
Other languages
English (en)
Inventor
Lars Eilertsen
Matias Melander
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.)
Novo Nordisk Health Care AG
Original Assignee
Novo Nordisk Health Care 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 Novo Nordisk Health Care AG filed Critical Novo Nordisk Health Care AG
Publication of WO2013053935A1 publication Critical patent/WO2013053935A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • 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
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2051—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
    • A61J1/2048—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
    • A61J1/2072—Venting means for internal venting

Definitions

  • the present invention relates generally to medical devices and more specifically to methods and arrangements for securing safe and sterile fluid access to medical containers.
  • both sterility and safety may be compromised.
  • To reduce the risk of contamination of the administrable substance it is customary to clean the respective rubber septa with an alcohol swab before needle penetration. This, however, is often considered a hassle by the user, especially if she/he needs to mix the substances and administer the resulting drug quickly to avert a serious situation.
  • US 5,466,220 discloses a drug mixing and transfer device comprising a vial and a syringe co-axially arranged to enable relative motion between them from a fluidly un- connected to a fluidly connected state. During this relative motion a needle on the syringe penetrates a vial seal to allow liquid to be transferred from the syringe into the vial.
  • the device itself is packaged in a flexible protective sterile packaging which is not removed until the vial and the syringe have been pushed together to establish a fluid connection via the needle. While such a device may overcome some of the above mentioned drawbacks of the traditional mixing procedure it appears to entail other inexpediencies.
  • WO 97/46203 discloses a pre-assembled pack for a drug reconstituting device, which pack comprises a vial co-axially aligned with a cartridge and separated therefrom by a double-ended needle element.
  • the needle element is supported by a two-part needle hub which comprises a protruding portion capable of collapsing within a base portion to cause penetration of a cartridge closure.
  • the cartridge closure engages a sleeve around one end of the double-ended needle element.
  • a frangible portion adjoining the two are broken. Thereby, a portion of the needle element becomes exposed to the surround- ing internal environment.
  • an object of the invention to provide an arrangement for securing safe and sterile access to a medical container. Further, it is an object of the invention to provide an arrangement for safe and sterile transfer of media between containers. In particular, it is an object of the invention to provide a simple, intuitive and easy to use arrangement for mixing substances contained in separate containers, which arrangement eliminates the risk of erroneous handling and ensures that sterility of the substances is maintained throughout the mixing procedure.
  • an assembly for a fluid transfer arrangement comprises a first medical container having an outlet opening and defining a general axis, a closure member for sealingly closing the outlet opening, and a connection member comprising a) a transversal base section from which a hollow piercing member pro- trudes in a direction towards the first medical container, and b) a cylindrical sleeve extending axially from the base section.
  • the hollow piercing member is arranged co-axially with the first medical container, and the cylindrical sleeve surrounds the hollow piercing member.
  • the assembly further comprises reception means fluidly connected with the hollow piercing member and structured to receive a second medical container.
  • the closure member com- prises a circumferential lip portion configured for sealing engagement with an inner surface of the cylindrical sleeve, to thereby define a fluid tight chamber.
  • the circumferential lip portion is capable of sliding along the inner surface of the cylindrical sleeve from a first position in which the closure member fluidly separates the hollow piercing member and the first medical container to a second position in which the hollow piercing member has penetrated the closure member and established fluid connection to the first medical container.
  • Such an assembly enables a fluid transfer arrangement, wherein no separate sterile barriers are needed to maintain an aseptic environment of the drug contacting surfaces.
  • the assembly can be incorporated as part of a pre-assembled device and the sharp piercing member can be completely shielded from the user, thereby avoiding potential stick injuries.
  • the as- sembly can be sterilised before assembly of the device, whereby the need for swabbing of at least one penetrable container closure by the user will be eliminated.
  • the assembly may further comprise vent means structured to allow air to escape the fluid tight chamber, when the circumferential lip portion slides along the inner surface of the cylindrical sleeve. Thereby, the force required to cause penetration of the closure member can be significantly reduced.
  • the vent means comprises a pair of ribs extending axially along an inner surface portion of the cylindrical sleeve and defining, together with the inner surface portion of the cylindrical sleeve, a fluid channel.
  • the vent means comprises an axially extending groove in an inner surface portion of the cylindrical sleeve.
  • the vent means may extend axially from the base section and terminate within the fluid tight chamber adjacent to the first position of the circumferential lip portion. This will allow the circumferential lip portion to seal the sterilised spike chamber while being in the first position and the vent means to depressurise the chamber shortly after the circumferential lip portion commences the sliding movement along the cylindrical sleeve.
  • the cylindrical sleeve may be designed to extend axially from the base section a distance which enables the entrapped air in the fluid tight chamber to be compressed to a degree allowing for penetration of the closure member by the hollow piercing member.
  • the circumferential lip portion may comprise a suitable elastic material, such as e.g. rubber.
  • a suitable elastic material such as e.g. rubber.
  • the entire closure member is made of a rubber material.
  • a fluid transfer device comprising a first med- ical container having an outlet opening and defining a general axis, a closure member for sealingly closing the outlet opening, a hollow piercing member arranged co-axially with the first medical container and protruding from a transversal base section in a direction towards the first medical container, and a cylindrical sleeve extending axially from the base section and surrounding the hollow piercing member.
  • the fluid transfer device further comprises a second medical container arranged in or for fluid communication with the hollow piercing member.
  • the closure member comprises a circumferential lip portion configured for sealing engagement with an inner surface of the cylindrical sleeve, to thereby define a fluid tight chamber housing the hollow piercing member.
  • the circumferential lip portion is capable of sliding along the inner surface of the cylindrical sleeve from a first position in which the clo- sure member fluidly separates the hollow piercing member and the first medical container to a second position in which the hollow piercing member has penetrated the closure member and established fluid connection to the first medical container.
  • the fluid transfer device may be used to combine a first medium contained in the first container and a second medium contained in the second container to obtain an administrable drug product.
  • the first medium may be a solvent for reconstitution of a powdered second medium.
  • references to a certain aspect or a certain embodiment e.g. "an aspect”, “a first aspect”, “one embodiment”, “an exemplary embodiment”, or the like
  • a particular feature, structure, or characteristic described in connection with the re- spective aspect or embodiment is included in, or inherent of, at least that one aspect or embodiment of the invention, but not necessarily in/of all aspects or embodiments of the invention.
  • any combination of features, structures and/or charac- teristics described in relation to the invention is encompassed by the invention unless expressly stated herein or clearly contradicted by context.
  • Fig. 1 shows an exploded view of a drug mixing arrangement employing an assembly according to an embodiment of the invention
  • Fig. 2 shows a longitudinal section view of the arrangement of Fig. 1 , in a pre-use state
  • Fig. 3 shows a longitudinal section view of the arrangement after fluid connection is estab- lished between the included reservoirs
  • Fig. 4 shows a longitudinal section view of the arrangement after removal of the cover
  • Fig. 5 shows a close-up perspective view of a mechanical connection between the cover and the syringe holder
  • Fig. 6 shows a transverse section view along line A-A of Fig. 3
  • Fig. 7 shows a close-up longitudinal section view of an assembly according to an embodiment of the invention as employed in the drug mixing arrangement of Fig. 1
  • Fig. 6 shows a transverse section view along line A-A of Fig. 3
  • Fig. 7 shows a close-up longitudinal section view of an assembly according to an embodiment of the invention as employed in the drug mixing arrangement of Fig. 1
  • Fig. 7 shows a close-up longitudinal section view of an assembly according to an embodiment of the invention as employed in the drug mixing arrangement of Fig. 1 .
  • Fig. 8 shows a longitudinal section view of an assembly according to another embodiment of the invention.
  • Fig. 1 is an exploded perspective view of a mixing device 1 for reconstitution of a powdered drug in a vial 20 using a solvent from a syringe 10.
  • the vial 20 comprises a wall 21 having an opening which is sealed by a vial stopper 23 (not visible in this view) and a seal cap 22.
  • the vial 20 is arranged in a vial holder 2 which serves to position and protect the vial 20.
  • a lock ring 3 is fitted over a portion of the vial holder 2 and locked against rotation relative to the vial holder 2 via a longitudinal internal rib (not visible) engaging a longitudinal groove 9 in the outer surface of the vial holder 2.
  • a tower 25 protrudes axially from the seal cap 22 in the direction away from the vial 20.
  • the tower 25 has an inner circumferential sealing rim 26 at its end portion, the purpose of which is explained below.
  • the wall 21 is made of glass and the vial holder 2 is made of a transparent plastic.
  • Other suitable materials may, however, be chosen depending on the specific application of the mixing arrangement 1 .
  • the lock ring 3 is connected to a coupling element 40 via a cam 91 on the interior surface of the lock ring 3 and a cam receiving bayonet groove (not visible) in an exterior surface of the coupling element 40.
  • the cam 91 is positioned at the end of the bayonet groove, whereby the lock ring 3 and the coupling element 40 are prevented from relative translational motion but allowed to undergo a limited relative rotation.
  • the coupling element 40 is a tubular sleeve which further comprises an exterior thread 43 at its distal end portion for engagement with an interior thread 7 (not visible in this view) in the vial holder 2, and an interior thread 41 at its proximal end portion for engagement with an exterior thread 31 of a syringe holder 30.
  • the coupling element 40 also has an exterior thread 42 arranged proximally of the exterior thread 43. The pitch of the interior thread 41 is greater than the pitch of the exterior thread 42.
  • the syringe holder 30 has a proximal portion adapted to receive and hold a portion of the syringe 10, and a distal portion which carries the exterior thread 31 and which is designed to accommodate a connector piece 50 comprising a sleeve body 51 and a distally pointing hollow spike member 52.
  • a number of ratchet arms 32 are arranged equidistantly along the circumference of a central portion of the syringe holder 30. The purpose of these ratchet arms 32 will be clear from the below.
  • the syringe 10 comprises a barrel 1 1 , the outlet of which is surrounded by a threaded Luer collar 13 and sealed by a syringe stopper 60.
  • a user manipulable piston rod 14 having a push face 15 for easy operation is adapted to drive a piston 19 (not visible in this view) in- side the barrel 1 1.
  • the barrel 1 1 holds a flange carrier 80 provided with opposite spreadable wings 81 for offering a more ergonomic grip of the syringe 10.
  • a cap 4 is adapted to cover the syringe 10 during storage and transportation of the mixing device 1 to prevent operation of the piston rod 14 and thereby to ensure that pressure is not prematurely applied to the contents of the syringe 10.
  • the cap 4 has an interior thread 5 (not visible in this view) adapted to engage with the exterior thread 42 for positioning of the cap 4 relative to the coupling member 40.
  • Fig. 2 is a longitudinal section view of the mixing device 1 in the assembled state, prior to a first use thereof, showing further details of the arrangement.
  • This state corresponds to the one in which the mixing device 1 is intended to be delivered by the manufacturer.
  • the piston rod 14 is in a retracted position in the barrel 1 1 , thereby defining a syringe interior 18 capable of holding a certain volume of a solvent (not shown).
  • the piston rod 14 is coupled firmly to the piston 19 via a jagged coupling head 16.
  • the cap 4 is fitted snugly around a collar 17 at the proximal end of the syringe 10 and the wings 81 are folded down along the barrel 1 1. This provides a user friendly slender configuration of the mixing device 1 .
  • a Luer 12 defining an outlet of the syringe 10, protrudes into the distal portion of the syringe holder 30 and is retained therein via a screw thread connection between the Luer collar 13 and a threaded inner portion 71 of a stopper fastener 70.
  • a couple of protrusions 72 are provided on the stopper fastener 70 to rotationally lock the stopper fastener 70 with respect to the syringe holder 30. This is described in more detail in connection with Fig. 6.
  • a lock snap 74 on the syringe holder 30 is engagement with the protrusions 72 to provide a bi-directional translational coupling between the stopper fastener 70 and the syringe holder 30.
  • a portion of the syringe stopper 60 is wedged between the Luer 12 and the threaded inner portion 71 and thereby provides a fluid tight engagement with the exterior surface of the Luer 12.
  • the syringe stopper 60 carries a filter 69 for filtering out any impurities of a passing liquid and has a penetrable section 61 allowing for easy rupturing of the syringe sealing by a suitable tool.
  • the connector piece 50 is slidably received in the hollow interior of the distal portion of the syringe holder 30.
  • the sleeve body 51 supports a transverse spike base 54 which carries the distally pointing hollow spike member 52 as well as a proximally pointing hollow spike member 53.
  • the hollow spike member 53 is arranged just distally of the penetrable section 61 and the hollow spike member 52 is arranged just proximally of a penetrable section 24 of the vial stopper 23.
  • the syringe 10 and the vial 20 are therefore fluidly unconnected at this point.
  • the syringe stopper 60 has at its distal end a circumferential sealing lip 62 which is adapted to sealingly engage with an interior portion of the sleeve body 51 to provide a fluid tight compartment 56 for the hollow spike member 53.
  • the tower 25 with the sealing rim 26 provides a fluid tight compartment 57 for the hollow spike member 52.
  • This particular construction thus enables the incorporation of a sterilised sub-assembly comprising the syringe stopper 60, the connector piece 50 and the vial stopper 23 during assembly of the mixing device 1 , and further ensures that sterility of the respective hollow spike members 52, 53 is maintained throughout storage, transportation and use of the mixing device 1 with no need for additional sterile barriers.
  • One or more vents 59 are provided in the sleeve body 51 to allow gas, e.g. air, entrapped within the sterile compartment 56 to escape during establishment of fluid connection between the syringe 10 and the vial 20, as will be explained in more detail below.
  • the coupling element 40 has a number of circumferentially spaced apart catch arms 45 extending downwards from a transversal portion at the end of the interior thread 41 for secur- ing firm attachment of the vial 20.
  • the wall 21 defines a vial interior 28 capable of holding an amount of powdered drug (not shown) to be reconstituted by the solvent from the syringe 10.
  • the wall 21 is flexibly supported by leaf springs 8 in the bottom of the vial holder 2 to account for manufacturing tolerances.
  • Fig. 3 shows the mixing device 1 after unscrewing of the cap 4 from the exterior thread 42 and an automatically effected establishment of fluid connection between the syringe interior 18 and the vial interior 28.
  • the cap 4 still covers the syringe 10, although now the cap 4 can be easily removed by simply pulling it away from the coupling element 40.
  • Axially extending ribs 6 are arranged on an interior surface of the cap 4 for engagement with the ratchet arms 32, providing for a unidirectional rotational coupling between the cap 4 and the syringe holder 30, ensuring that the cap 4 and the syringe holder 30 are locked against relative rotation during unscrewing of the cap 4 from the exterior thread 42.
  • the exterior thread 42 is a right-hand thread and the interior thread 41 is a left-hand thread, so when the cap 4 is unscrewed from the exterior thread 42, and the cap 4 thereby is moved axially away from the coupling element 40, the exterior thread 31 is screwed further into the interior thread 41 , whereby the syringe holder 30 is moved axially in the opposite direction towards the vial 20, while the ratchet arms 32 slide along the ribs 6. Because the pitch of the interior thread 41 is greater than the pitch of the exterior thread 42 the syringe holder 30, and thereby the syringe 10, moves axially a longer distance towards the vial 20 than the cap 4 moves away from the coupling element 40 during unscrewing of the cap 4 from the exterior thread 42.
  • the pitch difference in the present embodiment is designed to move the exterior thread 31 to the end of the interior thread 41 , and thereby to establish a fluid connection between the syringe 10 and the vial 20, upon less than one full revolution of the cap 4 relative to the coupling element 40.
  • the hollow spike member 52 has penetrated the penetrable section 24 and entered partly into the vial interior 28 and the hollow spike member 53 has penetrated the penetrable section 61 and entered partly into a chamber provided in the syringe stopper 60 between the penetrable section 61 and the filter 69.
  • the syringe interior 18 and the vial interior 28 are thereby in fluid communication via a lumen 55 extending through the respective spike members 52, 53 and the spike base 54.
  • Fig. 4 the cap 4 has been removed from the coupling element 40 and the piston rod 14 is operable for firstly driving the solvent out of the syringe 10 and into the vial 20 and subsequently withdrawing the reconstituted product from the vial 20 back into the syringe 10.
  • Fig. 5 is a close-up perspective view of a portion of the mixing device 1 showing the operative coupling between the cap 4 and the syringe 10.
  • a portion of the cap 4 has been cut away to reveal the engagement of one of the ratchet arms 32 with one of the ribs 6.
  • This ratchet mechanism will cause the cap 4 to slave the syringe holder 30, and thereby the syringe 10, when turned in the counter-clockwise direction, whereas the ribs 6 will ride over the ratchet arms 32 when the cap 4 is turned in the clockwise direction, ena- bling relative rotational movement between the cap 4 and the syringe holder 30 when the cap 4 is screwed onto the exterior thread 42.
  • Fig. 6 is a transverse section view along line A-A of Fig. 3, showing more clearly the interaction between the ribs 6 and the ratchet arms 32. It further shows the rotational lock between the syringe holder 30 and the stopper fastener 70. As can be seen the protrusions 72 fit into respective indentations 33 in the central portion of the syringe holder 30, whereby the stopper fastener 70 is forced to follow any rotational motion of the syringe holder 30.
  • Fig. 7 shows a longitudinal section of an assembly 100 comprising the connector piece 50, the syringe 10, the syringe stopper 60, and the stopper fastener 70, in an initial state corre- sponding to a pre-use condition of the mixing device 1 .
  • the figure shows in greater detail the vents 59, which are provided as channels defined by respective rib pairs 58, each rib pair 58 extending longitudinally from the spike base 54 to a point just below the circumferential sealing lip 62.
  • the respective rib pairs 58 will engage the circumferential sealing lip 62 and deform it locally at the contact areas to allow air entrapped within the compartment 56 to escape through the channels as the syringe stopper 60 continues to advance towards the spike base 54.
  • the force needed for collapsing the compartment 56 is comparable to the force needed to overcome the frictional forces between the circumferential sealing lip 62 and the sleeve body 51 , respectively the rib pairs 59.
  • Fig. 8 is a longitudinal section view of an assembly 200 according to another embodiment of the invention.
  • the assembly 200 comprises a vial 210, containing a powdered drug (not shown), and a connector piece 250, shown in a pre-use position.
  • the connector piece 250 comprises a transversal spike base 254 supporting a spike member 253 through which a lumen 255 extends.
  • the lumen 255 opens distally towards a piercing portion of the spike member 253 and proximally towards a port 252 adapted to receive another container (not shown), such as e.g. a syringe of the Luer type.
  • a sleeve body 251 extends axially from the spike base 254 in the direction of the vial 210 and surrounds the spike member 253.
  • the vial 210 is sealingly closed by a vial stopper 260, and the connector piece 250 is arranged such that a circumferential sealing lip 262 on the vial stopper 260 engages an inner portion of the sleeve body 251 to provide a fluid tight compartment 256.
  • the circumferential sealing lip 262 is capable of sliding along the inner wall of the sleeve body 251 from the position shown in Fig. 6 to a position in which the spike member 253 has pierced the vial stopper 260 and the distal opening of the lumen 255 is arranged completely within the vial 210.
  • a couple of lock beads 298 on the inner wall of the sleeve body 251 ensure that the connector piece 250 is not easily dismounted from the vial stopper 260.
  • a sterile barrier foil (not shown) may firstly be removed from the connector piece 250 to uncover the port 252.
  • a syringe containing a solvent for reconstitution of the powdered drug in the vial 210 is then connected to the port 252 and pressed towards the vial 210.
  • the connector piece 250 slides towards the vial 210, and the spike member 253 pierces the vial stopper 260 to establish fluid communication between the vial 210 and the syringe via the lumen 255.
  • a transfer of the solvent from the syringe to the vial 210 can now be executed.
  • the reconstituted drug can be transferred to the syringe, which can finally be removed from the port 252 and used as a delivery device.
  • Figs. 7 and 8 represent examples of assemblies for use in different fluid transfer arrangements. These assemblies can be sterilised by the manufacturer and used either as an external individual part of a fluid transfer arrangement or as an internal sub-assembly in a fluid transfer arrangement, while ensuring that the sterile environments surrounding the drug contacting surfaces are maintained.
  • the syringe holder 30 is forced downwards towards the vial 20 as the cap 4 moves upwards away from the lock ring 3.
  • the engagement between the lock snap 74 and the protrusions 72 will cause the stopper fastener 70 to move downwards with the syringe holder 30, and since the syringe 10 is thread- edly coupled with the stopper fastener 70 via the Luer collar 13 and the threaded inner por- tion 71 the syringe 10 will be forced to follow the downward movement of the syringe holder 30.
  • the connector piece 50 is held in the distal portion of the syringe holder 30 by a friction fit and as the exterior thread 31 travels along the interior thread 41 during the relative rotational motion between the cap 4 and the coupling element 40, and the syringe 10 and the vial 20 are thereby gradually brought closer to one another, the connector piece 50 will move further into the distal portion of the syringe holder 30.
  • the hollow spike member 52 will be pressed against the penetrable section 24 and the hollow spike member 53 will be pressed against the penetrable section 61 .
  • vents 59 in the form of axially extending ribs on the interior wall of the sleeve body 51 allow the compressed air in the compartment 56 to escape as the syringe stopper 60 is moved into abutment with the spike base 54.
  • the vents 59 extend from the spike base 54 and end just distally of the initial, pre-use position of the syringe stopper 60.
  • the compartment 56 can be maintained sterile until use of the mixing device 1 , while the syringe stopper 60 during use can be moved relative to the sleeve body 51 without resistance from entrapped air.
  • the thread engagement between the exterior thread 42 and the interior thread 5 is longer than the thread engagement between the exterior thread 31 and the interior thread 41 , so when the exterior thread 31 has travelled to the end of the interior thread 41 and fluid communication has been established between the syringe interior 18 and the vial interior 28 via the lumen 55 the cap 4 is still not released from the coupling element 40.
  • the order in which the respective penetrable sections 24, 61 are penetrated is insignificant as the user can not accidentally apply pressure to the syringe interior 18 through operation of the piston rod 14 until fluid communication is properly established between the syringe 10 and the vial 20.
  • the engagement between the ribs 6 and the ratchet arms 32 will still transfer the rotation of the cap 4 to the syringe holder 30.
  • the exterior thread 31 is no longer capable of relative motion with respect to the interior thread 41 , the syringe holder 30 and the coupling element 40 are forced to perform a joint rotational motion relative to the lock ring 3.
  • connection between the vial 20 and the coupling element 40 is tightened because the vial holder 2 presses the vial 20 against the transversal portion of the coupling element 40. This eliminates the risk of production toler- ances being the cause of a loose connection between the hollow spike member 52 and the vial 20.
  • the joint rotation of the syringe holder 30 and the coupling element 40 is relatively small as it corresponds to the last part of the rotation of the cap 4 that releases the interior thread 5 from the exterior thread 42.
  • the cap 4 When the cap 4 is released from the exterior thread 42 it can be removed to expose the syringe 10 for operation.
  • the user holds the mixing device 1 such that the syringe 10 faces upwards.
  • the piston 19 By depression of the piston rod 14 the piston 19 is advanced in the barrel 1 1 to force the solvent out through the Luer 12, further through the lumen 55 and into the vial 20, where it mixes with the powdered drug.
  • the mixing device 1 is then turned up-side down and the piston rod 14 is gradually released to allow the built up pressure in the vial 20 to cause or assist a transfer of the mixed product out of the vial 20, through the lumen 55 and into the syringe 10.
  • the piston rod 14 is pulled backwards in the barrel 1 1 to cause or assist the transfer of the mixed product from the vial 20.
  • the syringe 10 is removed from the rest of the arrangement. This is done by gripping the syringe holder 30 with one hand and the collar 17 with the other hand and then rotating the syringe 10 relative to the syringe holder 30.
  • the Luer collar 13 is screwed out of engagement with the threaded inner portion 71.
  • a circumferential groove 63 in the syringe stopper 60 is engaged by a mating ridge 73 on the stopper fastener 70 to lock the syringe stopper 60 against axial movement relative to the stopper fastener 70.
  • the syringe 10 is ready for connection with e.g. a cannula or a catheter immediately upon removal from the arrangement, without the user having to manually detach the syringe stopper 60 from the Luer 12 first. This reduces the number of manual steps to be performed even further.
  • the wings 81 can be unfolded to pro- vide for a better grip of the syringe 10 during the following administration.

Landscapes

  • 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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un ensemble (100, 200) pour agencement de transfert de fluide. Ledit ensemble (100, 200) comprend un premier récipient médical (10, 201) comportant une ouverture de sortie et délimitant un axe général, un élément de fermeture (60, 260) assurant la fermeture étanche de l'ouverture de sortie et un élément de raccordement comprenant a) une section de base transversale (54, 254) depuis laquelle un élément perforateur creux (53, 253) fait saillie dans la direction du premier récipient médical (10, 201) et b) un manchon cylindrique (51, 251) se prolongeant axialement depuis la section de base (54, 254). L'élément perforateur creux (53, 253) est disposé coaxialement au premier récipient médical (10, 201) et le manchon cylindrique (51, 251) entoure l'élément perforateur creux (53, 253). Ledit ensemble comprend, en outre, un moyen de réception (52, 252) en communication fluidique avec l'élément perforateur creux (53, 253) et conçu pour accueillir un second récipient médical. L'élément de fermeture (60, 260) comprend une partie lèvre circonférentielle (62, 262) conçue pour assurer un contact étanche avec une surface intérieure du manchon cylindrique (51, 251) afin de délimiter un compartiment étanche aux fluides (56, 256).
PCT/EP2012/070364 2011-10-14 2012-10-15 Compartiment stérile associé à un élément perforateur Ceased WO2013053935A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP11185246 2011-10-14
EP11185246.3 2011-10-14
US201161548922P 2011-10-19 2011-10-19
US61/548,922 2011-10-19

Publications (1)

Publication Number Publication Date
WO2013053935A1 true WO2013053935A1 (fr) 2013-04-18

Family

ID=48081406

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2012/070364 Ceased WO2013053935A1 (fr) 2011-10-14 2012-10-15 Compartiment stérile associé à un élément perforateur

Country Status (1)

Country Link
WO (1) WO2013053935A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017086867A1 (fr) * 2015-11-19 2017-05-26 Hemcheck Sweden Aktiebolag Dispositif de protection et procédé de réduction du risque du personnel médical de se piquer accidentellement avec une aiguille hypodermique

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5466220A (en) 1994-03-08 1995-11-14 Bioject, Inc. Drug vial mixing and transfer device
WO1997046203A1 (fr) 1996-06-03 1997-12-11 Applied Research Systems Ars Holding N.V. Dispositif de reconstitution d'un medicament injectable

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5466220A (en) 1994-03-08 1995-11-14 Bioject, Inc. Drug vial mixing and transfer device
WO1997046203A1 (fr) 1996-06-03 1997-12-11 Applied Research Systems Ars Holding N.V. Dispositif de reconstitution d'un medicament injectable

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017086867A1 (fr) * 2015-11-19 2017-05-26 Hemcheck Sweden Aktiebolag Dispositif de protection et procédé de réduction du risque du personnel médical de se piquer accidentellement avec une aiguille hypodermique

Similar Documents

Publication Publication Date Title
EP2787951B1 (fr) Dispositif médical doté d'un contrôle de séquence intégré
US9480623B2 (en) Pre-assembled fluid transfer arrangement
US20240024587A1 (en) System and method for safety syringe
EP1205173B1 (fr) Dispositif de sécurité pour agencement de seringue
EP3366268B1 (fr) Système d'étanchéité pour canule
EP3494951B1 (fr) Système de transfert fermé de fluides
EP2510914B1 (fr) Dispositif de connecteur
US20140318995A1 (en) Barrier Element Removal
CN107252523B (zh) 插管密封系统
US20250050027A1 (en) System and method for safety syringe
WO2013053935A1 (fr) Compartiment stérile associé à un élément perforateur
WO2004043514A2 (fr) Dispositif d'injection pre-rempli a aiguille retractable

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12770506

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 12770506

Country of ref document: EP

Kind code of ref document: A1