EP2921153A1 - Adapter zur Kopplung zweier Spritzen und Adaptersystem und zwei Spritzen - Google Patents

Adapter zur Kopplung zweier Spritzen und Adaptersystem und zwei Spritzen Download PDF

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Publication number
EP2921153A1
EP2921153A1 EP14161060.0A EP14161060A EP2921153A1 EP 2921153 A1 EP2921153 A1 EP 2921153A1 EP 14161060 A EP14161060 A EP 14161060A EP 2921153 A1 EP2921153 A1 EP 2921153A1
Authority
EP
European Patent Office
Prior art keywords
adapter
syringe
needle
coupling
receptacle
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
EP14161060.0A
Other languages
English (en)
French (fr)
Inventor
designation of the inventor has not yet been filed The
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.)
3M Innovative Properties Co
Original Assignee
3M Innovative Properties Co
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 3M Innovative Properties Co filed Critical 3M Innovative Properties Co
Priority to EP14161060.0A priority Critical patent/EP2921153A1/de
Priority to PCT/US2015/020967 priority patent/WO2015142849A1/en
Publication of EP2921153A1 publication Critical patent/EP2921153A1/de
Ceased legal-status Critical Current

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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
    • A61J1/2096—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
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting

Definitions

  • the invention relates to an adapter for establishing fluid communication between two syringes for transfer of a liquid/medicament from one syringe toward the other syringe.
  • the invention further relates to a system comprising the adapter and two syringes.
  • carpules are used - in a similar manner as ampoules - to transfer the medicament stored therein entirely or partially into a separate injection syringe by pushing the injection needle of the injection syringe through the septum and aspirating the medicament toward the injection syringe.
  • the septum usually made of a rubber material, typically seals with the injection needle so that removal of the medicament may result in causing a vacuum within the carpule. Such a vacuum may result in air leaking into the cartridge/syringe and/or the plug to move and eventually the injection needle to spike the plug.
  • repositioning of the injection needle in the carpule for example, to avoid spiking a moving plug may result in unintentionally pulling out the injection needle and may cause the risk of injuries.
  • US 2006/0155257 discloses an assembly for transferring a liquid between a vial and a syringe.
  • the assembly includes a housing having a central portion, the housing being open at one end and having a vial socket at the other opposite end adapted to receive and retain a vial having a penetrable closure.
  • the housing further includes a sleeve located within the central portion of the housing. The sleeve has a first portion, a second portion adjacent the first portion, and a shoulder between the first portion and the second portion.
  • the assembly also includes a protractible Luer adapter with a central hub having a first axial end and a second opposite axial end.
  • the first axial end has a hollow piercing member with a tip having an opening mounted thereon and the second axial end has an engaging member for releasably engaging a syringe, the hollow piercing member, the central hub, and the engaging member being in fluid communication with one another.
  • the invention in one aspect relates to an adapter for establishing fluid communication between two syringes.
  • the adapter is monolithically formed and comprises a first and second coupling.
  • the first coupling forms a hollow needle along a longitudinal axis and the second coupling forms a socket.
  • the adapter further has a channel establishing fluid communication between the needle and the socket.
  • the adapter further has a receptacle that extends at least partially around the needle and around the longitudinal axis.
  • the longitudinal axis preferably corresponds to a longitudinal axis of the adapter.
  • the adapter may be rotationally symmetric with the longitudinal axis forming the axis of symmetry.
  • the term "monolithically formed" is preferably regarded as formed in a single step from a raw material of a first shape into one piece of a different second shape.
  • the adapter may be molded from plastic granules in a single injection molding step.
  • a single molding step may include movement(s) of one or more mold parts, but may not include a removal of the adapter from the mold in any non-final shape.
  • the needle in a dimension of the longitudinal axis does not project outside the receptacle. Therefore the needle may be arranged such that the needle does not stick out over outer boundaries of the adapter. Accordingly the risk of injuries from a user contacting the needle may be minimized.
  • the adapter comprises only a single needle.
  • the needle preferably has a free end and a first and a second passageway.
  • the first passageway preferably forms part of the channel and forms a first opening in the needle adjacent the free end.
  • the second passageway preferably forms a second opening in the needle adjacent the free end and a venting opening in the adapter farther away from the free end of the needle.
  • first and second opening in the needle face away from each other.
  • air provided through the second opening may not reach the first opening during transfer of the liquid/medicament from one syringe into the other.
  • the venting opening may be formed laterally in the needle and located within the receptacle. Thus the venting opening cannot be unintentionally blocked, for example by a user holding the adapter.
  • the second opening has preferably a smaller cross-section than the first opening.
  • the smallest cross-section of the second passageway may have a smaller cross-section than the smallest cross-section of the first passageway.
  • the receptacle protrudes from a base of the adapter.
  • the base preferably extends radially outwardly from the longitudinal axis.
  • the receptacle further forms at least one detent protruding in a direction radially inwardly toward the longitudinal axis.
  • the detent in a dimension parallel to the longitudinal axis preferably overhangs a space between the detent and the base.
  • the receptacle may extend circumferentially around the needle and may form a ring-shaped space between.
  • the detent may be formed adjacent a free end of a latch that is formed by the receptacle.
  • the latch preferably protrudes in a dimension generally parallel to the longitudinal axis and in a direction toward the base.
  • the adapter may further have at least three latches each forming a detent. These latches may be distributed generally uniformly around the circumference of the receptacle.
  • the detent is adapted to form a non-releasable snap connection with a collar shaped end of a syringe placed into the receptacle. This prevents the adapter from being reused. Accordingly the adapter helps preventing cross-contamination.
  • the second coupling forms at least a Luer cone of a Luer-Lock fitting.
  • the second coupling forms an inner cone of a Luer -Lock fitting. Therefore the adapter is configured for detachably attaching a syringe having the respecting counter part of the Luer-Lock fitting.
  • the invention in a further aspect relates to a system comprising an adapter of the invention and a first and a second syringe.
  • the first syringe may be connectable or connected to the first coupling of the adapter and the second syringe may be connectable or connected to the second coupling of the adapter.
  • the first syringe has a first cartridge and a piston.
  • the first syringe may for example correspond to a carpule.
  • the first syringe may have a generally cylindrical barrel which rearwardly is closed by the piston, and which, further to the front, typically has a mouth-piece.
  • the mouth-piece preferably is formed by a bottleneck or constriction with respect to the barrel and arranged adjacent the barrel and further to the front has a widened portion with an opening.
  • the opening is preferably closed by a septum arranged over the widened portion and held in place by a jacket around the widened portion.
  • the bottleneck, the widened portion, the septum and the jacket in combination form the mouth-piece.
  • the second syringe has a second cartridge and a plunger.
  • the second cartridge and the plunger are preferably each provided with at least one finger plate for operating the second syringe.
  • the second syringe may correspond, for example, to a disposable injection syringe (with the injection needle being detached therefrom).
  • the mouth-piece of the first syringe and the first coupling of the adapter are preferably adapted for non-releasable interlocking with each other.
  • the second syringe preferably forms part of a Luer-Lock fitting.
  • the Luer-Lock of the second syringe and the second coupling of the adapter are preferably adapted for releasable interlocking with each other.
  • the receptacle in a dimension along the longitudinal axis has a sufficient length to entirely receive the mouth-piece of the syringe and further a section of the barrel first syringe and further has an inner cross-section that guidingly fits with the outer cross-section of the barrel.
  • the receptacle is adapted to guide the first syringe during mating the first syringe and the adapter.
  • the needle of the adapter is preferably offset at such a distance relative to the free end of the receptacle so that the receptacle and the barrel form a guiding relationship prior to the needle of the adapter puncturing the septum.
  • the system comprises an injection needle having a needle coupling forming part of a Luer-Lock fitting for attaching the needle to the second syringe.
  • the system may comprise a plurality of adapters and first and second syringes.
  • Fig. 1 shows a system 100 comprising a first syringe 10, an adapter 20 and a second syringe 30.
  • the adapter 20 is configured to establish fluid communication between the first and the second syringe 10, 30.
  • the adapter 20 has a first coupling 21 that is configured such the adapter 20 and the first syringe 10 can be attached with one another.
  • the adapter 20 has a second coupling 22 that is configured such the adapter 20 and the second syringe 30 can be attached with one another.
  • the first syringe 10 has a cartridge 11, a plug 12 closing a rear end of the cartridge 11, and a septum 13 closing a front end of the cartridge 11. Further the first syringe 10 is prefilled with a medicament.
  • the cartridge 11 is made of glass.
  • the septum 13 comprises a rubber membrane sealing a front opening of the cartridge 11.
  • the membrane is non-separably attached at the front end of the cartridge 11 by a jacket 14 which in the example is made of metal (in particular of aluminum).
  • the front end of the cartridge 11 together with the septum 13 forms a collar-shaped mouth-piece which can be received within the adapter 20.
  • the plug 12 is movable within the cartridge 11 for expelling the medicament therefrom.
  • the plug 12 in the example is also made of rubber.
  • the rubber material the plug 12 and the membrane of the septum 13 are made of is of the same type, preferably a brominated butyl rubber.
  • the syringe 10 is adapted to generally hermetically seal the medicament
  • the second syringe 30 has a cartridge 31 and a plunger 32 received within the cartridge 31 through a rear end of the cartridge 31.
  • the cartridge 31 forms a nozzle 313 at a front end of the cartridge 31.
  • the second syringe 30 is initially empty.
  • the second syringe 30 is a commercially available disposable syringe which is made of a plastic material.
  • the plunger 32 is movable within the cartridge 31. Typically the plunger 32 is (as shown) initially positioned at an end position adjacent the front end of the cartridge 31 and can be retracted toward the rear end of the cartridge 31 for aspirating a medicament into the cartridge 31.
  • the second syringe 30 has a pair of finger plates 311 at the cartridge 31 and a finger plate 321 at the plunger 32. Therefore the second syringe 30 can be operated for expelling a (previously aspirated) medicament by use of the finger plates 311, 321.
  • the plunger 32 further has a piston 322 which is formed by a front end of the plunger 32 and a seal (for example an O-ring) extending circumferentially around the front end of the plunger 32.
  • the second syringe 30 at its front end further forms a part of a Luer-lock fitting.
  • the nozzle 313 forms an outer cone of the Luer-Lock fitting.
  • a rim 312 forming an inner thread of the same Luer-Lock fitting is formed at the front end of the cartridge 31.
  • the rim 312 with the thread allows for detachably attaching a respective counter part of the Luer-Lock fitting, and the outer cone allows for sealingly connecting the nozzle 313 with an inner cone of the same counter part of the Luer-Lock fitting.
  • the medicament stored in the first syringe 10 can be at least partially transferred into the second syringe 30. This can be performed by retracting the plunger 32 of the second syringe 30. Thereafter the second syringe 30 can be detached from the adapter 20 and an injection needle or application tip (not shown in this view) may be attached to the nozzle 313 of the syringe 30.
  • the adapter 20 is non-detachably locked at the first syringe 10. This prevents the adapter from being reused, for example with a used syringe or different further medicament.
  • the adapter 20 further allows for transferring several partial amounts from the first syringe 10 to the second syringe 30 and the second syringe 30 may be used between the individual transfers of the partial amounts. Thereby the second syringe 30 may be reliably reattached several times to the adapter. This is in contrast to puncturing through a septum several times, and thus to adversely affect the sealing properties of the septum consecutively.
  • the adapter 20 further allows for transferring several partial amounts from the first syringe 10 to several different second syringes.
  • the adapter 20 may be closed by a plug (not shown) to seal a partially empty first syringe 10.
  • a plug may have a Luer-Lock coupling which is adapted for mating with at least the Luer cone of the adapter 20.
  • the first coupling 21 has a receptacle 23 extending circumferentially around a longitudinal axis A of the adapter 20.
  • the receptacle thus is configured to receive an end of a syringe (not shown in this view) in a guided manner along the longitudinal axis A therein.
  • a needle 24 is arranged within the receptacle 23 so that it automatically penetrates a syringe placed in the receptacle 23.
  • the second coupling 22 forms part of a Luer-lock fitting.
  • the second coupling 22 has an inner cone 221 (not visible in these views), and optional outer stems 222 for engagement with an inner thread of a counter part of the Luer-lock fitting.
  • Fig. 3 shows an embodiment of the adapter 20 in a cross-sectional view.
  • the adapter has a base 25 from which in a first direction the receptacle 23 protrudes. Further needle 24 protrudes in the first direction.
  • the free end 241 of the needle forms a sharp tip. Further the free end 241 of the needle 24 is offset in a dimension parallel to the first direction with respect to a free end 231 of the receptacle such that the free end 241 of the needle 24 does not stick out from the receptacle 23.
  • the needle 24 is hollow and therefore forms a passageway 242.
  • the passageway 242 forms part of a channel 26 through the entire adapter 20.
  • the passageway 242 forms a first opening 243 in the needle 24 adjacent the free end 241.
  • the needle 24 can penetrate through a septum of a syringe (not shown in this view) attached to the adapter 20 and establish a fluid communication between the syringe and the channel 26.
  • the needle 24 extends along the longitudinal axis A of the adapter 20 and the receptacle 23 extends coaxially to the longitudinal axis A.
  • a ring-shaped space is formed between the needle 24 and the receptacle 23 for receiving a front end of a syringe therein.
  • the adapter 20 further has detents 232 for locking a mouth-piece of a syringe received in the receptacle 23.
  • the detents 232 are adapted to snap behind and lock a collar-shaped mouth-piece of the syringe, placed in the receptacle 23 and moved past the detents 232.
  • the detents 232 are formed at the receptacle 23 and protrude radially inwardly tow the longitudinal axis A.
  • the receptacle 23 is configured to allow resilient movement of the detents in a dimension radially to the longitudinal axis A.
  • the detents 232 are adapted to be displaced radially outwardly and to automatically reset radially inwardly to the longitudinal axis A.
  • the resilient movement may be provided by elastic properties of the receptacle, for example provided by the material the receptacle is made of, the wall-thickness of the receptacle, structures shaped in the receptacle or a combination thereof.
  • the receptacle 23, the needle 24 and the associated components of the receptacle 23 and the needle 24 as described form the first coupling 21.
  • a barrel 223 extends in a second direction opposite of the first direction.
  • the first direction and the second direction are parallel to the longitudinal axis A and the base 25 extends perpendicular thereto.
  • the barrel 223 forms the second coupling 22.
  • the barrel 223 forms the inner cone 224 which widens in the second direction.
  • the inner cone 224 corresponds to a Luer cone having a 6% inclination.
  • the barrel 223 may have one or more stems (not shown) extending from the barrel 223 radially outwardly.
  • the channel 26 extends through the barrel 223, the base 25 and the needle 24 and thus entirely through the adapter 20.
  • the adapter has recesses 234 formed within the receptacle 23 and extending radially through the receptacle 23.
  • the recesses 234 provide for venting of the inside of the receptacle 23, for example during insertion of a syringe in the receptacle 23.
  • Fig. 4 shows a further embodiment of the adapter 20 in a cross-sectional view.
  • the embodiment is identical with the embodiment shown in Fig. 3 except that the needle 24 forms two passageways, a first passageway 242 and a second passageway 244. Again the first passageway 242 forms part of the channel 26 through the adapter 20.
  • the adapter 20 shown in Fig. 4 further differs from the embodiment in Fig. 3 in that the detents 232 are formed at free ends of latches 233 formed by the receptacle 23 and extending in a direction opposite of the first direction.
  • the second passageway 244 extends between a second opening 246 at the free end 241 of the needle 24 and a venting opening 245 in the needle adjacent the base 25.
  • the needle 24 of this embodiment has a first opening 243 and a second opening 246 at the free end 241.
  • the free end 241 of the needle 24 forms a sharp tip in the form a first surface 247 and second surface 248 merging in a sharp ridge at the free end 241.
  • the first and second surface 247, 248 are arranged in an acute angle relative to each other.
  • the first opening 243 and the second opening 246 are arranged in the needle to face away from each other.
  • the first opening 243 opens through the first surface 247 and the second opening 246 opens through the second surface 248.
  • the second passageway 244 is configured for supplying air into the syringe during removal of the medicament from the syringe through the first passageway 242.
  • the second passageway 244 preferably has a smallest cross-section which is smaller than the smallest cross-section of the first passageway 242.
  • Figures 5A - 5F illustrate the adapter 20 and the first and second syringe 10, 30 in use.
  • Fig. 5A shows the first syringe 10 at an initial stage entirely filled with the medicament, and the adapter 20 still detached from the first syringe.
  • Figures 5B and 5C illustrate the attaching of the adapter 20 to the first syringe 10. As indicated, the adapter 20 and the syringe 10 are pushed toward each other such that the septum 13 of the first syringe 10 is received within the first coupling 21 of the adapter 20.
  • the detents (not shown) snap behind the mouth-piece of the first syringe and lock the adapter 20 with the first 10.
  • FIG. 5F shows the empty first syringe 10 with the adapter 20 non-releasably attached thereto.
  • the syringe 10 and the adapter 20 can be disposed.
  • the second syringe 30 now containing the medicament is detached from the adapter and prepared for use, for example with an injection needle (not illustrated) placed on the nozzle 313 of the second syringe 30.

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP14161060.0A 2014-03-21 2014-03-21 Adapter zur Kopplung zweier Spritzen und Adaptersystem und zwei Spritzen Ceased EP2921153A1 (de)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP14161060.0A EP2921153A1 (de) 2014-03-21 2014-03-21 Adapter zur Kopplung zweier Spritzen und Adaptersystem und zwei Spritzen
PCT/US2015/020967 WO2015142849A1 (en) 2014-03-21 2015-03-17 An adapter for coupling two syringes and a system of an adapter and two syringes

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP14161060.0A EP2921153A1 (de) 2014-03-21 2014-03-21 Adapter zur Kopplung zweier Spritzen und Adaptersystem und zwei Spritzen

Publications (1)

Publication Number Publication Date
EP2921153A1 true EP2921153A1 (de) 2015-09-23

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EP14161060.0A Ceased EP2921153A1 (de) 2014-03-21 2014-03-21 Adapter zur Kopplung zweier Spritzen und Adaptersystem und zwei Spritzen

Country Status (2)

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EP (1) EP2921153A1 (de)
WO (1) WO2015142849A1 (de)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060155257A1 (en) 2002-11-08 2006-07-13 Reynolds David L Pharmaceutical delivery systems and methods for using same
US20100179506A1 (en) * 2009-01-15 2010-07-15 Eli Shemesh Vial adapter element
US20120330280A1 (en) * 2009-08-06 2012-12-27 Reynolds David L Airless mixing with a by-pass syringe
US20140014210A1 (en) * 2012-07-13 2014-01-16 Becton Dickinson and Company Ltd. Medical Vial Access Device with Pressure Equalization and Closed Drug Transfer System and Method Utilizing Same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060155257A1 (en) 2002-11-08 2006-07-13 Reynolds David L Pharmaceutical delivery systems and methods for using same
US20100179506A1 (en) * 2009-01-15 2010-07-15 Eli Shemesh Vial adapter element
US20120330280A1 (en) * 2009-08-06 2012-12-27 Reynolds David L Airless mixing with a by-pass syringe
US20140014210A1 (en) * 2012-07-13 2014-01-16 Becton Dickinson and Company Ltd. Medical Vial Access Device with Pressure Equalization and Closed Drug Transfer System and Method Utilizing Same

Also Published As

Publication number Publication date
WO2015142849A1 (en) 2015-09-24

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