WO2025202011A1 - Gabarit d'aide au perçage manuel d'aiguille d'extraction de liquide ou de pointe de pipette, adaptateur de flacon et procédé d'extraction de liquide à partir d'un flacon - Google Patents

Gabarit d'aide au perçage manuel d'aiguille d'extraction de liquide ou de pointe de pipette, adaptateur de flacon et procédé d'extraction de liquide à partir d'un flacon

Info

Publication number
WO2025202011A1
WO2025202011A1 PCT/EP2025/057599 EP2025057599W WO2025202011A1 WO 2025202011 A1 WO2025202011 A1 WO 2025202011A1 EP 2025057599 W EP2025057599 W EP 2025057599W WO 2025202011 A1 WO2025202011 A1 WO 2025202011A1
Authority
WO
WIPO (PCT)
Prior art keywords
jig
needle
vial
opening
pipette tip
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.)
Pending
Application number
PCT/EP2025/057599
Other languages
English (en)
Inventor
Gael Waiche
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.)
Merck Patent GmbH
Original Assignee
Merck Patent GmbH
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 Merck Patent GmbH filed Critical Merck Patent GmbH
Publication of WO2025202011A1 publication Critical patent/WO2025202011A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means

Definitions

  • a syringe or any other suitable apparatus is coupled to a Luer connector at a rear (i.e. opposite) end of the adapter to withdraw the liquid from the vial.
  • Vial adapters may be molded from medicalgrade polycarbonate and are compatible with Luer slip and Luer lock devices, such as syringes.
  • this combination is also used when inserting or withdrawing the vial-jig- needle combination to/from a receiving apparatus (that is to receive the liquid from the vial) that will benefit from the assembly to get liquid from the vial through the sterile needle without contact with the jig.
  • the gripping recesses of the jig are shaped and arranged to partially accommodate at least two, preferably three or four fingers of a hand of a user. This partial accommodation of several fingers of the hand promotes an intuitive and safe use of the jig during handling as it defines dedicated holding positions for the process.
  • the through-opening is dimensioned to frictiona lly engage a periphery of the needle or pipette tip, when inserted, by a defined distance in a direction essentially perpendicular to the opening diameter, thereby removably fixing the needle or pipette tip in position relative to the body.
  • the needle or pipette tip may comprise a flexible clip or flexible latch to releasably engage with the body of the jig.
  • the temporary fixation of the needle at a distinct insertion position contributes to the safety of the handling during insertion of the combination of jig and needle through the septum and supports the above-described centering function of needle and fingers.
  • the mechanical engagement also defines a perceptible indication that the needle is properly inserted into the through- opening of the jig and prevents or at least reduces tilting or separation of the needle relative to the jig while the vial-jig-needle combination is transferred to/from the receiving apparatus.
  • the body of the jig is flat and/or disc-shaped, preferably is substantially round- symmetrical.
  • the gripping recesses are formed as concave contour sections distributed about the outer periphery of the body.
  • the gripping recesses may be aligned with a fictive circle, that is preferably concentric with the through-opening.
  • transitions between the concave contour sections of the gripping recesses and intermediate peripheral tooth-like sections of the body are rounded.
  • the body of the jig may be made of a steam-sterilizable material, preferably from the group consisting of metals, plastic materials (or polymers), and ceramics.
  • a preferred steam-sterilizable material is stainless steel.
  • the body is polished, or has smooth edges, or may be polished and have smooth edges.
  • the above aspects individually or in combination, provide a simple design and choice in material of the jig that facilitates decontamination for repeated use (as no sharp edges, corners or pockets are involved in the jig), for example by sterilization, storage and handling.
  • the smooth edges also aid in avoiding damage to the gloves when working in an isolator with gloves.
  • the through-opening is aligned with a centroid of the body. This location of the through-opening for the needle supports the above-described centering function of needle and fingers during use and creates a certain balance of momentums.
  • the through-opening may have one or more recesses extending outward from a fictive round/circular outline to reduce a contact area with the needle or pipette tip when the same is inserted into the through-opening and leave a space for passing air alongside the needle or pipette tip.
  • the recesses at the periphery of the through-opening reduce the friction between the needle's periphery and the edge of the through-opening and help defining a desired holding and removing force between needle and jig. Further, such recesses may allow air to pass through the through-opening even in the inserted state of the needle, which is beneficial to maintain a venting effect through the needle even if the jig is more or less tightly placed on the top of the cap of the vial. Additionally, said recesses facilitate the use of clips or flexible latches for releasable engagement with the body of the jig.
  • the jig may have, overall, an outline that may be substantially similar in average diameter to an outline or diameter of a neck of a vial and/or may have an outline shape that may best be described as being like a gear wheel or guide pulley of a rear bicycle derailleur with rounded edges.
  • the present application also provides for a vial adapter which is a set or kit comprising a jig as described herein, and a mating liquid extraction needle having a shaft with a pointed tip at a leading end to be pierced into a septum of a vial cap, the shaft configured to be removably inserted through the through-opening of the jig, a fluidic connection passage extending from the leading end through the shaft to a connector, preferably a Luer- compatible connector, at a trailing end of the needle, and a vent passage communicating with the leading end of the shaft.
  • a vial adapter which is a set or kit comprising a jig as described herein, and a mating liquid extraction needle having a shaft with a pointed tip at a leading end to be pierced into a septum of a vial cap, the shaft configured to be removably inserted through the through-opening of the jig, a fluidic connection passage extending from the leading end
  • the vial adapter is a ready-to-use medical device intended for the transfer and mixing of liquids (drugs, injectable pharmaceuticals, vaccines) contained in vials and is a cost- effective solution forthe safe and rapid transfer and reconstitution of drugs between vials and syringes.
  • the adapter is designed for the optimal removal of liquids and reconstituted drugs, which may reduce residual volume and overfill requirements, and is compatible with common Luer (slip and/or lock) syringes while providing the effect of reduced waste volume due to the re-usability of the jig.
  • the liquid extraction needle or pipette tip is inserted through the through- opening of the body and is frictionally fixed in the through-opening before the jig is placed on the vial cap.
  • the gripping recesses 2b mainly serve to secure and improve the grip of the fingers of the hand of a user in a defined holding position (see Figure 4 as an example of a holding posture) and can as such be implemented by a number of such recesses 2b of any form separated by intermediate peripheral tooth-like sections 2a.
  • the recesses/tooth-like sections can be even implemented as knurled or toothed portions formed at a part of or the entire periphery of the body that effectively increase the friction between the body and the fingers of the user.
  • six gripping recesses 2b are formed in regular intervals as concave, indented contour sections distributed about the outer periphery of the body 2, wherein transitions or corners 2c between the concave contour sections of the gripping recesses 2b and the intermediate peripheral tooth-like sections 2a of the body 2 are rounded so as to be smooth and avoid any sharp edges.
  • the outline shape of the jig and roughly its size resembles a gear wheel or guide pulley with rounded edges that is frequently used as a pair in a rear derailleur of a bicycle with a chain drive.
  • the six gripping recesses 2b are aligned with a fictive circle, which preferably is concentric with the through-opening 3 so that the jig is overall substantially round-symmetrical.
  • the gripping recesses are thus shaped and arranged to partially accommodate at least two, preferably three or four fingers of a hand of a user in different orientations.
  • the number of recesses and their specific shape (depth, width, radius) and arrangement are not limited to the specific example but can vary.
  • the recesses my even be provided in an unsymmetrical arrangement with different intervals. However, because an unsymmetrical arrangement might restrict the use to a preferred orientation, a symmetrical and uniform arrangement is preferred.
  • the through-opening 3 is a hole through the thickness of the body 2 and is dimensioned to receive the needle or pipette tip 5 in that the same is inserted into and through the hole in a direction substantially perpendicular to a plane of a main face of the body 2 or perpendicular to the diameter of the hole.
  • the through-opening 3 is preferably dimensioned and formed so as to frictionally engage a periphery of the needle or pipette tip 5 when inserted by a defined distance in the direction perpendicular to the opening diameter, which distance is determined by the inclination of the sidewall of a shaft 6 of the needle or pipette tip 5 or the provision of a step 10 expanding the diameter of the shaft 6 of the needle or pipette tip 5.
  • the needle or pipette tip 5 is fixed in position relative to the body 2 by a frictional and/or form-locking mechanical engagement so that the leading end side protrudes from one side face of the body 2 by a distance required to be inserted into the volume of the vial and a trailing end side protrudes from the opposite side face of the body to allow for connection to a syringe or tube as described further below.
  • the needle or the pipette tip 5 may comprise a flexible clip or flexible latch to releasably engage with the body 2 of the jig 1.
  • a flexible clip or flexible latch may be configured to be automatically pressed in by the movement of the needle or the pipette tip into the through-opening 3 of the jig 1 and snap out again once fully inserted, or may need to be compressed by hand.
  • Such flexible clip or flexible latch adds, however, additional complexity in the manufacturing as well as the handling of the needles and pipette tips.
  • the needle 5 is separated from the jig 1 and (normally) discarded and the jig 1 is either re-used right away or collected for sterilisation and future re-use.

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)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

La présente demande concerne un gabarit d'aide au perçage manuel d'une aiguille d'extraction de liquide ou d'une pointe de pipette dans un septum d'un bouchon de flacon, un adaptateur de flacon comprenant le gabarit, et un procédé d'extraction d'un liquide d'un flacon à l'aide du gabarit, permettant, par rapport à des solutions existantes, une réduction significative du besoin en polymères généralement à base de pétrole pour la production, le transport et le stockage.
PCT/EP2025/057599 2024-03-25 2025-03-20 Gabarit d'aide au perçage manuel d'aiguille d'extraction de liquide ou de pointe de pipette, adaptateur de flacon et procédé d'extraction de liquide à partir d'un flacon Pending WO2025202011A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24305436 2024-03-25
EP24305436.8 2024-03-25

Publications (1)

Publication Number Publication Date
WO2025202011A1 true WO2025202011A1 (fr) 2025-10-02

Family

ID=90735477

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/057599 Pending WO2025202011A1 (fr) 2024-03-25 2025-03-20 Gabarit d'aide au perçage manuel d'aiguille d'extraction de liquide ou de pointe de pipette, adaptateur de flacon et procédé d'extraction de liquide à partir d'un flacon

Country Status (1)

Country Link
WO (1) WO2025202011A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996029113A1 (fr) 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Dispositif de regulation de fluide
US20100022985A1 (en) 2004-07-29 2010-01-28 Sullivan Rou H Vial adaptor
US20130144248A1 (en) 2010-02-22 2013-06-06 Fresenius Kabi Deutschland Gmbh Device to introduce or remove a fluid into or out of a container

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996029113A1 (fr) 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Dispositif de regulation de fluide
US20100022985A1 (en) 2004-07-29 2010-01-28 Sullivan Rou H Vial adaptor
US20130144248A1 (en) 2010-02-22 2013-06-06 Fresenius Kabi Deutschland Gmbh Device to introduce or remove a fluid into or out of a container

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