WO2025202011A1 - Jig for aiding manual piercing of liquid extraction needle or pipette tip, vial adapter and method of extracting liquid from vial - Google Patents

Jig for aiding manual piercing of liquid extraction needle or pipette tip, vial adapter and method of extracting liquid from vial

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
French (fr)
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/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting 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.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

The present application relates to a jig for aiding manual piercing of a liquid extraction needle or pipette tip into a septum of a vial cap, to a vial adapter including the jig, and to a method of extracting a liquid from a vial using the jig, allowing in comparison to existing solutions a significant reduction in the need of generally petroleum-based polymers in production, transport and storage.

Description

JIG FOR AIDING MANUAL PIERCING OF LIQUID EXTRACTION NEEDLE OR PIPETTE TIP, VIAL ADAPTER AND METHOD OF EXTRACTING LIQUID FROM VIAL
Technical Field
The present application relates to a jig for aiding manual piercing of a liquid extraction needle or pipette tip into a septum of a vial cap, to a vial adapter including the jig, and to a method of extracting a liquid from a vial using the jig, allowing in comparison to existing solutions a significant reduction in the need of generally petroleum-based polymers in production, transport and storage.
Background
Vial adapters are known and are single-use, sterile, non-invasive medical devices intended for the transfer and mixing of liquids (such as drugs, injectable pharmaceuticals, vaccines) contained in vials. Puncturing of an elastomeric closure/septum of a cap of the vial may be achieved by means of an integral plastic spike located in the center of the vial adapter that has overall a hat-like shape that can be placed onto the cap, with a peripheral skirt surrounding the cap and a part of the length of the neck of the vial.
After the adapter is mounted in place onto the neck of the vial, 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.
Figure 6 shows a known vial adapter A in a cross-sectional side view before the septum S of the cap C of the vial V oriented downward is pierced by the spike K of the adapter.
WO 96/29113 Al, for example, discloses a similar vial adapter termed fluid control device for use with a syringe and at least one medicinal vessel which is provided with an additional flow control member.
US 2010/022985 Al discloses a vial adapter for use in transferring liquid from a vial, the vial adapter comprising a body being dimensioned to receive the vial, and a hollow piercing member extending downwardly for puncturing the vial. US 2013/0144248 Al discloses a device for feeding liquid into or removing a liquid from a receptacle, the device having a spike and a housing connected to the spike, the spike having a liquid channel and a venting channel, and the housing having a liquid filter connect to the liquid filter chamber connected to the liquid channel and a venting filter chamber connected to the venting channel.
However, neither of these devices allows for being re-used either partially or fully, and they need to be completely discarded after use. Furthermore, these device are complicated to manufacture because they consist of a number of different components, which need to be assembled either manually or by machine to arrive at the final device.
While vial adapters are at present a cost-effective solution for the safe and rapid transfer and reconstitution of drugs between vials and syringes and reduce exposure to needlestick injuries and involve fewer steps and parts for the process, they are rather bulky parts and, due to the fact that they are single-use items, create a large waste volume which is an increasing concern.
The invention therefore aims at providing a solution for manually injecting/extracting a liquid (drugs, injectable pharmaceuticals, vaccines) contained in vials via the septum of the cap that improves product or process sustainability while keeping the efficiency of the core functions.
Summary
The present inventors have now surprisingly found that the above objectives can be achieved in a very simple manner by the present jig and vial adapter.
Thus, the present application provides for a jig for aiding manual piercing of a liquid extraction needle or pipette tip into a septum of a vial cap, the jig comprising
- a body having a through-opening through which the needle or pipette tip can be inserted; and
- a number of gripping recesses distributed about the periphery of the body and the through-opening.
Further, the present application also discloses a vial adapter comprising
- said jig, and - a 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.
The present application also provides for a method of extracting a liquid from a vial through a vial cap including a pierceable septum, comprising in sequence the following steps of
(a) manually placing said jig on the vial cap and aligning the through-opening of the body of the jig with the septum using two, preferably three or four fingers of a hand surrounding the periphery of the body of the jig;
(b) inserting a liquid extraction needle or pipette tip through the through-opening of the body into the septum; and
(c) connecting a syringe with a rear of the liquid extraction needle or pipette tip and extracting the liquid by the sucking action of the syringe.
Brief description of the drawings
Preferred embodiments will now be described with respect to the following attached exemplary, schematic, and non-limiting drawings:
Figure 1 shows a top plan view of the jig according to an embodiment.
Figure 2 shows a diametrical cross-sectional side view of the jig according to the embodiment of Figure 1.
Figure 3 shows a cross-sectional side view of a liquid extraction needle suitable for use with the herein defined jig (left) and a partial cross-sectional side view of the liquid extraction needle inserted through the jig according to the embodiment forming a vial adapter (right).
Figure 4 shows a perspective view from the top and exemplifying a manual application of the jig of the embodiment in combination with a liquid extraction needle for piercing the cap of a vial. Figure 5 shows a perspective side view of the jig of the embodiment in combination with a liquid extraction needle pierced through the cap of a vial.
Figure 6 shows a known vial adapter in a cross-sectional side view before a cap of a vial oriented downward is pierced by the spike of the adapter.
Detailed description
The present application particularly provides for a jig for aiding the manual piercing of a liquid extraction needle (throughout this application also simply referred to as "needle") or pipette tip into a septum of a vial cap, the jig comprising a body having a through- opening through which the needle or pipette tip can be inserted, and a number of gripping recesses distributed about the periphery of the body and the through-opening.
The present concept consists in separating the functions of the manual holding support and the liquid extraction by designing a potentially reusable jig that facilitates manual gripping during the process and allows safe and intuitive insertion of a (separate) liquid extraction needle or pipette tip which can be in the form of a minimalist single use part holding the application critical functions (sterility, piercing a rubber septum, providing a fluidic conduit to a Luer connector, and a venting function). The combination of the potentially reusable jig with the disposable single-time use sterile minimalist needle part reduces the size of the combined part and the volume of waste as compared to the existing solution of an integrated vial adapter, which is of particular advantage when the jig/needle assembly is to be used in an isolator, and which reduces the environmental impact. In comparison to the commonly used vial adapters having a hat-like shape as described above, the present jig allows using much simpler and thus more lightweight needles or pipette tips, thereby leading to a significant reduction of petroleum-based polymers required for their production but also resulting in a reduction in energy and packaging needed for their transport and storage.
The combination of the jig with the disposable needle inserted into the jig creates, despite of the reduced material consumption, a centering function by the needle and the user's fingers fostering proper placement during insertion of the needle into the vial cap's septum and protecting the user from injury and/or contamination.
The function of 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.
Preferably, 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.
Preferably, 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.
Alternatively to said frictional engagement 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, typically essentially perpendicular to a plane of the jig, 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.
Preferably, the body of the jig is flat and/or disc-shaped, preferably is substantially round- symmetrical. Preferably, 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. Preferably 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.
Preferably 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. Particularly the smooth edges also aid in avoiding damage to the gloves when working in an isolator with gloves.
Preferably, 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.
Preferably, 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.
In a preferred form that provides a number of the above advantages 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. 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.
Such vial adapter is also more flexible as it may combine the jig as the universal, re-usable component with different liquid extraction needle concepts requiring essentially only a correspondence and match between the through-opening in the jig and an outer diameter of the respective needle shaft.
The present application finally also provides for a method of extracting a liquid from a vial through a vial cap including a pierceable septum, comprising manually placing a jig as described herein on the vial cap and aligning the through-opening of the body of the jig with the septum using two, preferably three or four fingers of a hand surrounding the periphery of the body of the jig, inserting a liquid extraction needle or pipette tip through the through-opening of the body into the septum, and connecting a syringe with a rear of the liquid extraction needle or pipette tip and extracting the liquid by the sucking action of the syringe.
Preferably, 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 method as defined herein provides the described advantages of reduced consumed plastics while maintaining and supporting a safe and controlled intuitive handling that avoids injury for the user or spillage and contamination of the surroundings.
The present jig and vial adapter will now be described in more detail referring to Figures I to 5.
The jig 1 according to an embodiment as shown in Figures 1 to 5 generally serves as an aid or tool for supporting manual piercing of a liquid extraction needle or pipette tip 5 (see Figures 3 to 5) into a septum S, for example made of rubber, of a cap C usually crimped to a top end of a neck of a vial V. The term "vial" in the context of the disclosure is to refer to containers for liquids that are typically used in connection with an extraction needle or pipette to remove and/or add liquids from/to the interior volume of the container. The reference to an "extraction" is, in this context, not meant to limit the device or process to a removal of liquids from the container in a strict sense but also covers the reverse process, i.e. an injection of liquid through the cap via the needle.
The jig 1 comprises a body 2 having a through-opening 3 through which the needle or pipette tip 5 can be inserted, and a number of gripping recesses 2b distributed about the periphery of the body 2 and the through-opening 3.
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. In a more general form 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.
In the present embodiment of the jig 1 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. In this embodiment 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. In this way 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.
Alternatively to frictional engagement, 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. Such 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.
In the preferred embodiment the through-opening 3 is aligned with a centroid of the body 2 so as to balance the momentums and so as to intuitively center the jig between the fingers. Such alignment and position are, however, not mandatory.
The body 2 of the jig 1 is overall flat and/or disc-shaped and preferably is substantially round-symmetrical. The average diameter of its outline is preferably substantially similar to an outline or diameter of the neck or cap of the vial, with which it is to be used, but is in any case adapted to the distance of the fingers of a hand to allow intuitive ergonomic handling. The fact that the jig is flat overall allows, however, that the jig is used with smaller or larger caps/vials of a certain range unlike the hat-like vial adapters of the known type shown in Figure 6 that are to be matched to a particular type of cap only.
Preferably, the external shape and dimension of the body 2 of the jig 1 are selected such that the jig can be fitted onto or into a receptacle of a connected instrument when combined with the needle and vial.
The through-opening 3 has one or more recesses 3a extending outward from a fictive round/circular outline of the hole to reduce a contact area with the periphery of the needle or pipette tip 5 when the same is inserted into the through-opening 3. The recesses 3a also leave a space for passing air alongside the needle or pipette tip 5 for venting. In this sense the contour of the through-opening 3 may be symmetrical and may even resemble that of the body's 2 periphery but it may also be polygonal including triangular, rectangular or unsymmetrical in shape provided the matching needle or pipette tip 5 can be inserted to the desired length.
The body 2 is preferably as described above. With this structure and composition the jig has no sharp edges or creases or voids and can be easily and safely cleaned and sterilized to be re-used with another sterile needle or pipette tip 5.
The jig 1 is preferably designed to be used in conjunction with a one-time use disposable sterile liquid extraction needle 5 that is to be removably inserted into and through the through-opening 3 as described above and as shown in Figures 3 to 5. After use, the needle is withdrawn and discarded while the jig 1 can be sterilized and re-used (but can of course be discarded too and even then realizes, to a certain extent, the advantages of reduced waste and the flexibility of being used in conjunction with a variety of different needles). In a similar manner the liquid extraction needle 5 may - if appropriate - also be sterilized and re-used and in this case the possibility to separate the needle and jig facilitates sterilisation, too.
The liquid extraction needle 5 that can be used in conjunction with the jig 1 typically may have, as is shown in Figure 3, a central elongated shaft 6 with a pointed tip 11 at a leading end that is to be pierced into the septum S of the vial cap C. The shaft 6 is configured to be removably inserted through the through-opening 3 of the jig 1 until a mechanical engagement of the two fixes the needle relative to the base 2 of the jig. A fluidic connection passage 9 for extracting/injecting a liquid from/to the vial extends from the leading end through the length of the shaft 6 to communicate with a fluid connector, preferably a Luer-compatible connector 7 of the slip- or lock-type at a trailing end of the needle 5. A compatible Luer-type plug of a syringe or tube or pipe can be removably coupled to a receptacle 7b of the connector 7. Other types of releasable fluidic connectors can be alternatively used.
Preferably, the needle or pipette tip 5 comprises one or more ribs, for example, 2 or 3 or 4 or 5 or 6, ribs and/or channels that extend in longitudinal direction of the needle or pipette tip 5 along the shaft 6 or part of shaft 6. When inserted, these ribs and/or channels are configured to create a small gap between the needle or pipette tip 5 and the septum S, thereby allowing for venting between the interior volume of the vial V and the external atmosphere.
Alternatively, a vent passage 8 may be provided internal the needle or pipette tip 5 as illustrated in Figure 3. A vent passage 8 communicating an outlet opening 8a at the leading end of the shaft 6 at or near the tip 11 with an inlet opening 8b at a position of the needle or its shaft 6 that is outside of the vial in use extends along the length of the shaft 6. The inlet opening 8b is located at or near a step or protrusion 10 expanding the diameter of the shaft 6 and dimensioned such that it acts as a stopper against which the jig 1 may rest in a defined insertion posture as shown in the right representation of Figure 3. Thanks to the one or more recesses 3a leaving a space for passing air alongside the needle or pipette tip 5 for venting, the inlet opening 8b will not be obstructed even when the jig 1 is in place. The vent passage 8 generally facilitates rapid large-volume withdrawal of liquid without pressurizing the vial and reduces sprayback potential of toxic materials through pressure equalization.
The combination of the herein defined jig 1 and of a mating liquid extraction needle 5 forms a vial adapter providing the functionality of such devices as known in the art.
The jig 1 allows implementation of a method of extracting a liquid from a vial V through a vial cap C that includes a pierceable septum S. The method is roughly symbolized by Figure 4 and comprises manually placing the jig 1 on the vial cap C and aligning/automatically centering the through-opening 3 of the body 2 of the jig 1 with the septum S using two, preferably three or four fingers of a hand surrounding the periphery of the body 2 of the jig 1 and the cap C or the vial V. In Figure 4 reference numeral Hl indicates the holding of the needle 5 to transmit the piercing force, and reference numeral H2 shows the combination of fingers, jig 1 and vial V creating the auto-centering. The liquid extraction needle or pipette tip 5 (that is supplied in a sterile packaging and removed therefrom) can be either inserted through the through-opening 3 of the body 2 into the septum S and frictionally fixed in the through-opening 3 where the jig 1 is held in place on or at least aligned with the septum S or can alternatively be inserted through the through-opening 3 of the body 2 and frictionally fixed therein before the jig 1 is placed on the vial cap C. In order to transmit sufficient piercing force and avoid that the needle 5 is disengaged from the fixation in the through-opening 3 the fingers of the other hand of the user may grip and hold the needle 5 at its rear side facing away from the jig 1.
In the next step a syringe or tube or another device is connected with a rear of the liquid extraction needle or pipette tip 5 (for example at the Luer-type connector 7) and the liquid may be injected or extracted by the pushing/sucking action of the syringe. The combination of the vial-jig-needle may then be transferred to a receiving apparatus as a unit. In this apparatus the combination may be used when inserting or removing the vial- jig-needle combination to/from a receptacle of the receiving apparatus as a unit, in which apparatus the unit remains in place order to extract liquid from the vial through the sterile needle without contact with the jig.
After use, 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.

Claims

Claims
1. A jig (1) for aiding manual piercing of a liquid extraction needle or pipette tip (5) into a septum (S) of a vial cap (C), the jig (1) comprising
- a body (2) having a through-opening (3) through which the needle or pipette tip (5) can be inserted; and
- a number of gripping recesses (2b) distributed about the periphery of the body (2) and the through-opening (3).
2. The jig (1) according to claim 1, wherein the gripping recesses (2b) are shaped and arranged to partially accommodate at least two, preferably three or four fingers of a hand of a user.
3. The jig (1) according to claim 1 or claim 2, wherein the through-opening (3) is dimensioned to frictionally engage a periphery of the needle or pipette tip (5) when inserted by a defined distance in a direction essentially perpendicularto the opening diameter, thereby to fix the needle or pipette tip (5) in position relative to the body (2).
4. The jig (1) according to any one of claims 1 to 3, wherein the body (2) is flat and/or disc-shaped, preferably is substantially round-symmetrical.
5. The jig (1) according to any one of claims 1 to 4, wherein the gripping recesses (2b) are formed as concave contour sections distributed about the outer periphery of the body (2).
6. The jig (1) according to any one of claims 1 to 5, wherein the through-opening (3) is aligned with a centroid of the body (2).
7. The jig (1) according to any one of claims 1 to 6, wherein the through-opening (3) has one or more recesses (3a) extending outward from a fictive round/circular outline to reduce a contact area with the needle or pipette tip (5) when the same is inserted into the through-opening (3) and leave a space for passing air alongside the needle or pipette tip (5).
8. The jig (1) according to any one of claims 1 to 7, wherein the gripping recesses (2b) are aligned with a fictive circle, that is preferably concentric with the through- opening (3).
9. The jig (1) according to any one of claims 1 to 8, wherein transitions (2c) between the concave contour sections of the gripping recesses (2b) and intermediate peripheral tooth-like sections (2a) of the body (2) are rounded.
10. The jig (1) according to any one of claims 1 to 9, wherein the body (2) is made of a steam-sterilizable material, preferably from metal, preferably stainless steel, or plastic material, or ceramics, and preferably is polished and preferably has smooth edges.
11. The jig (1) according to any one of claims 1 to 10, wherein the jig (1) has, overall, an outline that is substantially similar in average diameter to an outline of a neck of a vial (V) and/or has an outline shape like a gear wheel or guide pulley of a rear derailleur with rounded edges.
12. A vial adapter comprising
- the jig (1) of any one of claims 1 to 11, and
- a liquid extraction needle (5) having a shaft (6) with a pointed tip (11) at a leading end to be pierced into a septum (S) of a vial cap (C), the shaft (6) configured to be removably inserted through the through-opening (3) of the jig (1), a fluidic connection passage (9) extending from the leading end through the shaft (6) to a connector (7), preferably a Luer-compatible connector, at a trailing end of the needle (5), and a vent passage (8) communicating with the leading end of the shaft (6).
13. A method of extracting a liquid from a vial (V) through a vial cap (C) including a pierceable septum (S), comprising in sequence the following steps of
(a) manually placing a jig (1) of any one of claims 1 to 11 on the vial cap (C) and aligning the through-opening (3) of the body (2) of the jig (1) with the septum (S) using two, preferably three or four fingers of a hand surrounding the periphery of the body (2) of the jig (1);
(b) inserting a liquid extraction needle or pipette tip (5) through the through- opening (3) of the body (2) into the septum (S); and (c) connecting a syringe with a rear of the liquid extraction needle or pipette tip (5) and extracting the liquid by the sucking action of the syringe.
14. The method according to claim 13, wherein 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.
PCT/EP2025/057599 2024-03-25 2025-03-20 Jig for aiding manual piercing of liquid extraction needle or pipette tip, vial adapter and method of extracting liquid from vial Pending WO2025202011A1 (en)

Applications Claiming Priority (2)

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

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PCT/EP2025/057599 Pending WO2025202011A1 (en) 2024-03-25 2025-03-20 Jig for aiding manual piercing of liquid extraction needle or pipette tip, vial adapter and method of extracting liquid from vial

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996029113A1 (en) 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Fluid control device
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 (en) 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Fluid control device
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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