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WO2009029010A1 - Dispositif, élément d'étanchéité et contenant de fluide - Google Patents

Dispositif, élément d'étanchéité et contenant de fluide Download PDF

Info

Publication number
WO2009029010A1
WO2009029010A1 PCT/SE2007/050591 SE2007050591W WO2009029010A1 WO 2009029010 A1 WO2009029010 A1 WO 2009029010A1 SE 2007050591 W SE2007050591 W SE 2007050591W WO 2009029010 A1 WO2009029010 A1 WO 2009029010A1
Authority
WO
WIPO (PCT)
Prior art keywords
sealing member
fluid container
opening
fluid
piercing member
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/SE2007/050591
Other languages
English (en)
Inventor
Håkan TÖRNQVIST
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.)
Carmel Pharma AB
Original Assignee
Carmel Pharma AB
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 Carmel Pharma AB filed Critical Carmel Pharma AB
Priority to JP2010522854A priority Critical patent/JP5615176B2/ja
Priority to ES07794201.9T priority patent/ES2542039T3/es
Priority to PCT/SE2007/050591 priority patent/WO2009029010A1/fr
Priority to EP07794201.9A priority patent/EP2190401B1/fr
Publication of WO2009029010A1 publication Critical patent/WO2009029010A1/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
    • 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

  • the present invention concerns a device for transferring a fluid to and/or from a fluid container having a sealing member.
  • the present invention also concerns a sealing member and a fluid container.
  • the device, sealing member and fluid container of the present invention are particularly, but not exclusively intended for transferring medical substances to and/or from a fluid container, however they may be used for transferring any kind of fluid, i.e. any continuous, amorphous substance whose molecules move freely past one another and that has the tendency to assume the shape of its container, to and/or from a fluid container.
  • Medical drugs and solvents are often supplied in glass or plastic containers, such as vials, bottles or bags, which are sealed by a rubber, plastic or elastomeric bung, stopper, membrane or puncturable cap.
  • Such sealing members prevent deterioration or contamination of the drug, allow the contents of a container to be mixed by shaking, and prevent the contents of the container from leaking out and contaminating the surroundings.
  • a cannula or a hollow spike comprising a flow channel and an opening that communicates with the flow channel, is usually inserted through such a sealing member to supply fluids to the container and to withdraw fluid therefrom.
  • an infusion fluid container is made of a rigid or semi-rigid material, i.e. if its walls are non-collapsible, an air inlet is required to withdraw medical fluid from the infusion fluid container and prevent the formation of a vacuum therein.
  • a spike having a medical fluid flow channel and an air inlet passage, usually comprising an air filter, is therefore used.
  • a cannula or spike When a container comprising medical fluid is nearly empty a cannula or spike is often used to withdraw the last few drops of the medical fluid (which may be very expensive and/or toxic) from the container to minimize waste and to facilitate cleaning/disposal of the container.
  • the cannula or spike is slowly and carefully retracted through the sealing member while withdrawing the medical fluid remaining in the container.
  • a toxic drug may leak out and contaminate the surroundings during such a procedure and non- filtered air containing undesirable particles such as dust, pollen or bacteria may be drawn into the cannula and thus contaminate the medical fluid therein.
  • containers are in fact provided with an extra amount of the drug that is to be withdrawn to allow for the fact that not all of the drug will be withdrawn from the container.
  • a user is then able to withdraw the recommended number of doses from the container but doing so will increase the cost of each container of medical fluid, increase waste and make cleaning or disposal of the container more complex.
  • sealing members are available in a wide variety of configurations, sizes and thicknesses, it is difficult to design a spike that is suitable for use with a plurality of different sealing members and which makes it possible to withdraw the last few drops of a medical fluid out of the containers in a safe and convenient way.
  • An object of the present invention is to provide a device that enables an efficient transfer of fluid into and/or out of a fluid container having a sealing member.
  • a device comprising a piercing member for penetrating the sealing member and an elongated body defining a longitudinal flow channel through which a fluid may flow into or out of the fluid container.
  • the device comprises at least one opening that communicates with the flow channel whereby the at least one opening is arranged to extend along at least 1 % preferably at
  • the length of the piercing member is defined as the distance from the tip of the piercing member to the point at which the width of the device increases by an amount that would require a substantially increased force to push that part of the device more deeply into an infinitely wide sealing member of a bottomless fluid container.
  • the length of the piercing member is defined as the distance from the tip of the piercing member to opposite end of the device.
  • Such a device allows the entire contents, or essentially the entire contents of the fluid > container to be drained from an inverted fluid container.
  • the inventive device also improves the mixing of fluids inside the container when the fluid container is inverted or in an upright position. If a liquid drug is to be mixed with a liquid solvent in an inverted or upright fluid container, for example, the mixing of the two liquids ⁇ is facilitated since a plurality of openings or an elongated opening allows a liquid drug/solvent to flow into the fluid container more quickly than if using a conventional device and mixing is improved due to the increased and more distributed inlet area and the increased turbulence caused thereby.
  • convection currents may speed up the mixing of the two fluids. Convection currents may also aid mixing if a refrigerated fluid enters the top of an upright fluid container containing a fluid having a higher temperature
  • the inventive device is suitable for use with a plurality of fluid containers comprising sealing members of different thicknesses (which can range from a few millimetres to a few centimetres) and different configurations (such as concave, bi-concave or M-shaped) if » the at least one opening extends over a length that is greater than the thickness of the thickest sealing member that the device is designed to penetrate.
  • the device comprises one opening that extends substantially along the entire length of the piercing member.
  • the device comprises a plurality of openings that are uniformly or non-uniformly spaced along the length of the piercing member.
  • the device comprises a retractable sleeve, such as a rubber, plastic or elastomeric sheath, that is arranged to at least partially cover and seal the at least one opening before the device is inserted into the sealing member of a fluid container.
  • the retractable sleeve is arranged to abut against the
  • the device comprises connecting means to connect it to a fluid container so that the device will not accidentally become detached from the fluid container when the device is in use, or prior to or after use.
  • the device comprises a ruled scale, which for example extends from the outermost edge of an opening in the direction from the interior of the fluid container outwards towards the sealing member. If the thickness of a sealing member at the point of insertion of the device is known, the ruled scale may be
  • the ruled scale may also be used to measure the thickness of the sealing member before the device is inserted into it.
  • the present invention also concerns a sealing member, such as a rubber, plastic or elastomeric bung, stopper, membrane or puncturable cap, for sealing an outlet of a fluid container, which sealing member comprises a device according to any of the embodiments of the invention whereby the device is integrally formed with the sealing
  • the device is slidably mounted on the sealing member so that the at least one opening of the device may be opened and closed by sliding the device back and forth with respect to the sealing member.
  • the present invention further concerns a fluid container that comprises a sealing member according to any of the embodiments of the invention.
  • Figure 1 shows a conventional device for transferring fluid to and/or from a fluid container
  • Figures 2-5 show devices for transferring fluid to and/or from a fluid container according to embodiments of the invention.
  • Figures 6-7 show sealing a sealing member according to an embodiment of the ? invention.
  • Figure 1 shows a conventional device 10 for transferring fluid to and/or from an inverted fluid container 12 having a sealing member 14 that hermetically seals the contents 22 of the fluid container 12.
  • the device 10 comprises a piercing member 16 for penetrating the sealing member 14 and an elongated body defining a longitudinal flow channel 18 through which the contents of the fluid container may flow into and/or out of the fluid container 12
  • sealing members 14 vary in thickness and toughness, the opening 20 of the device can become located at any of an infinite number of positions in the fluid container 12 depending on how much force the user applies when inserting the device 10 through the sealing member 14 and depending on whether the device is inserted substantially vertically or at an angle to the longitudinal axis of the fluid container 12. Once the contents 22 of the fluid container 12 have drained to a level just under the outermost edge 20a of the opening, no more fluid will be able to drain from the fluid container unless the device is withdrawn slightly. i
  • Figure 2 shows a device 24 in accordance with the present invention for transferring a fluid to and/or from an inverted fluid container 12 having a sealing member 14.
  • the device 24 comprises a piercing member 16 having a bevelled tip for penetrating the sealing member 14 and may also optionally comprise an elongated tubular body portion 24a of ⁇ any symmetrical or non-symmetrical cross-sectional form, such as circular, square, hexagonal or octagonal.
  • the elongated body portion 24a has a greater width than the width of the piercing member 16 and is not intended to be inserted through the sealing member 14 of a fluid container 12.
  • the elongated body portion 24a may comprise a drop chamber.
  • the device 24 may also optionally comprise an air/liquid inlet 24b.
  • the piercing member 16 defines a substantially longitudinal flow channel (not shown) through which the contents of the fluid container may flow into and/or out of the fluid container 12 and one elongated opening 20, that can be of any shape, such as rectangular, square, circular or oval, which communicates with the flow channel.
  • opening 20 extends longitudinally along about 50% of the length, L, of the piercing member 16, either from the tip of the piercing member or a few millimetres from the tip of the piercing member, to ensure that at least part of the at least one opening is located substantially adjacent to the innermost side 14a of a sealing member 14 when the device 10 is in use.
  • the maximum width of the opening 20 is equal to at least 20% of the
  • maximum width of the piercing member 16 preferably at least 50% of the maximum width of the piercing member 16.
  • the innermost side 14a of the sealing member 14 overlaps the elongated opening 20 when the device is in use.
  • the device 24 also comprises a ruled ) scale 26 to allow a user to accurately position the outermost edge 20a of the opening 20 if he/she knows the thickness of the sealing member 14 at the point of insertion of the device 24.
  • the device 24 may comprise plastic, such as thermoplastic material; metal, glass or a » ceramic material.
  • the length of the piercing member 16 may range from 0.5 - 5.0 cm or more, whereby the length of the piercing member is preferably 5 to 20 times its maximum width.
  • a rigid or semi-rigid fluid container 12 such as a glass
  • the inventive device 24 is equally suitable for use with a non-rigid fluid container, such as an infusion bag. Furthermore, even though an air inlet would be necessary when draining fluid from a rigid or semi-rigid fluid container, air inlets and air channels have not been illustrated in any of the drawings for the sake of clarity. The inventive device could however comprise any number of channels for air or ⁇ other fluids.
  • FIG. 3 shows a device 24 according to another embodiment of the invention before the device has been inserted into the sealing member of a fluid container.
  • the device comprises one opening 20 that extends substantially along the entire length, L, of the s piercing member 16 from behind its solid beveled tip towards the opposite end of the piercing member 16.
  • the length of the opening 20 will of course depend on the thickness of the thickest sealing member 14 that it is intended to penetrate.
  • the device 24 comprises a tightly fitting elastic retractable sleeve 28, comprising silicone rubber for example, that is arranged to at least partially cover and seal the at least one opening 20
  • the retractable sleeve 28 is arranged to abut against the outermost side 14b of the sealing member 14 when the device has been inserted into a fluid container 12 and to retract as the piercing member 16 penetrates more deeply into sealing member 14.
  • Figure 4 shows the device 24 of figure 3 after it has been inserted into the sealing member 14 of a fluid container 12. It can be seen that the part of the opening 20 inwards of the innermost side 14a of the sealing member 14 is exposed to the interior of the fluid container whereas the part of the opening 20 outwards of the outermost side 14b of the sealing member 14 is sealed, thereby preventing deterioration or contamination of the
  • the device 24 shown in figures 3 and 4 also comprises connecting means 30, to » grippingly engage the rim of the fluid container 12 to hold the device 24 firmly in place on the fluid container 12.
  • the connecting means 30 comprises two manually operable resilient arms comprising curved end regions that slidably engage the rim of the fluid container 12 when the device 24 has been pushed through the fluid container's sealing member 14.
  • the connecting means 30, which may be a snap-fit mechanism, a luer lock or
  • any other mechanical or non-mechanical connecting means may be arranged to cause the piercing member 16 of the device to penetrate the sealing member 14 of a fluid container 12 as the connecting means are engaged, thus providing fluid communication between the interior of the fluid container 12 and the flow channel of the device 24, i.e. fluid communication is provided when a luer lock is twisted into a locked position for ⁇ example.
  • the device comprises a piercing member shield/guard to prevent users from being hurt by the piercing member 16 and to prevent contamination of the piercing member 16.
  • the connecting means 30 also act as a piercing member shield/guard.
  • the at least one opening 20 of the inventive device 24 need not necessarily extend in a direction parallel or collinear to the longitudinal axis of the device 24, it/they may extend in a zig-zag pattern along the length of the piercing member 16 or I even be constituted by a plurality of openings that extend transversely to the longitudinal axis of the device 24.
  • Figure 5 shows a device 24 according to a further embodiment of the invention.
  • the device 24 comprises a plurality of openings 20 uniformly spaced along a distance d, which
  • the device 24 may for example comprise ten uniformly spaced openings 20 that extend 2 mm along the longitudinal direction of the piercing member 16, each thereby spaced 1 mm apart.
  • the piercing member 16 comprises a blunt end, which may be used to pierce a sealing member 14 having a thin
  • Figures 6 and 7 show a sealing member 32 according to an embodiment of the invention.
  • the sealing member 32 comprises natural or synthetic rubber or any other elastomer
  • the sealing member 32 comprises a device 24 according to any of the embodiments of the invention whereby the device 24 is integrally formed with the sealing member 32 or releasably/non-releasably connected thereto.
  • the device 24 is slidably mounted on the sealing member 32 so that the at least one opening 20 of the device may be opened and closed by sliding the device back and forth with respect to the > sealing member from a closed position as shown in figure 6 to an open position as shown in figure 7.
  • the device 24 may of course be arranged to stop at any number of further positions in addition to the fully open and fully closed positions that have been illustrated.
  • the inventive sealing member 32 may be inserted into the inlet/outlet of a fluid container 12 or may comprise means, such as a thread, to enable it to be attached to a fluid container for example.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Closures For Containers (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention porte sur un dispositif (24) de transfert d'un fluide (22) dans un contenant de fluide et/ou à partir de celui-ci (12), ledit contenant comportant un élément d'étanchéité (14). Le dispositif (24) comprend un élément de perçage (16) servant à pénétrer l'élément d'étanchéité (14) et un corps allongé formant un canal d'écoulement longitudinal (18) à travers lequel un fluide (22) peut s'écouler dans le contenant de fluide (12) et/ou hors de celui-ci, et au moins une ouverture (20) qui communique avec le canal d'écoulement (18). Ladite ouverture (20) est disposée pour s'étendre sur au moins 1 % de la longueur (l) de l'élément de perçage (16) pour garantir qu'au moins une partie de ladite ouverture (20) soit située sensiblement adjacente au côté le plus à l'intérieur (14b) d'un élément d'étanchéité (14) lors de l'utilisation du dispositif.
PCT/SE2007/050591 2007-08-30 2007-08-30 Dispositif, élément d'étanchéité et contenant de fluide Ceased WO2009029010A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2010522854A JP5615176B2 (ja) 2007-08-30 2007-08-30 流体移送装置
ES07794201.9T ES2542039T3 (es) 2007-08-30 2007-08-30 Dispositivo, elemento de sellado y recipiente para fluidos
PCT/SE2007/050591 WO2009029010A1 (fr) 2007-08-30 2007-08-30 Dispositif, élément d'étanchéité et contenant de fluide
EP07794201.9A EP2190401B1 (fr) 2007-08-30 2007-08-30 Dispositif, élément d'étanchéité et contenant de fluide

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2007/050591 WO2009029010A1 (fr) 2007-08-30 2007-08-30 Dispositif, élément d'étanchéité et contenant de fluide

Publications (1)

Publication Number Publication Date
WO2009029010A1 true WO2009029010A1 (fr) 2009-03-05

Family

ID=40387541

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2007/050591 Ceased WO2009029010A1 (fr) 2007-08-30 2007-08-30 Dispositif, élément d'étanchéité et contenant de fluide

Country Status (4)

Country Link
EP (1) EP2190401B1 (fr)
JP (1) JP5615176B2 (fr)
ES (1) ES2542039T3 (fr)
WO (1) WO2009029010A1 (fr)

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JP2010279409A (ja) * 2009-06-02 2010-12-16 Panasonic Corp 薬液吸入用複合針およびこれを用いた薬液容器並びに薬液吸入方法
WO2011058545A1 (fr) * 2009-11-12 2011-05-19 Medimop Medical Projects Ltd Dispositifs de transfert de fluide avec équipement d'étanchéité
USD641080S1 (en) 2009-03-31 2011-07-05 Medimop Medical Projects Ltd. Medical device having syringe port with locking mechanism
US8016809B2 (en) 2007-09-25 2011-09-13 Medimop Medical Projects Ltd. Liquid drug delivery devices for use with syringes with widened distal tips
US8021325B2 (en) 2004-04-29 2011-09-20 Medimop Medical Projects Ltd. Liquid drug medical device
US8070739B2 (en) 2005-08-11 2011-12-06 Medimop Medical Projects Ltd. Liquid drug transfer devices for failsafe correct snap fitting onto medicinal vials
USD669980S1 (en) 2010-10-15 2012-10-30 Medimop Medical Projects Ltd. Vented vial adapter
US8317743B2 (en) 2007-09-18 2012-11-27 Medimop Medical Projects Ltd. Medicament mixing and injection apparatus
USD674088S1 (en) 2012-02-13 2013-01-08 Medimop Medical Projects Ltd. Vial adapter
US8435210B2 (en) 2007-04-17 2013-05-07 Medimop Medical Projects Ltd. Fluid control device with manually depressed actuator
US8684994B2 (en) 2010-02-24 2014-04-01 Medimop Medical Projects Ltd. Fluid transfer assembly with venting arrangement
US8752598B2 (en) 2011-04-17 2014-06-17 Medimop Medical Projects Ltd. Liquid drug transfer assembly
US8753325B2 (en) 2010-02-24 2014-06-17 Medimop Medical Projects, Ltd. Liquid drug transfer device with vented vial adapter
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WO2019084371A1 (fr) * 2017-10-26 2019-05-02 Cook Regentec Llc Adaptateur pour flacons et seringues
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US10945921B2 (en) 2017-03-29 2021-03-16 West Pharma. Services IL, Ltd. User actuated liquid drug transfer devices for use in ready-to-use (RTU) liquid drug transfer assemblages
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Publication number Publication date
JP5615176B2 (ja) 2014-10-29
EP2190401A1 (fr) 2010-06-02
ES2542039T3 (es) 2015-07-29
JP2010537900A (ja) 2010-12-09
EP2190401B1 (fr) 2015-05-20
EP2190401A4 (fr) 2013-12-25

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