EP1827353A1 - Sicherheitsvorrichtung zur medizinischen anwendung - Google Patents

Sicherheitsvorrichtung zur medizinischen anwendung

Info

Publication number
EP1827353A1
EP1827353A1 EP05824072A EP05824072A EP1827353A1 EP 1827353 A1 EP1827353 A1 EP 1827353A1 EP 05824072 A EP05824072 A EP 05824072A EP 05824072 A EP05824072 A EP 05824072A EP 1827353 A1 EP1827353 A1 EP 1827353A1
Authority
EP
European Patent Office
Prior art keywords
bottle
chamber
pocket
tongue
vial
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.)
Granted
Application number
EP05824072A
Other languages
English (en)
French (fr)
Other versions
EP1827353B1 (de
Inventor
Farid Hamedi-Sangsari
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.)
MAPTECH
Original Assignee
MAPTECH
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 MAPTECH filed Critical MAPTECH
Publication of EP1827353A1 publication Critical patent/EP1827353A1/de
Application granted granted Critical
Publication of EP1827353B1 publication Critical patent/EP1827353B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
    • 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
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the present invention relates to a medical safety device for transferring a drug contained in a vial to an infusion bag or a hypodermic syringe.
  • the objects completely covering the bottle which are clipped on the bottle cap by the nurse at the time of use (developed by MAP): These devices are reliable for use because the bottle is guided along its length, however the vial can not be removed from the device because, since the vial is fully inserted into the device, it offers no grip for the fingers to extract.
  • the object of the present invention is therefore to provide a device for both safe transfer and separation of glass and plastics.
  • the patent FR2790749 discloses a device comprising two guides, the first guide comprises means capable of preventing the total withdrawal of the bottle after its introduction, these means may for example consist of elastic tabs fixed to the inner face and directed inwards. These tabs are elements on the cylinder and their function is to prevent withdrawal of the bottle before drilling the closure of the bottle.
  • the guide is of such length that it can not completely cover the bottle.
  • EP 195018 discloses a device comprising two guide elements, the first element comprises locking means provided for a mechanical locking engagement, when the device is in the use position, and the second element comprises a sliding locking ring.
  • the locking means of the first member is defined by a protrusion extending inwardly from an inner surface of a wall portion, a notch being provided in the wall portion and extending from the base of the first guide element to the projection. The projections are arranged below the notch.
  • the first guide element covers only the neck of the bottle.
  • Patent FR 2473017 discloses a sleeve constituted by a hollow cylindrical body having a circular partition.
  • the inlet of one of the sections has an inner lip that narrows the inlet to seal the vial in the axis of the sleeve prior to drilling the vial closure.
  • the sleeve is of such length that it can not completely cover the bottle.
  • Patent FR 2613220 discloses a holder-needle formed of two sleeve-shaped parts joined by a closed end wall, the portion intended to accommodate the neck of the bottle has radial cams or a circumferential rib for fixing the container.
  • the sleeve is of such length that it can not completely cover the bottle.
  • FR2780878 discloses a transfer cap for the passage of a drug between a vial and a solute bag comprising a tabular monoblock body and a needle, characterized by snap-fastening means in the form of a longitudinal tongue resiliently flexible and provided a boss facing inwards.
  • the present invention is an improvement of the device described in the patent FR2828803 in the name of the present applicant.
  • the patent FR2828803 describes a device for packaging a bottle for medical use economic consisting of a one-piece cylindrical body made of plastic material consisting of two parts, separated by a partition perpendicular to the axis of the tabular body: a lower portion for completely covering the glass vial and a smaller diameter upper portion constituted by a cylindrical chamber containing means, for example a bi-tip needle, for transferring the contents of the vial into a container, such as an infusion bag.
  • This device meets both the safety objectives of personnel and the protection against breakage, but since the bottle offers no outlet for its extraction, it is impossible to separate the glass bottle from the plastic device for purposes selective sorting.
  • the present invention proposes to solve this problem by providing an improvement to this device completely covering the bottle.
  • the device of the present invention consists of a tabular chamber whose open end allows the introduction of the bottle and the other end is closed by a partition carrying a hollow needle; the device completely covers the bottle during its use and is provided on the upper part of the chamber with elastic tongues whose free end is directed towards the inside of the chamber; the base of each tongue is an integral part of the chamber and each tongue is inscribed in an opening, surrounding the tongue on its other three sides and opening on the partition to a radial depth at least equal to the penetration of the free end of the tongue inside the chamber.
  • Figure 1 is a front view of the device according to the present invention with female luer lock.
  • Figure 2 is a sectional view of the device of Figure 1.
  • FIG. 3 is a top view of the device of FIG. 1.
  • FIG. 4 is a perspective view of the device of FIG. 1.
  • Figures 5A and 5B show a sectional view of the device of the present invention associated with a bottle in the inserted bottle position ( Figure 5A) or during extraction of the bottle ( Figure 5B).
  • Figure 6 is a sectional view of the upper part of the device according to the present invention with male luer lock.
  • FIGS. 7A and 7B show a sectional view of the upper part of the device according to the present invention with a shutter with a ruptible zone in the storage position (integral shutter, FIG. 7A) or in the use position (broken shutter, FIG. 7B).
  • FIGS. 8A and 8B show the device according to the present invention connected to an infusion bag by a flexible tubing containing a shutter with a ruptible area and equipped with suspension means, the suspension means being retracted to allow the introduction of the bottle (FIG. 8A) or the device / bottle / bag assembly being in the suspended position after activation of the suspension means (FIG. 8B).
  • FIGS. 1 to 4 show a device according to the present invention consisting of a tubular chamber (1) preferably cylindrical with an open end (2) intended to allow the introduction of the bottle (4), the other end being closed by a partition (3) perpendicular to the axis of the chamber (1) and serving inter alia abutment to the bottle (4).
  • This partition (3) comprises at its center a hollow needle (5) which passes through it, whose tip (6) is directed towards the open end of the chamber and whose length is sufficient to pierce the pierceable stopper of the bottle (4).
  • This needle (5) can be either of plastic molded integrally with the partition (3) and the Chamber (1) of the device, or stainless steel, it is then fixed to the wall by gluing or overmolding.
  • the present invention is characterized by openings (17) formed at the upper part of the tubular chamber (1) and opening on the partition (3).
  • the chamber (1) has one or more openings (17) distributed around its periphery.
  • Each opening (17) comprises an elastic tongue (7) whose free end (8) is oriented towards the inside of the chamber (1).
  • the distance between the free end (8) of the tongues (7) of the partition (3) is slightly greater than the total thickness of the cap of the bottle (4).
  • the base of the tongue (7) is an integral part of the chamber (1), the opening (17) surrounding the tongue (7) on its other three sides.
  • the width of the opening (17) is greater than the width of the tongue (7).
  • the openings (17) open on the partition (3) to a radial depth greater than the penetration of the tongues (7) inside the tubular chamber (1).
  • the shape of the free end (8) of the elastic tongues (7) will be studied so as to allow, for the comfort of use, the introduction of the bottle with a relatively weak force and its extraction with a much higher force for avoid any risk of inadvertent disconnection of the bottle during its agitation (for example an extraction force of 3 daN for a bottle weight not exceeding 50 g).
  • the side of the partition (3) opposite the chamber (1) comprises means for connecting the bottle (4), after its introduction into the chamber (1), an infusion bag (20) or a hypodermic syringe .
  • these means are of the female luer lock type (9).
  • the tubular chamber (1) comprises at its base means intended to increase the stability of the device in vertical position, to facilitate the distribution of the automated industrial process part and to present a larger surface to support the demolding effort. This is, for example a collar (21).
  • Figures 5A and 5B show the device of the present invention associated with a vial (4). In Figure 5A, the assembly is shown inserted bottle position.
  • the partition (3) serves as a stopper to the stopper of the bottle (4) perforated by the needle (5), the bottle is held in position by the tongues (7) and the tubular chamber (1) completely covers the body of the bottle ( 4).
  • FIG. 5B shows the extraction phase of the bottle.
  • the elastic tongues are pressed against the wall of the chamber which allows to release the bottle of the device.
  • the openings (17) are sized to allow the user's fingers to exercise a support on the bottle cap, so as to drive it from the tabular chamber (1); it can be recovered and then destroyed or recycled independently of the device.
  • Figure 6 is a sectional view of the upper part of a device according to the present invention.
  • the tubular chamber (1) is identical to that shown in Figures 1 to 4, but the means for connecting the bottle (4), after its introduction into the chamber (1), to a pocket of perfusion (20) or a hypodermic syringe are male luer lock type.
  • Figures 7A and 7B show a sectional view of the upper part of a device according to the present invention associated with an infusion bag (20).
  • the tubular chamber (1) is identical to that shown in Figures 1 to 4, but the means for connecting the bottle (4), after its introduction into the chamber (1), to the pocket of perfusion (20) are of the shutter type with ruptible area (11).
  • FIG. 7A shows the device according to the present invention, the rupturable zone shutter (11) being in the storage position (integral shutter).
  • the rupturable zone shutter (11) is formed of a cylindrical tubular part (12) having an outside diameter slightly greater than the inside diameter of the flexible tubing (13) for access to the pocket, so as to guarantee the tightness clamping assembly.
  • One end of this tubular portion (12) is open and the other is closed by a ruptible section, preferably of conical shape (14).
  • the largest diameter of this conical portion (14) is smaller than the inside diameter of the flexible tube (13) and the conical portion (14) is integral with the tubular portion (12) via a weakened zone (15).
  • the conical portion (14) has at least two fins (16) distributed on its periphery. These fins are preferably of triangular shape so as to facilitate the introduction of the rupturable shutter (11) in the tube (13).
  • the base of the triangular fins (16) is in a circle of diameter slightly greater than the internal diameter of the tube (13) and terminates at a sharp angle, so as to oppose the removal of the ruptible portion (14) out of the tube (13).
  • FIG. 7B shows the device according to the present invention with the rupturable zone shutter (11) in the use position (broken shutter).
  • the ruptible portion (14) rises from one to two mm to the inside the tube (13), then remains in this position thanks to the friction of the fins (16) on the tube (13) and the sharp angle of the base of the fins (16) acting as a non-return.
  • This embodiment prevents the ruptible zone (14) separated from the tubular portion (12) from returning to seal this tubular portion under the effect of gravity or the flow of liquid.
  • FIGS. 8A and 8B show the device according to the present invention connected to an infusion bag (20) by a flexible access tubing (13) for access to the bag containing a rupturable zone shutter (11) and provided with suspension means ( 18).
  • the suspension means are shown in retracted position to allow the introduction of the bottle (4). This improvement is particularly interesting when the connection of the device containing the bottle (4) to the infusion bag (20) is through the upper part of the bag.
  • FIG. 8B the device / flask / bag assembly is in the suspended position after activation of the suspension means.
  • These suspension means are for example constituted by a handle (18) that can be hooked on an infusion stem (19).
  • FIG. 1 The figures illustrate an embodiment in which the contents of a vial (4) are placed in communication with an infusion bag (20).
  • the system can be used to port the contents of one vial to another type of container, including a hypodermic syringe.
  • the device is packaged in sterile blister packs.
  • sterile blister packs are the "female luer lock” and “male luer lock” models.
  • the nurse extracts the device from its blister and then introduces the bottle (4) into the tubular chamber (1).
  • the nurse connects the device incorporating the vial to an infusion bag or syringe.
  • the nurse holds the device / bottle / bag assembly vertically, device downwards, then exerts some pressure on the bag (20): the liquid contained in the bag (20) s flows into the bottle (4) to fill it to about half of its volume.
  • the nurse agitates the whole until complete dissolution of the powder contained in the bottle, then returns the set, pocket down, and exerts some pressure on the pocket so that the contents of the bottle is completely transferred into the pocket .
  • the infusion is ready to be injected into the patient.
  • the nurse connects the device / vial assembly to a syringe containing the precise dose of the drug dilution solvent contained in the vial (4).
  • the nurse injects the entire contents of the syringe into the vial (4), then agitates the whole until complete dissolution of the powder contained in the vial (4).
  • the nurse then takes the prescribed medication dosage from the graduation of the syringe.
  • the contents of the syringe are then either transferred to a pocket or directly injected into the patient. The medicine remaining in the vial will be destroyed.
  • the device is assembled industrially on the pocket (20), instead of the conventional injection site (see Figures 8 and 8A) and it is inseparable from the pocket (20).
  • the rupturable area shutter (11) When the rupturable area shutter (11) is intact, it behaves like a waterproof plug.
  • the pouch / device assembly is then overwrapped tightly and sterilized.
  • the nurse proceeds as for luer connector devices, but it is exempt from unpacking maneuvers of the device and its connection to the pocket (20).
  • the nurse suffices to break the weakened zone (15) of the rupturable shutter (11) as described above.
  • the devices according to the present invention make it possible to obtain both the secure transfer of a medicament contained in a glass flask in a pouch or a hypodermic syringe and the elimination or recycling of waste by separation of glass and plastics. .
  • waste different materials, leftovers of drugs according to their level of dangerousness
  • the sorting of waste will be carried out either by the specialized service of the hospital or by an authorized external organization.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
EP20050824072 2004-12-07 2005-12-06 Sicherheitsvorrichtung zur medizinischen anwendung Expired - Lifetime EP1827353B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0452894A FR2878737B1 (fr) 2004-12-07 2004-12-07 Dispositif de securite pour flacon a usage medical
PCT/FR2005/051037 WO2006061537A1 (fr) 2004-12-07 2005-12-06 Dispositif de securite pour flacon a usage medical

Publications (2)

Publication Number Publication Date
EP1827353A1 true EP1827353A1 (de) 2007-09-05
EP1827353B1 EP1827353B1 (de) 2009-04-22

Family

ID=34952138

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20050824072 Expired - Lifetime EP1827353B1 (de) 2004-12-07 2005-12-06 Sicherheitsvorrichtung zur medizinischen anwendung

Country Status (7)

Country Link
US (1) US20080015496A1 (de)
EP (1) EP1827353B1 (de)
AT (1) ATE429205T1 (de)
DE (1) DE602005014140D1 (de)
ES (1) ES2326000T3 (de)
FR (1) FR2878737B1 (de)
WO (1) WO2006061537A1 (de)

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FR2878737B1 (fr) 2007-03-16
FR2878737A1 (fr) 2006-06-09
WO2006061537A1 (fr) 2006-06-15
US20080015496A1 (en) 2008-01-17
EP1827353B1 (de) 2009-04-22
ES2326000T3 (es) 2009-09-28
ATE429205T1 (de) 2009-05-15
DE602005014140D1 (de) 2009-06-04

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