EP1694269A1 - Kappe für die sichere verpackng einer medizinflasche - Google Patents

Kappe für die sichere verpackng einer medizinflasche

Info

Publication number
EP1694269A1
EP1694269A1 EP04805636A EP04805636A EP1694269A1 EP 1694269 A1 EP1694269 A1 EP 1694269A1 EP 04805636 A EP04805636 A EP 04805636A EP 04805636 A EP04805636 A EP 04805636A EP 1694269 A1 EP1694269 A1 EP 1694269A1
Authority
EP
European Patent Office
Prior art keywords
cap
needle
bottle
seal
twin
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
EP04805636A
Other languages
English (en)
French (fr)
Other versions
EP1694269B1 (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
MAP France SAS
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 MAP France SAS filed Critical MAP France SAS
Publication of EP1694269A1 publication Critical patent/EP1694269A1/de
Application granted granted Critical
Publication of EP1694269B1 publication Critical patent/EP1694269B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—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
    • A61J1/14—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
    • A61J1/2065—Connecting means having aligning and guiding means

Definitions

  • the subject of the present invention is a perforable cap pre-mounted on the needle of a safety packaging device for a vial for medical use.
  • This cap is mounted in a leaktight and sliding manner so as to avoid the "aerosol" phenomenon during the perforation of the stopper of the bottle or, for example, of the site of injection of an infusion bag.
  • the present invention is an improvement on patent application FR2828803 from the same applicant. This application describes a safety packaging device for a vial for medical use.
  • the purpose of the device described in this application is to offer the best security guarantees with regard to both the risk of breakage of the bottle, the risk of accidental puncture and the risk of leakage.
  • the substances contained in this type of bottle are substances potentially dangerous for users or the environment (anticancer, antibiotics, etc.). It is therefore very important to avoid contact with these substances.
  • Publication O0126718 describes a device for reconstituting a preparation using a hollow transfer element such as a needle.
  • the device avoids any risk of nebulization or accidental jet of the product at the time of its connection with the injection needle.
  • no patent describes a system analogous to that of the invention making it possible to avoid the "aerosol" phenomenon occurring when a container containing a powdery product is placed in communication with another container, for example an infusion bag.
  • the present invention makes it possible to solve the problem mentioned above by adding to a existing transfer device, a simple part which does not entail any significant additional cost for the whole.
  • FIG. 1 is a longitudinal sectional view of the cap of the invention, mounted on one of the ends (D) of a twin-pointed needle.
  • FIG. 1 is a longitudinal sectional view of the cap of the invention, mounted on one of the ends (D) of a twin-pointed needle.
  • FIG. 2 is a view in longitudinal section of the safety packaging device (O) equipped with the cap of the invention (L) with a partial view in section of the infusion bag (I) provided with its injection site ( J), before use.
  • Figure 3 is a partial sectional view of the system after percussion of the stopper (N) of the bottle (P) by the tip (M) of the twin-point needle.
  • Figure 4 is a partial sectional view of the system at the beginning of the perforation of the bottom of the cap (A) and the injection site (J) by the tip (D) of the twin-point needle.
  • FIG 5 is a partial sectional view of the system after complete perforation of the site (J) and sliding of the cap (L) over a sufficient length to connect the contents of the bag (I) and the bottle (P).
  • Figure 6 is a partial sectional view of the system after separation of the device (O) and the bag (I) at the end of use.
  • Figure 1 shows the cap (L) according to the present invention mounted on the end (D) of a needle.
  • the generally cylindrical cap (L) comprises a bottom (A) and an open end allowing it to be mounted on a needle.
  • the bottom (A) of the cap (L) has a thickness sufficiently fine to be easily perforated by the tip (D) of the needle.
  • the bottom (A) of the cap (L) is set back (H) relative to the end of the cap (L), so as to create one or more sealing ring (s) (G) intended (s) ) to improve the tightness of the cap / injection site contact of the infusion bag.
  • the open end of the cap has a centering cone (C) intended to facilitate its positioning on the tip of the needle as well as a flange (C) to facilitate the distribution of the part in automatic assembly.
  • the cap comprises sealing means allowing the cap to slide on the body of the needle. These sealing means may be one or more annular beads (E) placed (s) above the centering cone (F).
  • FIG. 2 represents the system used in the invention as a whole: safety packaging device (O) provided with the cap (L) and perfusion bag (I) with its injection site (J).
  • the safety packaging device (0) has a twin-pointed needle with two ends (D, M), it completely covers the bottle (P) closed by a perforable cap (N) and containing a powder (S) of substance active.
  • the quantity of powder (S) is such that there is a volume of free air (R) in the bottle (P).
  • FIG. 3 represents a view of the system after percussion of the stopper (N) of the bottle (P) by the lower point (M) of the twin-point needle.
  • FIG. 4 represents a view of the system at the time of the start of the perforation of the bottom of the cap (A) and of the injection site (J) by the point (D) of the twin-point needle.
  • FIG. 5 represents a view of the system after complete perforation of the site (J) and sliding of the cap (L).
  • the cap (L) slides along the body of the needle until the end of the twin-point needle has completely perforated the injection site, for example until the flange (C) of the cap (L) comes to abut against the partition carrying the twin-point needle.
  • the end (D) of the needle completely crosses the injection site (J) so as to communicate the contents of the bag (I) and the bottle (P).
  • Powder spray (S) ("aerosol" effect) will occur inside the bag and will therefore not pollute the outside environment.
  • Figure 6 shows a view of the system after use. Since the elastomeric seal at the injection site (J) has a self-sealing effect, the contents of the bag (I) remain in a closed environment after withdrawal of the needle.
  • the cap (L) of the present invention is preferably made of flexible or semi-rigid plastic (polyethylene, polypropylene, elastomer, etc.).
  • the cap is mounted on the end (D) of the twin-pointed needle, which will enter into communication with the infusion bag (J).
  • it can be mounted on the other end (M) of the needle.
  • you must first of all directly perforate the injection site (J) of the infusion bag (I) then simultaneously perforate the bottom (A) of the cap (L) and the stopper (N) of the vial ( P).
  • the lower part of the twin-pointed needle that is to say the portion of the needle which penetrates into the free volume (R) of the bottle (P) is sufficiently long to allow positioning of the cap (L) and its sliding along the body of the needle.

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)
  • Closures For Containers (AREA)
EP20040805636 2003-12-05 2004-12-03 Kappe für die sichere verpackng einer medizinflasche Not-in-force EP1694269B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0314295A FR2863161B1 (fr) 2003-12-05 2003-12-05 Capuchon pour conditionnement de securite pour flacon a usage medical
PCT/FR2004/003117 WO2005055917A1 (fr) 2003-12-05 2004-12-03 Capuchon pour conditionnement de securite pour flacon a usage medical

Publications (2)

Publication Number Publication Date
EP1694269A1 true EP1694269A1 (de) 2006-08-30
EP1694269B1 EP1694269B1 (de) 2012-02-08

Family

ID=34586334

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20040805636 Not-in-force EP1694269B1 (de) 2003-12-05 2004-12-03 Kappe für die sichere verpackng einer medizinflasche

Country Status (5)

Country Link
US (1) US20070112324A1 (de)
EP (1) EP1694269B1 (de)
AT (1) ATE544439T1 (de)
FR (1) FR2863161B1 (de)
WO (1) WO2005055917A1 (de)

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US7883499B2 (en) * 2007-03-09 2011-02-08 Icu Medical, Inc. Vial adaptors and vials for regulating pressure
FR2927533B1 (fr) 2008-02-18 2011-02-11 P2A Medical Capuchon de transfert securise
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IL202069A0 (en) 2009-11-12 2010-06-16 Medimop Medical Projects Ltd Fluid transfer device with sealing arrangement
IL202070A0 (en) 2009-11-12 2010-06-16 Medimop Medical Projects Ltd Inline liquid drug medical device
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USD737436S1 (en) 2012-02-13 2015-08-25 Medimop Medical Projects Ltd. Liquid drug reconstitution assembly
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ES2739291T3 (es) 2013-01-23 2020-01-30 Icu Medical Inc Adaptadores de vial de regulación de presión
IL225734A0 (en) 2013-04-14 2013-09-30 Medimop Medical Projects Ltd A ready-to-use medicine vial device including a medicine vial closure, and a medicine vial closure for it
US9943463B2 (en) 2013-05-10 2018-04-17 West Pharma. Services IL, Ltd. Medical devices including vial adapter with inline dry drug module
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IL247376A0 (en) 2016-08-21 2016-12-29 Medimop Medical Projects Ltd Injector assembly
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Also Published As

Publication number Publication date
FR2863161A1 (fr) 2005-06-10
US20070112324A1 (en) 2007-05-17
WO2005055917A1 (fr) 2005-06-23
ATE544439T1 (de) 2012-02-15
EP1694269B1 (de) 2012-02-08
FR2863161B1 (fr) 2006-09-01

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