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EP2753289A2 - Contenant pour liquides à point de rupture théorique - Google Patents

Contenant pour liquides à point de rupture théorique

Info

Publication number
EP2753289A2
EP2753289A2 EP12762212.4A EP12762212A EP2753289A2 EP 2753289 A2 EP2753289 A2 EP 2753289A2 EP 12762212 A EP12762212 A EP 12762212A EP 2753289 A2 EP2753289 A2 EP 2753289A2
Authority
EP
European Patent Office
Prior art keywords
container
liquid
predetermined breaking
breaking point
hollow needle
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
EP12762212.4A
Other languages
German (de)
English (en)
Other versions
EP2753289B1 (fr
Inventor
Christoph Sattig
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.)
Stryker European Holdings I LLC
Original Assignee
Stryker Ireland Ltd
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 Stryker Ireland Ltd filed Critical Stryker Ireland Ltd
Publication of EP2753289A2 publication Critical patent/EP2753289A2/fr
Application granted granted Critical
Publication of EP2753289B1 publication Critical patent/EP2753289B1/fr
Active 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • 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
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the invention relates to a container for holding a liquid, to a container filled with liquid and a container containing one with
  • Isobutyl rubber consists and which by means of a
  • Cover wall can be pierced. In such containers with lids there is a risk that escape volatile components along the sealing surfaces or through the material itself, or that the
  • Container Even on prolonged storage, prove to be compatible with the liquid drug. If substances are released from the container, they must be toxicologically
  • EP 0694498 AI and EP 0919215 AI describe the removal of a liquid from a sealed glass ampoule by means of a blunt, hard object, for example.
  • a thick-walled cannula The bottom of the glass ampoule and the adjoining shaft area can be from a
  • the ampoule bottom comprises a recessed area with a punctiform
  • the invention is based on the object, a
  • the container contains a hollow body and an elastomer septum.
  • the hollow body contains an inner wall of a single material, with the. the fluid is compatible.
  • On the hollow body a predetermined breaking point is provided, which with a hollow needle can be pierced.
  • the predetermined breaking point is covered by the elastomer septum, which is firmly connected to the hollow body.
  • the hollow needle tip is guided through the elastomer septum and stabilized when piercing the predetermined breaking point.
  • the preferred material for the septum includes silicone, isobytyl rubber and neoprene. Unless the fluid is in direct contact with the septum during storage, various commercially available septum materials may be used at a particularly low cost.
  • the thickness of the septum is selected depending on a desired degree of sealing to the hollow needle. If a very high sealing effect is required between the septum and the hollow needle, a thickness of the septum in a range of 3 mm is advantageous. If the requirements for the sealing effect, however, lower, so can a thickness of the
  • Class of polyamides in particular PA 6.6 or PA 12, or the class of cyclo-olefin copolymers (COC) proved.
  • Further preferred plastics used include the group polypropylene or polyethylene.
  • Polypropylene and polyethylene can advantageously be used in an aqueous, unproblematic liquid
  • Glasses are preferably used as glass, which are produced as glass hollow bodies and are suitable for pharmacy. Such glasses can after their
  • Hollow body particularly preferred glasses of the hydrolytic class 1 are used as for example
  • Borosilicate glasses The predetermined breaking point is formed from a Wandverdunnungsfleck of the hollow body. This Wandverdunnungsfleck may be formed as a Wandeinbuchtung.
  • the hollow body can be prepared starting from a vessel and a lid, which are welded or fused together after filling of the container, so that a seamless inner wall of a single
  • a standard needle can be used, which at its end opposite the
  • Needle tip has a common connection, where a syringe can be attached to suck out the liquid. It is also possible to use a hollow needle, which is supplied with the liquid-filled container and together with this represents a container. It is also conceivable, the liquid means
  • FIG. 1 shows a container filled with liquid
  • Figure 2 shows the items of another container and a
  • Figure 3 shows a further design of a container
  • Figure 5 shows a container with another
  • FIG. 6 shows a container with yet another one
  • Figure 1 illustrates a container filled with liquid, comprising a hollow body 10 and a septum 3 from
  • the hollow body 10 is constructed from a vessel 1 and a lid 2, wherein the Iimenwandung consists of a single material.
  • a predetermined breaking point 4 is provided in the cover 2 .
  • the vessel 1 is bottle-shaped, formed with a neck 11 and a flange 12, to easily perform the welding with the lid 2 can. This is favorable for the training of glass, since the weld of the
  • the predetermined breaking point 4 is in the middle of the lid 2 in the form of a
  • the predetermined breaking point 4 is covered by the septum 3, which may have a marking 30 as a puncture site, the sampling needle.
  • FIG 2 another possible shape of the container is shown.
  • the vessel 1 is cylindrical, formed with a bottom 13, in which the predetermined breaking point 4 - is located.
  • the elastomer septum 3 is above the.
  • Predetermined breaking point 4 attached to the bottom 13. After filling the container interior 10, the lid 2 is inserted with its insert 21 into the vessel opening 14 and the flange edge .22 is welded to the vessel edge 14a.
  • the container shape is suitable for the production of plastic, but also of glass.
  • a liquid extraction device 5 has been outlined, which is composed of a hollow needle 51 and a tubular body 52 having a transverse opening 53.
  • the hollow needle 51 and the tubular body 52 enclose a removal channel 50.
  • a transverse opening 53 can: a Filter, which is permeable to air or other gases, but impermeable to liquid.
  • a Filter which is permeable to air or other gases, but impermeable to liquid.
  • FIG. 3 shows another possible shape of the container.
  • the vessel 1 has a flange edge 12, on which the lid 2 is placed and secured by welding.
  • Predetermined breaking point 4 is formed as a semicircular dent in the bottom 13 of the vessel 1.
  • FIG. 3 also shows a further embodiment of the liquid removal device 5.
  • Guide grooves 55 has that cooperate with guide ribs 15 on the circumference of the vessel 1.
  • the guide grooves 55 and the guide ribs 15 extend in the axial direction of the cylindrical vessel 1 and thus guide the hollow needle 51 when breaking the predetermined breaking point 4 (FIG. 4).
  • FIG. 4 shows a further shape of the container with a flat cover 2, which is welded to the cylindrical edge 14a of the vessel 1.
  • FIG. 5 shows a further embodiment of the container and the liquid removal device 5.
  • the vessel 1 is ampullate-shaped, with a relatively narrow filling opening 16, which is closed by means of a cover 2 having an insert 21 and a flange edge 22.
  • the predetermined breaking point 4 is mounted in the bottom 13 and may be formed as a cylindrical recess, such as
  • the liquid removal device 5 has a screw-cap-shaped cage 54, which on the
  • Screw thread 17 cooperates on the circumference of the vessel 1.
  • FIG. 6 A further embodiment is shown in FIG. 6.
  • the predetermined breaking point 4 lies in the region of the portion 61 to be welded.
  • the handling during the removal of the liquid proceeds as follows:
  • Marked point 30 of the septum 3 pierces them and breaks through the predetermined breaking point 4 in order to
  • the liquid removal device 5 according to FIG. 2 is applied at a marked point 30 in order to puncture the septum 3 and the predetermined breaking point 4. As a result, a drainage channel 50 opens from the interior 10 of the container, thereby
  • Liquid can be derived in a not shown vessel.
  • the filter in the transverse opening 53 allows the rise of air or gas bubbles through the channel 50 into the interior 10 of the container.
  • gas pressure through the transverse opening 53 to push liquid out of the interior of the container.
  • the gas supply can take place through a cannula into the interior 50 of the hollow needle 51 in order to ensure a clear separation of the currents within the hollow needle
  • the hollow needle 51 is pressed by the guide device 54 through the septum 3 and becomes the predetermined breaking point 4
  • hollow body 10 made of glass or other brittle material can form when splitting the hollow needle tip through the predetermined breaking point 4 splinters through
  • Filter material to be intercepted may be employed in the channel 50 or the channel 50 communicates with a filter unit via which the liquid is delivered to the destination.

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)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

Contenant pour liquides à point de rupture théorique (4) recouvert d'une paroi élastomère (3). Le contenant forme un corps creux (10) fait d'un seul matériau compatible avec des liquides critiques tels que des médicaments. La paroi élastomère (3) et le point de rupture théorique (4) peuvent être percés au moyen d'une aiguille creuse (51) pour extraire le liquide du contenant.
EP12762212.4A 2011-09-07 2012-09-07 Contenant pour liquides à point de rupture théorique Active EP2753289B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011112516.0A DE102011112516B4 (de) 2011-09-07 2011-09-07 Gebinde mit einem Behälter zur Aufnahme einer Flüssigkeit und einer Flüssigkeitsentnahmeeinrichtung
PCT/EP2012/003762 WO2013034302A2 (fr) 2011-09-07 2012-09-07 Contenant pour liquides à point de rupture théorique

Publications (2)

Publication Number Publication Date
EP2753289A2 true EP2753289A2 (fr) 2014-07-16
EP2753289B1 EP2753289B1 (fr) 2016-04-06

Family

ID=46888991

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12762212.4A Active EP2753289B1 (fr) 2011-09-07 2012-09-07 Contenant pour liquides à point de rupture théorique

Country Status (4)

Country Link
US (1) US9642774B2 (fr)
EP (1) EP2753289B1 (fr)
DE (1) DE102011112516B4 (fr)
WO (1) WO2013034302A2 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11648179B2 (en) 2016-05-16 2023-05-16 Haemonetics Corporation Sealer-less plasma bottle and top for same
CN109152698B (zh) 2016-05-16 2022-07-01 美国血液技术公司 无密封件的血浆瓶及其顶盖
DE102018124115A1 (de) 2018-09-28 2020-04-02 Schott Schweiz Ag Primärpackmittel für pharmazeutische Substanzen

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US9642774B2 (en) 2017-05-09
WO2013034302A2 (fr) 2013-03-14
EP2753289B1 (fr) 2016-04-06
WO2013034302A3 (fr) 2013-05-30
DE102011112516A1 (de) 2013-03-07
DE102011112516B4 (de) 2024-02-29
US20140202980A1 (en) 2014-07-24

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