EP3565766A1 - Contenant - Google Patents

Contenant

Info

Publication number
EP3565766A1
EP3565766A1 EP17832738.3A EP17832738A EP3565766A1 EP 3565766 A1 EP3565766 A1 EP 3565766A1 EP 17832738 A EP17832738 A EP 17832738A EP 3565766 A1 EP3565766 A1 EP 3565766A1
Authority
EP
European Patent Office
Prior art keywords
container
sealing
container according
cap
piercing
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
EP17832738.3A
Other languages
German (de)
English (en)
Inventor
Michael Spallek
Johannes Geser
Philipp Spreng
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.)
Kocher Plastik Maschinenbau GmbH
Original Assignee
Kocher Plastik Maschinenbau 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 Kocher Plastik Maschinenbau GmbH filed Critical Kocher Plastik Maschinenbau GmbH
Publication of EP3565766A1 publication Critical patent/EP3565766A1/fr
Pending legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining 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
    • A61J1/1406—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
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1431—Permanent type, e.g. welded or glued
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • 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

Definitions

  • the invention relates to an at least partially filled and sealed container, in particular produced by a blow molding, filling and closing method, comprising at least one at least partially filled container body which is at least partially closed at the end by means of a head membrane and which has a cap part with a sealing part, that for a removal of the container contents with a holdornar- term piercing part ("spike") from the outside in a penetrating direction with specifiable actuating force is pervasive, which in a reverse extension direction with a predetermined pull-out force from the container is again removable bar.
  • a blow molding, filling and closing method comprising at least one at least partially filled container body which is at least partially closed at the end by means of a head membrane and which has a cap part with a sealing part, that for a removal of the container contents with a holdornar- term piercing part ("spike") from the outside in a penetrating direction with specifiable actuating force is pervasive, which in a reverse
  • the invention is characterized in that the removal of the piercing part aggravating means is present, by means of which the pull-out force is increased such that an unintentional removal of the piercing part is at least difficult, but the piercing force is not increased by this device.
  • a sealing part as part of the removal of the piercing part aggravating device is received in a cap portion of the container body such that when
  • Penetrating the sealing part as a constituent of the device there is a radial distance between a passage opening in the cap part and the inserted puncturing part, and that at least when it is removed from the container in the extension direction the radial distance is at least partially filled by the sealing part as the further component of the device, the at least one increased frictional force on the puncture at its application from the container at least partially exerts.
  • a pull-out movement inhibiting friction and compression zone is formed at the passage opening in the cap part.
  • the sealing part consists of a preferably soft, elastomeric material.
  • the sealing part extends between the cap part and a head membrane of a head part of the container and preferably has a depression on the end facing away from the head membrane of the head part of the container.
  • another seal surrounding the perforation point is formed on the head membrane.
  • the through-opening of the cap part may be covered towards the surroundings by a detachable flap part, a foil or the like, in order thereby to ensure that when the container is stored prior to putting it into use. to ensure better coverage of the sealing part.
  • a flap part a flap part
  • the cap member which is advantageously formed of a rigid plastic material may be connected to a collar of the container below its head part.
  • At least one further, separate sealing part can be accommodated in the cap part, as provided for a cannula passage
  • This second sealing member may be made of a different material than the first and / or have a different geometric shape and thus be easily adapted to the application.
  • the container thereby forms several applications, such as the possibility of introducing an additive by piercing the further sealing element, for example by means of an injection cannula.
  • the subject of the invention is also a cap part, which is provided for a container according to one of the claims 1 to 13.
  • Fig. 1 a, b shown in approximately half the size of a front view of two known infusion containers
  • FIG. 2 shows a slightly enlarged oblique perspective view of a separately shown cap part of an exemplary embodiment
  • FIG. each having a slightly enlarged drawn cross-section of the head portion of the container of Fig. 1a with attached cap portion, wherein a flexible head membrane of the head portion is shown in undeformed, occupied before attaching the cap portion position, and wherein the head portion of FIG. 3a the head part Fig. 2 corresponds to;
  • FIG. 3a one of the Figure 3a corresponding sectional view, wherein for carrying out a removal operation of the container contents, the state during the plunge movement of a puncturing part is shown;
  • FIG. 1 a and 1 b show two embodiments of the plastic container 2 according to the invention, each in the form of a known infusion
  • the head part 6 has a flexible head membrane 8 which is integral with the rest of the container wall and forms a removal region for a removal process of the container contents.
  • Such containers can be made with the known blow-fill-fill-process (BFS process).
  • BFS process blow-fill-fill-process
  • the head part 6 and thus the container 4 are open, such containers are produced by blow molding methods known per se, preferably by the stretch blow molding method or the injection stretch blow molding method.
  • the sealing member 16 is formed of an elastomeric material having a low rigidity and low hardness.
  • materials such as halobutyl rubber, synthetic rubber, eg polyisoprene, thermoplastic elastomers, silicone, natural rubber, nitrile rubber, are well suited for this purpose.
  • FIGS. 3 a and 3 b each show the geometry of the sealing part 16, which is arranged on the bottom 12 of the cap part 10 in alignment with a passage opening 18 of the cap part 10.
  • the passage opening 18 in the bottom 12 of the cap part 10 is to the environment from a - solid in the example of Fig.
  • the sealing member 16 has tabs (30) -side a continuous piercing membrane 24, which is penetrated during the removal process.
  • the sealing member 16 has head diaphragm (8) -side a central, aligned with the passage opening 18, recess 20 for a piercing part 22 of an infusion device (Fig. 4a and 4b).
  • the axially projecting sealing ring geometry 28 of the sealing part 16 seals the removal area on the head membrane 8 of the container head part 6.
  • the geometry and in particular the diameter of the passage opening 18 are selected in comparison to the diameter of the piercing part 22, that, see Fig. 4a, upon penetration of the piercing part 22 between the outer periphery and the passage opening 18, an annular channel 32 is formed.
  • FIG. 4b which shows the state shortly after the beginning of the extraction of the puncturing part 22, this annular channel 32 is filled by elastically deformed, displaced material of the sealing part 16, resulting in the extension movement, whereby an additional frictional force between Puncture 22 and bottom 12 of the cap member 10 is effective and wherein the displaced material forms a bead-like projection 34 on the outside of the bottom 12 as a further inhibiting friction zone.
  • FIG. 4b which shows the state shortly after the beginning of the extraction of the puncturing part 22
  • this annular channel 32 is filled by elastically deformed, displaced material of the sealing part 16, resulting in the extension movement, whereby an additional frictional force between Puncture 22 and bottom 12 of the cap member 10 is effective and wherein the displaced material
  • FIG. 5 shows a particular embodiment in which the sealing part 16 has a recess 20 and a recess 20 directly adjacent to the through-opening 18.
  • moving material of the sealing part 16, 26 into the annular channel 32 is retracted during the extension movement, and thus the further extraction of the piercing part 22 inhibiting additional frictional force effective.
  • a further sealing ring geometry 28 extends from the peripheral edge of the membrane 24 in the direction of the head membrane 8 of the container head part 6.
  • Fig. 6 shows a further particular embodiment similar to Fig. 5, in which the sealing member 16 has no membrane but a passage 19. This allows for minimal puncture forces, at the same time high Auszughememmung by the dichtwulst shame geometry 26 of the sealing member 16 near the passage opening 18 in the cap part 10th
  • Fig. 7 shows a further particular embodiment similar to Fig. 3b, with two separate, same sealing parts 16.
  • the passage opening 18 in the cap part 10 is conical, which facilitates the assembly of the respective sealing member 16 respectively sealing element in the cap part 10.
  • FIG. 8 shows a further special embodiment similar to FIG. 7 likewise with a conical geometry of the passage opening 18, with two separate Th, same sealing parts 16, but compared to the example in Fig. 7 with a streamlined sealing ring geometry 28th
  • FIG. 9a and 9b show a further particular embodiment similar to FIG. 7, with two separate, identical sealing parts 16 with geometry which is particularly easy to produce, applied to a container according to FIG. 1a (with head membrane 8) or FIG. 1b (FIG. without head membrane).
  • the material for the sealing part 16 has a Shore hardness according to ISO 868 of 10 to 60 Shore A, preferably from 20 to 50 Shore A, particularly preferably from 30 to 40 Shore A, as well as
  • the diameter of the passage opening 18 is at least 6 mm and at most 8 mm, preferably at least 6.2 mm and a maximum of 7.0 mm, more preferably at least 6.2 mm and a maximum of 6.8 mm, and
  • the elastomeric sealing part 16 fills the passage opening 18 of the cap part 10 or at least bears directly against its edge, and is preferably materially connected, for example by welding or gluing, to the bottom 12, and / or d) in the case of the embodiment according to FIG. 5 or FIG. 6, the difference D of the diameter of the passage opening 18 and the free inner diameter on the geometry 26 of the sealing part 16 is more than 1.5 mm, preferably more than 2 mm, especially preferably more than 2.5 mm.
  • the reduction of the actuating forces during insertion of the puncturing part 22 is achieved by a special embodiment of the sealing part 16 whose membrane 24 is either formed very thin or weakened, for example, by slots or perforations.
  • a second elastomeric, plug-type sealing part 38 may be provided on a further passage opening in the cap part 10, which is likewise covered by a tab part 30.
  • This sealing part 38 which also has an axially projecting sealing ring-like geometry for the abutment against the head membrane 8 of the container head part 6, can be pierced by means of an injection cannula for the addition of an additive to the container contents or for the removal of contents.
  • the cap parts were not welded onto containers but tested without them.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un contenant, constitué d'un corps de contenant rempli au moins en partie, et d'au moins une partie bouchon (10), qui présente au moins une partie d'étanchéité (16), laquelle peut être traversée de l'extérieur dans une direction de pénétration avec une force d'actionnement pouvant être prédéfinie pour qu'une partie de ponction (22) en forme d'épine creuse puisse prélever le contenu du contenant, et qui peut être à nouveau retirée du contenant dans une direction d'extraction opposée avec une force d'extraction pouvant être prédéfinie. L'invention est caractérisée en ce qu'un dispositif (16, 18) compliquant le retrait de la partie de ponction (22) est présent, et permet d'augmenter la force d'extraction de telle manière qu'un retrait involontaire de la partie de ponction (22) est au moins rendu difficile.
EP17832738.3A 2017-01-05 2017-12-13 Contenant Pending EP3565766A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017000048.4A DE102017000048A1 (de) 2017-01-05 2017-01-05 Behälter
PCT/EP2017/001425 WO2018127267A1 (fr) 2017-01-05 2017-12-13 Contenant

Publications (1)

Publication Number Publication Date
EP3565766A1 true EP3565766A1 (fr) 2019-11-13

Family

ID=61017877

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17832738.3A Pending EP3565766A1 (fr) 2017-01-05 2017-12-13 Contenant

Country Status (8)

Country Link
US (1) US11059638B2 (fr)
EP (1) EP3565766A1 (fr)
JP (1) JP7084401B2 (fr)
KR (2) KR102665502B1 (fr)
CN (1) CN109963793B (fr)
DE (1) DE102017000048A1 (fr)
RU (1) RU2748239C2 (fr)
WO (1) WO2018127267A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102639913B1 (ko) 2017-11-17 2024-02-23 코스카 패밀리 리미티드 유체 전달 매니폴드를 위한 시스템 및 방법
DE102017012091A1 (de) 2017-12-27 2019-06-27 Kocher-Plastik Maschinenbau Gmbh Verfahren zur Reduktion mikrobiologischer Kontamination
EP4294740A1 (fr) 2021-02-19 2023-12-27 Braunform GmbH Bouchon pour fermer un récipient destiné à administrer un médicament, et son procédé de production
DE102021104026A1 (de) 2021-02-19 2022-08-25 Braunform Gmbh Kappe zum Verschluss eines Behältnisses zur Verabreichung eines Arzneimittels und Verfahren zu dessen Herstellung
USD992110S1 (en) 2021-08-10 2023-07-11 Koska Family Limited Sealed fluid container

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US3905368A (en) * 1974-02-15 1975-09-16 Cutter Lab Pierceable access port assembly
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Also Published As

Publication number Publication date
JP7084401B2 (ja) 2022-06-14
KR20190104327A (ko) 2019-09-09
CN109963793A (zh) 2019-07-02
US20190225390A1 (en) 2019-07-25
KR20230074613A (ko) 2023-05-30
KR102665502B1 (ko) 2024-05-14
US11059638B2 (en) 2021-07-13
WO2018127267A1 (fr) 2018-07-12
KR102551438B1 (ko) 2023-07-06
RU2748239C2 (ru) 2021-05-21
DE102017000048A1 (de) 2018-07-05
JP2020504057A (ja) 2020-02-06
RU2019122134A (ru) 2021-02-05
CN109963793B (zh) 2021-11-05
RU2019122134A3 (fr) 2021-02-05

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