EP3388364A1 - Emballage pour dispositifs médicaux - Google Patents

Emballage pour dispositifs médicaux Download PDF

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Publication number
EP3388364A1
EP3388364A1 EP18165760.2A EP18165760A EP3388364A1 EP 3388364 A1 EP3388364 A1 EP 3388364A1 EP 18165760 A EP18165760 A EP 18165760A EP 3388364 A1 EP3388364 A1 EP 3388364A1
Authority
EP
European Patent Office
Prior art keywords
medical device
plastic film
cavity
film body
cavities
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
EP18165760.2A
Other languages
German (de)
English (en)
Inventor
Johannes Bolz
Daniel Burkschat
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.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
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 B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP3388364A1 publication Critical patent/EP3388364A1/fr
Pending legal-status Critical Current

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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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B65D75/367—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming several compartments
    • 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments

Definitions

  • the invention relates to a medical device packaging with at least two cavities for receiving in each case a medical device, wherein each cavity is designed as a deep-drawn shell of a sheet-like plastic film body.
  • Multi-part medical devices such as infusion sets or the like are packaged in bags that are labeled on the outside.
  • a blister pack for tablets is well known.
  • a known tablet package has a flat plastic film with deep-drawn cavities, which are designed shell-shaped, and in each of which a tablet is stored. The cavities are sealed in a ready-to-sell state by a metallic cover film which covers an entire surface of the plastic film body in a planar manner. Between the various cavities, the plastic film body and the cover sheet have perforations to allow separation of a single pack of a tablet at a time.
  • From the GB 2 216 864 A is a product packaging known in which individual containers are connected to each other via a common cover sheet, which also allows a tight closure of the respective receiving space of the container.
  • the containers are intended for food intake.
  • the object of the invention is to provide a medical device packaging of the type mentioned, which allows a space-saving and process-safe storage of medical devices in single pack.
  • the plastic film body is made of a flexible plastic film as a soft packaging for the medical device, and that the cavity is adapted to an outer contour of the medical device, that the medical device position and captive is added to the cavity.
  • the outer contour is understood to mean an outer contour of the entirety of the parts of the respective medical product that have been folded together or are positioned in a compact manner next to one another.
  • the design of the plastic film body as a soft packaging allows, in particular, elastic resilience, such as elastic extensibility or elastic deformability, of the plastic film body in the region of the at least one cavity.
  • the solution according to the invention enables space-saving and reliable storage of the respective medical device.
  • the solution according to the invention is particularly suitable for packaging medical devices in the form of infusion sets or similar multi-part sets, but also for tablets or capsules, ie for one-piece medical devices with a dimensionally stable outer shape.
  • Such medical devices are in particular tablets or capsules which have at least one medicinal agent.
  • a multi-part infusion set which serves as a medical device, advantageously consists of a drip chamber with piercing spike, a hose line with a roller clamp and a fitting to a catheter or the like, and optionally also from a Strömungsleitorgan such as a multi-way valve or the like.
  • the cavity is provided in the region of an upper side with at least one undercut, which secures the medical device in the inserted state. This ensures that the medical device can not fall out of the cavity again after an appropriate insertion into the cavity while the cavity is still open.
  • two cavities are arranged axisymmetrically next to one another. This makes it possible to reduce the packaging volume for medical device packaging. This embodiment is particularly advantageous in medical devices with unbalanced shape.
  • two infusion sets can be accommodated next to one another with correspondingly axisymmetric positioning of the individual parts of the two infusion sets to one another.
  • the plastic film body has an inclined separating line between the two cavities.
  • the desired cutting line preferably runs diagonally relative to outer edge regions of the plastic film body as well as relative to the pairwise adjacent cavities.
  • the desired separation line is formed by a perforation.
  • the perforation is preferably provided not only in the region of a surface of the plastic film body, but also in the region of the cover film, which serves to cover the surface of the plastic film body and to cover the cavities.
  • a cover sheet is particular a paper foil, which is applied cohesively to the surface of the plastic film body. Under cohesive application is advantageous to understand a bond.
  • the plastic film is designed at least partially transparent. As a result, a visual packaging can be achieved, which reveals the contents of the packaging from the outside.
  • the cover sheet made of paper.
  • This paper film can be made thin and flexible or thicker and dimensionally stable.
  • the paper foil can be water-repellent coated. Under the paper foil is also a sheet of cardboard to understand.
  • a medical device packaging comprises a plastic film body 1, which is made of an elastically deformable, in particular elastically extensible, plastic film.
  • the plastic film body 1 has a flat and flat, inherently rigid surface 3.
  • the plastic film body 1 is provided in the illustrated embodiment with two juxtaposed cavities 2, which are integrally formed by deep drawing in the plastic film body 1.
  • the cavities 2 are aligned axisymmetric to each other and are designed drop-like or like a hand ax.
  • the axis symmetry of the arrangement of the cavities 2 results relative to an axis of symmetry which runs orthogonally to the surface 3 of the plastic film body 1 centrally between the cavities 2.
  • the cavities 2 adjacent in pairs are identical to one another.
  • Each cavity 2 is starting from a bottom of the respective cavity 2 immediately below the surface 3 of the plastic film body 1 on opposite longitudinal sides of a Edge region in the region of an upper side of the respective cavity 2 provided with two undercuts 7, which allow a position assurance of a medical device 6 (shown in phantom) in the respective cavity 2.
  • the two undercuts 7 of each cavity 2 have mutually opposite and mutually parallel edge regions in the region of the surface 3 of the plastic film body 1, which expand in the region of its bottom outwards to corresponding side walls of the respective cavity 2 and thus form the undercuts.
  • a corresponding medical device 6 can be pressed from above into the cavity 2, whereby the edge regions of the undercuts 7 are elastically deformed. After complete immersion of the medical device 6 in the respective cavity 2, the edge regions of the undercuts 7 inevitably elastic back to their original position, whereby the desired position assurance of the medical device 6 is reached.
  • the medical device 6 is dimensionally stable designed as a one-piece product in tablet or capsule form.
  • Each cavity is provided in the region of the surface 3 of the plastic film body 1, each with an edge around the edge region of the cavity 2 running edge elevation.
  • This edge increase is materially and extensively connected to a cover sheet 5, which is a thin-walled metal foil, in particular an aluminum foil.
  • the plastic film body 1 has grip corners 4 at diagonally opposite corner regions, at which corresponding corners of the cover film 5 are not connected in a materially bonded manner to the surface 3 of the plastic film body 1. These can serve to facilitate removal of the cover sheet 5, if the cover sheet 5 does not tear open anyway by simply pushing out the respective medical product 6.
  • the two cavities 2 Between the two cavities 2 extends a diagonally extending desired cutting line 8 along a separation axis S in the region of the surface 3 of the plastic film body 1, which is designed as a perforation or differently designed, linear weakening of the plastic film body 1.
  • the two cavities 2 can be separated from one another, wherein they each form a single pack for the corresponding medical product 6.
  • the cover sheet 5 is provided at the same height as the desired separation line S with a desired separation line.
  • the cavities of the plastic film body 1 provided with corresponding medical products 6 can be closed in ready-to-use form Condition are easily separated from each other, resulting in two closed individual packages.
  • the medical device packaging according to the FIGS. 2 and 3 corresponds to the basic structure of the medical device packaging, as they are based on the Fig. 1 is shown. Functionally identical parts and sections are therefore provided with the same reference numerals with the addition of the letter a. The main difference is that the medical device packaging according to the FIGS. 2 and 3 designed to accommodate two each multi-part medical devices in the form of each one also referred to as infusion set infusion sets. Each infusion set has a drip chamber, a hose line and a roller clamp, which are connected to each other in the functional operating state.
  • the two medical products thus formed are symmetrically housed in each case in a cavity 2a, wherein the two cavities 2a as well as the arrangement of the parts of the two medical devices are each rotated by 180 ° in the plane 5a.
  • the medical device packaging thus formed has a plastic film body 1a made of a soft, elastic or plastically deformable film material, which is deep-drawn in coordination with the male contours of the parts of the respective medical device.
  • An in Fig. 2 Rear surface of the plane 3a is formed flat.
  • On this surface 3a of the plastic film body 1a is a cover film 5a cohesively, in particular by bonding, applied in Fig. 3 is shown overhead.
  • the plastic film body 1a is designed to be transparent so that the content of the respective cavity 2a can be seen by a viewer from the outside.
  • the desired separation line runs in the same way diagonally between the two cavities 2a of the plastic film body 1a, as in the embodiment according to FIG Fig. 1 the case is.
  • the cover foil 5a which is designed as a paper foil, can likewise be provided with a perforation or a similar, linear weakening in the region of the predetermined separating line 8a, which enables the two medical products 6a to be separated from one another in the packed state.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP18165760.2A 2017-04-11 2018-04-04 Emballage pour dispositifs médicaux Pending EP3388364A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102017206153.7A DE102017206153A1 (de) 2017-04-11 2017-04-11 Medizinproduktverpackung

Publications (1)

Publication Number Publication Date
EP3388364A1 true EP3388364A1 (fr) 2018-10-17

Family

ID=61911409

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18165760.2A Pending EP3388364A1 (fr) 2017-04-11 2018-04-04 Emballage pour dispositifs médicaux

Country Status (2)

Country Link
EP (1) EP3388364A1 (fr)
DE (1) DE102017206153A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024064663A1 (fr) * 2022-09-19 2024-03-28 Altria Client Services Llc Emballage coque à contre-dépouilles

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110147241A1 (en) * 2009-12-22 2011-06-23 Stanley Michael Marcinkowski Co-Packaged Articles
WO2014114297A1 (fr) * 2013-01-24 2014-07-31 Danapak Flexibles A/S Emballage alvéolaire sécurité enfants à ouverture contrôlée
US20160143808A1 (en) * 2014-11-26 2016-05-26 Mylan, Inc. Container for storage of a medicament

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3074540A (en) * 1959-07-31 1963-01-22 American Hospital Supply Corp Package for sterile articles
DE1486408A1 (de) * 1965-08-30 1969-04-17 Hoefliger & Karg Aufreisspackung
US4324331A (en) * 1980-08-08 1982-04-13 Zimmer, Inc. Packaging for surgical implements
GB8806274D0 (en) 1988-03-16 1988-04-13 Plastona Waddington Ltd John Improvements relating to packaging
JPH02166061A (ja) * 1988-12-17 1990-06-26 Matsuzawa Seisakusho:Kk ブリスタ包装体およびブリスタ包装方法
JP3373967B2 (ja) * 1995-02-02 2003-02-04 電気化学工業株式会社 プレフィルドシリンジのブリスター包装体
GB2335911A (en) * 1998-03-31 1999-10-06 Clinimed Storage pack
US6814236B2 (en) * 2001-12-31 2004-11-09 Ethicon, Inc. Blister tray with a package for a small device
DE202006019818U1 (de) * 2006-06-01 2007-04-05 Henkel Kgaa Packmitteleinsatz für Wasch- und Reinigungsmittelkörper
DK2163230T3 (da) * 2008-09-12 2013-06-03 Noba Verbandmittel Danz Gmbh U Co Kg Emballage til kirurgiske hjælpemidler, især til præparationstamponer
JP5332958B2 (ja) * 2009-06-29 2013-11-06 大日本印刷株式会社 プレフィルドシリンジ包装体及びプレフィルドシリンジ用パック

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110147241A1 (en) * 2009-12-22 2011-06-23 Stanley Michael Marcinkowski Co-Packaged Articles
WO2014114297A1 (fr) * 2013-01-24 2014-07-31 Danapak Flexibles A/S Emballage alvéolaire sécurité enfants à ouverture contrôlée
US20160143808A1 (en) * 2014-11-26 2016-05-26 Mylan, Inc. Container for storage of a medicament

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024064663A1 (fr) * 2022-09-19 2024-03-28 Altria Client Services Llc Emballage coque à contre-dépouilles

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Publication number Publication date
DE102017206153A1 (de) 2018-10-11

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