EP3388364A1 - Medical product package - Google Patents

Medical product package 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
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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)
French (fr)
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/en
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.

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  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

2.1 Eine Medizinproduktverpackung mit wenigstens zwei Kavitäten zur Aufnahme jeweils eines Medizinprodukts, wobei jede Kavität als tiefgezogene Schale eines flächigen Kunststofffolienkörpers gestaltet ist, ist bekannt.2.1 A medical device packaging with at least two cavities for receiving in each case a medical device, each cavity being designed as a deep-drawn shell of a flat plastic film body, is known.

2.2 Erfindungsgemäß ist der Kunststofffolienkörper aus einer flexiblen Kunststofffolie als Weichverpackung für das Medizinprodukt hergestellt, und die Kavität ist derart an eine Außenkontur des Medizinprodukts angepasst, dass das Medizinprodukt positions- und verliersicher in der Kavität aufgenommen ist.2.2 According to the invention the plastic film body is made of a flexible plastic film as a soft packaging for the medical device, and the cavity is adapted to an outer contour of the medical device, that the medical device position and is captive in the cavity.

2.3 Einsatz für Tabletteneinzelpackungen

Figure imgaf001
2.3 Use for single tablet packs
Figure imgaf001

Description

Die Erfindung betrifft eine Medizinproduktverpackung mit wenigstens zwei Kavitäten zur Aufnahme jeweils eines Medizinprodukts, wobei jede Kavität als tiefgezogene Schale eines flächigen Kunststofffolienkörpers gestaltet ist.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.

Mehrteilige Medizinprodukte wie Infusionsbestecke oder ähnliches werden in Beuteln verpackt, die außenseitig beschriftet sind.Multi-part medical devices such as infusion sets or the like are packaged in bags that are labeled on the outside.

Eine Blisterverpackung für Tabletten ist allgemein bekannt. Eine bekannte Tablettenverpackung weist eine flächige Kunststofffolie mit tiefgezogenen Kavitäten auf, die schalenförmig gestaltet sind, und in denen jeweils eine Tablette abgelegt ist. Die Kavitäten sind in darbietungsfertigem Zustand durch eine metallische Deckfolie verschlossen, die flächig eine gesamte Oberfläche des Kunststofffolienkörpers abdeckt. Zwischen den verschiedenen Kavitäten weisen der Kunststofffolienkörper und die Deckfolie Perforationen auf, um eine Abtrennung jeweils einer Einzelpackung einer Tablette zu ermöglichen.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.

Aus der GB 2 216 864 A ist eine Produktverpackung bekannt, bei der einzelne Behältnisse über eine gemeinsame Deckfolie miteinander verbunden werden, die zudem einen dichten Verschluss des jeweiligen Aufnahmeraums des Behälters ermöglicht. Die Behälter sind für die Aufnahme von Nahrungsmitteln vorgesehen.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.

Aufgabe der Erfindung ist es, eine Medizinproduktverpackung der eingangs genannten Art zu schaffen, die eine raumsparende und prozesssichere Lagerung von Medizinprodukten in Einzelpackung ermöglicht.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.

Diese Aufgabe wird dadurch gelöst, dass der Kunststofffolienkörper aus einer flexiblen Kunststofffolie als Weichverpackung für das Medizinprodukt hergestellt ist, und dass die Kavität derart an eine Außenkontur des Medizinprodukts angepasst ist, dass das Medizinprodukt positions- und verliersicher in der Kavität aufgenommen ist. Bei mehrteiligen Medizinprodukten ist unter der Außenkontur eine äußere Kontur der Gesamtheit der zusammengelegten oder in ähnlicher Weise kompakt nebeneinander positionierten Teile des jeweiligen Medizinproduktes zu verstehen. Die Gestaltung des Kunststofffolienkörpers als Weichverpackung ermöglicht insbesondere eine elastische Nachgiebigkeit wie eine elastische Dehnbarkeit oder eine elastische Verformbarkeit, des Kunststofffolienkörpers im Bereich der wenigstens einen Kavität. Die erfindungsgemäße Lösung ermöglicht eine raumsparende und prozesssichere Lagerung des jeweiligen Medizinprodukts. Hierdurch ist es möglich, ein Aufnahmevolumen der Kavität individuell an eine Form des jeweiligen Medizinprodukts anzupassen und das Kavitätsvolumen zu optimieren. Zudem wird gewährleistet, dass das Medizinprodukt in der Kavität nicht hin- und hergleiten oder herumgeschleudert werden kann. Beschädigungen des Medizinprodukts, die bei sorgloser Handhabung der Medizinproduktverpackung auftreten können, können hierdurch vermieden werden. Die erfindungsgemäße Lösung eignet sich insbesondere zur Verpackung von Medizinprodukten in Form von Infusionsbestecken oder ähnlichen mehrteiligen Sets, aber auch für Tabletten oder Kapseln, d.h. für einteilige Medizinprodukte mit einer formstabilen äußeren Form. Derartige Medizinprodukte sind insbesondere Tabletten oder Kapseln, die wenigstens einen medizinischen Wirkstoff aufweisen. Ein mehrteiliges Infusionsbesteck, das als Medizinprodukt dient, besteht vorteilhaft aus einer Tropfkammer mit Einstechdorn, einer Schlauchleitung mit einer Rollenklemme und einem Anschlussstück zu einem Katheter oder ähnlichem, sowie optional noch aus einem Strömungsleitorgan wie einem Mehrweghahn oder ähnlichem.This object is achieved in that 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. In the case of multi-part medical products, 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. This makes it possible to individually adapt a receiving volume of the cavity to a shape of the respective medical device and to optimize the cavity volume. It also ensures that the medical device in the cavity can not slide back and forth or be thrown around. Damage to the medical device, which can occur with careless handling of medical device packaging, can be avoided. 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.

In Ausgestaltung der Erfindung ist die Kavität im Bereich einer Oberseite mit wenigstens einem Hinterschnitt versehen, der das Medizinprodukt in eingesetztem Zustand sichert. Dadurch ist gewährleistet, dass das Medizinprodukt nach einem entsprechenden Einfügen in die Kavität bei noch offener Kavität nicht wieder aus der Kavität herausfallen kann.In an embodiment of the invention, 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.

In weiterer Ausgestaltung der Erfindung sind zwei Kavitäten achssymmetrisch nebeneinander angeordnet. Dadurch ist es möglich, das Packungsvolumen für die Medizinproduktverpackung zu reduzieren. Diese Ausgestaltung ist insbesondere vorteilhaft bei Medizinprodukten mit unsymmetrischer Form. So können insbesondere zwei Infusionsbestecke nebeneinander untergebracht werden mit entsprechend achssymmetrischer Positionierung der einzelnen Teile der beiden Infusionsbestecke zueinander.In a further embodiment of the invention, 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. In particular, 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.

In weiterer Ausgestaltung der Erfindung weist der Kunststofffolienkörper eine zwischen den beiden Kavitäten schräg verlaufende Solltrennlinie auf. Die Solltrennlinie verläuft vorzugsweise diagonal relativ zu Außenrandbereichen des Kunststofffolienkörpers wie auch relativ zu den paarweise benachbarten Kavitäten.In a further embodiment of the invention, 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.

In weiterer Ausgestaltung der Erfindung ist die Solltrennlinie durch eine Perforation gebildet. Die Perforation ist vorzugsweise nicht nur im Bereich einer Oberfläche des Kunststofffolienkörpers, sondern auch im Bereich der Deckfolie vorgesehen, die zum Abdecken der Oberfläche des Kunststofffolienkörpers und zum Abdecken der Kavitäten dient. Eine Deckfolie ist insbesondere eine Papierfolie, die stoffschlüssig auf die Oberfläche des Kunststofffolienkörpers aufgebracht ist. Unter stoffschlüssiger Aufbringung ist vorteilhaft eine Verklebung zu verstehen.In a further embodiment of the invention, 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.

In weiterer Ausgestaltung der Erfindung ist die Kunststofffolie zumindest teilweise transparent gestaltet. Hierdurch ist eine Sichtverpackung erzielbar, die von außen den Inhalt der Verpackung erkennen lässt.In a further embodiment of the invention, 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.

In weiterer Ausgestaltung der Erfindung besteht die Deckfolie aus Papier. Diese Papierfolie kann dünn und flexibel oder dicker und formstabiler gestaltet sein. Die Papierfolie kann wasserabweisend beschichtet sein. Unter der Papierfolie ist auch ein Flächengebilde aus Pappe zu verstehen.In a further embodiment of the invention, 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.

Weitere Vorteile und Merkmale der Erfindung ergeben sich aus den Ansprüchen sowie aus der nachfolgenden Beschreibung bevorzugter Ausführungsbeispiele der Erfindung, die anhand der Zeichnungen dargestellt sind.

Fig. 1
zeigt eine erste Ausführungsform einer erfindungsgemäßen Medizinproduktverpackung in perspektivischer Explosionsdarstellung,
Fig. 2
in einer Draufsicht eine weitere Ausführungsform einer erfindungsgemäßen Medizinproduktverpackung und
Fig. 3
eine Seitenansicht der Ausführungsform nach Fig. 2.
Further advantages and features of the invention will become apparent from the claims and from the following description of preferred embodiments of the invention, which are illustrated by the drawings.
Fig. 1
shows a first embodiment of a medical device packaging according to the invention in an exploded perspective view,
Fig. 2
in a plan view, another embodiment of a medical device packaging according to the invention and
Fig. 3
a side view of the embodiment according to Fig. 2 ,

Eine Medizinproduktverpackung gemäß der Zeichnung weist einen Kunststofffolienkörper 1 auf, der aus einer elastisch verformbaren, insbesondere elastisch dehnbaren, Kunststofffolie hergestellt ist. Der Kunststofffolienkörper 1 weist eine flächige und ebene, eigensteife Oberfläche 3 auf. Der Kunststofffolienkörper 1 ist bei der dargestellten Ausführung mit zwei nebeneinander angeordneten Kavitäten 2 versehen, die einstückig durch Tiefziehen in dem Kunststofffolienkörper 1 ausgeformt sind. Die Kavitäten 2 sind achssymmetrisch zueinander ausgerichtet und sind tropfenartig oder nach Art eines Faustkeils gestaltet. Die Achssymmetrie der Anordnung der Kavitäten 2 ergibt sich relativ zu einer Symmetrieachse, die orthogonal zu der Oberfläche 3 des Kunststofffolienkörpers 1 mittig zwischen den Kavitäten 2 verläuft. Die paarweise benachbarten Kavitäten 2 sind im Übrigen identisch zueinander ausgeführt.A medical device packaging according to the drawing 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. Incidentally, the cavities 2 adjacent in pairs are identical to one another.

Jede Kavität 2 ist ausgehend von einem Boden der jeweiligen Kavität 2 unmittelbar unterhalb der Oberfläche 3 des Kunststofffolienkörpers 1 auf gegenüberliegenden Längsseiten eines Randbereichs im Bereich einer Oberseite der jeweiligen Kavität 2 mit zwei Hinterschnitten 7 versehen, die eine Positionssicherung eines Medizinprodukts 6 (strichpunktiert dargestellt) in der jeweiligen Kavität 2 ermöglichen. Die beiden Hinterschnitte 7 jeder Kavität 2 weisen einander gegenüberliegende und parallel zueinander verlaufende Randbereiche im Bereich der Oberfläche 3 des Kunststofffolienkörpers 1 auf, die sich im Bereich ihrer Unterseite nach außen zu entsprechenden Seitenwandungen der jeweiligen Kavität 2 erweitern und so die Hinterschnitte bilden. Aufgrund der elastischen Verformbarkeit des Kunststofffolienmaterials des Kunststofffolienkörpers 1 kann ein entsprechendes Medizinprodukt 6 von oben her in die Kavität 2 hineingedrückt werden, wodurch die Randbereiche der Hinterschnitte 7 elastisch deformiert werden. Nach dem vollständigen Eintauchen des Medizinprodukts 6 in die jeweilige Kavität 2 stellen sich die Randbereiche der Hinterschnitte 7 zwangsläufig elastisch wieder in ihre Ausgangslage zurück, wodurch die gewünschte Positionssicherung des Medizinprodukts 6 erreicht ist.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. Due to the elastic deformability of the plastic film material of the plastic film body 1, 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.

Das Medizinprodukt 6 ist formstabil gestaltet als einteiliges Produkt in Tabletten- oder Kapselform.The medical device 6 is dimensionally stable designed as a one-piece product in tablet or capsule form.

Jede Kavität ist im Bereich der Oberfläche 3 des Kunststofffolienkörpers 1 mit jeweils einer um einen Randbereich der Kavität 2 herumlaufenden Randerhöhung versehen. Diese Randerhöhung wird stoffschlüssig und flächig mit einer Deckfolie 5 verbunden, die eine dünnwandige Metallfolie, insbesondere eine Aluminiumfolie, darstellt. Der Kunststofffolienkörper 1 weist an diagonal gegenüberliegenden Eckbereichen Griffecken 4 auf, an denen entsprechende Ecken der Deckfolie 5 mit der Oberfläche 3 des Kunststofffolienkörpers 1 nicht stoffschlüssig verbunden sind. Diese können dazu dienen, ein Abziehen der Deckfolie 5 zu erleichtern, falls die Deckfolie 5 nicht ohnehin durch ein einfaches Herausdrücken des jeweiligen Medizinprodukts 6 aufreißt.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.

Zwischen den beiden Kavitäten 2 erstreckt sich eine diagonal verlaufende Solltrennlinie 8 längs einer Trennachse S im Bereich der Oberfläche 3 des Kunststofffolienkörpers 1, die als Perforation oder als anders gestaltete, linienförmige Materialschwächung des Kunststofffolienkörpers 1 gestaltet ist. Entlang dieser Solltrennlinie 8 können die beiden Kavitäten 2 voneinander getrennt werden, wobei sie jeweils eine Einzelpackung für das entsprechende Medizinprodukt 6 bilden.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. Along this predetermined separating line 8, the two cavities 2 can be separated from one another, wherein they each form a single pack for the corresponding medical product 6.

In vorteilhafter Weise ist auch die Deckfolie 5 auf gleicher Höhe wie die Solltrennlinie S mit einer Solltrennlinie versehen. Dadurch können die mit entsprechenden Medizinprodukten 6 versehenen Kavitäten des Kunststofffolienkörpers 1 in darreichungsfertig verschlossenem Zustand in einfacher Weise voneinander getrennt werden, wodurch sich zwei verschlossene Einzelpackungen ergeben.Advantageously, the cover sheet 5 is provided at the same height as the desired separation line S with a desired separation line. As a result, 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.

Die Medizinproduktverpackung gemäß den Fig. 2 und 3 entspricht vom grundsätzlichen Aufbau her der Medizinproduktverpackung, wie sie anhand der Fig. 1 dargestellt ist. Funktionsgleiche Teile und Abschnitte sind daher mit gleichen Bezugszeichen unter Hinzufügung des Buchstabens a versehen. Wesentlicher Unterschied ist es, dass die Medizinproduktverpackung gemäß den Fig. 2 und 3 zur Aufnahme von zwei jeweils mehrteiligen Medizinprodukten in Form jeweils eines auch als Infusionsbesteck bezeichneten Infusions-Sets gestaltet ist. Jedes Infusions-Set weist eine Tropfkammer, eine Schlauchleitung und eine Rollenklemme auf, die im funktionsbereiten Betriebszustand miteinander verbunden sind. Die beiden so gebildeten Medizinprodukte sind in jeweils einer Kavität 2a symmetrisch untergebracht, wobei die beiden Kavitäten 2a wie auch die Anordnung der Teile der beiden Medizinprodukte jeweils um 180° rotiert in der Ebene 5a angeordnet sind. Die so gebildete Medizinproduktverpackung weist einen Kunststofffolienkörper 1a aus einem weichen, elastisch oder plastisch verformbaren Folienmaterial auf, das in Abstimmung zu den aufzunehmenden Konturen der Teile des jeweiligen Medizinproduktes tiefgezogen ist. Eine in Fig. 2 rückseitig der Zeichenebene befindliche Oberfläche 3a ist flächig ausgebildet. Auf diese Oberfläche 3a des Kunststofffolienkörpers 1a ist eine Deckfolie 5a stoffschlüssig, insbesondere durch Verklebung, aufgebracht, die in Fig. 3 obenliegend dargestellt ist. Der Kunststofffolienkörper 1a ist transparent gestaltet, so dass der Inhalt der jeweiligen Kavität 2a für einen Betrachter von außen erkennbar ist.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.

Die Solltrennlinie verläuft in gleicher Weise diagonal zwischen den beiden Kavitäten 2a des Kunststofffolienkörpers 1a hindurch, wie dies bei der Ausführungsform nach Fig. 1 der Fall ist. Die als Papierfolie gestaltete Deckfolie 5a kann im Bereich der Solltrennlinie 8a ebenfalls mit einer Perforation oder einer ähnlichen, linienförmigen Schwächung versehen sein, die ein Trennen der beiden Medizinprodukte 6a in verpacktem Zustand voneinander ermöglicht. Nach dem Trennen der Medizinproduktverpackung entlang der Solltrennlinie 8a ergeben sich zwei separat handhabbare, jeweils noch steril verschlossene Medizinproduktverpackungsteile, die jeweils ein einzelnes Infusions-Set umgeben.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. After the separation of the medical device packaging along the predetermined separation line 8a, two separately manageable, each still sterile sealed medical device packaging parts, each surrounding a single infusion set.

Claims (7)

Medizinproduktverpackung mit wenigstens zwei Kavitäten (2) zur Aufnahme jeweils eines Medizinprodukts (6), wobei jede Kavität (2) als tiefgezogene Schale eines flächigen Kunststofffolienkörpers (1) gestaltet ist, und mit einer Deckfolie (5), die eine offene Seite der Kavitäten (2) flächig überdeckt, dadurch gekennzeichnet, dass der Kunststofffolienkörper (1) aus einer flexiblen Kunststofffolie als Weichverpackung für das Medizinprodukt (6) hergestellt ist, und dass die Kavität (2) derart an eine Außenkontur des Medizinprodukts (6) angepasst ist, dass das Medizinprodukt (6) positions- und verliersicher in der Kavität (2) aufgenommen ist.Medical device packaging with at least two cavities (2) for accommodating in each case a medical device (6), wherein each cavity (2) is designed as a deep-drawn shell of a flat plastic film body (1), and with a cover film (5) which has an open side of the cavities (2). 2) flatly covered, characterized in that the plastic film body (1) from a flexible plastic film as a soft packaging for the medical device (6) is made, and that the cavity (2) is adapted to an outer contour of the medical device (6) that the Medical device (6) position and captive in the cavity (2) is added. Medizinproduktverpackung nach Anspruch 1, dadurch gekennzeichnet, dass die Kavität (2) im Bereich einer Oberseite mit wenigstens einem Hinterschnitt (7) versehen ist, der das Medizinprodukt (6) in eingesetztem Zustand sichert.Medical device packaging according to claim 1, characterized in that the cavity (2) is provided in the region of an upper side with at least one undercut (7), which secures the medical device (6) in the inserted state. Medizinproduktverpackung nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass zwei benachbarte Kavitäten achssymmetrisch zueinander angeordnet sind.Medical device packaging according to claim 1 or 2, characterized in that two adjacent cavities are arranged axisymmetric to each other. Medizinproduktverpackung nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Kunststofffolienkörper (1) eine zwischen den beiden Kavitäten schräg verlaufende Solltrennlinie (S) aufweist.Medical device packaging according to one of the preceding claims, characterized in that the plastic film body (1) has an obliquely extending between the two cavities predetermined separation line (S). Medizinproduktverpackung nach Anspruch 4, dadurch gekennzeichnet, dass die Solltrennlinie (S) durch eine Perforation gebildet ist.Medical device packaging according to claim 4, characterized in that the predetermined separation line (S) is formed by a perforation. Medizinproduktverpackung nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Kunststofffolie mindestens teilweise transparent gestaltet ist.Medical device packaging according to one of the preceding claims, characterized in that the plastic film is designed at least partially transparent. Medizinproduktverpackung nach Anspruch 1, dadurch gekennzeichnet, dass die Deckfolie (5) aus Papier besteht.Medical device packaging according to claim 1, characterized in that the cover sheet (5) consists of paper.
EP18165760.2A 2017-04-11 2018-04-04 Medical product package Pending EP3388364A1 (en)

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