EP1820485B1 - System and apparatus for extracting drugs - Google Patents

System and apparatus for extracting drugs Download PDF

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Publication number
EP1820485B1
EP1820485B1 EP20060003098 EP06003098A EP1820485B1 EP 1820485 B1 EP1820485 B1 EP 1820485B1 EP 20060003098 EP20060003098 EP 20060003098 EP 06003098 A EP06003098 A EP 06003098A EP 1820485 B1 EP1820485 B1 EP 1820485B1
Authority
EP
European Patent Office
Prior art keywords
ampoule
connector
reservoir
piston
adaptor
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.)
Not-in-force
Application number
EP20060003098
Other languages
German (de)
French (fr)
Other versions
EP1820485A1 (en
Inventor
Rudolf Zihlmann
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.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics 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 F Hoffmann La Roche AG, Roche Diagnostics GmbH filed Critical F Hoffmann La Roche AG
Priority to EP20060003098 priority Critical patent/EP1820485B1/en
Priority to DE200650005333 priority patent/DE502006005333D1/en
Priority to AT06003098T priority patent/ATE447923T1/en
Priority to DK06003098T priority patent/DK1820485T3/en
Priority to CA 2571909 priority patent/CA2571909A1/en
Priority to JP2007019066A priority patent/JP2007216008A/en
Priority to CN2007100059607A priority patent/CN101023904B/en
Priority to US11/675,337 priority patent/US7435246B2/en
Publication of EP1820485A1 publication Critical patent/EP1820485A1/en
Priority to HK08101681A priority patent/HK1111077A1/en
Priority to US12/120,527 priority patent/US8257336B2/en
Priority to US12/207,747 priority patent/US8187248B2/en
Application granted granted Critical
Publication of EP1820485B1 publication Critical patent/EP1820485B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S206/00—Special receptacle or package
    • Y10S206/828—Medicinal content
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00—Bottles and jars
    • Y10S215/03—Medical
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/9029—With coupling
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/9247—With closure
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/9682—Miscellaneous

Definitions

  • the invention relates to an adapter for a system for withdrawing a pharmaceutical from a reservoir.
  • liquid pharmaceuticals are often filled in reservoirs or containers, for example, in glass bottles with a few milliliters of content.
  • medical personnel can then join.
  • adapters may be used between the reservoir and the syringe.
  • Different versions of an adapter are for example US Pat. No. 6,591,876 known.
  • This adapter has a first container port for coupling to a first container, a second container port for coupling to a second container, a central portion between the two ports, and a cannula which secures the center portion from accidental contact inside the adapter.
  • the first container port has elements separated from each other by slots in its side wall to encompass a portion of the first container.
  • the second tank connection has in its side wall has two openings to receive on a front part of the second container, two laterally projecting parts similar to a snap closure.
  • the adapter has a locking mechanism that holds the adapter in a position in which the middle part is compressed after being coupled to the containers. In another implementation, this compression is not required.
  • the middle part is rigid and has two opposite gripping surfaces.
  • an adapter is used to make an ampule for an insulin pump, e.g. As an Accu-Chek® insulin pump of Roche Diagnostics GmbH, Germany, to fill with insulin.
  • an insulin pump e.g. As an Accu-Chek® insulin pump of Roche Diagnostics GmbH, Germany
  • the insulin pump continuously delivers insulin to the body.
  • Microprocessors control a motor, the z. B. every three minutes via a threaded rod a stopper moved into an insulin ampule.
  • An empty ampoule can be replaced either by the patient himself with insulin or by a finished ampoule.
  • Especially devices for self-administration of pharmaceuticals should be easy to use, easy to handle and without much effort.
  • document FR 285 3 830 discloses an adapter with all the technical features of the preamble of claim 1.
  • the invention relates to an adapter according to claim 1.
  • the apparatus is configured to have at least one detent mechanism having an elastic member.
  • the system has an ampule in which a piston movable therein is disposed, and an adapter having in a longitudinal direction a reservoir port and an ampule port for coupling to the ampule.
  • the vial port has at least one locking mechanism having an elastic member in a side wall. The elastic member corresponds to a portion of the sidewall that extends along the circumference thereof and merges into the sidewall at opposite ends.
  • an insulin pump is just one example of an application in which, in a preliminary step, a pharmaceutical, namely insulin for the treatment of diabetes, is taken from a container for use in another container in an administering device.
  • a pharmaceutical namely insulin for the treatment of diabetes
  • growth hormones in growth disorders erythropoietin (Epo) in renal insufficiency or general red blood cell deficiency or ⁇ -interferon in hepatitis or cancer treatment may be used as pharmaceuticals.
  • the various ways of carrying out the invention are not limited to liquid pharmaceuticals, although they are frequently removed from a reservoir in medical applications.
  • the invention is generally applicable to pharmaceuticals of different viscosities (from liquid to powdered lyophilisate to be dissolved in liquid).
  • FIG. 1 shows a schematic representation of an embodiment of a system 1 for removing a pharmaceutical, for.
  • the system 1 has an adapter 2 and an ampoule 6 with a piston 8 movable therein.
  • the terms "reservoir” and “ampoule” generally refer to a container suitable for receiving a substance is.
  • the reservoir 4 and the ampoule 6 may be made of a rigid or rigid material, such as. As plastic, glass, metal or may be made of a material which is flexible or elastic, such. As a film made of plastic or other material.
  • the pharmaceutical can be removed from the reservoir 4 and transferred into the ampoule 6.
  • the ampoule 6 and the reservoir 4 can be coupled to the adapter 2. This creates a connection between the interior of the reservoir 4 and the interior of the ampoule 6 by means of a hollow needle or cannula.
  • the filled ampoule 6 can then be e.g. , B. be used in an insulin pump.
  • a piston rod is removed from the piston 8, so that only one piston stopper remains in the ampoule 6 for sealing purposes.
  • the piston 8 is in the Figures 5 and 6A-6D shown in more detail.
  • FIG. 2 2 shows a side view of an embodiment of the adapter 2.
  • the adapter 2 has a reservoir connection 10, a middle part 12 and an ampoule connection 14.
  • the reservoir connection 10 couples to the reservoir 4 and has approximately the shape of a hollow cylinder, on the outer wall of which z. B. three, depressions 16 are located.
  • the depressions 16 generate on the inner wall bulges, which in the FIGS. 3 and 4 are shown.
  • the middle part 12 has in the illustrated embodiment, a cylindrical portion which the reservoir port 10 connects to the vial port 14.
  • the middle part 12 also has one or more, for example two, ribs 11 or rib elements 11, which project radially outwards and extend outside the cylindrical part between the reservoir connection 10 and the ampoule connection 14.
  • the ribs 11 facilitate the gripping or holding of the adapter 2.
  • the middle part 12 in the vicinity of the ampoule connection 14 has two opposite openings 18, through which, for example, the patient a front part of the ampoule 6 (eg FIG. 5 shown Luer connector) and thus also whether air or the pharmaceutical is located in the front part. This makes it easier for the patient at the end of the filling unwanted air in a known manner to remove from the ampoule 6.
  • the ampoule connection 14 couples to the ampoule 6 and has approximately the shape of a hollow cylinder whose diameter in the illustrated embodiment increases starting from the middle part 12. In the coupled state of the system, the vial port 14 receives a portion of the Luer port.
  • the ampoule connection 14 has in the embodiment shown also in its outer wall two opposite locking mechanisms, each consisting of two slots 22, 24 and an elastic member 20, hereinafter also web 20, exist.
  • the slots 22, 24 each produce openings and the elastic member 20 is elastically deformable in the radial direction.
  • the ampoule connection 14, in particular the locking mechanisms, are connected to the in FIG. 5 shown front part (eg in the form of a Luer connector) of the ampoule 6 adjusted.
  • the elastic member 20 and the slot are part of a locking mechanism. Also in this embodiment, the elastic element 20 is elastically deformable in the radial direction.
  • FIG. 3 shows a plan view of the in Fig. 2 shown adapter 2, so that the reservoir port 10 and a hollow needle 26 or cannula 26 are visible.
  • the outer wall of the reservoir connection 10 has a shape deviating from a circle.
  • the outer wall another, z. B. have a circular shape.
  • deviating from a circle shape results, for example, by flattening a circular outer wall in the region of the three recesses 16, for example by reshaping and by a molding process.
  • the recesses 16 are evenly distributed along the circumference of the outer wall and generate inside the reservoir port 10 bulges.
  • the non-circular shape allows the inclusion of reservoirs 4, which have slightly different diameters. As the size of the reservoir 4 increases, the shape approximates to an optimal circle. A difference between the non-circular shape and the shape of an optimal circle can be used as a deformation to compensate for different diameters. The bulges serve to retain the reservoir 4 in the adapter 2.
  • a circular bump 28 surrounds the cannula 26.
  • the diameter of the bump 28 is adapted to the outer diameter of one end of the reservoir front part.
  • the bulge 28 serves for length compensation of different reservoirs 4, since the bulge 28 can dip into the elastic septum (piercing membrane).
  • FIG. 4 shows a perspective view of the adapter 2, in the inter alia, one of the three elements 11 and one of the two locking mechanisms are visible.
  • FIG. 5 shows a schematic representation of the arranged in the ampoule 6 piston 8. The ampoule 6 is in FIG. 5 shown only in its front area.
  • the web 20 corresponds to an elongated portion of the outer wall, which extends along the circumference thereof and parallel to the slots 22, 24 and merges at its ends into the outer wall.
  • the slot 22 adjoins a longitudinal side of the web 20, and in the direction of the ampoule 6, the slot 24 adjoins a further longitudinal side of the web 20.
  • the web 20 may be curved into the interior of the vial port 14.
  • the adapter 2 is made in one embodiment of polypropylene (PP), which is elastically deformable. The web 20 is therefore also elastic, especially in the radial direction.
  • the front part of the ampoule 6 is based in one embodiment on a (male) Luer connector 30, which is equipped with a collar part 32.
  • the collar part 32 projects substantially perpendicularly from a longitudinal axis of the Luer connection 30.
  • the collar part 32 has two circular parts 36, 38 which are separated in the direction of the longitudinal axis by four struts 34 from each other. This results in between the parts 36, 38 four separate cavities 40th
  • the front part of the ampoule 6 is pushed into the ampoule connection 14 and the ampoule 6 and the adapter 2 are pressed against each other.
  • the circular collar part 36 initially pushes the webs 20 outwards.
  • the two webs 20 noticeably engage in the corresponding cavities 40.
  • the webs 20 encounter struts 34, the webs 20 can be positioned by slight axial rotation of the ampoule 6 and / or the adapter 2 so that they meet cavities 40 and the webs 20 can engage. In the detented state penetrates the circular collar portion 36 in the openings 22, and the webs 20 relax in their original state and thus ensure the coupling.
  • the patient may preferentially pull the ampule 6 and the adapter 2 apart in conjunction with an axial rotation of the ampule 6 and / or the adapter 2.
  • the struts 34 push the webs 20 outwards, whereby the ampoule 6 and the adapter 2 can be separated from each other with relatively little effort.
  • FIG. 6A and 6B show schematic representations of the piston 8, which has a piston rod 46 and a piston stopper 42.
  • FIG. 6B shows a longitudinal section through the piston 8.
  • the piston plug 42 is threadably connected to a front end of the piston rod 46 and has two sealing rings 44. Each sealing ring 44 lies in a groove which extends along the circumference of the piston stopper 42.
  • the front end of the piston rod 46 has a screw part 52, which is screwed into a blind hole of the piston butt 42.
  • the screw part 52 has an external thread which is adapted to a corresponding internal thread of the blind hole.
  • the piston rod 46 has an ergonomically shaped handle 48 on which the patient can grip and pull the piston 8.
  • the ergonomically shaped handle 48 connects seamlessly to the remaining part of the piston rod 46.
  • the handle 48 is generally designed so that the patient can grasp it comfortably and naturally with two (eg, between thumb and forefinger) or three fingers (eg, with thumb, forefinger, and middle finger). In particular, it offers the patient a relatively large grip surface. Edges that some patients may find uncomfortable or even painful are largely avoided.
  • the Figures 6C and 6D show schematic representations of the piston rod 46 without the piston plug 42.
  • the screw member 52 has a gap 50 which is extends along the longitudinal axis and divides the screw member 52 into two parts.
  • the two parts are elastic and can be pressed towards each other, for example, when the piston plug 42 is screwed.
  • the outer diameter of the screw part 52 is greater by a predetermined amount than the diameter of the internal thread of the piston stopper 42.
  • the elasticity of the separated by the gap 50 parts compensates for the specified difference in diameter and any existing manufacturing tolerances, d. H. the piston plug 42 compresses the parts according to its internal thread. The parts thus also press against the internal thread of the piston stopper 42, whereby a play-free connection is formed and the piston rod 46 and the piston stopper 42 are held together better. This is especially an advantage if the patient at the end of the filling process with a finger against the wall of the ampoule 6 knocks, so that possibly in the ampoule 6 existing air bubbles rise upwards.
  • This screw is designed so that the torque for releasing the piston rod 46 is smaller than the torque for rotating the piston plug 42 in the ampoule 6. This ensures that the piston rod 46 can unscrew without the piston plug 42 thereby rotates.
  • the above described embodiments of a system and apparatus for withdrawing a pharmaceutical from a reservoir 4 generally facilitate the removal of the pharmaceutical.
  • the filling of an empty ampoule 6 is made easier, especially for the patient.
  • the locking mechanism and the distributed cavities on the ampoule increase the likelihood that when coupling the ampoule 6 to the adapter 2, the web 20 snaps into a cavity 40.
  • the patient on the adapter 2 and / or on the ampoule. 6 pulls, possibly with a rotary motion.
  • the elastic web 20 then releases the collar part 32.
  • openings 18 and the slotted screw portion 52 are the openings 18 and the slotted screw portion 52.
  • the openings 18 on the adapter 2 facilitate the removal of unwanted air from the ampule 6 at the end of the filling process. Since the patient may knock on the ampoule 6 and / or the piston rod 46 under certain circumstances, it is advantageous that the slotted screw part 52 is firmly seated in the piston stopper 42 and does not come off unintentionally.

Abstract

The adaptor has an ampoule connector and a reservoir connector, respectively, coupled to an ampoule (6) and a reservoir (4), where the ampoule connector includes a locking mechanism with a resilient element. A movable piston (8) is arranged in the ampoule. A central part comprises a cylindrical part for connecting the reservoir connector to the ampoule connector. The central part includes ribs projecting radially outwardly and extending outside the cylindrical part between the reservoir connector and the ampoule connector.

Description

Technisches GebietTechnical area

Die Erfindung betrifft einen Adapter für ein System zum Entnehmen eines Pharmazeutikums aus einem Reservoir.The invention relates to an adapter for a system for withdrawing a pharmaceutical from a reservoir.

Stand der TechnikState of the art

In der Medizin sind vor allem flüssige Pharmazeutika oft in Reservoirs oder Behälter, beispielsweise in Glasfläschchen mit einigen Milliliter Inhalt, abgefüllt. Zum Beispiel medizinisches Personal kann dann bei. Bedarf mit einer Kanüle die Dichtung des Behälters durchstechen und eine Spritze mit der benötigten Menge an Pharmazeutikum aufziehen.In medicine, especially liquid pharmaceuticals are often filled in reservoirs or containers, for example, in glass bottles with a few milliliters of content. For example, medical personnel can then join. Use a cannula to pierce the seal of the container and draw up a syringe with the required amount of pharmaceutical.

Um das Hantieren mit freiliegenden Kanülen und die damit verbundene Verletzungsgefahr zu vermeiden, können Adapter zwischen dem Behälter und der Spritze verwendet werden. Verschiedene Ausführungen eines Adapters sind beispielsweise aus US 6 591 876 bekannt. Dieser Adapter hat einen ersten Behälteranschluss für die Kopplung an einen ersten Behälter, einen zweiten Behälteranschluss für die Kopplung an einen zweiten Behälter, ein Mittelteil zwischen den beiden Anschlüssen und eine Kanüle, die der Mittelteil geschützt vor unbeabsichtigter Berührung im Innern des Adapters hält. Der erste Behälteranschluss hat durch Schlitze in seiner Seitenwand voneinander getrennte Elemente, um einen Teil des ersten Behälters zu umfassen. Der zweite Behälteranschluss hat in seiner Seitenwand zwei Öffnungen, um an einem Vorderteil des zweiten Behälters zwei seitlich abstehende Teile ähnlich einem Schnappverschluss aufzunehmen. In einer Ausführung hat der Adapter einen Arretierungsmechanismus, der den Adapter nach dem Koppeln an die Behälter in einer Position hält, in der der Mittelteil komprimiert ist. In einer anderen Ausführung ist diese Komprimierung nicht erforderlich. Der Mittelteil ist dabei starr und hat zwei gegenüberliegende Griffflächen.To avoid handling exposed cannulas and the associated risk of injury, adapters may be used between the reservoir and the syringe. Different versions of an adapter are for example US Pat. No. 6,591,876 known. This adapter has a first container port for coupling to a first container, a second container port for coupling to a second container, a central portion between the two ports, and a cannula which secures the center portion from accidental contact inside the adapter. The first container port has elements separated from each other by slots in its side wall to encompass a portion of the first container. The second tank connection has in its side wall has two openings to receive on a front part of the second container, two laterally projecting parts similar to a snap closure. In one embodiment, the adapter has a locking mechanism that holds the adapter in a position in which the middle part is compressed after being coupled to the containers. In another implementation, this compression is not required. The middle part is rigid and has two opposite gripping surfaces.

In einer Anwendung dient ein Adapter dazu, eine Ampulle für eine Insulinpumpe, z. B. eine Accu-Chek® Insulinpumpe der Roche Diagnostics GmbH, Deutschland, mit Insulin zu füllen. Über einen dünnen Schlauch, dessen Kanüle unter der Haut sitzt, gibt die Insulinpumpe kontinuierlich Insulin an den Körper ab. Mikroprozessoren steuern einen Motor, der z. B. alle drei Minuten über eine Gewindestange einen Stopfen in eine Insulinampulle bewegt. Eine leere Ampulle kann der Patient entweder durch eine selbst mit Insulin nachgefüllte oder durch eine Fertigampulle ersetzen.In one application, an adapter is used to make an ampule for an insulin pump, e.g. As an Accu-Chek® insulin pump of Roche Diagnostics GmbH, Germany, to fill with insulin. Through a thin tube with a cannula under the skin, the insulin pump continuously delivers insulin to the body. Microprocessors control a motor, the z. B. every three minutes via a threaded rod a stopper moved into an insulin ampule. An empty ampoule can be replaced either by the patient himself with insulin or by a finished ampoule.

Vor allem Einrichtungen zur Selbstverabreichung von Pharmazeutika sollen bedienerfreundlich, einfach und ohne grösseren Kraftaufwand zu handhaben sein.Especially devices for self-administration of pharmaceuticals should be easy to use, easy to handle and without much effort.

Dokument FR 285 3 830 offenbart einen Adapter mit allen technischen Merkmalen des Oberbegriffs des Anspruchs 1.document FR 285 3 830 discloses an adapter with all the technical features of the preamble of claim 1.

Darstellung der ErfindungPresentation of the invention

Die Erfindung betrifft einen Adapter gemäß Anspruch 1.The invention relates to an adapter according to claim 1.

Es stellt sich auch die Aufgabe, ein System und eine Vorrichtung zum Entnehmen eines flüssigen Pharmazeutikums aus einem Behälter zu schaffen, so dass eine bedienerfreundliche Art der Kopplung zwischen Adapter und Ampulle und zwischen Adapter und Reservoir möglicht ist. Um dies zu ermöglichen ist in den hier beschriebenen Ausführungsbeispielen eines Systems und einer Vorrichtung die Vorrichtung so ausgestaltet, dass sie mindestens einen Arretierungsmechanismus hat, der ein elastisches Element aufweist.It is also an object to provide a system and apparatus for withdrawing a liquid pharmaceutical from a container so that a user-friendly way of coupling between adapter and ampoule and between adapter and reservoir is possible. To facilitate this, in the embodiments of a system and apparatus described herein, the apparatus is configured to have at least one detent mechanism having an elastic member.

Ein Aspekt betrifft demnach ein System zum Entnehmen eines Pharmazeutikums aus einem Reservoir. Das System hat eine Ampulle, in der ein darin beweglicher Kolben angeordnet ist, und einen Adapter, der in einer Längsrichtung einen Reservoiranschluss und einen Ampullenanschluss für eine Kopplung an die Ampulle hat. Der Ampullenanschluss hat mindestens einen Arretierungsmechanismus, der in einer Seitenwand ein elastisches Element aufweist. Das elastische Element entspricht einem Abschnitt der Seitenwand, der sich entlang deren Umfang erstreckt und an gegenüberliegenden Enden in die Seitenwand übergeht.One aspect therefore relates to a system for withdrawing a pharmaceutical from a reservoir. The system has an ampule in which a piston movable therein is disposed, and an adapter having in a longitudinal direction a reservoir port and an ampule port for coupling to the ampule. The vial port has at least one locking mechanism having an elastic member in a side wall. The elastic member corresponds to a portion of the sidewall that extends along the circumference thereof and merges into the sidewall at opposite ends.

Kurze Beschreibung der ZeichnungenBrief description of the drawings

Weitere Ausgestaltungen, Vorteile, neue Eigenschaften und Anwendungen der Erfindung ergeben sich aus der folgenden detaillierten Beschreibung unter Einbezug der Zeichnungen. In den Zeichnungen haben gleiche Elemente die gleichen Bezugszeichen. In den Zeichnungen zeigen:

  • Fig. 1 eine schematische Darstellung eines Ausführungsbeispiels eines Systems zum Entnehmen eines flüssigen Pharmazeutikums,
  • Fig. 2 eine Seitenansicht eines Ausführungsbeispiels eines Adapters,
  • Fig. 3 eine Draufsicht des in Fig. 2 gezeigten Adapters,
  • Fig. 4 eine perspektivische Ansicht des in Fig. 2 gezeigten Adapters,
  • Fig. 5 eine schematische Darstellung eines Kolbens in einer Ampulle,
  • Fig. 6A - Fig. 6B schematische Darstellungen eines Kolben mit einer Kolbenstange und einem Kolbenstopfen, und
  • Fig. 6C - Fig. 6D schematische Darstellungen der Kolbenstange.
Further embodiments, advantages, novel features and applications of the invention will become apparent from the following detailed description with reference to the drawings. In the drawings, like elements have the same reference numerals. In the drawings show:
  • Fig. 1 a schematic representation of an embodiment of a system for withdrawing a liquid pharmaceutical,
  • Fig. 2 a side view of an embodiment of an adapter,
  • Fig. 3 a top view of the in Fig. 2 shown adapter,
  • Fig. 4 a perspective view of the in Fig. 2 shown adapter,
  • Fig. 5 a schematic representation of a piston in an ampoule,
  • FIGS. 6A-6B schematic representations of a piston with a piston rod and a piston plug, and
  • FIGS. 6C-6D schematic representations of the piston rod.

Wege zur Ausführung der ErfindungWays to carry out the invention

Die verschiedenen Wege zur Ausführung der Erfindung sind im Folgenden ohne Einschränkung des Schutzbereiches mit Bezug auf eine Insulinpumpe als Verabreichungsvorrichtung beschrieben. Eine Insulinpumpe ist jedoch nur ein Beispiel für eine Anwendung, bei der in einem vorbereitenden Schritt ein Pharmazeutikum, nämlich Insulin zur Behandlung von Diabetes, von einem Behälter entnommen wird, um es dann in einem weiteren Behälter in einer Verabreichungsvorrichtung zu verwenden. In anderen Anwendungsbeispielen können Wachstumshormone bei Wachstumsstörungen, Erythropoietin (Epo) bei Niereninsuffizienz oder allgemeinem Mangel an roten Blutkörperchen oder α-Interferon bei der Hepatitis- oder Krebsbehandlung als Pharmazeutika verwendet werden.The various ways of carrying out the invention are described below without limiting the scope with respect to an insulin pump as an administering device. However, an insulin pump is just one example of an application in which, in a preliminary step, a pharmaceutical, namely insulin for the treatment of diabetes, is taken from a container for use in another container in an administering device. In other application examples, growth hormones in growth disorders, erythropoietin (Epo) in renal insufficiency or general red blood cell deficiency or α-interferon in hepatitis or cancer treatment may be used as pharmaceuticals.

Die verschiedenen Wege zur Ausführung der Erfindung sind ausserdem nicht auf flüssige Pharmazeutika beschränkt, obschon diese bei medizinischen Anwendungen häufig aus einem Reservoir entnommen werden. Die Erfindung ist jedoch allgemein für Pharmazeutika unterschiedlicher Viskositäten (von flüssig bis hin zu pulverförmigem Lyophilisat, das mit Flüssigkeit aufzulösen ist) anwendbar.Moreover, the various ways of carrying out the invention are not limited to liquid pharmaceuticals, although they are frequently removed from a reservoir in medical applications. However, the invention is generally applicable to pharmaceuticals of different viscosities (from liquid to powdered lyophilisate to be dissolved in liquid).

Figur 1 zeigt eine schematische Darstellung eines Ausführungsbeispiels eines Systems 1 zum Entnehmen eines Pharmazeutikums, z. B. eines flüssigen Pharmazeutikums, aus einem Reservoir 4. Das System 1 hat einen Adapter 2 und eine Ampulle 6 mit einem darin beweglichen Kolben 8. Die Begriffe "Reservoir" und "Ampulle" bezeichnen hier allgemein einen Behälter, der zur Aufnahme einer Substanz geeignet ist. Das Reservoir 4 und die Ampulle 6 können aus einem starren oder steifen Material sein, wie z. B. Kunststoff, Glas, Metall oder können aus einem Material sein, welches flexibel oder elastisch ist, wie z. B. eine Folie aus Kunststoff oder einem anderen Material. FIG. 1 shows a schematic representation of an embodiment of a system 1 for removing a pharmaceutical, for. The system 1 has an adapter 2 and an ampoule 6 with a piston 8 movable therein. The terms "reservoir" and "ampoule" generally refer to a container suitable for receiving a substance is. The reservoir 4 and the ampoule 6 may be made of a rigid or rigid material, such as. As plastic, glass, metal or may be made of a material which is flexible or elastic, such. As a film made of plastic or other material.

Mit Hilfe des Adapters 2 kann das Pharmazeutikum aus dem Reservoir 4 entnommen und in die Ampulle 6 überführt werden. Zur Entnahme des Pharmazeutikums sind die Ampulle 6 und das Reservoir 4 an den Adapter 2 koppelbar. Dadurch entsteht mittels einer Hohlnadel oder Kanüle eine Verbindung zwischen dem Innern des Reservoirs 4 und dem Innern der Ampulle 6. Zieht beispielsweise ein Patient den Kolben 8 aus der Ampulle 6 heraus, fliesst das Pharmazeutikum in die Ampulle 6. Die gefüllte Ampulle 6 kann dann z. B. in eine Insulinpumpe eingesetzt werden. In einem Ausführungsbeispiel wird dazu vom Kolben 8 eine Kolbenstange entfernt, so dass nur ein Kolbenstopfen zur Dichtung in der Ampulle 6 verbleibt. Der Kolben 8 ist in den Figuren 5 und 6A - 6D detaillierter gezeigt.With the help of the adapter 2, the pharmaceutical can be removed from the reservoir 4 and transferred into the ampoule 6. To remove the pharmaceutical, the ampoule 6 and the reservoir 4 can be coupled to the adapter 2. This creates a connection between the interior of the reservoir 4 and the interior of the ampoule 6 by means of a hollow needle or cannula. For example, if a patient pulls the piston 8 out of the ampoule 6, the pharmaceutical flows into the ampoule 6. The filled ampoule 6 can then be e.g. , B. be used in an insulin pump. In one embodiment, a piston rod is removed from the piston 8, so that only one piston stopper remains in the ampoule 6 for sealing purposes. The piston 8 is in the Figures 5 and 6A-6D shown in more detail.

Figur 2 zeigt eine Seitenansicht eines Ausführungsbeispiels des Adapters 2. Der Adapter 2 hat einen Reservoiranschluss 10, einen Mittelteil 12 und einen Ampullenanschluss 14. Der Reservoiranschluss 10 koppelt an das Reservoir 4 und hat näherungsweise die Form eines Hohlzylinders, an dessen Aussenwand sich entlang des Umfangs mehrere, z. B. drei, Vertiefungen 16 befinden. Die Vertiefungen 16 erzeugen an der Innenwand Aufwölbungen, die in den Figuren 3 und 4 gezeigt sind. FIG. 2 2 shows a side view of an embodiment of the adapter 2. The adapter 2 has a reservoir connection 10, a middle part 12 and an ampoule connection 14. The reservoir connection 10 couples to the reservoir 4 and has approximately the shape of a hollow cylinder, on the outer wall of which z. B. three, depressions 16 are located. The depressions 16 generate on the inner wall bulges, which in the FIGS. 3 and 4 are shown.

Der Mittelteil 12 hat im gezeigten Ausführungsbeispiel einen zylinderförmigen Teil, der den Reservoiranschluss 10 mit dem Ampullenanschluss 14 verbindet. Der Mittelteil 12 hat ausserdem ein oder mehrere, beispielsweise zwei, Rippen 11 oder Rippenelemente 11, die radial nach aussen abstehen und sich ausserhalb des zylinderförmigen Teils zwischen dem Reservoiranschluss 10 und dem Ampullenanschluss 14 erstrecken. Die Rippen 11 erleichtern das Greifen bzw. Halten des Adapters 2. Im gezeigten Ausführungsbeispiel hat der Mittelteil 12 in der Nähe des Ampullenanschlusses 14 zwei gegenüberliegende Öffnungen 18, durch die beispielsweise der Patient ein Vorderteil der Ampulle 6 (z. B. einen Teil eines in Figur 5 gezeigten Luer-Anschlusses) sehen kann und damit auch, ob sich Luft oder das Pharmazeutikum im Vorderteil befindet. Dies erleichtert es dem Patienten am Ende des Füllvorganges unerwünschte Luft in bekannter Art und Weise aus der Ampulle 6 zu entfernen.The middle part 12 has in the illustrated embodiment, a cylindrical portion which the reservoir port 10 connects to the vial port 14. The middle part 12 also has one or more, for example two, ribs 11 or rib elements 11, which project radially outwards and extend outside the cylindrical part between the reservoir connection 10 and the ampoule connection 14. The ribs 11 facilitate the gripping or holding of the adapter 2. In the embodiment shown, the middle part 12 in the vicinity of the ampoule connection 14 has two opposite openings 18, through which, for example, the patient a front part of the ampoule 6 (eg FIG. 5 shown Luer connector) and thus also whether air or the pharmaceutical is located in the front part. This makes it easier for the patient at the end of the filling unwanted air in a known manner to remove from the ampoule 6.

Der Ampullenanschluss 14 koppelt an die Ampulle 6 und hat näherungsweise die Form eines Hohlzylinders, dessen Durchmesser im gezeigten Ausführungsbeispiel vom Mittelteil 12 ausgehend zunimmt. Im gekoppelten Zustand des Systems nimmt der Ampullenanschluss 14 einen Teil des Luer-Anschlusses auf. Der Ampullenanschluss 14 hat im gezeigten Ausführungsbeispiel ausserdem in seiner Aussenwand zwei gegenüberliegende Arretierungsmechanismen, die jeweils aus zwei Schlitzen 22, 24 und einem elastischen Element 20, im folgenden auch Steg 20 genannt, bestehen. Die Schlitze 22, 24 erzeugen jeweils Öffnungen und das elastische Element 20 ist in radialer Richtung elastisch verformbar. Der Ampullenanschluss 14, insbesondere die Arretierungsmechanismen, sind an das in Figur 5 gezeigte Vorderteil (z. B. in Form eines Luer-Anschlusses) der Ampulle 6 angepasst.The ampoule connection 14 couples to the ampoule 6 and has approximately the shape of a hollow cylinder whose diameter in the illustrated embodiment increases starting from the middle part 12. In the coupled state of the system, the vial port 14 receives a portion of the Luer port. The ampoule connection 14 has in the embodiment shown also in its outer wall two opposite locking mechanisms, each consisting of two slots 22, 24 and an elastic member 20, hereinafter also web 20, exist. The slots 22, 24 each produce openings and the elastic member 20 is elastically deformable in the radial direction. The ampoule connection 14, in particular the locking mechanisms, are connected to the in FIG. 5 shown front part (eg in the form of a Luer connector) of the ampoule 6 adjusted.

In einem anderen Ausführungsbeispiel kann anstelle von zwei Schlitzen 22, 24 nur ein Schlitz vorhanden sein. In dieser Ausführung sind das elastische Element 20 und der Schlitz Teil eines Arretierungsmechanismus. Auch in dieser Ausführung ist das elastische Element 20 in radialer Richtung elastisch verformbar.In another embodiment, instead of two slots 22, 24, only one slot may be present. In this embodiment, the elastic member 20 and the slot are part of a locking mechanism. Also in this embodiment, the elastic element 20 is elastically deformable in the radial direction.

Figur 3 zeigt eine Draufsicht des in Fig. 2 gezeigten Adapters 2, so dass der Reservoiranschluss 10 und eine Hohlnadel 26 oder Kanüle 26 sichtbar sind. Im gezeigten Ausführungsbeispiel hat die Aussenwand des Reservoiranschlusses 10 eine von einem Kreis abweichende Form. In einem anderen Ausführungsbeispiel kann die Aussenwand eine andere, z. B. eine kreisrunde, Form haben. Die in Figur 3 dargestellte, von einem Kreis abweichende, Form ergibt sich beispielsweise durch ein Abflachen einer kreisrunden Aussenwand im Bereich der drei Vertiefungen 16, beispielsweise durch Umformen und durch einen Formungsprozess. Wie in Figur 3 gezeigt, sind die Vertiefungen 16 entlang des Umfangs der Aussenwand gleichmässig verteilt und erzeugen im Innern des Reservoiranschlusses 10 Aufwölbungen. Die nicht kreisrunde Form ermöglicht die Aufnahme von Reservoirs 4, die leicht unterschiedliche Durchmesser haben. Mit zunehmender Grösse des Reservoirs 4 nähert sich die Form einem optimalen Kreis an. Eine Differenz zwischen der nicht kreisrunden Form und der Form eines optimalen Kreises kann als Verformung zum Ausgleich verschiedener Durchmesser genutzt werden. Die Aufwölbungen dienen dabei dazu, das Reservoir 4 im Adapter 2 zurückzuhalten. FIG. 3 shows a plan view of the in Fig. 2 shown adapter 2, so that the reservoir port 10 and a hollow needle 26 or cannula 26 are visible. In the exemplary embodiment shown, the outer wall of the reservoir connection 10 has a shape deviating from a circle. In another embodiment, the outer wall another, z. B. have a circular shape. In the FIG. 3 shown, deviating from a circle shape results, for example, by flattening a circular outer wall in the region of the three recesses 16, for example by reshaping and by a molding process. As in FIG. 3 are shown, the recesses 16 are evenly distributed along the circumference of the outer wall and generate inside the reservoir port 10 bulges. The non-circular shape allows the inclusion of reservoirs 4, which have slightly different diameters. As the size of the reservoir 4 increases, the shape approximates to an optimal circle. A difference between the non-circular shape and the shape of an optimal circle can be used as a deformation to compensate for different diameters. The bulges serve to retain the reservoir 4 in the adapter 2.

Am Boden des Reservoiranschlusses 10 umgibt eine kreisrunde Aufwölbung 28 die Kanüle 26. Der Durchmesser der Aufwölbung 28 ist an den äusseren Durchmesser eines Endes des Reservoirvorderteils angepasst. Die Aufwölbung 28 dient zum Längenausgleich von verschiedenen Reservoirs 4, da die Aufwölbung 28 ins elastische Septum (Durchstechmembrane) eintauchen kann.At the bottom of the reservoir port 10, a circular bump 28 surrounds the cannula 26. The diameter of the bump 28 is adapted to the outer diameter of one end of the reservoir front part. The bulge 28 serves for length compensation of different reservoirs 4, since the bulge 28 can dip into the elastic septum (piercing membrane).

Die Wirkungsweise der Arretierungsmechanismen des Adapters 2 wird im Folgenden mit Bezug auf die Figuren 4 und 5 beschrieben. Figur 4 zeigt eine perspektivische Ansicht des Adapters 2, in der u. a. eines der drei Elemente 11 und einer der beiden Arretierungsmechanismen sichtbar sind. Figur 5 zeigt eine schematische Darstellung des in der Ampulle 6 angeordneten Kolbens 8. Die Ampulle 6 ist in Figur 5 nur in ihrem vorderen Bereich gezeigt.The operation of the locking mechanisms of the adapter 2 will be described below with reference to FIGS FIGS. 4 and 5 described. FIG. 4 shows a perspective view of the adapter 2, in the inter alia, one of the three elements 11 and one of the two locking mechanisms are visible. FIG. 5 shows a schematic representation of the arranged in the ampoule 6 piston 8. The ampoule 6 is in FIG. 5 shown only in its front area.

Der Steg 20 entspricht einem länglichen Abschnitt der Aussenwand, der sich entlang deren Umfang und parallel zu den Schlitzen 22, 24 erstreckt und an seinen Enden in die Aussenwand übergeht. In Richtung des Mittelteils 12 grenzt der Schlitz 22 an eine Längsseite des Stegs 20, und in Richtung der Ampulle 6 grenzt der Schlitz 24 an eine weitere Längsseite des Stegs 20. Wie in Figur 4 angedeutet, kann der Steg 20 ins Innere des Ampullenanschlusses 14 gekrümmt sein. Der Adapter 2 ist in einem Ausführungsbeispiel aus Polypropylen (PP) gefertigt, das elastisch verformbar ist. Der Steg 20 ist daher ebenfalls elastisch, vor allem in radialer Richtung.The web 20 corresponds to an elongated portion of the outer wall, which extends along the circumference thereof and parallel to the slots 22, 24 and merges at its ends into the outer wall. In the direction of the middle part 12, the slot 22 adjoins a longitudinal side of the web 20, and in the direction of the ampoule 6, the slot 24 adjoins a further longitudinal side of the web 20. As in FIG. 4 indicated, the web 20 may be curved into the interior of the vial port 14. The adapter 2 is made in one embodiment of polypropylene (PP), which is elastically deformable. The web 20 is therefore also elastic, especially in the radial direction.

Der Vorderteil der Ampulle 6 basiert in einem Ausführungsbeispiel auf einem (männlichen) Luer-Anschluss 30, das mit einem Kragenteil 32 ausgestattet ist. Der Kragenteil 32 steht im Wesentlichen senkrecht von einer Längsachse des Luer-Anschlusses 30 ab. Der Kragenteil 32 hat zwei kreisförmige Teile 36, 38, die in Richtung der Längsachse durch vier Streben 34 voneinander getrennt sind. Dadurch entstehen zwischen den Teilen 36, 38 vier voneinander getrennte Hohlräume 40.The front part of the ampoule 6 is based in one embodiment on a (male) Luer connector 30, which is equipped with a collar part 32. The collar part 32 projects substantially perpendicularly from a longitudinal axis of the Luer connection 30. The collar part 32 has two circular parts 36, 38 which are separated in the direction of the longitudinal axis by four struts 34 from each other. This results in between the parts 36, 38 four separate cavities 40th

Zum Koppeln der Ampulle 6 an den Adapter 2 wird das Vorderteil der Ampulle 6 in den Ampullenanschluss 14 geschoben und die Ampulle 6 und der Adapter 2 werden gegeneinander gedrückt. Der kreisförmige Kragenteil 36 drückt anfangs die Stege 20 nach aussen. Wenn die gegenüberliegenden Stege 20 auf Hohlräume 40 treffen, rasten die beiden Stege 20 merklich in die entsprechenden Hohlräume 40 ein. Sollten dabei die Stege 20 auf Streben 34 treffen, können die Stege 20 durch leichtes axiales Drehen der Ampulle 6 und/oder des Adapters 2 so positioniert werden, dass sie auf Hohlräume 40 treffen und die Stege 20 einrasten können. Im gerasteten Zustand dringt der kreisförmige Kragenteil 36 in die Öffnungen 22 ein, und die Stege 20 entspannen sich in ihren ursprünglichen Zustand und sichern somit die Kopplung.For coupling the ampoule 6 to the adapter 2, the front part of the ampoule 6 is pushed into the ampoule connection 14 and the ampoule 6 and the adapter 2 are pressed against each other. The circular collar part 36 initially pushes the webs 20 outwards. When the opposing webs 20 encounter cavities 40, the two webs 20 noticeably engage in the corresponding cavities 40. If the webs 20 encounter struts 34, the webs 20 can be positioned by slight axial rotation of the ampoule 6 and / or the adapter 2 so that they meet cavities 40 and the webs 20 can engage. In the detented state penetrates the circular collar portion 36 in the openings 22, and the webs 20 relax in their original state and thus ensure the coupling.

Zum Entkoppeln kann der Patient die Ampulle 6 und den Adapter 2 vorzugsweise in Verbindung mit einer axialen Drehung der Ampulle 6 und/oder des Adapters 2 auseinander ziehen. Bei einer Drehung drücken die Streben 34 die Stege 20 nach aussen, wodurch die Ampulle 6 und der Adapter 2 mit relativ geringem Kraftaufwand voneinander getrennt werden können.For decoupling, the patient may preferentially pull the ampule 6 and the adapter 2 apart in conjunction with an axial rotation of the ampule 6 and / or the adapter 2. Upon rotation, the struts 34 push the webs 20 outwards, whereby the ampoule 6 and the adapter 2 can be separated from each other with relatively little effort.

Figuren 6A und 6B zeigen schematische Darstellungen des Kolbens 8, der eine Kolbenstange 46 und einen Kolbenstopfen 42 hat. Figur 6B zeigt dabei einen Längsschnitt durch den Kolben 8. Der Kolbenstopfen 42 ist schraubbar mit einem vorderen Ende der Kolbenstange 46 verbunden und hat zwei Dichtringe 44. Jeder Dichtring 44 liegt in einer Nut, die sich entlang des Umfangs des Kolbenstopfens 42 erstreckt. Das vordere Ende der Kolbenstange 46 hat einen Schraubenteil 52, der in ein Sackloch des Kolbenstöpfens 42 geschraubt ist. Der Schraubenteil 52 hat ein Aussengewinde, das auf ein entsprechendes Innengewindes des Sackloches angepasst ist. Figures 6A and 6B show schematic representations of the piston 8, which has a piston rod 46 and a piston stopper 42. FIG. 6B shows a longitudinal section through the piston 8. The piston plug 42 is threadably connected to a front end of the piston rod 46 and has two sealing rings 44. Each sealing ring 44 lies in a groove which extends along the circumference of the piston stopper 42. The front end of the piston rod 46 has a screw part 52, which is screwed into a blind hole of the piston butt 42. The screw part 52 has an external thread which is adapted to a corresponding internal thread of the blind hole.

An einem hinteren Ende hat die Kolbenstange 46 einen ergonomisch geformten Griff 48, an dem der Patient den Kolben 8 greifen und ziehen kann. Der ergonomisch geformte Griff 48 schliesst sich nahtlos an den restlichen Teil der Kolbenstange 46 an. Der Griff 48 ist allgemein so gestaltet, dass der Patient ihn mit zwei (z. B. zwischen Daumen und Zeigefinger) oder drei Fingern(z. B. mit Daumen, Zeigefinger und Mittelfinger) bequem und natürlich fassen kann. Insbesondere bietet er dem Patienten eine relativ grosse Grifffläche. Kanten, die manche Patienten als unangenehm oder sogar als schmerzhaft empfinden könnten, werden dabei weitestgehend vermieden.At a rear end, the piston rod 46 has an ergonomically shaped handle 48 on which the patient can grip and pull the piston 8. The ergonomically shaped handle 48 connects seamlessly to the remaining part of the piston rod 46. The handle 48 is generally designed so that the patient can grasp it comfortably and naturally with two (eg, between thumb and forefinger) or three fingers (eg, with thumb, forefinger, and middle finger). In particular, it offers the patient a relatively large grip surface. Edges that some patients may find uncomfortable or even painful are largely avoided.

Die Figuren 6C und 6D zeigen schematische Darstellungen der Kolbenstange 46 ohne den Kolbenstopfen 42. Der Schraubenteil 52 hat einen Spalt 50, der sich entlang der Längsachse erstreckt und den Schraubenteil 52 in zwei Teile aufteilt. Die beiden Teile sind elastisch und können zueinander hin gedrückt werden, beispielsweise wenn der Kolbenstopfen 42 angeschraubt wird.The Figures 6C and 6D show schematic representations of the piston rod 46 without the piston plug 42. The screw member 52 has a gap 50 which is extends along the longitudinal axis and divides the screw member 52 into two parts. The two parts are elastic and can be pressed towards each other, for example, when the piston plug 42 is screwed.

Der Aussendurchmesser des Schraubenteils 52 ist um einen festgelegten Betrag grösser als der Durchmesser des Innengewindes des Kolbenstopfens 42. Die Elastizität der durch den Spalt 50 getrennten Teile gleicht die festgelegte Differenz der Durchmesser und evtl. vorhandene Fertigungstoleranzen aus, d. h. der Kolbenstopfen 42 drückt die Teile seinem Innengewinde entsprechend zusammen. Die Teile drücken somit auch gegen das Innengewinde des Kolbenstopfens 42, wodurch eine spielfreie Verbindung entsteht und die Kolbenstange 46 und der Kolbenstopfen 42 besser zusammengehalten werden. Dies ist vor allem dann ein Vorteil, wenn der Patient am Ende des Füllvorganges mit einem Finger gegen die Wand der Ampulle 6 klopft, so dass evtl. in der Ampulle 6 vorhandene Luftblasen nach oben steigen.The outer diameter of the screw part 52 is greater by a predetermined amount than the diameter of the internal thread of the piston stopper 42. The elasticity of the separated by the gap 50 parts compensates for the specified difference in diameter and any existing manufacturing tolerances, d. H. the piston plug 42 compresses the parts according to its internal thread. The parts thus also press against the internal thread of the piston stopper 42, whereby a play-free connection is formed and the piston rod 46 and the piston stopper 42 are held together better. This is especially an advantage if the patient at the end of the filling process with a finger against the wall of the ampoule 6 knocks, so that possibly in the ampoule 6 existing air bubbles rise upwards.

Diese Schraubverbindung ist dabei so ausgelegt, dass das Drehmoment zum Lösen der Kolbenstange 46 kleiner ist, als das Drehmoment zum Drehen des Kolbenstopfens 42 in der Ampulle 6. Dadurch ist gewährleistet, dass sich die Kolbenstange 46 abschrauben lässt, ohne dass sich der Kolbenstopfen 42 dabei mitdreht.This screw is designed so that the torque for releasing the piston rod 46 is smaller than the torque for rotating the piston plug 42 in the ampoule 6. This ensures that the piston rod 46 can unscrew without the piston plug 42 thereby rotates.

Die im vorhergehenden beschriebenen Ausführungsbeispiele eines Systems und einer Vorrichtung zum Entnehmen eines Pharmazeutikums aus einem Reservoir 4 erleichtern allgemein die Entnahme des Pharmazeutikums. In den beschriebenen Ausführungsbeispielen wird vor allem dem Patienten das Auffüllen einer leeren Ampulle 6 erleichtert. Der Arretierungsmechanismus und die verteilten Hohlräume an der Ampulle erhöhen die Wahrscheinlichkeit, dass beim Koppeln der Ampulle 6 an den Adapter 2 der Steg 20 in einen Hohlraum 40 rastet. Zum Entkoppeln genügt es, dass der Patient am Adapter 2 und/oder an der Ampulle 6 zieht, evtl. mit einer Drehbewegung. Der elastische Steg 20 gibt dann das Kragenteil 32 frei.The above described embodiments of a system and apparatus for withdrawing a pharmaceutical from a reservoir 4 generally facilitate the removal of the pharmaceutical. In the described embodiments, the filling of an empty ampoule 6 is made easier, especially for the patient. The locking mechanism and the distributed cavities on the ampoule increase the likelihood that when coupling the ampoule 6 to the adapter 2, the web 20 snaps into a cavity 40. For decoupling it is sufficient that the patient on the adapter 2 and / or on the ampoule. 6 pulls, possibly with a rotary motion. The elastic web 20 then releases the collar part 32.

Weitere Eigenschaften, die die Bedienung erleichtern, sind die Öffnungen 18 und der geschlitzte Schraubenteil 52. Die Öffnungen 18 am Adapter 2 erleichtern das Entfernen von unerwünschter Luft aus der Ampulle 6 am Ende des Füllvorganges. Da der Patient dabei unter Umständen an die Ampulle 6 und/oder die Kolbenstange 46 klopft, ist es von Vorteil, dass der geschlitzte Schraubenteil 52 fest im Kolbenstopfen 42 sitzt und sich nicht unbeabsichtigt löst.Other features that facilitate operation are the openings 18 and the slotted screw portion 52. The openings 18 on the adapter 2 facilitate the removal of unwanted air from the ampule 6 at the end of the filling process. Since the patient may knock on the ampoule 6 and / or the piston rod 46 under certain circumstances, it is advantageous that the slotted screw part 52 is firmly seated in the piston stopper 42 and does not come off unintentionally.

Claims (14)

  1. Adaptor (2) for a system (1) for removing a pharmaceutical product from a reservoir (4), which has in a longitudinal direction a reservoir connector (10) and an ampoule connector (14) for a coupling to an ampoule (6), wherein the ampoule connector (14) has at least one locking mechanism that comprises in a side wall an resilient element (20) that corresponds to a portion of the side wall, which extends along the periphery thereof and at opposing ends merges with the side wall, characterized in that the at least one locking mechanism further comprises a slot (22, 24), wherein the resilient element (20) extends parallel to the slot (22, 24).
  2. Adaptor (2) according to claim 1, wherein two opposing openings (18) are provided in a central part (12) between the reservoir connector (10) and the ampoule connector (14), through which a front part of the ampoule (6) is visible.
  3. Adaptor (2) according to claim 1, wherein at least one rib element (11) is provided on a central part (12) between the reservoir connector (10) and the ampoule connector (14), which extends radially outwardly between the reservoir connector (10) and the ampoule connector (14).
  4. Adaptor (2) according to claim 1, wherein two opposing openings (18) are provided in a central part (12) between the reservoir connector (10) and the ampoule connector (14), through which a front part of the ampoule (6) is visible, and wherein at least one rib element (11) is provided on the central part (12) between the reservoir connector (10) and the ampoule connector (14), which extends radially outwardly between the reservoir connector (10) and the ampoule connector (14).
  5. Adaptor according to one of the claims 1 to 4, wherein the at least one locking mechanism comprises at least two slots (22, 24), and wherein the resilient element (20) extends parallel to the slots (22, 24).
  6. Adaptor (2) according to one of the claims 1 to 2, wherein the reservoir connector (10) has a non-circular cross-section.
  7. Adaptor (2) according to one of the claims 1 to 3, wherein the reservoir connector (10) has at least one recess (16) in a side wall, which produces a bulge on an inside of the side wall.
  8. System for removing a pharmaceutical product from a reservoir (4), with an ampoule (6), in which a therein movable piston (8) is arranged, characterized in that an adapter (2) according to one of the claims 1 to 7 is provided.
  9. System according to claim 8, wherein the ampoule (6) has a Luer connector (30) with a collar part (32), which has two circular parts (36, 38) that are separated from one another in the direction of the longitudinal axis by four braces (34), so that four hollow spaces (40) that are separated from one another are produced, wherein the hollow spaces (40) are adapted to the resilient element (20).
  10. System according to claim 7 or 8, wherein the piston (8) has an ergonomically shaped grip (48).
  11. System according to one of the claims 7 to 9, wherein the piston (8) has a piston rod (46) and a piston stopper (42) that is screwably connected to the piston rod (46).
  12. System according to claim 11, wherein the piston rod (46) has a screw part (52) that is screwed into a blind hole of the piston stopper (42).
  13. System according to claim 12, wherein the screw part (52) has a gap (50) that extends along a longitudinal axis of the piston (8) and divides the screw part (52) into two parts.
  14. System according to claim 12, wherein the screw part (52) has an external diameter that is larger than a diameter of the blind hole by a fixed amount.
EP20060003098 2006-02-16 2006-02-16 System and apparatus for extracting drugs Not-in-force EP1820485B1 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
EP20060003098 EP1820485B1 (en) 2006-02-16 2006-02-16 System and apparatus for extracting drugs
DE200650005333 DE502006005333D1 (en) 2006-02-16 2006-02-16 System and device for withdrawing pharmaceuticals
AT06003098T ATE447923T1 (en) 2006-02-16 2006-02-16 SYSTEM AND DEVICE FOR EXTRACTING PHARMACEUTICALS
DK06003098T DK1820485T3 (en) 2006-02-16 2006-02-16 Plant and apparatus for taking pills
CA 2571909 CA2571909A1 (en) 2006-02-16 2006-12-21 System and device for removing pharmaceutical producs
JP2007019066A JP2007216008A (en) 2006-02-16 2007-01-30 System and device for removing pharmaceutical products
CN2007100059607A CN101023904B (en) 2006-02-16 2007-02-15 System and device for removing pharmaceutical products
US11/675,337 US7435246B2 (en) 2006-02-16 2007-02-15 System and device for removing pharmaceutical products
HK08101681A HK1111077A1 (en) 2006-02-16 2008-02-15 System and device for removing pharmaceutical products
US12/120,527 US8257336B2 (en) 2006-02-16 2008-05-14 System and device for removing pharmaceutical products
US12/207,747 US8187248B2 (en) 2006-02-16 2008-09-10 System and device for removing pharmaceutical products

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20060003098 EP1820485B1 (en) 2006-02-16 2006-02-16 System and apparatus for extracting drugs

Publications (2)

Publication Number Publication Date
EP1820485A1 EP1820485A1 (en) 2007-08-22
EP1820485B1 true EP1820485B1 (en) 2009-11-11

Family

ID=36658851

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20060003098 Not-in-force EP1820485B1 (en) 2006-02-16 2006-02-16 System and apparatus for extracting drugs

Country Status (9)

Country Link
US (3) US7435246B2 (en)
EP (1) EP1820485B1 (en)
JP (1) JP2007216008A (en)
CN (1) CN101023904B (en)
AT (1) ATE447923T1 (en)
CA (1) CA2571909A1 (en)
DE (1) DE502006005333D1 (en)
DK (1) DK1820485T3 (en)
HK (1) HK1111077A1 (en)

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US20080287886A1 (en) 2008-11-20
US20090012492A1 (en) 2009-01-08
DE502006005333D1 (en) 2009-12-24
DK1820485T3 (en) 2010-03-08
CA2571909A1 (en) 2007-08-16
CN101023904B (en) 2012-02-01
HK1111077A1 (en) 2008-08-01
CN101023904A (en) 2007-08-29
US8257336B2 (en) 2012-09-04
EP1820485A1 (en) 2007-08-22
JP2007216008A (en) 2007-08-30
US20070191764A1 (en) 2007-08-16
ATE447923T1 (en) 2009-11-15
US7435246B2 (en) 2008-10-14
US8187248B2 (en) 2012-05-29

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