Automatic injection device
13 claims: 7 independent, 6 dependent
- 1Autoinjektionsgerät zur Verabreichung eines Produkts, wenigstens umfassend:a) ein Gehäuse (1, 2, 3), b) ein vom Gehäuse (1, 2, 3) verschiebbar aufgenommenes Behältnis (B), aus dem durch Vorschieben eines Kolbens (K) Produkt durch eine Nadel (N) an einem Auslaß des Behältnisses (B) ausgeschüttet wird, c) ein vom Gehäuse (1, 2, 3) verschiebbar aufgenommenes Abtriebsglied (10) einer Antriebseinrichtung, das bei einer Autoinjektion zum Einstechen der Nadel (N) das Behältnis (B) dem Gehäuse (1, 2, 3) gegenüber bis zu einer vorgegebenen vorderen Position und zum Ausschütten von Produkt den Kolben (K) im Behältnis (B) vorschiebt, d) und eine Kopplung (12, 21, 22;17, 21, 27), die das Abtriebsglied (10) bis zum Erreichen der vorderen Position des Behältnisses (B) vom Kolben (K) entkoppelt und bei Erreichen dieser Position vom Behältnis (B) entkoppelt e) wobei das Abtriebsglied (10) bei Erreichen der vorderen Position des Behältnisses (B) zum Vorschieben des Kolbens (K) im Behältnis (B) mit dem Kolben (K) gekoppelt wird. dadurch gekennzeichnet, daß f) die Kopplung (12, 21, 22;17, 21, 27) eine kraftschlüssige Verbindung zwischen dem Abtriebsglied (10) und dem Behältnis (B) zumindest umfaßt.
- 2Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, daß das Abtriebsglied (10) bei dem Vorschieben unmittelbar auf das Behältnis (B) wirkt.
- 3Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, daß das Abtriebsglied (10) bei einem Vorschieben ein das Behältnis (B) in Vorschubrichtung drückendes Übertragungsglied (20) mitnimmt, daß die die Mitnahme bewirkende Kopplung (12, 21, 22;13, 23;17, 21, 27) zwischen dem Abtriebsglied (10) und dem Übertragungsglied (20) gelöst wird, wenn das Behältnis (B) seine vordere Position erreicht und daß das Abtriebsglied (10) bei seinem weiteren Vorschieben gegen den Kolben (K) drückend diesen im Behältnis (B) vorschiebt.
- 4Vorrichtung nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die kraftschlüssige Verbindung zwischen dem Abtriebsglied (10) und einem gegen das Behältnis (B) drückenden Übertragungsglied (20) besteht.
- 5Vorrichtung nach dem vorhergehenden Anspruch, dadurch gekennzeichnet, daß die Kopplung ein mit dem Abtriebsglied (10) verbundenes erstes Kopplungsmittel (12;17) und ein mit dem Übertragungsglied (20) verbundenes zweites Kopplungsmittel (22;27) aufweist, das mit dem ersten Kopplungsmittel (12;17) unmittelbar order über ein drittes Kopplungsmittel (21) in einem die Mitnahme des Übertragungsglieds (20) bewirkenden Eingriff steht, wobei wenigstens eines dieser Kopplungsmittel nachgiebig ausgebildet ist und unter dem Einfluß einer am Ende der Vorschubewegung des Behältnisses (B) auftretenden Kraft nachgibt und dadurch der Eingriff gelöst wird.
- 6Vorrichtung nach dem vorhergehenden Anspruch, dadurch gekennzeichnet, daß das dritte Kopplungsmittel (21) ein nachgiebiger Ring ist, der einen in Vorschubrichtung wirkenden Druck des ersten Kopplungsmittels (12;17) auf das zweite Kopplungsmittel (22;27) überträgt und bei Überschreiten einer in Vorschubrichtung wirkenden, vorgegebenen Maximalkraft über das erste Kopplungsmittel (12;17) oder das zweite Kopplungsmittel (22;27) hinaus verschoben wird.
- 7Vorrichtung nach einem der Ansprüche 3 bis 7, dadurch gekennzeichnet, daß zur Kompensation einer mit dem Vorschieben des Abtriebsglieds (10) einhergehenden Abnahme einer das Vorschieben bewirkenden Antriebskraft eine zwischen dem Übertragungsglied (20) und dem relativ dazu vorschiebenden Abtriebsglied (10) erzeugte Dämpfung ebenfalls abnimmt.
- 8Vorrichtung nach einem der Ansprüche 3 bis 8, dadurch gekennzeichnet, daß das Behältnis (B) durch eine Mehrkammerampulle gebildet wird und ein Mischglied, insbesondere ein Mischrohr, zum Vorschieben eines hinteren Kolbens (K2) in Richtung auf einen vorderen Kolben (K1) das Übertragungsglied (20) bildet.
- 9Vorrichtung nach dem vorhergehenden Anspruch, dadurch gekennzeichnet, daß das Übertragungsglied (20) wenigstens ein Dosiermittel (25, 26) aufweist, das im Zusammenwirken mit der Antriebseinrichtung die Auswahl einer zu verabreichenden Produktdosis ermöglicht.
- 10Vorrichtung nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß eine am Gehäuse (1, 2, 3) verschiebbar angebrachte Nadelschutzhülse (50) bei vorgeschobener Nadel (N) in einer die Nadel (N) umhüllenden vorderen Stellung gegen ein Zurückschieben dem Gehäuse (1, 2, 3) gegenüber gesperrt wird.
- 11Vorrichtung nach dem vorhergehenden Anspruch, dadurch gekennzeichnet, daß ein vom Gehäuse (1, 2, 3) verschiebbar aufgenommener Behältnishalter (30), der mit dem Behältnis (B) vorgeschoben wird, in der vorderen Position des Behältnisses (B) die Sperrung der Nadelschutzhülse (50) bewirkt.
- 12Vorrichtung nach einem der Ansprüche 3 bis 8, dadurch gekennzeichnet, daß das Übertragungsglied ein Behältnishalter ist.
- 13Vorrichtung nach einem der Ansprüche 1 bis 5, 8 bis 10 und 13, dadurch gekennzeichnet, daß die Kopplung ein oder mehrere elastisch nachgiebige Schnapper umfaßt und daß der oder die Schnapper unmittelbar am Abtriebsglied ausgebildet ist oder sind, das damit gegen eine Andruckfläche des Behältnisses oder des optionalen Übertragungsglieds drückt, oder daß der oder die Schnapper am optionalen Übertragungsglied vorgesehen ist oder sind.
Independent claims13
80 paragraphs, as filed
p0001Amoinjeknonsgeräte used for administration of products, in particular medical or cosmetically active liquids. It is an injection needle, through which the product is administered, automatically far stabbed a given stretch in a fabric after triggering a drive mechanism.
p0002An auto-injection device in which the invention is concerned, comprises at least a housing, a displaceably accommodated by the housing Behälmis from which a to veräbreichendes product is distributed by advancing a piston by means disposed at an outlet of the container needle, and a displaceably accommodated by the housing the driven member a Antriebseinrichnung that the container relative to the housing advances at an auto-injection for insertion of the needle in the feed Rich drying of the piston up to a predetermined forward position, and for dispensing of product the plunger in the container. Once the container has assumed its front position at a autoinjector, the needle has been advanced by a predetermined distance together with the container, wherein with the setting of the distance, the penetration depth of the needle is also defined substantially.
p0003Such trained autoinjector devices from the <patcit id="pcit0001" dnum="US159192A"><text>US-PS 159.192</text></patcit>, of the <patcit id="pcit0002" dnum="EP0516473B1"><text>EP 516 473 B1 0</text></patcit> and the <patcit id="pcit0003" dnum="US5643214A"><text>US-PS 5,643,214</text></patcit> known.
p0004In the known auto-injection devices the feeding of the container with the needle attached thereto is effected by pressure of the output member to the piston.
p0005From the <patcit id="pcit0004" dnum="EP0824923A1"><text>EP 0824923 A1</text></patcit> is an auto-injection device, in which the feed of the container are decoupled relative to the housing and the advance of the piston in the container from each other. The decoupling is effected by dissolving a pawl engagement.
p0006The invention has set itself the task of creating a autoinjector with a mechanically simple decoupling of the feed movement of the container and the advancing movement of the piston in the container, which enables a smoother transition between the two feed movements.
p0007According to the invention, the driven member is decoupled in a car injection device of the type described above until reaching the front position of the container from the piston and is disengaged on reaching the front position of the container from the container and coupled in the receptacle with the piston for displacing the piston. Advancing the container for insertion of the needle is not effected by means of the piston, ie there is, during this movement phase, no driving connection between the driven member and the piston. This reliably excluded that already during advancement of container product through a possible, albeit small, advancing movement of the piston in the container, ie, relative to the container, distributed. By the driven member is decoupled from the container and only now coupled to the piston in the forward position of the container, the piston is then advanced in the container at the earliest, when the needle has been inserted up to the desired depth in the tissue. The drive-side separation of the advancing movement of the container and the advancing movement of the piston in the container increases the accuracy of the dosage, since a contact pressure on the piston is not already exercised during advancement of the container and thus product can be distributed in advance.
p0008The driven member may act to advance the container directly on the container.
p0009Preferably, a transfer member is provided which is entrained by the driven member at a feeding, thereby acting on the container and / or a container holder, and so advances the container. The transfer element may also be a container holder, but is advantageously formed as a separate part thereof.
p0010is the releasable coupling between the output member and the transfer member. After loosening of the coupling in the front container position causes further advancement of the driven member, namely for advancing the plunger, no further advancement of the transmitting member more. The driven member is now free, at least in terms of his own advancing movement of the transmission member. It only pushes against the piston and pushes it in the container characterized before. Preferably, the transmission member is slidably received in and counter to the advancing direction of the piston from the housing.
p0011According to the invention the coupling between the driven member and the container includes a frictional connection between the driven member and the container or the transfer member, at least one with.
p0012Preferably, a positive and non-positively acting coupling for coupling and decoupling the output member with and use of the container as well as to and from the piston. Also in this embodiment, the coupling is preferably formed between the driven member and a transfer member, although a coupling would be conceivable directly with the container.
p0013The coupling is preferably formed by a snap connection. When advancing the driven member pushes a gate against a pressure surface and thereby pushing against the container. If the container has reached its front position in which it lies against the housing the stop, the snap connection is achieved by the further acting on the output member of driving force. The driven member is coupled to the piston and free from container or free advanced further from the transfer member. A slight shock when reaching the front receptacle position can be quite supportive desirable.
p0014At least one of the coupling forming means is designed resiliently, preferably elastically flexible. One or more snapper can be formed directly on the driven member, which thus pushes against a contact surface of the container or the transfer member, if one is used. Such snapper can also be provided on the transfer element.
p0015Particularly preferably a third Kopphmgsmittel is included for forming the coupling, which is then only yielding, preferably resiliently formed. Advantageously, the third coupling means is a resilient ring, in particular a spring ring, which is clamped between two opposing surfaces of the stripping section and the transmitting member, and either of these pressure faces on pushes once the container has reached its front position.
p0016The invention can advantageously also at autoinjector devices use, in which the container is formed by a so-called multi-chamber ampoule. Such multi-chamber ampoules, the product to be administered is obtained only by mixing the contents of the several chambers separated from one another when assembling the device. Each of the successively arranged chambers completed rearward means of a displaceable piston in the container. For mixing, a mixing element against the rear piston is pushed and pushes with his advancement in the container each of the piston forward to the foremost piston. When advancing is or connections are made to each adjacent anterior chamber, so that a content of the rear chamber is displaced respectively in the adjacent preceding that chamber.
p0017According to the invention forms the mixing member, known per se, which is in particular a mixing tube, then at the same time the transfer member for feeding the container. The mixing member is assigned according to the invention a double function. Structurally, this is preferably achieved in that the mixing member has a radially outwardly projecting ridge, preferably in the form of a circumferential shoulder, by means of which it presses against the rear end face of the container or, if preferred, against a rearward contact surface of a container holder, of the container takes along with his forced by the mixing element forward movement. The forward position of the container is preferably defined by an abutment such container holder against the housing.
p0018The housing may, both the container and the entire drive means envelop, preferably in the form of a sleeve, however, is used in its most general form only as a base member, relative to which the flow displacement movement of the container and the displacement movement of the output member of the drive device and is therefore not limited to, although preferred to be seen as enveloping housing.
p0019Embodiments of the invention will be described with reference to the <figref idrefs="f0001">figures 1</figref> and <figref idrefs="f0004">6</figref> explained. Show it:<dl id="dl0001" compact="compact"><dt>Fig. 1</dt><dd>an autoinjector with form and force-locking coupling,</dd><dt>FIG. 2</dt><dd>an autoinjector with positive feedback,</dd><dt>Fig. 3</dt><dd>the transfer member of the device according to <figref idrefs="f0002">FIG. 2</figref>.</dd><dt>FIGS. 4, 5</dt><dd>the lock on the needle shield of the device after <figref idrefs="f0002">FIG. 2</figref> and</dd><dt>Fig. 6</dt><dd>a autoinjector with a two-chamber ampoule and one designed as transmission element mixing tube.</dd></dl>
p0020<figref idrefs="f0001">Fig. 1</figref> shows an auto-injection device in the form of an injection pen in longitudinal section.
p0021The pen has a hollow cylindrical, circular cylindrical in the exemplary embodiment housing with a needle protector 1 at its front end, an adjoining front housing shell 2, and an adjoining rear housing sleeve 3 with this end face closing the housing cap 4. The front casing sleeve 2 encloses a cylindrical container B, which in turn is held centered in a container holder 30 coaxial with a central longitudinal axis of the housing. The container holder 30 is also sleeve-shaped and runs forward from in centering tongues, which press against the peripheral edge of the container B and center it in the front housing sleeve. 2 The container nishalter 30 is along the center axis of the housing back and forth slidably. When feeding the container holder 30 which is held container B is moved with it. In this case, one is arranged at a front end of the container B at an outlet of the injection needle N is pushed forwardly and engraved in the course of an auto-injection into and under the skin of a patient.
p0022In container B a piston K along the central longitudinal axis of the container B is displaced. By advancing the piston K is a contained in the container B product, in the embodiment of a medication liquid, such as insulin, displaced through the outlet into and through the injection needle N passes for dispensing the product. From piston K rearward protrudes from a piston rod via a rear container edge.
p0023The container B is widened flange along its rear edge. The container holder 30 is also correspondingly widened at its rear end and continued sleeve-shaped with a widened cross-section a little way over the container out. The container B is in the installed state with its rear widening at this widening facing shoulder surface of the container holder 30. An outer circumferential surface of the receptacle holder 30 is surrounded by a serving as a restoring member 33 compression spring which rests with a front end on a shoulder face of the front housing half 2 and from there does not extend all the way to a mating surface 31 which is formed by the widening of the container holder 30 on the container holder 30 and facing the aforementioned shoulder face of the front housing sleeve second During advancement of the container holder 30 and thus of the container B, the compression spring 33 is compressed between these two surfaces facing each other and springs thereby the advance movement during penetration of the needle N from. The surface 31 abuts during advancement against a shoulder surface which is formed in the region of a step-shaped widening of the front housing sleeve second The abutment of the shoulder surface 31 of the container holder 30 defines a front position of the container B and hence that length by which the needle N addition is in the front position of the container B on the front edge of the housing, whereby at the same time, correct placement of the pen on the skin condition, the penetration depth of the needle N is predetermined.
p0024A drive means for advancing the container B and K for advancing the piston in the container B is formed by a compression spring designed as a drive element 5 and a driven member 10th The drive could also be effected by means of a pressure medium. The driven member 10 is substantially sleeve-shaped having a rearwardly open sleeve pot which is closed by a bottom. At its front end, the driven member 10 is continued to the piston rod to the said base addition, a comparatively short distance far sleeve-shaped. The continuation forms a stamp 11 for pressing against the piston rod and pushing the plunger K in container B.
p0025In the illustrated initial condition of the injection pen is no immediate pressure of the punch 11 against the piston rod. It remains in the initial state, rather a small clearance between the punch 11 and the rear end face of the piston rod. In the illustrated initial condition of the pen where the container B is in its rear sliding position, the output member 10 is coupled to the container B. Immediately the output member 10 is coupled to a transmission member 20, which then acts directly on the container B. Likewise, the transmission member 20 could also act directly on the container holder 30, in which case would be provided between the container holder 30 and the container B carriers. In principle, the output member could directly press on a container or a container holder to advance the needle.
p0026The transmission member 20 is formed by a sleeve body, in its rear portion by a cross-sectional constriction encircling shoulder 22 is formed which serves as a front contact surface for a spring-elastic ring 21st The resilient ring 21 is held in an encircling on the outer circumferential surface of the driven member 10 in the area of the stamper 11 groove the driven member 10 secured against displacement. The ring 21 can be formed as closed soft-elastic ring, preferably it is, however, made of a hard material such as plastic or metal, and is perforated at a location so that the there mutually facing ends of the ring 21, a piece can be widely moved toward each other and the diameter of the ring can be reduced. The resilient ring 21, the shoulder 22 and the shoulder 22 facing wall 12 of the groove form a based on form and force closure, detachable coupling between the output member 10 and the transfer member 20. The ring 21 as a pressing and coupling means could also be as a bead be formed on the output member 10 or transmission member 20, which would then expire after the deflectable in tongues.
p0027The driven member 10 is in the in against the pressure of the driving element 5 <figref idrefs="f0001">Fig. 1</figref> illustrated starting position of a holding and release sleeve 6 held by a formed on the holding and release sleeve 6 release tab. 7 The connection is achieved by the release tab Einwärtsdrücken 7th
p0028To inject the product of the pen after removing a protective needle cap is set with the front edge of the needle guard 1 with light pressure on the skin. Subsequently, the release tab 7 is pressed and thereby dissolved the connection between the disengagement sleeve 6 and the housing. The driven member 10 is now pushed forward by the pressure of the drive member 5 in the housing. By coupling the advancing force of the driven member 10 from the groove wall 12 on the ring 21 and from this is transferred to the shoulder 22 and thus to the transmission member 20th The transmission member 20 presses with a front end face against the container B and the container holder 30, which, apart under the pressure of the transfer member 20 of any wall friction forces are first advanced without resistance in the housing. The needle N that has exactly in the feed direction, is pushed forward beyond the front edge of the needle guard 1 addition and penetrates into the fabric. The advancement of the container B and thus the penetration depth of the needle N is limited by abutment of the shoulder surface 32 of the container holder 30 against the housing side mating surface. The container B now occupies its front position.
p0029During the advancing movement of the container holder 30 and the container B is the coupling between the wear member 10 and the transfer member 20. The coupling is designed so that it dissolves when the front position of the container B is reached.
p0030This is done by the dimensioning of the resilient ring 21 and molding of serving as a support for the ring 21 shoulder 22. The shoulder 22 has an angle or an arc in the direction of further rearward to the narrower front section of the transmitting member 20th
p0031The resilient ring 21 is round in cross-section. In principle, the cross-sectional shape of the ring 21 and the shape of the shoulder 22 are merely coordinated to one another such that the resilient ring 21, the shoulder 22 does not have pushes before reaching the front container position, for which purpose the coupling at least the encountered during advancement of the container B the reaction force and for inserting the needle has to transfer force required, and that the coupling does not block after reaching the front container position, but certainly solves. Optimal tuning of the coupling is then, though solving wherever possible smoothly.
p0032If the coupling formed by the coupling means 12, 21 and 22 is released, or even already during the release, so that passes under pressure from the drive element 5 further advancing drive member 10 in pressure against the piston rod and is thereby coupled to the piston, which is now under the pressure of the driven member 10 B is pushed forward in the container, so that the product is displaced and is distributed through the needle N through.
p0033To compensate for the accompanying with the advance of the driven member 10 decrease the force of the drive member 5, the transfer member 20 may be formed conically divergently on its inner circumferential surface. The ring 12 would experience a decreasing in the course of moving the driven member 10 frictional force in such training. This development of the invention by controlled damping the driving force would benefit from the elasticity of the ring 21 or a similarly acting pressure means.
p0034As an alternative to these based on control of Gleitreibungskräften compensating the decrease of the driving force can be compensated also pneumatically. If pneumatic compensation of enclosed between the outer surfaces of the driven member 10 and the transmission member 20 room would as far as possible airtight. The guide ring inserted at the rear end of the transmission member 20 18 would form a seal to the output member 10, which would form a piston itself. Further, the sliding surfaces formed between the inner shell of the transmission member 20 and the opposing surface of the punch 11 may be formed as sealing surfaces. In this way be enlarging cavity between the outer surface of the output member 10 and the inner surface of the transmission member 20 would be formed during the advancement of the driven member 10th
p0035In the then trained as a guide sealing ring 18 would provide only a calibrated through hole, can flow into the otherwise tight cavity through which a medium, preferably air. The negative pressure generated by the advancing of the driven member in this cavity would be compensated for only after a delay, so that the Vorschiebegeschwindigkeit of the driven member 10 through the entire displacement of the piston K would remain constant.
p0036The spring 33 causes a cushion and thereby delay the advance movement of the container holder 30 to the container B. However, the container holder insert 30 and the container B at the beginning of its feed movement, a not disabled by the spring 33 part of the way back, as the shoulder 31 of the container holder 30 only after traveling this predetermined path part comes into contact pressure spring for 33rd The feed movement over the remaining distance to the front container position is then slowed 5 lower restoring force of the spring 33 compared to the force of the drive member through the. This rapid penetration of the needle then slowed advance speed in the deeper tissue layers is achieved as desired. On the front housing sleeve 2 formed stop lugs 2a keep the container holder 30 in its rearward position. Under the pressure of the drive element 5 and consequently the Behältnishälters 30 in the case of triggering but give the stop tabs according 2a. By means of the housing projects through the clamping handle 7 'are brought slidably received in the housing holding and release sleeve 6 and thus along the driven member 10 back to its rear position or stretched. In the rear position, a new container B can be used. The driven member 10 and the sleeve 6 are connected to each other accordingly.
p0037<figref idrefs="f0002">FIG. 2</figref> shows an embodiment not according to the invention an auto-injection device in turn in the form of a pen in a longitudinal section and in a cross section AA. In this pen the drive connection between the driven member and the container and the output member and the piston is purely form-fitting prepared and dissolved. He has a further difference to a needle protection device which covers the pre-discharged needle after withdrawal from the tissue and thereby reduces the risk of injury during subsequent handling.
p0038The housing is also formed by a front housing shell 2 and a rear casing sleeve 3rd The needle protector 1 is formed in this embodiment in one piece on the front housing sleeve second In the hollow cylindrical housing is again a container holder 30 in which a filled with the product to be administered container B is kept centered, back along the housing longitudinal axis and forth slidably mounted. When advancing to the insertion of the needle N of the container holder 30 is moved to a front stop face 31 against a housing-side abutment, whereby the front position of the container B and the penetration depth of the needle N is defined. After injection has taken place, the two housing sleeves 2 and 3 are unscrewed, whereby the container B and the container holder 30 of the transfer member 20 come free and the container holder 30 under the pressure of the designed as a return spring return element 33 having a rear stop surface 31 against a housing-side stop face to its rear position, the starting position is pushed back. In this rear position, a new container B are used. By screwing together the two housing sleeves 2 and 3 of the pen is the<figref idrefs="f0002">FIG. 2</figref> ready for the next injection.
p0039As in the embodiment of the <figref idrefs="f0001">Fig. 1</figref> affects the output member 10 of the pen <figref idrefs="f0002">FIG. 2</figref> via a transmission member 20 to the container; Also, the transmission member 20 could act on the container holder 30, then the container B mitnähme. The advance of the piston K is carried out in the container B by direct pressure of the stamp 11 of the output member 10 to the out of the container B protruding rearward piston rod, which is mounted projectingly on the piston K from its rear side or formed integrally with the piston K.
p0040In <figref idrefs="f0003">Fig. 3</figref> are the output member 10, the transmission member 20 and a guide means 40 according to their position in <figref idrefs="f0002">FIG. 2</figref> shown. In relation with the coupling and uncoupling of the output member 10 and the transmission member 20 is always on display in<figref idrefs="f0003">Fig. 3</figref> referenced.
p0041The driven member 10 is constituted by a solid cylindrical body having a punch 11 with a widened cross section. The drive member 5 is in turn constructed as a pressure spring and surrounds a cylindrical shaft part of the driven member 10. It is clamped in the initial position of the pen between the thickened stamp 11 and ribs 9, to extend from the rear casing sleeve 3 radially inwards on the cylindrical shank portion. The driven member 10 is held by gate 15 in its initial position.
p0042Several snapper 15 project away in extension of the cylindrical shaft portion of the drive member 10 of the cylindrical shank part and engage behind the radially inwardly projecting ribs. 9
p0043From the outer circumferential surface of the stamper 11 protrudes from a rib or a cam. 13 With the cam 13, the driven member 10 is in abutment against a rear end face 23 of the transmitting member 20. The transmission member 20 is a simple hollow cylindrical sleeve, preferably a circular cylindrical sleeve formed by the outer circumferential surface in a rear portion of a cam 25 radially outward protrudes. On the inner circumferential surface of the transfer gate 20 a in the longitudinal direction of the transmission member 20 extending, opening into the end face 23 release groove 24 is excluded. The groove 24 is at least so great that the cam 13 of the wear member can be added to their 10th
p0044The transmission member 20 is arranged longitudinally slidably and rotatably around the longitudinal axis in a substantially also simple hollow cylindrical, preferably circular cylindrical sleeve. This sleeve forms a guide means 40 for the transmission element 20, such that a displacement movement of the transmission member 20 is forced to be converted relative to the guide means 40 in a rotational movement of the transmitting member 20 about its longitudinal axis relative to the guide means 40, that the displacement movement is superposed a rotational movement. The guide means 40 is designed as a standalone sleeve against rotation in the housing and is received immovable. It could in principle also to the housing, here with the rear casing sleeve 3, be formed integrally, but this would make manufacturing more complicated.
p0045The relative rotation of the transmitting member 20 relative to the guide means 40 and the torsion in the housing geradgeführten driven member 10 is effected by means of a groove formed between the transfer member 20 and the guide means 40 a guide mechanism.
p0046In forming the link slot opposite a guide 41 except for these cams 25 on the inner circumferential surface of the guide means 40 to the cam 25 of the transmission link 20th The guide groove 41 has a rear straight groove portion 42 and an arcuate this further, optionally mono- obliquely expiring second groove 43, ie, the second groove portion 43 has a transverse component to the direction of the transmission element 20 on. In the initial position of the cam 25 comes to lie in the groove 42nd
p0047A trigger mechanism has an outer sleeve 4, a release button 7 and a return spring eighth The outer sleeve 4 surrounds the rear region of the rear casing sleeve 3 and is reciprocating on the outer circumferential surface of the rear housing shell 3 along their longitudinal axis and forth movable. The release button 7 is inserted into a central opening of the rear end face of the outer sleeve. 4 He passes through this opening with a close up on the latches 15 of the output member 10 extending inner sleeve.
p0048For injecting the pen is pressed against the skin, so that a back in the front region of the front housing sleeve 2 in the longitudinal direction and forth movable needle guard 50 is pushed against the pressure of a formed as a return spring return element 51 in the front housing shell 2 under the needle guard 1st In this state, the needle N is still behind the front edge, formed by the front ends of the shield 1 and the needle guard 50, back.
p0049The insertion of the needle N and the distribution of the product caused by pressing the shutter button 7 in the longitudinal direction of the pen on the output member 10 or its gate 15 to. The inner sleeve of the release button 7 via pushes the rear ends of the catches 15, which will consequently be elastically bent towards each other radially inwardly whereby the locking connection is attained with the housing-side ribs. 9
p0050The pressure of the driving element 5 is transmitted from the shared output member 10, which presses with its cam 13 against the rear end face 23 of the transfer member 20 on the transfer member 20, which in turn presses with its front surface against a rear flange surface of the container B. With the front end face of the same flange, the container B pushes the container holder 30, which in turn presses by means of the return element 33 against the housing opposite unmovable locking sleeve 60th However, the pressing force of the Rückstellelemnts 33 is opposite to that of the drive member 5 is comparatively low, so that under the pressure of the drive member 5, the driven member 10, the transmission member 20 and the container holder 30 are pushed forward with the container B along the housing longitudinal axis in the housing.
p0051In this case, the cam 25 of the transmitting member 20 slides in its guide groove 41. When the cam 25 enters in its advancement into the second groove portion 43, the transmission member 20 is forcibly forced due to the transverse component of the second groove portion 43 in rotation about its longitudinal axis. The course of the guide groove 41 is chosen such that by the forced relative rotation relative to the housing and relative to the driven member 10, the recessed in the transfer member 20 release groove 24, which opens in the end face 23, comes to lie in overlapping relationship to the cam thirteenth
p0052Once the release groove 24 covers the cam 13, the output member 10 is decoupled from the transmission member 20th The course of the guide groove 41 is so selected that the overlap is produced when the container holder 30 on the housing rests with its front abutment surface 31 on the stop and hence the container B is in its forward position. With the decoupling or release the output member 10 may be the transmission member 20 from under the pressure of the drive element 5 advance further. It presses against the piston rod, so that the piston K is advanced in the container B under the immediate pressure of the output member 10 until the product is distributed.
p0053The insertion of the needle N is determined by the course of the guide groove 41 as desired. By passing in a first part of the advance movement of the transmission element, especially in the feed direction and therefore the advancement of the transmission member 20 no resistance is opposed to the needle N stings initially a very rapidly. The Eindringsgeschwindigkeit is slowed down in the further penetration, since the guide groove 41 then also transversely to the feed direction, helically in the exemplary embodiment, extends and accordingly, the transmission member 20 experiences a dependent on the gradient of the guide portion 43 friction force in Führungsabschriitt 43 during advancement. In addition, the speed with which the needle pierces, reduced by the increasing restoring force of the restoring element 33rd
p0054The <figref idrefs="f0003">Figures 4 and 5</figref> show together with <figref idrefs="f0002">FIG. 2</figref> The operation of the needle protection device that prevents the needle N freely protrudes after pulling out from the tissues of the body and be canceled and may cause injury if handled carelessly. The essential feature of needle protection device that is blocked in a needle guard position for the purpose of piercing the housing opposite movable needle guard 50 after the withdrawal of the needle, so that it can no longer be pushed into the housing; an outside sliding over the housing would also be conceivable.
p0055<figref idrefs="f0003">Fig. 4</figref> shows the front part of the pen of <figref idrefs="f0002">FIG. 2</figref> in the forward position of the container parable B. The needle guard 50 has been pressed against the force of the return element 51 in its rearmost slide position of the housing sleeve 2 opposite. The needle N protrudes to the desired length from the housing and the needle protection sleeve 50 before.
p0056The needle shield 50 has a rear abutment surface and a forward abutment surface 50 to limit the displacement of the needle protection sleeve relative to the front housing sleeve 2 in the feed direction and counter to the advancing direction. When shuffling the needle guard 50 moves over the locking sleeve 60, which has a slanted or curved outwardly projecting hook 62 at its front end. The needle protection sleeve 50 has in an inner cladding region, with which it slides over the hook 62, the length of its maximum displacement path corresponding approximately to a slightly enlarged internal diameter. A transition region 52 between this widened front inner cross section to the subsequent internal cross-section is tapered such that the needle protection sleeve 50 under the pressure of the return member 51 to the rear transitional portion 52 can slide over the hook 62nd The needle guard 50 is provided behind the transitional portion 52 in a central area with longitudinal slots 53, the front end surfaces 54, as best shown in<figref idrefs="f0003">Fig. 5</figref> It can be seen form abutment surfaces for each one of the hooks 62nd
p0057The locking sleeve 60 is running in a plurality of uniformly distributed over the sleeve circumference arranged resilient tongues 61 at their free front ends of the hooks are formed 62nd The container holder 30 runs to its free front end also in tongues 34 from. By advancing the container holder 30 whose tongues 34 come to lie under the tongue 61 of the locking collar 60th Each of the tongues 61 is so supported radially inward and can not be bent radially inwards in front of the container position. The tongues 61 are not only supported by the tongues 34, but additionally pressed radially outwards. The tongues 34 are compared with the tongues 61 rigid or may be 61 against assumed to be rigid in a first approximation, these tongues.
p0058After withdrawal of the needle, the needle protective sleeve 50 is pushed by the return element 51 back from. On pushing because of the oblique course of the surface 52 and / or the corresponding inclined path of the hook 62 that hooks 62 whose expiring tip is also resiliently. However, once the needle guard 50 has been pushed forward again, saw 54 in the direction that its abutment surface comes to lie in front of the hook 62, it will be blocked by the lying in abutment against the stop surface 54 hook 62 against being pushed back. The hook 62 and the needle protective sleeve 50 are with pointing vertically to the direction of stop surfaces together. The needle N is in the in<figref idrefs="f0003">figure 5</figref> illustrated safety position protected after injection through the needle shield 50th
p0059The container holder 30 is thus at the same time also used as a sliding support for the elastic locking means 62 and fulfilled according to the invention, the double function of holding the container and the locking of the needle guard 50. The needle guard device does not require the inventive design of the auto-injection device, although more preferably in combination therewith is used. It is also with advantage in the generic auto-injection devices, and even unchanged also be used with injection devices in which the insertion of the needle by advancing the container relative to the housing is carried out manually.
p0060<figref idrefs="f0004">figure 6</figref> shows in longitudinal section and above a top view of a Autoinjektionspen, wherein the coupling of the driven member 10 with the container B and the piston K based on frictional and form closure. The coupling is in effect of the pen of<figref idrefs="f0001">Fig. 1</figref> comparable. In the following, always also refer to the data entered in the top view cross-sections and the detail X.
p0061In the container B of the pens <figref idrefs="f0004">Fig. 6</figref> is it to be mixed up against the front piston K1 to a so-called double-chamber ampoule, in the two product components in two successively arranged chambers, which are separated in the delivery state of the container B by a front piston K1 each other, only by advancing a rear piston K2. In the front at delivery chamber is generally a powdery drug, while in the chamber formed between the two pistons K1 and K2 a carrier liquid is stored.
p0062In which, in <figref idrefs="f0004">Fig. 6</figref> illustrated state are completely mixed in the past between the piston K1 and the container outlet anterior chamber already by advancing the rear piston K2 to against the front piston K1, the two components. The housing again has a front and a rear casing sleeve 2 and 3, which are firmly joined together, for example by screwing or clipping. A cover cap 4 is inserted into the rear casing sleeve 3rd The front casing sleeve 1 'is extended by the by a Nadelschuz 1 and a needle shield 50, against a restoring force is displaced back to the insertion of the needle N and after injection takes the advanced position.
p0063The container B is inserted into a receptacle holder 30 up to the stop and held centered. The container holder 30 can be advanced against the force of the return element 33 in the housing.
p0064Advancing the rear piston K2 is effected during assembly of the front housing shell 2 and the rear casing sleeve 3rd To this end, designed as a sleeve body 20, secured against rotating mixing member is accommodated in the rear housing sleeve 3rd The mixing member 20 has a front sleeve portion having an outer diameter which is smaller than the inner diameter of the container B, and an opposite this front sleeve portion widened rear sleeve region. A transition between the two sleeve portions is formed as a radially projecting from the front sleeve shoulder area 28th The shoulder 28 is formed circumferentially; However, they can also be formed by at least one radially projecting web. With its rear end face, the mixing member 20 abuts against radially from the rear housing 3 sleeve inwardly projecting webs 9, which can also be formed as a circumferential wall on. In assembling the device, ie, during the screwing of the two housing sleeves 2 and 3, the thus secured against displacement in the rear casing sleeve 3 taken mixing member 20 is inserted into the rear open container B, and pushed therein by the. It pushes the rear piston K2 to from the front piston K1 to the rear piston K2 in the<figref idrefs="f0001">Fig. 1</figref> has reached the position shown. In this position the pistons K1 and K2 and the screwing of the housing sleeve 2 and 3 is completed.
p0065In the rear casing sleeve 3, the drive device is arranged which comprises the driving element 5 in the form of a compression spring and the rod-shaped driven member 10, which is linearly guided in the housing. The drive member 5 is 9 oppositely facing between the webs 9 and the webs in the feed direction, is clamped circumferential shoulder surface of the driven member 20th
p0066The driven member 10 is back to a central longitudinal axis of the housing, which coincides with its own central longitudinal axis, between two positions of rotation and forth recorded rotatable. To rotate the driven member 20 is a housing lengthening dosing D is provided. In its rear region, which projects into the dosing sleeve D, comprises the output member 10 in the feeding direction extending guiding grooves, into which a in the cover cap 4 protrudes, the cap 4 in relation to rotatable, displacement secure guide sleeve 6a and a rotatable and secured against displacement accommodated in the housing indicator sleeve 8 engage. The guide sleeve 6 is secured against rotating with the dosing sleeve D, as best seen in section HH. The guide sleeve 6 is used to transmit the rotation of the dosing D to the driven member 10. The indicator sleeve 8, which secured against rotation is connected to the output member 10, the display of the rotational position of the output member 10 and hence the display of the set dose quantity used. It is for this purpose provided at its outer periphery with indicia, in the embodiment with two marks for each one of two Drehendstellungen of the driven member 10. The markings can be read through a housing opening. The indicator sleeve 8 and the guide sleeve 6a, together with the mixing member 20 as a linear guide for the driven member 10th
p0067The driven member 10 is held in the illustrated rear starting position by a lock and release mechanism. The blocking and release means comprises a Auslösmechanik 7a in the form of a release button, which acts transversely to the direction of the output member 10 to a locking means 7b. The structure and operation of the locking and release mechanism is best seen in the synopsis of the longitudinal section and cross section FF.
p00687b the locking means is formed by a sleeve body with a through-opening which is penetrated by the driven member 10th The blocking means 7b is 10 performed for the purpose of its linear guide transversely to the feed and the longitudinal direction of the driven member between two straight ridges of the housing. These two housing webs each face, the sleeve body of the blocking means 7b accordingly on just outside surfaces. The passage opening of the locking means 7b is larger than the outer diameter of the projecting through the output member, the blocking agent is 10. 7a by pressure on the release means 7b transversely displaced against the force of a formed as a pressure spring return member 7c to the feed direction of the driven member 10th In the blocking position the driven member abuts 10 with a shoulder 29 formed by a thickening 7b against a rear end face of the locking means. By a transverse displacement of the blocking means 7b of the stop is achieved. The driven member 10 comes from the blocking means 7b free and can advance 5 under the pressure of the drive member in the longitudinal direction.
p0069A safety device ensures that the release means 7a only then actuated and thereby the driven member 10 can be released when a container B has been inserted into the housing. The safety device comprises a triggering lock body 70 and a compression spring 19. The trigger lock body 70 has a central sleeve portion, from which protrude forwardly in the longitudinal direction two webs 70a (section E-E). The two webs 70a extend through two correspondingly shaped slots in the shoulder 28 of the mixing element 10 and abut the rear edge of the container B. From central sleeve portion of the trigger lock body 70 projects a third web 70b in the longitudinal direction from the rear. This third ridge 70b projects through the release means 7, as can best be seen in the synopsis of the longitudinal section with the two sections FF and GG.
p0070At the height of the release means 7, ie in which the triggering means 7a by projecting area, the third ridge 70b of the trigger lock body 70 a longitudinal slot. In these longitudinal slot has a radially projecting inwardly projecting rib 7d moves the release means 7a in a actuation of the release means 7a, when the slot of the trigger locking body 70 is at the same height as the inner rib 7d of the release means 7a. In saw behind the slitted region longitudinally of the third web 70b eye again forms a closed web. Between the housing-side web 9 and one of the inner lateral surface of the central sleeve portion of the trigger locking body 70 inwardly projecting shoulder, the compression spring 19 is tensioned. Is a container B is used, the trigger locking body 70 presses with its front ridges 70a against the rear edge of the container B and is thus in the longitudinal section of the<figref idrefs="f0001">figure 1</figref> position shown held in the inner fin retract 7d of the release means 7a in the slot of the trigger lock body 70 and the locking means can move transversely 7b. If e has not been inserted in the container, the trigger locking body 70 is pushed forward by the pressure spring 19 in the therefore then free annular gap until the middle sleeve section of the trigger locking body 70 abuts against the shoulder 28 of the mixing element 10th In this blocking position of the trigger lock body 70 of the rear, closed area of the third rib 70b comes to rest against the inner rib 7d of the release means 7a. A transverse displacement of the release means 7a is not possible this case. The drive means is then locked.
p0071there is a drive coupling, which causes the mixing member 20 taken at a feeding of the driven member 10 from the driven member 10, that is itself pushed forward relative to the housing interposed between the mixer 20 and the mixing member 20 projects through the driven member 10th The coupling is made by a shape-based and force-fitting connection in the front region of the mixing member 20 to that of the coupling of the embodiment<figref idrefs="f0001">figure 1</figref> balances. The mixing member 20 takes a dual function the function of a transfer member, and is accordingly referred to as a mixing and transfer member 20th
p0072In contrast to the coupling in the embodiment of <figref idrefs="f0001">Fig. 1</figref> in which the <figref idrefs="f0004">Fig. 6</figref> added the resilient ring 21 in a groove formed on the inner surface of the mixing and transfer member 20 slot, and the output member 10 accordingly has only one moving within mixing and transfer member 20 causing pressure surface 17 of the ring 21. The pressure surface 17 forms a first coupling agent, a contact surface formed by the groove of the mixing and transfer member 20 27 is a second, and the ring 21, a third coupling means.
p0073The mixing and transfer member 20 and the driven member 10 form a metering device in a cylinder disposed within the container B range. The mixing and transfer member 20 is provided for this purpose in a located behind the first coupling means 17 inner cladding region with a recess. The recess has two extending in the feed direction grooves 25 and 26, the angular offset are arranged parallel next to one another. The grooves 25 and 26 are of different lengths in the feed direction. The küizere groove 25 is formed as a blind groove in the outer surface, and the longer groove 26 is limited in the feed direction by the rear web of the recording for the third coupling means 21st At their rear ends open the grooves 25 and 26 at the same height with respect to the feed direction in a widening of the recess of, as best seen in conjunction of the longitudinal section with the sections CC, DD and EE. The widening of the recess extends up to the rear end surface of the front barrel portion of the mixing and transfer member 20. The there expiring, oppositely facing side walls of the spacers are each extended in the advance direction by one of the two grooves 25 and 26th
p0074The driven member 10 is provided with a radially projecting cams 16th In the initial state of the injection device, the cam 16 engages with the widening of the recess of the mixing and transfer member 20th The recess with the two grooves 25 and 26 forms a first metering means and the cam 16 is a second dosing means of the metering device.
p0075In a first metering position, the cam 16 is located in alignment with the groove 25 on to the extending in the advancing direction first side wall of the widening and in the second metering position, the cam 16 is in alignment with the groove 26 on the extending in the feed direction the second side wall of the widening of the recess at. Between these two Dosierstellungen the driven member 10 is back in the initial state of the injection device and forth rotatable about its longitudinal axis. The two side walls of the wide groove define the two rotational and Dosierstellungen of the driven member 10, and the lengths of the two narrow grooves 25 and 26 define the set of distributable during an injection drug solution.
p0076The widening of the recess in the mixing and transfer member 20 could be extended 25 in the feed direction until the end of the short groove, so that the recess would have in the direction of a simple step-like course.
p0077For performing an autoinjector, the autoinjector to the front, the housing or the front needle protection 1 against retractable needle protection sleeve 50 'to a tissue surface, in particular the human skin, is placed. By pressing against the tissue surface, the needle guard 50 'is pushed back in a rearmost position relative to the housing. The injection needle N, which is pointing firmly attached to the outlet in the feed direction on the container B, is initially 50 'their front tip also still surrounded by the needle shield 1 and pushed over needle guard to over and thus does not affect nor the tissue surface.
p0078For actuating, that is for insertion of the needle and for distribution of the active solution, the user presses after having brought to 10 by means of the driven member of the dosing D in the desired rotational or dosing position, the trigger means 7a in the radial direction inwardly. By Einwärtsdrücken the blocking means 7b is pushed under the stop shoulder 29, and the output member 10 is released. Under the pressure of the drive member 5, the driven member 10 and by means of the coupling also the mixing and transfer member 20 is advanced relative to the housing. The form and force fit between the output member 10 and the mixing and transfer member 20 is sufficiently strong to cause the entrainment of the mixing and transfer member 10, in turn, by means of its shoulder 28 against the container holder 30 and the container B oppressive this relative to housing and against the restoring force of the body flats 33 to in a forward position to advance, which is defined by a housing-side stop 31a.
p0079In the forward position of the container holder 30 and the container B the coupling releases the driving connection between the driven member 10 and the mixing and transfer member 20. Under the continuing pressure of the drive element 5, because of the fixation of the mixing and transfer member 20 of the compliant ring 21 compressed and pushed over the sloping shoulder 17th The driven member 10 pushes now also relative to the mixing and transfer member 20 before and further presses the two pistons K1 and K2 in the container in the direction towards the container outlet to also available. Drug solution is discarded by the forward position of the container B lanced into the fabric needle N passes.
p0080The feed movement of the output member 20 is limited in the first dispensing position by the front end of the groove 25th In the first dosing position, the distribution is completed, when the cam 16 in the circumferential direction abuts extending groove wall on this.
4 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| US11623051B2 | Cited by | United States of America | Applicant |
| US10238810B2 | Cited by | United States of America | Applicant |
| EP0516473A | Cites | European Patent Office (EPO) | – |
| EP0824923A | Cites | European Patent Office (EPO) | – |
| US5320609A | Cites | United States of America | – |
| US5391151A | Cites | United States of America | – |
| US5643214A | Cites | United States of America | – |
34 members in 8 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 19822031 | Germany | – | |
| 19822031 | Germany | A | |
| 99810407 | European Patent Office (EPO) | A |
Members34
| Document | Office | Kind | |
|---|---|---|---|
| EP0956873A2 | European Patent Office (EPO) | A2 | |
| DE19822031A1 | Germany | A1 | |
| JPH11347121A | Japan | A | |
| DE19822031C2 | Germany | C2 | |
| EP0956873A3 | European Patent Office (EPO) | A3 | |
| US6280421B1 | United States of America | B1 | |
| US2001049496A1 | United States of America | A1 | |
| US6620137B2 | United States of America | B2 | |
| EP0956873B1 | European Patent Office (EPO) | B1 | |
| EP1568388A1 | European Patent Office (EPO) | A1 | |
| AT302034T | Austria | T | |
| ATE302034T1 | Austria | T1 | |
| DE59912414D1 | Germany | D1 | |
| DK0956873T3 | Denmark | T3 | |
| ES2248975T3 | Spain | T3 | |
| EP1568388B1 | European Patent Office (EPO) | B1 | |
| AT376849T | Austria | T | |
| ATE376849T1 | Austria | T1 | |
| DE59914542D1 | Germany | D1 | |
| PT1568388E | Portugal | E | |
| EP1875935A2 | European Patent Office (EPO) | A2 | |
| DK1568388T3 | Denmark | T3 | |
| ES2294594T3 | Spain | T3 | |
| EP1875935A3 | European Patent Office (EPO) | A3 | |
| JP4306873B2 | Japan | B2 | |
| EP1875935B1 | European Patent Office (EPO) | B1 | |
| AT455568T | Austria | T | |
| ATE455568T1 | Austria | T1 | |
| DE59915128D1 | Germany | D1 | |
| DK1875935T3 | Denmark | T3 | |
| EP1568388B2This record | European Patent Office (EPO) | B2 | |
| DK1568388T4 | Denmark | T4 | |
| ES2294594T5 | Spain | T5 | |
| EP1568388B9 | European Patent Office (EPO) | B9 |
68 legal events, as 11 offices reported them to INPADOC
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|---|---|---|---|
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| Ep patent has been republished in amended form after opposition at epoOppositionRPEO | RPEO | SE | |
| Modification of the scope of the patentAUFRECHTERHALTUNG DES PATENTES IN GEAENDERTER FORMAEN | AEN | CH | |
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Numbers
- Publication
- 1568388
- Application
- 50102946
Titles3
- German
- Autoinjektionsgerät
- English
- Automatic injection device
- French
- Dispositif automatique d'injection
Classification
- CPC, 13
- A61M5/46
- A61M5/2033
- A61M5/2066
- A61M5/24
- A61M5/2448
- A61M5/3155
- A61M5/31595
- A61M5/3202
- A61M5/326
- A61M2005/2086
- A61M2005/3247
- A61M2205/14
- A61M2005/206
- IPC, 5
- A61M5 20
- A61M5 315
- A61M5 32
- A61M5 24
- A61M5 46
Designated states19
- Contracting states, 19
- Austria
- Belgium
- Switzerland
- Cyprus
- Germany
- Denmark
- Spain
- Finland
- France
- United Kingdom
- Greece
- Ireland
- Italy
- Liechtenstein
- Luxembourg
- Monaco
- Netherlands (Kingdom of the)
- Portugal
- Sweden
