EP2066373A1

EP2066373A1 - Splash-resistant injection device

Info

Publication number: EP2066373A1
Application number: EP07720137A
Authority: EP
Inventors: Philippe Kohlbrenner; Peter Stettler; Patrick Hostettler; Juergen Wittmann; Martin Wittwer
Original assignee: Tecpharma Licensing AG
Current assignee: Tecpharma Licensing AG
Priority date: 2006-09-15
Filing date: 2007-05-11
Publication date: 2009-06-10
Also published as: US20090254044A1; WO2008031235A1; US20190247587A1; EP4159257A1; CN101594898B; WO2008031239A1; CN101588830A; US10300211B2; DK2076303T3; JP4955772B2; US20090247959A1; US20140350484A1; CN101594896A; US10350363B2; EP2076303A1; DE102007022791A1; PL3626289T3; JP2010503432A; WO2008031238A1; JP2010503434A

Abstract

The invention relates to an injection device, the delivery element (90) of which is guided in a liquid-tight manner in relation to the housing (20). To achieve this, the delivery element (90) preferably has a substantially smooth, cylindrical outer wall region and is surrounded by at least one annular sealing element (D2).

Description

Splash-proof Injection device

Technical area

The present invention relates to a device for administering a fluid product. The device may be designed as an injection device for injecting an adjustable dose of the product and in particular in the form of an injection pen, i. of a compact pen-shaped injection device.

State of the art

The prior art discloses a large number of injection devices for metered administration of medicaments, such as insulin, growth hormones or osteoporosis preparations, which have to be administered regularly. On the one hand, such devices should reliably and precisely dispense a presettable dose. On the other hand, they should be highly user-friendly and user-friendly. This is even more so since they are usually operated by the patient himself.

The medicament can be accommodated in a replaceable container in the form of a carpule which can be inserted into a carpule holder. This can then be attached to a housing of the injection device, for example by a screw or a bayonet connection. To dispense a product plug in the carpule is advanced by a conveyor with a conveying element in the form of a piston rod. In particular, compact pen-shaped administration devices are known in which the distribution takes place automatically after a first triggering ("power-assisted pens"). The dose is usually preset in such devices by a rotation on a Dosierknopf. The device has a drive, eg a spring drive, which is tensioned when setting the dose. The device is triggered by pressing in a triggering device, which may be identical to the dosing button. In this case, the drive generates a drive movement, for example in the form of a rotational movement, which is converted into a propulsion movement of the piston rod. In the case of a drive by a rotary movement, the piston rod is usually formed as a threaded rod on which a drive nut runs.

DE-A 10 2004 063 644, DE-A 10 2004 063 647, WO-A 2004/002556 and DE-A 102 29 122 disclose injection devices which represent general state of the art for the present invention.

When changing the container, the piston rod may inadvertently come into contact with liquids, be it by accidentally displaced glass with a drink, or by a broken container containing the liquid medication. As a result, liquid can penetrate into the interior of the injection device and impair its function.

Presentation of the invention

It is therefore an object of the present invention to provide an administering device in which the penetration of liquid into the interior of the device is prevented.

These objects are achieved by a device having the features of claim 1. Advantageous developments are specified in the dependent claims. The device according to the invention for administering a fluid product thus comprises a housing and a conveying element for conveying the product from a reservoir. The conveyor element extends outwardly from the interior of the housing and is movable relative to the housing. In this case, the conveying element with respect to the housing or a housing-fixed element is liquid-tight, at least splash-proof, sealed. This effectively prevents ingress of liquids.

A corresponding seal may be formed directly between the conveyor element and the housing. But it is also conceivable that a first seal between the conveying element and a member which is movable relative to the housing, is formed, and a second seal between the movable member and the housing is formed. The movable element can e.g. be arranged so that it is movable only during a change of the reservoir and is immobile during the actual administration to the housing. It may in particular be sleeve-shaped.

Preferably, the conveying element has a substantially smooth, cylindrical see, preferably circular cylindrical outer wall area, which is surrounded by at least one annular sealing element. In this way, a simple and efficient sealing can be achieved, as is not possible with the piston rods with external thread of the prior art. The length of the smooth outer wall region corresponds at least to the distance between the distal end position and the proximal starting position, between which the conveying element is movable during the course of administration in order to ensure a seal over this entire region. A "substantially smooth" outer wall region is to be understood as meaning an area in which there are no structures such as threads or grooves that could oppose an efficient sealing effect. On the other hand, however, the outer wall area can have very fine structures, in particular in the region below 100 micrometers, preferably below 10 micrometers which are suitable for at least not impairing or even improving the sealing effect, for example a microstructure or nanostructuring. These structures may have a preferred direction to inhibit the flow of liquids.

The at least one annular sealing element preferably comprises at least one circumferential, flexible sealing lip, which rests on the cylindrical outer wall area and acts as a wiper in the manner of a windshield wiper. The contact angle between the sealing lip and the outer wall region is preferably less than 90 degrees. It may, however, be e.g. also be designed as a ring with a round or polygonal cross-section.

The conveying element is preferably guided rotatably relative to the housing. As a result, a seal is simplified compared to a conveying element that performs a combined translational and rotational movement. The conveying element is preferably driven by a rotary movement, e.g. via a threaded connection with a rotatable element. For this purpose, the administering device preferably comprises a drive device for generating the rotational movement relative to the housing, wherein the rotational movement in a suitable manner causes a feed movement of the conveying element along the feed axis.

In order to allow a substantially smooth outer wall area, the conveying element in a preferred embodiment has an internal thread, whose threaded axis extends along the feed axis. Characterized the thread used for the drive is moved inwards, and it is adapted to the needs of the sealing design of the outside of the conveyor element allows.

With the internal thread is then a threaded element with an external thread engaged. This threaded element is preferably fixed relative to the housing along the feed axis and of the drive device in a Rotary movement displaceable about the feed axis to advance the conveyor element along the feed axis.

Preferably, the interior of the housing is completely sealed liquid-tight against the outside of the housing, so not only in the area in which the conveying element is guided to the outside, but also in other areas, e.g. in the range of moving dosing or actuating elements.

In particular, the delivery element and / or an e-element sealingly cooperating therewith may be made of a hydrophobic material or may be hydrophobic coated in order to achieve or improve a sealing effect by avoiding capillary creep.

The device can furthermore have at least one ball bearing, which absorbs forces transmitted between the conveying element and the housing. By providing a ball bearing, frictional losses caused during administration due to the transfer of forces between the impeller and the housing are substantially minimized.

A ball bearing is particularly advantageous if the device comprises at least one rotatable element cooperating with the conveying element and a drive device for generating a rotational movement of the rotatable element relative to the housing, wherein the rotational movement of the rotatable element along (preferably linear) advancing movement of the conveying element along a feed axis in a distal direction causes, preferably by a threaded engagement, which is preferably non-blocking. In this case, the ball bearing is advantageously arranged such that it receives along the feed axis acting (axial) forces, which are transmitted from the (preferably non-rotatable) relative to the housing conveying element on the rotatable element on the housing, ie between the rotatable element and the Housing act. Generally speaking, therefore, axial, in particular transmitting forces acting in the proximal direction between the conveyor element and the housing via a rotatable and axially displaceable connection. In the prior art, a sliding connection between the rotatable element and the housing or a housing-fixed element is usually provided for this purpose. In the present invention, however, at least one ball bearing is provided, which is preferably arranged between the rotatable element or an associated element on the one hand and the housing or on the other hand at least during the administration housing-fixed element. As a result, friction losses can be avoided during the rotation of the rotatable element.

Preferably there are two ball bearings which are preferably arranged to provide forces along the feed axis in both the proximal direction and the opposite distal direction, i. the direction in which the feed takes place can record. Axial forces in the proximal direction usually arise during administration, while axial forces in the distal direction can arise, in particular, when the delivery element is spring-loaded in the distal direction, as is the case in a preferred embodiment. The spring serving for it is preferably so weak that it does not cause expulsion of the product from the reservoir. Rather, it serves to automatically bring the conveying element into its distal end position during a reservoir change, ie to extend it completely when the reservoir is removed from the housing. If the conveying element is connected to the rotatable element of suitable connection, this will cause the rotatable element is set in rotation when the conveying element extends due to the spring force. In order to keep the necessary spring force small, a ball bearing is of particular advantage, since it minimizes the frictional forces acting during the extension of the conveying element.

In particular, the device can be configured as follows: The conveying element is designed sleeve-shaped with a proximal and a distal end and has an internal thread. The conveying element is located along the thrust direction rotatably guided relative to the housing. It is (axially) movable between a proximal and a distal end position along the feed direction. The rotatable element has an external thread which cooperates with the internal thread of the conveying element.

In a preferred embodiment, such an internal threaded conveying element is surrounded radially at least partially by a guide sleeve having a proximal end and a distal end. The length of this guide sleeve preferably corresponds at least to the maximum feed area of the conveying element, i. the distance between the distal and the proximal end position of the conveying element. Near its distal end, the guide sleeve is rotatably connected at least during administration with the housing or a housing-fixed element. The conveyor element is rotatably guided along the feed direction in the guide sleeve. Preferably, the conveying element is at least in the region of its proximal end with the interior of the guide sleeve in a rotationally fixed engagement, but allows an axial displacement. For this purpose, in the region of the proximal end, an engagement structure projecting radially outwardly from the outer circumferential surface of the conveying element, e.g. in the form of a plurality of longitudinal ribs, formed with a complementary structure, e.g. in the form of a plurality of longitudinal grooves, cooperating on the inner peripheral surface of the guide sleeve. The device then preferably further comprises an outer sleeve having a proximal and a distal end which in turn at least partially radially surrounds the guide sleeve. Near its proximal end, this outer sleeve is connected to the rotatable element. Near its distal end, the outer sleeve is guided rotatably and non-displaced relative to the guide sleeve via the at least one ball bearing.

The considerations underlying this embodiment can be summarized as follows: The conveyor element should be secured against rotation relative to the stationary housing and longitudinally guided. In this case, the conveying element is preferably substantially smooth on its outer side or on others Way can be configured arbitrarily. This implies that the conveying element is longitudinally guided only in the region of its proximal end in a rotationally fixed to the housing element. However, this in turn requires that this non-rotatable element is at least as long that the guide is ensured over the entire range of the feed of the conveying element. To ensure this, a sleeve-like structure of the rotationally fixed member is chosen, which is therefore referred to as a guide sleeve, with a length of this guide sleeve which corresponds at least to the feed region of the conveying element. To drive the conveying element, the rotatable element must furthermore be arranged in the interior of the conveying element. In order to ensure a threaded engagement over the entire feed area, the rotatable element must extend at least over a length from proximal to distal in the conveying element, which corresponds to the feed area. The only available access to the rotatable element consists of the proximal end. A drive of the rotatable element must therefore take place via its proximal end. At the same time, the rotatable element must be supported in any way relative to a housing-fixed element. This bearing must be able to absorb axial forces, as axial forces are transmitted from the conveyor element via the threaded engagement with the rotatable element. Although a storage could be provided directly at the proximal end of the rotatable element. However, this would take up a lot of space in an area that should be available for other tasks if possible. It is therefore desirable to move the location of storage to another location, as close as possible to one of the ends of the housing. This is done here with the help of the outer sleeve, which is firmly connected to the rotatable element and this quasi continues along the outside of the guide sleeve to the distal direction. The storage then takes place between the outer sleeve and the guide sleeve, in the region of the distal end of the outer sleeve. As a result, a very compact unit is created, the radially relatively much space-demanding storage comes to rest in a proximal region, where it only slightly disturbs, and which makes it possible in the radial gap between the outer sleeve and the housing further elements of the Housing injection device. Furthermore, the fact that the outer sleeve (and thus ultimately the rotatable element) is mounted on the guide sleeve and not on the housing itself, that the entire unit of guide sleeve, outer sleeve, bearing, rotatable member and conveyor element relative to the Housing specifically designed to be movable, for example in the context of a container change.

The reservoir is preferably held in a container holder, which is releasably attachable to the housing. When fastening, it is preferably guided relative to the housing such that it performs a combined rotational movement about an axis of rotation and translational movement along the axis of rotation relative to the housing. The device then preferably further comprises a spring element and a latching element. These elements are arranged such that the spring element generates a spring force acting essentially along the axis of rotation on the latching element. The latching element thereby causes in a predetermined holding position of the container holder a releasable latching connection, by which the container holder is fixed relative to the housing. For this purpose, for example, protrude in projection of the locking element in a recess of the container holder or a non-rotatable element. A reverse arrangement is conceivable. The latching connection is preferably designed so that it is by a movement of the container holder relative to the housing, which is opposite to the movement in the fastening, again detachable, i. the locking connection does not need to be unlocked manually.

It is therefore preferably provided a connection in the manner of a screw or preferably bayonet connection between the container holder and the housing or between them connected to these elements. In customary bayonet connections between two elements, an element with a bayonet pin in a suitably shaped slot or in a corresponding groove is guided in the manner of a slot guide of the other element until the bayonet pin reaches an end position (corresponding to the holding position). In such compounds, the problem is an unintentional To avoid sliding back of the pin out of the end position. A similar problem arises with screw, which are fixed by a clamping force and can also solve unintentionally. The present embodiment solves this problem by providing an axially spring loaded (and axially movable) detent member. Such a locking element ensures a defined fixation of the container holder in the holding position, without the risk of unintentional release exists. The connection is only solvable by overcoming a sufficiently large force. This wear, which could lead to a leaching of the connection, avoided. By the latching element is spring-loaded in the axial direction, a simple and space-saving design of the locking element and the spring element is made possible.

As a rule, the container will be a container with a cylindrical wall region and a plug which can be displaced therein, a so-called carpule, which defines a longitudinal direction and is accommodated in a container holder with a correspondingly elongate shape. When mounting on the housing, the container holder is preferably rotated about this longitudinal direction, i. the axis of rotation coincides with the longitudinal axis. To administer the product, the stopper is advanced through the conveying element along the longitudinal direction. More generally, thus preferably, the feed direction of the conveying element corresponds to a direction along the axis of rotation about which the container holder is rotated during its attachment.

There are various possibilities for the arrangement of the spring and latching element. According to a preferred embodiment, the locking element is rotatably relative to the housing and releasably locked in the locking position with an element which is rotationally fixed relative to the container holder. In other words, the locking element does not follow the rotation of the container holder, but remains in the fastening of the container holder rotationally fixed to the housing. However, the reverse arrangement is conceivable in which the locking element is rotatably relative to the container holder. In a preferred embodiment, the device comprises a driving element. The entrainment element is guided relative to the housing in such a way that it is entrained by the container holder when the container holder is fastened to the housing and when the container holder is detached from the housing, and is set in motion which comprises a rotational movement about the axis of rotation. The conveying element is then preferably sealed by a first seal against the driving element, and the driving element is sealed by a second seal relative to the housing. The entrainment element can be fixable relative to the housing in at least one predetermined position, for example via a detachable latching connection, as described above. The carrier element then holds the container holder. The container holder is thus fixed indirectly, via the driving element, relative to the housing in this case.

In an advantageous embodiment, the device comprises a relative to the housing rotatably arranged guide element, which may be formed in particular as a guide sleeve. This guide member may be rigidly connected to the housing, in particular be made in one piece with this, or it may be axially displaceable relative to the housing. The driving element, which can also be configured as a sleeve and can then be referred to as a bayonet sleeve, is at least rotatably connected to the guide element. The spring element and the latching element are preferably arranged rotationally fixed relative to the guide element, and the latching element is releasably latched in the holding position of the container holder with the driving element. In particular, the guide element relative to the housing rotatably and axially displaceable and the driving element, although rotatably, but be axially fixed to be connected to the guide element. This configuration makes it possible for further parts of the device arranged in the housing, which are connected to the guide element, to be displaced axially when the container holder is attached to the housing. As a result, the administration device can automatically be used, for example, when the container holder is released. reset and brought back to a ready state when attaching the container holder. In particular, it is possible in this way, when releasing the container holder, to move the interior of the device (in particular the drive device and optionally a triggering device connected thereto) in a distal direction so that the triggering device, which can be configured as a pushbutton, can move into the device Housing is retracted and indicates that the device is not ready.

In this case, the carrier element is preferably guided relative to the housing such that it is entrained by the container holder when the container holder is fastened to the housing and offset relative to the housing in a combined rotational movement about the axis of rotation and translation along the axis of rotation in a proximal direction.

Preferably, the driving element between two defined end positions is movable, and the locking element causes in both positions a releasable locking connection, by which the driving element is fixed relative to the housing. In this case, the driving element assumes its first end position when the container holder assumes its holding position, and it assumes its second end position when the container holder is removed from the housing. Preferably, the latching element is releasably latched in both the first end position and in the second end position directly to the driving element.

The entrainment element is preferably in at least one guide slot relative to the housing, i. on the actual housing itself or on a housing-fixed element, guided, in particular by one or more corresponding pin. Likewise, the container holder when mounting on the housing in at least one guide slot, guided in the manner of a bayonet connection, relative to the housing.

The latching element is preferably designed in the form of a ring which extends around the axis of rotation and in particular around the feed element. stretches. On the ring suitable locking lugs may be formed. This locking element can be axially spring-loaded by a separate spring element. This may be, for example, a pressure-loaded coil spring or another type of elastic element. However, the spring element preferably has the form of a ring which extends around the axis of rotation and is curved about an axis perpendicular to the axis of rotation, so that the spring force is generated by compressing the spring element along the axis of rotation.

Preferably, the locking element is formed integrally with the spring element. This leads to a particularly simple embodiment. In particular, the locking element may be formed as a projecting in the direction of the axis of rotation projection on the spring element. This is particularly advantageous if the spring element, as described above, has the shape of a curved ring.

Brief description of the drawings

Preferred embodiments of the invention will now be described with reference to the drawings, in which:

1 is an exploded perspective view of an injection device according to a first embodiment;

FIG. 2 shows a longitudinal section through the injection device of FIG. 1; FIG.

FIG. 3 shows an enlarged detail from FIG. 2; FIG. 4 shows a longitudinal section through an arrangement of a guide sleeve and a coupling sleeve in the injection device of FIG. 1; Fig. 5A is a plan view of a ball bearing ring; Fig. 5B is a sectional view of the ball bearing ring in the plane A - A; Fig. 6 is a perspective view of a coupling sleeve; Fig. 7 is a longitudinal section through selected parts of the injection device of Figure 1; 8 is a perspective view of a bayonet sleeve; > fc t. UJ ₁ LUU / I

14

Fig. 9A is a plan view of a bayonet spring;

Fig. 9B is a side view of the bayonet spring of Fig. 9A;

Fig. 9C is a perspective view of the bayonet spring of Fig. 9A;

FIG. 10 shows a longitudinal section through selected parts of the injection device of FIG. 1; FIG.

11A is a longitudinal section through selected parts of the injection device of Figure 1 with a dose-limiting ring in its end position ..;

11B shows a longitudinal section through selected parts of the injection device of FIG. 1 with the dose-limiting ring in its initial position;

Fig. 12A is a perspective view of a coupling shaft with a dose limiting ring of the injection device of Fig. 1;

FIG. 12B shows the parts of FIG. 12A in an exploded view; FIG.

FIG. 12C shows the coupling shaft of FIG. 12A in a perspective view from another viewing direction; FIG.

Fig. 13 is an exploded view of a locking sleeve, a clutch spring and a support ring;

Fig. 14 is a perspective view of selected parts of the injection device of Fig. 1; FIG. 15 is an exploded perspective view of the proximal end of FIG

Injection device of Fig. 1;

Fig. 16 is a longitudinal section through the injection device of Fig. 1 in the

Starting position;

17 shows the longitudinal section of FIG. 16 after a first metering up to half the maximum dose; FIG.

FIG. 18 shows the longitudinal section of FIG. 16 after a first metering up to the full maximum dose; FIG.

FIG. 19 shows the longitudinal section of FIG. 16 after a first triggering and a second metering; FIG. FIG. 20 shows a longitudinal section through the injection device of FIG. 1 after complete emptying of the carpule; FIG. Fig. 21 is a longitudinal section through an injection device according to a second

Embodiment.

Detailed description of preferred embodiments

The basic structure and the basic operation of an injection device according to the invention will first be explained below with reference to FIGS. 1 and 2, before the construction of the device and the mode of operation of the metering mechanism are explained in detail with reference to FIGS. 3 to 20 for a first embodiment. A second embodiment will be discussed with reference to FIG. 21.

Basic structure and operation

1 shows an injection device in the form of an injection pen in an exploded perspective view. Fig. 2 shows the device in longitudinal section. The following description refers to the apparatus in the assembled state as shown in FIG.

The injection device has a housing sleeve 20, in which a mechanism for setting and pouring a dose is housed. The housing sleeve 20 is substantially circular cylindrical and thereby defines a longitudinal axis. A container holder in the form of a cartridge sleeve 30 is detachably fastened to a distal end of the housing sleeve 20 via a bayonet connection described in more detail below. This takes a container in the form of a carpule 40 with a liquid drug in which a plug 41 is slidably guided. This limits a drug reservoir R of variable volume within the carpule. Instead of a carpule, another container may be present whose volume is variable, for example a container with concertina-like folded walls in the manner of a bellows. Through a long Stretched viewing window 34 in the cartridge case 30, the contents of the carpule 40 can be controlled. At the distal end of the cartridge case 30, a needle holder 31 is screwed, which carries a hollow needle (cannula) 32 serving as an injection needle, the proximal end of which projects through a sealing septum into the medication reservoir R. A peelable needle shield 33 surrounds the forwardly projecting portion of the needle 32 and protects a user from accidental puncturing. A protective sleeve 10, whose distal end is permanently closed with a protective cap 50, is pushed over the cartridge sleeve 30. Inside the protective sleeve 10, a retaining ring 11 is mounted with locking arms 12 extending in the proximal direction. The ends of the latching arms 12 are releasably latched to the cartridge sleeve 30. While the invention is explained herein with reference to an injection device having a needle 32, it is also conceivable that the injection device has a plurality of needles or no needle as in a jet injector.

At the proximal end of the housing sleeve 20, a metering sleeve 60 is rotatably disposed therein with a push button 80. The dosing sleeve serves to set a dose to be dispensed from the medicament reservoir R and to tension a drive device with a drive element in the form of a diagrammatically indicated only, acting as a torsion coil spring 310. The set dose is displayed on a display drum 70 and can through a window 21 in the Housing sleeve 20 are read, which is covered by a transparent cover 22. Correcting (reducing) the set dose is possible in a simple manner by turning back the dosing sleeve 60. Below is explained in detail with reference to the other figures, as this setting is made possible.

With reference to these parts, the following directions can be defined, to which reference will be made in the following: The distal direction is the direction in which the administration takes place, ie it points along the longitudinal axis from the push button 80 in the direction of the hollow needle 32. The proximal direction is accordingly defined as the opposite direction. ned. If reference is made to a direction of rotation (clockwise, counterclockwise), this refers to the direction of rotation that is perceived when looking along the longitudinal axis in the distal direction.

After setting the dose, the hollow needle 32 is pierced through the skin of the patient, and it is triggered a dose distribution by the user presses the push button 80 into the dosing sleeve 60. By a mechanism described in detail below, a rotational movement is generated by the drive means, which is converted into a propulsion of a Förderele- element in the form of a feed sleeve 90 in the distal direction. The feed sleeve 90 pushes the stopper 41 of the medicament bobbin 40 by a set amount in the distal direction via a feed flange 100 arranged at its distal end, whereby the release of the medicament from the reservoir R is effected. The feed sleeve 90 thus acts as a piston rod for the piston formed by the feed flange 100 and the plug 41. After the end of the administration, the user releases the push button 80 again. The display drum is entrained during the advance of the feed sleeve 90 of the drive device such that it returns to its zero position in the course of the distribution. This means that the injection pen is immediately ready for the next dose setting.

If the drug in the drug reservoir R is running low, ie the feed sleeve 90 has almost completely extended, this is detected by a dose limiting device described in more detail below in the injection pen. The dose limiting device then only allows the user to set a maximum of the remaining available residual dose. During a subsequent change of carpule, the dose limiting device as well as the display drum 70 automatically return to the initial state. So no manual reset is required.

The structure and mode of operation of the mechanics are described in detail below. Structure of the mechanics

FIG. 3 shows an enlarged view of the rear (proximal) region of the injection device of FIG. 1. The structure of this region will now be described in detail essentially from the inside to the outside.

The feed sleeve 90 is in turn rotatably mounted in a rotatably and slidably disposed to the housing guide sleeve 110 and slidably mounted in the longitudinal direction. For this purpose, the feed sleeve 90 has at its proximal end a plurality of radially outwardly projecting guide cam 91, which are guided in complementary longitudinal grooves on the inside of the guide sleeve 110.

The guide sleeve 110 is particularly well visible in the Fig. 4, which illustrates the interaction of the guide sleeve with other parts. The guide sleeve 110 has at its distal end a radially outwardly projecting, circumferential annular flange 111 with radial bores 112. An annular bearing holder 130 is pushed from the proximal side over the guide sleeve 110, surrounds the annular flange 111 radially and is rigidly connected to the drawing via radial dowel pins.

A coupling sleeve 120 is rotatably supported between the annular flange 111 of the guide sleeve 110 and an inwardly projecting shoulder 132 of the bearing holder 130. As will be described in more detail below, the coupling sleeve 120 is connected via a threaded rod 180 with the feed sleeve 90 and therefore forms part of a conveyor, which is driven by a rotational movement and causes a feed of the conveying element in the form of the feed sleeve. The coupling sleeve 120 therefore absorbs considerable axial forces during operation, which are transmitted via their bearing to the guide sleeve 110, the bearing holder 130, the mechanism holder 150 and thus ultimately to the housing. In order to make storage as low-loss as possible, the storage takes place via ball bearings. For this purpose, a first ball bearing ring 140 is provided between the flange 111 of the guide sleeve and a radially circumferential flange 124 of the coupling sleeve 120. Another such ball bearing ring 140 is disposed between the flange 124 and an end face of the bearing holder 130.

The ball bearing ring 140 is shown in detail in FIGS. 5A and 5B. He carries a plurality of bearing balls 141 (here twelve pieces). These run, as can be seen in Fig. 3, in flat, circular grooves which are formed in both end faces of the radial flange 124 of the coupling sleeve 120, in the corresponding end face of the flange 111 of the guide sleeve 110 and in the end face of the bearing holder 130.

The coupling sleeve 120 is shown together with the ball bearing rings 140 (but without balls 141) in FIG. 6. As can be seen particularly well here, a plurality of longitudinal ribs 122 are formed on the cylindrical sleeve body 121, which extend over a considerable part of the length of the sleeve body in the longitudinal direction up to its proximal end. In between there are corresponding grooves. A thickening 123 is followed by the flange 124, which adjoins the ball bearing rings 140 on both sides.

In Fig. 7 it is shown how the unit of guide sleeve 110 and bearing holder 130 in a sleeve-shaped mechanism holder 150 rotationally fixed, but is held displaceable in the longitudinal direction.

The mechanism holder 150 has a distal portion 151 with an enlarged inner and outer diameter and a proximal portion 152 with a slightly smaller inner and outer diameter. These two sections are connected by a step 153. The outside of the distal portion 151 is held rigidly in the housing sleeve 20. Thus, the entire mechanism holder 150 is immovable relative to the housing, thus forming functional a part of the housing.

Adjacent to the step 153, at least two longitudinal slots 154 are formed in the mechanism holder 150. In the bearing holder 130 pins are used, which are not shown in Fig. 7. These protrude radially beyond the bearing holder 130 and into the longitudinal slots 154 of the mechanism holder. As a result, the bearing holder 130 and the guide sleeve 110 fixedly connected thereto are displaceably guided in the longitudinal direction between a distal and a proximal end position and secured against rotation in the mechanism holder 150. Towards the proximal end, an external thread 157 is formed on the outer lateral surface of the mechanism holder 150. On the inner surface a plurality of longitudinal grooves 158 are formed in this area.

In the distal direction, a bayonet sleeve 160 adjoins the guide sleeve 110 and the bearing holder 130, which is also shown in FIG. 8. It is held on the bearing holder 130 in the axial direction and rotatable relative thereto. With an inwardly projecting annular flange 161, it supports the unit of guide sleeve 110 and bearing holder 130 with the coupling sleeve 120 held therein in the distal direction. The bayonet sleeve 160 has two axially projecting in the distal direction and diametrically opposite arms 162 having radial openings 163. In these openings radially outwardly projecting pins are used, which run in two as slide guides (positive guides) acting guide slots 155 of the mechanism holder 150. These guide slots 155 are designed so that the bayonet sleeve 160 is forcibly displaced axially in the proximal direction during a rotation in the counterclockwise direction (in the sense of the definition given above, ie when viewed along the longitudinal axis in the distal direction). In this way, the unit of guide sleeve 110, bearing holder 130 and coupling sleeve 120 is displaced in the proximal direction. Conversely, upon rotation of the bayonet sleeve 160, this unit will move clockwise in the distal direction. Parallel to the guide slots 155 another pair of guide slots 156 extends around radial pins 36 of a locking area 35 of the cartridge case 30 to receive (see Figures 1 and 3). When inserting the cartridge case 30 into the housing, therefore, the cartridge tube is subject to a forced guidance, so that the cartridge case 30 performs a combined rotational movement and displacement. The cartridge sleeve 30 is designed so that it is coupled in its movement with the arms 162 of the bayonet sleeve 160 and the bayonet sleeve 160 entrains.

The guide slots 155 are of finite length and limit the movement of the bayonet sleeve between a distal and a proximal end position. In Fig. 7, the proximal end position is shown. In particular, the guide slots 155 allow the bayonet sleeve to rotate 90 degrees between these positions.

In order to releasably rotatably fix the bayonet sleeve in its two end positions relative to the guide sleeve 110 and thus to fix relative to the housing sleeve 20, a bayonet spring 170 is arranged between the bayonet sleeve 160 and the guide sleeve 110. This is shown in detail in FIGS. 9A to 9C. The bayonet spring 170 has a substantially flat and annular basic body 171 acting as a spring element. For this basic body protrude two diametrically opposite, axially flat projecting protrusions or projections 172 as locking elements or locking cams axially in the distal direction. Two diametrically opposite flat tongues 173 protrude inwards and come to lie in corresponding flat recesses of the guide sleeve 110. As a result, the bayonet spring 170 is held against rotation on the guide sleeve 110. As can be seen in Fig. 9B, the base body 171 is slightly bent about an axis perpendicular to the longitudinal axis in such a manner that the center of curvature is on the same side of the bayonet spring as the projections 172 (ie, distal). As a result, the bayonet spring 170 between the guide sleeve 110 and the bayonet sleeve 160 is permanently biased such that the projections 172 are pressed in the distal direction against the corresponding counter surface on the annular flange 161. In this counter surface four depressions are present, which are spaced at intervals of 90 Degree are arranged around the longitudinal axis. In the proximal end position, the projections 172 come to lie in a first pair of these recesses, while in the distal end position, in which the bayonet sleeve is rotated by 90 degrees, they are received in the second pair of recesses. As a result, there are two defined latching positions in which the bayonet sleeve 160 is releasably latched to the guide sleeve 110 via the bayonet spring 170 with the projections 172. In both positions, a certain force must first be overcome in order to move the bayonet sleeve again in the direction of the respective other end position. The recesses may be differently pronounced, for example, be different deep, so that in the two detent positions a different release force is required.

In one locking position, the cartridge sleeve 30 is held in a rotationally and non-displaceably manner on the guide sleeve 110 via its coupling with the bayonet sleeve 160 and thus ultimately on the housing. In the other detent position, the carpule sleeve 30 is released from the housing. The bayonet sleeve 160 is in turn locked in this position with the guide sleeve 110 and thereby fixed to the housing 20 rotationally and non-displaceably. In this way, it is ensured that the cartridge tube when inserted into the guide slots 156, the arms 162 of the bayonet sleeve again in the correct position about the longitudinal axis "finds" and then can take them after releasing the locking connection.

In the present example, the locking elements are formed as projections 172 integral with the spring element in the form of the base body 171. Instead, however, a separate locking element, for example in the form of a rigid ring with locking cams, can be provided, which is pressed by the spring element in the axial direction. Instead of projections, the latching element can also have depressions which then interact with corresponding projections of the counter-surface. In the present example, the locking element is rotationally fixed to the housing. Instead, it can also be rotationally fixed to the bayonet sleeve. The spring element can also be designed differently for generating an axial force. So there are multiple modifications of the lock shown here between the cartridge case 30 and the housing possible.

FIG. 10 shows the parts of the injection device shown in FIG. 7 together with further components. In particular, the feed sleeve 90 is now inserted into the guide sleeve 110. At its proximal end, the feed sleeve 90 has a short internal thread 92, in which a hollow external threaded rod 180 is guided. This is connected at its proximal end via a transverse pin 181 rigidly connected to the coupling sleeve 120. A feed of the feed sleeve 90 in the distal direction is thus carried out by the coupling sleeve 120, which is indeed rotatably mounted, performs a rotational movement. Because of the rigid connection between coupling sleeve 120 and external threaded rod 180, this rotational movement also causes rotation of the external threaded rod 180. The feed sleeve 90, with its internal thread 92, runs on the external threaded rod 180, similar to a nut. The feed sleeve 90 is rotationally fixed relative to the guide sleeve 110, since it runs over the guide cam 91 in longitudinal grooves on the inside of the guide sleeve 110. In this way, the feed sleeve 90 is axially advanced upon rotation of the externally threaded rod 180. Overall, therefore, a rotational movement of the coupling sleeve 120 is converted into an axial displacement of the feed sleeve 90.

As can be seen from Fig. 3, the feed sleeve 90 is supported in this feed movement by a long, loaded on pressure coil spring 190, which is arranged in the interior of the threaded rod 180 and guided on a guide needle 200. The coil spring 190 presses an annular thickening 201 near the distal end of the guide needle 200 in the distal direction against the feed flange 100. An axial pin 202 protrudes into a corresponding blind hole of the feed flange 100 and is rotatable in this blind hole.

Furthermore, in FIG. 10, a substantially cylindrical transmission sleeve 210 is inserted into the mechanism holder 150 from the proximal side. ben, which partially surrounds the coupling sleeve 120. The transmission sleeve 210 has a plurality of longitudinal ribs 212 on the outside. The outer diameter of the transmission sleeve 210 is chosen so that it is freely rotatable in the interior of the mechanism holder 150 despite their outer longitudinal ribs. On the inside, the transmission sleeve 210 has an internal thread 211, in which a dose-limiting ring 220 runs with a corresponding external thread 221. In the interior of the dose-limiting ring 220, particularly clearly visible longitudinal grooves 222 are present in FIGS. 12A and 12B, in which the longitudinal ribs 122 of the coupling sleeve 120 (see FIG. As a result, the dose limiting ring 220 is on the one hand displaceable in the axial direction on the coupling sleeve, on the other hand guided in the internal thread of the transmission sleeve 210. A rotation of the coupling sleeve 120 relative to the transmission sleeve 210 thus leads to a rotation and axial displacement of the dose limiting ring 220th

The axial displacement range of the dose limiting ring is limited in the distal and in the proximal direction. This will be explained with reference to FIGS. 11A, 11B, 12A and 12B.

In FIGS. 11A and 11B, a coupling shaft 230 is connected to the transmission sleeve 210. The coupling shaft has an axis 231 with a transverse bore 232 near the proximal end 233. From the distal end of the axle, a circumferential flange 234 extends radially outward. From this, an annular flange 235 in turn extends axially in the distal direction. The outer diameter of the flange 234 is greater than that of the annular flange 235, whereby the flange 234 projects radially beyond the annular flange 235 and forms a stop for the transmission sleeve 210. The annular flange 235 is inserted into the transmission sleeve 210, so that it rests with its proximal end on the flange 234. The annular flange is secured by radial pins in the transmission sleeve 210, which are inserted into bores 237. As a result, the coupling shaft 230 and the transmission sleeve 210 are connected to one another in a torque-proof and non-displaced manner. In the interior Surface of the annular flange 235 a plurality of longitudinal grooves 238 are formed.

Figures 12A and 12B show the coupling shaft 230 and the dose limiting ring 220 alone. At the dose-limiting ring 220, a radial stop 223 is formed, which cooperates with a corresponding radial stop 236 on the annular flange 235 of the coupling shaft. A radial stop is understood to mean a stop face whose surface normal points substantially in the tangential direction and which is designed to cooperate with a corresponding counter-face. The radial stop is thus stressed primarily in the tangential direction (ie in the direction of rotation) instead of in the axial direction. As a result, a radial stop avoids the risk of jamming, which occurs when two parts axially collide with one another via a screw connection, and which is particularly pronounced with a small pitch of the screw thread. The radial stop 236 here limits the screw movement of the dose-limiting ring 220 in the proximal direction. In FIG. 11A, the dose-limiting ring 220 is shown in the resulting proximal end position, whereas FIG. 11B is shown in a distal starting position.

In an inwardly facing, chamfered in the distal direction annular flange 213 at the distal end of the transmission sleeve 210, the proximal end of a locking sleeve 280 is rotatably clicked. For better clarity, the locking sleeve 280 is not shown in FIG. However, it is shown in FIG. 13. The locking sleeve includes an annular main body 281 from which four arms 282 extending in the distal direction extend in the distal direction. The main body has on its inner surface longitudinal grooves 284 which are interlocked with the longitudinal ribs 122 of the coupling sleeve 120. As a result, the locking sleeve 280 is displaceable in the longitudinal direction relative to the coupling sleeve 120, but secured against rotation. At the end of the arms 282, inwardly extending flange portions 283 are provided. The possible displacement range is limited in the proximal direction by these flange areas. These meet in the proximal end position the locking sleeve 280, as shown in FIG. 3, to the distal end of the longitudinal ribs 122 of the coupling sleeve 120 at. On the outer peripheral surface of the main body 281 longitudinal ribs are formed. These longitudinal ribs engage in the position of FIG. 3 in the inner longitudinal grooves 158 of the mechanism holder 150 a. As a result, the locking sleeve 280 is axially displaceable in this position relative to the mechanism holder 150, but secured against rotation. Ultimately, the locking sleeve 280 thus secures the coupling sleeve 120 against rotation in the mechanism holder 150 in this position. However, as will be explained below, the locking sleeve 280 is displaceable so far in the distal direction that it comes out of engagement with the mechanism holder 150 can and with respect to this then together with the coupling sleeve 120 is rotatable.

The locking sleeve 280 is biased by a coupling spring 290 in the proximal direction. The clutch spring is in the form of a pressure-loaded coil spring, which surrounds the arms 282 of the locking sleeve 280 and abuts with its proximal end on the distal end side of the main body 281. At the distal end of the clutch spring 290 this is held on a support ring 300 which abuts in the distal direction to the bearing holder 130 and on the inside of which longitudinal grooves are formed.

In FIG. 14, the unit of FIG. 10 is shown with yet further components. On the mechanism holder 150, the previously mentioned display drum 70 is now held. In addition, a stop sleeve 240 can be seen. As can be seen in FIG. 2, the stop sleeve 240 is immovably connected to the housing sleeve 20 by means of pins which project into the radial holes 242 which can be seen in FIG. 14. At its distal end radial stops 243 are formed. Its proximal end is serrated, i. There are teeth 244 frontally formed for a ratchet connection to be described.

The display drum 70 has an internal thread, which can be seen in FIG. This runs on the external thread 157 of the mechanism holder, which is particularly well recognizable in Figures 7 and 10. At its proximal end, the display drum 70 tapers to an annular portion 72. On the inside of the annular portion 72 longitudinal grooves are formed. With these longitudinal grooves, the display drum 70 is secured against rotation, but guided displaceably in the longitudinal direction on the longitudinal ribs 212 of the transmission sleeve 210. By combining this longitudinal guide on the transmission sleeve and the thread guide on the mechanism holder, a rotation of the transmission sleeve 210 results in a combined rotation and longitudinal displacement of the indicator drum 70. This movement is limited by radial engagement in both directions. At the proximal end, a radial stop cooperates with the radial stop 243 of the stop sleeve 240. At the distal end, a corresponding radial stop 73 cooperates with a radial stop 159 of the mechanism holder 150. As a result, the screw movement of the display drum 70 is limited in both directions by radial stops.

In the following, the mechanism for setting a dose and triggering the administration of this dose will now be explained with reference to FIGS. 3 and 15. At the proximal end of the housing sleeve 20, the already mentioned metering sleeve 60 is arranged. It is axially verschiebegesichert with a spring ring 61 and rotatably fixed to the stop sleeve 240. The dosing sleeve 60 is rotatable about the longitudinal axis of the housing sleeve 20 via a slip clutch in the form of a ratchet connection in both a clockwise and counterclockwise direction, wherein it can assume a plurality of predefined detent positions. This mechanism will be explained below.

Inside the dosing sleeve 60, an inner ring 250 is arranged and rigidly connected to the dosing sleeve 60. The inner ring 250 has a plurality of longitudinal grooves in its radial inner surface. In the distal direction of the inner ring 250, a ratchet ring 260 is held axially displaceably, but secured against rotation, in the dosing sleeve 60. The ratchet ring 260 is formed jagged on its distal end side, complementary to the teeth 244 of the serration. th proximal end face of the stop sleeve 240, so that teeth of the ratchet ring 260 can engage in recesses of the end face of the stop sleeve 240 and vice versa. The ratchet ring 260 is axially displaceable between the distal end surface of the inner ring 250 and the serrated proximal end face of the stop sleeve 240 by a certain amount. The amount by which an axial displacement is possible is at least so great that the serrated end faces of the ratchet ring 260 and the stop sleeve 240 can disengage. The ratchet ring 260 is resiliently urged against the stop sleeve 240 by a spring force. For this purpose, a plurality of axial bores 251 in the form of blind holes are provided in the inner ring 250. In at least one of these holes, preferably in at least two holes at a uniform distance along the circumference of the ring, pressure-loaded coil springs 252 are used. The coil springs 252 press the ratchet ring elastically against the stop sleeve.

In the rest position, the ratchet ring 260 with its serrated end face is in engagement with the serrated end face of the stop sleeve 240. As a result, the ratchet ring and the dosing sleeve 60 connected to it take one of several defined angular positions about the longitudinal axis. Upon rotation of the metering sleeve 60 relative to the housing sleeve 20, the teeth of the ratchet ring 260 and the stop sleeve 240 slide against each other against the axial spring force of the coil springs 252 until they disengage and engage again in the next defined angular position. In this way, a latching connection which can be released resiliently by turning with a sufficient torque is produced in a plurality of predefined angular positions of the metering sleeve 60 relative to the housing sleeve 20. This mechanism can also be referred to as a double-slip clutch.

By turning the metering sleeve 60 clockwise, the coil spring 310 can be stretched, which is indicated in Fig. 3. The coil spring 310 has a

A plurality of spring coils, which rotate around the longitudinal axis and are arranged radially to the longitudinal axis one above the other. The inner end of the spiral the 310 is fastened to a spring holding region 311 of the coupling shaft 230, which is particularly clearly visible in FIG. 12C. The outer end of the coil spring 310 is attached to a spring sleeve 320, which is rotatably held in the stop sleeve 240.

On the coupling shaft 230, a clutch plate 270 is mounted and secured by a pin 271 in the transverse bore 232 of the coupling shaft 230 against rotation and displacement. The clutch disc 270 has a plurality of longitudinal ribs on its outer peripheral surface. In the position of Fig. 3, these longitudinal ribs engage in the complementary longitudinal grooves on the inside of the inner ring 250, but can be brought out of engagement by an axial displacement.

The metering sleeve 60 has an axial passage opening, in which the push button 80 is arranged axially displaceable. The push button 80 is with a plurality of radially resilient arms 81 rotatably and non-displaced clicked on the proximal end 233 of the coupling shaft 230. He pushes with its distal end against a proximal end face of the clutch disc 270. Inside the push button 80 is a coil spring 82, which abuts with its proximal end to the inner end face of the push button and presses with its distal end against a support ring 83. The support ring 83 has on its outer peripheral surface longitudinal ribs which are guided in corresponding longitudinal grooves in the inner Mantelfäche the push button 80. As a result, the support ring 83 in the push button 80 rotatably and axially displaceable. At its distal end face of the support ring 83 is formed flat jagged. The proximal end face of the clutch disc 270 is designed to be jagged in a complementary manner, so that the support ring 83 is axially toothed with the clutch disc 270. When dispensing the drug, the clutch disc 270 rotates relative to the support ring 83. The serrated surfaces slide on each other, so that the teeth alternately into and out of engagement. This produces a distinctive click sound that indicates to the user that a takes place. The toothing of the support ring 83 and the clutch disc 270 is preferably designed such that each click corresponds to just one unit (or a predetermined multiple of a unit) of the administered medicament.

seal

The entire mechanism for setting the dose and the distribution is splash-proof housed in the housing sleeve 20. For this purpose there are four seals D1, D2, D3 and D4 in total. The seal D1 comprises a sealing ring, which bears sealingly between the mechanism holder 150 and the bayonet sleeve 160. The mechanism holder 150 is immovable and tightly mounted in the housing 2, while the bayonet sleeve 160 relative to the mechanism holder 160 is both displaceable and rotatable and is sealed via the seal D1 relative to the housing. The seal D2 comprises a further, here flat-shaped sealing ring which bears sealingly between the bayonet sleeve 160 and the smooth outer side of the feed sleeve 90. Furthermore, the feed flange 100 is arranged tightly on the feed sleeve 90. In this way, the region of the injection device located proximally from the bayonet sleeve 160, including the interior of the advancing sleeve 90, is completely sealed against the area lying distally therefrom. If fluids should enter this distal area, e.g. because of a fracture of the drug bundle 40, they can not penetrate into the difficult mechanics and pollute or stick them.

The other two seals are located at the proximal end of the injection device. The seal D3 comprises a sealing ring which bears sealingly between the dosing sleeve 60 and the stop sleeve 240. The stop sleeve 240 is immovable and tightly mounted in the housing sleeve 20, while the dosing sleeve 60 against the stop sleeve 240 is rotatable. The seal D4 comprises a further sealing ring, which rests sealingly between the dosing sleeve 60 and the push button 80. In addition, on the window 21, a transparent te window cover 22 attached liquid-tight. As a result, the entire mechanism, which is limited to the outside through the housing sleeve 20, the metering sleeve 60 and the push button 80, also completely sealed to the outside and so completely protected against the ingress of liquids. Even a rain shower or accidentally overturned by the user glass of water can therefore not harm the injection device.

In particular, the seal to the feed sleeve out is preferably designed such that it acts as a scraper, similar to a windscreen wiper in the car. For this purpose, at least to the distal side preferably a smallest possible contact angle between the surfaces of the sealing element and the feed sleeve. This can be below 90 degrees.

Instead of conventional seals or in addition thereto, the parts to be sealed against one another can have a hydrophobic surface, in particular be formed from or coated with a hydrophobic material. A hydrophobic surface prevents the parts from being wetted. As a result, water droplets emit water and creep of liquids through gaps between the parts to be sealed due to capillary effect is effectively prevented. The provided with a hydrophobic surface, against each other to be sealed parts can therefore be arranged at a certain distance (gap) to each other without the sealing effect is lost ("virtual seal").

A hydrophobic surface is understood here to mean a surface for which the contact angle of a water droplet is at least 90 degrees, preferably at least 110 degrees. The contact angle is the angle between the surface normals of the water droplet and the respective surface at the contact point. Examples of materials having hydrophobic properties are PTFE (polytetrafluoroethylene) or PVDF (polyvinylidene fluoride). Many other materials, especially for thin coatings in the range of a few micrometers, are known. In experiments, various pins and a sleeve were nanotechnologically provided with a hydrophobic coating. 20 pins with outside diameters of 10.0 to 11.9 mm were examined in increments of 0.1 mm. The pins were placed centrally in a sleeve with 12 mm inner diameter, which corresponds to gap thicknesses of 0.05 mm to 1.0 mm in increments of 0.05 mm. The interior of the sleeve was then charged with water. A sealing effect was observed up to a gap thickness of about 0.5 mm.

With mutual rotation between pin and sleeve, a sealing effect was observed up to a gap thickness of about 0.25 mm.

To improve the sealing effect, the surfaces may be micro- or nanostructured, i. be provided with structures whose dimensions are in the nanometer to micrometer range. These structures may have a preferred direction to inhibit the flow of liquids on the surface in one direction. Thus, e.g. Shed be provided.

clutches

In the following, the mode of operation of the injection device will now be explained. Reference is first made to FIG. 16, in which the injection device is shown in its initial position before the first use. The above-explained mechanism for setting and dispensing a dose has three clutches K1, K2, and K3 for the transmission of torques. Each of these couplings can be brought into and out of engagement with each other by an axial movement of two components.

The coupling K1 is formed by the longitudinal grooves on the inner surface of the axial flange 235 of the coupling shaft 230 as a coupling input member in cooperation with the longitudinal ribs 122 on the outside of the coupling sleeve 120 (see Fig. 5) as a coupling output member. In the position of FIG. 16, this coupling is disengaged, ie the teeth formed by the longitudinal grooves and longitudinal ribs is disengaged. The coupling K1 can be coupled by an axial displacement of the coupling shaft 230 in the distal direction.

The coupling K2 is formed by the longitudinal grooves in the radial inner surface of the inner ring 250 as a coupling input member in cooperation with the longitudinal ribs on the radial outer surface of the clutch disc 270 as a coupling output member. In the position of Fig. 16, this coupling is coupled, i. the teeth formed by the longitudinal grooves and longitudinal ribs is engaged. The clutch K2 can be disengaged by an axial displacement of the clutch disc 270 in the distal direction.

The coupling K3 is formed by the longitudinal ribs on the outside of the outer annular flange 282 of the locking sleeve 280 as a coupling input member in cooperation with the longitudinal grooves 158 on the inner surface of the mechanism holder 150 as a coupling output member. In the position of FIG. 13, this coupling is engaged. It can be disengaged by an axial displacement of the locking sleeve 280 in the distal direction.

All three clutches K1, K2 and K3 can be engaged or disengaged by the push button 80 is moved far enough axially. Thereby a certain order is kept. When pressing the push button 80, the clutch disc 270 and the coupling shaft 230 fixedly connected to it are displaced in the distal direction. Initially, the clutch K1 comes into engagement, ie the clutch shaft is coupled to the coupling sleeve 120 for torque transmission. At the same time, the coupling shaft 230 advances the transmission sleeve 210 in the distal direction. This takes the locking sleeve 280 in the distal direction, whereby the clutch spring 290 is compressed. When the clutch K1 first engages, the locking sleeve 280 has not advanced sufficiently far to disengage from the mechanism holder 250 with its outer annular flange 282. The coupling K3 is thus initially still engaged. The same applies to the clutch K2: The clutch disc 270 is initially still in engagement with the inner ring 250. First, so now all three clutches are engaged. When the push button 80 is further inserted, next the clutch K2 disengaged. In a further further insertion, finally, the clutch K3 also disengaged. So it follows the following order:

• Initial state: K1 disengaged, K2 and K3 engaged.

• Pressing the push button 80: K1 engages, then K2 disengages, then K3 disengages.

FIG. 19, which will be described in more detail later, shows the injection device when the push-button 80 is fully depressed. The clutch K1 is now engaged while the clutches K2 and K3 are disengaged.

When the push button 80 is released, the engagement of the clutches takes place in the reverse order. In this case, the clutch spring 290 pushes the locking sleeve 280, the transmission sleeve 210, the clutch shaft 230, the clutch disc 270 and the push button 80 back into the distal starting position.

The couplings K1, K2 and K3 and the ratchet connection allow the targeted transmission of torque between five functionally independent units. A first unit is formed by the housing sleeve 20, the mechanism holder 150, the stop sleeve 240 and the spring ring 320. This unit may be functionally interpreted as a holding device or a housing in an expanded sense. It represents the stationary reference system for all movements.

A second unit is formed by the metering sleeve 60, the inner ring 250 and the ratcheting ring 260. It can be functionally understood as a rotatable metering device. This metering device is via the ratchet connection solvable on the housing, but held torque-resistant up to a certain value.

A third unit is formed by the clutch disc 270, the clutch shaft 230 and the transmission sleeve 210, which are all rigidly connected to each other, and by the associated coil spring 310, which acts as the actual drive element. This unit can be understood as a drive device. The rotational movement of the drive device is limited by two limiting elements, both of which are guided on the transmission device. The first limiting element is formed by the display drum 70, which limits the range of movement of the drive device in both directions, a metering direction and a correction and Ausschüttrichtung. The second limiting element is formed by the dose-limiting ring 220, which limits the range of movement of the drive device at least in one direction, the metering direction, independently of the first limiting element. The drive device can be releasably coupled by means of the clutch K2 in a rotationally fixed manner to the metering device, which makes it possible to tension the drive element in the form of the spiral spring 310.

A fourth unit comprises the coupling sleeve 120 and the threaded rod 180, which form a rigid unit, the elements on which these parts are mounted, namely the guide sleeve 110, the bearing holder 130 and the ball bearing rings 140, and the feed sleeve 90. This unit provides a Conveyor, which converts a rotational movement of an input member in the form of the coupling sleeve 120 in a feed of the conveying element in the form of the feed sleeve 90. Your input member is releasably rotatably coupled by the clutch K1 with the drive device. In addition, it is releasably rotatably coupled to the holding device (i.e., the housing) via the clutch K3.

Furthermore, a triggering device is present, which primarily comprises the push button 80 and serves to operate the clutches K1 to K3. functionality

The injection device is operated as follows. Starting from the starting position of FIG. 16, a dose to be administered is initially set. For this purpose, the dosing sleeve 60 is rotated clockwise. The dosing sleeve takes over the clutch K2 the clutch disc 270 and the clutch shaft 230 with. As a result, the coil spring 310 is wound up. The resulting torque is maintained by the ratchet connection between the co-rotating ratchet ring 260 and the stationary stop sleeve 240. By the rotation of the coupling shaft 230 and the transmission sleeve 210 and the display drum 70 guided thereon are also rotated. The display drum 70 is also displaced axially in the proximal direction because of their thread guide on the mechanism holder 150, thus performs a total of a screw movement in the proximal direction. As a result, marks on the surface of the display drum 70 pass under the window 21 and indicate the currently set dose. Furthermore, due to its threaded engagement with the interior of the transmission sleeve 210 and due to its rotationally secured arrangement on the coupling sleeve 120, the dose limiting ring 220 is displaced in the proximal direction.

Fig. 17 shows the injection device after half the maximum single dose has been set. The display drum has moved halfway between its distal and proximal end positions to the rear. In addition, the dose limiting ring 220 has moved in the proximal direction by an amount proportional to the set single dose.

The rotation of the metering sleeve 60 in the clockwise direction is limited on the one hand by the maximum range of movement of the display drum 70, on the other hand by the maximum range of movement of the dose limiting ring 220. The display drum 70 abuts after a predetermined number of revolutions of the metering sleeve 60 with its proximal radial stop against the stop sleeve 240, unless the rotation of the metering sleeve 60 has not previously by the Dose limiting ring 220 has been limited, as described in more detail below. As a result, further rotation of the dosing sleeve 60 is no longer possible. This position corresponds to the maximum adjustable single dose. This situation is shown in FIG.

If the set dose is corrected, ie reduced, the dosing sleeve 60 can be turned counterclockwise against the force of the ratchet connection. Since the ratchet in this direction also has to absorb the torque of the coil spring 310, the ratchet connection is designed asymmetrically: The frontal toothing has on the side which is loaded by a torque acting counterclockwise on the dosing, a larger pitch angle on than on the side which is loaded at a torque in a clockwise direction (see the configuration of the teeth 244 in Fig. 14). In this case, the absolute angle of the angle between the respective flank of a tooth on the end face of the ratchet ring 260 or on the end face of the stop sleeve 240 and a cross-sectional area through the injector is understood as the pitch angle.

The distribution of the dose thus set takes place by pressing the push button 80. As a result, first the clutch K1 is engaged. This creates a rotationally fixed connection between the coupling shaft 230 on the one hand and the coupling sleeve 120 and the threaded rod 180 rigidly connected thereto on the other. Now all three clutches K1, K2 and K3 are engaged. Upon further depression of the pushbutton 80, the clutch K2 disengages. As a result, the rotationally fixed connection between the metering sleeve 60 on the one hand and the coupling shaft 230 with the coupling sleeve 120 now coupled and threaded rod 180 on the other hand is canceled. This causes the ratchet connection no longer absorbs the torque of the coil spring 310. The system is still rotatably held on the clutch K3 in the mechanism holder 150 and thus in the housing sleeve 20. When the push button 80 is pressed further still, the clutch K3 also disengages. At this moment, the torque of the coil spring 310 is free and acts on the threaded rod 190 via the coupling shaft 230 and the coupling sleeve 120. As a result, these parts are rotated in a counterclockwise direction. Through its threaded engagement with the threaded rod 190, the feed sleeve 90 undergoes an axial displacement in the distal direction. About the feed flange 100, the feed sleeve pushes the plug 41 in the carpule 40 before. In this way, the drug is released.

During dispensing, significant axial forces are applied to the advancement sleeve 90: The torque of the coil spring 310 is converted to a force in the advancing direction that drives the plug 41 in the carpule 40. These forces are absorbed by the ball bearings between the coupling sleeve 120 on the one hand and the guide sleeve 110 and the bearing holder 130 on the other hand friction, so that frictional opposing forces that could reduce the driving torque can be minimized.

During dispensing, the display drum 70 is again entrained counterclockwise by the rotation of the transfer sleeve 210, and is thereby again distally moved because of its threaded engagement with the stationary mechanism holder 150 until it resumes its distal home position. In this position, it is prevented by a radial stop on further rotation, whereby the distribution is terminated. After the end of the distribution, the display drum again displays the dose "zero".

The payout can be interrupted at any time by the push button 80 is released. As a result, the clutches K3 and K2 engage again, and the clutch K1 disengages again. The display drum 70 indicates the remaining remaining dose that is still being dispensed when the push button is pressed again, thereby continuing the dispensing.

The dose-limiting ring 220 maintains its axial position during dispensing, as the transmission sleeve 210 and the coupling sleeve 120, between which the dose-limiting ring 220 is located, rotate synchronously. After the end of the distribution, the injection device is ready for the next injection process. Compared to FIG. 16, however, two components have changed their position: on the one hand, the feed sleeve 90 has migrated in the distal direction in accordance with the distributed dose. On the other hand, the dose-limiting ring 220 has also migrated by a proportional amount in the proximal direction. Apart from this, the state after the end of the injection corresponds to the initial state of FIG. 16. Thus, with each further injection, the advancement sleeve 90 moves further in the distal direction, while the dose-limiting ring 220 moves in the proximal direction. This is illustrated in FIG. 19, which depicts the injection device after initially administering a first dose which corresponds to half the maximum single dose, and then again setting a dose with the dosing sleeve which in turn corresponds to half the maximum individual dose. The display drum now shows again, as in FIG. 15, half the maximum single dose, while the dose-limiting ring 220 now occupies a position in the transmission sleeve 210, which corresponds to the sum of the previously set doses, in this case twice the maximum single dose.

The maximum axial travel by which the dose-limiting ring 220 can travel in the proximal direction in the transfer sleeve corresponds to the contents of a completely filled carpule. As soon as the sum of the set doses on the dosing sleeve corresponds to the carpule contents, the dose-limiting ring 220 reaches its proximal end position and abuts with its radial stop on the axial annular flange 235 of the coupling shaft 230, as shown in FIG. 12A. As a result, the metering sleeve 60 is prevented from further rotating in a clockwise direction. It can therefore be set no larger dose than the dose corresponding to the remaining amount of the drug in the carpule. Fig. 20 shows this situation, in which no more metering is possible, although the display drum is in the distal starting position, ie the zero position. Accordingly, the feed sleeve 90 has reached its distal end position, so it is maximally extended. ren.

Karpulenwechsel

To replace the carpule, the cartridge sleeve 30 is released against the elastic resistance of the bayonet spring 170 from the mechanism holder 150 and out through the corresponding guide slot 156 in the mechanism holder out. As a result, the bayonet sleeve 160 is forcibly also twisted along its own, parallel guide slot 155 and simultaneously displaced in the distal direction. As a result, the guide sleeve 110 is pulled in the distal direction. As a result, all the axially associated moving parts, in particular the coupling sleeve 120, the threaded rod 190, the locking sleeve 280, the transmission sleeve 210, the coupling shaft 230, the clutch disc 270 and the push button 80 also migrate in the distal direction. In particular, the push button 80 is thus drawn into the dosing sleeve 60 and thus indicates that the injection device is not ready for operation.

By this axial displacement of the various parts of the mechanism, the clutches K2 and K3 come out of engagement, while K1 was already out of engagement. Should a dose have been discontinued but not administered prior to the cartridge replacement, the correspondingly wound coil spring 310 now rotates the clutch shaft 230 and the associated transfer sleeve 210 counterclockwise until the display drum 70 has reached its distal end position and through its Radial stop on the mechanism holder 150 prevents further turning back. In this way, the display drum 70 is returned to its distal home position, the zero position. So there is an automatic reset of the dose display to zero.

If there was still a residual amount of the drug in the carpule 40 before the carpule change, then the feed sleeve 90 was not yet maximally extended before the cartridge change, so had not yet their reached distal end position. When removing the carpule sleeve 30, the coil spring 190 now presses the guide needle 200, the feed flange 100 and the feed sleeve 90 in the distal direction. As a result, the threaded rod 180 is rotated via its screw connection with the interior of the feed sleeve 90 in rotation. In this case, the threaded rod 180 takes in particular the coupling sleeve 120 and the dose-limiting ring 220. The dose limiting ring 220 is displaced in this rotation by its threaded engagement with the transmission sleeve 210 in its proximal end position. Once the dose limiting ring 220 has reached this starting position, it prevents further rotation of the coupling sleeve 120 and the threaded rod 180, so that no further extension of the feed sleeve 90 is possible. The feed sleeve 90 has now reached its distal end position. This situation is shown in FIG. Overall, so now is the display drum 70 in the neutral position, the dose limiting ring 220 in the proximal end position and the feed sleeve 90 in its distal end position.

Now, a new carpule 40 is inserted into the cartridge case 30, and the cartridge case 30 with the carpule 40 received therein is axially guided in the proximal direction against the housing sleeve 20. Initially, the plug 41 of the carpule presses the feed flange 100 and the feed sleeve 90 against the force of the coil spring 190 in the proximal direction. As a result, in turn, the threaded rod 180 is rotated. The threaded rod again takes the coupling sleeve 120 and the dose limiting ring 220 with. Thereby, the dose limiting ring is moved in the distal direction, ie in the direction of its initial position due to its threaded engagement with the transmission sleeve 210. The amount by which it is displaced in this direction corresponds to the dose present in the carpule 40. For a fully filled carpule, the dose-limiting ring 220 migrates to its distal starting position. The cartridge sleeve 30 is then inserted into the mechanism holder 150, with the radial pins 36 of the cartridge sleeve 30 again engaging in the guide slots 156 in the mechanism holder 150 (compare FIGS. 1 and 3). Due to the positive guidance of the cartridge case 30 when inserting into the mechanism holder 150, in turn, the bayonet sleeve 160 is forced to follow the movement of the cartridge case 30 in the corresponding guide slots. The bayonet sleeve 160 is thereby returned to its proximal end position, in which it is releasably locked by the bayonet disc 170 (see Figures 8 to 10). The injection device is now back in the starting position of Fig. 16 and is available after screwing a new needle holder 31 for a new sequence of administrations available.

Second embodiment

FIG. 21 shows as a variant a second embodiment of the injection device according to the invention. The operation is substantially the same as in the first embodiment. Like-acting parts are therefore designated by the same reference numerals as in the first embodiment. In the following, only the essential differences will be discussed.

In the second embodiment, the stop sleeve 240 omitted. Their function is taken over by the correspondingly elongated housing sleeve 20.

The drive device, which is formed in the first embodiment, apart from the coil spring 310, from the clutch disc 270, clutch shaft 230 and transmission sleeve 210 is here formed by other parts, namely by a connecting shaft 400 (with thereon integrally formed clutch disc 401) , a first transmission sleeve 410 closed at the proximal end and a second transmission sleeve 420 adjoining thereto distally. These three parts are in turn rigidly connected to one another.

While in the first embodiment the display drum served not only to indicate the set dose, but also to limit the maximum adjustable single dose in the dosing direction and to limit the movement in the dispensing direction, the latter function is used in the second embodiment. tion form taken over by a second dose limiting ring 430. This is rotatably, but axially displaceably guided in the housing sleeve 20. With an internal thread, it runs on a corresponding external thread of the first transmission sleeve 410. Its axial movement is limited by two radial stops between a distal starting position, which corresponds to the zero position, and a proximal end position, which corresponds to the maximum adjustable dose. In this way, it takes over the stop functions of the display drum according to the first embodiment.

The display drum 70 is guided in the second embodiment via a rigidly connected to it driving sleeve 440 axially and rotatably on the second transmission sleeve 420. Their operation is otherwise the same as in the first embodiment.

Apart from these differences, structure and operation of the injection device are substantially the same as in the first embodiment.

Other variants

The differences between the first and the second embodiment show that the functions of the injection device according to the invention can be achieved in many ways and the invention is in no way limited to the exemplary embodiments presented above. Various other modifications are possible. These may be due in particular to production-technical requirements.

LIST OF REFERENCE NUMBERS

R drug reservoir D1 seal

D2 seal

D3 seal D4 seal

K1 first clutch

K2 second clutch

K3 third clutch

10 protective sleeve

11 retaining ring

12 detent arm

20 housing sleeve

21 windows

22 window cover

30 cartridge case

31 needle holder

32 hollow needle

33 Needle protection cover

34 viewing window

35 locking area

36 cones

40 carpule

41 plugs

50 protective cap

60 dosing sleeve

61 spring washer

70 display drum

72 annular area

73 Radial stop

80 push button

81 arm

82 coil spring

83 support ring

90 feed sleeve

91 guide cams

92 internal thread 100 feed flange

110 guide sleeve

111 flange

112 bore

120 coupling sleeve

121 sleeve body

122 longitudinal rib

123 thickening

124 flange

130 storage holders

132 shoulder

140 ball bearing ring

141 Bearing ball

150 mechanism holder

151 distal section

152 proximal section

153 level

154 longitudinal slot

155 guide slot

156 guide slot

157 external thread

158 longitudinal groove

159 radial stop

160 bayonet sleeve

161 ring flange

162 arm

163 opening

170 bayonet spring

171 basic body

172 lead

173 tongue

180 external threaded rod 181 cross bolts

190 coil spring

200 guide needle

201 thickening

202 cones

210 transmission sleeve

211 female thread

212 longitudinal rib

213 ring flange

220 dose limiting ring

221 external thread

222 longitudinal groove

223 radial stop

230 coupling shaft

231 axis

232 cross bore

233 proximal end

234 flange

235 ring flange

236 Radial stop

237 bore

238 longitudinal groove

240 stop sleeve

242 hole

243 radial stop

244 tooth

250 inner ring

251 bore

252 coil spring

260 ratchet ring

270 clutch disc

271 pen 280 locking sleeve

281 main body

282 arm

283 Flange area 284 Longitudinal groove

290 clutch spring

300 support ring

310 spiral spring

311 spring holding area 320 spring sleeve

400 connecting shaft

401 clutch disc

410 first transmission sleeve

420 second transmission sleeve 430 second dose limiting ring

440 driving sleeve

Claims

claims

A device for administering a fluid product, comprising a housing (20) and a conveying element (90) for conveying the product from a reservoir (40), wherein the conveying element (90) from the

Inside the housing outwardly extends and relative to the housing (20) is movable, characterized in that the conveying element (90) relative to the housing (20) is guided liquid-tight.

2. Device according to claim 1, wherein the conveying element (90) along a feed axis between a proximal starting position and a distal end position is movable and has a substantially smooth, cylindrical outer wall portion whose length at least the distance between the distal end position and the proximal Starting position corresponds, and wherein the cylindrical outer wall portion of at least one annular sealing element (D2) is surrounded.

3. Device according to claim 2, wherein the at least one annular sealing element comprises at least one circumferential sealing lip, which rests on the cylindrical outer wall region.

4. Device according to one of claims 1 to 3, wherein the conveying element (90) is guided rotatably relative to the housing.

5. Device according to one of claims 1 to 4, which comprises a drive means (310) for generating a rotational movement relative to the housing (20), wherein the rotational movement causes a feed movement of the conveying element (90) along a feed axis.

6. Apparatus according to claim 5, wherein the conveying element (90) has an internal thread whose threaded axis along the feed axis extends, and wherein the device comprises a threaded member (180) having an external thread, which is in engagement with the internal thread.

7. Device according to claim 6, wherein the threaded element (180) is fixable relative to the housing (20) along the feed axis and by the drive means (310) in a rotational movement about the feed axis displaceable to advance the conveyor element (90) along the feed axis.

8. Device according to one of the preceding claims, wherein the interior of the housing (20) is sealed completely liquid-tight relative to the exterior of the housing (20).

9. Device according to one of the preceding claims, wherein the conveying element (90) and / or a sealingly cooperating with this element consists of a hydrophobic material or is hydrophobic coated.

10. Device according to one of the preceding claims, wherein the conveying element (90) and / or a sealingly cooperating with this element to improve the sealing effect on a surface is micro- or nanostructured.

11. Device according to one of the preceding claims, wherein at least a first seal (D2) between the conveying element (90) and a housing movable member (160) is formed, and at least one second seal (D1) between the movable member (160 ) and the housing (20) or a housing-fixed element (150) is formed.

12. Device according to claim 11, wherein the movable element (160) is movable only with a change of the reservoir (40) and during the administration is immovable relative to the housing (20).