WO2003070303A2

WO2003070303A2 - Needle insertion device having a transversely moving retaining element

Info

Publication number: WO2003070303A2
Application number: PCT/CH2003/000041
Authority: WO
Inventors: Beat Steffen; Stefan Jost; Rainer Ponzer; Markus Tschirren
Original assignee: Tecpharma Licensing Ag
Priority date: 2002-02-21
Filing date: 2003-01-21
Publication date: 2003-08-28
Also published as: AU2003201258A1; WO2003070303A8; DE10207276A1; WO2003070303A3

Abstract

The invention relates to a needle insertion device for an implement (1) provided for administering an injectable product. The administering implement (1) comprises a product reservoir and a penetrating needle (3) that is connected to the reservoir. The needle insertion device comprises: a) a needle protective sleeve (5), and; b) a retaining sleeve (10/15), which is joined to the needle protective sleeve (5), can move in relation to said needle protective sleeve (5) along a common longitudinal axis (L) while being displaced in an advancing direction, and into which the administering implement (1) can be inserted in such a manner that the penetrating needle (3) projects beyond the retaining sleeve (10/15) in the advancing direction; c) whereby the retaining sleeve (10/15) comprises at least one retaining element (16) that, by effecting a retaining engagement that can be released, prevents an inserted administering implement (1) from axially moving in relation to the retaining sleeve (10/15). The invention is characterized in that; d) the retaining element (16) can transversely move in relation to the longitudinal axis (L) whereby being able to effect and release the retaining engagement.

Description

Needle insertion device with a transversely movable holding element

The invention relates to a needle insertion device for a device for dispensing an injectable product. The device is preferably an injection device. The needle insertion device is used for insertion, i.e. the insertion of a needle into a tissue. The preferred application is administration to humans, particularly preferably subcutaneous or intramuscular administration. The delivery of the product to animals or plant tissue should not be excluded.

Needle insertion devices are known, for example, from US Pat. No. 5,282,793 and US Pat. No. 5,980,491. In the known insertion devices, a delivery device, for example a simple syringe or an injection pen, is inserted into the sleeve-shaped insertion device. In the inserted state, the dispenser protrudes through an inner holding sleeve, which holds the dispenser axially immovable. The injection needle of the dispenser protrudes beyond a front end of the holding sleeve. The holding sleeve is received and guided so that it can move axially back and forth in an outer sleeve. In an initial position of the insertion device, the outer sleeve surrounds the injection needle up to at least its tip and at least over part of its circumference. In this position, the outer sleeve and the holding sleeve are blocked relative to each other. A compression spring is arranged between the two sleeves and is tensioned in the locked position of the sleeves. If the blockage is released and the compression spring is thereby triggered, it presses the holding sleeve in a forward direction relative to the outer sleeve, so that the injection needle is advanced beyond the foremost end of the outer sleeve in order to penetrate a tissue. In the insertion device of US Pat. No. 5,980,491, the delivery device is screwed into the holding sleeve. The insertion and removal of the dispenser is therefore lengthy. In addition, both the holding sleeve and the dispenser must each be threaded. According to US Pat. No. 5,282,793, the dispenser is inserted into the holding sleeve until it is firmly seated in the holding sleeve. The user therefore has to pull the dispenser with some force to remove the tight fit again.

Furthermore, the handling of the insertion devices is not optimal with regard to the triggering of the advancing movement of the holding sleeve and delivery device during the needle insertion.

It is therefore an object of the invention to provide a needle insertion device that is easier to handle. In particular, the dispenser should be easily separable from the needle insertion device.

The invention relates to a needle insertion device for a device for dispensing an injectable product. The delivery device can in particular be an injection device, for example a simple syringe or, more preferably, a so-called injection pen. Injection pens are known from human medicine in many applications, for example from the administration of growth hormones and from diabetes therapy for the administration of insulin. Growth hormones and insulin are preferred examples of an injectable product. The insertion device is particularly suitable for self-administration of injectable products, i.e. in uses where a user is self-administering the product. This type of product delivery is common in the administration of insulin and the administration of growth hormones, but also in other applications.

The needle insertion device comprises a needle protection sleeve and a holding sleeve which are mechanically connected to one another in such a way that the holding sleeve is relative to the needle protection sleeve along a common longitudinal axis Driving direction is movable. The holding sleeve serves to receive the dispensing device and is shaped such that the dispensing device can be inserted into the holding sleeve and is held in the holding sleeve in a predetermined position relative to the holding sleeve. The dispensing device can preferably be inserted into the holding sleeve along the longitudinal axis, the dispensing device preferably being inserted into the holding sleeve from behind, with the injection needle first. The dispensing device is received and held in the holding sleeve in such a way that the injection needle protrudes over a front end of the holding sleeve in the direction of advance. The holding sleeve has at least one holding element for holding the dispensing device. The holding element can be a separate part that is axially non-movably connected to the holding sleeve. More preferably, however, the holding sleeve itself forms the at least one holding element directly in one piece. The holding element is designed such that it holds the dispensing device in a releasable holding engagement in a predetermined axial position relative to the holding sleeve - and thereby also relative to the needle guard sleeve. The holding engagement prevents an axial movement of the dispensing device relative to the holding sleeve against the direction of advance and preferably also in the direction of advance.

The holding sleeve can be moved along the longitudinal axis relative to the needle guard sleeve from a starting position to a front position and preferably from the front position to the starting position. In the starting position, a needle tip of the injection needle is behind a front end of the needle guard sleeve or at least does not protrude beyond the needle guard sleeve. The needle protection sleeve preferably completely surrounds the injection needle and, apart from a front opening for the injection needle, preferably offers complete needle protection. In principle, however, it would also be conceivable that the needle guard sleeve partially surrounds the injection needle protruding from the front end of the dispensing device, as is described, for example, in US Pat. No. 5,980,491. According to the invention, the holding element is movable transversely to the longitudinal axis in such a way that it is moved transversely to the longitudinal axis out of the holding engagement. Of course, the movement takes place relative to the dispensing device if such is received and held in the holding sleeve. Furthermore, this transverse movement takes place relative to the needle guard sleeve and preferably also relative to a section of the holding sleeve which extends in the longitudinal direction and serves to guide the holding sleeve through the needle guard sleeve. The holding element can preferably be moved out of the holding engagement against an elastic restoring force. The elastic restoring force can be obtained by applying a separate spring element to the holding element. However, it is more advantageous if the holding element is connected to the holding sleeve, in particular if the holding sleeve forms the holding element in one piece and is shaped such that the elastic restoring force is generated in the holding element itself by the movement from the holding engagement. In this latter, preferred embodiment, the holding element is an elastic, preferably shape-elastic, snap.

The holding element can also be a separate element from the holding sleeve, which is movably connected to the holding sleeve transversely to the longitudinal axis. In this configuration, it can be, for example, simply a pin-shaped. In particular, it can form a slide, which can preferably be pressed into the holding sleeve against an elastic restoring force, in order to release a holding engagement with the dispensing device based on positive locking and / or frictional locking. This can be achieved, for example, in that the slide engages around a dispensing device accommodated in the holding sleeve at least over part of its circumference.

In preferred embodiments, the holding sleeve is elastically deformable in at least one holding sleeve section. The elastic deformability is such that a compression of a hollow cross section of the holding sleeve along a first cross-sectional axis causes the holding element to move transversely to the longitudinal axis from the holding engagement. As soon as the holding engagement is released, the dispenser can be easily removed from the holding sleeve. To separate the delivery device and insertion device, the holding sleeve only has to be pressed together with one hand and the delivery device removed with the other.

In particular, unscrewing is not necessary due to the invention. By releasing the holding engagement by means of a movement transverse to the longitudinal axis of the holding sleeve, the expenditure of force can be significantly reduced in comparison with a holding engagement which is carried out by a simple insertion movement in the longitudinal direction of the holding sleeve. It is also advantageous that such a holding intervention can be released, so to speak, at the push of a button. With regard to the manufacture of the holding engagement, it should be pointed out that for this purpose the holding element preferably snaps automatically into the holding engagement transversely to the longitudinal axis. The dispensing device then only has to be inserted into the holding sleeve to produce the holding engagement. The movement of the holding element for releasing and producing the holding engagement preferably takes place radially to a central longitudinal axis of the holding sleeve. In principle, however, the direction of movement can also point in any other direction transverse to the central longitudinal axis.

The elastic hollow cross section has at least one cross-sectional segment which is elastically deformable transversely to the longitudinal axis and preferably extends only over part of the circumference of the hollow cross section. It can preferably be deformed along the first cross-sectional axis into the hollow cross-section, particularly preferably radially inwards.

In a preferred first embodiment, the holding element extends the elastically deformable cross-sectional segment, preferably axially. The holding sleeve forms an axis of rotation for an expanding movement of the holding element between the elastically deformable cross-sectional segment and the holding element. It preferably forms an intermediate section which projects inward beyond the elastically deformable cross-sectional segment. If the dispenser is in the holding sleeve is received, the intermediate section lies against the dispensing device on the outside or comes into contact through the compression, as a result of which the axis of rotation is obtained in this embodiment, about which the holding element can be spread outward from the holding engagement.

In a second embodiment, the holding element extends another cross-sectional segment of the hollow cross-section, which can be elastically deformable, but does not have to be deformable. In the second embodiment, the compression of the hollow cross-section along the first cross-sectional axis causes the hollow cross-section to widen along another, second cross-sectional axis. The first and second cross-sectional axes preferably point perpendicular to one another. The other cross-sectional segment and the holding element are formed on the second cross-sectional axis. As a result of the elastic widening of the hollow cross section, the other cross-sectional segment and thus together the holding element are moved along the second cross-sectional axis in order to release the holding engagement.

The holding engagement can only be based on positive locking or only on positive locking or on a combination of positive locking and non-positive locking. This applies both to the prevention of a movement of the dispensing device relative to the holding sleeve in the direction of advance as well as against the direction of advance.

In a preferred embodiment, the holding element is designed as an elastically bendable snap tongue which projects axially. A stop surface pointing in the direction of advance is formed on the catch tongue, with which the holding element snaps behind the rear end face of the dispensing device in the holding engagement and thereby hooks onto the dispensing device. Such a locking engagement based on positive locking prevents movement of the dispensing device against the direction of advance. The holding engagement preferably also prevents the dispensing device from being able to move in the direction of advance relative to the holding sleeve. Preventing movement in the The direction of advance is preferably based on a positive and non-positive connection in combination.

Although basically only one holding element must be provided, two holding elements are formed in a preferred embodiment, which lie opposite one another and are moved apart, preferably spread apart, for releasing the holding engagement, and are accordingly moved towards one another for producing the holding engagement. More than two holding elements can also be provided, which are preferably arranged uniformly distributed over the circumference of the holding sleeve. In the case of two or even more holding elements, the plurality of holding elements are preferably of identical design.

The holding sleeve is axially movably received in an outer sleeve and is preferably guided so as to be secured against rotation. The outer sleeve preferably forms the needle guard sleeve directly. However, it can also be carried out separately from the needle guard and mechanically connected to the needle guard. The outer sleeve is resilient in a sleeve section in order to be able to compress the elastically deformable hollow cross section of the holding sleeve along its first cross-sectional axis. The formation of a resilient area in the outer sleeve is also advantageous in the case of a differently designed holding element, for example in the case of a separate holding element movably connected to the holding sleeve. In this section, the outer sleeve is preferably too flexible in the radial direction in the direction of the central longitudinal axis of the holding sleeve. The resilient portion can extend all the way around the circumference of the outer sleeve. However, it preferably extends over the circumference only over a limited angular range of at most 60 °. It is particularly advantageous if two such areas are arranged diametrically opposite one another. In this case, the elastically deformable hollow cross-section of the holding sleeve should also be elastically deformable on its two sides, which face the two flexible regions. The needle insertion device can be an exclusively manually operated insertion device or, more preferably, an auto insertion device. In the design as an auto-insertion device, a drive device is provided for an automatic advance of the holding sleeve from the starting position into the front position and also a triggering device for the drive device. The drive device is preferably formed by a mechanical spring element, particularly preferably by a compression spring. Alternatively, however, it can also be based on the effect of a fluid pressure and, in this case, preferably be a pneumatically active drive device. If the insertion device can be used several times, the holding sleeve is preferably moved back against an elastic restoring force of the drive device from the front position into the starting position, so that the drive device exerts a force directed in the forward direction on the holding sleeve in the starting position.

The release device has a manually actuated release element, which is particularly preferably provided in a front half of the outer sleeve. The release device can either release the drive device or, more preferably, block the holding sleeve relative to the outer sleeve. In the second embodiment, an insertion device, the holding sleeve of which has to be moved manually in the advancing direction, can also have such a triggering device, so that the explanations for the triggering device apply equally to auto-insertion devices and to manually operated insertion devices. In both cases, the arrangement according to the invention in the front half of the outer sleeve improves the ergonomics. The insertion device can be handled more easily during needle insertion. If, as in the known devices, a release device is arranged in the rear half or even at the rear end of the outer sleeve, the positioning and holding of the insertion device and the simultaneous release require the use of both hands or a special skill with a one-handed design. However, by triggering according to the invention in the front half, and there Advantageously, as far forward as possible, the insertion device can be securely positioned with one hand at the desired puncture site and the release device can be actuated with the same hand.

In the preferred embodiment, in which the holding sleeve in the starting position is prevented from moving in the forward direction by a positive connection relative to the outer sleeve, the positive connection is preferably a latching connection. For this purpose, the triggering device comprises a first stop which is axially immovably connected to the needle guard sleeve and a second stop which is axially immovably connected to the holding sleeve. These at least two stops are in a blocking engagement against each other to stop in order to prevent the holding sleeve from advancing from the starting position. If the insertion device is an auto-insertion device, the drive device preferably presses the second stop connected to the holding sleeve in the advancing direction against the first stop. At least one of the stops is formed on a snap tongue, which is elastically bendable transversely to the longitudinal axis of the holding sleeve and is bent against its elastic restoring force from the blocking engagement and automatically snaps into the blocking engagement due to the elastic restoring force. The actuating element of the actuating device presses the latch tongue out of the blocking engagement when actuated.

The applicant reserves the right to direct an application to this aspect of the invention, namely the triggering in the front half of the insertion device, the independent claims of which do not specify the manner in which the delivery device is held by the holding sleeve. For example, claim 1 can only form the subject of such an application with the features a), b) and c) in combination with one of claims 15 to 18.

It should be pointed out that the invention relates both to a device comprising a delivery device and an insertion device and to an insertion device alone. An insertion device according to the invention can in particular be based on Dispensing devices can be adapted for which an insertion device was not originally intended, ie it can be a retrofit device.

Furthermore, reference is made to the subclaims which describe further advantageous features of the invention.

An embodiment of the invention is explained below with reference to figures. Features that become apparent from the exemplary embodiment further develop the subject matter of the claims individually and in each combination of features. Show it:

Figure 1 shows an auto-insertion device with a recorded

Dispensing device in a starting position, Figure 2 shows the auto-insertion device and the dispensing device of Figure 1 in a foremost position of the dispensing device, Figure 3 shows the auto-insertion device and the dispensing device in the position of Figure 2 in a longitudinal section rotated by 90 °, Figure 4 den Cross section AA of Figure 1 and

5 shows the cross section B-B of Figure 2.

FIG. 1 shows an auto-insertion device and a delivery device 1 inserted into the insertion device in a longitudinal section. The insertion device is formed by two sleeve bodies, namely a needle guard 5 and a holding sleeve 10/15, which is movably received and guided in the needle guard 5 along a common longitudinal axis L. The needle guard sleeve 5 projects beyond the holding sleeve at both axial ends. The holding sleeve 10/15 cannot be rotated relative to the needle guard sleeve 5 by the two sleeves 5 and 10/15 being axially linearly guided against one another via at least two guide surfaces extending in the direction of the longitudinal axis L. The two guide surfaces can in particular be formed by a guide groove and an engaging guide rib, one of which is secured against rotation with the Needle protection sleeve 5 and the other secured against rotation is connected to the holding sleeve 10/15.

The holding sleeve 10/15 is formed by two separately manufactured sleeve bodies which are rigidly connected to one another, so that axial relative movements and rotary movements of the sleeve bodies relative to one another are not possible. The two sleeve bodies are therefore understood below as the front sleeve section 10 and the rear sleeve section 15 of a single holding sleeve 10/15. The needle guard sleeve 5 is also formed from several, separately manufactured parts. An outer sleeve forms the main part of the needle guard sleeve 5. The holding sleeve 10/15 is received in this outer sleeve and guided axially linear. A base is attached to a front end of the outer sleeve and has a central through opening, but apart from the through opening closes the outer sleeve at its front end. Because of their firm connection, the outer sleeve and the base are understood below as a single needle guard sleeve 5. Furthermore, recesses are provided in a cylindrical, in the exemplary embodiment circular-cylindrical, central section of the needle guard sleeve 5, each of which is provided in the jacket of the needle guard sleeve 5 as a perforated jacket region, i.e. as a recess, are formed. A release element 8, which is radially flexible with respect to the longitudinal axis L, is inserted into a front recess. An element 9 which is radially flexible with respect to the longitudinal axis L is likewise inserted into two rear recesses, which are diametrically opposite one another. The elements 8 and 9 are preferably resilient.

A compression spring 12 is arranged in an annular gap between the front holding sleeve section 10 and the needle guard sleeve 5. A rear end of the compression spring 12 is supported on a radially inwardly projecting shoulder of the needle guard sleeve 5. With its front end, the compression spring 12 presses against a radially outwardly projecting shoulder of the front holding sleeve section 10. In the starting position of the holding sleeve 10/15, the compression spring 12 is tensioned and presses on the holding sleeve 10/15 with its elastic tensioning force along the longitudinal axis L in the direction of advance. However, the holding sleeve 10/15 is blocked against movement in the direction of advance with the aid of a pair of stops in a blocking engagement comprising a first stop 7 and a second stop 11. The needle guard sleeve 5 forms the first stop 7 directly in the form of an axial end face in its front recess. The front holding sleeve section 10 has at its front end a catch 11 with a front, axial end face. This end face is the opposite end face to the first stop 7 and is therefore also referred to synonymously as the second stop 11. The second stop or catch 11 is flexurally elastic transversely to the longitudinal axis L, in the exemplary embodiment radially to the longitudinal axis L, and can best be characterized as an axially extending catch tongue.

With regard to the catch 11, which forms the second stop, reference is also made to the cross section A-A of FIG. 4. In order to obtain the catch 11 in the form of a catch tongue, the front holding sleeve section 10 is provided with two axial slots 11 a from its front end face. The snapper 11 remains between the two slots 11a. The snapper tongue is thickened at its front end radially outward relative to the remaining lateral surface of the holding sleeve section 10 in order to obtain the counter-stop surface for the first stop 7 in the thickened region.

In the starting position shown in FIG. 1, the thickened area of the snapper 11 is accommodated in the front recess of the needle guard sleeve 5. Radially above the catch 11, the front recess is closed by the flexible element 8. The resilient element 8 forms a trigger element. By radial pressure from the outside against the release element 8, the catch 11 is elastically bent inwards out of the blocking engagement with the first stop 7. If the catch 11 has been bent out of the blocking engagement, the holding sleeve 10/15 is pressed in by the pressure spring 12 Headed towards the bottom of the needle guard sleeve 5. The dispensing device 1 is held by the holding sleeve 10/15 so that it cannot move axially, so that it is advanced together with the holding sleeve 10/15 relative to the needle guard 5 and pushes the needle 3 through the opening of the bottom of the needle guard 5. The joint propulsion movement of the holding sleeve 10/15 and the dispensing device 1 is limited by an end stop 6, which is formed by the bottom of the needle guard sleeve 5. The holding sleeve 10/15 is advanced to this end stop 6 and then assumes its front end position.

This front end position is shown in Figures 2 and 3 in two longitudinal sections rotated by 90 ° to each other. The injection needle 3 protrudes from the needle guard sleeve 5 over its entire length.

The triggering device, which is formed by the triggering element 8 and ultimately also by the two stops 7 and 11, is advantageously arranged in the front half of the needle guard sleeve 5. It has only a distance from the front end of the needle guard sleeve 5 which corresponds to the path length which the holding sleeve 10/15 and the dispensing device 1 are jointly driven for the purpose of needle insertion. Only the thickness of the bottom of the needle guard sleeve 5 and the half axial extent of the front recess are added to this distance if the distance is measured with respect to the center of the trigger element 8.

FIGS. 2 and 3 in connection with FIG. 5 also show in particular how the dispensing device 1 is axially fixed in the holding sleeve 10/15, that is to say is prevented from moving axially relative to the holding sleeve 10/15. As can best be seen in FIG. 5, the rear holding sleeve section 15 has a hollow cross section which is stretched in its cross-sectional plane. A first cross-sectional axis Qi and a second cross-sectional axis Q, which intersect one another in the longitudinal axis L, form the two mutually perpendicular main axes of the hollow cross section. The hollow cross section is along the first Cross-sectional axis Qi is broader both along its clear inner diameter and in terms of its outer diameter than along the second cross-sectional axis Q ₂ . Overall, the hollow cross-section is oval. The hollow cross section is divided into four cross-sectional segments, two of which are provided with the reference number 17 and two with the reference number 18. The two cross-sectional segments 18 lie diametrically opposite one another on one side of the first cross-sectional axis Qi. The cross-sectional segments 17 lie diametrically opposite one another on one side of the second cross-sectional axis Q ₂ . Overall, the two cross-sectional segments 17 and the two cross-sectional segments 18 form a hollow cross-section 17/18 that is symmetrical with respect to the first cross-sectional axis Qi and the second cross-sectional axis Q ₂ .

The two cross-sectional segments 17 extend as far as the outer circumferential surface of the dispensing device 1. However, there is a free space between the cross-sectional segments 18 and the outer circumferential surface of the dispensing device 1, which extends in the circumferential direction up to the cross-sectional segments 17. Seen in the hollow cross section 17/18, each of the free spaces extends over an angle of approximately 120 °. The hollow section 17/18 of the rear holding sleeve section 15 is elastically deformable into the free spaces.

At its rear end, the rear holding sleeve section 15 forms two holding elements 16, which are diametrically opposite one another with respect to the longitudinal axis L and can be seen in FIG. 3. Each of the holding elements 16 extends axially one of the cross-sectional segments 18 and, in the exemplary embodiment, is formed in one piece with the cross-sectional segments 17 and 18. The axial extension is such that the rear holding sleeve section 15 forms an intermediate section between the cross-sectional segments 18 and the holding elements 16, with which the rear holding sleeve section 15 lies against the outer jacket of the dispensing device 1 or is at most a small distance apart. As a result, an axis of rotation is obtained for each holding element 16, about which the holding element 16 in question is at a Compressing the cross-sectional segments 18 is spread radially outwards by the dispensing device 1.

The holding elements 16 each form a snap hook with an axially facing, radially extending end face, which is obtained by the fact that the holding element 16 in question, seen from its rear end, initially thickens in a wedge shape radially inward to form at its thickest point to jump back radially outward face concerned. On their front-facing end faces, the holding elements 16 hook onto a counter end face (FIG. 3) of the dispensing device 1, which counter face forms a holding engagement surface 4. The holding engagement of the holding elements 16 prevents the dispensing device 1 from being able to move against the direction of advance relative to the holding sleeve 10/15. The holding engagement is purely positive in this regard. The wedge shape of the holding elements 16 also prevents the dispensing device 1 from being able to move out of the holding engagement in the advancing direction relative to the holding sleeve 10/15. In this regard, the holding engagement is positive and non-positive. The dispensing device 1 is provided with corresponding counter surfaces to the wedge surfaces of the holding elements 16. As a result, the dispensing device 1 is fixed in a precisely predetermined axial position by the holding engagement on the holding sleeve 10/15.

In order to separate the insertion device and the delivery device 1 from one another, the holding engagement must be released. The cross-sectional segments 18 are dimensionally elastic for the convenient release of the holding engagement. The hollow cross section 17/18 formed by the cross-sectional segments 17 and 18 can also be shape-elastic overall. The elasticity is such that the hollow cross section 17/18 can be elastically narrowed along the first cross-sectional axis Qi. By pressing the cross-sectional segments 18 into the free spaces, the holding elements 16 are spread apart from one another about their axes of rotation and the holding engagement is thereby released. As an alternative to the spreading movement by forming axes of rotation and levers, the elasticity of the hollow cross-section 17/18 can be such that a narrowing of the hollow cross-section 17/18 along the first cross-sectional axis Qi causes an expansion of the hollow cross-section along the second cross-sectional axis Q ₂ . The holding elements 16 extend the cross-sectional segments 17 in this embodiment. By widening, the holding elements 16 are moved away from one another, so that the dispensing device 1 comes free from the front end faces of the holding elements 16 and is pulled out to the rear from the holding sleeve 10/15 and the needle guard sleeve 5 can be. In contrast to the exemplary embodiment shown, the rear holding sleeve section 15 in this embodiment is also not guided towards the dispensing device 1 in the extension of the cross-sectional segments 18 to the rear. The free spaces are thus continuously formed towards the rear. The holding sleeve 10/15 does not have any further differences in this alternative. By squeezing the two cross-sectional segments 18, the other two cross-sectional segments 17 are thus moved apart.

So that the manual pressure required for the compression can be applied from the outside to the two cross-sectional segments 18, the two rear cutouts of the needle guard sleeve 5 on the first cross-sectional axis Qi are also left free. The rear recesses are each closed by a flexible element 9. The flexible elements 9 can also be referred to as pressure elements because of their function. Due to the axial linear guidance of the holding sleeve 10/15 on the needle guard sleeve 5, the positioning of the two cross-sectional segments 18 forming the free spaces is ensured radially under the respective flexible component 9.

The handling of the needle insertion device is thus particularly simple and is to be summarized below:

For automatic needle insertion, in a first step the delivery device 1 is inserted with the injection needle 3 first from the rear along the longitudinal axis L inserted into the needle guard sleeve 5 and the holding sleeve 10/15 accommodated therein. Due to their wedge shape, the two holding elements 16 form a gradually narrowing inlet and, upon insertion, press elastically with a slight pressure against the outer lateral surface of the dispensing device 1. As soon as the dispensing device 1 with its end face 2a has passed the holding elements 16, the holding elements 16 jump due to their elastic clamping force radially inward into the position shown in Figure 3. At this moment, the holding engagement is established and the dispensing device 1 is axially fixed relative to the holding sleeve 10/15. The holding sleeve 10/15 and the dispensing device 1 fixed by it now assume the starting position shown in FIG. 1 relative to the needle guard sleeve 5. In the starting position, the holding sleeve 10/15 is prevented from moving forward along the longitudinal axis L by the interaction of the two stops 7 and 11. The compression spring 12 is under tension. The needle 3 is behind the bottom of the needle guard 5 and is surrounded by the needle guard 5 protective. At the same time, the needle guard sleeve 5 forms a needle shield, ie the user can see the injection needle 3 at most through the front opening in the bottom of the needle guard sleeve 5. In the sense of the invention, however, a needle guard sleeve is also understood to mean a component which only offers privacy protection but no needle contact protection.

For an injection, the user grips the insertion device with one hand and places it vertically or at an angle on the skin with the bottom of the needle guard sleeve 5. It is assumed that a product dose to be administered with the delivery device 1 has already been selected. He then triggers the insertion device sitting on the skin by pressing the trigger element 8. The triggering can be carried out conveniently with a finger of the same hand with which the user holds and guides the insertion device.

After the administration of the product, subcutaneously in the exemplary embodiment, the insertion device is lifted off the skin and the injection needle is thereby pulled out of the skin. In the front end position, which the holding sleeve 10/15 takes up immediately after the injection relative to the needle guard sleeve 5, the cross-sectional segments 18 of the elastically deformable hollow cross section 17/18 of the holding sleeve 10/15 come to lie radially under the two pressure elements 9. The holding engagement of the holding elements 16 can therefore be released by compressing the elastic hollow cross section 17/18 along the first cross-sectional axis Qi. By pressing the two pressure elements 9, the two holding elements 16 are spread apart from the holding engagement and the dispensing device 1 can be removed from the insertion device if, for example, the product reservoir of the injection device 1 has already been completely emptied.

At this point, it should be pointed out that the holding engagement in the starting position of the holding sleeve 10, 15 (FIG. 1) cannot be released, since the pressure elements 9 and the elastic hollow cross section 17/18 are not at the same height in relation to the Longitudinal axis L, are. In the starting position, the needle guard sleeve 5 protects the elastic hollow cross section 17/18 against compression.

LIST OF REFERENCE NUMBERS

1 dispenser

2 housings

3 puncture needle

4 holding engagement surface

5 needle protection sleeves, outer sleeve

6 end stop

7 first stop

8 release element

9 pressure element, flexible area

10 holding sleeve, front section

11 second stop, catch 11a slot

12 drive device

13 14

15 holding sleeve, rear section

16 holding element, snapper

17 cross-sectional segment

18 cross-sectional segment L longitudinal axis

Claims

Needle insertion device with transversely movable holding element

1. Needle insertion device for a device (1) for dispensing an injectable

Product, the dispensing device (1) having a product reservoir and a needle (3) connected to the reservoir, the needle insertion device comprising: a) a needle guard (5), b) and a holding sleeve (10) connected to the needle guard (5) / 15), which can be moved relative to the needle guard sleeve (5) along a common longitudinal axis (L) in a direction of advance and into which the dispensing device (1) can be inserted such that the injection needle (3) in the direction of advance via the holding sleeve (10 / 15) protrudes, c) the holding sleeve (10/15) having at least one holding element (16) in order to prevent an inserted dispensing device (1) from releasing an axial movement relative to the holding sleeve (10/15), characterized in that that d) the holding element (16) is movable transversely to the longitudinal axis (L) in order to be able to produce and release the holding engagement.

2. Needle insertion device according to claim 1, characterized in that the holding element (16) is movable against an elastic restoring force from the holding engagement.

3. Needle insertion device according to one of the preceding claims, characterized in that the holding element (16) is a snap formed in one piece from the holding sleeve (10/15).

4. needle insertion device according to one of the preceding claims, characterized in that the holding sleeve (10/15) has an elastically deformable hollow cross-section (17/18), and a compression of the hollow cross-section (17/18) along a first

Cross-sectional axis (Qi) a movement of the holding element (16) transverse to the

Longitudinal axis (L) causes to release the holding engagement.

5. Needle insertion device according to the preceding claim, characterized in that the hollow cross section (17/18) has at least one cross-sectional segment (18) which is elastically deformable transversely to the longitudinal axis (L), preferably radially inwards.

6. needle insertion device according to the preceding claim, characterized in that the holding sleeve (10/15) between the elastically deformable cross-sectional segment (18) and the holding element (16) alone or together with a dispensing device held by the holding sleeve (10/15) (1) forms an axis of rotation around which the holding element (16) executes a spreading movement for releasing the holding engagement.

7. needle insertion device according to one of the two preceding claims, characterized in that the holding element (16) axially extends the elastically deformable cross-sectional segment (18).

8. Needle insertion device according to one of the three preceding claims, characterized in that the holding sleeve (10/15) projects radially inward between the elastically deformable cross-sectional segment (18) and the holding element (16) over the elastically deformable cross-sectional segment (18), to form an axis of rotation around which the holding element (16) is spread radially outwards by the compression of the hollow cross section (17/18).

9. needle insertion device according to one of claims 1 to 5, characterized in that the compression of the hollow cross-section (17/18) along the first cross-sectional axis (Q1) an expansion of the hollow cross-section (17/18) along another, second cross-sectional axis (Q2 ) and thereby the movement of the holding element (16) transversely to the longitudinal axis (L), preferably along the second cross-sectional axis (Q2).

10. Needle insertion device according to one of the preceding claims, characterized in that the holding sleeve (10/15) relative to the needle guard sleeve (5) from a starting position in which the needle guard sleeve (5) the injection needle (3) to, at least one Surrounds the needle tip and at least partially in the circumferential direction, in a direction of advance into a front position in which the injection needle (3) projects beyond the needle guard sleeve (5) and that the needle guard sleeve (5) has the elastically deformable hollow cross section (17/18) at least in the starting position of the holding sleeve (10/15) protects against compression.

11. Needle insertion device, characterized in that the holding sleeve (10/15) is guided along the longitudinal axis (L) in an outer sleeve which forms the needle guard sleeve (5) or extends along the longitudinal axis (L), and that the outer Sleeve for compressing the elastically deformable hollow cross-section (17/18) has a resilient area (9).

12. Needle protection device according to one of the preceding claims, characterized in that the holding sleeve (10/15) in an outer sleeve, which forms the needle protection sleeve (5) or extends along the longitudinal axis (L), secured against rotation along the longitudinal axis (L) is led.

13. Needle insertion device according to one of the preceding claims, characterized in that the holding sleeve (10/15) has at least two holding elements (16) which are moved apart by the compression in order to release the holding engagement.

14. The needle insertion device according to one of the preceding claims, characterized in that an inner diameter of the hollow cross-section (17/18) measured on the first cross-sectional axis (Qi) is larger than an inner diameter of the hollow cross-section (17. Measured on the second cross-sectional axis (Q ₂ ) / 18).

15. Needle insertion device according to one of the preceding claims, characterized in that the at least one holding element (16) forms a stop to counter the dispensing device (1) in the holding engagement by positive engagement with a movement relative to the holding sleeve (10/15) to prevent the direction of advance.

16. Needle insertion device according to one of the preceding claims, characterized in that the holding sleeve (10/15) in the holding engagement by positive and non-positive engagement prevents movement of the dispensing device (1) relative to the holding sleeve (10/15) in the direction of advance ,

17. Needle insertion device according to one of the preceding claims, characterized in that the at least one holding element (16) transverse to the longitudinal axis (L), preferably radially to the longitudinal axis (L), is flexible.

18. Needle insertion device according to one of the preceding claims, characterized in that the needle insertion device for propelling the holding sleeve (10/15) has a drive device (12) and a release device (7, 8, 11) with an actuatable release element (8 ) and that the release element (8) is provided in a front half of an outer sleeve, which forms or extends the needle protection device (5) and in which the holding sleeve (10/15) is movably guided along the longitudinal axis (L).

19. Needle insertion device according to the preceding claim, characterized in that the release element (8) is provided at a height of the outer sleeve measured in the longitudinal direction, which in the starting position of the holding sleeve (10/15) is on the injection needle (3) then takes the front end of the dispenser (1).

20. Needle insertion device according to one of the two preceding claims, characterized in that the triggering device (7, 8, 11) has a first stop (7) which is axially immovably connected to the needle guard sleeve (5) and one with the holding sleeve (10/15 ) axially non-movably connected second stop (11), and that the stops (7, 11) in an initial position of the holding sleeve (10/15) in which the needle guard sleeve (5) the puncture needle (3) up to at least one needle tip and surrounds at least partially in the circumferential direction, are in a blocking engagement against each other on the stop to prevent the propulsion of the holding sleeve (10/15).

21. Needle insertion device according to the preceding claim, characterized in that a snapper (11) on a transverse to the longitudinal axis (L) elastically bendable latch tongue forms one of the stops (7, 11) and the trigger element (8) can be pressed against the latch tongue is to move the stop formed by the catch (11) out of the blocking engagement.

22. Device for administering an injectable product, the device comprising: a) a dispensing device (1) with a housing (2), a reservoir for the product contained in the housing (2), a needle (3) connected to the reservoir and a conveying device for dispensing the product from the reservoir and through the injection needle (3), b) and a needle insertion device according to one of the preceding claims, from the holding sleeve (10/15) of which the dispensing device (1) is held.

3. Device according to the preceding claim, characterized in that the holding sleeve (10/15) has an elastically deformable hollow cross section (17/18), that a compression of the hollow cross section (17/18) along a first cross-sectional axis (Qi) a movement of the Holding element (16) transversely to the longitudinal axis (L) in order to release the holding engagement and that the elastically deformable hollow cross section (17/18) of the holding sleeve (10/15) surrounds a section of the housing (2), wherein in the holding engagement along The first cross-sectional axis (Qi) between the housing (2) and the hollow cross-section (17/18) leaves at least one space for the compression of the hollow cross-section (17/18).