HK1128643B - Insertion head with needle protection integrated into the handle - Google Patents

Description

Insertion head with needle protection provided in the handle

Technical Field

The invention relates to an insertion head for medical or pharmaceutical use, which can be placed on organic tissue, preferably on human skin, and which has an insertion device which is introduced into the tissue when the insertion head is placed on the tissue or possibly also only after the insertion head is placed on the tissue. The insertion head may in particular be a component of an injection kit for injecting a medicament.

Background

DE 19821723 discloses an insertion head with a base having an underside which can be placed on organic tissue, beyond which a flexible sleeve which is connected to the base in a non-movable manner projects and which is introduced into the tissue when the base is placed on the surface of the tissue. The cannula is stabilized for penetration into the tissue by a penetrating needle that passes through the cannula. In order to prevent the user from being injured by the projecting puncturing needle and to prevent the puncturing needle together with the insertion device from being damaged, a cylindrical needle protection device is releasably fastened to the underside of the insertion head. The needle protection requires a certain space and there is a risk of being released from the insertion head during inadvertent operation. Furthermore, to remove the needle protection device, the user needs two hands, one of which is also in the vicinity of the freely protruding puncturing needle after removal of the needle protection device.

From german patent application No. nr.102004039408.3, an insertion head with an insertion device is known, which can be moved from a protective position, in which the insertion device is received in a receptacle and in which the insertion device projects beyond the underside of the insertion head and is introduced into the tissue when the insertion head is placed on a tissue surface, into an insertion position. The receptacle is an integral part of the insertion head, which for this purpose forms a cavity that is open toward the underside. In the protective position, the insertion device is completely received in the cavity forming the receptacle, in particular its free end does not protrude beyond the lower side or protrudes laterally. The insertion head advantageously does not require any separate protective device for the insertion device, and is therefore flat in the delivery state as in the use state, that is to say as flat as in the state placed on the tissue. However, the insertion head is lengthened by the integrally formed receptacle.

Disclosure of Invention

The object of the present invention is to provide an insertion head which, like the insertion head of DE 102004039408, can be handled without risk and which is compact in the use state, i.e. after placement on a tissue surface and introduction of the introduction device.

An insertion head according to the invention comprises a base having an underside which can be placed on organic tissue, an insertion device which can be inserted into the tissue, and a receptacle which receives at least one free end of the insertion device in a protective position of the insertion device.

According to the invention, in the protective position of the insertion device, at least the free end of the insertion device does not protrude beyond the underside of the base. More precisely, the insertion device is mounted so as to be movable away from the base, so that it can be moved relative to the base from the protective position into an insertion position in which a free end of the insertion device projects beyond the underside. Preferably, the insertion device is retracted over its entire length behind the underside of the base in the protective position and is completely covered, preferably opaque. In a preferred embodiment, the insertion device is at least substantially parallel to the underside or the bearing surface of the base in the protective position. This is advantageous for a flat design of the base, the height of which is measured perpendicular to the underside. Furthermore, the receptacle is releasably connected to the base. In the connected state, the receptacle provides protection for the insertion device, so that the base is relieved of this function and therefore the length otherwise required for performing the protection function is omitted on the base. The receptacle is open to the underside of the base. In principle, an opening is only sufficient for the insertion device, but preferably the releasable receiving holder is pan-shaped or bowl-shaped, preferably shaped like a half-pan or half-bowl, surrounding the base or a part of the base. The receptacle can preferably be simply removed upward from the base after the connection has been released.

For ease of handling, the insertion head is preferably provided with a handle extending from the base. The handle or, in the case of a preferably multi-part handle, at least one handle part can be releasably connected to the base. Such a handle or such a handle part preferably forms a releasable receiving seat for the insertion device. In a further preferred embodiment, the handle has a handle part projecting high from the upper side of the base, from which the receiving socket projects laterally.

Preferably, the handle is multi-component and comprises a handle part which is movable relative to the base and to another handle part or, if necessary, to a plurality of other handle parts. The movable handle part is preferably coupled to the insertion device in such a way that a movement of this handle part causes a movement of the insertion device. The other handle part preferably forms a kinematic seat for the movable handle part, which in the connected state is immovable relative to the base and preferably forms a releasable receptacle. In principle, the movable handle part instead constitutes a releasable receiving seat. A plurality of handle parts can also together form the receptacle.

Since the handle is provided with a movable handle part, the movement of the insertion device can be brought about solely by the gripping and manipulation of the handle. The handle itself forms a support for the movable handle part. In this sense, the part of the handle that forms the support is referred to as the further handle part. The movable handle part can be configured, for example, as a push button. The other member may be a housing from which such a button projects. In an equally preferred embodiment, the two grip parts together form the grip, for example they each form half of a total of two-part grips.

For automatic placement by means of the inserter according to the invention, the insertion head preferably has a holding structure on its handle, which is in holding engagement with the holding device of the inserter. If the handle, as is preferred, has a handle part which is connected to the base in a non-movable manner and a handle part which can be moved relative to this handle part, the non-movable handle part preferably forms the holding structure. The holding structure can in particular be integrally formed on the handle or the immovable handle part, preferably the holding structure is at least rigidly connected to the handle or the immovable handle part.

The movable handle part preferably forms the receiving element described above in connection with the system formed by the insertion head and the inserter, but is referred to below as movable handle part as long as a particularly preferred embodiment of the insertion head is described. In principle, however, the receiving element of the system need not be a handle part, but can merely serve for coupling between the activation element and the introduction device.

In a preferred embodiment, the movable handle part is movable at least substantially parallel to the underside of the base. In particular, a linear movement is possible here. As an alternative to a purely translatory movement, the second component can also be mounted, for example, pivotably movable.

The at least one further handle part is preferably connected to the base in an immovable manner. In principle, however, it is also conceivable for the two grip parts to be connected to the base so as to be movable relative to the base.

In order to transmit the movement of the movable handle part to the insertion device, a rigid coupling can be provided, i.e. the movable handle part and the insertion device can be rigidly connected to one another, which can also be understood as an integrally formed structure. A rigid coupling can be easily achieved, for example, if the insertion device can be pivoted preferably, even if the movable handle part can be pivoted. In contrast to the insertion head of german patent application No. nr.102004039408.3, the insertion head according to the invention still has the advantage that the further grip part can be used as a support for the user and that the tissue does not have to be subjected to the forces applied for the swiveling movement by the base, that is to say, this forces are taken up by the user by the grip of the further grip part. If the user has an inserter, in particular an inserter according to the invention, which is placed on the tissue with an inserter according to the invention and during which the insertion device is introduced, the inserter withstands this force.

In a preferred embodiment, the movable handle part and the introduction device are coupled to each other by a transmission. An advantage of such a coupling is that the mobility of the handle part does not have to be matched to the mobility of the insertion device, but rather both mobilities can each be designed individually and optimally. In particular, the insertion device can thus be guided in a pivoting motion and the movable handle part can be guided in a translational motion, preferably in a linear motion. In the case of a pivoting mobility of the handle part, the pivoting axis of the handle part can be different from the pivoting axis of the insertion device. The insertion device is preferably pivotable about a pivot axis which is at least substantially parallel to the underside of the base, which also applies to all embodiments of the movable handle part, while the pivotable handle part is pivotable about a pivot axis which is at least substantially at right angles to the underside. However, it is also advantageous if, in the case of the use of a pivotably movable handle part, the axis of rotation of this handle part is spaced apart from the axis of rotation of the pivotably movable insertion device in parallel. In such a case, the pivot angle of the handle part can be transmitted to the insertion device with a reduction or preferably an increase in speed by means of a transmission.

A preferred drive-technical coupling comprises a gear wheel and a toothed rack which are in toothed engagement with one another and mesh with one another when the handle part is moved. The toothed rack is preferably connected to the movable handle part in such a way that a movement of the handle part in the longitudinal direction of the toothed rack is converted into a rotational movement of a gear wheel, which in this case is connected to the insertion device. In the case of a correspondingly fine toothing or pitch, a short stroke of the movable handle part can be converted into a rotary movement of the toothed wheel over a large part of a complete revolution, preferably into a rotary movement of the toothed wheel of a quarter of a revolution. Preferably, the movable handle part is formed integrally with the rack. Instead of a coupling by means of one or possibly more gear wheel pairs, the clutch can also be designed as a guide curve part and an engagement element or comprise such a guide curve joint, although a coupling by means of a tooth engagement is preferably produced.

The handle is in a preferred embodiment releasably connected to the base as already mentioned. Preferably, such a connection is released when the insertion device is moved into the insertion position, particularly preferably automatically when the movable handle part is moved. As an alternative, however, it is also conceivable in principle to provide the handle or the base with a further movable part, the connection to the base being released by actuation of the part. The connection between the handle and the base can be established by a purely frictional connection, but preferably the connection is based solely on a form-fit connection or on a combination of a form-fit connection and a frictional connection. In order to establish the connection, the base and the handle are each provided with at least one connecting element, which engage with each other when the connection is present. In order to be able to release the connection, it is preferred that at least one of the connection elements is releasable from the engaged state against the restoring spring force. In a preferred embodiment, the movable handle part serves not only for the transfer of the insertion device into the insertion position, but also for the release of the connection by the second handle part being released, for example elastically bent, from the engaged state by contact, preferably sliding contact, with one of the connection elements during its movement, against the elastic force, from the engaged state. Although less preferred, the further handle part may alternatively be integrally formed with the base or may be non-releasably secured thereto. However, in such an embodiment, the further handle part should be as short as possible.

If the insertion head is not special, that is to sayUnique (A)) The handle or, for example, the receptacle, which is formed integrally on the handle, is not an integral part of such a handle, but it is nevertheless preferred that the insertion device is also automatically moved from the protective position into the insertion position by a manual operation which is necessary for releasing the receptacle. Thus, for example, a button or another actuating element can be attached to the releasable receptacle, or such an element can be suitably connected to the receptacle and the receptacle can be released from the base by actuating the actuating element.

The introducer may be a bend resistant cannula or needle. Preferably, the introduction device is flexible at least in tissue. In particular, the insertion device can have a flexural rigidity which, in the inserted state, is reduced by the interaction occurring between the material of the insertion device and the tissue surrounding the material of the insertion device. Alternatively, the insertion device can also be configured in a conventional manner as a flexible sleeve, for example, and be stabilized during insertion into the tissue by a puncture device that is resistant to bending. The introduction device preferably extends longitudinally in the introduction direction and is preferably elongate.

If the insertion device is flexible at the time of shipment, i.e. not only by interaction with the tissue, the insertion device is preferably stabilized by means of a piercing device in order to prevent the insertion device from bending during insertion into the tissue. The puncturing device can be designed in particular as a thin puncturing needle. If the introduction means has been introduced into the tissue, the penetration means is preferably removed. Such a puncturing device is preferably removed by removing the releasable receiving seat, for example by using the handle. If the puncturing device is preferably not already connected to the releasable receptacle in the protective position, it is preferably automatically connected to the receptacle or to a component connected thereto when the puncturing device is moved into the insertion position. For this purpose, a coupling element is provided at the end of the puncturing device facing away from its free end, which coupling element, at the end of the movement into the introduction position or shortly before the end, is in coupling engagement with a mating coupling element connected to the releasable receiving receptacle. The connection preferably comprises a form-fitting connection, although in principle a purely frictional connection is possible. The connecting element of the puncturing device can in particular form a snap connection together with the counter-connecting element. In principle, only a simple snap-in from the rear (hindregriff) with respect to a specific direction is sufficient for a form-fitting connection, in which direction the releasable receptacle should be removed from the base; a resilient snap engagement is not essential.

The insertion means preferably project from the underside of the housing in the insertion position. In principle, however, the insertion device may instead protrude from one side of the housing, as long as it protrudes over a sufficient length from the lower side for insertion into the tissue. The insertion device preferably protrudes over the lower side of the housing in the insertion position over a length that is adapted to the subcutaneous injection, preferably directly from the lower side or protruding from the lower side. For injection into the skin or muscle tissue, the introduction device is correspondingly shorter or longer. As an introduction device is meant a length section that enters the tissue during injection.

In a preferred embodiment, the introduction device is movably permanently connected to the base. The insertion device is permanently connected to the base, which means that the insertion device is not released from the base at least for the movement from the protective position into the insertion position and/or from the insertion position into the protective position. Preferably, the introduction site is even permanently connected to the base in the sense that the introduction device cannot be released from the base at all, at least not without the use of special forces or only by destruction.

Preferably, the introduction device is connected to the base such that the introduction device can be swiveled relative to the base. However, it is preferred that only the insertion device is optional or that at least its free end can be deflected again into the releasable receptacle after deflection out. In such an embodiment, the base and the joint element connected to the introduction device form a revolute joint. The insertion device can, for example, be formed on the joint element itself, and can preferably project from the joint element transversely to the axis of rotation of the joint, or it can in principle also be connected to the joint again in an articulated manner. In the position which is occupied by the insertion position when the free end of the insertion device is displaced forward beyond the lower side, the longitudinal axis of the insertion device and the lower side enclose an acute angle of preferably less than 50 °. Preferably, the angle is less than 30 °, so that the longitudinal axis or the insertion device is at least substantially parallel to the lower side or the bearing surface of the base at the moment of the deflection. The longitudinal axis of the insertion device, which is rotatable about the axis of rotation, preferably intersects the axis of rotation. If the longitudinal axis of the insertion device does not intersect the axis of rotation, but intersects it at a distance, the distance is preferably significantly smaller than the length of the insertion device. Preferably, the distance is at most half the penetration depth or length of the insertion device. The angle of rotation of the introduction device is in a preferred embodiment 90 ° ± 10 °. In an equally preferred embodiment, however, the pivoting angle can also be smaller, in particular if the insertion device in the insertion position is not oriented perpendicularly to the underside of the base, but is oriented at an acute angle to the underside of the base, which acute angle is however at least 30 °. Accordingly, the pivot angle is preferably at least approximately 30 ° in the illustrated embodiment or is each at an intermediate value between approximately 30 ° or approximately 90 °. In principle, the pivot angle can also be greater than 90 °.

In an alternative embodiment, the base for the insertion device forms a displacement guide on which the insertion device is guided in translation during its movement from the protective position into the insertion position and/or from the insertion position into the protective position. In one embodiment, the base and the joint element connected to the insertion device together form a sliding joint. In a preferred embodiment, the insertion device projects from the joint element in a simple manner, preferably in the sliding direction. In a further alternative, the insertion device or the stable puncturing device has a bending stiffness which enables the insertion device or, if appropriate, a stable puncturing device to be bent with the respective free end into the receptacle in the direction of the underside of the base, so that the free end projects into the receptacle and is releasably positioned in the receptacle with the base or, on the other hand, is held in this bent state against the resilience of the insertion device which is reset. In particular, an embodiment is conceivable in which the insertion device encloses an acute angle with the underside of the base in the insertion position. It is also conceivable for such a bending to be provided for the insertion device to be fastened to the base or the releasable receptacle at a distance behind the underside of the base, in order to obtain a certain bending line already inside the cavity of the insertion head. On the other hand, it is preferred that the insertion device projects in the insertion position directly from the underside which, in use, is in contact with the tissue surface or as close as possible to this underside, i.e. is clamped on or at the underside at a shortest possible distance, preferably fixedly or optionally axially movably and in other directions, so that the length of the insertion device or a puncture device stabilizing it, which is bendable when entering the tissue, is as short as possible. In any case, it is preferred to use an introduction means which in the introduction position projects directly from the lower side or in proximity thereto, if the introduction means is not curved for the protective position.

Although it is sufficient for the insertion device to be movable in only one direction, that is to say once relative to the base, and then preferably from the protective device into the insertion position, it may be preferred for the insertion device to be movable back and forth between the two positions, so that the insertion device can be moved into the insertion position for use purposes and again into the protective position for waste disposal purposes. The connection between the insertion device and the housing is preferably or preferably comprises a form-fitting connection, which may in particular form a joint. Alternatively, the connection can also be a purely force-transmitting connection or even a purely material connection, for example, if the insertion device is bent in the protective position.

The insertion head is preferably a component of an injection kit for injecting insulin, an analgesic or another drug which can be injected by means of an infusion solution, or is provided for one of the described uses. Instead of being used for drug injection or in principle also another injectable product, the insertion head can also be used for diagnostic purposes. In such applications, the introduction device may serve as a carrier for a sensor, for example for measuring a glucose concentration in a body fluid or another physical and/or biochemical parameter which is or may be decisive for the health condition of the patient. The insertion head can also be designed as a perfusion device for diagnostic purposes. In such a configuration, the introduction device is flowed through by a flushing liquid (Spuflussigkeit) after introduction into the tissue, which flushing liquid absorbs one or more specific contents of the body fluid during the flow-through in order to analyze the flushing liquid enriched with the relevant content or contents. Finally, the insertion head can have means for injecting the product and constitute, in combination, the diagnostic means. The insertion device can be shaped in a matching manner for the supply of a product, in particular possibly a medicament or a flushing liquid, or for the removal of a body fluid or one or more substances contained in a body fluid. In this application, the introduction device forms at least one flow cross section. The insertion device can also be used in combination for feeding and removing material. If the insertion head is designed merely as a measuring device, the insertion device can also be used merely for placing the sensor or a part of the sensor, i.e. purely as a mechanical insertion device. In a development as a measuring device, the insertion head is used in addition to the mechanical insertion for transmitting control signals to the sensor and/or for transmitting measurement signals of the sensor. In a combined application, the insertion head finally has at least one flow cross section for the material transport, i.e. a flow line, and at least one signal line. The signal line can be dispensed with if the sensor is provided for wireless reception of control signals and/or wireless transmission of measurement signals. Finally, the insertion device can also have two or more individually protruding insertion elements. For example, a first introduction element can be used to deliver material into the tissue, and a second, further introduction element can be used to deliver material out of the tissue or just to place a sensor or a part of a sensor. With a plurality of insertion sections each having a flow cross section, it is also possible to inject different materials with the same insertion head. This can also be achieved with an introduction device which forms a plurality of individual flow cross sections in a common section.

According to a further preferred embodiment, a safety catch can be provided for receiving the insertion head according to the invention in the receptacle, wherein the receptacle receives the insertion device together with the insertion needle or only the insertion needle in the protective position or optionally in another position, such as a locked position, and the insertion device can be introduced into the safety catch, optionally together with the insertion needle or only the insertion needle, for example, in the protective position in the receptacle. Due to the elastic properties of the puncturing needle, the needle tip of the puncturing needle is elastically deformed or laterally deflected along the safety slide when it is pivoted into the protective position or into the receiving seat after use, in order then to engage behind the safety shoulder in the stop recess. In this position, the puncturing needle is then held securely in the protective position. This prevents damage to the contaminated puncturing needle.

According to a further preferred embodiment, the movable handle part can be pushed into the other handle part, so that after the process for transferring the insertion device from the protective position into the insertion position has ended, the control ramp on the movable handle part is moved towards the offset ramp on the connecting element which reversibly connects the base to the handle, in order to offset the engagement element out of its engagement position, so that the handle and the base can be separated. This embodiment, in particular in combination with the use of the second line of the slotted guide, is particularly advantageous for switching the insertion head according to the invention from the piercing function to the delivery function for delivering the medicament without applying a load to the tissue of the patient.

According to a further preferred embodiment, the insertion device can be assigned a holding structure which moves together with the insertion device, wherein the holding structure has a stop shoulder which, when the further handle part is pulled out of the movable handle part, enters into a fixed engagement with the engagement element in order to be able to prevent the puncturing device from being deflected out again.

According to a preferred embodiment, the receptacle is formed integrally with the handle or the further handle part. In this case, the receptacle is provided separately from the base.

In addition, the insertion device can preferably be assigned a holding device which moves together with the insertion device, wherein the holding device comprises a locking device. This locking structure should be situated opposite a wall of the movable handle part which extends parallel to the direction of movement of the movable handle part. In this way, the engagement element on the inner side of the wall body and the locking structure can be reversibly engaged in the protective position of the insertion device. By means of this measure, the insertion device with the puncturing needle can be reliably held in the protective position in the receiving seat, so that the desired swiveling actuation of the insertion device with the puncturing needle can subsequently be achieved with the movable handle part after overcoming the initial resistance provided by the securing means and the engagement element.

According to a further preferred embodiment of the invention, the insertion head can be provided with an insertion device which is held on the base by a pivot axis or a swivel axis. A slide or a journal can be provided, which is arranged eccentrically with respect to the rotational axis and preferably separately from this rotational axis, wherein a slotted guide is provided, which is operatively connected to the slide. The movement of the movable handle part relative to the base on a first line (Strecke) of the first section of the chute guide transfers the slide from a first position corresponding to the protective position of the insertion device or of the insertion needle into a second position corresponding to the insertion position of the insertion device. This embodiment makes it possible to achieve a relatively complex guide path for the insertion device to be pivoted out of the receiving socket, wherein at the same time relatively low forces have to be applied by the movable handle part and warping between the individual components of the mechanism is largely impossible.

According to another preferred embodiment of the invention, a connecting element may be provided, which reversibly connects the base with the handle, wherein the handle is movable on a second line perpendicular to the direction of extension of the insertion device in the insertion position in order to release the handle from the base, wherein the chute guide has a second section corresponding to the second path, so that the insertion device does not move with it when released, that is, by means of a suitable design of the guide groove, a movement of the handle parallel to the body surface or to the surface of the tab, also referred to below as adhesive (Pflaster), can be achieved after the insertion of the insertion needle and the insertion device into the patient without excessive fatigue of the organic tissue due to the parallel forces. In this way, the handle region and thus the puncturing needle can be detached from the insertion device in an advantageous manner by actuating these relevant parts and in this case in particular by actuating the movable handle part, in order to trigger and decouple the puncturing needle.

In this way, according to the invention, the contaminated puncturing device or puncturing needle can be pivoted back into the movable handle part.

According to a further preferred embodiment of the invention, the insertion head can be provided with an insertion device which is held on the base by a pivot axis or a swivel axis. A slide can be provided, which is arranged centreless with respect to the rotational axis and preferably separately from this rotational axis, wherein a slotted guide is provided, which is in operative connection with the slide. The movement of the movable handle part relative to the base on a first line (Strecke) of the first section of the chute guide transfers the slide from a first position corresponding to the protective position of the insertion device or of the insertion needle into a second position corresponding to the insertion position of the insertion device. This embodiment makes it possible to achieve a comparatively complex guide path for the insertion device to be pivoted out of the receiving socket, wherein at the same time comparatively little force must be applied by the movable handle part and warping between the individual components of the mechanism is largely impossible.

According to another preferred embodiment of the invention, a connecting element may be provided, which reversibly connects the base with the handle, wherein the handle is movable on a second line perpendicular to the direction of extension of the insertion device in the insertion position in order to release the handle from the base, wherein the chute guide has a second section corresponding to the second path, so that the insertion device does not move with it when released, that is, by means of a suitable design of the guide groove, a movement of the handle parallel to the body surface or to the surface of the tab, also referred to below as adhesive (Pflaster), can be achieved after the insertion of the insertion needle and the insertion device into the patient without excessive fatigue of the organic tissue due to the parallel forces. In this way, the grip region and thus the puncturing needle can be detached from the insertion device for triggering and decoupling by actuating the relevant parts and, in particular, the movable grip part, in an advantageous manner.

Triggering and decoupling can also take place immediately after one another. In this process, the slider has already passed through the entire guide track, so that the cannula or insertion device together with the puncturing needle has already been deflected and the handle part is decoupled simultaneously or immediately before the application of the needle-carrying cannula. In this case, there is only a readily releasable connection between the section of the insertion head according to the invention remaining in or on the patient's body and the section to be removed.

Preferably, the insertion device can be assigned a locking mechanism which reversibly holds the insertion device in the protective position. For example, the further handle part can be provided with a stop shoulder, which can be brought into reversible engagement with a complementary stop means on the movable handle part. If a resistance is overcome, the other handle part can be moved relative to the movable handle part and the cannula together with the puncturing needle can be moved or pivoted into the application position.

In addition, the insertion device can advantageously be assigned a cannula housing which moves together with the insertion device, wherein the cannula housing comprises a locking structure. This locking structure should be situated opposite a wall of the movable handle part which extends parallel to the direction of movement of the movable handle part. In this way, the engagement element on the inner side of the wall body and the locking structure can be reversibly engaged in the protective position of the insertion device. By means of this measure, the insertion device with the puncturing needle can be reliably held in the protective position in the receiving seat, so that the desired swiveling actuation of the insertion device with the puncturing needle can subsequently be achieved with the movable handle part after overcoming the initial resistance provided by the securing means and the engagement element.

According to a further preferred embodiment, a safety catch can be provided for receiving the insertion head according to the invention in the further handle part, wherein the further handle part receives the insertion device together with the insertion needle or only the insertion needle in the protective position, and the insertion device can be engaged in the safety catch, optionally together with the insertion needle or only the insertion needle, in the protective position in the receptacle. Due to the elastic properties of the insertion device together with the puncturing needle, the needle tip of the puncturing needle is elastically deformed or laterally deflected along the safety slide when pivoted into the protective position or into the receiving seat in order to subsequently engage behind the safety shoulder in the stop recess. In this position, the puncturing needle with the insertion device is then held securely in the protective position. The safety slide can also be arranged in the receptacle or in the movable handle part or partially on a different component.

According to a further preferred embodiment, the movable handle part can be pushed into the further handle part in such a way that after the process for transferring the insertion device from the protective position into the insertion position has ended, the control ramp on the movable handle part is moved towards a deflection ramp on a connecting element which reversibly connects the base to the handle for deflecting the connecting device out of its engagement position, so that the handle and the base can be separated. This embodiment, in particular in combination with the use of the second line of the slotted guide, is particularly advantageous for switching the insertion head according to the invention from the piercing function to the delivery function for delivering the medicament without applying a load to the tissue of the patient.

Preferably, not only is the base rotatably or pivotally connected to the cannula housing, but also the needle holder is rotatably or pivotally connected to the second or the first handle member. In this case, the two rotary or swivel mechanisms preferably have a common center or a common axis.

In this way, according to the invention, the contaminated puncturing device or puncturing needle can be pivoted back into the second handle part.

Preferred features are also disclosed in the dependent claims and combinations thereof.

Drawings

Embodiments of the invention are explained in detail below with the aid of the figures. The features disclosed in the exemplary embodiments form the subject matter of the claims individually and in each combination, and also preferably further form the embodiments described above. Wherein:

figure 1 is an insertion head of a first embodiment together with an introducer device in a protective position,

figure 2 is the insertion head with the introduction device in the introduction position,

figure 3 is a handle of the insertion head of the first embodiment,

figure 4 is the base of the insertion head of the first embodiment together with the lead-in device in the lead-in position,

figure 5 is a view of the handle shown in figure 3,

figure 6 is a view of the base shown in figure 4 with an introducer,

figure 7 is an insertion head of a second embodiment together with an introducer device in a protective position,

figure 8 is the insertion head of the second embodiment together with the introduction device in the introduction position,

figure 9 is a handle of the insertion head of the second embodiment,

figure 10 is the base of the insertion head of the second embodiment together with the lead-in device in the lead-in position,

figure 11 is a view of the system of insertion head and inserter of the first embodiment before activation,

figure 12 is a view of the system of the first embodiment after activation,

figure 13 is a view of the system of insertion head and inserter of the second embodiment before activation of the insertion head,

FIG. 14 is a view of the system of the second embodiment after activation, an

Figure 15 is a view of the system of the second embodiment after placement of the insertion head onto a tissue surface,

figure 16 is a side view of the insertion head together with the lead-in device in the protective position,

figure 17 shows the insertion head according to figure 16 with the insertion device in the insertion position,

fig. 18 shows the insertion head according to fig. 16 and 17, wherein the handle with the puncturing needle has been detached from the base and the insertion device,

figure 19 is a side view of another handle section and movable handle section in a released condition from the base,

figure 20 is a cross-sectional view of the insertion head together with the lead-in device in the protective position,

figure 20a is a cross-sectional view taken from the section of figure 20,

figure 21 is a sectional view of the insertion head according to figure 20 with the insertion device in the insertion position,

FIG. 22 is a sectional view of the handle with the piercing section when separated from the base with the introduction device which can be placed on the patient,

FIG. 23 is a cross-sectional view of the other handle section and the movable handle section after the movable handle section has been pulled out from the other handle section, and an enlarged cross-sectional view taken at section C,

fig. 23a is a section D-D according to fig. 23, which is perpendicular to the section according to fig. 23,

figure 24 is a perspective view of an insertion head according to the invention before application,

figure 25 is a view of the insertion head according to figure 24 after application,

FIG. 26 is the view of the insertion head according to FIGS. 24 and 25 after removal of the further grip element and the movable grip element and the puncturing needle,

figure 27 is a perspective view of the further handle part and the movable handle part after the movable handle part has been pulled out of the further handle part,

figure 28 is a view of the base of the insertion head according to figures 24 to 27 after the connection of a connector for the delivery of a drug,

FIG. 29 is a schematic view of the insertion head together with the introduction device and the puncturing needle in the protective position without the further handle part,

FIG. 30 shows the insertion head according to FIG. 29 with the insertion device and the insertion needle in the application position,

FIG. 31 is a side view of the insertion head with the lead-in device in the protective position, and

fig. 32 is a plan view of the insertion head according to fig. 31, section E-E.

In the following, identical or at least functionally identical components are generally denoted by the same or similar reference numerals, so that a renewed description is not necessary in most cases. The components of the individual embodiments are largely interchangeable, that is to say can be combined with one another. Other features, objects, and advantages of the present invention can be obtained from the embodiments described below.

Detailed Description

Fig. 1 shows a longitudinal section through an insertion head according to a first exemplary embodiment. The insertion head comprises a base having a receptacle or receptacle 1 and a flat part 2, the receptacle 1 and the flat part 2 being formed integrally from plastic. The bases 1, 2 can be placed with their lower side U onto organic tissue. Furthermore, the insertion head comprises a two-part handle having a first handle part 10 and a second handle part 12. The handle part 10 is connected to the base in an immovable but releasable manner. The handle part 12 is held movably on the handle part 10, wherein the handle part 12 can be moved linearly not only relative to the handle part 10, but also relative to the base 1, 2. The axis of movement of the handle part 12 is parallel to the lower side U of the base 1, 2. The direction of movement is indicated by an arrow on the upper side of the handle part 12.

The bases 1, 2 support the insertion device 5 in a pivotable manner about a pivot axis parallel to the underside U. The lead-in means 5 extend longitudinally. In the present exemplary embodiment, the insertion device 5 is designed as a flexible sleeve. Penetrating through the insertion device 5 is a puncturing device 15 embodied as a thin needle, which has a flexural rigidity sufficient to puncture the puncturing device 15 together with the adjoining insertion device 5 surrounding it through the skin surface into the subcutaneous tissue and thus into the insertion device 5. In a preferred embodiment, an adhesive pad is provided on the lower side U for fixing the insertion head to tissue, preferably to a skin surface.

The joint element 6 pivots the insertion device 5 and thus the puncturing device 15 together, the joint element 6 forming the axis of a rotary joint having a rotary axis as joint axis. The bases 1, 2 then form a further joint element of the rotary joint, which joint element is in the form of a bushing or, if appropriate, also in the form of an open bearing bore. On the rotational axis of the joint, an externally meshing gear wheel 8 is arranged on each side of the joint element 6, and the gear wheel 8 is connected in a rotationally fixed manner to the joint element 6, for example, is formed in one piece. One of the two toothed wheels 8 can be seen in fig. 1. While the other gear wheel is placed on the opposite side of the joint element 6 and is covered by the receiving part 1 of the base 1, 2. The penetration means 15 is passed through the joint element 6. A supply device 7 for a pharmaceutical liquid, such as insulin, is connected to the joint element 6. The supply device 7 projects from the joint element 6 at approximately right angles to the insertion device 5. The joint element 6 forms together with the supply device 7, the gear wheel 8, the introduction device 5 and the puncturing device 15 a unit for the rotational movement of the joint element 6 and the gear wheel 8 and for the swiveling movement of the other components.

The movable handle part 12 is provided with two toothed racks 18, which toothed racks 18 are in gear engagement with one of the toothed wheels 8. Of the two toothed racks 18, only the toothed rack that interacts with the covered gear wheel can be seen. A likewise similar toothed rack 18 interacts with the visible toothed wheel 8. In the case of a movement of the handle part 12 in the direction indicated by the directional arrow, in which the first handle part 10 guides the handle part 12, the two toothed racks 18 engage with the two toothed wheels 8, so that the movement of the handle part 12 is converted into a rotational movement of the joint element 6 and into a swiveling movement of the insertion device 5 and the puncturing device 15 and the supply device 7.

The pivoting movement transfers the insertion device 5 from its protective position shown in fig. 1 into the insertion position. In the protective position, the insertion means 5 and the puncturing means 15 are at least substantially parallel to the lower side U of the base 1, 2. The sections of the insertion device 5 and of the puncturing device 15 which project in the same direction from the joint element 6 are received in a common protective position in a cavity which is surrounded by the receiving element or receptacle 1, except for the underside U. With the introduction device 5 in the protective position, it is ensured that the user is not injured on the puncturing device 15 and, on the contrary, the introduction device 5 and the puncturing device 15 are not inadvertently damaged by handling. The receptacle 1 also preferably forms a shield so that the user cannot see the puncturing device 15 from the upper side of the insertion head and also from the side view. The adhesive pad, which is preferably mounted on the lower side, is provided with a passage slot for the insertion means 5 and the puncturing means 15.

The toothed rack 18 is correspondingly formed on the underside of two torsion-resistant tongues (Zungen) facing the underside U, which project in the direction of movement from the side sections of the grip element 12. From the side parts of the handle part 12, at least one further tongue projects in the direction of movement beyond the two tongues forming the toothed rack 18, which further tongue serves for the linear guidance of the movable handle part 12 on the guide formed by the handle part 10.

In order to introduce the introduction means 5 into the body tissue up to under the skin or possibly only into the skin, the user clamps the grip of the insertion head between the thumb and the index finger. The handle parts 10 and 12 are each provided with a correspondingly shaped lateral recess. By pressing the handle parts 10 and 12, the movable handle part 12 is pressed up to the stop formed by the first handle part 10. In this movement, the two toothed racks 18 engage with the gear wheel 8, so that a translational movement of the handle part 12 is converted into a rotational movement of the articulation element 6 and thus into a swiveling movement of the insertion device 5 and the puncturing device 15. The stroke of the handle part 12, the diameter of the gear wheel 8 and the fineness of the toothing are selected such that a movement of a few millimeters, for example 4 or 5 millimeters, of the handle part 12 causes a pivoting movement of the insertion device and the puncturing device 15 into an insertion position, in which the insertion device 5 and the puncturing device 15 protrude at least approximately at right angles from the underside U of the base 1, 2, the pivoting movement having a magnitude of at least substantially 90 °.

Fig. 2 shows the insertion head with the insertion device and the puncturing device 5, 15 in the insertion position.

At the end of the pivoting movement, the puncturing device 15 is already connected to the handle 10, 12, in this embodiment to the movable handle part 12. In the protective position (fig. 1), there is no contact between the puncturing device 15 and the handles 10, 12, so that the puncturing device 15 can be swiveled freely together with the introduction device 5. For the connection, a connecting element 16 is arranged at the proximal end of the puncturing device 15 in the introduction position, to which connecting element 16 the puncturing device 15 is fastened in the present exemplary embodiment, wherein the proximal end of the puncturing device 15 protrudes beyond the articulation element 6. The connecting element 16 has one or two raised tabs, with which the connecting element 16 catches a mating connecting element of the handle part 12 from behind with respect to the longitudinal direction of the puncturing element 15. The mating connecting elements of the movable handle part 12 are configured as shoulder surfaces which can be snapped in correspondingly from behind.

To place the insertion head on a tissue surface and to introduce the introduction device 5 into the tissue, the user grasps the handles 10, 12 of the insertion head and moves the insertion head towards the tissue surface. During this process, the puncturing device 15 pierces the tissue surface, preferably the skin of a person, and penetrates into the skin. The proximal insertion device 5 is introduced into the skin together with the piercing device 15 until the insertion head rests with its underside U on the tissue surface and is in the process fixed adhesively on the skin surface, preferably by means of an adhesive pad. For injecting the drug, the piercing device 15 is removed and the supply device 7 is connected to a drug container, preferably a drug pump, via a connector co-acting with the supply device 7. To achieve this, the handles 10, 12 are released from the bases 1, 2 beforehand. Only after squeezing or pushing the handle parts 10 and 12 can the release take place. However, the connection automatically releases upon movement of the handle part 12, so that the handles 10, 12 can be pulled down in the proximal direction, upwards in fig. 2. In a straight pulling movement, the insertion device 15 slides through the insertion device 5 and the articulation element 6, and the flow cross section of the insertion device 5 is thereby released, so that it is also simultaneously fluidically connected to the supply device 7 after the insertion device 15 has been pulled out. In this connection, the insertion head can be constructed as described in DE 19821723C 1 and DE 102004039408.3.

Fig. 3 and 4 show two parts of the insertion head which are released from one another, namely the base 1, 2 with the insertion device 5 and the handle 10, 12 with the puncturing device 15, in a position aligned with one another, in which the longitudinal axis of the insertion device 5 and the longitudinal axis of the puncturing device 15 are aligned with one another. Fig. 3 also shows a recess 3 in the base parts 1, 2, into which recess 3 one of the two toothed racks 18 enters when the handle part 12 is moved in the connected state and in this case meshes with the gear wheel 8 arranged in this recess 3. The gap 3 is in the shape of a slit. Furthermore, a connecting element 19 of the handle 10, 12 can be seen, which connecting element 19, in the connected state, engages in a form-fitting manner in a mating connecting element of the base 1, 2 and thereby holds the handle 10, 12 on the base 1, 2 and is fixed together with the contact surfaces of the handle 10, 12 and the base 1, 2 relative to the base 1, 2. The connecting element 19, for example, a cigarette-shaped (cigarette-shaped) element, projects from the elastic web 13, which projects from the grip part 10 in the distal region, in a direction parallel to the underside U of the base 1, 2 and, in the connected state, projects into a recess of the base 1, 2, for example, into a hole which is formed in accordance with the connecting element 19, so that, when the connection is present, a movement of the grip 10, 12 in the longitudinal direction of the puncturing section 15 is prevented. In order to release this connection, a further tongue, not shown, projects from a lateral section of the movable handle part 12, which tongue, when the handle part 12 is moved, is moved between the base 1, 2 and the web 13 supporting the connecting element 19 and bends the web 13 away from the base 1, 2 over a distance, but with a sufficient extent to release the positive connection between the connecting element 19 and the counter-connecting element, so that the handle 10, 12 with the puncturing device 15 can be pulled off the base 1, 2 in the longitudinal direction of the puncturing device 15.

Fig. 5 and 6 show a view of the rear side of the parts of the insertion head which are released from one another, facing away from one another in fig. 1 to 4. In this view, fig. 6 shows, in particular, the mating connecting element 9 of the base 1, 2, which mating connecting element 9 holds the handle 10, 12 on the base 1, 2 in the connected state, i.e., in the engaged state with the connecting element 19.

The bases 1, 2, which are shown individually in fig. 4 and 6, are the supports for the insertion device 5 and the components 6, 7 and 8, which form a swivel unit, the bases 1, 2 remaining on the tissue surface and in this sense being retaining elements. The handles 10, 12, which now serve as a support for the puncturing device 15, are then to be cleaned or, if necessary, released again from the puncturing device 15 and ready for use, while the puncturing device 15 is cleaned. The retaining members 1-9 may thus preferably be flat and cause no interference when worn under a garment. The insertion device 5 is flexible, so that the insertion device 5 is not perceived as disturbing in the inserted state, but has sufficient stability for reliably ensuring the supply of the medicament.

The handles 10, 12 may also be used in some embodiments of the insertion head, in which embodiments the introduction device is not factory flexible like the introduction device 5, but has sufficient bending stiffness for the puncturing action without external stabilizing means. In such an embodiment, the additional puncturing device 15 may be omitted. The handles 10, 12 are used in such an embodiment only for handling the insertion head, but not as a support for the stabilizing piercing device 15. The insertion device 5 modified in this way can be designed in particular as a puncturing cannula with a hollow cross section or as a puncturing needle with a solid cross section and one or more flow channels arranged on the outer circumference, which becomes more flexible after insertion by interaction with the tissue.

Figures 7 to 10 show a second embodiment of the insertion head. The insertion head of the second embodiment corresponds to the insertion head of the first embodiment, except for the differences explained below.

For example, an adhesive pad is shown in an exemplary manner, which is fastened to the underside U and can also be attached to the insertion head of the first exemplary embodiment.

The receiving seat 1 and the first handle part 11 have been modified with respect to the first embodiment. In contrast to the first exemplary embodiment, the insertion device 5 and the puncturing device 15 are received in the receptacle 1 formed by the receiving element only over a short section. In the second exemplary embodiment, the handle, more precisely the handle part 11 of the handle, forms a receptacle 14 for the insertion device 5 and the puncturing device 15. The receptacle 1 is laterally provided with a recess 4 in the form of a slot which is open toward the lower side U, and the insertion device 5 and the puncturing device 15 protrude from the receptacle 1 through the recess 4 in the protective position. The receptacle 1 itself is received in the receptacle 14. The receptacle 14 is open toward the bottom side U, but otherwise encloses the insertion device 5 and the puncturing device 15, preferably visually.

In order to pivot the insertion device 5 and the puncturing device 15 from the protective position into the insertion position, the user performs the manual operation steps described with reference to the first exemplary embodiment, i.e. presses the movable handle part 12 against the modified handle part 11. When the gear wheels are engaged, the insertion device 5 and the puncturing device 15 are pivoted out of the receptacle 1 and in particular out of the receptacle 14 into the insertion position in the recess 4.

Fig. 8 shows the insertion head of the second exemplary embodiment with the insertion device 5 and the puncturing device 15 in the insertion position.

With regard to the second embodiment, fig. 9 and 10 correspond to fig. 3 and 4 with regard to the first embodiment. However, as can be seen in particular from fig. 10, the bases 1, 2 of the second exemplary embodiment are preferably shortened to a certain extent compared to the bases 1, 2 of the first exemplary embodiment, since it is no longer the bases 1, 2 but rather the handles 11, 12 for the insertion device 5 and the puncturing device 15, in the protective position of the insertion device 5 and the puncturing device 15, which assumes a protective function.

Fig. 11 shows a first embodiment of a system comprising the insertion head of the first embodiment and an Inserter (Inserter) for placing the insertion head on tissue such that the user does not have to clamp the insertion head between the fingers when placing. In particular, the user does not have to hold the handle of the insertion head when transferring the insertion device 5 into the insertion position. Activating the insertion head by means of the inserter. Thus, the user can be more reliably protected against needle stick injuries and also the insertion device 5 and the puncturing device 15 can be more reliably protected against damage due to inadvertent handling.

The inserter has an inserter housing 20, which inserter housing 20 is constructed as a sleeve element with a bottom and has substantially the shape of a pot when viewed from the outside. The inserter housing 20 receives the holding means for the insertion head as well as the drive means. The retaining means then comprise a retaining spring, such as a leaf spring, which retains the insertion head in the initial position shown in fig. 11 relative to the inserter housing 20. In the holding engagement, the catch spring engages behind a holding structure 17 formed on the handle 10, 12, which holding structure 17 can be seen in fig. 1, 2, 3 and 5. The holding engagement state is releasable against the restoring elastic force of the fastening spring.

The drive means comprise a feed element 22, which feed element 22 is arranged in the inserter housing 20 in a linearly movable manner in and counter to a feed direction V. The feed direction V coincides with the central longitudinal axis of the inserter housing 20. Furthermore, the drive means comprise a power generator (kraft) 23 acting on the feed element 22 in the feed direction V. The power generator 23 comprises two pairs of arms 24 connected to each other in an articulated manner, wherein the two pairs of arms 24 are arranged in a symmetrical manner with respect to the central longitudinal axis of the inserter housing 20, i.e. with respect to the feed direction V. Each arm pair is suspended in a rotational joint 25 that is fixed in position relative to the inserter housing 20. The two arms 24 of the respective arm pair are connected to one another in a freely rotating joint 26 in a rotatable manner. Furthermore, the arm 24 facing away from the fixed joint 25 is correspondingly connected to the feed element 22 in a rotary joint 27. A plurality of springs, not shown, or possibly just one spring, tension this arm-joint-feed-member-arrangement in the feed direction V. The means constituted by the arm 24 and the joints 25, 26 and 27 guide the feed member 22; additionally or alternatively, the inner housing surface of the inserter housing 23 may guide the feeding element 22. Furthermore, a blocking element 29 is provided, which blocking element 29 is in a blocking engagement with the inserter housing 20, which blocking engagement prevents a feed movement of the feed element 22. The locking element 29 can form a locking engagement together with the envelope structure formed by the inserter housing 20 or also with a further structure fixedly connected to the inserter housing 20 with respect to the feed direction V. The latched engagement is released by operation of a button-like release 28.

Furthermore, the inserter comprises an activation element 21, which activation element 21 is connected to the inserter housing 20 in such a way that it can be moved in and counter to the feed direction V. The activation element 21 forms a sleeve with respect to the inserter housing 20, so that a two-part, telescopic inserter housing with housing parts 20 and 21 is obtained in its entirety. However, due to the difference in function, the housing part 21 is also referred to as an activation element. The activation element 21 constitutes the lower side U of the inserter₂₁The lower side surface U of the inserter for placing the insertion head₂₁Is placed on the tissue surface and preferably also with the lower side U₂₁Is placed on the tissue surface. In the initial position occupied by the insertion head, shown in fig. 11, the lower side U of the inserter₂₁And the lower side U of the held insertion head correspondingly points in a feed direction V which at least substantially forms a plane normal to the two lower sides.

The activation element 21 comprises an outer sleeve part and an inner sleeve part, which are arranged on the lower side U₂₁Are connected to each other and leave an annular gap therebetween. The inserter housing 20 projects into this annular slot and guides the activation element 21 in a sliding movement.

In the state shown in fig. 11, the activation element 21 assumes an in-moved position relative to the inserter housing 20 and the inserter has a shortest length measured in the feed direction V. In this state of the inserter, the insertion head is inserted, i.e. the insertion head is placed in retaining engagement with the retaining device of the inserter. Instead of inserting the insertion head, the insertion device can also be held by the insertion head on the support surface. The position and geometry of the retaining means are selected so that the retaining engagement is automatically produced upon nesting. Immediately after receiving the insertion head, for example by insertion, the insertion device 5 of the insertion head is in its protective position. In this sense, the insertion head is not yet activated. The inserter is provided with an associated means, namely the activation element 21, by manipulation of which the introduction device can be moved into the introduction position and in this way the insertion head can be activated.

For activating the insertion head, the activation element 21 and the insertion head form a joint with one another, in the present example a curved joint (Kurvengelenk). The two joint elements of the joint are a guide curve part 21a which forms the activation element 21 and an engagement element 12a which is formed by the movable handle part 12. The activation element 21 acts on the insertion device 5 by means of a coupling, in which the movable grip part 12 forms an input element or a receiving element of the insertion head. If the activation element 21 is moved relative to the inserter housing 20 in the feed direction V, the guide curve part 21a slides over the engagement element 12a, that is to say over the contact surface of the receiving element, that is to say of the movable handle part 12, which constitutes the engagement element 12 a. By means of the pressure contact of the guide curve element 21a and its curve inclined to the feed direction V, the grip part 12 is moved transversely to the feed direction V toward the other grip part 10, and the insertion device 5 is returned as described in connection with such an insertion headTurning into the introduction position. The movable grip part 12 forms the engagement element 12a at its upper end facing away from the base 1, 2, in the present exemplary embodiment with its outer edge. The guide curve part 21a faces the lower side U of the inserter₂₁. The inclination is selected such that the guide curve part 21a faces away from the lower side U₂₁Is inclined in the direction of feed V away from the insertion head or from the insertion device 5 pivoted out in the activated state or from the central longitudinal axis of the inserter. The inclination angle is kept constant throughout, and the guide curve member 21a is a slope, that is, an inclined line or plane.

For practical operation, the user, after receiving the insertion head, grasps the activation element 21 of the inserter with one hand, for example by grasping the activation element 21, and pulls the inserter housing 20 with the other hand counter to the feed direction V relative to the grasped activation element 21. This is also understood to mean the actuation of the activation element. The feed element 22 and power generator 23 move with the inserter housing 20 relative to the activation element 21. The insertion head, which is held in the initial position by the holding device, is carried along, that is to say likewise moves counter to the feed direction V relative to the activation element 21. The engaging element 12a slides along the guide curve part 21 a. By means of this interface based on pure pressure contact, the movable grip part 12 is moved transversely to the feed direction V and the insertion device 5 is pivoted into the insertion position. The inserter housing 20 and the activation element 21 perform a removal movement relative to each other, at the end of which the insertion head is activated.

Fig. 12 shows the system of inserter and insertion head in its activated state. The inserter housing 20 and the activation element 21 occupy a removed position relative to each other. In the removed state, the walls of the inserter housing 20 and the activation element 21 are enclosed up to the free ends of the insertion device 5 and the puncturing device 15The activated insertion head, i.e. the tip of the puncturing device 15, is on the lower side U of the inserter₂₁Is set back a distance.

The inserter housing 20 and the activation element 21 are latched relative to each other in the removed position. In the latched state, no relative movement is possible in the feed direction V or counter to the feed direction V. Upon reaching the removed position, the inserter housing 20 and the activation element 21 automatically latch with each other.

To place the insertion head, the user places the inserter on the skin surface. After placement of the inserter, the user squeezes toward the release 28. The release 28 acts on the blocking element 29 via a curved joint, in the present exemplary embodiment via a simple ramp pair. Under the action of the release 28, the blocking element 29 is moved out of the blocking engagement with the inserter housing 20, so that the feed element 22 can be moved in the feed direction V by the power generator 23. The power generator 23 suddenly accelerates the feed member 22. The feed element 22 acts like a hammer on the insertion head. In a first phase of the feed movement, the fastening spring is ejected from the retaining engagement with the retaining structure 17 of the insertion head, i.e. the retaining engagement is released. The acceleration of the feed element 22 in the feed direction V is so great that a purely pressure contact between the feed element 22 and the insertion head is reliably maintained until the lower side U of the insertion head rests against the lower side U of the inserter₂₁At the same height and thus placed on the tissue surface. Whereas the previously described piercing means 15 has pierced the skin surface, entered the tissue and in the process brought the introduction means 5.

After the insertion head is placed on the skin surface, the user grasps the handles 10, 12 and pulls them off the base 1, 2. In the process, the puncturing device 15 is automatically pulled out of the insertion device 5 and pulled off the base 1, 2.

In order to likewise automate the withdrawal process of the puncturing device 15, in a preferred variant of the inserter, the holding engagement between the holding device of the inserter and the holding structure 17 of the insertion head is maintained and is not released by the acceleration of the advancing element 22, as in the illustrated exemplary embodiment. In one variant, the holding device is connected to the feed element 22, in particular in a stationary manner, so that it carries out the pushing-out movement of the feed element 22 in the feed direction V. To release the retained engagement, the inserter may be provided with a remover that automatically releases the insertion head from the retained engagement upon pushing on the inserter housing 20 and activation element 21 after removing the inserter from the tissue. Alternatively, such a detacher may also be provided completely independently of the activation element 21 and may be separately manipulated to release the retained engagement.

Figures 13 to 15 show a system of a second embodiment comprising an insertion head and an inserter. The insertion head is the one shown in fig. 7 to 10, but may be the same as in the first embodiment. Only changes were made on the inserter. The corresponding components of the inserter of the second embodiment are similar in their function to the components of the inserter of the first embodiment and are correspondingly denoted by reference numerals increased by the number ten compared to the reference numerals of the first embodiment. Thus, the explanation regarding the first embodiment applies, in particular, with respect to the shape and connection and relative movement of the inserter housing 30 and activation element 31. In principle, the same applies with regard to the feed element 32, the holding device and the power generator 33, and also with regard to the release 38 and the blocking element 39. The explanations with respect to the first embodiment also apply to the second embodiment, as long as no differences are indicated below and no further explanations are to be made from the figures.

The inserter of the second embodiment differs from the inserter of the first embodiment mainly in the articulation through which the activation element 31 acts on the insertion head for activating the insertion head by a pulling movement of the inserter housing 30 relative to the activation element 31. In the second exemplary embodiment, the insertion device itself forms the joint, i.e. a joint with two joint elements 31a and 41a, one of which forms the activation element 31 and the other of which forms the actuator element 41. The actuator 41 is supported by the inserter housing 30 in such a way that it can be moved back and forth transversely to the feed direction V, in the present embodiment at right angles to the feed direction V. The joints 31a, 41a are again a curved joint. The guide curve member 31a corresponds to the guide curve member 21a of the first embodiment. The actuating element 41 forms an engagement element 41a which slides along the guide curve part 31a over the extension of the inserter and, due to the inclined curve of the guide curve part 31a, moves the actuating element 41 transversely in the direction of the central longitudinal axis of the inserter when the inserter is pulled up. In this way, in the joints 31a, 41a, the movement performed by the inserter housing 30 when pulled up relative to the activation element 31 counter to the feed direction V is converted into a transverse movement of the actuator 41. The articulation or engagement elements 41a of the actuating element 41 are designed as guide curve elements, but are referred to in the transmission art as engagement elements. Alternatively, the engagement element 41a can also be designed, for example, as a simple cam or as a stub shaft. Likewise, the engagement element 41a may be referred to as a guide curve part, and in another modification the articulation element 31a may be shaped as an extended cam or stub shaft.

The inserter activates the insertion head via an interface which is in turn designed as a purely pressure contact and which is present between the actuating element 41 and the receiving element or the movable grip part 12 of the insertion head. This purely, so to speak, loose pressure contact simplifies the handling process, since no special articulation has to be established for activating the insertion head, it is sufficient to receive the insertion head and to actuate the activation element 31 in conjunction therewith, which is done in the exemplary embodiment by the pulling-up movement. The pressure contact, that is to say the pressure exerted by the actuating element 41, acts on the movable handle part 12 in a manner parallel to the direction of movement of the handle part 12 relative to the base 1, 2. By means of the intermediate connection of the actuating element 41 and the complete displacement of the articulations 31a, 41a to the inserter, no forces are preferably exerted on the grip part 12 in the second embodiment transversely to the direction of movement of the grip part 12.

Figure 14 shows the system together with an activated insertion head. The pulling movement of the inserter housing 30, during which the insertion device 5 and the puncturing device 15 are pivoted into the insertion position such that their common longitudinal axes point in the feed direction V, is also understood to mean the actuation of the activation element 31. The movable handle part 12 releases the connection between the handles 10, 12 and the bases 1, 2 as explained in connection with the insertion head. However, the frictional connection existing between the introduction device 5 and the puncturing device 15 holds the base 1, 2 on the handle 10, 12 in the engaged state, as in the first exemplary embodiment.

The blocking element 39 is also in a blocking engagement with the inserter housing 30 or with a structure fixedly connected to the inserter housing 30, which blocking engagement is released by manipulation of the release 38 and the feed element 32 is accelerated by the power generator 33 in the feed direction V. The acceleration takes place again abruptly, so that the drive 32, 33 of the second exemplary embodiment acts like a hammer. The driving force is generated by two helical torsion springs, each of which acts on one of the two pairs of support arms, respectively. The arms 24, which are fixed in the stationary rotary bearing 35, are coupled to one another by means of a gear mesh, which serves to synchronize the two arm pairs with respect to the movement out.

In order to be able to prepare the inserter for reuse after the insertion head has been placed, the actuator 41 must be returned from the final position shown in fig. 14 into the final position shown in fig. 13. The activation element 31 and the actuator element 41 form a further joint 31b, 41b for this return movement, the further joint 31b, 41b in this exemplary embodiment likewise being a curved joint. The activation element 31 forms a guide curve part 31b for the other joint and the actuation element 41 forms an engagement element 41 b. The guide curve part 31b extends at least substantially parallel to the guide curve part 31 a. The guide curve elements 31a and 31b are formed on an inner sleeve part of the activation element 31, the guide curve element 31a being formed on an inner surface of the inner sleeve part and the guide curve element 31b being formed on an outer surface of the inner sleeve part. Which are opposite each other at substantially the same height with respect to said feed direction V. The engagement element 41b is likewise situated opposite the engagement element 41a with an effective spacing, so that the inner sleeve part of the activation element 31 can be moved in and out between the two engagement elements 41a and 41 b.

Figure 15 shows the system of the second embodiment together with the placed insertion head. Removing the inserter from the insertion head. The user then pulls the handles 10, 12 off the bases 1, 2 and connects the insertion head to the catheter of a syringe pump. In a modification of the first embodiment already mentioned, in which the holding device is connected in a stationary manner to the feed element 32 and accordingly also holds the handles 10, 12, the inserter and thus also the handles 10, 12 which are held together are removed from the base. Subsequently, the holding engagement is released, preferably by means of an additional detacher, and the handle 10, 12 is cleaned together with the puncturing device 15 or only the handle 10, 12.

In order to prepare the inserter for use with another insertion head, the user again pushes the inserter housing 30 and activation element 31 together into a moved-in position as it is shown in fig. 13 together with the inserted insertion head. In the inward movement, the inner sleeve part of the activation element 31 is moved between the engagement elements 41a and 41b of the actuating element 41. During this displacement movement, a further articulation is produced between the guide curve part 31b and the engagement element 41 b. In the inward movement, the actuating element 41 is thereby moved back again in the joints 31b, 41b into the end position assumed in fig. 13, i.e. laterally, preferably radially, outward relative to the central longitudinal axis of the insertion device.

The feed element 32, which is moved out in the feed direction V under the action of the spring device 33, and the lower side U of the inner sleeve part facing away from the activation element 31₃₁Are opposed to each other. The feed movement of the feed element 32 is stopped by a stop contact on this end face. The geometry of the activation element 31 is designed such that it reaches the lower side U of the insertion head at the lower side U₃₁And thus the activation element 31 stops the feed element 32 exactly in the moved-out position of the telescopic elements 30, 31 just when the skin surface is touched with the inserter placed. During the inward movement of the inserter housing 30 relative to the activation element 31 or of the activation element 31 relative to the inserter housing 30, the advancing element 32 is pressed deeper into the inserter housing 30 due to the stop contact of the activation element 31 against the force of the power generator 33 until the latching element 39 is again in the latched engagement as exemplarily shown in fig. 13 and 14.

Fig. 16 shows a further embodiment of an insertion head according to the invention. The insertion head comprises a movable handle part 12, which movable handle part 12 can be pushed into the other handle part 10. The movable handle part 12 is pushed into the other handle part 10, whereby the sleeve housing 17b is deflected around the joint 6. The cannula housing 17b in this case also supports the insertion device 5 and the puncturing device 15 in the protective position. During the actuation of the movable handle part 12, the slide 44 is displaced in the gate guide 42 essentially downward in the direction of the joint element 6, which causes the holding structure 17 and thus the insertion device and the puncturing needle to perform a rotational or swiveling movement. As soon as the slide block or journal 44 reaches the curve region of the gate guide 42, the pivoting movement from the protective position into the guide-in position is completed. The other handle part 10 is further provided with a connecting means 16b, which connecting means 16b is in engagement with a corresponding section 49 on the base 1 for reversibly connecting the base with the handle 10, 12 thereby.

Of course, the slide can also have another position.

Thus, the slide 44 can also be arranged further down and move substantially upwards when the components 17a, 17b are deflected. In this case, different configurations can be used for the chute guide and the slide.

According to fig. 17, the movable handle part 12 is lowered into the further handle part 10, wherein the insertion movement of the movable handle part 12 into the further handle part 10 has caused the insertion device 5 together with the puncturing device 15 to be displaced out of the receiving seat 14 (see fig. 19) and into the insertion position. This embodiment according to fig. 16 thus provides a connection between the handle part and the displaceable insertion device as an alternative to the previously explained embodiments.

Fig. 18 shows how the handle consisting of the handle parts 12 and 10 can be released from the base 1. The base 1 comprises a recess 49, with which recess 49 the connecting means 16b of the handles 10, 12 are engaged (see fig. 16 and 17), while in the illustration according to fig. 18 the engagement has been removed, so that the handles 10, 12 can be removed from the base 1.

Fig. 19 shows the handle 10, 12 according to fig. 18, wherein the movable handle part 12 has been pulled out of the other handle part 10, so that the slide or journal 44 is guided essentially upward in the slotted guide 42, as a result of which the cannula housing 17b and the needle holder 17a, together with the puncturing device 15 fastened to the needle holder 17a, are deflected again into the original protective position in the receptacle 14 or into a locking position close to this protective position. The connecting means 16b at the end of the spring webs 16a now has no function, since it no longer needs to remain connected to the base 1.

Fig. 20 shows the insertion head according to a further embodiment of the invention before use or during storage. The introduction means 5 with the puncturing means 15 partially received therein are in a protective position in the receiving seat 14. On the lower side U, a protective film is applied to the web 13 or the adhesive (Pflaster)13 in order to maintain the adhesive position of the adhesive 13 in effect. Furthermore, according to fig. 20, a stop 58 is provided in order to be able to introduce and remove the puncturing device 15, wherein subsequently a seal should be ensured against the introduction device 5. Correspondingly, a baffle 56 is also provided for the connection section that is connected vertically to the puncturing device 15, which baffle 56 should be able to be connected in a sealing manner to the supply line or to the convector (see fig. 28).

On the needle holder 17a, which is arranged on the cannula housing 17b and is used to hold the puncturing device 15, a locking structure 46 is provided on the side facing away from the base 1, which locking structure 46 is obtained from the sectional view according to fig. 20 a. In the illustrated state, the engagement element 48 is in engagement with the locking mechanism 46 and generates a resistance force which prevents the movable handle part 12 from being accidentally introduced into the other handle part 10. The operator of the insertion head according to this embodiment of the invention must initially provide a higher force expenditure for overcoming the engagement between the engagement element 48 and the securing structure 46 and for carrying out a pivoting process for pivoting the insertion device 5 with the puncturing device 15 from the protective position in the receiving socket 14, as shown in fig. 20, into the application position, as shown in fig. 21.

The locking mechanism 46 can also be realized with a locking device corresponding to the elements 52, 54, which can be provided, for example, on the other and the movable handle parts 10, 12 and can be unlocked by pushing one of the handle parts into the other.

Fig. 22 shows the insertion device of fig. 21 with the insertion device 5, 15 inserted into the tissue of a patient. That is to say that the insertion device or insertion needle 15 has been pulled out of the insertion device 5. The flap 58 is closed and the introducing means 5 is ready to introduce the drug into the patient's body.

Fig. 23 shows how the movable handle part 12 is pulled out of the other handle part 10 again, so that the sleeve housing 17b is pivoted back into its position assigned to the protective position. The puncturing device 15 is pivoted past the original protective position into a position above the protective position, i.e. above a stop shoulder 60 explained below. In this position, the puncturing device 15 is secured, as can be seen in the enlarged view C, by the engagement of a stop shoulder 60 at the end of the needle holder 17a with the engagement element 48. In this position, it is now no longer possible to displace the contaminated puncturing device 15 out of the handle 10, 12 again, since a locking effect is provided here by the engagement element 48 in conjunction with the stop shoulder 60. The puncturing device 15 is held in the locked position behind the stop shoulder. Fig. 23a shows section D-D according to fig. 23 for showing a securing link 50, which securing link 50 serves to transfer used or contaminated piercing devices 15 into a fixed link section behind the securing shoulder 50 a. In contrast, the unused sterile puncturing device is held in another position before the safety shoulder 50a before use.

In the sectional view according to fig. 23a, a guide 62 can also be seen, which guide 62 can guide the movable handle part within the other handle part 10. If the puncturing device 15 is pivoted into an inactive position in the receiving seat 14, the puncturing device 15 is moved by the safety slide 50 with a flexible deformation in order to be subsequently relieved of pressure in the upper region of the safety slide 50 behind the safety shoulder 50a and is snapped back into the position shown directly in fig. 23a in order to be then held securely in the position shown and locked there.

Fig. 24 to 28 show different phases of the application of the insertion head according to the invention. Fig. 24 shows the movable grip part 12 in a position protruding from the further grip part 10, in which the insertion device 5 with the puncturing needle is in its protective position. In the illustration according to fig. 25, the movable grip part 12 has been moved into the other grip part 10, so that the insertion device with the puncturing device can be punctured into the body of the patient, as can be seen from fig. 26. Fig. 26 now shows a state, according to which the insertion device with the insertion device 15 has been inserted into the body of the patient, wherein the insertion device 15 now has no further function and can be pulled out of the insertion device, i.e. the base 1 and the handles 10, 12 can be separated from one another.

According to fig. 27, the movable grip part 12 has now been pulled out of the other grip part 10, wherein the puncturing device 15 has again been transferred into the protective position.

According to fig. 28, a connector 64, now having a delivery line, may be connected to the base for delivering a medicament, such as insulin.

Fig. 29 shows that the guide link 42 has a first section 42a of length a. This line a serves to deflect the cannula housing 17b and thus the insertion device 5 with the puncturing device 15 to the right in the illustrated case by actuating or advancing the movable handle part 12, so that the slide 44 is moved essentially downward in the direction of the joint element 6, while the insertion device 5 is transferred from the protective position into the application or insertion position. The second section 42b of the slotted link guide 42 is then used to provide a clearance on the second line b in order to be able to unlock and thus to be able to displace the connecting device 16b out of the engagement recess 49.

In fig. 30, the slide 44 has reached the other end of the chute guide 42 relative to the illustration according to fig. 29, and accordingly, according to fig. 30, the insertion device 5 with the puncturing device 15 is not only in its application position, but also the handle 10, 12 is unlocked and can be removed from the base 1, with the puncturing device 15 being pulled out of the insertion device 5.

In addition, in the embodiment according to fig. 31, an unlocking mechanism is shown, in particular in section E-E, and in fig. 32, again. As can be seen, the movable handle part 12 has a control ramp which, after the introduction of the movable handle part 12 into the other handle part 10, moves toward a deflection ramp 54 for the purpose of shifting the connecting element 16 out of its engagement with the engagement recess 49 on the base 1 in this way. The movement for displacing the insertion device 5 with the puncturing device 15 corresponds to the line 42a having the length a, while the movement for guiding the control ramp 52 to the displacement ramp 54 corresponds to the section 42b of the guide link 42 according to fig. 29.

List of reference numerals

1 base, receiving base

2 base, flat member

3 gap

4 voids

5 introduction device

6 Joint element

6a joint element counterpart

7 supply device

8 gear

9 connecting element

10 another handle part

11 another handle part

12 moving handle part, receiving element

12a joint element, engaging element, pressure contact surface

13 contact piece

14 receiving seat

15 lancing device

16 connecting element

16a spring tab

16b connecting device

17 holding structure

17a needle frame

17b casing shell

18 rack

19 connecting element

20 inserter housing

21 activating element

21a joint element, guide curve part

22 feeding element

23 Power generator

24 support arm

25 rotating joint

26 rotating joint

27 rotating joint

28 releaser

29 locking element

30 inserter housing

31 activating element

31a joint element, guide curve part

31b joint element, guide curve part

32 feed element

33 Power generator

34 support arm

35 rotating joint

36 rotating joint

37 rotating joint

38 releaser

39 blocking element

40-

41 actuator

41a joint element, engaging element

41b joint element, engaging element

42 chute guide device

42a rotary guide section

42b unlocking guide section

44 sliding block, journal

46 anti-loosing structure

48 engaging element

49 engaging clearance

50 safety chute

50a safety shoulder

52 control ramp

54 offset ramp

56. 58 baffle

60 stop shoulder

62 guide device

64 connector

U underside

Direction of V feed

Claims (38)

1. An insertion head for medical or pharmaceutical use, the insertion head comprising:

a) a base (1, 2) having a lower face (U) that can be placed on organic tissue, wherein the base comprises a small receptacle (1) and a flat piece (2), said small receptacle and flat piece being formed in one piece;

b) an insertion device (5) that can be inserted into the tissue and is movably supported by the base (1, 2),

c) wherein the insertion device (5) can be moved relative to the base (1, 2) from a protective position, in which a free end of the insertion device (5) is retracted into the underside (U) of the base (1, 2) and completely concealed, into an insertion position, in which the free end projects beyond the underside (U),

d) and a large receptacle (14) which is open toward the lower side (U) of the base (1, 2) and which can be released from the base (1, 2), the large receptacle (14) receiving at least the free end of the insertion device (5) in the protective position of the insertion device (5),

it is characterized in that the preparation method is characterized in that,

e) the handle (11, 12, 14) is releasably connected to the base (1, 2) and forms the large releasable receptacle (14),

f) the handle (11, 12, 14) has a handle part (11, 12) projecting upwards from the upper side of the base (1, 2), and the releasable large receptacle (14) projects laterally from the handle part (11, 12), wherein the releasable large receptacle (14) surrounds the base (1, 2) in a pot-like or bowl-like manner,

g) the insertion head further comprises an articulation element (6), the base (1, 2) and the articulation element (6) forming an articulation with each other, and the introduction device (5) protruding from the articulation element (6), this being achieved in that the longitudinal direction of the introduction device (5) intersects the axis of movement of the articulation.

2. The insertion head as claimed in claim 1, characterized in that the small receptacle (1) opens out onto the underside (U) of the base (1, 2), the small receptacle (1) receiving a section of the insertion device (5) in the insertion position of the insertion device (5), and the insertion device (5) projecting through the recess (4) of the small receptacle (1) into the releasable large receptacle (14).

3. An insertion head according to claim 2, characterized in that the releasable large receptacle (14) extends the small receptacle (1) in the longitudinal direction of the insertion device (5) and receives the small receptacle (1).

4. The insertion head according to claim 2, characterized in that the small receptacle (1) has an outer surface which descends convexly outward in the direction of the lower side (U) of the base (1, 2) from the upper side of the base (1, 2).

5. Insertion head according to claim 1, characterized in that the insertion device (5) can be pivoted into the insertion position.

6. Insertion head according to claim 1, characterized in that the handle (11, 12, 14) comprises a handle part (12) which is movable relative to the base (1, 2), and that the movable handle part (12) is coupled to the introduction means (5) such that a movement of the movable handle part (12) relative to the base (1, 2) causes a movement of the introduction means (5).

7. Insertion head according to claim 6, characterized in that the movable handle part (12) is coupled to the introduction device (5) by means of a transmission (8, 18).

8. The insertion head according to claim 7, characterized in that the transmission means (8, 18) couple the movable handle part (12) to the introduction means (5) by means of a toothed engagement between the gear wheel (8) and the toothed rack (18).

9. The insertion head according to claim 8, characterized in that the movable handle part (12) is connected to the toothed rack (18) formed on the movable handle part (12), and the insertion device (5) is connected to the toothed wheel (8) in toothed engagement with the toothed rack (18).

10. The insertion head according to claim 8, characterized in that the insertion device (5) is rotatable about a rotational axis and is connected in a rotationally fixed manner to the toothed wheel (8) which is rotatable about the rotational axis and is in toothed engagement.

11. The insertion head according to claim 6, characterized in that the connection existing between the base (1, 2) and the handle (11, 12) is released upon movement of the movable handle part (12).

12. Insertion head according to claim 11, characterized in that a first connecting element (9) is formed on the base (1, 2) and a second connecting element (19) is formed on the handle (11, 12, 14), the first and second connecting elements (9, 19) being in a connecting engagement with each other, and at least one of the first and second connecting elements (9, 19) being movable out of engagement against a spring force.

13. The insertion head according to claim 12, characterized in that the movable handle part (12) is in contact with one of the first and second connecting elements (9, 19) when the movable handle part (12) is moved and moves the first connecting element (9) out of engagement with the second connecting element (19) against the spring force.

14. Insertion head according to claim 6, characterized in that the handle (11, 12, 14) comprises a further handle part (11, 14) and that the movable handle part (12) and the further handle part (11, 14) are clampable between two fingers of one hand, wherein one of the handle parts (11, 12, 14) is squeezed by one of the fingers, whereby the movable handle part (12) can be moved towards the further handle part (11, 14).

15. The insertion head according to claim 6, characterized in that the movable handle part (12) is movable relative to the base (1, 2).

16. The insertion head according to claim 6, characterized in that the movable handle part (12) is guided in a linear manner.

17. The insertion head according to claim 6, characterized in that the movable handle part (12) is movable parallel to the underside (U) of the base (1, 2).

18. An insertion head according to claim 14, characterized in that the further handle part (11, 14) is immovable relative to the base (1, 2) in the connected state and that the further handle part (11, 14) forms the releasable large receiving seat (14).

19. The insertion head according to claim 1, characterized in that the handle (11, 12, 14) projects upwards from the upper side of the base (1, 2).

20. Insertion head according to claim 1, characterized in that the introduction means (5) is flexible and is stabilized by a piercing means (15), the piercing means (15) being movable together with the introduction means (5) from the protective position into the introduction position.

21. An insertion head according to claim 20, characterized in that the puncturing means (15) is connected to the releasable large receptacle (14) when the insertion means (5) is moved into the insertion position.

22. An insertion head according to claim 20, characterized in that the puncturing means (15) together with the releasable large receptacle (14) can be released from the base (1, 2) and the introduction means (5).

23. Insertion head according to claim 1, characterized in that the insertion means (5) extends longitudinally in a longitudinal direction and that the longitudinal direction encloses an acute angle of less than 50 ° with the underside (U) of the base (1, 2) when the free end of the insertion means (5) protrudes beyond the underside (U) when moved into the insertion position.

24. The insertion head according to claim 1, characterized in that the base (1, 2) supports the insertion device (5) in a pivotable manner about a rotational axis, and in that the insertion device (5) has a longitudinal axis which intersects the rotational axis.

25. The insertion head as claimed in claim 1, wherein the large receptacle (10, 14) receives the insertion device (5, 15) in the protective position, and a safety catch (50) is provided in the large receptacle (10, 14).

26. The insertion head according to claim 25, wherein the safety catch can be brought into a locking position assigned to the insertion device (5, 15) close to the protective position.

27. The insertion head according to claim 26, wherein a safety shoulder (50a) is assigned to the locking position.

28. The insertion head according to claim 14, wherein the movable grip part (12) can be pushed into the other grip part (11, 14) in such a way that a control ramp (42) on the movable grip part (12) strikes a deflection ramp (54) on the connecting element (16) after the process for transferring the insertion device (5, 15) from the protective position into the insertion position has ended and is deflected out of the engagement position in such a way that the grip and the base can be separated, wherein the connecting element (16) reversibly connects the base (1) to the grip (10, 12).

29. An insertion head according to claim 18, wherein said large receptacle (14) and said further handle part (10) are integral, wherein said large receptacle is not an integral part of said base (1).

30. An insertion head according to claim 20, wherein a retaining structure (17) is assigned to the insertion device, which retaining structure (17) moves together with the insertion device, wherein the retaining structure (17) has a stop shoulder (60), which stop shoulder (60) engages in a locking manner with an engagement element (48) on the movable handle part (10) when the movable handle part (12) is pulled out of the further handle part, in order to prevent a renewed deflection of the puncturing device (15).

31. The insertion head according to claim 30, wherein the retaining structure (17) comprises a locking structure (46), the locking structure (46) being opposite a wall of the movable handle part (12) extending parallel to the direction of movement of the movable handle part (12), wherein an engagement element (48) on the inner side of the wall is reversibly engageable with the locking structure (46) in the protective position of the insertion device (5, 15).

32. The insertion head according to claim 6, characterized in that:

-the introduction means (5, 15) are held on the base (1) by a rotation axis (6);

-a slide (44);

-a chute guide (42) is provided, which chute guide (42) is in operative connection with the slide (44);

-wherein the movement of the movable handle part (12) relative to the base transfers the slide (44) guided by the chute guide (42) on a first line (a) of a first section (42a) of the chute guide from a first position corresponding to the protection position of the lead-in device (5, 15) into a second position corresponding to the lead-in position of the lead-in device (5).

33. An insertion head according to claim 32, wherein a connecting device (16b) is provided, which connecting device (16b) reversibly connects the base (1) to the handle (10, 12), wherein the movable handle part can be moved on a second line (b) perpendicular to the direction of extent of the insertion device (5, 15) in the insertion position in order to release the handle from the base, wherein the slotted guide (42) has a second section (42b) corresponding to the second line (b).

34. An insertion head according to claim 31, wherein the insertion device (5, 15) is assigned the locking mechanism, which reversibly fixes the insertion device (5, 15) in the protective position.

35. The insertion head according to claim 31, wherein a cannula housing (17b) is assigned to the introduction device, which cannula housing (17b) moves together with the introduction device, wherein the cannula housing (17b) comprises the locking structure (46).

36. An insertion head as claimed in claim 18, wherein a securing slot (50) is provided in the further handle part (10) and/or the large receiving socket (14) and/or the movable handle part (12) which receive the insertion device (15) in the protective position, the insertion device (5, 15) being engageable in the securing slot (50) in the protective position.

37. The insertion head according to claim 14, wherein the movable grip part (12) can be pushed into the further grip part (10) in such a way that a control ramp (52) on the movable grip part (12) strikes a deflection ramp (54) on the connecting element (16) after the end of the process for transferring the insertion device (5, 15) from the protective position into the insertion position and is deflected out of the engagement position in such a way that the grip and the base can be separated, wherein the connecting element (16) reversibly connects the base (1) to the grip (10, 12).

38. An insertion head according to claim 30, wherein the stop shoulder (60) is in positioning engagement with an engagement element (48) during a relative movement of the movable handle part (12) with respect to the further handle part (10) for preventing a renewed deflection of the puncturing device (15).