HK1125870B - System composed of an insertion head and an inserter - Google Patents

Description

System consisting of an insertion head and an inserter

Technical Field

The invention relates to a system comprising an insertion head for medical or pharmaceutical use and an inserter for automatically placing the insertion head onto organic tissue, preferably onto the skin of a person. The insertion head may in particular be a component of an injection kit for injecting a medicament.

Background

An insertion head is known from DE 19821723C 1, which comprises a base with a guide projecting from the underside of the base. The insertion device is designed as a flexible sleeve. The insertion needle stabilizes the introduction device, which is introduced into the tissue of the patient. As a protection against needle-stick injuries, a needle protection is releasably fastened to the base. The removal process of the needle guard is cumbersome. Furthermore, the insertion device projecting from the underside together with the puncturing needle and the needle protection device greatly increases the packaging volume of the insertion head.

Another problem is the placement of the insertion head on the tissue. This is particularly problematic in the case where the user himself uses the insertion head himself, for example, when self-injecting a medicament. The insertion head is introduced into the tissue, which may awaken the user's affective disorder. For some users, the dislike of a needle is provoked upon seeing it. Accordingly, the user concerned is very unstable when placing the insertion head on the tissue. In order to avoid said aversion and possibly also instability later in operation which could lead to incorrect operation, inserters have been developed by means of which the placement of the insertion head on the tissue can be automated. An example of such an inserter is disclosed in DE 20320207U 1.

In an insertion head known from german patent application No. nr.102004039408, the insertion device is movably supported by the base, so that the disadvantages are overcome. The introducer device occupies a protective position for storage, delivery, and handling until introduction into the tissue. For insertion, the insertion device can be moved from the protective position into an insertion position. As a preferred movement, a swiveling movement is disclosed. The insertion head is advantageously compact when the insertion device assumes the protective position and the risk of injury is no longer present in the protective position. However, to be introduced into the tissue, the introduction device must be moved into the introduction position and placed onto the tissue.

Disclosure of Invention

The object of the invention is also to provide an inserter for an insertion head with a movable insertion device, such as the insertion head described in DE 102004039409, which inserter can receive the insertion head and, after release, automatically place it on the tissue, including the introduction of the insertion device into the tissue.

A system according to the invention, consisting of an insertion head and an inserter, comprises an insertion head with a base which has a lower side or bearing surface which can be placed on tissue and an introduction device which is movably supported by the base. The insertion device is movable relative to the base from a protective position, in which at least the free end of the insertion device is retracted behind the underside of the base, into an insertion position, in which the free end projects beyond the underside and can enter tissue. The inserter comprises an inserter housing, holding means for holding the insertion head in an initial position, and drive means. The inserter housing has a through-opening for the insertion head on the underside facing the tissue when the insertion head is placed. For placement, the inserter housing may be placed on tissue with its underside. The holding device can be connected to the inserter housing movably or positionally fixed, preferably rigidly. The retaining means preferably holds the insertion head in the initial position such that the lower side of the insertion head and the lower side of the inserter housing point in the same direction. The drive device is designed such that it can move the insertion head from the initial position in a feed direction directed through the through-opening of the inserter housing. The drive means can simultaneously form the holding means by holding the insertion head during the movement up to the placement on the tissue or during a substantial part of such a movement and releasing the insertion head only at the end of such a movement or only after the placement on the tissue. In a preferred embodiment, however, the holding device and the drive device are separated from one another and the insertion head is released immediately at the beginning of its movement out of the holding engagement, the holding device holding the insertion head in the holding engagement in the initial position.

Furthermore, according to the invention, the inserter comprises an activation element which can be moved relative to the holding device and which can be actuated by a user, by means of which activation element the insertion device of the insertion head can be acted upon in order to move the insertion device into the insertion position. Although it is possible in principle to act on the insertion head and in particular on the insertion head introduction means when the drive means moves the insertion head in the feed direction, in a preferred embodiment the activation element acts on the insertion head when the insertion head assumes the initial position relative to the inserter housing and is in the retaining engagement with the retaining means, that is to say when the insertion head is stationary. The activation element can also simultaneously form a release of the inserter, with which the drive device can be released and the insertion head can thus be moved to the tissue. In such an embodiment, a suitable process control mechanism preferably causes the insertion head to be activated in a first step, that is to say by a transfer movement of the insertion device into the insertion position, and releases the movement of the insertion head in a subsequent step. In a preferred embodiment, however, the activation element serves only for activating the insertion head, and a release, such as a release button, is additionally provided on the inserter for releasing. The system according to the invention combines the advantages of an insertion head with a movable insertion device with the advantages of automated placement on tissue.

For the purpose of functioning, the activation element and the insertion device are connected or coupled to one another by means of a coupling.

The coupling the activation element and the insertion device comprises in a preferred embodiment a joint with two joint elements which are automatically brought into engagement with each other or can be brought into such an engagement when the insertion head is in the initial position or during the movement of the insertion head. Preferably, the joints are curved joints, i.e. one of the joint elements in such an embodiment is a guide curve part and the other joint element is an engagement element guided on the guide curve part. The activation element may in particular form one of the joint elements, acting on at least one of the joint elements. Although less preferred, the joint can also be embodied, for example, as a helical joint or as a two-gear wheel toothing or as a one-gear and one-rack gear toothing. A curvilinear joint provides a large design space for the translation of the movement of one of the joint elements to the movement of the other joint element.

In the articulation, that is to say in the connection established by the articulation, one of the articulation elements can be moved relative to the other articulation element, preferably also relative to the inserter housing, preferably in or counter to the feed direction of the insertion head. If the joint is preferably designed as a curved joint, the guide curve part of the curved joint has an inclination relative to the feed direction during this movement. The engaging element can in such a case be moved preferably transversely to the feed direction. The inclination of the guide curve element can in particular be constant, so that a straight guide curve element is obtained. In principle, however, the inclination angle can also be varied and the guide curve element can be curved, for example.

The activation element acts on a receiving element of the insertion head, which is movably supported by the base of the insertion head. The receiving element is connected to the insertion device rigidly or preferably in an articulated manner, so that the insertion device is moved into the insertion position when the receiving element is moved relative to the base. The activation element preferably acts on the receiving element via or in the joint. In principle, however, the coupling between the activation element and the receiving element can also be free of joints, that is to say if the activation element presses directly against the receiving element or pulls on the receiving element and the receiving element is only moved in this movement in a simple manner.

The coupling between the activation element and the insertion device, preferably between the activation element and the receiving element, comprises in a preferred embodiment a loose, i.e. purely pressure contact. The two elements in pressure contact each form a contact surface for pressure contact. The purely pressure contact without further connections simplifies the mechanical structure and facilitates the release of the insertion head and the insertion of a new insertion head. The two contact surfaces for pressure contact preferably form the interface between the insertion head and the inserter. In a preferred embodiment, the mentioned receiving element of the insertion head forms one of the contact surfaces. The other contact surface can then be formed directly on the activation element or on an actuating element, via which the activation element acts on the insertion device.

The joint contained in the coupling between the activation element and the insertion device is formed solely by the insertion head, for example between the mentioned receiving element and the insertion device, when the activation element acts directly on the insertion head. Preferably, the joint forms the interface between the insertion head and the inserter, i.e. the inserter and the insertion head each form one of the two joint elements of the joint. More preferably, the knuckle is provided on one side of the inserter. Furthermore, in the above-described embodiment, it is preferable that the activation element and the actuator element together form the joint. The inserter housing in such embodiments movably supports the activation element and the actuator relative to each other. The actuator can in particular, as already mentioned, form a contact surface for a preferably purely pressure contact at the interface between the inserter and the insertion head.

In the last-mentioned embodiment, the activation element and the actuating element form the joint with one another, in which embodiment a further joint is preferably provided. The activation element and the actuating element may in such an embodiment optionally form the joint and the further joint with each other. The inserter housing supports the activation element in a first direction and is movable back and forth in a direction opposite the first direction. In addition, the inserter housing supports the actuator in another second direction and is movable back and forth in a direction opposite the second direction. The direction of movement of the activation element and the direction of movement of the actuating element can be oriented, in particular, at right angles to one another. The activation element acts on the actuation element in the joint when the activation element is moved in the first direction. When moved in the opposite direction, the activation element then acts on the actuating element in the other joint. In one of the joints, a movement of the actuating element is generated, with which the actuating element acts on the insertion head, indirectly via one or more transmission elements or preferably directly on the mentioned receiving element. In the other joint, the actuator moved out under the action described above is returned to the initial position. The further joint is preferably likewise designed as a curved joint, and the explanations given with respect to the curved joint already explained apply in this respect.

In a preferred embodiment, the actuator is shaped as a housing part and can be moved relative to the inserter housing in or counter to the feed direction. Preferably, the inserter housing guides the activation element in a sliding movement. As a housing part, the activation element can be designed in particular like a sleeve. Preferably, the activation element can be moved back and forth in the feed direction or counter to the feed direction. The activation element can be moved in the feed direction until it reaches a moved-out position and, counter to the feed direction, until it reaches a moved-in position. The inserter housing and the activation element in the described embodiment constitute a telescopic housing. The activation element in the embodiment described preferably forms the underside of the insertion device with which the insertion device can be placed on the tissue for placing the insertion head. If the activation element assumes the retracted position relative to the inserter housing and the telescopic part formed by inserter housing and activation element accordingly has its shortest length, the insertion head can be inserted comfortably through the open underside of the inserter and placed in retaining engagement with the retaining device. The insertion head is activated by the removal of the activation element or, conversely, by the removal of the inserter housing, that is to say the insertion device is moved into the insertion position. The inserter is in this case elongated in the feed direction. During the movement of the insertion device into the insertion position, the insertion device is preferably visually concealed by the activation element or the inserter housing, i.e. the telescopic part formed by the inserter housing and the activation element forms a shield. In the removed position of the inserter housing and activation element, the introduction means takes up its introduction position and is retracted with its free end behind the lower side of the inserter. The locking device prevents the telescopic part consisting of the inserter housing and the activation element from being shortened in the state in which the holding device holds the insertion head. If the manipulatable activation element is mentioned, this is also to be understood as a movement of the inserter housing relative to the activation element held by the user, that is to say a relative movement between the inserter housing and the activation element, which moves the introduction device into the introduction position.

In addition to the system of inserter and insertion head, the invention also relates to an inserter which can be designed in particular as explained above.

The insertion head described in DE 102004039408 may form the insertion head of the system according to the invention. In order to move the insertion device of the insertion head from the protective position into the insertion position, it is sufficient for example to provide an activation element, which is designed at least at one end as a small rod or as a narrow plate, which is supported by the inserter housing so as to be movable back and forth transversely to the feed direction. The activation element is moved for activation between the base and a grip part of the insertion head, which is rigidly connected to the insertion device with respect to a rotational movement. The activation element moved between the base and the handle member erects the handle member. Due to the torsion-resistant coupling, the insertion device is moved into the insertion position in the process. A space may be left between the base of the insertion head and the handle, into which space the activation element can be introduced transversely to the feed direction without erecting the handle piece. In one embodiment, the inserter housing supports the activation element in a manner that complements the lateral movement and also moves counter to the feed direction. If the activation element moved in between the base and the grip part is moved counter to the advancing direction, the grip part is pivoted into the insertion position and the insertion device is thereby also pivoted into the insertion position. The handle part forms a guide curve part and the activation element forms an engagement element of the curve joint. If the activation element is mounted so as to be movable only transversely with respect to the feed direction, it is alternatively possible, although less preferred, to activate it only in the first phase of the feed movement of the insertion head, i.e. to transfer the guide means into the guide position.

The following are also additionally described with respect to such an insertion head:

in the protective position, at least one free end of the insertion device is retracted behind the underside of the base. Preferably, the insertion device is retracted in the protective position over its entire length behind the lower side and is completely covered, preferably also 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 construction of the base, wherein the height of the base is measured at right angles to the underside. In the insertion position, the free end projects beyond the underside and can be inserted into tissue.

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.

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 means preferably protrudes over the underside of the housing over a length which is adapted to the subcutaneous injection, preferably directly from the underside or protruding from the underside. 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.

At the moment when the free end of the insertion device is displaced forward beyond the underside, the insertion position assumes exactly a position in which an acute angle, preferably less than 50 °, is enclosed between the longitudinal axis of the insertion device and the underside of the base. 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 insertion device is pivoted about a rotational axis, the longitudinal axis of which preferably intersects the rotational axis. 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 pivot angle can also be smaller, in particular if the insertion device in the insertion position is not oriented at right angles to the underside of the base, but at an acute angle, which 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 ° and approximately 90 °. In principle, the pivot angle can also be greater than 90 °.

According to the invention, the insertion head comprises a handle extending from the base, which handle has a first handle part and a second handle part which can be moved relative to the first handle part and the base. The movable second handle part is coupled to the insertion device such that a movement of the second handle part causes a movement of the insertion device into the insertion position.

Since the handle is provided with a movable handle part, the movement of the introduction device can be caused solely by the gripping and manipulation of the handle. The handle itself forms a support for the movable second handle part when the insertion head is placed manually. In this sense, the part of the handle that forms the support is referred to herein as the first handle part. The second grip part can be configured, for example, as a push button. The first handle part may be a housing from which such a button projects. In an equally preferred embodiment, the two grip parts together form the grip only, 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 its handle, has a holding structure 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 an immovable manner and a handle part which can be moved relative to this handle part, the immovable part preferably forms the retaining structure. The retaining structure can be formed in particular integrally on the handle or the immovable handle part, preferably at least rigidly connected to the handle or the immovable handle part.

The movable handle part preferably forms the receiving element mentioned above in connection with the system of insertion head and inserter, but is referred to below as movable handle part, provided that 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 merely serves for coupling between the activation element and the introduction device.

In a preferred embodiment, the movable second handle part is at least substantially movable 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 grip part can also be mounted, for example, in a swivelable manner.

The first handle part is preferably non-movably connected with the base. In principle, however, it is also conceivable for the two grip parts to be connected to the base in such a way that they can be moved relative to the base.

In order to transmit the movement of the second handle part to the insertion device, a rigid coupling can be provided, i.e. the second handle part and the insertion device can be rigidly connected to one another, which can also be understood to mean an integrally formed structure. A rigid coupling can be easily achieved, for example, if the insertion device can preferably perform a pivoting movement, even if the second handle part can perform a pivoting movement. 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 first handle part can be used as a support for the user and 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 first handle 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 second handle part and the insertion device are coupled to one another 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 rotational movement and the second handle part can be guided in a translational movement, preferably in a linear movement. In the case of a swiveling movement of the second grip part, too, the swivel axis of the second grip part can be different from the swivel axis of the insertion device. The insertion device is preferably pivotable about a rotational axis which is at least substantially parallel to the underside of the base, which also applies to all embodiments of the second handle part, while the pivotable second handle part is pivotable about a rotational 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 swivelably movable second handle part, the axis of rotation of this second handle part is spaced apart from the axis of rotation of the swivelably movable insertion device in parallel. In such a case, the pivoting angle of the second 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 gear engagement with one another and engage one another when the second handle part is moved. The toothed rack is preferably connected to the second handle part in such a way that a movement of the second handle part in the longitudinal direction of the toothed rack is converted into a rotational movement of the gear wheel, which in this case is connected to the insertion device. In the case of a smaller gear wheel diameter, the shorter stroke of the second handle part can be converted into a rotational movement of a large part of a complete revolution of the gear wheel, preferably into a rotational movement of a quarter of a revolution of the gear wheel. Preferably said movable second handle part is integrally formed with said rack.

The handle is in a preferred embodiment releasably connected to the base. Preferably, this connection is automatically released when the second handle part is moved, i.e. when the insertion device is moved into the insertion position. 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 is based solely on a form-fitting connection or a combination of a form-fitting connection and a frictional connection. For the purpose of establishing the connection, the base and the handle, preferably the first handle part of the handle, are each provided with at least one connecting element, which are in engagement with one another 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 a restoring spring force. In a preferred embodiment, the movable second handle part serves not only for transferring the insertion device into the insertion position, but also for releasing the connection by the second handle part being released from the engagement state, for example elastically bent away from the engagement state, by contact, preferably sliding contact, with one of the connection elements during its movement against the elastic force. Although less preferred, the first handle component may alternatively be integrally formed with the base or non-releasably secured thereto. However, in such an embodiment, the first handle part should be as short as possible.

In the protective position, at least the free end of the insertion device, preferably the entire insertion device, is received in a receptacle, which is formed by either the base or the handle. If the handle forms the receptacle, the base forms a partial receptacle which is received in the receptacle formed by the handle, as long as the handle is connected to the base when a preferably releasable handle is used.

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 device is introduced into the tissue, the penetration device is preferably removed. Preferably, the handle is also used for removing such a puncturing device. If the puncturing device is preferably not already connected to the handle in the protective position, the puncturing device is preferably automatically connected to the handle when it is moved into the insertion position. For this purpose, a connecting element, preferably a snap-in element, is provided at the end of the insertion device facing away from the free end of the puncturing device, which connecting element, with or shortly before the end of the movement into the insertion position, engages in a connecting manner with a mating connecting element of the handle. The connection preferably comprises at least a form-fitting connection, although in principle a purely frictional connection is possible. The connecting element of the puncturing device can together with the counter-connecting element form in particular a snap-in connection. In principle, only a simple snap-in from the rear (hindregriff) with respect to a specific direction would be sufficient for a form-fitting connection, in which direction the handle should be removed from the base; a resilient snap engagement is not necessarily required.

The insertion head is for medical or pharmaceutical, including cosmetic, use. At least the underside of the base is formed so as to be compatible with the tissue. The insertion head is preferably part of an injection kit for injecting insulin, an analgesic or another drug which can be injected by means of an infusion. 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 inclusions of the body fluid during the flow-through in order to analyze the flushing liquid enriched with the relevant inclusion or inclusions. Finally, the insertion head can have a device for injecting the product and can form the diagnostic device in a systematic manner. The introduction device can be designed for the supply of a product, in particular a medicament or a flushing liquid, or for the discharge of a body fluid or of one or more substances contained in a body fluid, i.e. in such an embodiment the introduction device forms at least one flow cross section. The introduction device can also be used in the form of a system for the supply and removal of material. If the insertion head is designed as a measuring device, the measuring device can also be used only for placing the sensor or a part of the sensor, i.e. purely as a mechanical insertion device. In a development of the measuring device, the latter serves, in addition to the mechanical insertion function, to transmit control signals to the sensor and/or to transmit measuring signals of the sensor. In a combined application, the measuring device finally has at least one flow cross section for the material transport, that is to say 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 separately projecting insertion sections. For example, a first insertion section can be used to feed material into the tissue, and a further insertion section can be used to feed material out of the tissue or to insert only 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.

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

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

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 rotational 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 imparts a pivoting movement to the insertion device 5 and thus to the puncturing device 15, the joint element 6 forming the shaft of a rotary joint having an axis of rotation 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 axis of rotation of the joint, an externally toothed gear wheel 8 is arranged on each side of the joint element 6, and the gear wheels 8 are connected to the joint element 6 in a rotationally fixed manner, for example integrally formed. 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 handle part 12 is moved transversely to the feed direction V toward the other handle part 10, and the insertion device 5 is as explained in connection with such an insertion headIs rotated 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 extend beyond the free walls of the insertion device 5 and the puncturing device 15The end portion surrounds the 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.

List of reference numerals

1 base, receiving base

2 base, flat member

3 gap

4 voids

5 introduction device

6 Joint element

7 supply device

8 gear

9 connecting element

10 first handle part

11 first handle part

12 second handle part, receiving element

12a joint element, engaging element, pressure contact surface

13 contact piece

14 receiving seat

15 lancing device

16 connecting element

17 holding structure

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

U underside

Direction of V feed

Claims (28)

1. A system consisting of an insertion head and an inserter for placing the insertion head on organic tissue,

a) the insertion head includes:

a1) a base (1, 2) having a lower side (U) that can be placed on tissue;

a2) and an introduction device (5) movably supported by the bases (1, 2),

b) the inserter comprises:

b1) an inserter housing (20; 30) the inserter housing (20; 30) on the lower side there is an opening for the insertion head,

b2) and the inserter housing (20; 30) connected holding means for holding the insertion head in an initial position,

b3) -drive means (22, 23; 32. 33) is driven by means of the drive device (22, 23; 32. 33) which is movable along a longitudinal axis through the inserter housing (20; 30) is directed in a feed direction (V), and

b4) a movable and manipulable activation element (21; 31) by means of which activation element (21; 31) can act on the introduction device (5),

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

c) the insertion head comprises a receiving element which can be moved by means of the activation element (21; 31) relative to the base (1, 2), wherein the movement of the receiving element relative to the base (1, 2) moves the insertion device (5) from a protective position, in which a free end of the insertion device (5) is retracted behind the underside (U) of the base (1, 2), into an insertion position, in which the free end projects beyond the underside (U) of the base (1, 2).

2. The system as claimed in claim 1, characterized in that the coupling the activation element (21; 31) to the introduction device (5) comprises a joint having two joint elements (12a, 21 a; 31a, 41a) which are or can be brought into engagement.

3. The system according to claim 2, characterized in that the activation element (21; 31) forms one of the joint elements (21 a; 31 a).

4. The system according to claim 2, characterized in that the articulation elements (12a, 21 a; 31a, 41a) are guide curve parts (21 a; 31a) and engagement elements (12 a; 41a) guided on the guide curve parts.

5. System according to claim 4, characterized in that one of the guide curve part (21 a; 31a) and the engaging element (12 a; 41a) is movable relative to the other in or against the feed direction (V), and that said guide curve part (21 a; 31a) has an inclination relative to said feed direction (V).

6. System according to claim 4, characterized in that one of the guiding curve part (21 a; 31a) and the engaging element (12 a; 41a) is movable relative to the inserter housing (20; 30) in or against a feed direction (V), and that the guiding curve part (21 a; 31a) has an inclination relative to the feed direction (V).

7. System according to claim 5, characterized in that one of the guiding curve parts (21 a; 31a) and the engaging elements (12 a; 41a) is movable relative to the other transversely to the feed direction (V), and that the guiding curve parts (21 a; 31a) have an inclination relative to the feed direction (V).

8. System according to claim 5, characterized in that one of the guide curve part (21 a; 31a) and the engagement element (12 a; 41a) is movable relative to the inserter housing (20; 30) transversely to the feed direction (V), and that the guide curve part (21 a; 31a) has an inclination relative to the feed direction (V).

9. System according to claim 5, characterized in that the guide curve element (21 a; 31a) is inclined away from the insertion device (5) in the insertion position in the feed direction (V).

10. The system of claim 2, wherein said inserter constitutes said joint (31a, 41 a).

11. The system according to claim 2, characterized in that the receiving element is rigidly or hingedly connected to the introduction device (5) and the activation element (21; 31) acts on the receiving element via the joint (12a, 21 a; 31a, 41 a).

12. The system as claimed in claim 2, characterized in that the coupling the activation element (21; 31) to the introduction device (5) comprises a purely pressure contact, by means of which the activation element (21; 31) acts on the introduction device (5).

13. The system according to claim 12, wherein said receiving element forms a contact surface (12a) for said pressure contact.

14. The system according to claim 13, wherein the receiving element forms one of the articulation elements (12 a).

15. System according to claim 2, characterized in that the inserter movably supports an actuator (41) and that the actuator (41) constitutes the articulation element (41a) of the articulation.

16. System according to claim 2, characterized in that the inserter movably supports an actuator (41) and that the actuator (41) together with the activation element (31) forms the articulation (31a, 41 a).

17. The system as claimed in claim 15, characterized in that the actuator element (21; 41) forms a contact surface (21 a; 41a) for the pressure contact.

18. The system according to claim 17, characterized in that the activation element (31) and the actuator element (41) form the joint (31a, 41a) and a further joint (31b, 41b) with each other and are each supported by the inserter housing (30) in a manner movable back and forth, and the actuator element (41) is moved in one direction by means of the joints (31a, 41a) and in the opposite direction by means of the further joint (31b, 41 b).

19. The system as claimed in claim 2, characterized in that the inserter housing (20; 30) supports the activation element (21; 31) in such a way that it can be moved in or against the feed direction (V) up to an advanced or extended position and guides the activation element (21; 31) in a sliding manner.

20. System according to claim 2, characterized in that the activation element (21; 31) in the removed position extends the inserter housing (20; 30) in the direction of feed (V) and forms the lower side (U) of the inserter which can be placed on the tissue₂₁；U₃₁) And has a through-opening for the insertion head on the underside.

21. The system as claimed in claim 2, characterized in that the inserter comprises a release (28) for the drive means (22, 23; 32, 33) and a latching element (29), which latching element (29) latches the drive means in a retaining position in a latched engagement with the inserter housing (20; 30) and can be released from the latched engagement by manipulation of the release (28).

22. A system according to claim 2, characterized in that said holding means comprise a fastening spring which in said initial position holds said insertion head in a holding engagement and said holding engagement can be released by the driving force of said driving means (22, 23; 32, 33) against the elastic force of said fastening spring.

23. System according to claim 2, characterized in that the drive means (22, 23; 32, 33) comprise a feed element (22; 32) acting on the insertion head in the initial position of the insertion head and a power generator (23; 33) acting on the feed element (22; 32) in the feed direction (V).

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

25. System according to claim 24, characterized in that the base (1, 2) supports the introduction device (5) in a manner pivotable about a rotational axis, and that the introduction device (5) has a longitudinal axis which intersects the rotational axis or intersects the rotational axis at a distance of at most half the length of the introduction device (5).

26. The system according to claim 2, wherein the insertion head further comprises a handle (10, 12; 11, 12, 14) extending from the base (1, 2) and a coupling (8, 18), wherein the handle (10, 12; 11, 12, 14) has a first handle part (10; 11, 14) and a second handle part (12) which can be moved relative to the base (1, 2) and the first handle part (10; 11, 14), and the coupling (8, 18) converts a movement of the second handle part (12) into a movement of the insertion device (5).

27. System according to claim 26, characterized in that the handle (10, 12; 11, 12, 14) is releasably connected to the base (1, 2) and that this connection is released upon movement of the second handle part (12).

28. System according to claim 26, wherein said handle (11, 12, 14) forms a receiving seat (14), which receiving seat (14) receives the lead-in device (5) in the protective position of said lead-in device (5).