CN101355979B - Insertion head with needle protection integrated into the handle - Google Patents

Abstract

The invention relates to an insertion head for medical or pharmaceutical use, comprising: e) a base with an underside (U) that can be placed on organic tissue; An introduction device (5) movably supported by said base (1, 2), g) wherein said introduction device (5) is movable relative to said base (1, 2) from a protective position to an introduction position , wherein in the protected position the free end of the introduction means (5) is retracted behind the underside (U) of the base (1, 2), and in the introduction position the free end ends protruding beyond said underside (U), h) and open towards the underside (U) of said base (1, 2) and releasable from said base (1, 2) A receptacle (14) which receives at least the free end of the introduction device (5) in the protective position of the introduction device (5).

Description

Insertion head with needle guard in the handle

technical field

The present invention relates to an insertion head for medical or pharmaceutical use, which can be placed on organic tissue, preferably human skin, and has an introduction device, after which the insertion head is placed on said tissue The introduction device is introduced into the tissue when the insertion head is placed on the tissue or possibly only after the insertion head has been placed on the tissue. In particular, the insertion head can be a component of an injection set for injecting medicaments.

Background technique

From DE 198 217 23, an insertion head with a base is disclosed, the base has an underside that can be placed on the organic tissue, and a flexible sleeve that is immovably connected to the base protrudes beyond the The lower side of the cannula is guided 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 piercing needle which passes through the cannula. In order to protect the user from injury by the protruding piercing needle and to prevent damage to the piercing needle together with the introduction device, a cylindrical needle guard is releasably fastened to the underside of the insertion head. The needle guard requires a certain amount of space and there is a risk that it will come loose from the insertion head in the event of inadvertent handling. Furthermore, to remove the needle guard, the user needs two hands, one of which is still in the vicinity of the freely protruding piercing needle after removal of the needle guard.

From the German patent application Nr. 10 2004 039 408.3 an insertion head with an introduction device is known which can be moved from a protective position into an introduction position in which the introduction device is received in a receptacle In the insertion position, the introduction device then protrudes beyond the underside of the insertion head and guides into the tissue when the insertion head is placed on the tissue surface. The receptacle is an integral component of the insertion head, which for this purpose forms a cavity which is open towards the lower side. In the protective position, the introduction device is completely accommodated in the cavity forming the receptacle, in particular its free end does not protrude beyond the lower side or laterally. Although the insertion head advantageously does not require any separate protection means for the introduction device and is therefore as flat in the delivery state as in the use state, that is to say in the state placed on tissue flat. However, the insertion head is lengthened due to the integrally formed receptacle.

Contents of the invention

The object of the present invention is to provide an insertion head which, like the insertion head of DE 10 2004 039 408, can be handled without risk, and in the state of use, that is to say placed on the tissue surface and inserted into the Very compact after the introduction described above.

An insertion head according to the invention comprises a base with an underside that can be placed on organic tissue, an introduction device that can be introduced into the tissue, and a device that receives the introduction device in a protected position of the introduction device. A receptacle for at least one free end.

According to the invention, in the protected position of the introduction device at least the free end of the introduction device does not protrude beyond the underside of the base. More precisely, the introduction device is mounted movably away from the base, so that it can be moved relative to the base from the protective position into an introduction position, in which the introduction device The free end protrudes beyond the underside. In the protected position, the introduction device is preferably set back over its entire length behind the underside of the base and is completely covered, preferably opaquely covered. In a preferred embodiment, the introduction device is at least substantially parallel to the underside or support surface of the base in the protective position. This is advantageous for a flat design of the base, the height of which is measured perpendicularly to the underside. Furthermore, the receptacle is releasably connected to the base. In the connected state, the receptacle provides protection for the introduction device, so that the base relieves this function and thus saves length on the base that would otherwise be necessary to fulfill the protective function. The receiving seat is open towards the lower side of the base. In principle, the opening is only sufficient for the introduction device, but preferably the releasable receptacle is pot-shaped or bowl-shaped, preferably in the shape of a half-pot or half-bowl, surrounding the base or part of the base. The receptacle can preferably be easily removed upwards from the base after the connection has been released.

For ease of handling, the insertion head is preferably provided with a handle protruding from the base. The handle or, in the case of a preferably multi-part handle, at least one handle part can be detachably connected to the base. Such a handle or such a handle part preferably forms a releasable receptacle for the introduction device. In a further preferred embodiment, the handle has a handle part projecting high from the upper side of the base, and the receptacle protrudes laterally from the handle part.

Preferably, the handle is multi-part and comprises a handle part which is movable relative to the base and a further handle part or optionally relative to several other handle parts. The movable handle part is preferably coupled to the introduction device in such a way that a movement of this handle part causes a movement of the introduction device. A further handle part preferably forms a support for the movement of 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 forms a releasable receptacle. A plurality of handle parts can also jointly form the receiving seat.

Since the handle is provided with movable handle parts, movement of the introduction device can be brought about only by grasping and actuating the handle. The handle itself forms a mount for the movable handle part. In this sense, the part of the handle which forms the seat is referred to here as a further handle part. The movable handle part can be designed, for example, as a button. Said further part may be a housing from which such a button protrudes. In a likewise preferred embodiment, the two handle parts together only form the handle, eg they each form one half of a total two-part handle.

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

The movable handle part preferably forms the receiving element described above with respect to the system consisting of the insertion head and the inserter, but will be referred to below as a movable handle as long as a particularly preferred embodiment of the insertion head is described. Handle parts. In principle, however, the receiving element of the system does not have to be a handle part, but can only be used for the 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, this can be a linear movement. As an alternative to a purely translational movement, it is also possible, for example, to mount the second part in a pivotable manner.

The at least one further handle part is preferably immovably connected to the base. In principle, however, it is also conceivable that the two handle parts are 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 introduction device, a rigid coupling can be provided, that is to say, the movable handle part and the introduction device can be rigidly connected to each other, and the rigid connection is also It can be understood as an integrally formed structure. A rigid coupling can easily be achieved, for example, if the introduction device is preferably pivotable, if the movable handle part is also pivotable. 10 2004 039 408.3 with respect to the insertion head of German patent application Nr. The base absorbs the force exerted for the pivoting movement, more precisely, this force is absorbed by the user by gripping the other handle part. If the user has an inserter, in particular an inserter according to the invention, the inserter is subjected to this force, wherein the insertion head is placed on the tissue with the inserter according to the invention and in the process guides the Induction.

In a preferred embodiment, the movable handle part and the introduction device are coupled to each other via a transmission. An advantage of such a coupling is that the mobility of the handle part does not have to correspond to the mobility of the introduction device, but both mobility can be optimally configured individually. In particular, it is thus possible to guide the insertion device in a rotary motion and the movable handle part in a translational motion, preferably linearly. In case the handle part also has rotational mobility, the axis of rotation of the handle part can differ from the axis of rotation of the introduction device. The insertion device is preferably pivotable about an axis of rotation at least substantially parallel to the underside of the base, this also applies to all embodiments of the movable handle part, while the pivotally movable handle The part is pivotable about an axis of rotation at least substantially at right angles to the underside. However, it is also advantageous if, when a pivotally movable handle part is used, the axis of rotation of the handle part is spaced parallel to the axis of rotation of the pivotally movable insertion device. In such a case, the swivel angle of the handle part can be transmitted to the insertion device by means of a transmission in a reduced or preferably accelerated manner.

A preferred transmission coupling comprises a pinion and a toothed rack, which are in toothed engagement with each other and mesh with each other when the handle part is moved. The toothed rack is preferably connected to the movable handle part such 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 connected to the introduction device in this case . With a correspondingly fine toothing or pitch, the relatively short lift of the movable handle part can be converted into a rotational movement of the gear over a large fraction of a complete revolution, preferably into a quarter-turn rotation. Preferably said movable handle part is integrally formed with said rack. Instead of a coupling via one or optionally several gear pairs, the clutch can also be designed as a guide curve part and a toothing element or include such a guide curve joint, although the coupling is preferably produced by means of tooth meshing.

In a preferred embodiment, the handle is detachably connected to the base as already mentioned. This connection is preferably released automatically when the introduction device is moved into the insertion position, especially preferably when the movable handle part is moved. As an alternative, however, it is in principle also conceivable to assign a further movable part to the handle or the base, by actuation of which the connection to the base is released. Although the connection between the handle and the base can be produced by a purely frictional connection, it is preferred that the connection is based solely on a form-fitting connection or on a combination of form-fitting and frictional connections. To establish the connection, the base and the handle are each provided with at least one connection element, which engage with each other when the connection is present. In order to be able to release the connection, preferably at least one of the connecting elements can be released from the engaged state against a restoring spring force. In a preferred embodiment, the movable handle part is used not only for transferring the introduction device into the introduction position, but also for releasing the connection, in that the second handle part By contact, preferably sliding contact, with one of the connecting elements, the elastic force is released from the engaged position, eg elastically bent out of the engaged position. Although less preferred, the further handle part may alternatively be integrally formed with the base, or be non-releasably fixed to the base. However, in such an embodiment, the further handle part should be as short as possible.

)把手或者比如由于所述可松开的接纳座一体成形在所述把手上该接纳座因而不是一种这样的把手的组成部分，但仍然优选所述导入装置通过对所述接纳座的松开来说所必需的手动操作也自动地从所述保护位置运动到所述导入位置中。因此，在所述可松开的接纳座上比如可以安装按钮或者另一种操纵元件，或者这样的元件可以合适地与所述接纳座相连接并且所述接纳座可以通过所述操纵元件的操纵与所述基座松开。If the insert is not special that is unique (

) handle or for example because the releasable receptacle is integrally formed on the handle the receptacle is not an integral part of such a handle, but it is still preferred that the introduction means The necessary manual operation is also automatically moved from the protective position into the introduction position. 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 actuated by the actuating element. Release from the base.

The introduction device may be a bend-resistant cannula or a needle. Preferably the introducing device is flexible at least in tissue. In particular, the introduction device can have a flexural stiffness which is reduced in the introduced state due to interactions occurring between the material of the introduction device and the tissue surrounding the material of the introduction device. Alternatively, the introduction device can also be configured in a conventional manner as flexible, for example as a flexible sleeve, and stabilized during insertion into the tissue by a bending-resistant piercing device. The introduction device preferably extends longitudinally in the introduction direction and is preferably elongated.

If the introduction device is flexible at the factory, that is to say it does not only become flexible through interaction with the tissue, then the introduction device is preferably stabilized by means of a piercing device in order to prevent The introduction device is bent when introduced into the tissue. In particular, the piercing device can be designed as a thin piercing needle. If the introduction device has been introduced into the tissue, the piercing device is preferably removed. Such piercing means are preferably removed by removing the releasable receptacle, for example with the handle. If, as is preferred, the piercing device is not yet connected to the releasable receptacle in the protective position, then the piercing device is preferably automatically connected to the The receptacle or a component connected to the receptacle is connected. To this end, on the end of the piercing device facing away from its free end, a connecting element is provided, which connects with a A mating connection element connected to the releasable receptacle is in connection engagement. Although the connection can in principle be a purely frictional connection, it preferably includes a form-fit connection. The connecting element of the piercing device can in particular form a snap connection together with the counter connecting element. In principle, for a form-fit connection, only a simple clamping from behind is sufficient in the direction in which the releasable receptacle is to be pulled from the base. seat; therefore a resilient snap-in engagement is not strictly required.

In the insertion position, the introduction device preferably protrudes from the underside of the housing. In principle, however, the introduction device can instead protrude from one side of the housing as long as it protrudes beyond the underside by a sufficient length for introduction into the tissue. In the insertion position, the introduction device preferably protrudes beyond the underside of the housing with a length adapted to the hypodermic injection, preferably protrudes directly from the underside or protrudes from the underside. For injections inside the skin or into muscle tissue, the introduction device is correspondingly shorter or longer. By introducing means is meant a length section that enters the tissue during injection.

In a preferred embodiment, the introduction device is permanently movably connected to the base. The introduction device is permanently connected to the base, which means that the introduction device is at least suitable for movement from the protection position into the protection position and/or from the introduction position into the protection position. The movement does not loosen from the base. Preferably the introduction point is even permanently connected to the base in the sense that the introduction means cannot be released from the base at all, at least not without the use of special force or only by breaking to loosen.

Preferably, the introducing device is connected to the base, so that the introducing device can rotate relative to the base. However, preferably only the optional introduction device or at least its free end can be pivoted again into the releasable receptacle after being deflected out. In such an embodiment, the base and the articulation element connected to the introduction device form a rotational joint. The introduction device preferably simply protrudes from the joint element transversely to the axis of rotation of the joint, for example by being formed on the joint element itself, or it can in principle also be articulated again. connected to the joint. In the position just occupied by the introduction position when the free end of the introduction device is deflected forward beyond the lower side, the longitudinal axis of the introduction device encloses an acute angle with the lower side, preferably less than 50° . Preferably, the angle is smaller than 30°, so that the longitudinal axis or the introduction means is at least substantially parallel to the underside or support surface of the base at the moment of deflection. The longitudinal axis of the introduction device, which pivots about the axis of rotation, preferably intersects the axis of rotation. If the longitudinal axis of the introduction device does not intersect the axis of rotation, but instead intersects at a distance, this distance is preferably significantly smaller than the length of the introduction device. Preferably, the distance is at most half the penetration depth or length of the introduction device. In a preferred embodiment, the rotation angle of the introduction device is 90°±10°. In an equally preferred embodiment, however, the swivel angle can also be smaller, especially if the introduction device is not directed perpendicularly to the underside of the base in the introduction position, but rather relative to the base The underside of the seat points at an acute angle, but the acute angle is at least 30°. Accordingly, the swivel angle in the described embodiment is preferably at least approximately 30° or intermediate values in each case between approximately 30° or approximately 90°. In principle, the swivel angle can also be greater than 90°.

In an alternative embodiment, the base for the introduction device forms a movement guide in which the introduction device moves from the protective position into the introduction position and/or from the introduction position The movement into the protective position is guided in translation on this displacement guide. In one such embodiment, the base and the joint element connected to the introduction device together form a sliding joint. In a preferred embodiment, the introduction device protrudes from the joint element simply, preferably in the sliding direction. In yet another alternative, the introducing device or a stabilizing piercing device has a bending stiffness that enables the introducing device or, if necessary, a stabilizing piercing device Bending into the receptacle with the corresponding free end in the direction of the underside of the base, so that the free end protrudes into the receptacle and is in contact with the base in the receptacle Loosely positioned together or otherwise releasably held in this bent state against the resetting elasticity of the introduction device. In particular, such an embodiment is conceivable if, in the insertion position, the insertion device encloses an acute angle with the underside of the base. It is also conceivable for such a bending that the introduction means is fixed on the base or on the releasable receptacle at a distance behind the underside of the base for The interior of the cavity of the insertion head already has a somewhat curved line. On the other hand, it is preferred that the introduction means protrude in the introduction position directly from the lower side which in use comes into contact with the tissue surface or as close as possible to this lower side, that is to say Preferably fixedly or possibly axially movable and fixedly clamped in other directions on or to the lower side at a distance as short as possible, so that the introduction device or one of them The length of the stable piercing device which can bend when penetrating into the tissue is as short as possible. In any case, it is preferred to use an introduction means which protrudes directly from the underside or protrudes close to the underside in the insertion position, if the introduction means is not bent for the protective position.

Although it is sufficient to solve the problem that the introduction means can only be moved in one direction, that is to say once relative to the base, and can then preferably be moved from the protection means into the introduction position, it may be preferred The introduction device can be moved back and forth between the two positions, so that the introduction device can be moved into the introduction position for use and again into the protection position for waste disposal. The connection between the introduction device and the housing is preferably a form-fit connection or preferably includes a form-fit connection which, in particular, can form a joint. If the introduction device is bent in the protective position, the connection can alternatively be a purely force-conductive connection or even a purely material connection, for example.

The insertion head is preferably part of an injection set for injecting insulin, analgesics or other medicaments that can be injected by means of an infusion, or is provided for one of these uses. Instead of being used for drug injection or in principle also for another injectable product, the insertion tip can also be used for diagnostic purposes. In such applications, the introduction device may serve as a carrier for sensors, such as those used to measure glucose concentrations in body fluids or another physical and /or biochemical parameters. The insertion head can also be designed as a perfusion device for diagnostic purposes. In such a configuration, after introduction into the tissue, an irrigation liquid (Spülflüssigkeit) flows through the introduction device, which absorbs one or more specific constituents of the body fluid as it flows through. for the analysis of flushing fluids rich in related inclusions or multiple inclusions. Finally, the insertion head can have means for injecting the product and in combination form a diagnostic device. The introduction device can be configured in a suitable manner for the supply of a product, which may in particular be a drug or an irrigation liquid, or for the discharge of a body fluid or for the discharge of one or more substances contained in a body fluid. In this application, the introduction device forms at least one flow cross-section. The introduction device can also be used in combination for the supply and removal of material. If the insertion head is only designed as a measuring device, the introduction device can also be used only for accommodating a sensor or a part of a sensor, that is to say is used purely as a mechanical introduction device. In a further development of the measuring device, the insertion head is also used, in addition to the mechanical introduction, to transmit control signals to the sensor and/or to transmit measurement signals of the sensor. In a combined application, the insertion head ultimately has at least one flow cross-section for material delivery, that is to say a flow line, and at least one signal line. Signal lines can be dispensed with if the sensor is designed to receive control signals wirelessly and/or transmit measurement signals wirelessly. Finally, the introduction device can also have two or more separately projecting introduction elements. For example, a first introduction element may be used to deliver material into the tissue and another second introduction element may be used to deliver material out of the tissue or simply to place a sensor or a part of a sensor. With a plurality of introduction 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, in order to accommodate the insertion head according to the invention in the receptacle, the receptacle accepts the The introduction device, together with the piercing needle or only receiving the piercing needle, can be provided with a safety slide, the introduction device optionally together with the piercing needle or only the piercing needle in a protective position, for example in the receiving seat It can be imported into the safety chute. Due to the elastic properties of the piercing needle, the needle tip of the piercing needle is elastically deformed or deflected laterally along the safety slide after use when it is turned back into the protective position or receptacle, In order to then engage behind the locking shoulder in the locking recess. In this position, the piercing needle is then securely held in the protective position. In this way, it is no longer possible to be injured by a contaminated lancet.

According to another preferred embodiment, the movable handle part can be pushed into another handle part, so that the control ramp on the movable handle part is used to transfer the introduction device from the protective position at the end The process into the lead-in position is followed by an offset ramp on the connecting element reversibly connecting the base to the handle for offsetting the engaging element from its engaged position, thereby The handle and base can be separated. This configuration, in particular in conjunction with the use of the second line of the slideway guide, is particularly advantageous for switching the insertion head according to the invention from the piercing function into the one for delivering the drug without exerting a load on the patient's tissue. supply function.

According to another preferred embodiment, the introduction device can be assigned a retaining structure which moves together with the introduction device, wherein the retaining structure has a locking shoulder which is When the further handle part is pulled out of the movable handle part, it enters into a fixed engagement with the engagement element in order to be able to prevent the piercing device from being deflected out again.

According to a preferred embodiment, the receptacle is formed in one piece with the handle or the other handle part. In this case, the receptacle is arranged separately from the base.

Furthermore, the introduction device can preferably be assigned a retaining structure that moves together with the introduction device, wherein the retaining structure includes a loosening-locking structure. This locking structure should lie opposite a wall of the movable handle part that extends parallel to the direction of movement of the movable handle part. As a result, the engagement element on the inner side of the wall can be brought into reversible engagement with the locking structure in the protective position of the introduction device. By means of this measure, the introduction device together with the piercing needle can be held securely in the protected position in the receptacle so that it can subsequently be combined with the movable handle part overcoming the loosening protection. And the initial resistance provided by the engaging element still achieves the desired rotational manipulation of the introducing device together with the piercing needle.

According to a further preferred embodiment of the invention, the insertion head can be provided with an introduction device which is held on the base via a swivel or swivel axis. A slide or journal can be provided which is arranged centroidally with respect to the axis of rotation and preferably separately from this axis of rotation, wherein a link guide is provided which is connected to the axis of rotation. The slider is in active connection. A movement of the movable handle part relative to the base along a first path of the first section of the slideway guide moves the slide from a position corresponding to the insertion device or into the The first position of the protective position of the needle is shifted into a second position corresponding to the introduction position of the introduction device. This refinement makes it possible to implement a relatively complex guiding path for the introduction device to be pivoted out of the receptacle, wherein relatively small forces have to be applied simultaneously via the movable handle part and in the individual components of the mechanism Warpage between them is impossible to the greatest extent possible.

According to another preferred embodiment of the invention, a connecting element can be provided, which reversibly connects the base to the handle, wherein in order to release the handle from the base, the The handle can move on a second line perpendicular to the extension direction of the introduction device in the introduction position, wherein the chute guide has a second section corresponding to the second line, so that the The introduction device does not move together when it is released, that is to say, the handle can be parallel to the body surface or Movement parallel to the surface of the web—hereinafter also referred to as plaster—without excessive fatigue of the organic tissue due to parallel forces. In this way, the handle region can be detached from the base and thus the piercing needle can be separated from the base in an advantageous manner by actuating the relevant parts and here in particular by actuating the movable handle part. Separated from the above-mentioned induction, in order not only to trigger but also to decouple.

As a result, according to the invention, the contaminated piercing device or piercing needle can be swiveled back into the movable handle part.

According to a further preferred embodiment of the invention, the insertion head can be provided with an introduction device which is held on the base via a swivel or swivel axis. A slide can be provided which is arranged centrally with respect to the axis of rotation and preferably separately from this axis of rotation, wherein a link guide is provided which is operatively connected to the slide among. A movement of the movable handle part relative to the base along a first path of the first section of the slideway guide moves the slide from a position corresponding to the insertion device or into the The first position of the protective position of the needle is shifted into a second position corresponding to the introduction position of the introduction device. This embodiment enables a relatively complex guiding path for the introduction device to be pivoted out of the receptacle, in which relatively small forces have to be applied simultaneously via the movable handle part and in the individual components of the mechanism Warpage between parts is impossible to the greatest extent possible.

According to another preferred embodiment of the invention, a connecting element can be provided, which reversibly connects the base to the handle, wherein in order to release the handle from the base, the The handle can move on a second line perpendicular to the extension direction of the introduction device in the introduction position, wherein the chute guide has a second section corresponding to the second line, so that the introduction The device does not move together when it is released, that is to say, the handle is parallel to the body surface or parallel to the Movement of the surface of the web—hereinafter also referred to as plaster (Pflaster)—without excessive fatigue of the organic tissue due to parallel forces. In this way, the handle region can be detached from the base and thus the piercing needle in an advantageous manner by actuating the associated parts and here in particular by actuating the movable handle part. Separated from the introduction, both for triggering and for decoupling.

Triggering and decoupling can also be performed one after the other. In the process, the slider has passed the entire slide guide continuously, whereby the cannula or introduction device with the piercing needle has been deflected, and at the same time or immediately before the cannula with needle is applied The handle parts are decoupled. Here, however, there is still only an easily releasable connection between the section of the insertion head according to the invention that remains in or on the body of the patient and the section to be removed.

Preferably, the introduction device can be provided with an anti-loosening structure, which reversibly holds the introduction device in the protective position. Thus, for example, the other handle part can be provided with a locking shoulder, which can be brought into reversible engagement with a complementary locking mechanism 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 piercing needle can be moved or swiveled into the application position.

Furthermore, the introduction device can advantageously be assigned a sleeve housing which moves together with the introduction device, wherein the sleeve housing comprises a loosening-proof structure. This locking structure should lie opposite a wall of the movable handle part that extends parallel to the direction of movement of the movable handle part. As a result, the engagement element on the inner side of the wall can be brought into reversible engagement with the locking structure in the protective position of the introduction device. By means of this measure, the introduction device together with the piercing needle can be held securely in the protected position in the receptacle so that it can subsequently be combined with the movable handle part overcoming the loosening protection. And the initial resistance provided by the engaging element still achieves the desired rotational manipulation of the introducing device together with the piercing needle.

According to another preferred embodiment, in order to accommodate the insertion head according to the invention in the further handle part, wherein the further handle part receives the introduction device together with the piercing needle or only in the protective position To accommodate the piercing needle, a safety slide can be provided, in which the introduction device can engage, optionally together with the piercing needle or only the piercing needle in a protective position in the receptacle middle. Due to the elastic properties of the insertion device and the piercing needle, the needle point of the piercing needle is elastically deformed or laterally along the safety slide when it is pivoted into the protective position or receptacle. Offset so that it then engages in the locking recess behind the safety shoulder. In this position, the piercing needle is then securely held together with the introduction device in the protective position. The securing link can also be arranged in the receptacle or in the movable handle part or can be arranged in parts on different components.

According to another preferred embodiment, the movable handle part can be pushed into the other handle part, so that the control bevel on the movable handle part ends up being used to guide the introduction device from the the shifting of the protective position into the introduction position is followed by a shifting ramp on the connecting element reversibly connecting the base to the handle for biasing the connecting means out of its engaged position, The handle and base can thus be separated. This configuration, in particular in conjunction with the use of the second line of the slide guide, is particularly advantageous in order to switch the insertion head according to the invention from the piercing function to the feeding function without stressing the patient's tissue. Drug delivery function.

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

According to the invention, a soiled piercing device or piercing needle can thus be returned to the second handle part.

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

Description of drawings

Embodiments of the invention are explained in detail below with the aid of the drawings. The features disclosed in the exemplary embodiments form the subject-matter of the claims both individually and in any combination of features, and preferably also in further developments described above. in:

Fig. 1 is the insertion head of the first embodiment together with the introduction device in the protective position,

Figure 2 is the insertion head together with the introduction device in the introduction position,

Figure 3 is the 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 introduction means in the introduction 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 together with the introduction device,

Fig. 7 is the insertion head of the second embodiment together with the introduction device in the protective position,

Figure 8 shows the insertion head of the second embodiment together with the introduction means in the introduction position,

Figure 9 is the 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 introduction means in the introduction position,

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

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

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

Figure 14 is a view after activation of the system of the second embodiment, and

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

Figure 16 is a side view of the insertion head with the introduction device in the protected position,

FIG. 17 shows the insertion head according to FIG. 16 with the introduction device in the introduction position,

Figure 18 is the insertion head according to Figures 16 and 17, wherein the handle has been separated from the base and the introduction device together with the piercing needle,

Figure 19 is a side view of another handle part and the movable handle part in a state released from the base,

Figure 20 is a sectional view of the insertion head together with the introduction device in the protected position,

Figure 20a is a cross-sectional view of a cutaway portion from Figure 20,

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

Figure 22 is a sectional view of the handle with the piercing section separated from the base with the introduction device that can be placed on the patient's body,

23 is a sectional view of another handle part and a movable handle part after the movable handle part is pulled out from the other handle part, and a sectional view of an enlarged section C,

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

Figure 24 is a perspective view of an insertion head according to the present invention prior to application,

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

26 is a view of the insertion head according to FIGS. 24 and 25 after removing the other handle part and the movable handle part and piercing the needle,

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

Figure 28 is a view of the base of the insertion head according to Figures 24 to 27 after connecting the connector for drug delivery,

29 is a schematic view of the insertion head with the introduction device and the piercing needle in the protected position without the other handle part,

FIG. 30 is a view of the insertion head according to FIG. 29 with the introduction device and the piercing needle in the application position,

Figure 31 is a side view of the insertion head with the introducer in the protected position, and

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

Components that are identical or at least functionally identical below are generally designated with identical or similar reference symbols, so that a repeated description is not necessary in most cases. The components of the individual embodiments are mostly interchangeable, that is to say they can be combined with one another. Other characteristics, objects, and advantages of the present invention can be obtained from the embodiments described below.

Detailed ways

FIG. 1 shows a longitudinal section through an insertion head of a first embodiment. The insertion head comprises a base which in turn has a receptacle or receptacle 1 and a flat part 2 which are integrally formed from plastic. The bases 1 , 2 can be placed with their underside U on tissue. Furthermore, the insertion head includes a two-part handle with a first handle part 10 and a second handle part 12 . The handle part 10 is immovably but releasably connected to the base. The handle part 12 is movably held on the handle part 10, wherein the handle part 12 can not only move linearly relative to the handle part 10, but also move linearly relative to the base 1, 2 . The axis of movement of the handle part 12 is parallel to the underside 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 introduction device 5 in a pivotable manner about an axis of rotation parallel to the lower side U. The introduction device 5 extends longitudinally. In the present exemplary embodiment, the introduction device 5 is designed as a flexible sleeve. A piercing device 15 configured as a thin needle is passed through the introduction device 5 , the bending rigidity of which is sufficient to push the piercing device 15 together with the adjacent introduction device 5 surrounding it through the skin. The surface penetrates into the subcutaneous tissue and is thus introduced into the introduction device 5 . In a preferred embodiment, an adhesive pad is provided on the underside U for fixing the insertion head on tissue, preferably on the skin surface.

The joint element 6 , which together performs a pivotal movement of the introduction device 5 and thus the piercing device 15 , forms the axis of the swivel joint, which has an axis of rotation as the joint axis. The bases 1 , 2 then form a further joint element of the swivel joint, which is designed in the shape of a bushing or optionally also in the shape of an open bearing bore. On the axis of rotation of the joint, an external gear 8 is arranged on both sides of the joint element 6 and is connected to the joint element 6 in a rotationally fixed manner, for example integrally formed. One of the two gears 8 can be seen in FIG. 1 . The other gear is placed on the opposite side of the articulation element 6 and is covered by the receptacle 1 of the base 1 , 2 . The piercing device 15 passes through the joint element 6 . A supply device 7 for a medicinal fluid, such as insulin, is connected to the articulation element 6 . The supply device 7 protrudes from the articulation element 6 approximately at right angles to the introduction device 5 . Joint element 6 together with supply device 7 , gear 8 , insertion device 5 and piercing device 15 form a unit of rotational movement with respect to joint element 6 and gear 8 and rotational movement with respect to the other described components.

The movable handle part 12 is provided with two racks 18, and the racks 18 are in gear meshing with one of the gears 8 respectively. Of the two toothed racks 18, only the toothed rack cooperating with the covered toothed wheel can be seen. A likewise toothed rack 18 interacts with the visible pinion 8 . In the case of movement of the handle part 12 in the direction indicated by the directional arrow, wherein the first handle part 10 guides the handle part 12 in this movement, the two toothed racks 18 are connected to the The two gears 8 mesh so that the displacement movement of the handle part 12 is converted into a rotational movement of the articulation element 6 and a swiveling movement of the introduction device 5 and piercing device 15 and the supply device 7 .

The pivoting movement transfers the introduction device 5 from its protective position shown in FIG. 1 into the introduction position. In the protective position, the introduction means 5 and the piercing means 15 are at least substantially parallel to the underside U of the base 1 , 2 . The sections of the introduction device 5 and the piercing device 15 protruding in the same direction beyond the articulation element 6 are accommodated in a common protective position in a cavity which, apart from the underside U Surrounded by the receptacle or receptacle 1 . The introduction device 5 in the protective position ensures that the user cannot be injured by the piercing device 15 and that the introduction device 5 and the piercing device 15 are not damaged by inadvertent handling. The receptacle 1 also preferably forms a barrier, so that the piercing device 15 is invisible to the user from the upper side of the insertion head and also when viewed from the side. The adhesive pad, which is preferably mounted on the underside, is provided with through-slits for the introduction device 5 and the piercing device 15 .

The toothed rack 18 is correspondingly formed on the underside facing the underside U of two torsionally fixed tongues which protrude from side parts of the handle part 12 in the direction of movement. From the side part of the handle part 12, beyond the two tongues forming the toothed rack 18, at least one other tongue protrudes in the direction of motion, which is used in the construction of the handle part 10. The movable handle part 12 is guided linearly on the guide.

In order to introduce the introduction device 5 into the body tissue down to the skin or possibly only into the skin, the user clamps the handle of the insertion head between the thumb and forefinger. The handle parts 10 and 12 are each provided with correspondingly shaped lateral recesses. 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 . During this movement, the two toothed racks 18 mesh with the pinion 8 , so that the translational movement of the handle part 12 is converted into a rotational movement of the articulation element 6 and thus into the introduction device 5 And the rotary motion of piercing device 15. The stroke of the handle part 12, the diameter of the gear 8 and the fineness of the teeth are selected such that a movement of a few millimeters of the handle part 12, such as 4 mm or 5 mm, causes the introduction means and piercing means 15 into an introduction position in which the introduction device 5 and the piercing device 15 protrude at least approximately at right angles, the amplitude of which is at least substantially a swivel angle of 90°. The underside U of the base 1, 2.

FIG. 2 shows the insertion head with the introduction device and the piercing device 5 , 15 in the introduction position.

At the end of the pivoting movement, the piercing device 15 is already connected to the handles 10 , 12 , in the exemplary embodiment to the movable handle part 12 . In the protective position ( FIG. 1 ), there is no contact between the piercing device 15 and the handles 10 , 12 , so that the piercing device 15 can pivot freely together with the introduction device 5 . In order to establish the connection, a connecting element 16 is arranged on the proximal end of the piercing device 15 in the insertion position, and this connecting element 16 is fixed in the present embodiment, wherein the piercing device 15 protrudes beyond the joint element 6 with the proximal end. The connecting element 16 has one or two raised tabs, with which the connecting element 16 engages the mating connecting element of the handle part 12 from behind with respect to the longitudinal direction of the piercing element 15 . The mating connecting element of the movable handle part 12 is designed as a corresponding shoulder surface which can engage from behind.

To place the insertion head on the tissue surface and 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. In the process, the piercing device 15 pierces the tissue surface, preferably the human skin, and penetrates into the skin. The close-fitting introduction device 5 is inserted into the skin together with the piercing device 15 until the insertion head rests with its underside U on the tissue surface and in the process is preferably adhesively fixed to the skin by means of an adhesive pad. On the surface. For injecting the medicament, the piercing device 15 is removed and the supply device 7 is connected to a medicament container, preferably a medicament pump, via a coupling cooperating with the supply device 7 . To achieve this, the handles 10 , 12 are previously released from the base 1 , 2 . Release is only possible after squeezing or pushing the handle parts 10 and 12 . However, the connection is automatically released when the handle part 12 is moved, so that the handles 10 , 12 can be pulled down in the proximal direction, upwards in FIG. 2 . In a straight pull-down movement, the piercing device 15 slides through the introduction device 5 and the articulation element 6 and thus releases the flow cross-section of the introduction device 5 so that the flow cross-section The piercing device 15 is also in fluid connection with the supply device 7 at the same time. In this regard, the insertion head can be configured as described in DE 198 21 723 C1 and DE 10 2004 039 408.3.

3 and 4 show the two parts of the insertion head that are released from each other, namely the base 1 , 2 with the introduction device 5 and the handle 10 , 12 with the piercing device 15 , these two parts are in relation to each other. In an aligned position, in which the longitudinal axis of the introduction device 5 and the longitudinal axis of the piercing device 15 are aligned with one another. Also visible in FIG. 3 is the recess 3 in the base 1 , 2 into which one of the two toothed racks 18 enters when the handle part 12 moves in the connected state and Here it meshes with a gear 8 arranged in the recess 3 . The gap 3 is in the shape of a slit. In addition, the connecting element 19 of the handle 10 , 12 can be seen, which in the connected state engages in a form-fitting manner in the mating connecting element of the base 1 , 2 and thus connects the handle 10 , 12 are held on said base 1 , 2 and are fixed relative to said base 1 , 2 together with the contact surfaces of said handle 10 , 12 and said base 1 , 2 . The connection element 19 projects in a direction parallel to the underside U of the base 1 , 2 from an elastic web 13 protruding from the handle part 10 in the distal region in the form of a cigarette butt. out and, in the connected state, protrude into the interspace of the base 1, 2, for example into a hole shaped congruently with the connection element 19, thereby preventing the handle 10, 12 from moving along the connection when there is a connection. The movement of the piercing section 15 in the longitudinal direction. In order to release this connection, another tongue, not shown, protrudes from the side part of the movable handle part 12, and this tongue moves to the bases 1, 2 and 2 when the handle part 12 is moved. Between the tabs 13 that support the connecting element 19, and make the tabs 13 bend away from the base 1, 2 for a distance, but the bending is sufficient to loosen the connection between the connecting element 19 and the mating connection. The form-fit connection between the elements makes it possible to pull the handle 10 , 12 together with the piercing device 15 from the base 1 , 2 in the longitudinal direction of the piercing device 15 .

FIGS. 5 and 6 again show views of the parts of the insertion head released from one another from the rear side facing away in FIGS. 1 to 4 . In this view, in FIG. 6 in particular the mating connecting element 9 of the base 1 , 2 can be seen, which in the connected state, that is to say in the engaged state with the connecting element 19 , will The handles 10 , 12 are held on the base 1 , 2 .

Bases 1, 2, shown individually in FIGS. Ostensibly, and in that sense are reserved pieces. The handles 10 , 12 now serving as holders for the piercing device 15 are then, on the contrary, to be cleaned or, if necessary, loosened again from the piercing device 15 and used again by a person, while the piercing device 15 is cleaned up. The holder 1 - 9 can thus preferably be flat and not cause interference when worn under clothing. The introduction device 5 is flexible, so that the introduction device 5 is not perceived as disturbing in the introduced state, but is sufficiently stable for a reliable supply of the drug.

The handles 10, 12 can also be used in some embodiments of the insertion head, in which the introducer is not flexible at the factory like the introducer 5, but can be used without external stabilization. The case of the device has sufficient bending rigidity for the piercing action. In such an embodiment, the additional piercing device 15 can be omitted. In this embodiment, the handles 10 , 12 are only used for actuating the insertion head, but not as supports for the stabilizing piercing device 15 . The introduction device 5 modified in this way can in particular be configured as a piercing sleeve with a hollow cross section or as a piercing needle with a solid cross section and one or more flow channels arranged on the outer circumference, said piercing sleeve or After introduction, the piercing needle becomes more flexible by interaction with the tissue.

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 fastened to the underside U is shown by way of example, which can also be mounted on the insertion head of the first exemplary embodiment described.

Compared with the first embodiment, modifications are made to the receiving seat 1 and the first handle part 11 . In contrast to the first exemplary embodiment, the introduction device 5 and the piercing device 15 are only accommodated over a short section in the receptacle 1 formed by the receptacle. In the second embodiment, the handle, more precisely the handle part 11 of the handle, forms a receptacle 14 for the introduction device 5 and the piercing device 15 . The receptacle 1 is laterally provided with a gap 4 in the form of a slit that is open to the lower side U, through which the introduction device 5 and the piercing device 15 pass through the gap 4 from the receptacle in the protective position. Seat 1 sticks out. The receptacle 1 itself is accommodated in the receptacle 14 . The receptacle 14 is open towards the underside U, but otherwise surrounds the introduction device 5 and the piercing device 15 , preferably blocks them from view.

In order to swivel the introduction device 5 and the piercing device 15 from the protective position into the introduction position, the user carries out the manual operation steps described with the aid of the first exemplary embodiment, that is to say the movable handle part 12 Squeeze towards the modified handle part 11. During gear engagement, the introduction device 5 and the piercing device 15 are pivoted in the recess 4 from the receptacle 1 and in particular from the receptacle 14 into the introduction position.

FIG. 8 shows the insertion head of the second embodiment with the introduction device 5 and the piercing device 15 in the introduction position.

With respect to the second embodiment, FIGS. 9 and 10 correspond to FIGS. 3 and 4 with respect to the first embodiment. However, looking at FIG. 10 in particular, it can be seen that the base 1, 2 of the second embodiment is preferably shortened compared to the base 1, 2 of the first embodiment, because the base is no longer The seats 1 , 2 but the handles 11 , 12 for the introduction device 5 and the piercing device 15 assume a protective function in the protective position of the introduction device 5 and the piercing device 15 .

Fig. 11 shows the system of the first embodiment, which system includes the insertion head of the first embodiment and an inserter (Inserter), which is used to place the insertion head on the tissue, so that the user can place the insertion head on tissue. It is not necessary to clamp the insertion head between the fingers. In particular, the user should not hold the handle of the insertion head when transferring the introduction device 5 into the introduction position. The insertion head is activated by means of the inserter. As a result, the user can be more reliably protected from needlestick injuries and also the introduction device 5 and the piercing device 15 can be more reliably prevented from being damaged due to inadvertent handling by the inserter.

The inserter has an inserter housing 20 , which is designed as a sleeve part with a base and which, viewed from the outside, has essentially the shape of a pot. The inserter housing 20 accommodates holding means and drive means for the insertion head. The retaining device then comprises a clamping 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 held engaged state, the clamping spring engages from behind a retaining structure 17 formed on the handle 10 , 12 , which can be seen in FIGS. 1 , 2 , 3 and 5 . The retained engagement state can be released against the return elastic force of the fastening spring.

The drive device comprises a feed element 22 which is arranged in the inserter housing 20 in such a manner that it can be moved linearly in and against the feed direction V in the feed direction V. The advancing direction V coincides with the central longitudinal axis of the inserter housing 20 . Furthermore, the drive device includes a power generator 23 which acts 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 symmetrical with respect to the central longitudinal axis of the inserter housing 20, that is to say with respect to the feed direction V arranged in a symmetrical manner. Each pair of support arms is suspended in a swivel joint 25 which is fixed relative to the inserter housing 20 . The two arms 24 of the respective arm pair are connected to one another in a rotationally movable manner in a free pivot joint 26 . Furthermore, the support arm 24 facing away from the stationary joint 25 is correspondingly connected to the feed element 22 in a swivel joint 27 . Springs, not shown, or possibly only one spring, tension the support arm-knuckle-advancing element-arrangement in the advancing direction V. The device formed by the arm 24 and the knuckles 25, 26 and 27 guides the feed element 22; in addition or instead, the inner housing surface of the inserter housing 23 can guide the feed element twenty two. Furthermore, a locking element 29 is provided which is in a locking engagement with the inserter housing 20 and which prevents the advancing movement of the advancing element 22 . The locking element 29 can form a locking engagement together with the envelope formed by the inserter housing 20 or likewise with another structure which is fixedly connected to the inserter housing 20 with respect to the advancing direction V. FIG. The locked engagement can be released by actuating the button-shaped release 28 .

Furthermore, the inserter comprises an activation element 21 , which is connected to the inserter housing 20 in such a manner that it can move in the advancing direction V and counter to it. The activation element 21 forms a sleeve with respect to the inserter housing 20 , so that overall a two-part, telescopic inserter housing with housing parts 20 and 21 results. In addition, however, due to the difference in function, the housing part 21 is referred to as an activation element. The activation element 21 forms the lower side U _{21 of} the inserter, _with which the inserter can be placed on the tissue surface for the placement of the insertion head, and is preferably also placed on the on the tissue surface. In the initial position occupied by the insertion head shown in _FIG . The direction V forms at least substantially a plane normal for the two undersides.

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

In the state shown in FIG. 11 , the activation element 21 assumes a retracted position relative to the inserter housing 20 and the inserter has a shortest length measured in the advance direction V. In FIG. In this state of the inserter, the insertion head is inserted, that is to say the insertion head is brought into a holding engagement with the holding device of the inserter. Instead of inserting the insertion head, the inserter can also be shrouded by the insertion head on the support surface. The position and geometry of the retaining means are selected such that the retaining engagement is automatically produced upon snagging. Immediately after the insertion head has been received, for example by being inserted, 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 associated means, namely the activation element 21 , by actuation of which the introduction device can be moved into the insertion position and in this way the insertion head can be activated.

To activate the insertion head, the activation element 21 and the insertion head form a joint with one another, in the exemplary embodiment a curved joint. The two articulation elements of the joint are the guide curve part 21 a forming the activation element 21 and the toothing element 12 a formed by the movable handle part 12 . The activation element 21 acts on the introduction device 5 by being coupled, and in this coupled state the movable handle part 12 forms the input or receiving element of the insertion head. If the activation element 21 is moved relative to the inserter housing 20 in the advance direction V, the guide curve part 21a slides onto the engagement element 12a, that is to say onto the receiving element. That is to say above the contact surface of the movable handle part 12 which forms the engagement element 12a. Due to the pressure contact of the guide curve part 21 a and its curved course obliquely to the feed direction V, the handle part 12 moves transversely to the feed direction V towards the other handle part 10 and the introduction The device 5 is pivoted into the insertion position as described for such an insertion head. At its upper end facing away from the base 1 , 2 , the movable handle part 12 forms the engagement element 12 a in the exemplary embodiment with its outer edge. The guide curve 21a is directed toward the underside U ₂₁ of the inserter. The angle of inclination is selected such that the guide curve 21 a is inclined from the end facing away from the underside U ₂₁ in the feed direction V away from the insertion head or away from the guide swiveled out in the activated state. The device 5 is either tilted away from the central longitudinal axis of the inserter. The inclination remains constant everywhere, and the guide curve 21a is a ramp, that is to say an inclined line or surface.

For actual operation, the user, after receiving the insertion head, grasps the activation element 21 of the inserter with one hand, such as holding the activation element 21, and with the other hand against the gripped The activating element 21 pulls the inserter housing 20 against the feed direction V. This is also to be understood as manipulating the activation element. The feed element 22 and the power generator 23 move together 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 entrained, that is to say likewise moved relative to the activation element 21 counter to the direction of advance V. The engaging element 12a slides along the guide curve part 21a. Via this purely pressure-contact based interface, the movable handle part 12 is moved transversely to the feed direction V and the introduction device 5 is pivoted into the introduction position. The inserter housing 20 and the activation element 21 perform an extraction 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 assume a displaced position relative to each other. In the removed state, the walls of the inserter housing 20 and the activating element 21 enclose the activated insertion head beyond the free ends of the introduction device 5 and the piercing device 15, that is to say the The tip of the piercing device 15 is set back a distance behind the underside U ₂₁ of the inserter.

The inserter housing 20 and the activation element 21 are locked relative to each other in the extended position. In the locked state, no relative movement is possible in or against the advancing direction V. When the extended position is reached, the inserter housing 20 and the activation element 21 are automatically locked into one another.

To position the insertion head, the user places the inserter on the skin surface. After placing the inserter, the user squeezes against the release 28 . The release 28 acts on the locking element 29 via a curved joint, in the exemplary embodiment via a simple ramp. Under the action of the releaser 28, the locking element 29 leaves the locking engagement state with the inserter housing 20, so that the feeding element 22 can move along the feeding direction under the action of the power generator 23. V movement. The power generator 23 suddenly accelerates the feed element 22 . The feed element 22 then acts on the insertion head like a hammer. During the first phase of the feed movement, the clamping spring springs out of the retaining engagement with the retaining structure 17 of the insertion head, that is to say the retaining engagement is released. The acceleration of the feed element 22 in the feed direction V is so great that a pure pressure contact between the feed element 22 and the insertion head is reliably maintained until the underside U of the insertion head rests on At the same height as the underside U ₂₁ of the inserter and thus rests on the tissue surface. Previously, the piercing device 15 has already pierced into the skin surface, into the tissue and in the process drives the introduction device 5 .

After the insertion head has been placed on the skin surface, the user grasps the handle 10 , 12 and pulls it off the base 1 , 2 . During this process, the piercing device 15 is automatically pulled out of the introduction device 5 and off the base 1 , 2 .

In order to also automate the pulling-out process of the piercing device 15 , in a preferred variant of the inserter, a retaining mechanism between the retaining device of the inserter and the retaining structure 17 of the insertion head is maintained. Engaged state, and does not release due to the acceleration of the feed element 22 as in the illustrated embodiment. In one of the described variants, the holding device is connected in particular to the feed element 22 in a stationary manner, so that the holding device carries out an ejection movement of the feed element 22 in the feed direction V together. In order to release the holding engagement, the inserter can be provided with a detacher which, after removing the inserter from the tissue, automatically pushes the inserter housing 20 and the activation element 21 The insertion head is released from the retained engagement. Alternatively, such a detacher can also be arranged completely independently of the activation element 21 and can be actuated separately to release the holding engagement.

Figures 13 to 15 show a second embodiment system comprising an insertion head and an inserter. The insertion head is the one shown in FIGS. 7 to 10, but may also be the same insertion head as in the first embodiment. Only changes were made on the inserter. Corresponding parts of the inserter of the second embodiment are similar in their function to the parts of the inserter of the first embodiment, and these parts are correspondingly denoted by reference numerals increased compared to the first embodiment. denoted by the numeral ten. The explanations regarding the first embodiment therefore apply, especially with regard to the shape and connection and relative movement of the inserter housing 30 and the activation element 31 . In principle, the same applies with respect to the feed element 32 , the holding device and the power generator 33 as well as the release 38 and the locking element 39 . The explanations regarding the first exemplary embodiment also apply to the second exemplary embodiment, as long as no differences are indicated below and no further explanations are drawn 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 insertion through the The insertion head is activated by a pull-up movement of the tool housing 30 relative to the activation element 31. In the second embodiment, the inserter itself constitutes the joint, that is to say a joint with two articulation elements 31a and 41a, one of which constitutes the activation element 31 and the other One joint element forms the actuator 41 . The actuating element 41 is supported via the inserter housing 30 in such a manner that it can move back and forth transversely to the advancing direction V, in the exemplary embodiment at right angles to the advancing direction V. The joint 31a, 41a is 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 engaging element 41a which slides along the guide curve part 31a on the prolongation of the inserter and pulls up the insertion due to the inclined curve course of the guide curve part 31a. When the device is inserted, the actuator 41 is moved laterally in the direction of the central longitudinal axis of the inserter. In the joints 31 a , 41 a the movement performed by the inserter housing 30 relative to the activation element 31 when pulling up is thus converted into the actuator element 41 , opposite to the direction of advance V. lateral movement. The articulation element or toothing element 41 a of the actuator 41 itself is designed in the manner of a guide curve, but is referred to here as a toothing element in transmission technology. As an alternative, the toothing element 41 a can also be designed, for example, as a simple cam or as a spindle. Likewise, the toothing element 41a can be referred to as a guide curve, and in another variant the articulation element 31a can be formed as a protruding cam or as a pin.

The inserter activates the insertion head via an interface, which in turn is designed as a pure pressure contact and is present between the actuator element 41 and the receiving element or the movable handle part 12 of the insertion head. This pure, so to speak, loose pressure contact simplifies the handling process, because no special articulation has to be established for activating the insertion head, it is sufficient to receive the insertion head and in conjunction with actuating the activation element 31 , which in This is done in the described embodiment by the pulling up movement. The pressure contact, that is to say the pressure exerted by the actuator 41 acts on the movable handle part 12 parallel to the direction of movement of the handle part 12 relative to the base 1 , 2 . By interfacing the actuator 41 and moving the joints 31a, 41a completely to the inserter, preferably transversely to the direction of movement of the handle part 12 there is no direction towards the handle part in the second embodiment. 12 Apply any force.

Figure 14 shows the system with an activated insertion head. The pulling-up movement of the inserter housing 30 is also understood to be the actuation of the activation element 31 , during which the introduction device 5 and the piercing device 15 are pivoted into the introduction position so that their common longitudinal The axis points in the feed direction V. The movable handle part 12 releases the connection between the handles 10 , 12 and the base 1 , 2 as described for the insertion head. However, the frictional connection existing between the introduction device 5 and the piercing device 15 holds the base 1 , 2 on the handle 10 , 12 in the remaining engaged state as in the first embodiment.

The locking element 39 is also in a locking engagement state with the inserter housing 30 or a structure fixedly connected to the inserter housing 30, and the locking engagement state is released by the manipulation of the release device 38, and the The power generator 33 accelerates the feed element 32 in the feed direction V. Here again, the acceleration takes place suddenly, so that the drives 32 , 33 of the second exemplary embodiment act like a hammer. The driving force is generated by two helical torsion springs, and each of the two helical torsion springs acts on one of the two support arm pairs respectively. The support arms 24 , which are fixed in a stationary swivel bearing 35 , are coupled to each other by a gear mesh, which serves to synchronize the extension movement of the two support arm pairs.

In order to be able to prepare the inserter for reuse after the insertion head has been placed, the actuating element 41 must return from the final position shown in FIG. 14 to the final position shown in FIG. 13 . For this return movement, the activation element 31 and the actuator element 41 form a further joint 31b, 41b, which is likewise a curved joint in this exemplary embodiment. The activation element 31 forms a guide curve 31 b for the other joint, and the actuator element 41 forms a toothing element 41 b. The guide curve part 31b extends at least substantially parallel to the guide curve part 31a. The guide curve parts 31 a and 31 b are formed on the inner sleeve part of the activation element 31 , the guide curve part 31 a is formed on the inner surface of the inner sleeve part and the guide curve part 31 b is formed on the outer surface of the inner sleeve member. They lie opposite one another at approximately the same height with respect to said advance direction V. The engagement element 41b is also situated opposite the engagement element 41a at an effective distance, so that the inner sleeve part of the activation element 31 can be moved in and out between the two engagement elements 41a and 41b.

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

In order to prepare the inserter for use with another insertion head, the user again places the inserter housing 30 together with the activation element 31 as shown in FIG. 13 together with the inserted insertion head. The same is pushed into a shifted-in position. During the retraction movement, the inner sleeve part of the activation element 31 is moved between the toothing elements 41 a and 41 b of the actuator element 41 . During this insertion movement, a further articulation takes place between the guide curve part 31b and the toothing element 41b. During the insertion movement, the actuating element 41 thus returns to the end position assumed in FIG. 13 in the joints 31b, 41b, that is to say transversely with respect to the central longitudinal axis of the inserter. , preferably radially outward.

The feed element 32 , which is moved out in the feed direction V under the action of the spring device 33 , lies opposite the end face of the inner sleeve part facing away from the underside U ₃₁ of the activation element 31 . The advancing movement of the advancing element 32 is stopped by the stop contact on this end face. The geometrical dimensions of the activating element 31 are designed in such a way that the activating element 31 when the underside U of the insertion head reaches the height of the underside U ₃₁ and thus just touches the skin surface when the inserter is placed The advance element 32 is precisely stopped in the extended position of the telescopic elements 30 , 31 . During the insertion movement of the inserter housing 30 relative to the activation element 31 or during the insertion movement of the activation element 31 relative to the inserter housing 30 , the feed element 32 is driven by the activation element The stop contact of 31 is pressed deeper into the inserter housing 30 against the force of the power generator 33 until the locking element 39 is again in the locked engagement as exemplarily shown in 13 and 14 .

FIG. 16 shows another embodiment of the insertion head according to the invention. The insertion head comprises a movable handle part 12 which can be pushed into the other handle part 10 . Pushing the movable handle part 12 into the other handle part 10 causes the sleeve shell 17 b to pivot around the joint 6 . In this case, the cannula housing 17b also supports the introduction device 5 and the piercing device 15 in the protective position. During the actuation of the movable handle part 12 , the slider 44 is moved in the slot guide 42 substantially downwards in the direction of the joint element 6 , which causes the holding structure 17 and thus the introduction device to And the piercing needle performs a rotational movement or a swivel movement. As soon as the slide or pin 44 has reached the curve region of the link guide 42 , the pivoting movement from the protective position into the introduction position is completed. Said further handle part 10 is also provided with connection means 16b which are in engagement with corresponding sections 49 on said base 1 for thereby reversibly connecting said base to The handles 10, 12 are connected.

Of course, the slider can also have another position.

The slider 44 can therefore also be arranged lower and moves substantially upwards when the components 17a, 17b are deflected. In this case, different configurations can be used for the link guide and the slide.

According to FIG. 17 , the movable handle part 12 is sunk into the further handle part 10 , wherein an insertion movement of the movable handle part 12 into the further handle part 10 has caused the introduction device to 5 is displaced together with the piercing device 15 out of the receptacle 14 (see FIG. 19 ) and into the insertion position. This embodiment according to FIG. 16 thus provides an alternative connection between the handle part and the deflectable introduction device as an alternative to the embodiment explained above.

FIG. 18 shows how the handle consisting of handle parts 12 and 10 can be detached from the base 1 . The base 1 includes a recess 49 with which the connection means 16b on the handles 10, 12 are in engagement (see FIGS. 16 and 17), and in the schematic illustration according to FIG. cancel, 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 slider or journal 44 is in the sliding position. Guided substantially upwards in the slot guide 42, the sleeve housing 17b and the needle holder 17a together with the piercing device 15 fixed on the needle holder 17a are deflected again, more precisely to the original, at The protective position in the receptacle 14 is shifted into a closed position close to this protective position. The connection device 16b at the end of the spring lug 16a now has no function, since it no longer needs to remain connected to the base 1 .

FIG. 20 shows an insertion head according to another embodiment of the invention before use or during storage. The introduction device 5 with the piercing device 15 partially accommodated therein is in a protective position in the receptacle 14 . On the web 13 or adhesive plaster 13 , a protective film is pasted on the lower side U to keep the pasting position of the adhesive plaster 13 effective. Furthermore, a stop 58 is provided according to FIG. 20 so that the piercing device 15 can be inserted and removed, wherein the sealing of the introduction device 5 is then to be ensured. Correspondingly, a stopper 56 is also provided for the connection section connected vertically to the piercing device 15, which stopper 56 is to be able to be connected to the supply line or to the convector in a sealed manner (see FIG. 28 ).

On the needle frame 17a arranged on the cannula shell 17b for holding the piercing device 15, an anti-loosening structure 46 is arranged on the side facing away from the base 1, and the anti-loosening structure 46 is removed from the obtained from the screenshot in Figure 20a. In the state shown, the engagement element 48 is in engagement with the locking structure 46 and produces a resistance which prevents the movable handle part 12 from being unintentionally introduced into the further handle part 10 . According to the operator of the insertion head according to this embodiment of the present invention, a higher force consumption must initially be provided for overcoming the engagement between the engaging element 48 and the locking structure 46 and for thereby A pivoting process is carried out for pivoting the introduction device 5 together with the piercing device 15 from the protective position in the receptacle 14 as shown in FIG. 20 into the application position as shown in FIG. 21 .

The anti-loosening structure 46 can also be realized with a locking device corresponding to the elements 52, 54, which can be arranged, for example, on the other handle part and the movable handle part 10, 12. And it can be unlocked by pushing one of the handle parts into the other handle part.

FIG. 22 shows the introduction device in FIG. 21 for piercing into the patient's tissue together with the piercing device 5 , 15 . This means that the piercing device or piercing needle 15 has been pulled out of the introduction device 5 . The shutter 58 is closed and the introduction device 5 is ready to introduce medicine into the patient's body.

It can be seen in FIG. 23 how the movable handle part 12 is pulled out of the other handle part 10 again, so that the sleeve housing 17 b is swung back into its position assigned to the protective position. The piercing device 15 is pivoted past the original protective position into a position above it, ie above the locking shoulder 60 explained below. In this position, the piercing device 15 is secured, as can be seen in enlarged view C, by the locking shoulder 60 on the end of the needle holder 17a being realized by the engagement element 48. engage. In this position, the contaminated piercing device 15 can no longer be deflected out of the handle 10 , 12 again, because the engagement element 48 in conjunction with the locking shoulder 60 provides a Latching effect. The piercing device 15 is held behind the locking shoulder in the locked position. FIG. 23 a shows the section D-D according to FIG. 23 for showing the safety chute 50, which is used to transfer the used or contaminated piercing device 15 to a fixed, fixed position on the safety lug. In the chute section behind the shoulder 50a. In contrast, unused sterile piercing devices remain in the other position in front of safety shoulder 50a until they are used.

In the sectional view according to FIG. 23 a , a guide device 62 can also be seen, which guides the movable handle part within the further handle part 10 . If the piercing device 15 is swiveled into an inactive position in the receptacle 14 , the piercing device 15 is moved through the securing slide 50 under flexible deformation, so that In the upper region of the securing slide 50, it is then unloaded behind the securing shoulder 50a and snapped back into the position directly shown in FIG. 23a in order to then remain securely in the position shown. And locked there.

24 to 28 show different stages of application of the insertion head according to the invention. FIG. 24 shows the movable handle part 12 in the position protruding from the other handle part 10 , in which position the introduction device 5 with the piercing needle is in its protective position. In the schematic illustration according to FIG. 25, the movable handle part 12 has been moved into the other handle part 10, so that, as can be seen from FIG. 26, the introduction device together with the penetration device can penetrate the patient's body. FIG. 26 now shows a state according to which the introduction device with the piercing device 15 has been pierced into the patient's body, wherein the piercing device 15 now has no other function and can be pulled out of the introduction device , That is to say, the base 1 and the handles 10, 12 can be separated from each other.

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

According to Figure 28, a connector 64 with a delivery line can now be connected to the base for delivery of a drug such as insulin.

FIG. 29 shows that the guide link 42 has a first section 42a with a length a. This line a is used for actuating or advancing the cannula housing 17b and thus the introduction device 5 together with the piercing device 15 through the movable handle part 12 in the case shown. The deflection to the right causes the slide 44 to move substantially downwards in the direction of the joint element 6 , while the introduction device 5 is transferred from the protective position into the application position or introduction position. The second section 42b of the slideway guide 42 is then used to provide a clearance on the second line b to be able to be unlocked so that the connecting device 16b can be displaced from the engagement recess 49 come out.

In FIG. 30 the slider 44 has reached the other end of the slideway guide 42 relative to the schematic diagram in FIG. 29 , correspondingly according to FIG. In the application position, the handles 10 , 12 are also unlocked relative to the base 1 and can be removed, wherein the piercing device 15 is pulled out of the introduction device 5 .

Furthermore, an unlocking mechanism is shown in the embodiment according to FIG. 31 , which is indicated in particular by the section E-E, and which is shown again in FIG. 32 . As can be seen, the movable handle part 12 has a control ramp which, after introducing the movable handle part 12 into the further handle part 10, moves towards a deflection ramp 54 for passing In this way, the connecting element 16 is shifted out of its engagement with the engagement recess 49 on the base 1 . The movement for deflecting the introduction device 5 together with the piercing device 15 corresponds to the line 42a with length a, while the movement for guiding the control ramp 52 to the deflection ramp 54 corresponds to the guidance according to FIG. 29 Section 42b of the chute 42 .

List of reference signs

1 base, receiving seat

2 bases, flat pieces

3 gaps

4 gaps

5 induction device

6 joint elements

6a joint element counterpart

7 supply device

8 gears

9 connecting elements

10 another handle part

11 another handle part

12 Movable handle parts, receiving elements

12a Articulating elements, engaging elements, pressure contact surfaces

13 tabs

14 receiving seats

15 piercing device

16 connection elements

16a spring contact

16b connection device

17 Keep Structure

17a needle holder

17b bushing housing

18 racks

19 connecting elements

20 inserter housing

21 activation elements

21a Joint element, guide curve part

22 feed elements

23 power generator

24 arms

25 swivel joints

26 swivel joints

27 swivel joints

28 releaser

29 locking elements

30 inserter housing

31 activation element

31a Joint element, guide curve part

31b Joint element, guide curve part

32 feed elements

33 power generator

34 arms

35 swivel joints

36 swivel joints

37 swivel joints

38 releaser

39 locking elements

40-

41 actuators

41a Articulation elements, engaging elements

41b Articulating elements, engaging elements

42 chute guide

42a Rotary guide section

42b unlock guide section

44 slider, journal

46 anti-loose structure

48 engaging elements

49 Engagement Clearance

50 safety chute

50a insurance shoulder

52 control slope

54 offset bevel

56, 58 baffles

60 stop shoulder

62 guide

64 connector

U lower side

V feed direction

Claims (38)

1. the insert head that is used for medical science or pharmaceutical applications, this insert head comprises:

A) have the pedestal (1,2) of the downside (U) that can be placed in the organic organization, wherein pedestal comprises little admittance seat (1) and flat pieces (2), and said little admittance and flat pieces are integrally formed;

B) can import in the said tissue, through the supported movably gatherer (5) of said pedestal (1,2),

C) wherein said gatherer (5) can move to from protective position with respect to said pedestal (1,2) and import the position; The downside (U) that wherein moves back to said pedestal (1,2) at the free end of gatherer described in the said protective position (5) is with interior and complete crested; And stretch out above said downside (U) at free end described in the said importing position

D) unlimited and big the admittances seat (14) that can unclamp from said pedestal (1,2) with towards the downside (U) of said pedestal (1,2), the free end of this gatherer (5) is being admitted in this big admittance (14) at least in the protective position of said gatherer (5),

It is characterized in that,

E) handle (11,12,14) releasably is connected with said pedestal (1,2) and forms said releasable big admittance seat (14),

F) said handle (11,12,14) has from the upper side of said pedestal (1,2) the handle member (11,12) to upper process; And said releasable big admittance seat (14) stretches out from said handle member (11,12) in the side; Wherein said releasable big admittance seat (14) pot shape or bowl-shape the said pedestal (1,2) that surrounds

G) this insert head also comprises joint component (6); Said pedestal (1,2) and said joint component (6) form a joint each other; And said gatherer (5) stretches out from said joint component (6), and the mode that the axis of movement in the longitudinal direction of this point through said gatherer (5) and said joint intersects realizes.

2. by the described insert head of claim 1; It is characterized in that; The said little seat (1) of admitting opens wide towards the downside (U) of this pedestal (1,2); A said little section admitting seat (1) in the importing position of said gatherer (5), admitting this gatherer (5), and said gatherer (5) passes the said little space (4) of seat (1) of admitting and stretches in said releasable big admittances (14).

3. by the described insert head of claim 2, it is characterized in that the said releasable big seat (14) of admitting has prolonged said little admittance seat (1) along the longitudinal direction of said gatherer (5), is admitting said little admittance seat (1).

4. by the described insert head of claim 2, it is characterized in that said little admittance seat (1) has an outer surface, this outer surface descends to outer ring face arch ground from the direction of the downside (U) of the upper side said pedestal of court (1,2) of said pedestal (1,2).

5. by the described insert head of claim 1, it is characterized in that said gatherer (5) can be turned back in the said importing position.

6. by the described insert head of claim 1; It is characterized in that; Said handle (11,12,14) comprises can be with respect to said pedestal (1,2) active grip members (12); And said active grip member (12) and said gatherer (5) coupling mutually make said active grip member (12) cause the motion of said gatherer (5) with respect to said pedestal (1, the 2) motion of carrying out.

7. by the described insert head of claim 6, it is characterized in that said active grip member (12) is by means of actuating device (8,18) and said gatherer (5) coupling mutually.

8. by the described insert head of claim 7, it is characterized in that said actuating device (8,18) makes said active grip member (12) and said gatherer (5) coupling mutually by means of the engagement of the tooth between gear (8) and the tooth bar (18).

9. by the described insert head of claim 8; It is characterized in that; Said active grip member (12) is connected with said tooth bar (18) on being formed in this active grip member (12), and said gatherer (5) be connected with said gear (8) that said tooth bar (18) is in the tooth engagement.

10. by the described insert head of claim 8, it is characterized in that, said gatherer (5) can round rotating shaft turn round and antitorque change ground with can round said rotating shaft rotation, be in the said gear (8) of tooth in meshing and be connected.

11., it is characterized in that being connected when said active grip member (12) moves of between said pedestal (1,2) and handle (11,12), existing unclamped by the described insert head of claim 6.

12. by the described insert head of claim 11; It is characterized in that; At first Connection Element (9) and second Connection Element (19) that on said handle (11,12,14), has been shaped of being shaped on the said pedestal (1,2); Said first and second Connection Elements (9,19) are in the engagement that connects each other, and at least one Connection Element in said first and second Connection Elements (9,19) can overcome elastic force motion disengaging engagement.

13. by the described insert head of claim 12; It is characterized in that; Said active grip member (12) contacts with a Connection Element in said first and second Connection Elements (9,19) when said active grip member (12) moves, and makes the Connection Element of winning (9) overcome the elastic force motion to break away from the engagement with second Connection Element (19).

14. by the described insert head of claim 6; It is characterized in that; Said handle (11,12,14) comprises another grip member (11,14); And said active grip member (12) and said another grip member (11,14) can be clamped between two fingers of a hands, and wherein each uses wherein finger extruding one of them grip member (11,12,14), can make said active grip member (12) towards said another grip member (11,14) motion thus.

15., it is characterized in that said active grip member (12) can move with respect to said pedestal (1,2) by the described insert head of claim 6.

16. by the described insert head of claim 6, it is characterized in that, guide said active grip member (12) with linear mode.

17., it is characterized in that said active grip member (12) can be parallel to downside (U) motion of said pedestal (1,2) by the described insert head of claim 6.

18. by the described insert head of claim 14; It is characterized in that; Said another grip member (11,14) can not move with respect to said pedestal (1,2) in the state that connects, and said another grip member (11,14) constitutes said releasable big admittance seat (14).

19. by the described insert head of claim 1, it is characterized in that, said handle (11,12,14) from the upper side of said pedestal (1,2) to upper process.

20. by the described insert head of claim 1; It is characterized in that; Said gatherer (5) is flexible and is stablized through thrusting device (15) that the said device (15) that thrusts can move to the said importing position from said protective position with said gatherer (5).

21., it is characterized in that the said device (15) that thrusts is connected with said releasable big admittance seat (14) by the described insert head of claim 20 when said gatherer (5) moves in the said importing position.

22., it is characterized in that the said device (15) that thrusts can unclamp from said pedestal (1,2) and said gatherer (5) together with said releasable big admittance seat (14) by the described insert head of claim 20.

23. by the described insert head of claim 1; It is characterized in that; Said gatherer (5) is longitudinal extension along the longitudinal direction; And when the free end of said gatherer (5) is moving under the situation in the said importing position outstandingly when surpassing said downside (U), the downside (U) of said longitudinal direction and said pedestal (1,2) surrounds one less than 50 ° acute angle.

24. by the described insert head of claim 1, it is characterized in that said pedestal (1,2) can support said gatherer (5) pivotally round rotating shaft, and said gatherer (5) has longitudinal axis, this longitudinal axis intersects with said rotating shaft.

25. by the described insert head of claim 1, wherein said big admittance seat (10,14) is being admitted said gatherer (5,15) in protective position, in this big admittance seat (10,14), is provided with insurance chute (50).

26. by the described insert head of claim 25, wherein can with said insurance chute place set to said gatherer (5,15), near the locked position of coupler of said protective position.

27., wherein set insurance convex shoulder (50a) for said locked position of coupler by the described insert head of claim 26.

28. by the described insert head of claim 14; Wherein said active grip member (12) can push in said another grip member (11,14); Make the control inclined-plane (42) on the said active grip member (12) after the process that is used for gatherer (5,15) is transferred to from said protective position said importing position finishes, run into the skew inclined-plane (54) on the Connection Element (16); And skew is come out from the position of engagement; Make said handle and said pedestal to separate, wherein said Connection Element (16) is connected said pedestal (1) reversiblely with said handle (10,12).

29. by the described insert head of claim 18, wherein said big admittance seat (14) and said another grip member (10) are one, wherein said big admittance seat is not the ingredient of said pedestal (1).

30. by the described insert head of claim 20; Wherein set maintenance structure (17) for said gatherer; This maintenance structure (17) is together moved with said gatherer; Wherein said maintenance structure (17) has stop convex shoulder (60), and engaged element (48) the location engagement of this stop convex shoulder (60) when said active grip member (12) is pulled out from said another grip member (10) and on said active grip member is used to stop and saidly thrusts device (15) deflection once again and come out.

31. by the described insert head of claim 30; Wherein said maintenance structure (17) comprises anti-loose structure (46); This anti-loose structure (46) is opposed with the wall body that the direction of motion that is parallel to said active grip member (12) of said active grip member (12) is extended, and wherein the engaged element on the inboard of this wall body (48) is in the reversible engagement with said anti-loose structure (46) in the protective position of said gatherer (5,15).

32., have following characteristic by the described insert head of claim 6:

-said gatherer (5,15) remains on the said pedestal (1) through rotating shaft (6);

-slide block (44);

-being provided with chute guider (42), this chute guider (42) and said slide block (44) are among effect is connected;

-wherein said active grip member (12) is gone up the slide block (44) of will be said guiding through chute guider (42) with respect to the motion of said pedestal at first circuit (a) of first section (42a) of said chute guider and is transferred to the second position of the importing position that is equivalent to said gatherer (5) from the primary importance of the protective position that is equivalent to said gatherer (5,15).

33. by the described insert head of claim 32; Wherein be provided with connecting device (16b); This connecting device (16b) is connected said pedestal (1) reversiblely with said handle (10,12); Wherein for said handle is unclamped from said pedestal; Said active grip member can be gone up the bearing of trend motion that imports the gatherer (5,15) in the position perpendicular to being at second circuit (b), and wherein said chute guider (42) has and corresponding second section of said second circuit (b) (42b).

34. by the described insert head of claim 31, wherein set said anti-loose structure for said gatherer (5,15), this anti-loose structure is fixed on said gatherer (5,15) in the said protective position reversiblely.

35. by the described insert head of claim 31, wherein set sleeve shell (17b) for said gatherer, this sleeve shell (17b) together moves with said gatherer, wherein said sleeve shell (17b) comprises said anti-loose structure (46).

36. by the described insert head of claim 18; Wherein in protective position, admitting in said another grip member (10) and/or the said big admittance seat (14) and/or the said active grip member (12) of said gatherer (15) and be provided with insurance chute (50), said gatherer (5,15) is engageable in this insurance chute (50) in said protective position.

37. by the described insert head of claim 14; Wherein said active grip member (12) can push in said another grip member (10); Run into the skew inclined-plane (54) on the Connection Element (16) after making the process that is being used for gatherer (5,15) is transferred to from said protective position said importing position on the control inclined-plane (52) on the said active grip member (12) finish; And skew is come out from the position of engagement; Make said handle and said pedestal to separate, wherein said Connection Element (16) is connected said pedestal (1) reversiblely with said handle (10,12).

38. by the described insert head of claim 30; Wherein said stop convex shoulder (60) is used to stop and saidly thrusts device (15) deflection once again and come out when said active grip member (12) carries out relative motion with respect to said another grip member (10) and engaged element (48) location engagement.

Images