CH713379A2 - Cannula insertion mechanism for a patch device. - Google Patents

Abstract

A cannula insertion mechanism for a patch device having a base which may be part of the housing of the patch device and a carriage on which an insertion cannula is fixed and on which at least one guide element, in particular two guide cams, is arranged. The mechanism further comprises a drive lever, from which at least one arm projects with a free end, wherein the free end has an arm guide element, in particular in the form of a cam and wherein the drive lever is either rotatably mounted on the base or rotatably mounted on the carriage and arranged. Furthermore, the mechanism comprises a drive means, in particular a drive spring, especially a torsion spring, which can store and release energy. The drive lever is displaceable by releasing energy from the drive means in a rotational movement relative to the carriage and the base. At least one line guide is arranged on the base, on which the at least one guide element of the carriage engages, so that the carriage is displaceably mounted along the line guide but secured against rotation and the longitudinal dimensions of the line guides define and limit the insertion movement of the insertion cannula. At the base or the carriage further at least one transverse guide is fixedly arranged with a length which extends transversely to the line, wherein the arm guide element of the at least one arm of the drive lever in the transverse guide can be displaced and guided rotatably. The drive lever is arranged in a variant on the carriage when the at least one transverse guide is arranged on the base. If the at least one transverse guide is arranged on the carriage, in another variant the drive lever is arranged on the base.

Description

description

Technical field The invention relates to injection and infusion devices, in particular injection and infusion devices, which are applied, in particular glued, to the administration of a substance directly to the skin of the user, which are also known as patch devices. In particular, the invention relates to mechanisms for the insertion of cannulas, in particular so-called soft or soft cannulas, which are made for example of polytetrafluoroethylene or property-like materials.

General Description A delivery device for fluid products, in particular an infusion pump or an injection device, in particular a patch infusion pump or a patch injector, may in principle be suitable for the administration of a wide variety of medicaments, provided that the medicament has a consistency which corresponds to the infusion pump or the injection device can be distributed. However, the aforementioned consistency, meaning for example the viscosity, may make it reasonable to optimize the design of the injection device or the infusion pump in order to make the use of the medicament as pleasant as possible for the user. One possibility for such optimization is the use of so-called patch devices (patch infusion pump, especially in the treatment of diabetes with insulin, or patch injectors, especially administration of high viscosity antibody formulations). The devices are stuck by means of plaster directly on the body of the user and then no longer need to be held manually or stowed for example in a holster.

The term "medicament" here includes any flowable medical formulation which is suitable for controlled administration by an agent, such as. A cannula or hollow needle, for example comprising a liquid, a solution, a gel, an emulsion or a fine suspension containing one or more medicinal agents. "Drug" may be a single drug composition or a premixed or co-formulated multi-drug composition from a single container. Drug includes drugs such as peptides (eg, insulins, insulin-containing drugs, GLP-1 containing as well as derived or analogous preparations), proteins and hormones, biologically derived or active agents, hormone or gene based drugs, nutritional formulas, enzymes, and other substances both in the art solid (suspended) or liquid form, but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier substances.

Patch devices in the sense of the present application, ie patch infusion pumps or patch injectors, often include so-called (cannula) insertion mechanisms, which serve to introduce a cannula into the tissue of the person using it. Some of these patch devices use soft infusion cannulas made of plastic, especially biocompatible fluoropolymers, for the delivery of the fluid medicament. This has the advantage that the soft infusion cannula potentially causes less pain on movement of the surrounding tissue of the user than an infusion cannula of a rigid material such as steel. Another advantage of the soft infusion cannulae is that it can not break with soft cannulas. In order to be able to insert a soft infusion cannula into the tissue at all, an insertion cannula (or an insertion needle) made of a rigid material such as steel is used. This insertion cannula is passed through the infusion cannula prior to insertion of the infusion cannula and protrudes beyond the open end of the infusion cannula. The insertion cannula is inserted into the tissue along with the infusion cannula during insertion. When the infusion cannula has reached its final position in the tissue, the insertion cannula is withdrawn. Only the soft infusion cannula remains in the tissue.

From US 7 128 727 B2 a patch infusion pump 10 with an insertion mechanism is known, with which a soft infusion cannula 38 is introduced by means of an insertion cannula 62 into the tissue. The mechanism described uses for the insertion movement of the infusion cannula and the subsequent withdrawal of the insertion cannula separate springs 70 resp. 82, so at least one spring 70, which provides the energy for the insertion movement and at least one spring 82, which provides the energy for the return movement.

From the US 2014 142 508 A1 a patch infusion pump 100 with insertion mechanism is known, with which a soft infusion cannula 176 is introduced by means of an insertion cannula 174 into the tissue. The drive of the insertion mechanism is realized with a torsion spring 181. In this case, the drive spring 181 is connected to a slide 184 via an arm system 183a, 183b. The two partial arms 183a and 183b are connected to each other via a hinge, so that the two partial arms 183a, 183b are rotatable in a plane relative to each other. The disclosed insertion mechanism allows the execution of the insertion movement and the withdrawal movement with a spring 181.

It is an object of the invention to provide alternative cannula insertion mechanisms for delivery devices, particularly patch devices such as patch infusion pumps or patch injectors, which are inexpensive to manufacture while providing high reliability.

The object is achieved according to the independent claim, advantageous developments emerge from the dependent claims, the description and the figures.

In the following description, the terms distal and proximal with respect to position and direction indications are used. Distal means from the point of view of the fluid path of the administering device to the person using and proximal corresponding to the reverse. For example, the movement of an infusion cannula, which is introduced into the tissue of the person using it, is a movement in the distal direction, also referred to below as insertion direction.

One aspect of the invention includes a cannulation mechanism for a patch device, in particular a patch infusion pump or a patch injector. In the following description will be discussed in particular insertion mechanisms for patch infusion pumps, but which can be used in the same form for patch injectors, or could be used in other delivery devices without departing from the invention.

In one aspect of the invention, the patch infusion pump comprises a housing. The housing may be constructed in one or more parts and comprises a so-called base, which represents the region of the housing which is arranged on the skin of the user using plaster. The base itself may be designed in several parts and may also include inserts, in particular guide elements, which are mounted during assembly to the base.

In one aspect of the invention, the patch infusion pump includes an insertion mechanism for placing a flexible or soft infusion cannula in tissue of the user. The flexible or soft infusion cannula is introduced into the tissue with the aid of an insertion cannula.

In one aspect of the invention, the insertion mechanism of the patch infusion pump comprises a drive spring, in particular a torsion spring, and a drive or rocker arm (hereinafter referred to as drive lever). The drive lever has an axis of rotation, from which at least one arm protrudes transversely, in particular approximately perpendicular, to the axis of rotation. At the free end of the at least one arm of the drive lever, an arm guide element is arranged, for example in the form of a cam. The drive lever can be moved by energy from the drive spring in a rotational movement about its axis of rotation. Alternatively, a spiral spring, a torsion bar or a wound on an axis and tensioned rubber band could be used as a drive spring. In further alternative embodiments, the drive spring could be replaced by another type drive means, in particular, could be used instead of the drive spring, an electric drive to put the drive lever in the rotational movement. For example, an electric motor, in particular a stepping motor, which would optionally move the drive lever via a gear and / or one or more toothed racks, could be used. As a transmission, a worm gear would be conceivable in particular. As an alternative electric drives and drives are conceivable which contain piezo or shape memory elements. An advantage of an electric drive would be the simplified starting and stopping of the insertion mechanism via activation and deactivation of the electric drive.

In one aspect of the invention, the insertion mechanism of the patch infusion pump comprises a carriage on which the insertion cannula is fixed. The carriage is slidably mounted on the housing, for example the base. For this purpose, the housing comprises linear guides, for example grooves, in which guide elements of the carriage can be mounted, so that the carriage can be moved along the guides. The linear guides may be straight or curved. The guides dictate the insertion movement by their configuration and thus define an insertion movement axis along which the carriage can be moved. In the initial state, the infusion cannula is drawn over the insertion cannula, which is deposited in the tissue of the user using the insertion cannula as part of the insertion process. After deposition, the insertion cannula is withdrawn from the tissue through the infusion cannula, leaving the lumens of the two cannulas interconnected, such that the drug passes from a reservoir via a supply line and, optionally, a pumping element through the insertion cannula into the infusion cannula and into the tissue the user can be directed.

In one aspect of the invention, the insertion mechanism of the patch infusion pump comprises at least one transverse guide, in which arm guide elements of the at least one arm of the drive lever can be performed. For this purpose, the at least one transverse guide lies in the same plane as the linear guides which define the insertion movement, or in a plane parallel thereto. In the former case, the transverse guides, such as the linear guides on the housing, in particular the base, are fixedly arranged. In the second case, the transverse guides are arranged in particular on the carriage. As the name suggests transverse guidance, the elongated pronounced at least one transverse guide is arranged transversely to the linear guides of the housing, in particular approximately perpendicular to the linear guides.

In one aspect of the invention, the drive lever is arranged rotatable about its axis of rotation at the base of the housing, wherein the rotation axis is approximately perpendicular to the insertion axis of movement defined by the linear guides (also arranged on the base) and the base. In a possible and advantageous case, the ration axis intersects the insertion movement axis. The drive lever in this aspect comprises two projecting arms which have cams as arm guide elements. For example, the arms may have a 180 degree orientation on the drive lever. Alternatively, the difference in orientation can also deviate from 180 °. In this aspect, the carriage can be displaced relative to the drive lever along the insertion movement axis. Next, the carriage on two mutually directed away transverse guides, which have at their free ends sockets for receiving the arm guide elements. The Almführungselemente can be passed through the sockets along the transverse guides after recording. The transverse guides have at the free end opposite end closures, by which a movement of the arm guide elements can be limited in the transverse guides. In the initial position and biased drive spring, the arm guide element of a first arm of the drive lever is in engagement with a first transverse guide on the carriage. The drive spring may be disposed in this aspect of the invention with one end fixed to the base and a second end on the drive lever, so that when a torsion spring is used as a drive spring, the torque of the spring between the base and drive lever acts. If the insertion mechanism is activated, in particular released, the drive spring causes the drive lever and thus also the two arms to rotate (about the axis of rotation of the drive lever). Now, the arm guide element of the first arm moves along the first transverse guide in the direction of the socket. Since the arm guide element describes a circular movement and moves linearly in the transverse guide, however, the transverse guide and thus also the slide must perform a compensation movement along the insertion movement axis (first partial movement). As mentioned, the insertion needle is fixedly arranged on the carriage and thus makes the movement of the carriage with it and is displaced in the insertion direction after activation. If the arm guide element of the first arm reaches the socket during further movement (in the axial direction of the drive lever), it can leave the first transverse guide through the socket. At about the same time reaches the free end of the second arm with its arm guide element, the version of the second transverse guide and enters the second transverse guide. Upon further rotation of the drive lever, notabene always in the same direction and driven by the drive spring, the guide of the arm guiding element of the second arm in the second transverse guide causes the carriage to start to move in the opposite direction along the insertion movement axis (second partial movement), whereby the withdrawal movement of the insertion needle begins. This movement continues until the arm guide element of the second arm reaches the conclusion of the second transverse guide. At this point, the movement is stopped and also the slide and thus the insertion cannula stand still. The insertion process is thus completed.

In the just described aspect of the invention is to mention that the flow of the insertion process can be influenced in particular by the choice of the orientation of the two arms of the drive lever. It may be desired, for example, that the carriage between the two partial movements, ie the movement in the insertion direction and the retreat, stops short without the rotation of the drive lever must be stopped. If one chooses the orientations of the two arms so that before the Armführungselement of the second arm inserted through the socket in the second transverse guide, the arm guide element of the first arm has left the first transverse guide, the drive lever rotates without the carriage is moved.

In an alternative aspect of the invention, which is very similar to the preceding aspect and represents an alternative in the context of the invention, in contrast to the preceding aspect, in this aspect, drive lever and transverse guide interchanged in the insertion mechanism are arranged. Due to the said similarity to the previous aspect, the differences are discussed here. The drive lever is rotatably mounted on the carriage in this aspect and is moved with the carriage when the carriage moves along the linear guides. The transverse guides are brought together in this aspect to form a transverse guide, which, like the linear guides, are fixedly arranged on the base and designed, for example, as a groove. The drive lever in this aspect comprises only one arm with an arm guide element at its free end, which is guided in all states of the insertion mechanism in the transverse guide. The drive spring is in this aspect of the invention, for example, designed as a torsion spring, wherein a first end of the drive spring is fixedly arranged on the carriage and a second end of the drive spring fixed to the drive lever, so that stored energy can be released as relative rotation between the carriage and the drive lever , Upon activation of the insertion mechanism in this aspect, the release of energy from the drive spring causes the drive lever to rotate relative to the carriage and therefore also to the base. Since the drive lever is guided via the arm guide element in the transverse guide (linear), the carriage must compensate for the movement of the arm guide element in the transverse guide by moving along the linear guides. In this way, the insertion cannula, which is fixedly arranged on the carriage, is moved along the insertion movement axis, in the first part of the insertion process in the insertion direction. The movement of the carriage in the direction of insertion (which corresponds to the distal direction) continues until the arm of the drive lever has the same orientation as the insertion movement axis. In this situation, the insertion process has reached the vertex of movement, and thus the insertion cannula has reached the deepest point in the tissue of the person using it. At this point, the soft infusion cannula is deposited and fixed at its proximal end so that it remains in the tissue. If the drive lever continues to rotate in the same direction, then the engagement of the arm guide element in the transverse guide forces a displacement of the carriage in the opposite direction. This retraction movement also moves the insertion cannula back so that it is pulled out of the user's tissue. The withdrawal movement is limited by the proximal end of the linear guides, which stops the movement of the guide elements of the carriage in the proximal direction. The insertion process is complete. If the boundary were missing through the proximal end of the linear guides, the drive lever would continue to rotate until a proximal apex was reached at which the carriage would again change direction and would be displaced in a distal direction upon further movement. The process would continue until the drive energy from the drive spring was used up.

Central to the present invention is that only one spring or drive means (see above) is needed without reversing the direction of the whole insertion process and also the structure of the insertion mechanism can be kept relatively simple, which ensures the reliability.

Figures [0020]

Fig. 1 exploded view of the insertion mechanism of a patch pump 1 according to a first embodiment of the invention

Fig. 2 view of the parts of the patch pump shown in Fig. 1 in the assembled state

3 is a plan view of the arrangement of FIG. 2nd

4 shows a vertical section through the arrangement from FIG. 2

Fig. 5 horizontal section through the arrangement of Fig. 2, wherein only a part of the arrangement is shown

Fig. 6 detail of the cannula guide of the arrangement of Fig. 2 in vertical section

Fig. 7a and 7b insertion mechanism of the patch pump 1 immediately after release of the mechanism

Fig. 8a and 8b insertion mechanism of the patch pump 1 in the phase of insertion of the cannulas 3a and 3b

9a and 9b insertion mechanism of the patch pump 1 in the state in which the cannulas 3a and 3b are completely inserted (before the withdrawal of the insertion cannula 3a)

10a and 10b insertion mechanism of the patch pump 1 in the phase of withdrawal of the insertion cannula 3a

Fig. 11a to 11c insertion mechanism of the patch pump 1 at the end of the insertion process, with fully retracted insertion cannula 3a

Fig. 12 exploded view of the insertion mechanism of a patch infusion pump 100 according to a second embodiment of the invention

Fig. 13 View of the parts of the patch infusion pump shown in Fig. 12 in the assembled state, which corresponds to the initial state

FIG. 14 Partial vertical section through the arrangement of FIG. 13

15 shows a horizontal section through a region of the insertion mechanism from FIG. 13

Fig. 16 Detail view of the release mechanism in the initial state

Fig. 17 insertion mechanism of FIG. 13 immediately after release

Fig. 18 Detail view of the release mechanism immediately after release

Fig. 19 insertion mechanism of Fig. 13 during the insertion of the needles 103a and 103b

20a and 20b insertion mechanism of the patch infusion pump 100 in the state in which the needles 103a and 103b are completely inserted (before the withdrawal of the insertion cannula 103a)

Fig. 21 insertion mechanism of the patch pump 100 in the phase of withdrawal of the insertion cannula 103a

Fig. 22 insertion mechanism of the patch pump 100 at the end of the insertion process, with fully retracted insertion cannula 103a

Description of the Figures The following description of the figures and figures show and describe various possible embodiments and embodiments of the invention. This is not a final list of possible embodiments of the invention, but only examples. The skilled person will be apparent from the description and illustration of further embodiments of the invention, without departing from the idea of the invention. Such embodiments not shown here are expressly mitgemeint in this document. Also, by combinations of parts of described embodiments, further, obvious to those skilled embodiments, embodiments may arise, without thereby abandoning the idea of the invention. Such embodiments not shown here are expressly mitgemeint in this document.

1 to 11c show a first embodiment of a cannula insertion mechanism according to the invention for a patch device, here by way of example for a patch infusion pump 1. Fig. 1 shows an exploded view of the first embodiment. It should be noted that, for reasons of clarity, the illustration does not show the entire patch-in-fusion pump, but only the parts thereof which are of importance for the insertion mechanism. Fig. 2 shows the insertion mechanism of Fig. 1 in the assembled state, which represents the initial state of the insertion mechanism. FIG. 4 shows a vertical section through the arrangement of FIG. 2. FIG. 5 shows a horizontal section of a section of the arrangement of FIG. 2. FIG. 6 likewise shows a detail section of FIG Arrangement of Fig. 2, wherein here the arrangement of the cannulas and the optional guide tube 3d are shown. Figures 7a to 11c illustrate the cannula insertion mechanism of the first embodiment of the invention in the various stages of the insertion process.

The patch infusion pump 1 comprises a housing 2 with a base 2a, on which the insertion mechanism is constructed (see FIGS. 1 to 6), and which may be embodied in one or more parts, and also designed as an insert for the housing 2 can be. The base 2a is adhered, for example, by means of a plaster (not shown) directly or indirectly to the skin of the person using, the patch being placed between the skin and the base 2a. In the region of the base, in which the infusion cannula is inserted through the skin into the tissue, the patch has an opening through which the infusion cannula can be passed. The base 2a comprises four linear guides 2b which are in the form of grooves. Further, a spring holder 2c is fixed to the base 2a, the function of which will be discussed later. Furthermore, the base 2a also comprises an approver holder 2d, on which a releaser 7 is rotatably mounted. As a further device, the cannula guide 2e, which also includes the insertion guide 2f, the funnel-shaped guide 2h and the optional guide tube guide 2g, is fixedly arranged on the base (see also FIG. 6). The base 2a with the elements 2a to 2g can be embodied in one or more parts. In the simplest case, the base 2a with the elements 2a to 2g is designed as an injection-molded part made of plastic. Alternatively, for example, the cannula guide 2e may be configured as one or more additional parts made of plastic, metal or a combination of plastic or metal. In possible embodiments, for example, the linear guides 2b could also be executed skeleton-like and glued into the base, welded or snapped.

The insertion mechanism of the first embodiment comprises a carriage 6. The carriage 6 is mounted on the guide cam 6c linearly displaceable in the linear guides 2. So that the carriage does not get out of the guides, one or more of the guide cams 6c and complementary to one or more of the linear guides 2b can be designed snapping into each other, so that, for example, a dovetail guide can arise. The carriage 6 further comprises a first guide arm 6a and a second guide arm 6b, which are oriented approximately perpendicular to the linear guides and extend approximately parallel to the base surface of the base 2a. On the upper sides of both guide arms 6a, 6b in each case a groove 6g and 6h, respectively. Both grooves 6g, 6h respectively have an opening 6i at the free ends of the guide arms 6a, 6b. 6y up. Further, the carriage 6 comprises the release cam 6f, which in interaction with the releaser 7 can hold or block the insertion mechanism in the initial state. At the distal end of the carriage 6, the insertion cannula holder 6e is fixed, wherein the insertion cannula 3a is fixed to the insertion cannula holder 6e with its insertion cannula carrier 3c. Releasably connected to the insertion cannula holder 6e is the (infusion) cannula holder 9, to which the infusion cannula 3b and optionally the guide tube 3d are firmly attached (see also FIG. 6).

The insertion mechanism of the first embodiment comprises the cannula ensemble 3, which comprises the cannula support 9 with the cannula support base 9a. At the cannula support base 9a, the infusion cannula 3b is firmly anchored as mentioned. Furthermore, the cannula ensemble 3 comprises the insertion cannula support 3c. In the insertion cannula carrier 3, the insertion cannula 3a and the lead 3e are firmly anchored. In this case there is a fluid connection between supply line 3e and insertion cannula 3a. In practice, the substance to be administered, for example the liquid medicament, can be supplied from the reservoir (optionally via a pumping element) via the supply line of the insertion cannula. In the initial state, the insertion cannula 3a protrudes through the lumen of the infusion cannula 3b, with the distal tip of the insertion cannula 3a protruding from the distal end of the infusion cannula 3b. When the infusion cannula 3b is inserted into the tissue of the person using and the insertion cannula is withdrawn, the insertion cannula still protrudes into the infusion cannula 3b and thus establishes the fluid connection between the inlet 3e and the infusion cannula 3b so that the substance to be administered is supplied to the person using it can be. The infusion cannula 3b is movably mounted together with the cannula carrier 9 on the insertion cannula 3a, wherein in the initial state cannula carrier 9 and insertion cannula carrier 3c are firmly connected to one another via the snap arms 9b on the insertion cannula holder 6e.

Referring to Fig. 6 and 11c, the arrangement of the cannulas 3a, 3b and the guide tube 3d will be discussed. In an optional embodiment of the first embodiment, the cannula ensemble 3 comprises the guide tube 3d, whose task is to mechanically stabilize the cannula ensemble 3 during the movement in the distal direction (see, for example, FIG. 2 or 3). The guide tube 3d encloses the infusion cannula 3b. In this case, the guide tube 3d has a longitudinal slot on its side facing the base 2a. If the cannula ensemble is displaced in the distal direction, the guide tube 3d is opened along the slot in the area of the cannula guide 2e and removed from the remaining cannula ensemble 3, i. e. the infusion cannula 3b and the insertion cannula 3a are separated and not guided via the insertion guide 2f through the base 2a in the direction of tissue, but passed via the guide tube guide 2g inside the housing 2. Since the proximal end of the guide tube 3d is fixed to the cannula support 9, the guide tube 3d remains in place together with the infusion cannula, while the insertion cannula 3a is withdrawn.

Fixedly connected to the spring holder 2c is one end of the drive spring 5, which is designed in the present example as a helical torsion spring. Alternatively, however, the drive spring could also be designed for example as a helical torsion spring, coil spring, torsion bar or on an axle on rolled-up and stretched rubber band. The second end of the drive spring 5 is fixedly connected to the sleeve-shaped rotation axis 4 d of the drive lever 4. The sleeve-shaped rotation axis 4d is mounted concentrically with the drive spring 5 via the spring holder 2c. Energy, which is stored in the drive spring, can put the drive lever 4 in a rotation about the axis of the spring holder 2c via the arrangement described in this paragraph.

The drive lever 4 comprises a first arm 4a and a second arm 4b, both of which extend approximately perpendicularly away from the axis of rotation 4d. At the free ends of the arms 4a and 4b, the cam 4e respectively. 4f, which may be either in engagement with the groove 6g (cam 4e) or in engagement with groove 6h (cam 4f), depending on the rotational orientation of the drive lever, which may result in a phase between the interventions (depending on the arrangement of the Arms 4a and 4b to each other), in which no cam 4e, 4f in engagement with one of the grooves 6g resp. 6h is. Alternatively, the situation may arise that both cams 4e and 4f respectively in engagement with the groove 6g respectively. 6h (see Fig. 9a).

The insertion mechanism of the first embodiment further comprises the release coupler 7. The release coupler 7 comprises the release coupler rotation axis 7a, by means of which the release coupler is rotatably mounted in the release coupler attachment 2d. Furthermore, the release device 7 comprises release arm 7b, on which the retaining cam 7c is fixed. In the initial state prevents this retaining cam 7c by engagement with the release cam 6f a movement of the carriage from the starting position addition. The engagement and the particular shape of the retaining cam 7c are particularly clearly visible in FIG. The retaining cam 7c is concavely formed on that surface which faces the lateral surface of the release cam 6f - matching the configuration of the lateral surface of the release cam 6f, which in the example in FIG. 5 is convex. Alternatively, convex and concave surfaces could also be reversed. Alternatively, the surfaces could have other shapes which allow stable support of the carriage 6 in at least the starting position. The insertion mechanism is released by a rotation of the releaser 7, so that retaining cam 7c and release cam 6f are disengaged.

Referring to Figs. 2 to 11c, the function of the insertion mechanism of the first embodiment according to the invention will be described below. Fig. 2 to 6 show different representations of the insertion mechanism in the initial state. In the initial state of the cam 4e of the first arm 4a is in engagement with the groove 6g of the first guide arm 6a of the carriage 6. The biased drive spring 5 causes via the rotation axis 4d of the drive lever 4, a torque and a correspondingly acting force, which from the first arm 4a the first guide arm 6a of the carriage is transmitted. Since retaining cams 7c and release cams 6f are engaged in this state, the force causes no movement.

Figs. 7a and 7b show the insertion mechanism immediately after release, that is, after the holding cam 7c and release cam 6f have been disengaged. Now, the torque causes a rotation of the drive lever 4 in a counterclockwise direction, since the carriage 6 is now movable. The carriage 6 begins to move distally along the linear guides 2b, wherein also the cannula ensemble is moved with. As can be seen in FIGS. 8a and 8b, the cam 4e moves in the groove 6g in the direction of the open groove end 6i. Insertion cannula 3a and infusion cannula 3b are pushed by the movement of the carriage 6 via insertion guide 2f in the direction of the tissue of the person using.

9a and 9b show the insertion mechanism in the state in which the insertion cannula 3a and the infusion cannula 3b are completely inserted into the tissue (vertex of the carriage movement), after which the drive lever 4 has further rotated in a counterclockwise direction. At this moment both cams 4e and 4f are in engagement with the associated grooves 6g, resp. 6h, wherein cam 4f has engaged in the groove 6h just before reaching the vertex through the open end 6j. As the drive lever 4 continuously rotates further, the cam 4e leaves the groove 6g through the open end 6i after reaching the vertex. As a result of this change in the engagement, upon further rotation of the drive lever 4, the direction in which the carriage 6 shifts changes as it begins to move back along the linear guides 2b, counter to the insertion direction.

As can be seen in FIGS. 9a and 9b, the cannula carrier 9 is decoupled from the insertion cannula holder 6e at the apex and fixed to the cannula guide 2e. Shortly before reaching the vertex (as shown in Fig. 9, the support arms 9c of the cannula support 9 are deflected inwardly by the funnel-shaped guide 2h of the cannula guide 2e, so that on the one hand a connection between the support arms 9c and the cannula guide 2e and others the connection the snap arms 9b is released with the insertion cannula holder 6e.

Figures 10a and 10b show the insertion mechanism shortly after the withdrawal movement has started. The torque from the drive spring 5, which acts on the drive lever 4 and allows it to rotate further, also causes due to the engagement between cam 4f and groove 6h, the movement of the carriage 6 in the proximal direction. As can clearly be seen in FIGS. 10a and 10b, the insertion cannula 3a is now moved out of the infusion cannula.

If the drive lever continues to rotate in a counterclockwise direction, the cam 4f reaches the closed end of the groove 6h, whereby a further movement of the drive lever is prevented and the insertion process is completed as a whole.

In one embodiment of the first embodiment, the energy stored in the drive spring is so dimensioned that residual energy is stored after the insertion process, so that the cam 4f is actively pressed into the end of the groove 6h.

The first embodiment shown (as well as analogously described below) of the insertion mechanism allows elegant and simple way a reciprocating motion with only one direction of rotation of the drive lever, which makes it possible to use only one spring for the insertion mechanism.

A further (second) embodiment of the insertion mechanism according to the invention is shown in FIGS. 12 to 22. The identifiers in this embodiment were named analogously to the embodiment of FIG. 1, the numbering was made such that z. For example, the base 2a of the embodiment of FIG. 1 is analogous to the portion 102a of the embodiment of FIG. 12. Since the function of the embodiment of FIG. 8 is analogous or identical to that of FIG. 1, the differences between the two embodiments will be discussed in more detail below and, consequently, not all details of the insertion mechanism.

12 shows an exploded view of this alternative embodiment with the patch pump 100, wherein it should also be noted in this embodiment that the illustrations of FIGS. 12 to 22 do not show the entire patch infusion pump 100 for reasons of clarity, but only the parts thereof which are of importance for the insertion mechanism. Fig. 13 shows a perspective view of the insertion mechanism of Fig. 12 in the assembled state (which corresponds to the initial state of the insertion mechanism).

Fig. 14 shows a vertical partial section through the arrangement of Fig. 13, wherein the drive spring has not been cut. Fig. 15 shows a horizontal section through a part of the arrangement of Fig. 13. Fig. 16 shows a detail of the insertion mechanism, namely the release device with the releaser 107 in the initial state. 17 shows a view of the insertion mechanism immediately after release, the release element 107 is to be noted here. Fig. 18 shows the same detail as Fig. 16 but now in the state immediately after release. Fig. 19 shows a view of the insertion mechanism in the phase in which the insertion cannula 103a is inserted together with the infusion cannula 103b in the distal direction (insertion direction) through the cannula guide 102e into the tissue of the using person.

Fig. 20a is a view of the insertion mechanism in the state in which the needles 103a and 103b are fully inserted and before the insertion cannula 103a is retracted. Fig. 20b shows a partial vertical section through the insertion mechanism in the state of Fig. 20a, wherein the drive spring 105 has not been cut.

Fig. 21 shows the insertion mechanism in the phase of insertion needle withdrawal, i.e. the insertion cannula 103a is moved counter to the direction of insertion in the proximal direction. Fig. 22 shows the insertion mechanism after completion of the entire insertion process, so after the insertion cannula was completely withdrawn.

Analogous to the first embodiment, the patch infusion pump 100 comprises a housing 102 having a base 102a. Fixed to the base 102a are the linear guides 102b, which serve to guide the movements of the carriage 106. As in the first embodiment, the cannula guide 102e is also fixed to the base. Furthermore, the base 102a comprises a further linear guide 102c which is oriented in the plane of the base 102a approximately perpendicular to the linear guides 102b. The linear guides 102b as well as the linear guides 102c are channel-shaped in the example shown. Alternatively, and obvious to those skilled in the art, they could also be rail-like and project out of the surface of the base 102a.

The insertion mechanism of the second embodiment further comprises a carriage 106, which has the guide cam 106c, which in turn are slidably mounted in the linear guides 102b, so that the carriage 106 is displaceably mounted but secured against rotation on the base 102a. The carriage further comprises the insertion cannula holder 106e, via which a fluid connection between the supply line 103e and the insertion cannula 103a of the cannula ensemble 103 is produced (for details, reference is made here to the first embodiment). Further, the carriage also includes the release arm 106f, which protrudes from the housing-like spring bearing 106d of the carriage and at the free end of a bore 106k is arranged.

The insertion mechanism of the second embodiment further comprises a rocker arm 104 having a rotation axis 104d and a rocker arm 104a at the free end of the cam 104f and the blocking recess 104g are arranged.

The cam 104f is rotatably and slidably mounted in the assembled state in the linear guide 102c. In the region of the rotation axis 104d, a drive spring 105 is mounted coaxially on the rotation axis 104d. One end of the drive spring 105 is firmly connected to the rocker arm 104. The other end of the helical torsion spring formed as a drive spring 105 is fixedly connected to the spring bearing 106d of the carriage. In the assembled state, the rocker arm 104 is mounted on the lever bearing axle 1061 of the carriage (see FIG. 14). For this purpose, the rotational axis 104d of the oscillating lever 104 has a bore 104h, through which the lever bearing axis 1061 is guided.

Fig. 13 shows the insertion mechanism of the second embodiment in the initial state (further illustrations of this state are Figs. 14 to 16). It can be seen in Fig. 13 that the release arm 106f is directly above the rocker arm 104a. In this case, the release agent 107 is guided through the bore 106k and protrudes into the blocking recess 104g. In the initial state, the drive spring 105 is biased so that a torque in the counterclockwise direction acts on the rocker arm 104a. The blocking recess 104g is channel-shaped and has the stop 104i at its closed end. In the initial state, the torque now causes engagement of stop 1041 and release 107, so that rotation of the rocker arm is inhibited in the initial state (see detail in Fig. 16).

In order to release the insertion mechanism of the second embodiment, the releaser 107 is pulled out of engagement with the stop 104t away from the base 202a (see FIGS. 17 and 18). Now, since the rocker arm 104 can rotate relative to the carriage 106, the insertion mechanism begins to move. The rocker arm 104 now rotates counterclockwise relative to the carriage 106 (see FIG. 19), with the rocker arm 104a of the rocker arm 104 being displaced over the cam 104f in the linear guide 102c, at the same time the carriage connected to the rocker lever 104 via the lever bearing axle 1061 moves 106 in the distal direction to compensate for the movement of the rocker arm 104. As a result, the cannula ensemble is also moved in the distal direction, thus the insertion movement of the insertion cannula 103a and the infusion cannula 103b takes place as a result. With regard to release, other possibilities are known to the person skilled in the art, the release via the pin-shaped release 107 is merely to be understood as an example.

Figs. 20a and 20b show the insertion mechanism with complete insertion of the insertion cannula 103a and the infusion cannula 103b but before the withdrawal of the insertion cannula. In the view of FIG. 20a, it can be seen that the oscillating lever 104 lies completely below the carriage 106. The oscillating lever arm 104a now points in the proximal direction (see also FIG. 20b) and thereby also predetermines the maximum displacement of the carriage 106 in the distal direction, whereby the insertion depth of the cannulas is also determined. In this state, cannula support 109 is coupled and fixed together with the infusion cannula 103b and the guide tube 103 to the cannula guide 102e.

Now, the rocker arm 104 continues to rotate counterclockwise due to the applied torque from the drive spring 105, the carriage 106 and thus also the insertion cannula begins to move back in the proximal direction (see FIG. 21). If the cams 106c reach the respective proximal end of the linear guides 102b, further movement of the carriage is blocked, with the still applied torque on the oscillating lever 104 holding the carriage in this end position. The insertion process is complete.

Identifier 1 Patch pump 2 Casing 2a Base 2b Linear guides for carriages 2c Spring holder 2d Freigeber holder 2e Cannula guide 2f Insertion guide 2g Guide tube guide 2h Funnel-shaped guide 3 Needle assembly 3a Insertion cannula 3b Infusion cannula 3c Insertion cannula carrier 3d Guide tube 3e Supply line 4 Drive lever 4a First arm 4b Second arm 4d Rotation axis 4e cam 4f cam 5 drive spring 6 slide 6a first guide arm 6b second guide arm 6c guide cam 6d opening for rotation axis 6e insertion cannula holder 6f release cam 6g guide groove in first guide arm 6h guide groove in second guide arm 6i open groove end 6j open groove end 7 release 7a release lever rotation axis 7b release cam 9 Cannula support 9a cannula support base 9b snap arms 9c support arms 100 patch infusion pump 102 housing 102a base 102b line guides for carriages 102c guide for oscillating lever arm 102e cannula guide Insertion cannula 103b Infusion cannula 103c Insertion cannula support 103d Guide tube 103e Supply line 104 Oscillating lever 104a Cam lever 104e Cam 104d Rotation axis 104f Cam 104g Blocking recess 104h Bore 104i Stop 105 Drive spring 106 Carriage 106c Guide cam 106d Spring bearing (housing-shaped) 106e Insertion cannula holder 106f Release arm 106k Bore 1061 Lever bearing shaft 107 Releaser (Pen) 109 cannula carrier 109a cannula carrier base 109b snap-in arms

Claims (20)

109c holding arms claims 1. A cannula insertion mechanism for a patch device with - a base, which may be part of the housing of the patch device, - a carriage on which an insertion cannula is fixedly arranged and on which at least one guide element, in particular two guide cams, is arranged, - A drive lever, projecting from which at least one arm having a free end, wherein the free end has an arm guide element, in particular in the form of a cam and wherein the drive lever is either rotatably mounted on the base or rotatably mounted on the carriage and arranged --einem drive means, in particular a drive spring, for example a torsion spring, wherein the drive lever is displaceable by releasing energy from the drive means in a rotational movement relative to the carriage and the base, wherein at least one line guide is arranged on the base, at which engages the at least one guide element of the carriage, so the sled slidably mounted but non-twisted along the lines and defined the lines the insertion movement of the insertion and limited to the base or the carriage at least one transverse guide with a length which extends transversely to the line, wherein the arm guide element of the at least one arm of the Drive lever in the transverse guide slidably and rotatably guided, wherein the drive lever is arranged on the carriage when the at least one transverse guide is arranged on the base, or the drive lever is arranged on the base, when the at least one transverse guide is arranged on the carriage. 2. cannula insertion mechanism according to claim 1 with an infusion cannula made of soft plastic, in particular PTFE, which is designed to be pulled over the insertion cannula. 3. cannula inserting mechanism according to the preceding claim, wherein the insertion cannula is a steel cannula. 4. cannula inserting mechanism according to one of the preceding claims, wherein the drive means is a drive spring. 5. cannula inserting mechanism according to the preceding claim wherein the drive spring is a torsion spring and has a helical shape. 6. cannula inserting mechanism according to claim 4, wherein the drive spring is a torsion spring, which has the form of a coil spring. The cannula insertion mechanism of any one of claims 2 to 6, wherein the drive lever is disposed on the base and the cannula insertion mechanism includes first and second transverse guides disposed on the carriage. The cannula inserting mechanism of claim 7, wherein the drive lever comprises a first arm and a second arm each having an arm guide member in the form of a cam at the free ends of the arms. 9. cannula insertion mechanism according to claim 8, wherein the first and second transverse guide arm-shaped protrude from the carriage and along its length comprise a groove which at the respective free end of the first and second transverse guide has an open end through which the cams are introduced into the transverse guide, wherein that the open end of the groove opposite end of the groove is closed and makes the movement of the cam limited. 10. A method for moving a soft infusion cannula from a housing of a patch device according to claim 9 from a starting position in which the infusion cannula is completely in the housing, in a position in which it protrudes beyond the housing, wherein in the starting position, the cam of the first Arm is mounted in the groove of the first transverse guide close to its closed end, the method comprising at least the following steps, - a rotation of the drive lever, wherein the cam of the first arm is guided along the groove of the first transverse guide in the direction of the open end, whereby, in consequence, the carriage is moved together with the insertion cannula and the soft infusion cannula along the at least one line guide in the distal direction, and wherein the infusion cannula is pulled over the insertion cannula, - fixing the soft infusion cannula to a part of the housing in a distal position, the infusion channel le protrudes from the housing in this position, - a cam of the cam of the first arm from the groove of the first transverse guide, wherein the drive lever continues to rotate, - an introduction of the cam of the second arm in the groove of the second transverse guide through the open end, wherein the drive lever continues to rotate, - a guide of the cam of the second arm in the groove of the second transverse guide towards its closed end, wherein the carriage and the insertion cannula move in the proximal direction and moves the insertion cannula through the infusion cannula in the proximal direction and the infusion cannula remains in its distal position. 11. A method for moving a soft infusion cannula from a housing of a patch device according to the preceding claim, the method comprising at least the following additional step, - releasing the insertion mechanism, thereby allowing rotation of the drive lever relative to the carriage and the base, and wherein the rotation is driven by energy from drive means. 12. A method for moving a soft infusion cannula from a housing of a patch device according to one of the two preceding claims, wherein the method comprises at least the following additional step, - stopping the movement of the cam at the closed end of the groove of the second transverse guide, whereby the Movement of the carriage and the insertion cannula is stopped. The cannula insertion mechanism of any of claims 2 to 6, wherein the drive lever is disposed on the carriage and the cannula insertion mechanism comprises a groove-shaped transverse guide disposed on the base. 14. The cannula inserting mechanism of claim 13, wherein the drive lever comprises an arm having an arm guide member in the form of a cam at the free end of the arm. 15. The cannula insertion mechanism of claim 14, wherein the at least one line guide is grooved. 16. A method for moving a soft infusion cannula from a housing of a patch device according to claim 15 from a starting position in which the infusion cannula is completely in the housing, in a position in which it protrudes beyond the housing, wherein the cam of the arm in the groove the transverse guide is mounted, wherein the method comprises at least the following steps, a rotation of the drive lever, wherein the cam of the arm along the groove of the transverse guide is directed in the direction, whereby in consequence the carriage together with the insertion cannula and the soft infusion cannula along the at least moving a line guide in the distal direction, and with the infusion cannula being pulled over the insertion cannula, - fixing the soft infusion cannula to a part of the housing in a distal position, with the infusion cannula projecting out of the housing in this position, - further turning the drive lever , wherein the cam d arm is further passed along the groove transverse guide in the same direction, wherein the drive lever continues to rotate, and wherein the carriage and the insertion cannula move in the proximal direction and the insertion cannula is moved through the infusion cannula in the proximal direction and the infusion cannula in its distal Position remains. 17. A method for moving a soft infusion cannula from a housing of a patch device according to the preceding claim, the method comprising at least the following additional step, - releasing the insertion mechanism, thereby allowing rotation of the drive lever relative to the carriage and the base, and wherein the rotation is driven by energy from drive means. 18. A method for moving a soft infusion cannula from a housing of a patch device according to one of the two preceding claims, wherein the method comprises at least the following additional step, - stopping the movement of the carriage by reaching a closed proximal end of the at least one groove-like lines, whereby the movement of the carriage and the insertion cannula is stopped. 19. The cannula insertion mechanism of claim 1 to 6, wherein the carriage comprises a proximal end, on which a release cam is arranged, which is slightly perpendicular to the base, wherein on the base a release is arranged, which rotatably mounted about a Freigeberrotationsachse relative to the base wherein the release further comprises a release arm which protrudes from the free rotation axis and the free end of which is arranged a retaining cam, wherein the retaining cam in the initial position of the cannula insertion mechanism is in engagement with the release cam and prevents movement of the carriage in the distal direction in the starting position , and by rotating the releaser relative to the base, the engagement between the release cam and the retaining cam is achieved. 20. cannula inserting mechanism according to claim 14 or 15, wherein fixed to the carriage abragender a release arm, at the free end of a connecting element, in particular a bore, is attached, wherein at the free end of the arm of the drive lever, a blocking element, in particular, a blocking recess, is arranged, wherein the cannula insertion mechanism further comprises a release, in particular a pin or split pin, which is in the starting position of the cannula insertion mechanism through the connecting element into the blocking element feasible, so that carriage and drive lever in the initial position are mutually secured against rotation.