WO2018134705A1

WO2018134705A1 - Cannula insertion mechanism for a patch device

Info

Publication number: WO2018134705A1
Application number: PCT/IB2018/050161
Authority: WO
Inventors: Seline STAUB; Ursina Streit; Jürg HIRSCHEL; Patrick Hostettler; Christian Schrul
Original assignee: Tecpharma Licensing Ag
Priority date: 2017-01-19
Filing date: 2018-01-11
Publication date: 2018-07-26
Also published as: CH713377A2

Abstract

The invention relates to a drive, which moves back and forth, for an insertion mechanism for an administering device, having a base (2a) and a guide track (2h) formed in or on the base. The drive also comprises a drive track (2b), which is connected to the base and which has a plurality of drive sections, wherein a first drive section (2c) and a second drive section (2d) lie opposite each other and extend parallel to the guide track. A slide (6) is provided on the base (2a) in a rotationally fixed manner and can be slid along or in the guide track (2h) between end positions. A drive wheel (4) is rotatably mounted in the slide, and a torque source (5) is connected between the slide (6) and the drive wheel (4), by means of which torque source the drive wheel (4) can be set into rotation. In the event of rotation of the drive wheel (4), the slide (6) slides on the guide track (2h) in the distal direction by means of engagement of the drive wheel (4) in the first drive section (2c), until at the distal end of the first drive section (2c) the engagement of the drive wheel switches from the first drive section (2c) to the second drive section (2d) by means of further rotation of the drive wheel (4) and the slide (6) consequently slides along or in the guide track (2h) in the proximal direction.

Description

Cannula insertion mechanism for a patch device

Technical area

The invention relates to injection and infusion devices, in particular injection and infusion devices, which are applied to the administration of a substance directly to the skin of the person using, in particular glued, which are also known as patch devices. In particular, the invention relates to mechanisms for inserting cannulas, in particular so-called soft cannulas, which are made, for example, from fluoropolymers (such as polytetrafluoroethylene) or property-like materials.

general description

An administering 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 drugs, provided that the drug has a consistency with which the infusion pump or Injection device is distributable. 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.

As used herein, the term "medicament" includes any fluid medical formulation suitable for controlled administration by an agent, such as an agent. 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 a cannula in the tissue of the to introduce the person using it. Some of these patch devices use soft infusion cannulas made of plastic, especially biocompatible fluoropolymers, for administering the fluid medicament. This has the advantage that the soft infusion cannula potentially causes less pain to the user using the surrounding tissue than an infusion cannula made 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 together 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.

In some insertion mechanisms, the inner lumen of the insertion cannula is part of the fluid pathway over which the fluid medicament is administered. In this case, the insertion cannula in the retraction described above is not completely pulled out of the infusion cannula, so that the fluid to be administered drug is passed from the insertion cannula into the infusion cannula and from there via one or more openings of the infusion cannula into the tissue of the person using.

US Pat. No. 7,127,727 B2 discloses a patch infusion pump 10 with an insertion mechanism with which a soft infusion cannula 38 is introduced into the tissue with the aid of an insertion cannula 62. 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 US 2014142508 A1 a patch infusion pump 100 with insertion mechanism is known, with which a soft infusion cannula 176 is introduced into the tissue with the aid of an insertion cannula 174. 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 drives for alternative cannula insertion mechanisms, as well as 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 1, advantageous developments emerge from the dependent claims, the description and the figures. In the following description, the terms distal and proximal are used in reference to position and direction indications. 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.

[011] One aspect of the invention includes a cannulation mechanism for a patch device, particularly a patch infusion pump or a patch injector. In the following description, in particular insertion mechanisms for patch infusion pumps are discussed, which however can also be used in the same form for patch injectors, or could also be used in other administration devices without deviating from the invention.

[012] In one aspect of the invention, the patch infusion pump includes 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 can be designed in several parts and can also include inserts, such as in particular guide elements, which are mounted at the Monday at the base.

[013] 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 gear, wherein the drive spring can transmit energy to the gear, which thereby can be set in motion, in particular rotation. In an advantageous embodiment, the drive spring is designed as a torsion spring, which may have a helical or spiral shape. Alternatively, the torsion spring could be a torsion bar or a stretched rubber band wound onto an axle. The drive spring can already be biased in the delivery state of the insertion mechanism (ie the patch device). Alternatively, the power spring may be biased prior to use. The person skilled in this relevant methods are known.

In one aspect of the invention, the insertion mechanism comprises a carriage on which the insertion cannula is fixedly arranged, wherein the carriage is operatively coupled to the gear, so that a movement, in particular rotation of the gear movement of the carriage and thus the insertion cannula for May have consequences. 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 so that the medicament can be delivered via the insertion cannula into the infusion cannula and subsequently into the tissue of the user. [016] In one aspect of the invention, the insertion mechanism of the patch infusion pump includes a guide slot (advantageously with one or more sub-gates) along which the gear may be passed over serrations or pin assemblies, with rotation of the gear via the guide along the serrations or pin assemblies can be transformed into a translation of the gear axis relative to the guide slot.

In one aspect of the invention, a plurality of serrations and pin assemblies are disposed along the guide slot such that the gear axis is staggered in different directions relative to the guide slot in a staggered manner.

In one aspect of the invention, the gear is only partially occupied by teeth at its periphery, whereby it can be divided into two sectors, a first sector which is toothed and a second sector in which no teeth are present. In alternative embodiments, the gear could also have more than two sectors, with toothed and untoothed sectors alternating.

In one aspect of the invention, the guide slot comprises a first toothed part raceway and a second toothed part raceway, the first and second part raceways facing each other (antiparallel or mirrored), and the teeth of the first sector of the gearwheel first at the toothing of the unroll the first part of the track and then roll on the second part of the track on further rotation of the gear in the same direction and the teeth of the first sector are either in engagement with the first part of the gate or the second part of the gate, but not in engagement with both simultaneously. This sequential engagement of the teeth results in this aspect of the invention in that the gear axis moves during the engagement of the teeth of the first sector in the teeth of the first part of the gate relative to the guide link along the first part of the gate in the distal direction and following the engagement of the teeth of the moved first sector in the toothing of the second part of the slide along the second part of the gate in the proximal direction, so that a reciprocating motion between the guide slot and gear axis is formed.

In a partial aspect of the foregoing aspect of the invention, the maximum angle comprising the first sector of the gear is defined as follows:

maximum angle _{first sector}

= 180 ° - ((angle per tooth)

* Total number of teeth in simultaneous engagement with a partial setting)

In a further partial aspect of the preceding aspect of the invention, the relative movement between the first Teilkulisse and the gear, while the gear rolls on the first part of the gate and the teeth of the first sector in engagement with the teeth of the first part of the gate, corresponds to the path the insertion cannula during insertion of the infusion cannula into the tissue.

In one aspect of the invention, the gear is toothed along the entire circumference, hereinafter referred to as a full gear. [023] In one aspect of the above aspect of the invention, the guide slot comprises a linear pin assembly fixedly disposed relative to the base (in an alternative embodiment, displaceability of the pin assembly transverse to the insertion direction would be conceivable). The full gear rotates the pin assembly during the insertion process (insertion and retraction), wherein the carriage participates in the movement of the Vollzahnradachse along the pin assembly. The teeth of the full gear are in the insertion of the insertion and infusion cannula in engagement with a first side of the pin assembly and roll it along. At a first end of the pin assembly, the full gear rolls around the first end of the pin assembly toward a second side of the pin assembly (also referred to as the turning or apex of the movement). Subsequently, the teeth of the full gear are engaged with the second side of the pin assembly. Since now the side of the engagement changed, the full-toothed axis moves in the same direction of rotation of the full gear (torque orientation from the drive spring does not change) against the direction of insertion for the purpose of withdrawal of the insertion cannula. The movement of the full-toothed axis is guided in an advantageous embodiment by a guideway associated with the guide slot. The distance which the gear performs in the insertion direction, ie how far the needles are displaced in the insertion direction, depends on the length of the linear pin arrangement and is independent of the dimensioning of the full gear.

In an alternative aspect of the above aspect of the invention, the guide slot comprises a toothed slide instead of a pin assembly. The toothed gate is fixed to the housing wall of the patch infusion pump, for example, at the base, forming an elongated protrusion that projects from the wall into the patch infusion pump. The circumferential side wall of the elongated elevation is toothed, wherein the full gear can engage in this toothing and can move along along this by rotation. As a result, the gear makes a very similar movement as in the previous sub-aspect (pin arrangement).

In an advantageous variant of the two preceding partial aspects of the above aspect of the invention, the full gear lacks one or a few teeth. When the idler gear moves toward the vertex of movement described above during the insertion movement, it may be advantageous for the full-tooth axis (associated with the carriage and the cannulas) to not move at the apex for a moment. To realize this function, one or a few teeth are removed from the full gear, which actually at the apex in engagement with the pin assembly resp. the teeth would come. This has the consequence that the full gear at the apex rotates for a moment, without the Vollzahnradachse moves, and until such time until teeth of the full gear engage again with the pin assembly or the toothing. Thereafter, the full gear moves again and performs the return movement.

Further aspects of the invention are given below:

In one aspect, the invention includes a cannula insertion mechanism for a patch device

a housing comprising a base, which can also serve as the basis for the patch device and which can be attached directly or indirectly to the skin of the user,

at least one guideway fixedly attached to the housing and defining at least part of an insertion path, a carriage, which is displaceably mounted in the at least one guideway in and against an insertion direction along the guideway,

a steel cannula fixedly mounted on the carriage and projecting from the carriage approximately parallel to the direction of displacement,

a drive spring, in particular a torsion spring, whose axis is approximately perpendicular to the at least one guideway and can be fixedly attached to the carriage with a first end of the drive spring,

a gear which is fixedly attachable to a second end of the drive spring, the axis of rotation of which coincides with the axis of the drive spring,

wherein the toothing of the toothed wheel comprises a first sector of the toothed wheel,

a guide slot extending at a distance from the at least one guide track, the distance resulting from the geometric dimensions of the carriage, drive spring and gear, and which is fixedly connected to the housing or the base,

wherein the guide slot comprises at least one partial slide which runs concurrently with the guide track,

wherein the at least one partial slat comprises in each case a toothing or pin arrangement which, depending on the rotational orientation of the toothed wheel, can be brought into engagement with the teeth of the first sector,

wherein the gear is set by the release of energy from the drive spring in a rotational movement and thereby

the slide with the steel cannula can be displaced into a movement along the at least one guide track by engagement of the teeth of the toothed wheel with the toothing or pin arrangement of the at least one partial slide.

[028] In one aspect, the invention includes a cannula insertion mechanism for a patch device having a soft plastic cannula, particularly PTFE, which is designed to be pulled over the steel cannula.

In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the drive spring is a torsion spring and has a helical shape.

[030] In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the drive spring is a torsion spring that is in the form of a coil spring.

[031] In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the gear comprises a second sector in which there is no toothing.

In one aspect, the invention comprises a cannula insertion mechanism for a patch device, wherein the guide slot comprises two partial toothed lobes, wherein the two partial lobes are in the same plane and the toothings are spaced apart, and wherein the distance of the two partial lobes from each other is determined by the diameter of the gear without the teeth. [033] In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the gear is rotatably mounted on the carriage such that upon release of energy from the drive spring, the gear is rotated relative to the carriage.

In one aspect, the invention comprises a cannula insertion mechanism for a patch device, wherein in the rotation of the gear, the teeth of the first sector of the gear in a first phase engage with the teeth of the first part of the gate, whereby on the arrangement of the gear on Slide the carriage is moved along the guideway in the insertion direction and

Wherein the teeth of the first sector of the gear engage in a second phase in engagement with the toothing of the second part of the gate, whereby the carriage is moved along the guide path against the insertion direction via the arrangements of the gear on the carriage.

In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the first sector of the gear defines a pitch diameter with its teeth, whereby the arc resulting from the sector angle of the first sector and the pitch diameter results in the insertion route of the cannula insert ,

[037] In one aspect, the invention includes a cannula insertion mechanism for a patch device wherein the sector angle of the first sector is less than 180 °.

[038] In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the first and second sub-gates are interconnected via further sub-gates.

[039] In one aspect, the invention comprises a cannula insertion mechanism for a patch device, wherein the guide slot comprises a partial gate with a pin assembly, wherein the pins of the pin assembly are approximately perpendicular to the direction of insertion and are arranged in a straight line, the distances between the pins Pens are constant.

In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the sector angle of the first sector is 360 °, the teeth of the gear are arranged along the entire circumference of the gear.

In one aspect, the invention comprises a cannula insertion mechanism for a patch device comprising two parallel linear guideways, the carriage having guide elements which are in engagement with the two guideways and permit displacement of the carriage along the guideways, and wherein the carriage a linearly slidable on the carriage spring bearing comprises, on which the first end of the drive spring is fixedly mounted

In one aspect, the invention includes a cannula insertion mechanism for a patch device, wherein the gear is rotatably mounted on the spring bearing and thereby linearly slidably mounted in the carriage, wherein a displacement of the gear relative to the carriage in a direction is possible, which is approximately is perpendicular to the axis of rotation of the gear and also perpendicular to the guideway or the guideways. characters

Figure 1 exploded view of the insertion mechanism of a patch infusion pump 1 according to a first embodiment of the invention

Figure 2 View of the parts of the patch infusion pump shown in Figure 1 in assembled

Status

Figure 3 view of Figure 2, but without the lid 8 of the insertion mechanism

FIG. 4 shows a horizontal section through the insertion mechanism from FIG. 2

FIG. 5 partial vertical section through the insertion mechanism from FIG. 2

Figures 6a and 6b detailed view of the insertion mechanism on Figure 2 before release

Figures 6c and 6d detailed view of the insertion mechanism on Figure 2 after release

Figures 7a to 7g horizontal sectional views of the first embodiment of the insertion mechanism

FIG. 2 in different phases of the insertion of the infusion cannula 3b FIG. 8 Exploded view of the insertion mechanism of a patch infusion pump 100 according to an alternative embodiment

Figure 9 View of the parts of the patch infusion pump 100 shown in Figure 8 in assembled

State (in the initial state)

FIG. 10 shows a plan view of the arrangement from FIG. 9

FIG. 11 A vertical partial section through the arrangement from FIG. 9

Figures 12a and 12b horizontal sections at different heights through the arrangement of Figure 9, which the

Represent initial state.

Figures 13a to 13c perspective view and horizontal sections through the embodiment of Figure 8 during the insertion movement

Figures 14a to 14c perspective view and horizontal sections through the embodiment of Figure 8 after insertion, before the withdrawal of the insertion cannula 103a

Figures 15a to 15c perspective view and horizontal sections through the embodiment of Figure 8 during the withdrawal of the insertion cannula 103a

Figures 16a to 16c vertical and horizontal sections through the embodiment of Figure 8 after done

Retraction of the insertion cannula 103a

FIG. 17 shows an exploded view of the insertion mechanism of a patch infusion pump 200 according to an alternative embodiment

18 shows the parts of the patch infusion pump 200 shown in FIG. 17 in the assembled state (in the initial state)

FIG. 19 a vertical partial section through the arrangement from FIG. 18

FIG. 19b detail from FIG. 19a Horizontal section through the arrangement of Figure 18

View of the insertion mechanism of the patch infusion pump 200 immediately after release of the insertion mechanism

Horizontal section through the arrangement of Figure 18 immediately after release of the insertion mechanism

Horizontal section through the arrangement of FIG. 18 during the insertion movement Horizontal section through the arrangement of FIG. 18 after insertion, before the withdrawal of the insertion cannula 203a

Horizontal section through the arrangement of Figure 18 during the withdrawal of the insertion cannula 203a

Horizontal section through the arrangement of Figure 18 after the withdrawal of the insertion cannula 203a

Exploded view of the insertion mechanism of a patch infusion pump 300 according to another embodiment

View of the parts of the patch infusion pump 300 shown in FIG. 27 in the assembled state (initial state)

Vertical partial section through the arrangement of FIG. 28

View of the insertion mechanism of the patch infusion pump 300 immediately after release of the insertion mechanism

Vertical partial section through the insertion mechanism in the state of FIG. 30

View of the insertion mechanism of the patch infusion pump 300 in the final state after insertion of the infusion cannula 303b and the withdrawal of the insertion cannula 303a. Exploded view of the insertion mechanism of a patch infusion pump 400 according to another embodiment

View of the parts of the patch infusion pump 400 shown in FIG. 33 in the assembled state (initial state)

Vertical partial section through the arrangement of FIG. 34

Horizontal section through part of the arrangement of Figure 34 (representing the initial state)

Vertical section through the insertion mechanism of the patch infusion pump 400 when released

Horizontal section through a part of the arrangement from FIG. 34 during the insertion Horizontal section through a part of the arrangement from FIG. 34 after insertion, before withdrawal of the insertion cannula 403a

Horizontal section through a part of the arrangement of Figure 34 during the withdrawal of the insertion cannula 403a

Perspective view of the arrangement of Figure 34 in the final state FIG. 42 A vertical partial section through an embodiment modified on the basis of the embodiment of FIG. 27 with the patch infusion pump 500, in which the insertion mechanism moves in the vertical direction

FIG. 43 Exploded view of the insertion mechanism of a patch infusion pump 600 FIG. 44 View of the parts of the patch infusion pump 600 shown in FIG. 43 in the assembled state (initial state)

figure description

[043] 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. Also, by combinations of parts of described embodiments, further embodiments, obvious to the person skilled in the art, embodiments may arise, without departing from the idea of the invention. Such embodiments not shown here are expressly mitgemeint in this document.

[044] FIGS. 1 to 7g 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 infusion pump, but only the parts thereof which are important for the insertion mechanism. FIG. 2 shows the insertion mechanism from FIG. 1 in the assembled state. Figure 3 shows the same view as Figure 2, wherein the lid 8 has been removed in Figure 3. Figure 4 shows a horizontal section through the insertion mechanism near the base 2a. Figures 5 to 6d show further details of the first embodiment. FIGS. 7a to 7g then represent different states in the process of insertion of the infusion cannula 3b.

The patch infusion pump 1 comprises a housing 2, of which in the figures of the first embodiment in each case the base 2a is shown. The base 2a is adhered, for example, by means of a plaster (not shown) directly 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 insertion mechanism of the first embodiment comprises a cannula ensemble 3 comprising a cannula support 9 with a cannula support base 9a. At the cannula carrier base 9a, the infusion cannula 3b is firmly anchored. 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 Drug, supplied from the reservoir (optionally via a pumping element) via the feed 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 it, the insertion cannula 3a is withdrawn (out of the tissue) through the infusion cannula 3b, the insertion cannula 3a still protruding into the infusion cannula 3b after completion of the retraction, thus preventing fluid communication Feed line 3e and infusion cannula 3b produces, so that the substance to be administered to the user can be supplied. 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 connected to one another indirectly via the snap arms 9b.

The guide track 2h, which guides the insertion movement of the cannula ensemble 3 through its course, is embedded in the base 2a. Furthermore, the base 2a also comprises the cannula guide 2f, whose function is to introduce the infusion cannula 3b and the insertion cannula 3a through the base 2a at a predetermined angle into the tissue.

[048] The insertion mechanism of the first embodiment further includes a guide slot 2b fixedly attached to the base 2a. The guide slot 2b comprises in this embodiment, two partial scenes 2c and 2d, wherein in both a respective toothing 10a resp. 10b. The guide slot 2b is closed except for the opening 2g at the distal end. Placed in the scenery is the gear 4, as well visible in Figure 4, for example. In the sectional view of Figure 4, it can be seen that the gear can be divided into two sectors 4a and 4c, wherein the first sector 4a has teeth 4b and the second sector 4c carries no teeth. Teeth 4b can first engage one after another in the toothing 10a and subsequently in the toothing 10b. Perpendicular to the actual gear level of the gear 4 is the gear axis 4d, which is designed as a sleeve.

The insertion mechanism of the first embodiment further comprises a carriage 6 which has an approximately cylindrical shape, see Figure 1. Figure 5 shows the carriage 6 in a sectional view. Carriage 6 comprises a carriage axis 6b which extends through the gear axis 4d into the guide track 2h. The gear 4 is rotatably mounted on the carriage axis 6b. Between the carriage 6 and the gear 4, the drive spring 5 is arranged, wherein one end of the spring 5 is fixedly connected to the gear 4 and the second end of the spring 5 is connected to the carriage. When drive spring 5 is a torsion spring.

Insertion cannula carrier 3c and slide 6 are firmly connected to each other via the cannula bridge 6c. The snap arms 9b of the cannula holder 9 are snapped in the initial state with the cannula bridge 6c. The cannula bridge 6c comprises a guide pin 6h (not visible), which, like the carriage axis 6b, engages in the guide track 2h, so that the carriage 6 is mounted so as to be secured against rotation with respect to the guide track 2h and thus relative to the base 2a. In the initial state, a rotation of the gear 4 relative to the carriage 6 (ie also the base 2a) is prevented, however, via the engagement of the catch of the release arm 6a in the blocking cam 4e ( see Figure 6b). In order to prevent deflection of the release arm 6a to the outside, the insertion mechanism comprises the First embodiment also has a cup-shaped releaser 7. The releaser 7 is mounted on the carriage secured against rotation by the engagement of securing cams 6d of the carriage 6 in the rotation-preventing opening 7c of the releaser 7. As shown in FIG. 6a, the releaser 7 comprises a release window 7a. The releaser is mounted on the carriage 6 via the spring elements 7b and can be pressed in the direction of the base 2a for the purpose of triggering the insertion process. In this case, the release window 7a shifts in the direction of the base (see Figures 6c and 6d). Now comes the release arm 6a at the level of the release window 7a to lie and thus can deflect outwards, so that blocking cam 4 and release arm 6a disengage. As a result, the applied torque can be released from the drive spring 5.

[051] In the first embodiment shown, the drive spring 5 is tensioned in the clockwise direction, so that a counterclockwise torque acts on the gear 4 during release. Thus, when released, the gear 4 begins to rotate counterclockwise (FIG. 7a). By the engagement of the teeth 4b in the toothing 10a of the first part of the gate 2c, the gear 4 and thus also the carriage 6 moves along the guide track in the distal direction. Thus, in the sequence, the cannula ensemble is moved in this direction. The movement in the distal direction continues (FIG. 7b) until the teeth 4b are disengaged from the toothing 10a (FIG. 7c). At the same time, the cannula holder 9 reaches the cannula guide 2f. Cannula guide 2f comprises a funnel-like tapering guide 2i, which then deflects the holding arms 9c of the cannula holder 9 inwards, whereby they are brought into engagement with the cannula holder 2j. By the deflection of the support arms 9c inwards, the snap arms 9b are in turn deflected outwards, whereby the engagement of the snap arms 9b in the cannula bridge 6c is released. Since there is still a torque applied to the gear 4, this continues to rotate in the counterclockwise direction (Figure 7d). It shifts for a moment no longer along the guideway 2h, but rotates in place until the teeth 4b get into engagement with the teeth 10b of the second part of the gate 2d. Although the gear 4 continues to rotate in the same direction, the gear 4 now begins to move in the proximal direction along the guide track (Figure 7e), with the gear and the carriage 6 is zurückschoben. Since the connection between cannula support 9 and cannula bridge 6c is released, only the insertion cannula support 3c is pushed back with the cannula bridge, but not the cannula support 9. As a result, the insertion cannula 3a is withdrawn through the infusion cannula 3b and the infusion cannula remains firmly attached to the cannula holder 2j. Just before the teeth 4b come out of engagement with the teeth 10b (Figure 7f, the release arm 6a blocks further rotation of the gear 4 by engaging the stop sidewall 4f.) This stops the movement Alternatively, other variants are possible for end stops of the movement could in particular be designed so that the gear could come out of engagement with the second part of the gate at the end of the retraction movement, without a renewed engagement in the teeth of the first part of the gate is possible. would continue to turn the gear in place without the carriage 6 would move on, so that the retraction movement would also be completed.

As mentioned, the releaser 7 is spring-mounted and secured against rotation on the carriage 6. Triggering / releasing the insertion device thus takes place against the resistance of the spring elements 7b. The lid 8, which covers the region of the guide slot 2b on the base 2a, has a trigger opening 8a, through which the releaser 7 can be actuated in the initial state of the insertion mechanism. [053] In one embodiment of the first embodiment, the cannula ensemble 3 comprises a guide tube 3d, whose task is to mechanically stabilize the cannula ensemble 3 during the movement in the distal direction (see FIG. 3). The guide tube 3d encloses the infusion cannula 3b and is fixedly arranged on the cannula carrier base 9a. In this case, the guide tube 3d has a longitudinal slot on its side facing the base 2a. If the cannula ensemble 3 is displaced in the distal direction, the guide tube 3d is opened along the slot in the region of the cannula guide 2f and from the rest of the cannula ensemble

3, i. e. the infusion cannula 3b and the insertion cannula 3a separated and not passed through the base 2a in the direction of tissue.

[054] The illustrated first embodiment (as well as the following) of the insertion mechanism elegantly and easily permits reciprocating movement with a rotational direction of the gear, making it possible to use only one spring for the insertion mechanism. The insertion path, as the path the insertion cannula 3a makes in the distal direction, depends on the one hand on the size (ie the angle) of the first sector 4a of the gear 4, and on the other hand on the diameter (pitch circle diameter) of the gear

4, which also determines the distance from the first part gate 2c and second part gate 2d. The dimensioning of the first sector has already been discussed above.

[055] The first embodiment shown is simply a modification. For example, the guideway 2h can run straight (as a result, the partial scenery would also be straight).

Another embodiment of the insertion mechanism according to the invention is shown in FIGS. 8 to 16c. The identifiers in this embodiment were named analogously to the embodiment of Figure 1, the numbering was made such that z. B. the base 2a of the embodiment of Figure 1 is analogous to the part 102a of the embodiment of Figure 8. Since the function of the embodiment of FIG. 8 is analogous or identical to that of FIG. 1, particular emphasis will be given below to the differences between the two embodiments.

FIG. 8 shows an exploded view of this alternative embodiment with the patch infusion pump 100, wherein it should also be noted in this embodiment that the illustrations of FIGS. 8 to 16c do not show the entire patch infusion pump 100 for reasons of clarity, but only the parts of which are important for the insertion mechanism. FIG. 9 shows a perspective view of the insect mechanism from FIG. 8 in the assembled state. FIG. 10 shows a plan view of the arrangement from FIG. 9.

As in the case of the first embodiment of FIG. 1, in the embodiment of FIG. 8 the ensemble of carriages 106 with the cannula ensemble 103 first performs a displacement in the distal direction during insertion, with the infusion cannula 103b using the insertion cannula 103a is introduced into the tissue of the person using, and subsequently the carriage 106 is moved back together with the insertion cannula 103a back in the proximal direction, wherein the cannula support 109 is held together with the infusion cannula 103b on the cannula holder 102j. The required drive energy for the insertion movement is from the prestressed Drive spring 105 provided. Drive spring 105 is a torsion spring, in the example shown a helical torsion spring, whereby a helical torsion spring could be used. The actual drive of the insertion mechanism via the gear 104. In the initial state, the drive spring 105 is biased.

The carriage 106 is secured against rotation but is displaceably mounted in and against the insertion direction in the guideways 102h and 102h 'of the base 102a. Fixed to the base 102a is the guide slot 102b, which includes a pin assembly 102c with pins 110 and the gear guide 102k, with the pin assembly 102c oriented according to the direction of insertion - as seen, for example, in FIG. The teeth 104b of the gear can be engaged with the pin assembly 102c (see Figures 12b, 13c, 14b and 15c). Between carriage 106 and gear 104, the spring housing 111 is arranged. The spring housing 111 is secured against rotation by way of the guide spring 111b and the spring housing guide 106e, but is mounted displaceably in the carriage 106 transversely to the insertion direction. Between spring housing 111 and gear 104, the drive spring 105 is arranged, wherein one end of the drive spring 105 is fixedly mounted on the spring housing 111 and the other end of the drive spring 105 is fixedly mounted on the gear 104. The spring housing 111 further comprises a spring housing 111 fixed to the spring housing 111c, on which the gear 104 is rotatably mounted. The spring housing axis 111c extends through the gear 104 into the gear guide 102k (see FIG. 11). The gear guide 102k thus performs, together with the carriage 106, the movement of the spring housing relative to the base 102a. Upon release of the stored energy from the drive spring 105, the gear 104 rotates clockwise relative to the carriage 106 (see Figures 12b, 13c, 14b and 15c). By engagement of the teeth 104b of the gear 104 with the pins of the pin assembly 102c, the ensemble of gear 104, spring 105, spring housing 111 and cannula assembly 103 and slide 106 are displaced along the pin assembly 102c in the insertion direction. At the apex of the movement, the cannula holder 109 is fixed to the cannula holder 102j analogously to the first embodiment from FIG. 1 (FIG. 14b). Around the vertex of the insertion movement, gear 104 changes (during continuous clockwise rotation) from one side of pin assembly 102c to the other. This is possible because the spring housing 111 is mounted displaceably in the carriage 106 transversely to the insertion direction. After the change of sides, the gear 104 continues to rotate in the clockwise direction, with the result that the carriage 106 is displaced counter to the direction of insertion, ie the insertion cannula 103a is pulled out of the tissue in the proximal direction through the infusion cannula 103b.

The carriage 106 includes a release arm 106a, which is shown in FIG. 8, for example. At its free end tooth 106f is arranged. Base 102a also includes a releaser 107 having a snap arm 107b which is fixedly attached to the base 102a via the releaser base 107a. The snap-action arm 107b can be deflected via the pushbutton 107c. In the initial state of the insertion mechanism, as shown in Figs. 9 and 10, carriage 106 is held in its proximal position by engagement of tooth 106f and snap-in arm 107b. This connection also holds the spring force of the drive spring 105 by blocking the displacement in the direction of insertion and prevents rotation of the gear 104. Actuation of the button 107c enables the connection between the tooth 106f and the snap arm 107b to be released, thus saving energy stored in the drive spring 105 can be converted into a rotation of the gear 104. At the end of the withdrawal movement of the insertion cannula 103a advised by the displacement of the carriage 106 in proximal Direction of the tooth 106f and the Schnapparm 107b again engage and thereby block further rotation of the gear 104. Without this re-engagement of tooth 106f and Schnapparm 107b, it would be conceivable that the gear 104 would rotate further, if enough energy in the drive spring 105th stored, and the carriage 106 would be placed in a sequence in a reciprocating motion until the drive spring 105 would be fully relaxed.

The different phases of the insertion process in the embodiment of FIG. 8 are shown in different representations of FIGS. 12a to 16c.

In the embodiment as well, a guide tube 103d (analogous to guide tube 3d) can serve for the mechanical stabilization of the cannula ensemble. Functions and parts are the same as in the first embodiment.

An obvious difference between the embodiment of Figure 1 and Figure 8 results in the gear. While the gear 4 is divided into a first sector 4a (with teeth 4b) and a second sector 4c (without teeth), gear 104 of the embodiment of FIG. 8 comprises only one sector 104a, which however extends over 360 °, ie the whole Gear. This simplification has to do with the fact that the two partial scenes 2c and 2d from the first embodiment in the embodiment of FIG. 8 have been brought together to form the pin assembly 102c and are now arranged centrally in the guide slot 102b. As a result, the gear 104 can be passed around the pin assembly 102c, allowing a continuous tooth arrangement on the gear 104.

Compared to the embodiment of FIG. 1, the embodiment of FIG. 8 has at least the advantage that the insertion path, that is to say the path by which the infusion cannula 103b is displaced in the direction of tissue during insertion, can be adapted relatively easily. Namely, by adjusting the length over which the pin assembly 102c extends, the insertion path can be adjusted without changing the dimensioning of the gear or slide. When the insertion path is lengthened, the gearwheel does not need to be enlarged in the embodiment of FIG. 8, which may be necessary in the embodiment of FIG. 1 if the maximum angle for the first sector is exceeded for a constant gear size (see general Description). The embodiment of FIG. 8 can thereby be kept narrow even with longer insertion paths.

Another embodiment of the insertion mechanism according to the invention is shown in FIGS. 17 to 26. The identifiers in this embodiment were named analogously to the embodiment of Figure 1, the numbering was made such that z. B. the base 2a of the embodiment of Figure 1 is analogous to the part 202a of the embodiment of Figure 17. Since the function of the embodiment from FIG. 17 is also analogous to that of FIG. 1, particular attention is given below to the differences between the two embodiments.

FIG. 17 shows an exploded view of this further embodiment of the insertion mechanism according to the invention for a patch infusion pump 200, wherein it should also be noted in this embodiment that For reasons of clarity, the illustrations of FIGS. 17 to 26 do not show the entire patch infusion pump 200, but only the parts thereof which are of importance for the insertion mechanism. FIG. 18 shows the insertion mechanism of the patch infusion pump 200 in the assembled state, before the triggering of the insertion mechanism (also referred to as initial state). FIG. 19 a shows a vertical section (drive spring 205 is not cut) through the arrangement from FIG. 18.

[067] FIG. 19b shows a detail from FIG. 19a, in which the separation of the optional guide tube 203d from the infusion cannula 203b and the insertion cannula 203a is shown. 19b also shows the guidance of the infusion cannula 203b and the insertion cannula 203a through the base 202a along the cannula guide 202f in the direction of the tissue of the user (at this point reference is made to the description of the previous embodiments, which operate the same as in FIG Figure 19b).

FIG. 20 shows a horizontal section through the arrangement of FIG. 18 in the initial state, this illustration being discussed in detail in connection with the release of the insertion mechanism.

FIG. 21 shows a view of the insertion mechanism of the patch infusion pump 200 immediately after release of the insertion mechanism. Figure 22 shows the insertion mechanism immediately after release as horizontal section, while in the horizontal section of Figure 23 has started the movement of the carriage 206 in the insertion direction. In the horizontal section of FIG. 24, the infusion cannula 203b has been completely inserted into the tissue and the withdrawal of the insertion cannula 203a is pending. FIG. 25 likewise shows the insertion mechanism from FIG. 17 during the withdrawal movement of the insertion cannula 203a in horizontal section, while FIG. 26 also shows the final state of the insertion mechanism in a horizontal section.

[070] In addition to the fact that the guideways 202h are not bent with respect to the guideway 2h, the main difference between the embodiment of Figure 17 and that of Figure 1 is the reversed motion of the gear and guideway. In the embodiment of Figure 1, during the insertion movement, the gear 4 moves together with the carriage 6 along the guide track 2h relative to the base 2a. The carriage 6 is guided over the guide elements 6b in the guideways 2h. The guide slot 2b is fixedly arranged on the base 2a. In the embodiment of Figure 17, the guide slot 202b is disposed on the carriage 206 which moves along the track 202h during the insertion process. The gear 204 is rotatably mounted on the spring holder 202k, which in turn is fixedly and immovably arranged on the base 202a.

Another difference between the embodiments of FIGS. 1 and 17 results from the release (alternatively called release) of the insertion mechanism, which has been solved in an elegant manner in the embodiment of FIG. 17. The mode of operation of the release will now be explained with reference to FIGS. 17, 18, 20 and 22 in particular. [072] As already mentioned, the gear 204 is rotatably mounted on the spring holder 202k rotatably. Between the gear 204 and the spring holder 202k, the drive spring 205 is arranged, which is designed as a helical torsion spring. It should be mentioned again at this point that the drive spring could also have other shapes, in particular, for example, the spring with the spring holder integrated could be designed as a torsion bar, which would be firmly connected at one end to the gear 204. Back to the shown version; one end of the drive spring 205 is fixedly connected to the spring holder 202k, the other fixed to the gear 204. Energy stored in the spring 205 can then be converted into a rotation of the gear 204 relative to the base 202a. As in the embodiment of Figure 1, the gear 204 is divided into a first sector 204a with teeth 204b and a second sector 204c without teeth, for the kinematics between gear 204 and guide slot 202b is made to the description of the embodiment of Figure 1, as the Kinematics works analogously (taking into account the differences described above). As mentioned, the guide slot 202b is fixedly arranged on the carriage 206 and, like the embodiment of FIG. 1, has a first part race 202c and a second part race 202d.

[073] In the initial state, the spring 205 is biased so that a moment acts on the gear 204, which is transmitted via the teeth 204b to the first part race 202c on the carriage 206. As a result, the carriage 206 pushes in the distal direction. In the initial state, however, this movement is blocked. For this purpose, release arms 202I are arranged at the base, which have a free end with tooth 202m. One tooth 202m in the initial state engages a tooth 206f of the carriage 206 (the embodiment of Figure 17 has such a tooth 206f on both sides of the carriage 206). In order to prevent flexion of the free end 202m of the release arm 202I outwardly in the initial state, the insertion mechanism of the patch infusion pump 200 further comprises a release bracket 207.

[074] The release bracket 207 is connected to the base 202a via the guide arms 207b, which are slidably mounted in the guides 202o. The release bracket further comprises the spring members 207a, the free ends 207d of which protrude from the protrusions 202n of the release arms 202I and thus resiliently urge the release bracket in the distal direction. The bay 207c of the release bracket 207 supports the gear axis 204d and pushes this also in the distal direction (see, for example, Figure 18).

As mentioned, Figure 20 shows a horizontal section through the insertion mechanism in the initial state. Here, it becomes clear how the blocking zones 207e of the release bracket 207 prevent the free ends of the release arms 202m from deflecting. The insertion mechanism can now be released by displacing the release clamp in the proximal direction against the spring force induced by the spring elements 207a. The displacement of the release clamp 207 in the proximal direction also causes the blocking zones 207e to shift in the proximal direction.

[076] In Figs. 21 and 22, the insertion mechanism when the release tab 207 is operated is shown. In this condition, the free ends 202m of the release arms 202I can now flex outward, allowing movement of the carriage 206 distally along the guideways 202h. The force acting on the gear 204 torque from the spring 205 now causes the gear starts to rotate, and that in the embodiment of Figure 17 in the counterclockwise direction. Accordingly, the carriage 206 shifts in the distal direction, whereby the cannula ensemble 203 is also displaced in the insertion direction, which leads analogously to the embodiments described above for insertion of insertion cannula 203a and infusion cannula 203b into the tissue of the user. FIG. 23 shows the insertion mechanism during the movement in the insertion direction.

FIG. 24 shows the insertion mechanism when the cannulas 203a and 203b have been inserted, but before the withdrawal of the insertion cannula 203a. As in the embodiment of Figure 1, gear 204 rotates between the insertion and withdrawal of the insertion cannula 203a through an angle at which the teeth 204b are neither in engagement with the first sub-gate 202c nor the second sub-gate 202d. Here the carriage stops. FIG. 24 shows the moment in which the teeth 204b are just engaged with the second part gate 202d. It should be noted that due to the dimensioning of the first sector 204a and the circle diameter of the gear 204, the most proximal tooth of the second sub-gate, half-tooth 206g, is cut so that the movement of the gear 204 is not blocked by undesired interference with the second sub-gate 202d. It should further be noted that in the state of FIG. 24 the cannula support 209 is fixedly connected to the cannula holder 202j (analogously to the previous embodiments) and thus the infusion cannula 203b remains in place when the insertion cannula 203a retracts.

In FIG. 25, the return movement of the carriage is already in progress, that is, the carriage is moving counter to the insertion direction. As with the embodiment of FIG. 1, the carriage 206 has changed the direction of travel, with the gear 204 always rotating therein.

[079] The end of the withdrawal is shown in FIG. In this state, the arc of the distal end of the guide slot 202b prevents further movement of the carriage 206 in the proximal direction, in which the sheet comes into abutment with the gear 204. Due to the fact that a part of the teeth 204b is further in engagement with the toothing of the second part of the slide 202d, also a further rotation of the gear 204 is no longer possible. The insertion mechanism has subsequently reached its final state.

Another embodiment of the insertion mechanism according to the invention is shown in FIGS. 27 to 32. The identifiers in this embodiment were named analogously to the embodiment of Figure 1, the numbering was made such that z. B. the base 2a of the embodiment of Figure 1 is analogous to the part 302a of the embodiment of Figure 27. Since the function of the embodiment from FIG. 27 is analogous or identical to that of FIG. 1, particular attention is given below to the differences between the two embodiments.

[081] FIG. 27 shows an exploded view of this further embodiment of the insertion mechanism for a patch infusion pump 300, wherein it should also be noted in this embodiment that the illustrations of FIGS. 27 to 32 do not show the entire patch infusion pump 300 for reasons of clarity only the parts thereof which are important for the insertion mechanism. [082] In the embodiment of FIG. 27 too, the guideways 302h are straight. With the exception of the release and the end blocking, the embodiment of FIG. 27 functions the same as the embodiment of FIG. 1. Otherwise, reference is made to the description of the embodiment of FIG.

[083] The base 302a of the patch infusion pump 300 includes u. a. the guideways 302h, in which the carriage 306 is slidably guided (but secured against rotation) via its guide elements 306b. As in the embodiment of FIG. 1, the drive spring 305 is disposed between the carriage 306 and the gear 304. In the initial state, the torsion spring designed as a drive spring 305 is biased so far that the stored energy reaches at least for a complete insertion. The gear 304 is rotatable in the carriage

Stored 306. The base 302a further includes the guide slot 302b, which includes the first sub-gate 302c and the second sub-gate 302d. During the insertion process, the gear 304 rolls (counterclockwise) with its teeth 304b of the first sector 304a first on the first part slide 302c in the insertion direction (ie distal direction), then rotates out of engagement with the first part slide 302c, continues rotating without intervention in the Part of the scenes until the teeth 304b reach the second part of the gate 302d and get into engagement with it, so that upon further rotation of the gear 304, the carriage is moved in the proximal direction in order to have retracted the insertion tube to completion of the insertion process.

[084] As mentioned, one of the differences between the embodiments of FIGS. 1 and 27 is the release of the insertion mechanism (ie the triggering). Referring to Figs. 27 to 31, the following will be given to the initiation of the insertion process. Movably arranged on the carriage 306 is the releaser 307, which is arranged in the release bearing 306a on its axis of rotation 307c.

The releaser 307 can be easily rotated about its horizontal axis of rotation 307c. At the distal end of the releaser 307, the blocking element 307b is fixed, which can best be seen in FIG. In the initial state, as shown in Figure 28, the blocking element 307b engages in the blocking recess 304e. As can be clearly seen in Figure 27, the blocking recess 304e is channel-shaped and terminates in the stop flank 304g. Due to the counterclockwise torque acting on the gear from the spring, in the initial state, the blocking element 307b and the stop flank 304g engage and block rotation of the gear 304 relative to the carriage 306.

[086] The releaser 307 includes at its proximal end the edge 307a, which in the initial state presses against the arm-shaped fuse 306d. The fuse 306d is designed as a flexible arm. If, for releasing the insertion mechanism, the releaser 307 is pressed at its proximal end in the direction of the base 302a, the securing device 306d deviates in the proximal direction, whereby the edge 307a is moved in the direction of the base 302a and consequently the engagement between the blocking element 307b and the stop flank 304g is released as the approver

307 is rotated about its axis of rotation 307c. Thus, rotation of the gear 304 relative to the carriage 306 is now possible and the insertion process starts.

[087] At the end of the insertion process, as shown in FIG. 32, the teeth 304b are still in engagement with the second sub-gate 302d, which means that the torque still acting causes a further shift in the slot. at least 306 could result in the proximal direction, but this is prevented by the proximal end 3021 of the guideways 302h, in which the end 3021 blocks further movement of the guide element 306b. The insertion process is thus finished and the mechanism stops.

Another embodiment of the insertion mechanism according to the invention is shown in FIGS. 33 to 41. The identifiers in this embodiment were named analogously to the embodiment of FIG. 8, the numbering was carried out in such a way that z. For example, the base 102a of the embodiment of FIG. 8 is analogous to the portion 402a of the embodiment of FIG. 33. Since the function of the embodiment of FIG. 33 is analogous to that of FIG. 8, the differences between the two embodiments will be discussed below. It is also expressly made to the description of the embodiment of Figure 8 at this point.

FIG. 33 shows an exploded illustration of this alternative embodiment with the patch infusion pump 400, wherein it should also be noted in this embodiment that the illustrations of FIGS. 33 to 41 do not show the entire patch infusion pump 100 for reasons of clarity, but only the parts of which are important for the insertion mechanism. Figure 34 shows a perspective view of the insertion mechanism of Figure 33 in the assembled state.

FIG. 35 shows a perspective and partial vertical section through the insertion mechanism of the patch infusion pump 400, wherein the drive spring 405 as well as the gear 404 have not been cut. The insertion mechanism is shown in Figure 35 in its initial state with preloaded drive spring 405. FIG. 36 shows a horizontal section through the insertion mechanism in the same state as in FIG. 35.

FIG. 37 shows a vertical section through the insertion mechanism at the moment of release of the mechanism in which the engagement between the release arm 406a with the tooth 406f and the releaser 407 is released. It should be added that only the teeth are shown by the releaser 407, which, respectively, the carriage in its proximal starting position, respectively. Hold end position. Those skilled in the art will appreciate possible overall implementations of the releaser 407 from the various variants shown in this specification and its general knowledge, without departing from the spirit of the present invention.

The various phases of the insertion process are shown in Figures 36, 38, 39 and 40 in the form of horizontal sections through the insertion mechanism. FIG. 36 shows the initial state as well as the final state. FIG. 38 shows the insertion mechanism of the patch infusion pump 400 during the insertion movement in the distal direction. FIG. 39 shows the embodiment of FIG. 33 at the moment in which the toothed wheel 404 together with the Carriage 406 and the needle assembly 403 at the apex of the movement are. Figure 40 shows the insertion mechanism during withdrawal of the insertion cannula 403a. 41 shows a perspective view of the insertion mechanism of the patch infusion pump 400 in the final state after insertion, it being worth mentioning here that the teeth 406f and release 407 are again engaged, so that further rotation of the gear 404 is prevented. [093] There are differences between the embodiments of FIGS. 8 and 33. The main difference lies in the guidance. The guide slot 102b in the embodiment of Figure 8 includes the pin assembly 102c. In the embodiment of FIG. 33, as an alternative to the pin assembly 102c, the toothed part race 402c has been arranged. Functionally, the pin assembly 102c is a reduced special case of the toothed parting cuscles 402c. Both variants function equivalently.

Another difference between the embodiments of Figures 8 and 33 is in the release, it being noted that the release of Figure 33 is not fully shown in the figures.

The linear guide tracks 102h, 102h 'and 402h, or the guide elements 106b and 406b on the slides 106 and 406, are also designed differently. These are functionally equivalent alternatives.

[096] Based on the embodiment of Fig. 27, Fig. 42 shows a slightly modified embodiment in a patch infusion pump 500. As shown in Fig. 42, the insertion mechanism is not disposed on the base 502a but on the wall 502e and the movement of the insertion mechanism vertical instead of horizontal. Otherwise, the insertion mechanism of the embodiment of Figure 42 has the same structure as that of Figure 27 and also works in the same manner, which is why reference is also made to the description of Figures 27 to 32 and again to the references there. The identifiers in FIG. 42 are selected analogously to the identifiers from FIGS. 27 to 32.

Another embodiment in the form of the patch infusion pump 600, which is based primarily on the embodiment of FIG. 27, is shown in FIGS. 43 and 44. The designators in FIGS. 43 and 43 are selected analogously to the designators from FIGS. 27 to 32. As in the embodiment of FIG. 42, the insertion mechanism of the patch infusion pump 600 is disposed on the wall of the patch infusion pump 600, namely on the wall 602e. In contrast to the embodiment of Figure 27, the insertion movement of the insertion mechanism along the circumference of the wall 602e, which is why z. B. the carriage 606 is slightly curved.

FIG. 43 shows an exploded view of the insertion mechanism of the patch infusion pump 600. FIG. 44 shows the insertion mechanism of the patch infusion pump 600 assembled in its initial state.

identifiers

2b guide slot

Patch pump 2c first part scenery

2d second part scenery

2 housing 2e wall

2a base 2f cannula guide g opening 9 cannula support h guide track 9a cannula support base guide (funnel-like) 9b snap-on j cannula holder 9c low-arm cannula ensemble 10a tooth first part chisel insertion needle 10b tooth second part slide infusion cannula

c insertion cannula carrier 100 patch pumped guide tube

e Supply line 102 Housing

102a base

Gear 102b Guide chuck first sector 102c Pin arrangement (partial gate) b Teeth 102h Guidewayc second sector 102h 'Guideway gearwheel axis 102i Guide

e Blocking cam 102j Needle holder stop flank 102k Gear guide drive spring 103 Needle assembly

103a insertion cannula

Carriage 103b Infusion cannula Release arm 103c Insertion cannula carrier Carriage axis 103d Guide tubec Cannula bridge 103e Supply line

d safety cams

h guide pin 104 gear

104a first sector

Freebie 104b teeth

a release window

b Spring element 105 Antriebfederc anti-rotation

106 sleds

Cover 106a release arm

a trigger opening 106b guide elements

106c cannula bridge

106e spring housing guide 106f tooth 203b infusion cannula

203c insertion cannula carrier

107 release 203d guide hose

107a release base 203e supply line

107b Schnapparm

107c push button 204 gear

204a first sector

109 cannula support 204b teeth

109a cannula support base 204c second sector 109b snap-in arms 204d gear axle 109c holding arms

205 drive spring

110 pens

206 sleds

111 spring housing 206b guide elements 111 a housing 206c cannula bridge 111b guide spring 206f tooth

111c Spring Housing Axle 206g Half-tooth

200 patch infusion pump 207 release clamp

207a spring elements

202 housing 207b guide arms 202a base 207c bay

202b guide slot 207d free end

202c first part scenery 207e blocking zone

202d second part of the scenery

202f cannula guide 209 cannula holder

202h guideways 209a cannula carrier base

202i guide 209b snap arms

202j Needle Holder 209c Retaining arms

202k spring holder

202I release arms 300 patch infusion pump

202m free end with tooth

202n bulge 302 housing

202o guide 302a base

302b guide frame

203 cannula ensemble 302c first partial set 203a insertion cannula 302d second partial set 302e wall 400 patch infusion pump

302h guideway

3021 proximal end of guideway 402 housing

402a base

303 cannula ensemble 402b guide slot 303a insertion cannula 402c tooth assembly 303b infusion cannula 402f cannula guide

303c insertion cannula carrier 402h guideway

303d guide tube 402i guide

303e supply line 402j needle holder

402k gear guide

304 gear

304a first sector 403 cannula ensemble 304b teeth 403a insertion cannula

304c second sector 403b infusion cannula

304d gear axle 403c insertion cannula carrier

304e blocking recess 403d guide tube

304g stop flank 403e supply line

305 drive spring 404 gear

404b teeth

306 sleds

306a release bearing 405 drive spring 306b guide elements

306c cannula bridge 406 slides

306d fuse 406a release arms

406b guide elements

307 Release 406e Spring Housing Guide 307a Edge 406f Tooth

307b blocking element

307c rotation axis 407 release (teeth)

309 cannula carriers 409 cannula carriers

309a Cannula Carrier Base 409a Cannula Carrier Base

309b snap arms 409b snap arms

309c holding arms 409c holding arms

41 1 spring housing a housing

b guide spring

c Spring Housing Axle 600 Patch Infusion Pump

602 housing

Patch infusion pump 602a base

602c first Teilkulisse housing 602d second Teilkulissea base 602e wall

d second part of the scenery 602h guideway wall

603 cannula ensemble cannula ensemble

604 gear

gear

605 Drive spring drive spring

606 sleds

carriage

Claims

claims

A reciprocating drive for an insertion mechanism for an administering device

- a flat or domed base

a guideway formed in or on the base defining a proximal and a distal end and a straight line or curve therebetween

a drive track connected to the base comprising a plurality of drive sections, wherein a first drive section and a second drive section are opposite one another and parallel to the straight line or to the curve of the guide track,

a rotation-proof slide is provided on the base and displaceable along or in the guideway between a proximal slide end position and a distal slide end position,

a drive wheel at least rotatably mounted in the carriage,

a torque source is connected between the carriage and the drive wheel, by means of which the drive wheel can be set in rotation relative to the base and slide,

wherein upon rotation of the drive wheel of the carriage, starting from in particular the proximal Schlittenendposition by a positive or non-positive engagement of the drive wheel in the first drive section along or in the guideway moves in the distal direction until the distal end of the first drive section of the positive or non-positive engagement of the Drive wheel from the first to the second drive section by further rotation of the drive wheel changes and thus the carriage moves along or in the guideway in the proximal direction.

2. A drive according to the preceding claim, wherein the carriage a supply line is arranged with a lumen and guided in or on the carriage through which a substance to be administered, in particular a fluid medicament, can be passed.

3. A drive according to the preceding claim, wherein at the distal end of the carriage, a cannula bridge is arranged, at which the supply line terminates and a proximal end of an insertion cannula is arranged with a lumen, wherein the lumen of the supply line and the lumen of the insertion cannula are interconnected in that the substance to be administered can be conducted from the supply line into the insertion cannula, and wherein the insertion cannula makes a displacement of the carriage in the distal as well as in the proximal direction.

4. A drive according to the preceding claim, wherein the first and the second drive portion each comprise a toothing or a pin arrangement, wherein the drive wheel is a gear and wherein the gear can engage with the toothing or the pin arrangement.

5. A drive according to claim 4, wherein the gear comprises a first sector which is toothed, wherein the first sector may comprise up to 360 °.

6. A drive according to the preceding claim, wherein the torque source can be maintained by a release device in a locked, in particular biased state.

7. A drive according to claim 6, wherein the release device consists of a releasable rotation between the drive wheel and the carriage or between the drive wheel and the base.

8. A drive according to claim 7, wherein the release means consists of a releasable fuse which prevents displacement of the carriage relative to the base.

9. A cannula insertion mechanism for a patch device, comprising

a drive according to one of claims 3 to 8,

an infusion cannula with a distal end and a proximal end, through which the insertion cannula can be passed,

wherein a cannula carrier is fixedly arranged at the proximal end of the infusion cannula, wherein on the cannula carrier a connecting means, in particular one or more snap arms, is arranged, via which the cannula carrier is detachably connectable to the cannula bridge when the insertion cannula is passed through the infusion cannula so far the cannula carrier abuts against the cannula bridge.

10. cannula insertion mechanism according to the preceding claim with a drive according to claim 5 to 8, wherein the first sector of the gear less than 360 °, in particular less than 180 °, and the gear comprises a second sector, which has no toothing.

11. The cannula insertion mechanism according to the preceding claim, wherein the teeth of the first sector of the gear engage in the movement of the carriage in the distal direction in the toothing or pin arrangement of the first drive portion, wherein at the end of the first drive portion, the gear is rotated so far that the teeth except Engage with the toothing or the pin arrangement of the first drive section, wherein the teeth of the first sector with further rotation of the gear immediately or after further rotation by a certain angle engage the toothing or pin arrangement of the second drive section, whereby in the sequence further rotation of the gear of the carriage in the proximal direction shifts.

12. The cannula insertion mechanism according to the preceding claim, wherein at the distal end of the first drive portion, the connecting means of the cannula support is moved by guide elements on the base, so that the connection between the cannula support and cannula bridge is released and the connection means is fixed to the base.

13. cannula insertion mechanism according to claim 9 with a drive according to one of claims 5 to 8, wherein the drive track comprises a pin assembly which consists of linearly arranged behind one another pins, wherein a first longitudinal side of the pin assembly serves as a first drive section and a second longitudinal side serves as a second drive section .

wherein the carriage comprises a linearly displaceable on the carriage transversely to the guide rail spring bearing, on which the gear is rotatably mounted,

at the end of the first drive portion formed by the last pin in the pin assembly, the gear rotates about the last pin, the spring bearing being displaced transversely of the carriage, and thus moved together with the gear to the second longitudinal side of the pin assembly, such that the gear engages with the second drive section.

14. A cannula insertion mechanism according to the preceding claim, wherein the first sector of the gear comprises 360 °.

15. The cannula insertion mechanism according to claim 13, wherein the first sector of the toothed wheel is smaller than 360 ° by an angle α,

the toothed wheel and the first drive section being arranged relative to each other such that at the end of the first drive section the toothed wheel has rotated so far that the teeth of the first sector are disengaged from the pin arrangement and the carriage remains in place for rotation of the toothed wheel through the rotation angle α, before, upon further rotation, the teeth of the first sector re-engage the pin assembly and the carriage moves along with the gear along the second drive portion in the proximal direction.

16. cannula insertion mechanism according to claim 9 with a drive according to claim 3, wherein the drive wheel is configured as a friction wheel, wherein the drive track comprises a plurality of drive portions, which constitute friction surfaces for the friction wheel, wherein the friction wheel rolls upon release of torque from the torque source to the friction surfaces.

17. The cannula insertion mechanism according to any one of claims 9 to 16, wherein the displacement of the carriage in the proximal direction is limited by a stop in the proximal Schlittenendposition, in particular the proximal end of the guide track, whereby the rotation of the drive wheel is stopped.

18. A cannula insertion mechanism according to any one of claims 9 to 17, wherein the torque source is a spring, in particular a torsion spring, which has a helical or spiral shape.

19. A cannula insertion mechanism according to any one of claims 9 to 17, wherein the torque source is a torsion bar.

20. A patch pump comprising a cannula insertion mechanism according to any one of claims 9-19.

21. A patch injector comprising a cannula insertion mechanism according to any one of claims 9-19.