Field of disclosure

The present disclosure is related to the field of ambulatory infusion pumps. It is particularly related to drive units for such devices, as well as to dosing units. Ambulatory infusion pumps for infusing a liquid d rug into a patient's body over an extended time period and carried by a patient substantially continuously.

Background, prior art

Ambulatory infusion pumps are well known in the art for example in the therapy of Diabetes Mellitus by Continuous Subcutaneous Insulin I nfusion (CSI I ) as well as in pain therapy or cancer therapy and are available from a number of suppliers.

According to a classic and well-established design, those ambulatory infusion pumps or systems are typically of the syringe-driver type. A number of drawbacks of such devices is known in the art. In particular, they have a limited precision because they involve delivering very small drug amounts, typically in the nanolitre range, directly out of a drug cartridge as primary drug reservoir, having an overall drug volume in the millilitre range. Therefore, additional concepts and architectures have been proposed which use a dedicated dosing unit downstream from the primary drug reservoir, comprising, e.g. , a micro membrane pump or a micro piston. Those dosing units are designed for precise metering of small volumes. While several designs for such dosing units are known in the art, they are rather complex. Most of them are expensive and/or critical with respect to large scale manufacture. The EP 1 970677A1 discloses a system with a miniaturized metering piston pump with a dosing cylinder that is repeatedly coupled to and filled from a larger primary drug reservoir, followed by coupling the dosing cylinder to an infusion site and infusing the liquid drug out of the dosing cylinder in incremental steps, typically in the nanolitre or microliter range, and over an extended time period of e. g. a number of hours up to more than a day, in dependence of the patient's specific therapeutic needs. When the dosing cylinder is emptied, it is filled again from the primary drug reservoir. After emptying the primary drug reservoir, both the metering pump and the primary drug reservoir may be discarded and replaced. For alternatively coupling the dosing cylinder to the reservoir and the infusion site, a valve system is proposed. The present document is based on a design of an infusion pump device in accordance with EP 1 970677A1 .

Summary of disclosure

The EP21 63273A1 discloses a dosing unit according to the principles established by EP 1 970677A1 . According to the EP2 1 63273A1 , the dosing unit is - typically releasably - coupled to a single drive unit which is used for both piston movement and valve switching in dependence of the piston position. Valve switching is achieved by moving, e.g. rotating, the dosing cylinder of the dosing unit relative to a stationary valve member, thus establishing alternative fluidic communication of the dosing cylinder with either an inlet or an outlet. The valve switching does in particular not involve a liquid administration towards the patient, which is achieved via piston d isplacement.

The EP2881 1 28A1 discloses, in accordance with EP 1 970677A1 , a design where the valve switching and the piston movement are carried out via separate drives with separate dedicated actuators, rather than a common actuator. While requiring some additional hardware effort, critical design issues are avoided and the overall control structure is simplified.

Since dosing unit is generally a disposable of considerably shorter lifetime as compared to the drive arrangements and further functional units such as user interface and control circuitry, a modular design is required for cost reasons, where the dosing unit can be separately replaced. For such a modular design that is also assumed in the context of the present disclosure, simple and fault-tolerant coupling and decoupling by a largely untrained and potentially visually and/or motoric impaired user is required.

It is desirable to allow safe and defined coupling of the valve respectively the piston with the associated valve drive unit respectively pump drive unit without requiring the involved interface structures to be in a specific and well-defined reference state. In this context, the EP2881 1 28A1 discloses a design where the valve and the valve drive unit couple via a step switching mechanism.

It is an overall objective of the present invention to improve the state of the art regarding drive units and in particular valve drive units for a dosing unit as explained before. It is a particular objective to provide a valve drive unit that is compact and of robust design and can favourably be manufactured in a cost-efficient way.

In a general sense, the overall objective is achieved by the subject of the independent claims. Exemplary and favourable embodiments are defined by the dependent claims and the overall disclosure of the present document. The overall objective is in particular achieved based on using a valve drive unit with SMA (Shape Memory Alloy) wires as actuators. The SMA wires act on a pivoting member that transforms a length variation (contracting respectively lengthening of the SMA wires) into a rotational movement that is transferred, via an interface structure, to the valve unit of the dosing unit.

The use of SMA actuators in the context of ambulatory infusion pumps, for example insulin pumps, is generally known, for example from the US201 301 97438A1 , US7226278B2 , US66561 58 B2, US201 1 03 1 9862A1 , US201 1 000981 4A1 , and W09938551 A1 . According to these documents, an SMA actuator is used directly for the drug dosing. In some cases, a dosing valve is opened and closed via an SMA actuator, wherein drug is administered as long as the valve is opened .

According to the present invention , in contrast, an SMA actuator is used for controlling respectively switching a control valve that couples the dosing cylinder of the dosing unit alternatively with the patient, e. g. via an infusion line, or with a drug cartridge or generally a primary drug reservoir. The valve switching and accordingly actuation of the SMA actuator, however, does itself not result in any drug administration. Instead, drug administration is controlled by the separate pump drive unit, with the dosing cylinder and the piston forming a positive displacement metering pump as established and proven design.

In an aspect, the overall objective is achieved by a valve drive unit. The valve drive unit may especially be designed for use as part of a drive unit and in combination with a dosing unit as explained further below. The valve drive unit includes a first SMA wire and a second SMA wire, wherein the first and second SMA wire can be alternatively activated.

The valve drive unit further includes a pivoting member. The pivoting member is pivotable arranged around a pivoting member axis. The pivoting member includes a valve driver. The valve driver is arranged at a distance from the pivoting member axis. The first and second SMA wire are coupled to the pivoting member such that an activation of the first SMA wire causes the pivoting member to pivot into a first direction and an activation of the second SMA wire causes the pivoting member to pivot into a second direction, the second direction being opposite to the first direction. For coupling of the first and second SMA wire, the pivoting member includes a first and second SMA coupling structure.

The valve driver is designed to releasable engage a valve driver coupler of a valve unit, such that, in the engaged state, a pivoting of the pivoting member is transmitted to the valve driver coupler via the valve driver. As explained further below in more detail, the releasable engagement may especially be a releasable meshing engagement. The coupling between valve driver and the valve driver coupler is such that the transfer function between the valve driver and the valve driver coupler is continuous, i. e. a continuous ( pivoting ) movement of the valve driver results in a corresponding continuous movement of the valve driver coupler, in contrast to a step switching mechanism with a discontinuous transfer function.

As will be explained in more detail further below, the pivoting member transforms a linear movement, in particular a contraction respectively extension of the SMA wires into a corresponding pivoting of the pivoting member. The pivoting member accordingly serves as transforming member. Because the valve driver is an integral part of the pivoting member, a pivoting of the pivoting member also results in a pivoting of the valve driver around the pivoting member axis on a (circular) path that is determined by the distance between the pivoting member axis and the valve driver.

SMA wires allow the generation of a large ( pulling ) force when they contract upon being heated (typically via their electric resistance when a driving current flows through the wire) , but can be passively strained or lengthened with little force below the activation temperature. In many applications, it is a disadvantage of SMA actuators that the usable stroke length upon contraction is small and in a range of few percent of the wire length at the most. For this reason, the use of SMA actuators is impossible in many applications, or complex mechanical kinematics are required in order to amplify the stroke length. A valve drive unit in accordance with the present disclosure, in contrast, can be realized in a compact way and with a low number of components.

Each of the first and second SMA wires contracts, after having previously been passively expanded , upon being activated by means of heating the SMA wire with an electric current, striving to return to its memorized shape and length. In operation, the current is provided to the first and second SMA wires such that, at any point in time, only the first SMA wire, only the second SMA wire, or none of the first and second SMA wire is activated, but not both of them. For this purpose, the valve drive may include corresponding valve drive control circuitry. In this document, the expressions "memorized shape" and "memorized length" refer to the design -given shape and length that the SMA wires strives to return upon being heated to the activation temperature. While not being essential, the memorized shape of the SMA wires is typically straight or close to straight.

In addition to the pivoting member, the first and second SMA wire are each coupled to a fixed support structure and accordingly act between the pivoting member and the support structure.

In the context of operating a valve unit of a dosing unit as discussed further below in more detail, a pivoting of the pivoting member and the valve driver into the first direction results in a shutoff body of the valve unit moving into a filling position. Similarly, a pivoting of the pivoting member and the valve driver into the second direction results in the shutoff body moving into a draining position. Switching between the filling position and the draining position is accordingly achieved by selectively activating the first respectively the second SMA wire. In an embodiment, the valve driver is a meshing pin.

The first and second SMA wire may be made from any suited SMA material as known in the art, in particular copper-aluminium-nickel or nickel-titanium, but may also be made by alloying other materials such as zinc, copper, gold and iron. Typically, the first and second SMA wire are of identical design and dimensioning, resulting in a symmetric setup.

In an embodiment, the vale drive does, as such, not include blocks that would limit the pivoting of the pivoting member in an end position. I nstead, pivoting of the pivoting member is, in operation, limited by valve blocks of the valve unit. Similarly, in typical embodiments no catches, latches or the like are required for maintaining the pivoting member in a pre-determined position.

In an embodiment, the arrangement of the first and second SMA wires is such that an activation of the first SMA wire lengthens the second SMA wire and an activation of the second SMA wire lengthens the first SMA wire. In such embodiment, one of the first and second SMA wire is, in a stationary situation where none of the SMA wires is activated, in a contracted state (with a minimum length ) while the other of the first and second SMA wire is in a lengthened or strained state (with a maximum length ). In operation, the state of the first and second SMA wires is reversed with each valve switching between the inlet position and the draining position of the shutoff body. This arrangement is advantageous in so far as no further counter-force elements, such as springs, are required for expanding the SMA wires. In an embodiment, the pivoting member includes a first SMA coupling structure and a second SMA coupling structure. The first SMA coupling structure couples to the first SMA wire and the second SMA coupling structure couples to the second SMA wire. The first respectively second SMA coupling structures are further arranged on opposite sides of the pivoting member axis.

In an embodiment, the first and second SMA wire each are U-shaped. In such embodiment, the base of the U -shaped SMA wires (the area where both legs of the "U" meet) is coupled to the pivoting member, while the free ends of both legs are coupled to the support structure. Via the first and second SMA coupling structure, the first and second SMA wire are accordingly deflected or folded back by e. g. 1 80°. Typically, both legs are parallel for each of the first and second SMA wire. Further typically, the legs of both U-shaped SMA wires are parallel. Further typically, the U-shape is symmetric, with both legs having the same length.

The U-shaped form of this type of embodiment results in a "folding" of the first and second SMA wire in halves. In this way, the total forces that are exerted by the legs sum up and the total pulling force is accordingly doubled for a U -shaped arrangement as compared to an SMA wire having the length of a single leg. For a given required total force, thinner SMA wires may accordingly be used, with the electric resistance increasing with decreasing diameter. Further, since the electric resistance depends on the total length of the SMA-wires, the electric resistances of a U -shaped arrangement is accordingly double the electric resistance of a single leg of identical diameter. The folded design accordingly results in a comparatively high electric resistance, which is favourable in order to limit the required current for heating. I n principle, also another folding, e. g. a threefold folding ( resulting in an "N-shape") or a fourfold folding ( resulting in an "M - shape") would be possible. Such arrangements, however, are typically less favourable in view of the required overall installation space and general design constraints.

In all of these arrangements where the first respectively second SMA wire is deflected or folded back by the pivoting member, the pivoting member is, fully or in an area of coupling with the SMA wires, favourably made from metal, metal coated or generally conductive. This has the favourable effect that the considerably deformed part of the SMA wires where they are deflected respectively folded back is electrically shortcut by the pivoting member. Consequently, at least most of the heating current does not flow through this part of the SMA wires, but through the pivoting member. For a U -shaped design of the SMA wires the major current flow is accordingly from one of the legs via the pivoting member to the other leg and not via the base of the U . The deformed base is accordingly, in contrast to the legs not heated to the activation temperature. Thereby, the mechanical load of the SMA wires is significantly red uced .

In a variant, the two legs of a U -shaped SMA wire may be replaced by two separate pieces of SMA wire. Similarly, an N-shape or M -shape arrangement may be replaced by three respectively four separate pieces of SMA wire.

In an embodiment, the first SMA wire is coupled to a support structure via a first spring structure and the second SMA wire is coupled to the support structure via a second spring structure. As will be explained in more detail in the following, coupling via a spring structure is favourably to prevent an overload and accordingly a damage of the valve actuator that may otherwise occur under adverse circumstances.

In an embodiment where the first and second SMA wire are U -shaped as explained before, the first and second spring structure may each comprise of two separate spring elements, with each spring element individually coupling one leg of an SMA wire to the support structure. In an example, the spring elements are leaf springs that are at an end firmly coupled to the support structure, e. g. by screwing or riveting.

Typically, the first and second spring structure, and in an embodiment with four spring elements as explained before, all four spring elements are of identical design and dimensioning , resulting in a symmetric setup.

In an embodiment, the first spring structure is arranged to maintain a coupling between the first SMA wire and the first spring structure in a constant position for a force that is exerted by the first SMA wire below a first threshold force. Likewise, the second spring structure is arranged to maintain a coupling between the second SMA wire and the second spring structure in a constant position for a force that is exerted by the second SMA wire below a second threshold force. Beyond the pulling force that is exerted by the first respectively second SMA exceeding the first respectively second threshold force, the first respectively second spring element is deflected. In a typical embodiment, the first and second threshold force are chosen to be identical.

In an embodiment, the first spring structure limits a force that may be exerted by the first SMA wire and the second spring structure limits a force that may be exerted by the second SMA wire.

It is to be understood that the memorized length of the SMA wire that corresponds to the memorized shape is subject to manufacture tolerances. Also, the required contraction of the first respectively second SMA wire is determined by a number of dimensions that are subject to tolerances. To cope with this situation, the memorized length of the SMA wires must be selected such that it is shorter than the minimum length that can be practically assumed in operation. In an operational state, further movement of the pivoting member is blocked upon the shutoff-body of the valve unit assuming either of its end positions, i. e. the filling position respectively the draining position. Since the SMA wires further strive, at respectively above the activation temperature, to assume their memorized length, a rigid coupling of the SMA wires to the support structure results in a steep force increase, potentially even damaging the SMA wire and the valve drive unit as a whole. Such overload situation is prevented by the coupling via spring structures in that the coupling between the SMA wires and the spring structures is allowed to move if the force exceeds the threshold force. An overload situation in which the force needs to be limited may, in addition, to the before-discussed situation where further movement is blocked, especially occur under adverse environmental conditions, in particular at high temperatures, e. g. storing temperatures that may be above an activation temperature of the SMA wires, resulting in a contraction of both the first and second SMA wire. The resulting overload may damage the whole valve driver, and cause, e. g. the SMA wires to rip. In such situation, the elastic coupling via the spring structure favourably limits the force.

Favourably, a fixed support member is provided for each of the spring element and the spring elements are arranged to rest on the fixed support and to be lifted off from the support member upon being deflected. The support members may be part of or rigidly attached to the support structure. I n the neutral state, each of the spring elements rests on its support member with a pre-set nominal contact force that corresponds to the threshold force as mentioned before. U pon one of the first and second SMA wires being activated and therefore contracting, the contact force of the corresponding spring elements is reduced by the pulling force that is exerted by the activated SMA wires, with the spring elements still resting on their support members without being deflected. Only upon the contact force becoming zero, the corresponding spring elements are lifted off and are accordingly deflected. The deflection is towards the pivoting member, thereby reducing the distance between the coupling and the pivoting member. In operation, this situation occurs with respect to either of the first and second SMA wire upon the shutoff- body of the valve unit assuming either of its end positions and further movement of the pivoting member being accordingly blocked. It further occurs with respect to both the first and second SMA wire if the environmental temperature exceeds the activation temperature of the SMA wires.

In an embodiment, the first spring structure serves as switch element to interrupt a current supply of the first SMA wire upon a force that is exerted by the first SMA wire on the support structure exceeding a first switching force. Similarly, the second spring structure serves as switch element to interrupt a current supply of the second SMA wire upon a force that is exerted by the second SMA wire on the support structure exceeding a second switching force. I n an embodiment, the first and second switching force correspond to the first and second threshold force as explained before.

The first and second switching force are design-given and typically identical. The first and second switching force is selected somewhat larger as compared to the force that needs to be exerted by an SMA wire for valve actuation, but smaller than the maximum pulling force that may be exerted by the SMA wires without damage. As discussed above and further below in more detail, valve blocks are typically provided that limit the movement of the shutoff body to a range between the filling position and the draining position, respectively, as end positions. As explained before, the contact force becomes zero if either of the end positions is reached, with further contracting of the activated SMA wire resulting in the associated spring elements being lifted off respectively loosing contact with their support member(s). For the here-discussed type of embodiment, the current is provided to the first and second SMA wire by the first and second spring structure respectively the spring elements, and the associated supports. A spring element loosing contact with its associated support accordingly results in the current supply to the SMA wire being interrupted. Interruption of the current supply is favourably subsequently detected by the valve drive control circuitry which, in turn, switches off respectively disables the current respectively power supply of the SMA wire. The first and second switching force for this type of embodiment are given by the nominal contact forces between spring elements and support members as explained before.

Since SMA-based actuators are activated by heating of SMA elements, in the present context SMA wires, energy efficiency is a general topic of concern and in particular in the context of battery-powered applications, like ambulatory infusion pumps. For an acceptable degree of efficiency, fast heating of the SMA wires to or beyond the activation temperature is generally desirable in order to limit thermal losses. Fast heating calls for a large current. Upon further movement being blocked and further contraction of an SMA wire to the memorized length being prevented, the electric energy that is provided to the SMA wires is fully converted into thermal loss energy. The before-mentioned type of embodiment with the spring structure serving as switch ensures a quick interruption of the power supply in the end positions. Therefore, a favourably large current can be used without causing excessive losses. Furthermore, automatic switching off prevents the SMA wires to be damaged by heating beyond a temperature limit where it loses its favourable material properties.

In a further aspect, the overall objective is achieved by a drive unit for use in combination with a dosing unit that includes a metering pump unit and a valve unit. The drive unit includes a pump drive unit. The pump drive unit includes a pump actuator and a pump driver that is coupled to the pump actuator. The pump driver is desig ned to releasably engage a piston of the metering pump unit for transmitting a pump driving force and/or pump driving torque from the pump actuator to the piston, thus displacing the piston in a dosing cylinder of the metering pump unit. The drive unit further includes a valve drive unit as discussed above and further below. The phrase "metering pump unit" indicates that the unit is suited and designed for administering well-defined volumes in a controlled way. In a typical design that is assumed in the following, the pump unit is a positive displacement pump of the syringe-type where the administered volume is given as the product of the (controllable and/or measurable) piston displacement and the cross- sectional area of the piston.

The coupling of the pump driver and the piston is such that the piston is, in dependence of the pump driving force and/or pump driving torque, displaced in a proximal or an opposite distal direction.

Releasable coupling of the dosing unit and the drive unit allows the design of a modular ambulatory infusion pump with a durable unit that includes the drive unit and may include a user interface, control circuitry, and the like, and a separate disposable unit that is designed for a single application of, e.g. , a number of days only and may include the dosing unit and a liq uid drug reservoir. Such embodiment is assumed here and in the following. In contrast to the disposable unit, the durable unit - also referred to as pump device further below - is typically designed for an extended lifetime of typically several months or even years.

The phrase "releasable coupling" accordingly refers to a design that allows mechanical coupling and decoupling of the dosing unit and the drive unit, with the decoupling not causing damage to at least the drive unit. For this purpose, corresponding mechanical mounting structures may be provided at both the dosing unit and the drive unit as will be exemplary described further below.

The pump drive unit and the valve drive unit are functionally separate in that an activation does not affect the valve drive unit and vice versa. The pump actuator only moves the pump driver and the first and second SMA wire as valve actuator only move the pivoting member and the valve driver. With other words, the drive unit is designed to separately control the valve unit and the metering pump unit of the dosing unit.

The drive unit may further include circuitry for controlling the valve drive and the pump drive. While not being essential, the pump actuator is typically a rotatory actuator, such as a standard DC motor, a stepper motor or a brushless DC motor. The control circuitry may be designed to control the pump drive unit and the valve drive unit to control the repeated execution of: a) Controlling the valve drive unit to move the shutoff body of a valve unit of the dosing unit into a filling position; b) Controlling , with the shutoff body being in the filling position, the pump drive unit to move the piston inside the dosing cylinder of the metering pump unit into a distal direction, thus increasing a filling volume of the dosing cylinder and filling the dosing cylinder with liquid drug; c) Controlling the valve drive unit to move the shutoff body from the filling position into a draining position; d ) Controlling, with the shutoff body being in the draining position, the pump drive unit to move the piston inside the dosing cylinder of the metering pump unit in a number of discrete or incremental dosing steps into a proximal direction, thus decreasing the filling volume of the dosing cylinder and dosing liquid drug out of the dosing cylinder.

In such a sequence, the dosing steps are carried out in accordance with therapeutic dosing requirements and may include the dosing of a drug amount on demand in a short time period and/or the dosing of drug increments over an extended time period according to an e. g. pre-programmed or continuously modified dosing schedule. The control logic is further such that piston movements (activation of the pump actuator) and shutoff body movements (activation of either of the first or second SMA wire) do not occur in parallel, but only sequential.

In an embodiment, the method includes, in a step ( b 1 ) that is executed between steps ( b) and (c), controlling , with the shutoff body being in the filling position; the pump drive unit to move the piston inside the dosing cylinder of the metering pump unit into the proximal direction, thus pre-tensioning the valve drive system. By this step, the considerable slackness that may be present in the system is compensated for.

In an embodiment, the design of the drive unit is such that the pump driver engages the piston and the valve driver engages the valve driver coupler via a common relative engagement movement between the drive unit and the dosing unit. The engagement movement may especially be a linear relative movement between the drive unit and the dosing unit.

Decoupling of the drive unit and the dosing unit is favourably carried out by a linear relative displacement movement in the opposite direction. Such decoupling movement favourably disengages the pump driver and the piston, as well as the valve driver and the valve driver coupler. The drive unit may further include and/or be operatively coupled to other components that are typically present in an ambulatory infusion pump, such as general control circuitry and a power supply. The drive unit may in particular include and/or be operatively coupled to monitoring circuitry and/or one or more monitoring sensors for monitoring the state of the pump drive unit and/or the valve drive unit, such as a valve state. The drive unit may further include and/or be operatively coupled to monitoring circuitry and/or one or more monitoring sensors for monitoring the state of the piston and or the valve state of the dosing unit during operation. The control circuitry is typically based on one or more microcontroller(s) and or microcomputer(s) with corresponding firmware and/or software code. The control circuitry may also include an e. g. wireless communication interface, a display, an acoustic and/or tactile alarm device, and one or more input elements, such as push buttons. The control circuitry may especially be designed to control the repeated execution of a sequence as explained before.

According to a further aspect, the overall objective is achieved by a dosing unit. The dosing unit is designed to releasably couple to a drive unit as explained above and further below. The dosing unit includes a metering pump unit. The metering pump unit includes a dosing cylinder and a piston. The piston is arranged in sealing sliding engagement inside the dosing cylinder. The piston is further designed to engage, in the coupled state, with the pump driver of the drive unit. For this purpose, the piston may especially include a pump driver coupler.

The dosing unit further includes a valve unit, the valve unit having a filling port, the filling port being designed for fluidic coupling with a liquid drug reservoir, a draining port, the draining port being designed for fluidic coupling with an infusion site interface, and a shutoff body, the shutoff body being pivotable between a filling position where it fluidic couples the filling port with the dosing cylinder and an alternative draining position where it fluidic couples the dosing cylinder with the draining port.

The dosing unit further includes a valve driver coupler. The valve driver coupler is coupled to or integral with the shutoff body and is designed to engage, in the coupled state, with the valve driver of the drive unit such that a pivoting of the pivoting member is transmitted to the valve driver coupler via the valve driver.

The coupling between valve driver and the valve driver coupler is such that the transfer function between the valve driver and the valve driver coupler is continuous, i. e. a continuous ( pivoting ) movement of the valve driver results in a corresponding continuous movement of the valve driver coupler and accordingly a continuous movement of the shutoff body.

Further aspects of the dosing unit are discussed above and/or further below in the context of exemplary embodiments. It is important that the pump driver coupler and the valve driver coupler as interface structure to the pump drive unit and the valve drive unit are structurally and functionally distinct and a movement of the piston does not cause a movement of the shutoff body, and vice versa. The valve unit is further designed such that between the filling position and the draining position does not involve the movement respectively displacement of liquid. Valve switching is accord ingly displacement free.

In an embodiment, the valve driver coupler includes a funnel-shaped engagement structure. The engagement structure aligns the valve driver coupler and the valve driver with respect to each other during a relative engagement movement between the drive unit and the dosing unit. During the engagement movement between drive unit and dosing unit, the valve driver of the valve drive unit, for example a meshing pin as explained before, first enters the funnel-shaped engagement structure in its widest section. U pon the engagement movement advancing, the meshing pin moves to a narrower and narrower section of the engagement structure, and the clearance between the meshing pin and the walls of the engagement structure is narrowed. If required by the relative positions of the meshing pin and the engagement structure, the meshing pin is automatically positioned and aligned by the engagement structure. In an end section, the funnel -shaped engagement structure may have parallel walls at a distance to each other such that the meshing pin is, at the end of the engagement movement, situated between the sidewalls of the engagement structure with little slackness or play. The engagement movement accordingly simultaneously serves as alignment movement that aligns the valve driver and the valve driver coupler with respect to each other. During subsequent operation, the valve driver coupler follows the movement of valve driver. Any movement of the meshing pin during the engagement movement is associated with a corresponding change in the length of the first and second SMA wire. At this point, it is favourable that an activated ( heated ) SMA wire may exert a large pulling force, while a non-activated SMA wire may be passively deformed and in particular lengthened respectively stretched with little force. In an embodiment, the valve unit includes valve blocks, the valve blocks blocking a further pivoting of the shutoff body upon assuming the filling position respectively the draining position. Alternatively or additionally, valve driver blocks may be provided as part of the valve drive unit and limit the movement of the valve driver, in particular in case it is not coupled to a dosing unit.

In a further aspect, the overall objective is achieved by an ambulatory infusion pump, in particular ambulatory insulin pump. The ambulatory infusion pump includes a drive unit and a dosing unit as discussed above and further below. In a typical embodiment of an insulin pump, the ambulatory infusion pump further includes a drug reservoir with a filling volume of, e. g. 1 .5 ml to 3 ml of liquid insulin formulation. In an example of an insulin pump, the dosing unit has a typical filling volume ( maximum filling volume of the dosing cylinder) in a range of 0.05 ml to 0.2 ml, for example 0.075 ml in a specific example.

Brief description of the figures

Fig. 1 a, 1 b show an exemplary embodiment of a valve drive unit;

Fig. 2 shows an ambulatory infusion pump in a functional view

Fig. 3 shows an embodiment of a pump device and dosing unit in a perspective view;

Fig. 4 shows the device of Figure 3 with removed housing in a perspective view;

Fig. 5 shows a further embod iment of a valve drive unit in operative coupling with a dosing unit in a perspective view;

Fig. 6 shows a section of a valve drive unit;

Fig. 7 shows a front view of a pump device and a dosing unit;

Fig. 8 shows a dosing unit in a perspective view. Exemplary embodiments

In the following, exemplary embodiments are discussed in more detail with additional reference to the figures.

It is to be noted that in the following description, terms indicating a direction, position, or orientation, such as "left", "right", "upper, lower", "top, "bottom", "proximal", "distal" are merely intended to improve the reader's understanding and exclusively refer to the figures. They do not imply any particular directions or orientations for the application.

In the following, reference is first made to Fig ure 1 a and Figure 1 b, showing an exemplary embodiment of a valve drive unit 1 in a schematic top view ( Figure 1 a ) and perspective view ( Figure 1 b), respectively.

The valve drive unit 1 includes a first SMA wire 1 0a and a second SMA wire 1 0b both of which are exemplarily arranged along a straight line and parallel to each other and form, in combination, a valve actuator. One end of the first respectively second SMA wire 1 0a, 1 0b is coupled to a pivoting member 1 2 via a corresponding SMA coupling structure 1 4a respectively 1 4b. Exemplarily, the SMA coupling structures 1 4a, 1 4b are realized as pins that project from a (exemplarily disk-shaped ) main body 1 2' of the pivoting member 1 2. The pivoting member 1 2 is arranged pivotable around a fixed pivoting member axis A, and the SMA coupling structures 1 4a, 1 4b are arranged at opposite sides of the pivoting member axis A, with the distance to the pivoting member axis A each defining a lever arm. A ( pulling ) force that is exerted onto the first respectively second SMA coupling structure 1 4a respectively 1 4b accordingly causes the pivoting member 1 2 to pivot around the pivoting member axis A in opposite directions, thereby transforming the linear movement of the SMA wires 1 0a, 1 Ob into a pivoting movement. The opposite end of each of the first SMA wire 1 0a and the second SMA wire 1 0b is coupled to a fixed support structure 1 1 . An exemplarily pin-shaped valve driver 1 3 is arranged at a distance from the pivoting member axis A and projects parallel to the pivoting member axis A from the main body 1 2'. The main body 1 2' and the valve driver 1 3 form, in combination, a crown wheel with the valve driver 1 3 as single tooth. The valve driver 1 3 and the SMA coupling structures 1 4 a, 1 4b are formed integral with or are rigid ly attached to the main body 1 2', thus forming common structural unit.

Together with the valve drive unit 1 , a valve driver coupler 3 1 2 of a valve unit is shown. The valve driver coupler 3 1 2 exemplarily is realized by a disk that is pivotable arranged around a shutoff body axis B. the shutoff body axis B may coincide with a dosing unit axis ( not shown ). The valve driver coupler 3 1 2 includes a valve driver engagement structure 3 1 3. The valve driver engagement structure is realized as slot in the circumference of the valve driver coupler 3 1 2 and is designed to releasable engage with the valve driver 1 3 with little play. The shutoff body axis B is exemplarily perpendicular to and intersects with the pivoting member axis A.

In the shown configuration, the second SMA wire 1 0b is exemplarily activated ( heated ) and thereby shortened. Consequently, the pivoting member 1 2 pivots around pivoting member axis A in the indicated direction. Because of the engagement between the valve driver 1 3 and the valve driver engagement structure 3 1 3 , also the valve driver coupler 3 1 2 rotates around the shutoff body axis B as indicated. At the same time, the ( not activated ) first SMA wire 1 0a is passively lengthened . An alternative activation of the first SMA wire 1 0a with the second SMA wire 1 0b being un-activated would result in the pivoting member 1 2 and the valve driver coupler 3 1 2 to into the opposite directions, with the second SMA wire 1 Ob being passively lengthened. In the following, reference is additionally made to Figure 2. Figure 2 shows an ambulatory infusion pump device in operative coupling to the patient in a symmetric functional view.

The ambulatory infusion pump device includes a dosing unit 3 , and a drive unit, with the drive unit including a pump d rive unit 2 and a valve drive unit 1 . The ambulatory infusion pump device includes, in an operational state, a liquid drug reservoir 5. It is to be noted that only those structural and functional units are shown that are of particular relevance in view of the present disclosure. Other units, such as power supply, user interface etc. are typically present as well.

The dosing unit 3 includes a metering pump unit 30 and a valve unit 3 1 . The metering pump unit 30 includes a dosing cylinder 300 and a piston 302 sealing and sliding arranged inside of the dosing cylinder 300 in a syringe-like way. In a proximal front wall of the dosing cylinder 300, a bore is arranged as pump port 301 that fluidic couples the inner volume of the dosing cylinder 300 with the valve unit 3 1 . The valve unit 3 1 may alternatively be in a filling state, 3 1 5b (the shutoff body 3 1 5 in the filling position ) or in a draining state 3 1 5a (the shutoff body 3 1 5 in the draining position ) . During operation, the valve unit 3 1 is repeatedly switched between those states. The reservoir 5 is fluidic coupled to the valve unit 3 1 via a filling port 3 1 0. The patient 900 is fluidic coupled to the valve unit 3 1 via a draining port 3 1 1 and an infusion site interface 890. It is noted that the infusion site interface 890 is exemplarily shown as integral with an infusion line, e.g. a catheter. Alternatively, the infusion pump device may be as a patch pump that is directly attached to a patient's body e. g. via an adhesive pad. Here, the infusion site interface may be directly a cannula. The valve unit 3 1 includes a shutoff body 3 1 5 that is sealing and rotatable arranged in a valve bearing. The shutoff body 3 1 5 includes a flow channel arrangement that realizes, in dependence of a rotational position of the shutout body, either the filling state 3 1 5b or the draining state 3 1 5a, respectively. The valve unit 3 1 is typically arranged in line with and proximal from the dosing unit 30. In a typical arrangement that is also assumed in the following, the shutoff body axis is parallel to and optionally coincides with a longitudinal axis of the dosing cylinder 300 along which the piston 302 is displaced. This arrangement, however, is not essential.

The dosing unit 3 further includes, as part of the valve unit 3 1 , a valve driver coupler 3 1 2 for switching the valve unit 3 1 between the filling position, 3 1 5b, and the draining position 3 1 5a. Similarly, the dosing unit 3 includes, as part of the metering pump unit 30, a pump driver coupler 303 for displacing the piston 302 inside the dosing cylinder 300 as explained before. The pump driver coupler 303 may be fully or partly integral with the piston 302.

The operation of the metering pump unit 30 and the valve unit 3 1 is independent from each other. That is, the piston 302 may be displaced inside the dosing cylinder 300 without affecting the state of the valve unit 3 1 . Likewise, the state of the valve unit 3 1 may be changed respectively switched without affecting the position of the piston 302 inside the dosing cylinder 300. Further, a valve switching between the filling state and the draining state does not involve a liquid displacement between the filling port 3 1 0 and the draining port 3 1 1 resulting from the movement of the shutoff body 3 1 5. Consequently, a valve switching does not involve the dosing of liquid to the patient. This aspect is of particular relevance because the controlled and metered dosing is carried out exclusively by controlled displacement of the piston 302. For highly concentrated drugs such as typical liquid insulin formulations, an unintended drug administration resulting from the valve switching may result in undesired and potentially severe medical complications.

In a typical arrangement, the dosing unit 3 with the metering pump unit 30 and the valve unit 3 1 is formed as a compact device and in an integ ral way. Therefore, the pump port 301 is, in contrast to the filling port 3 1 0 and the draining port 3 1 1 , not accessible from outside the dosing unit 3.

With respect to the valve unit 3 1 , it is further noted that Figure 2 only shows the states 3 1 5a, 3 1 5b where either of the filling port 3 1 0 or the draining port 3 1 1 is coupled to the pump port 301 . In a further intermediate state, however, all three ports 301 , 3 1 0, 3 1 1 are closed, resulting in fluidic isolation.

The pump drive unit 2 includes the pump driver 21 that is desig ned to releasable engage the pump driver coupler 303 for displacing the piston inside the dosing cylinder 300 as explained before. The pump drive unit 2 further includes a pump actuator 20, typically a motor as mentioned before. The pump actuator may further include a reduction gear and/or a rotatory-to-linear transformation gear. The pump drive unit 2 is, as a whole, typically realized as spindle drive or screw drive that transforms a rotatory actuator movement into a reversible linear displacement movement of the pump driver 21 , and, via the pump driver coupler, 303 , of the piston 302. The pump driver 21 may be realized as plunger. The pump driver coupler 303 may be firmly attached to or integrated into a distal portion of the piston 302. The pump driver21 and the pump driver coupler 303 are designed for push-pull-coupling, e.g. as bayonet coupling, snap-fit coupling, or the like. A reciprocal movement of the pump driver 21 results in a corresponding reciprocal piston movement in proximal or distal direction, respectively. The valve drive unit 1 is designed in accordance with the present disclosure and includes a pivoting member 1 2 and a valve driver 1 3 , and a first and second SMA wire, 1 0a, 1 0b, which form, in combination a valve actuator.

The pump actuator 20 and the first and second SMA wire 1 0a, 1 Ob as valve actuator are coupled to control unit or control circuitry 40 which controls their operation.

The pump drive unit 2 , the valve drive unit 1 and the control circuitry 40 typically belong to a common compact device that is also referred to as "pump" device" and forms the part of the ambulatory infusion pump device that is designed for an extended lifetime of a number of months, e. g. six months, or years, while the dosing unit 3 and the reservoir 5 are disposable of substantially shorter lifetime.

In the following, reference is additionally made to Figure 3 and Figure 4. Figure 3 shows major components of an exemplary embodiment of an ambulatory infusion pump in a schematic perspective view. The ambulatory infusion pump device is designed in accordance with Figure 2 as discussed before.

In the figures, a proximal direction indicated by "P" and a distal direction as indicated by "D". The ambulatory infusion pump comprises reusable pump device 4 that is designed for an extended lifetime of typically a number of years and therefore also referred to as "durable unit". By way of example, the ambulatory infusion pump is an insulin pump that is carried by a person with diabetes substantially continuously nig ht and day. The overall size of the infusion pump is such that it can be carried concealed from view, for example in a trousers pocket with the belt clip, or the like or can be attached to the body as a patch pump. The pump device 4 has a housing ( not referenced ) which carries components such a power supply, and a user interface. The pump device 4 in particular integrates the valve drive unit 1 , the pump drive unit 2, and the control circuitry or control unit 40 as discussed before with reference to Fig ure 2. The ambulatory infusion pump further comprises a dosing unit 3 that is designed for a lifetime of typically a number of days up to, e. g. two weeks. Resulting from their different application time, the pump device 4 and in particular the pump drive unit 2 on the one hand and the dosing unit 3 on the other hand are designed for releasable mechanical and operational coupling.

Both Figure 3 and Figure 4 show the ambulatory infusion pump with a pump device 4 and a dosing unit 3 being somewhat spaced apart from each other, i. e. in an unconnected state, but in a relative orientation that corresponds to the orientation during application. In contrast to Figure 4, housing components of the pump device 4 and the disposable unit 3 are removed.

In addition to the components that are shown in Figures 2, 3 , the ambulatory infusion pump includes, in an operational state, the drug reservoir 5. The shown embodiment is designed for use in combination with a cylindrical drug cartridge of, e. g. 1 .5 ml to 3 ml filling volume. The drug cartridge couples with the dosing unit 3 via a cartridge coupler 32 that includes a mechanical and fluidic interface structure In a coupled state, the cartridge extends along the proximal-distal direction. The fluidic interface structure includes a hollow cannula ( not visible) to pierce a septum of the drug cartridge, thus fluidic coupling the inner volume of the drug cartridge with the inlet port 3 1 0 of the dosing unit 3.

Coupling of the pump device 4 and the dosing unit 3 is achieved via a linear movement of the dosing unit 3 relative to the pump device 4 in a distal direction, as indicated by a dashed arrow. The pump device 4 includes a cartridge receptacle 41 that receives the drug cartridge, and a dosing cylinder receptacle 41 a that receives the metering pump unit 30 of the dosing unit 3 for the application time of the dosing unit 3 and the cartridge.

For the mechanical coupling or mounting, the pump device 4 and the dosing unit 3 are provided with a pump device mounting structure 42 that is designed to receive the pump cylinder 300 and an optional sensor assembly 33. In an assembled state, the pump device 4 and the dosing unit 3 form, in combination, a watertight or water protected assembly during application. Decoupling is carried out by a corresponding linear counter- movement of the dosing unit 3 relative to the pump device 4 in proximal direction, potentially involving the unlocking are releasing of snap fit elements, catches. The optional sensor assembly 33 comprises an elongated plate that extends parallel to the dosing cylinder 300 and may include, e. g. a fluidic pressure transfer membrane, a flow sensor or flow detector, and/or an air sensor. As mating counter-element to the pump device mounting structure 42, the dosing unit 3 includes a corresponding dosing unit mounting structure. In this embodiment, a proximal end of the sensor assembly 33 is connected to other components of the dosing unit 3 , in particular the metering pump unit 30 and a disposable housing 35. The disposable housing 35 includes, at its distal end, a circumferential sealing 34.

In addition to the before mentioned elements, the dosing unit 3 includes the metering pump unit 30 and the valve unit 3 1 . The whole dosing unit 3 is favourably designed and provided as a common integral unit. The dosing unit 3 is realized as inline arrangement with the valve unit 3 1 being arranged proximal from the metering pump unit 30. The drug reservoir, in particular drug cartridge may be provided already coupled to the cartridge coupler 32, or may be separate and coupled by the user. The overall arrangement and design of the dosing unit 30 is realized in accordance with Figure 2 and the corresponding description.

In the following, reference is additionally made to Figure 5, illustrating the cooperation between the valve drive unit 1 and the valve unit 3 1 . The valve driver coupler 3 1 2 includes the slot-shaped valve driver engagement structure 3 1 3 that is discussed further below in more detail and engages, in the coupled state as shown in Figure 5 , the pin- shaped valve driver 1 3 that projects from the body of the pivoting member 1 2 and into the valve driver engagement structure 3 1 3. The shutoff body 3 1 5 of the valve unit 3 1 is formed integral with the valve driver coupler 3 1 2 and is itself not visible in Figures 3 , 4.

In this shown example, the dosing unit 3 is realized as in-line design with the piston displacement axis (corresponding to the longitudinal axis of the dosing cylinder 300 and extending between distal and proximal) being coincident respectively identical with the shutoff body axis B (see also Figures 1 , 7 ), as explained before in the context of Figure 2.

In contrast to embodiment of Figures 1 a, 1 b, the first SMA wire 1 0a and the second SMA wire 1 0b each are substantially U-shaped. For each of the first SMA wire 1 0a and the second SMA wire 1 0b, the base of the U -shaped SMA wires (the area where both legs of the "U" meet) is coupled to the pivoting member 1 2 via SMA coupling member 1 4a, 1 4b in the form of hooks in which the bases of the first SMA wire 1 0a and the second SMA wire rest. The hooks are, like the pins of the embodiment of Figure 1 a, 1 b, arranged on opposite sides of the pivoting member axis A, thus transforming a shortening of the first SMA wire 1 0a respectively the second SMA wire 1 0b into pivoting movements in opposite directions, with the other of the first SMA wire 1 0a and second SMA wire 1 0b being passively lengthened . Via the engagement between the valve driver 1 3 and the valve driver coupler 3 1 2 respectively the engagement structure 3 1 3 , the pivoting movement of the pivoting member 1 2 results in a corresponding pivoting of the valve driver coupler 3 1 2 and the shutoff body 3 1 5 around the shutoff body axis B.

From the pivoting member 1 2, the legs of the SMA wires 1 0a, 1 0b extend parallel in distal direction and are separately coupled to the support structure 1 1 which is exemplarily realized as printed circuit board. The support structure 1 1 may be part of or rigidly connected to other parts of the pump structure and is in particular rigidly coupled to the housing of the pump device 4. The support structure is sufficiently stiff to absorb the forces that are exerted by the first and second SMA wire 1 0a, 1 0b without significant deformation.

The pivoting member 1 2 as a whole or at least the SMA coupling structures 1 4a, 1 4b are favourably made from metal or metallized such that the heating current through the SMA wires 1 0a, 1 Ob is shortcut as explained before in the general description.

In the following, reference is additionally made to Figure 6. Figure 6 shows the distal end section of the first SMA wire 1 0a and the support structure 1 1 in a detailed view. Close to its free ends, the legs of the SMA wire 1 0a, 1 0b each have a thickening which is exemplarily realized as a sleeve 1 5 that is firmly connected to the corresponding SMA wire, e. g. by crimping or soldering. Via the sleeve 1 5, each leg of the first SMA wire 1 0a, is hooked in an exemplarily slot-shaped recess ( not referenced ) that is arranged at a free end section of a first leaf spring 1 6a. The opposite end of the first leaf springs 1 6a is firmly attached to the support structure 1 1 , e.g. via screwing, riveting, clamping, or the like. Close to the free end, each of the two leaf springs rests on a support member that is exemplarily realized as dome-shaped rivet 1 7. As best visible in Fig. 4, the same principle is applied to the second SMA wire 1 0b that is coupled to the support structure via second leaf springs 1 6b. In a non-elongated state of the SMA wire 1 0a, the first leaf springs 1 6a rest on the corresponding rivets 1 7 with a nominal contact force that acts in distal direction and is at the same time a threshold force and switching force as explained before in the general description. In combination, the first leaf springs 1 6a accordingly serve as first spring structure that strain the first SMA wire 1 0a by exerting a force in distal direction. Similarly, the second leaf springs 1 6b serve as second spring structure that strain the second SMA wire 1 0b.

The first and second leaf springs 1 6a, 1 6b and the rivets 1 7 are typically from metal and therefore conductive and/or have a conductive coating. The valve drive control circuitry (a functional component of the control unit or control circuitry 40, see Figure 2 ) is connected to the rivets 1 7. For activating the first SMA wire 1 0a, an electric power supply is connected the rivets 1 7 , thereby establishing a current flow from the power supply, via one of the rivets 1 7 and the associated first leaf spring 1 6a, the first SMA wire 1 0a, the other first leaf spring 1 6a and associated rivet 1 7, and back to the power supply.

As explained before, the shortening of the activated first SMA 1 0a wire results in a pivoting movement of the pivoting member 1 2 unit further movement is blocked. At the same time, the contact force between the first leaf springs 1 6a and the associated rivets 1 7 is reduced due to the pulling force that is exerted by the first SMA wire 1 0a. Further reducing the length of the activated first SMA wire 1 0a results in the first leaf springs 1 6a being lifted off and loosing contact with the associated rivets 1 7, resulting in the current flow being interrupted and heating of the first SMA wire 1 0a stops. The same applies for the second SMA wire 1 0b in an analogue way. The leaf springs 1 6a, 1 6b accordingly serve as end position switches or end position sensors that detect if the shutoff body 3 1 5 assumes either of its end positions. A further advantageous effect of the shown arrangement occurs when the whole pump device 4 (or a drive unit as pre-assembled subunit) is exposed to a high temperature, e. g. during storage or transport, beyond the activation temperature. As explained before, both the first SMA wire 1 0a and the second SMA wire 1 0b will be activated and will accordingly shorten. As apparent, e. g. from Fig. 4, such situation results in a considerable mechanical stress on all of the support structure 1 1 , the SMA wires 1 0a, and the pivoting member 1 2, including its bearing. Without the elasticity of the leaf springs 1 6a, 1 6 b, the structure may well be damaged in this situation. Both the first and second leaf springs 1 6a, 1 6b, however, will be elongated in this case and be lifted off the rivets 1 7, thereby limiting the pulling force that is exerted by the first and second SMA wires 1 0a, 1 Ob to an acceptable value within the desig n limits.

In the following, reference is additionally made to Figure 7. Fig ure 7 shows the arrangement of Fig. 4 in a front view (with the viewing direction being from proximal to distal), with the valve driver 1 3 engaging the engagement structure 3 1 3 of the valve driver coupler 3 1 2.

The dosing unit 3 includes a blocking structure that is exemplarily realized as ring section 3 1 4 concentric with the dosing cylinder 300 and the shutoff body axis B (exemplarily identical with the dosing cylinder axis and the piston displacement axis). The ends 3 1 4a, 3 1 4b of the ring section 3 1 4 serve as valve blocks that block further movement of the valve driver coupler 3 1 2 - and, in an engaged state, of the pivoting member 1 2 with valve driver 1 3 - upon a corresponding surface of the valve driver coupler 3 1 2 hitting the block. In Fig ure 7, the valve driver coupler 3 1 2 is shown in a configuration where it hits the upper valve block 3 1 4a. In the following, reference is additionally made to Figure 8. Figure 8 shows the dosing unit 3 in a perspective view. It can be seen that the engagement structure 3 1 3 is a funnel-shaped recess, having a proximal portion 3 1 3a with parallel sidewalls and a trapezoidal distal portion 3 1 3 b with converging sidewalls. At the distal end, the width of the distal portion 3 1 3 b is widest. At the proximal end of the distal portion 3 1 3 b, its width corresponds to the width of the proximal portion 3 1 3 a. When coupling the dosing unit 3 with the pump device 4 by a inserting the dosing unit 3 includes the dosing cylinder receptacle 41 a (see Figure 3 ), the valve d river coupler 1 3 ( not visible in Figure 8) will first enter the trapezoidal distal portion 3 1 3 b and be g uided into the proximal portion 3 1 3a where it stays for subsequent operation. During this insertion and coupling process, the pivoting member 1 2 with the valve driver 1 3 and the valve driver coupler 3 1 2 are aligned with respect to each other as explained before.

When the coupling is finished (and the dosing cylinder 300 is situated in the dosing cylinder receptacle 41 a) , the valve driver 1 2 and the valve driver coupler 3 1 2 are in correct engagement and relative alignment, but in a generally undefined state. That is, the shutoff body (and accordingly the valve driver 1 2 and the valve driver coupler 3 1 2 ) may be in any position between the filling position and the draining position. When activating the valve drive 1 for the first time, less than a full stroke will accordingly be required until the shutoff body assumes the filling position or the draining position as either of its end positions, and further movement is blocked. In the here-described embodiment, reaching of either of the end positions automatically results in an interruption of the power supply. Alternatively or additionally, however, a monitoring sensor that monitors the position of the shutoff body 3 1 5 (or, equivalently, of the valve driver coupler 3 1 2 ), such as dedicated end switches light barrier, or the like may be present as part of the control unit or control circuitry 40.