Metering device comprising housing parts which are operatively connected during a displacement process
The multi-part housing and cannula insertion mechanism in the infusion pump address the bulkiness and comfort issues of existing pumps by enabling actuation through housing displacement, ensuring compactness and precision in fluid delivery.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- TRIPENSO AG
- Filing Date
- 2024-10-08
- Publication Date
- 2026-07-02
Smart Images

Figure EP2024078267_02072026_PF_FP_ABST
Abstract
Description
[0001] Dosing device with housing components that are connected during dislocation
[0002] The present invention relates to a dosing device for the subcutaneous and / or intravenous administration of a defined quantity of a fluid, in particular an infusion solution, a liquid drug solution or therapy, and / or for subcutaneous and / or intravenous sampling and / or measurement using a cannula.
[0003] By definition, a dosing device according to the invention can be understood as an infusion pump, as one possible embodiment. Infusion pumps, also called patch pumps, which are the subject of the proposed solution described below, can be worn in a fixed position on the human body and deliver a specific quantity of a fluid, in particular an infusion solution, continuously or according to a predetermined quantity-time profile, either subcutaneously or intravenously, into the human body within a specific time period to achieve a desired concentration and thus a corresponding effect. The range of such fluids, especially infusion solutions, extends from low to high viscosity, from simple low-molecular-weight substances with a molecular weight of a few Daltons to high-molecular-weight substances with a molecular weight of up to 1,000,000 Daltons.From simple saline solutions to highly complex biological agents such as peptides, proteins, monoclonal antibodies, vaccines of all kinds, pain medications, cancer therapies, or nutrient solutions, dosing devices can deliver the desired quantity precisely and safely to the appropriate location in the human body. Not only immunizing, preventive, prophylactic, or therapeutic fluids or infusion solutions, but also fluids important in analytical therapies, fluids containing nutrients, or even combinations of all the aforementioned fluids can be administered with such infusion pumps with the required precision and / or within a desired therapeutic and / or beneficial range.
[0004] Dosing devices, and in particular infusion pumps, have been used in the treatment of diabetes mellitus since the 1970s. These pumps typically deliver a fluid containing water, excipients, and the peptide (hormone) insulin. Sometimes, such infusion pumps also deliver other fluids. Over the years, continuous innovation has reduced the size of these insulin-containing infusion pumps from that of a backpack to the most compact infusion pump currently available (Omni-pod® by Insulet, Acton, MA, USA), measuring just 52 x 39 x 14 mm.While pumps worn on the belt (or in a pocket or under clothing) with infusion sets (simply put, a tube with a connection for the infusion pump at one end and an infusion port, usually providing direct access to the recipient's body, at the other) were common between 1990 and 2015, patients have been increasingly switching to particularly small, skin-attached or adhesive dosing devices, so-called patch pumps, for several years now. Patch pumps are not only extremely compact and therefore usually discreet, but also often have the advantage that no infusion set is needed as an interface to the human body. The tubing of an infusion set has the disadvantage of being prone to tangling and, in the worst case, tearing off, especially with children playing or during sports.Furthermore, the tubing can kink, causing a build-up of pressure within the tubing and / or the infusion pump, which is then abruptly released when the kink is released. Additionally, tubing can cause errors in precise infusion. The difference in elevation between an infusion pump worn on the abdomen and an infusion port on the upper arm creates back pressure, which, for example, can reach up to 1 meter (10,000 Pa) in taller individuals, impacting the mechanics of the infusion pump. If the recipient then lies down, for example, to sleep, the pressure created by the aforementioned fluid column disappears. These changes in position, in turn, lead to variations in the precision of the infusion.Theoretical tests according to IEC 60601-2-24 do not consider such fluctuations in infusion rate precision, as only a static system is tested. Nevertheless, risk analyses regarding the hazards of an infusion set are usually critical. Especially with young children, constant and close monitoring is essential when using an infusion pump with an infusion set.
[0005] Patch pumps are delivered either as a ready-to-use infusion pump (except for filling) or as a kit consisting of several components. After unpacking and, where necessary, assembly, these infusion pumps are filled. Filling is usually done using a separate filling system, filling accessories, or a syringe, which typically transfers a portion of the contents of a bottle containing, for example, 10 ml of infusion solution into the reservoir of the infusion pump. After filling, the patch pump is placed on the recipient's body, and the infusion cannula, which is connected directly or indirectly to the reservoir, is inserted subcutaneously or intravenously at its other end. During filling, the user must take care to introduce as few air bubbles as possible into the reservoir.These air bubbles prevent controlled delivery, as gases can be compressed orders of magnitude more than fluids, resulting in undefined flow rates due to pressure differences. Furthermore, accidental insertion of the infusion cannula, which is directly or indirectly connected to the reservoir, into a vein can occur, and in the worst case, the air bubbles could lead to an air embolism.
[0006] A generic dosing device is disclosed in US 2004010 207 A1. This patent discloses a portable infusion pump comprising a reservoir container with an interior chamber and a cannula assembly with an infusion cannula and a cannula insertion mechanism. The infusion cannula is fluidically coupled to the interior chamber of the reservoir container via a cannula end on the container side. When the cannula insertion mechanism is actuated, it is moved from an initial state to an actuated state, thereby radially loading the infusion cannula so that the other end of the cannula, namely the recipient-side end, is moved from an initial position to an insertion position. After use, when the infusion pump is to be removed from the recipient, the recipient-side cannula end must be withdrawn from the recipient's tissue.In the known infusion pump, the cannula insertion mechanism and the recipient-side cannula end can be returned to their original state or position via a separate drive with an actuator. The drive is designed to generate an electrical charge that causes a shape-memory element to contract. Alternatively, the drive can also incorporate a piezoelectric actuator or a solenoid.
[0007] One challenge is that the well-known infusion pump, due to its separate drive which requires corresponding installation space within the housing of the infusion pump, is relatively large and bulky and is therefore uncomfortable to wear on the body.
[0008] The invention is based on the objective of further developing known infusion pumps in such a way that an improved dosing device is provided with regard to wearing comfort and thus with regard to energy efficiency, compactness, weight and ease of use.
[0009] This task is solved by a dosing device according to the claims.
[0010] The dosing device according to the invention, in particular an infusion pump, for preferably subcutaneous administration of a fluid, comprising a housing, a reservoir container with an interior space for receiving the fluid and a cannula arrangement,
[0011] - wherein the housing is multi-part and comprises a first housing part and a second housing part,
[0012] - wherein the cannula arrangement comprises a cannula insertion mechanism and an infusion cannula with a container-side cannula end and a receiver-side cannula end on which a cannula tip is formed,
[0013] - wherein the infusion cannula is fluidically coupled, in particular fluidically coupled, to the interior of the container or to the reservoir container at its container-side cannula end,
[0014] - wherein a state of the cannula insertion mechanism can be shifted or changed between an initial state and an actuation state,
[0015] - wherein the cannula insertion mechanism, when moved into the actuated state or in the actuated state, is operatively connected to the infusion cannula in such a way that the recipient-side cannula end can be moved, in particular abruptly, from an initial position to an insertion position, in particular by elastic bending or elastic deformation of the infusion cannula and / or a pivoting, in particular an elastic pivoting, of the recipient-side cannula end, so that the fluid can be administered subcutaneously via the cannula tip by means of the metering device and through the recipient-side cannula end of the infusion cannula, which has been moved into the insertion position,
[0016] - wherein a first group of components of the dosing device are coupled to the first housing part and a second group of components of the dosing device are coupled to the second housing part, each in a housing-fixed manner or each formed as a section of the housing,
[0017] - wherein components of the first group are operatively connected to components of the second group when the housing parts are moved relative to each other, in particular when the housing parts are brought together to produce an assembled state of the dosing device by means of an assembly movement or when the dosing device is disassembled, in particular being operable, activatable, adjustable, convertible, manipulable or generally operable.
[0018] This also creates the possibility for the cannula insertion mechanism, as a component of the dosing device, to interact with its complementary housing part. The cannula insertion mechanism can thus be shifted between at least two defined states, and intermediate states are not excluded.
[0019] In this context, the initial state of the cannula insertion mechanism means that the mechanism is inactive with respect to the infusion cannula, or that it is not operatively connected to the cannula, or at least does not influence the position of the cannula. If necessary, the cannula insertion mechanism may be pre-tensioned in its initial state to allow it to move into the actuated state, so that when the state of the cannula insertion mechanism changes, energy is available to move it.
[0020] In this context, the actuation state of the cannula insertion mechanism means that when it is moved into the actuation state or is in the actuation state, the infusion cannula is moved from its initial position to its insertion position.
[0021] In any case, this creates a dosing device that offers the advantage that functions of the dosing device itself can be performed during assembly or disassembly. The relative displacement of the housing parts is thus used as a switch, so that, for example, the cannula insertion mechanism is influenced in a specific way when this switch is activated. This also applies to other components of the dosing device and is not limited to the cannula insertion mechanism. It should also be mentioned here that, as a further relative movement of the two housing parts acting as a switch, safety measures, particularly those related to patient safety, can be initiated.For example, it is conceivable that the position of the infusion cannula can be detected by means of a control device of the dosing unit, whereby if the dosing unit is disassembled while the infusion cannula is in the insertion position, appropriate safety measures for the patient can be initiated, which safety measures can in any case be initiated by disassembling the dosing unit. In any case, further and multifaceted advantageous applications are conceivable in this sense, whereby the following description only mentions a few exemplary use cases.
[0022] Furthermore, it may be advantageous if the reservoir container is designed in a hollow cylindrical or hollow ovoid shape with a first longitudinal extension along a central axis of the reservoir container, wherein the housing has a second longitudinal extension, wherein the second longitudinal extension is aligned along the first longitudinal extension or substantially parallel to the first longitudinal extension, wherein the second longitudinal extension is aligned with a longitudinal axis of a Cartesian coordinate system and the metering device does not have a longer longitudinal extension than the second longitudinal extension in either the direction of a transverse axis or in the direction of a normal axis of the Cartesian coordinate system.
[0023] Thus, the dosing device has a maximum longitudinal extent along the second longitudinal extent, whereby a maximum longitudinal extent in this context means that the housing does not have a dimension greater than the maximum longitudinal extent along any direction of a coordinate axis of the Cartesian coordinate system.
[0024] This allows the dosing device to be manufactured as compactly as possible, while still enabling the use of standard reservoir containers as purchased components. Consequently, the preferred direction for assembling or disassembling the dosing device can also be along its maximum longitudinal extent, thus synergistically enabling the dosing device to be handled in a way that maximizes its compact design. In this context, it can also be provided that the reservoir container can be inserted or installed into the housing essentially along the second longitudinal extent of the housing.
[0025] Similarly, as an alternative or additional feature, the assembly movement for producing an assembled state of the dispensing device can also include a movement vector for joining the housing parts with a significant portion parallel to the second longitudinal dimension of the housing. This allows the maximum longitudinal dimension of the dispensing device to be utilized to the greatest possible extent during assembly or disassembly. For example, this allows for the utilization of as much kinetic energy as possible in a clamping mechanism that is subsequently tensioned, or, again, for the largest possible contact area for an electrical contact.
[0026] In this context, it can be particularly advantageous if the two housing parts of the dispensing device are brought together in a sealing manner when assembled, preferably with the insertion of or coupling to a sealing element. This maximum possible movement allows for a particularly tight seal of the dispensing device.
[0027] An advantageous embodiment is one in which the cannula insertion mechanism is functionally connected to its complementary housing part, whereby the state of the cannula insertion mechanism can be changed when the housing parts are displaced relative to each other.
[0028] In this context, the complementary housing part refers to the housing part in which the cannula insertion mechanism is not fixed or positioned when the dosing device is separate.
[0029] For example, the cannula insertion mechanism can be moved from its initial position to its actuated position, or vice versa, both during assembly and disassembly of the dispensing device. This enables several potentially advantageous scenarios for actuating the cannula insertion mechanism of the dispensing device. However, it is also possible that the cannula insertion mechanism can be moved from an intermediate state between the actuated state and the initial state—essentially from an undefined state—into one of the two defined states by shifting the housing parts relative to each other. For instance, it is conceivable that the cannula insertion mechanism exists in an undefined state between the actuated state and the initial state, with the two housing parts of the dispensing device separated.When the housing is assembled, it can be advantageous if the cannula insertion mechanism is reset to its initial state during assembly. This initial state could, for example, represent a cannula insertion mechanism ready for insertion, whereby the insertion, i.e., the transition to the actuation state, can be initiated by a further event or action, such as manual interaction by a user.
[0030] According to further training, it is possible for the housing to interact with the cannula insertion mechanism in such a way that the cannula insertion mechanism can be switched from its actuated state to a state in which the recipient-side cannula end remains unaffected by the cannula insertion mechanism by shifting the housing parts relative to each other. This is primarily a safety-related measure to protect the user, i.e., a patient, from injury caused by the infusion cannula when the user is handling the dosing device.
[0031] Furthermore, it can be advantageous if the infusion cannula, by moving the cannula insertion mechanism from its actuated state, performs a return movement, particularly a return of elastic deformation, either automatically or by force, especially spring-driven movement, which allows the recipient-side end of the cannula to be moved back from the insertion position to the initial position, particularly back to the initial position. This, in turn, is a measure that improves patient safety.
[0032] Furthermore, the cannula insertion mechanism can be repositioned or transferred to its initial state when the housing parts are moved relative to each other or when the dosing device housing is assembled. In this initial state, the cannula insertion mechanism is ineffective with respect to the infusion cannula, or the recipient end of the cannula remains unaffected by the cannula insertion mechanism. This measure simplifies the use of the dosing device and improves user safety. For example, it allows the cannula insertion mechanism to be tensioned without affecting the infusion cannula, provided it includes a corresponding tensioning device.Thus, in this example of a possible measure of the previously mentioned feature, the infusion cannula is in any case not displaced, so that the protection of the user from injuries caused by the infusion cannula is improved.
[0033] Furthermore, the cannula insertion mechanism may include an insertion device, in particular an insertion actuator or a pivotable insertion lever, which is coupled or couplingable to the infusion cannula in a force-transmitting manner, wherein the insertion device is displaceable, in particular pivotable, between a starting position and an actuating position, and wherein the insertion device is electrically or mechanically controllable. In particular, it may be provided that the insertion device is operatively connected to its complementary housing part, such that, in particular, a mechanical insertion device can be pre-tensioned, activated, or charged with mechanical energy, for example, by assembling the dosing device.
[0034] According to a particular embodiment, the insertion device is designed as an insertion actuator, wherein the infusion cannula can be displaced from its initial position and during its movement to the insertion position by means of the insertion actuator, in particular by elastic bending and / or pivoting of the infusion cannula in the direction of the insertion position, so that the recipient-side end of the cannula can be displaced from the initial position to the insertion position, in particular abruptly, and / or that the cannula insertion mechanism can be returned from its actuated state to its initial state by the insertion actuator being movable back from its actuated position to its initial position, and / or that the housing with the insertion actuator is designed to interact in such a way thatthat by shifting the two housing parts relative to each other, the injection actuator can be moved from its actuating position to a position in which the infusion cannula is at least partially, and in particular completely, relieved of pressure from the injection actuator.
[0035] According to an advantageous embodiment, it can be provided that the displacement of the two housing parts relative to each other is or comprises a, in particular linear, displacement of the two housing parts relative to each other, preferably that the displacement comprises a directional component that runs parallel or orthogonal to the underside of the housing.
[0036] In particular, it can be advantageous if the cannula insertion mechanism comprises a return element by the actuation of which the cannula insertion mechanism can be moved from its actuated state, in particular to its initial state, wherein the return element slides along an inclined contact surface of a housing section of the housing, in particular a ramp-shaped housing section, when the two housing parts are moved relative to each other, thereby moving the return element, in particular pivoting or displacing it, preferably that the housing section with the inclined contact surface is fixed to one housing part and the return element is fixed to the other housing part.
[0037] Furthermore, it may be provided that the cannula end on the container side can be coupled to the interior of the container or to the reservoir container by means of the assembly movement, in particular by moving the two housing parts relative to each other.
[0038] Furthermore, it can be provided that the two housing parts are designed as a disposable housing part and as a reusable housing part, preferably that the reservoir container, the adhesive patch for attaching to the body and the infusion cannula, in particular also the housing section with the inclined contact surface, are mounted on the disposable housing part, which preferably together form a pre-assembled disposable unit, and / or that the cannula insertion mechanism and / or the insertion device, in particular also the return element and / or a drive source, in particular a drive motor, and optionally further drive elements, are mounted on the reusable housing part, which preferably together form a pre-assembled reusable unit.
[0039] It is also advantageous to have a design in which the reservoir container is permanently connected to the housing, in particular the disposable housing part, in particular without tools and / or without force, or forms a replaceable cartridge, preferably that the reservoir container can be installed in a pre-filled state together with the disposable housing part as a pre-assembled unit or the replaceable cartridge can be installed in a pre-filled state.
[0040] Furthermore, it may be advantageous if the two housing parts are designed as a disposable housing part and a reusable housing part, wherein the reusable housing part comprises a power supply device, in particular a rechargeable power supply device, and a display, wherein the disposable housing part comprises a further power supply device, in particular a battery, wherein the power supply device is electrically coupled when moving housing parts into the assembled state of the dispensing device and / or is electrically coupled in the assembled state of the dispensing device, so that the power supply device can be recharged by means of the further power supply device.Advantageously, in this context, it can be provided that a control device for the dosing device can be activated by means of the electrical coupling of the power supply devices, whereby actions are initiated upon activation by means of the control device. Examples of these actions may include the controlled recharging of the power supply device, the fluidic coupling of the infusion cannula with the interior of the container, the flushing of the infusion cannula, or the return of the cannula insertion mechanism to its initial state.
[0041] Furthermore, the dosing device may include a user interface with a display and / or with an operating unit having one or more buttons, preferably that the user interface is part of the reusable unit.
[0042] In connection with the invention described above, the following additional aspects regarding the cannula-shooting mechanism are also worth mentioning.
[0043] For example, an embodiment of a dosing device is particularly advantageous which is designed as an infusion pump for administering a defined quantity of a fluid, especially an infusion solution, wherein the infusion pump has a reservoir container with an interior which, in particular at least in one section, is designed to receive the fluid, wherein the infusion pump has a cannula arrangement with an infusion cannula and a cannula insertion mechanism, wherein the infusion cannula is fluidically connected or connectable to the interior of the reservoir container via a container-side cannula end, and the infusion cannula extends from the container-side cannula end along its axial extent to a receiver-side cannula end on which a cannula tip is formed.wherein the cannula insertion mechanism is transferable from an initial state to an actuated state and is designed to subject the infusion cannula to stress upon actuation from its initial state, in particular to cause an elastic bending or rotation of the infusion cannula, so that the recipient-side cannula end is moved from an initial position to an insertion position, in particular abruptly, wherein the cannula insertion mechanism is reversible from its actuated state to its initial state, wherein the infusion pump has a multi-part housing for receiving the reservoir container and the cannula assembly, and wherein the housing interacts with the cannula insertion mechanism in such a way that, by a displacement of two housing parts relative to each other, the cannula insertion mechanism is transferred from its actuated state to a statein which the cannula insertion mechanism relieves the infusion cannula at least partially, in particular completely.
[0044] The fundamental consideration is to return the cannula insertion mechanism from its activated state to its original, and specifically its initial, state, through a measure that is necessary anyway after use, thereby allowing the infusion cannula to return to its restoring position. Thus, after use, the upper part of the infusion pump is removed for reuse and / or to re-fill the pump. In the proposed infusion pump, two housing parts, as will be explained in more detail below, are movable relative to each other and, in particular, can be detached. This movement automatically adjusts the cannula insertion mechanism, thereby enabling the aforementioned restoring movement of the infusion cannula.The recipient end of the cannula is then withdrawn from the tissue of the infusion recipient, either automatically or by force, particularly spring-driven, and preferably moved completely back into the housing of the infusion pump. Since the displacement of the two housing parts is directly linked to an adjustment of the cannula insertion mechanism, no separate drive is required. Instead, the force applied to the housing parts is used to adjust the cannula insertion mechanism. This results in smaller overall dimensions. Wearing such an infusion pump is particularly comfortable for the user.
[0045] Specifically, it is proposed that the housing interacts with the cannula insertion mechanism in such a way that, by displacing two housing parts relative to each other, the cannula insertion mechanism is transitioned from its actuated state to a state in which it at least partially, and in particular completely, relieves the infusion cannula. Depending on the embodiment, and especially on the kinematics of the cannula insertion mechanism, this can involve radial or axial relief.
[0046] Furthermore, it can be advantageous if a displacement of the two housing parts returns the cannula insertion mechanism to its initial state, which has the advantage that the cannula insertion mechanism is already activated for the next use, particularly with a single movement. In principle, it is also conceivable that the cannula insertion mechanism first reaches an intermediate state, which is then preferably sufficient to move the infusion cannula out of the recipient's tissue. The final return to the initial state can then be achieved subsequently, optionally in another way, in particular by displacing the two housing parts relative to each other in a different direction, or by displacing two other housing parts, or one housing part and another housing part relative to each other.
[0047] In this context, it may be advantageous that the state in which the cannula insertion mechanism relieves the infusion cannula is the initial state of the cannula insertion mechanism, preferably that the cannula insertion mechanism completely relieves the infusion cannula in the initial state.
[0048] According to the previously described further development, it is possible that the state in which the cannula insertion mechanism relieves the infusion cannula is an intermediate state of the cannula insertion mechanism, preferably that the cannula insertion mechanism can be returned from the intermediate state to its initial state by a displacement of the two housing parts relative to each other in a different direction or of two other housing parts of the housing or of one of the housing parts and another housing part of the housing relative to each other.
[0049] An advantageous embodiment also includes a provision that, by transitioning the cannula insertion mechanism from its actuated state to the state in which the cannula insertion mechanism relieves the infusion cannula, in particular to its initial state, the infusion cannula, especially when it is inserted into the tissue of the infusion recipient, performs a return movement automatically or by force, in particular by spring force, by which the recipient-side end of the cannula is moved back from the insertion position to the initial position, in particular to the initial position.
[0050] Thus, to ensure that the recipient end of the cannula exits the tissue, the infusion cannula can automatically perform a return movement. Separate drives or mechanisms are not required for this. However, it is also conceivable that the infusion cannula could perform the return movement using a drive mechanism, particularly a spring drive.
[0051] According to a further development, it is possible that the cannula insertion mechanism has an insertion actuator, in particular a pivotable insertion lever, which is coupled or can be coupled to the infusion cannula in a force-transmitting manner and which is movable, in particular pivotable, between an initial position and an actuating position, and that the insertion actuator, when it is in its initial position, defines the initial state of the cannula insertion mechanism, and, when it is in its actuating position, defines the actuating state of the cannula insertion mechanism.
[0052] Furthermore, it may be provided that the insertion actuator is designed to apply stress to the infusion cannula when moving from its initial position, in particular to cause an elastic bending or pivoting of the infusion cannula, so that the recipient-side cannula end is moved from the initial position to the insertion position, in particular abruptly, and / or that the cannula insertion mechanism is returned from its actuated state to its initial state by moving the insertion actuator back from its actuated position to its initial position, and / or that the housing interacts with the insertion actuator in such a way that, by displacing the two housing parts relative to each other, the insertion actuator is moved from its actuated position to a position in which the insertion actuator at least partially, in particular completely, relieves the infusion cannula of stress.
[0053] These advantageous further developments of the infusion pump or the injection mechanism of the infusion pump concern an injection actuator, which is a particularly effective means of moving the infusion cannula into one and / or the other position.
[0054] According to a particular embodiment, it is possible that the displacement of the two housing parts relative to each other is or includes a, in particular linear, displacement of the two housing parts relative to each other, preferably that the displacement takes place with a directional component that runs parallel or orthogonal to the underside of the housing.
[0055] This clarifies the movement of the two housing parts relative to each other, which effects the adjustment of the cannula insertion mechanism. In this way, a sliding movement is particularly easy and intuitive to perform. According to an advantageous embodiment, the cannula insertion mechanism can be provided with a return element, the actuation of which returns the cannula insertion mechanism from its actuated state to the state in which the cannula insertion mechanism at least partially relieves the infusion cannula, in particular to its initial state; preferably, the return element is the insertion actuator or is coupled to it in a force-transmitting manner.
[0056] In particular, it can be advantageous if the actuation of the feedback element consists in the feedback element sliding along an inclined contact surface of a housing section of the housing, in particular a ramp-shaped housing section, when the two housing parts are moved relative to each other, whereby the feedback element is moved, in particular pivoted or shifted, preferably that the housing section with the inclined contact surface is fixed to one housing part and the feedback element is fixed to the other housing part.
[0057] These possible further developments concern a return element whose sliding along an inclined contact surface of a housing section, in particular a ramp-shaped housing section, causes the adjustment of the cannula insertion mechanism. The return element is preferably the insertion actuator itself, but can also be a separate element coupled to the insertion actuator in a force-transmitting manner, the movement of which the insertion actuator follows.
[0058] Furthermore, the infusion pump may be provided with two or more reservoir containers, each with an interior space which, in particular at least in one section, is designed to hold a fluid.
[0059] It is also advantageous to have a design in which the cannula arrangement may have two or more infusion cannulas, one of which is assigned to each of the reservoir containers, and, in particular, a cannula insertion mechanism for each infusion cannula.
[0060] Accordingly, the proposed infusion pump can have not just one, but two or more reservoirs. Similarly, it can also be equipped with two or more infusion cannulas and / or cannula insertion mechanisms. This allows for the simple administration of larger quantities of one fluid or different fluids.
[0061] Furthermore, it may be advantageous if the two housing parts are a disposable housing part and a reusable housing part, preferably that the reservoir container and the infusion cannula, in particular also the housing section with the inclined contact surface, are mounted on the disposable housing part, preferably forming a pre-assembled disposable unit, and / or that the cannula insertion mechanism and / or the insertion actuator, in particular also the return element and / or a drive source, in particular a drive motor, and optionally further drive elements, are mounted on the reusable housing part, preferably forming a pre-assembled reusable unit.
[0062] Furthermore, it may be provided that the reservoir container is permanently connected to the housing, in particular the disposable housing part, or forms a replaceable cartridge; preferably, that the reservoir container can be installed in a pre-filled state together with the disposable housing part as a pre-assembled unit, or that the replaceable cartridge can be installed in a pre-filled state.
[0063] It is therefore particularly advantageous if the housing is multi-part and includes one housing part on which disposable components (i.e., components not reused after the reservoir is emptied) are stored, and another housing part on which reusable components (i.e., components reusable after the reservoir is emptied) are arranged. This is advantageous from both an environmental and economic perspective, as it eliminates the need to dispose of the entire infusion pump after the reservoir has been emptied. In principle, it is even conceivable to design the reservoir as a replaceable cartridge, thus requiring only the reservoir, possibly along with the infusion cannula, adhesive patch, and / or traction device, to be replaced after use.
[0064] Furthermore, it may be provided that the infusion pump has a primary or secondary battery as an energy source, in particular a primary or secondary battery that can be removed individually, preferably that the energy source is part of the disposable unit.
[0065] It is also advantageous to have a design in which the infusion pump may have a user interface with a display and / or with a control unit which may have one or more buttons, preferably that the user interface is part of the reusable unit.
[0066] In connection with the cannula insertion mechanism s, a method for deactivating a portable infusion pump can also be mentioned, wherein the infusion pump has a reservoir container with a container interior which, in particular at least in one section, is designed to receive the fluid, wherein the infusion pump has a cannula arrangement with an infusion cannula and a cannula insertion mechanism, wherein the infusion cannula is fluidically connected to the container interior of the reservoir container via a container-side cannula end and the infusion cannula extends from the container-side cannula end along its axial extent to a receiver-side cannula end on which a cannula tip is formed, wherein the cannula insertion mechanism previously transitioned from an initial state in which, upon actuation, it subjected the infusion cannula to radial or axial load.so that the receiver-side cannula end has been moved from an initial position to an insertion position, has been brought into an actuation state, wherein the cannula insertion mechanism is returned from its actuation state to its initial state, and wherein the infusion pump has a multi-part housing for receiving the reservoir container and the cannula assembly.
[0067] It is essential that two housing parts of the housing are displaced relative to each other, thereby transferring the cannula insertion mechanism from its actuated state to a state in which the cannula insertion mechanism relieves the infusion cannula, radially or axially, at least partially, and in particular completely.
[0068] To better understand the invention, it is explained in more detail with reference to the following figures.
[0069] They each show, in a highly simplified, schematic representation:
[0070] Fig. 1 ... an infusion pump a) arranged on the upper arm of the infusion recipient, as well as b) in a perspective top view and c) in a perspective bottom view; Fig. 2 ... a perspective view of an infusion pump in the open state, divided into two housing parts, with corresponding functional components;
[0071] Fig. 3 ... the different states of the cannula arrangement and the disposable housing part, as well as the injection actuator and the reusable housing part;
[0072] It should be noted at the outset that in the differently described embodiments, identical parts are provided with the same reference numerals or component designations, and the disclosures contained in the entire description can be applied analogously to identical parts with the same reference numerals or component designations. Furthermore, the positional designations chosen in the description, such as top, bottom, side, etc., refer to the figure directly described and illustrated, and these positional designations must be applied analogously to the new position if the position changes.
[0073] The preferred embodiment of a dosing device 32, shown in Figures 1 to 3, relates to a portable infusion pump 1 for administering a defined quantity of a fluid, in particular an infusion solution. For the definition and areas of application of an infusion pump 1, reference is made to the introductory part of the description.
[0074] The infusion pump 1 has a reservoir container 2 with an interior space which, in particular at least in one section, is designed to receive the fluid.
[0075] Furthermore, the infusion pump 1 has a cannula arrangement 3 with an infusion cannula 4 and a cannula insertion mechanism 5.
[0076] The infusion cannula 4 is fluidically connected or connectable to the interior of the reservoir container 2 via a container-side cannula end 6 and extends from the container-side cannula end 6 along its axial extent to a receiver-side cannula end 7, on which a first cannula tip is formed.
[0077] The cannula insertion mechanism 5 can be transferred or moved from an initial state 8 to an actuation state 9 and is designed in such a way that, upon actuation from its initial state 8, it loads the infusion cannula 4, here radially, in particular causing an elastic bending or pivoting of the infusion cannula 4, so that the recipient-side cannula end 7 is moved from an initial position 10 to an insertion position 11, in particular abruptly.According to another embodiment, not shown here, the cannula insertion mechanism 5 may also be designed so that, upon actuation, it axially loads the infusion cannula 4 from its initial state 8, in particular by introducing a force into a beam or a spring rod, which in turn introduces an axial force into an axial section of the infusion cannula 4, so that the recipient-side cannula end 7 is moved from the initial position 10 to the insertion position 11, in particular abruptly. Although the following discussion will focus exclusively on the variant with radial loading, the corresponding explanations also apply to the variant with axial loading.
[0078] As shown in Fig. 1, the infusion pump 1 can be worn by an infusion recipient 12 on the body under clothing, in particular in the position fixed and / or glued position on the skin and is therefore portable regardless of location.
[0079] The administration of an infusion solution is intravenous and / or subcutaneous, and thus corresponds to the delivery of an infusion directly into the tissue of an infusion recipient 12, in particular into the human body.
[0080] As shown in Fig. 3a), the initial state 8 is the state of the cannula insertion mechanism 5 before its actuation, in which the infusion cannula 4 with its receiver-side cannula end 7 is still in the initial position 10 and, in particular, does not protrude from the infusion pump 1 otherwise.
[0081] In contrast, and as shown in Fig. 3b), the actuation state 9 is the state of the cannula insertion mechanism 5 after its actuation, in which the infusion cannula 4 with its receiver-side cannula end 7 is in the insertion position 11 and otherwise protrudes from the infusion pump 1.
[0082] Here, and preferably, the cannula insertion mechanism 5 can be returned from its actuated state 9 to its initial state 8, as can be seen from the combined view of Figures 3c) and 3d). Accordingly, after the infusion pump 1 has been used, when it is to be removed from the infusion recipient 12, the cannula insertion mechanism 5 can be returned from its actuated state 9 to its initial state 8 for the purpose of deactivating the infusion pump 1, i.e., to allow the withdrawal of the recipient-side cannula end 7 from the tissue of the infusion recipient 12.
[0083] The term "infusion cannula 4" used here refers to a tube, preferably made of plastic or metal, in particular a stainless steel alloy or a nickel-titanium alloy, which is either directly or via another interface connected to the reservoir container 2 at its first end, or is connected directly or via another interface to the reservoir container 2 only during the preparation of an infusion, for example, by piercing a septum. The second end of the tube is usually inserted directly into the body of the recipient 12 during subcutaneous infusion, or rather, inserted into their skin tissue. Here, and preferably, the infusion cannula 4 has an outer diameter of less than 500 µm, preferably less than 350 µm, and more preferably less than 300 µm.
[0084] Furthermore, and as can be seen from Fig. 2 and Fig. 3, the infusion pump 1 has a multi-part housing 13 for receiving the reservoir container 2 and the cannula arrangement 3.
[0085] It is essential that the housing 13 interacts with the cannula insertion mechanism 5 in such a way that, by displacing two housing parts 20, 23 of the housing 13 relative to each other, the cannula insertion mechanism 5 is moved from its actuated state 9 to a state in which the cannula insertion mechanism 5 relieves the infusion cannula 4, here radially, or alternatively, according to the alternative embodiment above, axially, at least partially, and in particular completely. Preferably, this displacement of the two housing parts 20, 23 relative to each other occurs in a disassembly movement in which the two housing parts 20, 23 are separated from each other and / or the housing 13 is opened.
[0086] The term "radial relief" used here means that in this state, the infusion cannula 4 is subjected to less radial stress by the cannula insertion mechanism 5 than in the actuated state 9, so that the cannula insertion mechanism 5 no longer holds the infusion cannula 4 in the insertion position 11 with its recipient-side cannula end 7 or blocks it from retracting. Correspondingly, "axial relief" means that in this state, the infusion cannula 4 is subjected to less axial stress by the cannula insertion mechanism 5 than in the actuated state 9. As can be seen from Fig. 3, because the radial stress by the cannula insertion mechanism 5 decreases, the infusion cannula 4 can then return to its position, in particular to the position, preferably automatically, in which the recipient-side cannula end 7 is again in the initial position 10.In particular, due to the decreasing, here radial, load, the infusion cannula 4 can return to a position in which the recipient-side cannula end 7 is at least largely retracted into the housing 13.
[0087] In this context, it should be emphasized that here, and preferably, the retraction of the infusion cannula 4 is directly accompanied by the retraction of the cannula insertion mechanism 5. The infusion cannula 4 thus follows the movement of the cannula insertion mechanism 5 directly. However, according to another embodiment not shown here, these two processes can also be separated. In this case, the cannula insertion mechanism 5 would be retracted, but the infusion cannula 4 would be moved back independently. The preferred case, however, is the one shown here, in which both processes coincide.
[0088] Here, and preferably, it is further provided that the state in which the cannula insertion mechanism 5 radially relieves the infusion cannula 4 is the initial state 8 of the cannula insertion mechanism 5, preferably that the cannula insertion mechanism 5 completely radially relieves the infusion cannula 4 in the initial state 8.
[0089] In the preferred state of complete radial relief shown in Fig. 3a), the infusion cannula 4 is no longer subjected to radial stress, or at least not to any significant stress, by the cannula insertion mechanism 5. This allows the infusion cannula 4 to return completely to its position where the recipient-side cannula end 7 is again in its initial position 10, and / or to a position where the recipient-side cannula end 7 is completely or almost completely retracted into the housing 13, i.e., no longer protrudes from it. This occurs automatically, but can alternatively be spring-driven or driven in some other way.
[0090] Here, and preferably, the cannula insertion mechanism 5 passes through an intermediate state in which it only partially relieves the radial pressure on the infusion cannula 4. Here, and preferably, the cannula insertion mechanism 5 is returned beyond the intermediate state to its initial state, whereby the infusion cannula 4 is also moved back accordingly.
[0091] In principle, it is also conceivable that the cannula insertion mechanism 5 can only be returned to the intermediate state and not to the initial state by the relative movement of the two housing parts 20, 23, wherein in this intermediate state the infusion cannula 4 is preferably no longer radially loaded by the cannula insertion mechanism 5 or at least no longer significantly loaded, so that the infusion cannula 4 can return completely to its position in which the recipient-side cannula end 7 is again in the initial position 10, and / or to a position in which the recipient-side cannula end 7 is completely retracted into the housing 13.
[0092] From the intermediate state, the cannula insertion mechanism 5 can then be returned to its initial state 8 by another measure, for example, another mechanism, in particular by displacing the two housing parts 20, 23 relative to each other in a different, preferably opposite, direction. Alternatively, it is also conceivable to displace two other housing parts of the housing 13 or one of the housing parts 20, 23 and another housing part of the housing 13 relative to each other in order to return the cannula insertion mechanism 5 from the intermediate state to the initial state 8. For the transition of the cannula insertion mechanism 5 from the intermediate state to the initial state 8, it is then preferably such that the displacement of the respective two housing parts 20, 23 relative to each other takes place in an assembly movement in which the two housing parts 20, 23 are connected to each other and / or the housing 13 is closed.Alternatively, this relocation can also take place in a disassembly movement, in which the two housing parts 20, 23 are separated from each other.
[0093] In the intermediate state under discussion here, the infusion cannula 4 is still subjected to radial stress, but no longer to such an extent that its recipient-side cannula end 7 would be held in the insertion position 11 or blocked. Not shown in Fig. 3c), but nevertheless conceivable, the recipient-side cannula end 7 is already completely retracted into the housing 13, i.e., it no longer protrudes from it.
[0094] As shown in Fig. 3d), it is preferably provided that by moving the cannula insertion mechanism 5 from its actuated state 9 to the state in which the cannula insertion mechanism 5 radially partially or completely relieves the infusion cannula 4, in particular to its initial state 8, the infusion cannula 4, especially when it is inserted into the tissue of the infusion recipient 12, automatically performs a return movement by which the recipient-side cannula end 7 is moved back from the insertion position 11 to the initial position 10, in particular to the initial position 10.
[0095] Not shown in the figures, as mentioned above, instead of an automatic return movement, it is also conceivable that the infusion cannula 4 performs a driven return movement, i.e., is moved back by a separate return mechanism, for example, a spring. However, the preferred case, and therefore also shown in Fig. 3, is the present case in which the infusion cannula 4 is mounted and designed in such a way that it can perform the return movement automatically.
[0096] For this purpose, the infusion cannula 4, particularly in a central cannula section, has a correspondingly high flexural strength and / or flexural stiffness.
[0097] The infusion cannula 4, between the cannula end 6 on the container side and the cannula end 7 on the recipient side, preferably has a central cannula section and at least one adjacent end cannula section, in particular a first end cannula section adjacent to the cannula end 7 on the recipient side and a second end cannula section adjacent to the cannula end 6 on the container side. Preferably, the cannula insertion mechanism 5 engages the central cannula section of the infusion cannula 4 when activated.
[0098] Here, and preferably, the central cannula section is reinforced to withstand the radial force exerted by the cannula insertion mechanism 5 in the actuated state 9. Accordingly, as shown in Figs. 3b) and c), the central cannula section is elastically deformable under the corresponding force exerted by the cannula insertion mechanism 5, but, as can be seen in Fig. 3d), returns to its original shape when the force is released.
[0099] The reinforcement described above is provided, as shown in Fig. 3, by a sheathing or material reinforcement of the central cannula section, thus ensuring increased flexural strength and / or flexural stiffness in this area of the infusion cannula 4.
[0100] Furthermore, it is preferably provided that the cannula insertion mechanism 5 has an insertion actuator 14, in particular a pivotable insertion lever 15, which is coupled or can be coupled to the infusion cannula 4 in a force-transmitting manner and which is movable, in particular pivotable, between an initial position 16 and an actuating position 17, and that the insertion actuator 14, when it is in its initial position 16, defines the initial state 8 of the cannula insertion mechanism 5, and, when it is in its actuating position 17, defines the actuating state 9 of the cannula insertion mechanism 5.
[0101] As shown in Fig. 3, and preferably, the force of the injection actuator 14 is applied to the infusion cannula 4 in the form of a pivotably mounted injection lever 15. Alternatively, but not shown here, the force of the injection actuator 14 can also be applied to the infusion cannula 4 in the form of a linearly movable injection part.
[0102] In the initial state 8 of the cannula insertion mechanism 5, the insertion actuator 14 is in its initial position 16, as can be seen in Figs. 3a) and d), and in the actuated state 9 of the cannula insertion mechanism 5, the insertion actuator 14 is thus in its actuated position 17, as shown in Figs. 3b) and c).
[0103] The proposed sequence of the insertion process of the infusion cannula 4 into the tissue of the infusion recipient 12 is shown in Fig. 3 a) and b).
[0104] The injection actuator 14, here the injection lever 15, is initially mechanically locked in its initial position 16 in a pre-tensioned, in particular spring-tensioned, state against movement towards its actuating position 17. This locking is provided by a locking device, which can be triggered, in particular, mechanically or electrically. The locking device therefore includes a locking cam 18, as shown in Fig. 3, which is preferred in this respect.
[0105] As can be seen from Fig. 3a), the locking cam 18, in its detent position, prevents the injection lever 15 from pivoting towards its actuation position 17. If the locking cam 18 leaves the pivoting range of the injection lever 15, as shown in Fig. 3b), it releases the pre-tensioned injection lever 15, so that the injection lever 15 springs forward due to its pre-tension and radially loads the infusion cannula 4, in particular abruptly, so that the recipient-side cannula end 7 is again moved from the initial position 10 to the insertion position 11, in particular abruptly.
[0106] The preload is provided here, and preferably as shown in Fig. 3, by a spring element designed as a torsion spring. Not shown, but nevertheless alternatively preferred, the spring element can also be designed as a compression or tension spring.
[0107] Furthermore, the locking device, not shown in detail here, has in particular a mechanical pull element which extends from the housing 13 of the infusion pump 1 and is designed for manual actuation of the locking cam 18.
[0108] Not shown, but alternatively preferred, the relocation of the locking cam 18 from the detent position to the release position can be effected, in particular, electromechanically. The locking device also includes an associated actuator.
[0109] The injection actuator 14, here the injection lever 15, can be designed as a multi-part assembly, in particular with two arms running in parallel planes, wherein one part or arm interacts with the locking device and the other part or arm interacts with the infusion cannula 4 as described.
[0110] Furthermore, it is preferably provided that the insertion actuator 14 is designed to radially load the infusion cannula 4 from its initial position 16 during its movement, in particular to cause an elastic bending or pivoting of the infusion cannula 4, so that the recipient-side cannula end 7 is moved from the initial position 10 to the insertion position 11, in particular abruptly.
[0111] Additionally or alternatively, as shown here, it can be provided that the cannula injection mechanism 5 is returned from its actuated state 9 to its initial state 8 by moving the injection actuator 14 from its actuated position 17 back to its initial position 16.
[0112] It can also be provided additionally or alternatively, as here, that the housing 13 interacts with the injection actuator 14 in such a way that, by displacing the two housing parts 20, 23 of the housing 13 relative to each other, the injection actuator 14 is moved from its actuating position 17 into a position in which the injection actuator 14 relieves the infusion cannula 4 radially at least partially, in particular completely.
[0113] Here, and preferably, the position in which the injection actuator 14 radially relieves the infusion cannula 4 is the starting position of the injection actuator 14, wherein preferably the injection actuator 14 completely radially relieves the infusion cannula 4 in the starting position.
[0114] In principle, it is also conceivable that the insertion actuator 14 can only be returned to an intermediate position, corresponding to the intermediate state of the cannula insertion mechanism 5, and not to the initial position, by the relative movement of the two housing parts 20, 23, wherein in this intermediate position the infusion cannula 4 is preferably no longer subjected to radial stress by the insertion actuator 14, or at least no longer subjected to any significant stress, so that the infusion cannula 4 can return completely to its position in which the recipient-side cannula end 7 is again in the initial position 10, and / or to a position in which the recipient-side cannula end 7 is completely retracted into the housing 13.
[0115] From the intermediate position, the injection actuator 14 can then be returned to its initial position by another measure, for example, another mechanism, in particular by the aforementioned displacement of the two housing parts 20, 23 relative to each other in a different, preferably opposite, direction. Alternatively, as mentioned, a displacement of two other housing parts of the housing 13 or of one of the housing parts 20, 23 and another housing part of the housing 13 relative to each other is also conceivable in order to return the injection actuator 14 from the intermediate position to the initial position.
[0116] The displacement of the two housing parts 20, 23 relative to each other is, or preferably comprises, a linear displacement of the two housing parts 20, 23 relative to each other, preferably with a directional component that runs parallel or orthogonal to the underside of the housing. Preferably, the displacement occurs exactly parallel to or at a very acute angle to the underside of the housing, as shown here, or, according to another embodiment not shown here, exactly orthogonal to the underside of the housing. In Fig. 2, the two housing parts 20, 23 are shown, in particular their preferred relative fit and position relative to each other. As can be seen from Fig. 3, the displacement of the two housing parts 20, 23 relative to each other is, as shown, a linear displacement of the two housing parts 20, 23 relative to each other.The term encompasses means that during the relocation, the movement of the two housing parts 20, 23 relative to each other can consist of several successive partial movements, one of which is a linear sliding movement.
[0117] A displacement of the housing parts 20, 23 at a very acute angle to the underside of the housing, i.e. the side of the lower housing part 20 which is facing the infusion receiver 12 in the intended state of the infusion pump 1, preferably means an angle to the underside of the housing which is less than 30°, preferably less than 20° and further preferably less than 10°.
[0118] As shown in Fig. 3, the displacement therefore preferably takes place along a direction that is orthogonal or almost orthogonal to the insertion direction, i.e. the direction of movement of the recipient-side cannula end 7.
[0119] As further shown in Fig. 3, it is preferably provided that the cannula insertion mechanism 5 has a return element 19, by actuation of which the cannula insertion mechanism 5 is transferred from its actuated state 9 to the state in which the cannula insertion mechanism 5 radially at least partially relieves the infusion cannula 4, in particular to its initial state 8. As already explained, the return element 19 is preferably the insertion actuator 14 itself, but can also be coupled to it as a separate force-transmitting element.
[0120] The return element 19 is the component of the cannula insertion mechanism 5 that is adjusted by the relative movement of the two housing parts 20, 23 such that the cannula insertion mechanism 5 is returned. Here, and preferably, this component is the insertion actuator 14. This actuator thus performs a dual function: firstly, the insertion of the infusion cannula 4, and secondly, the return of the cannula insertion mechanism 5. In this context, "force-transmitting coupling" means that the return element 19 can also be a separate element from the insertion actuator 14, for example, a separate arm, and can be integrally formed with the insertion actuator 14 or connected to it by a form-fit, force-fit, and / or material-fit connection. With this in mind, as shown in Fig.Figure 3 shows, and it is preferably provided that the actuation of the feedback element 19, here of the injection actuator 14, consists in the feedback element 19 sliding along an inclined contact surface 21 of a housing section 22 of the housing 13, in particular a ramp-shaped housing section 22, when the two housing parts 20, 23 are moved relative to each other, whereby the feedback element 19 is moved, in particular pivoted or shifted, preferably that the housing section 22 with the inclined contact surface 21 is fixedly arranged on one housing part 20 and the feedback element 19 on the other housing part 23.
[0121] The respective housing-mounted arrangement can be seen in Fig. 3. The housing section 22 with the inclined contact surface 21 is arranged on the lower housing part 20, here preferably as an injection-molded web, and the return element 19 is arranged on the upper housing part 23, here preferably as a pivotable lever.
[0122] The movement of the two housing parts 20, 23 along a first direction of movement, as shown in Fig. 3, thus causes a movement of the return element 19, in particular of the injection actuator 14, or a part thereof, in a direction different from that, here in a pivoting direction about a geometric axis x of the return element 19, in particular of the injection actuator 14.
[0123] As shown in Fig. 3, and thus preferred, the return element 19 is the injection actuator 14. In the embodiment presented here, the injection actuator 14 therefore slides along the inclined contact surface 21 when the two housing parts 20, 23 are moved relative to each other, whereby the injection actuator 14, or the injection lever 15, moves back from its actuating position 17 to its initial position 16.
[0124] Not shown, but equally conceivable and preferred, is the return element 19 coupled to the injection actuator 14 in a force-transmitting manner. In this alternative embodiment, the separate return element 19 slides along the inclined contact surface 21 when the two housing parts 20, 23 are displaced relative to each other, causing it to displace and transmit its movement to the injection actuator 14, so that the injection actuator 14 moves back from its actuated position 17 to its initial position 16.
[0125] As already mentioned in the introduction, the infusion pump 1 has, preferably, two or more reservoir containers 2, each with an interior space which, particularly at least in one section, is designed to hold a fluid. Figure 2 below shows two reservoir containers 2.
[0126] If these fluids contain different fluids, in this case two different fluids, as also proposed, the infusion pump 1 can be set up to deliver these fluids to the infusion receiver 12 simultaneously or independently of each other by appropriately controlling the drive source 24.
[0127] In this context, "Ansteuem" always refers to an actuation initiated by a control unit of the infusion pump 1.
[0128] Furthermore, and preferably, the cannula arrangement 3 comprises two or more infusion cannulas 4, each of which is assigned to one of the reservoir containers 2. The infusion cannulas 4 can all be configured as proposed. Furthermore, the infusion pump 1 preferably has a cannula insertion mechanism 5 for each infusion cannula 4. By appropriately controlling the multiple cannula insertion mechanisms 5, in particular the multiple locking devices or the multiple sperm moi 18, it is then possible to insert first one and then the other infusion cannula 4 into the tissue of the infusion recipient 12 in a single insertion event. Alternatively or additionally, it is also conceivable that the multiple cannula insertion mechanisms 5, in particular the multiple locking devices or sperm moi 18, can be controlled by the multiple cannula insertion mechanisms 5.the multiple sperm moi 18 can be controlled in such a way that several or all can be actuated simultaneously and thus several or all infusion cannulas 4 can be inserted simultaneously into the tissue of the infusion recipient 12.
[0129] In principle, according to another embodiment not shown here, it is also conceivable that a common cannula insertion mechanism 5 is provided for several or all infusion cannulas 4. This would make it possible to insert these infusion cannulas 4 simultaneously into the tissue of the infusion recipient 12 by activating the common cannula insertion mechanism 5.
[0130] The multiple infusion cannulas 4 and reservoir containers 2 are particularly important with regard to the aforementioned possible administration of at least two different fluids, as this prevents the fluids from mixing in a common infusion cannula 4 before being administered to the recipient 12, thus ensuring that the fluids are delivered separately into the recipient's tissue 12. It is also conceivable to provide one and the same fluid in multiple reservoir containers 2, thereby achieving a seamless delivery of this fluid into the recipient's tissue 12 over a longer period.In both cases, it is conceivable that initially only one infusion cannula 4 is inserted and the associated reservoir container 2 is at least partially emptied, and the fluid is introduced into the tissue of the infusion recipient 12, before another infusion cannula 4 is inserted and its associated reservoir container 2 is at least partially emptied, and the fluid is introduced into the tissue of the infusion recipient 12. Alternatively, several infusion cannulas 4 can be inserted from the outset, and the reservoir containers 2 are emptied one after the other, at least partially, and the fluid is introduced into the tissue of the infusion recipient 12.
[0131] It is therefore the case that either a common cannula insertion mechanism 5 is provided, or, here and preferably, two or more cannula insertion mechanisms 5 are provided, namely preferably one for each infusion cannula 4, which preferably all interact with the housing 13 in such a way that, by a displacement of the two housing parts 20, 23 relative to each other, the cannula insertion mechanisms 5 are, preferably simultaneously, transferred from their actuated state 9 into the state in which the respective cannula insertion mechanism 5 radially relieves the associated infusion cannula 4.
[0132] In the latter case, several cannula insertion mechanisms 5 can be returned from their actuation state 9 towards the initial state 8 with only one relative movement of the two housing parts 20, 23 to each other, regardless of whether a parallel or sequential insertion of the infusion cannula 4 into the tissue of the infusion recipient 12 is possible.
[0133] As shown in Fig. 2 and Fig. 3, it is here and preferably further provided that the two housing parts 20, 23 are a disposable housing part 20 and a reusable housing part 23.
[0134] The disposable housing part 20 preferably houses the reservoir container 2 and the infusion cannula 4, and in particular also the housing section 22 with the inclined contact surface 21, which preferably together form a pre-assembled disposable unit 25. Preferably, a further power supply device, for example, a secondary battery that is particularly removable, is also part of the disposable unit 25, which is preferably stored in a battery compartment and can thus be separated from the disposable unit 25 for recycling. Furthermore, the disposable unit 25 includes, for example, an adhesive patch for attaching the infusion pump 1 to the body. The disposable unit 25 preferably consists of no more than 15 components (individual parts).
[0135] Additionally or alternatively, as shown here, the cannula insertion mechanism 5 and / or the insertion actuator 14, in particular also the return element 19 and / or a drive source 24, in particular a drive motor, and optionally further drive elements, are mounted on the reusable housing part 23, which preferably together form a pre-assembled reusable unit 26. Preferably, electronic components, in particular control components, a power supply device 28, in particular a rechargeable power supply device 28, a user interface 29 with a display 30 and / or with an operating unit 31, which may have one or more buttons, are also part of the reusable unit 26 and are mounted here on the reusable housing part 23.
[0136] The Display 30 is an example of a display that does not require a constant power supply, such as an ePaper or Memory in Pixel Display.
[0137] As can be seen in Fig. 2, the disposable housing part 20 is the housing part facing the user during use. After its intended use, this part is removed from the body, separated from the reusable housing part 23, and then disposed of.
[0138] The reusable housing part 23 shown in Fig. 2 above is, as described above, separated from the disposable housing part 20 after its intended use and can then be placed back onto a new, unused disposable housing part 20, since the reusable components stored on it are reusable.
[0139] Fig. 1a) shows the practical arrangement of the portable infusion pump 1, for example, on the upper arm of the infusion recipient 12. The housing 13 can be fixed or glued to the skin.
[0140] Fig. 2 shows that the reservoir container 2 is fluidically connected to the infusion cannula 4.
[0141] In the production of the mechanical connection between the two housing parts 20, 23 shown in Fig. 2, in addition to any positive locking, at least a force-fit connection is created, which on the one hand ensures the coupling from the drive source 24 to the reservoir container 2, in particular to a metering piston of the reservoir container 2, and on the other hand also ensures, if necessary, a desired electrical connection between electrical contacts 27.
[0142] Furthermore, it is preferably provided that the reservoir container 2 is inseparably connected to the housing 13, in particular the disposable housing part 20, or forms a replaceable cartridge; preferably, that the reservoir container 2 can be installed in a pre-filled state together with the disposable housing part 20 as a pre-assembled unit, or that the replaceable cartridge can be installed in a pre-filled state.
[0143] In this context, the term "indissoluble" refers to a connection between reservoir container 2 and housing 13, in particular the disposable housing part 20, that cannot be separated without destruction. The "pre-filled state" here means that the reservoir container 2 is already filled with infusion solution before its intended first use.
[0144] Finally, a method for deactivating an infusion pump 1 is also worth mentioning, wherein the infusion pump 1 is designed for administering a defined quantity of a fluid, in particular an infusion solution. The infusion pump 1 has a reservoir container 2 with an interior space which, in particular at least in one section, is designed to receive the fluid, and a cannula assembly 3 with an infusion cannula 4 and a cannula insertion mechanism 5, wherein the infusion cannula 4 is fluidically connected to the interior space of the reservoir container 2 via a container-side cannula end 6, and the infusion cannula 4 extends from the container-side cannula end 6 along its axial extent to a receiver-side cannula end 7, on which a cannula tip is formed, wherein the cannula insertion mechanism 5 is previously from an initial state 8 in which, upon actuation, it inserts the infusion cannula 4.radially or axially, loaded, such that the recipient-side cannula end 7 has been moved from an initial position 10 to an insertion position 11, has been brought into an actuation state 9, wherein the cannula insertion mechanism 5 is returned from its actuation state 9 to its initial state 8, and wherein the infusion pump 1 has a multi-part housing 13 for receiving the reservoir container 2 and the cannula assembly 3. In this context, the term deactivation means bringing the infusion pump 1 into a state in which the recipient-side cannula end 7 is at least largely retracted into the housing 13 and the infusion pump 1 can be removed from the infusion receiver 12.
[0145] The essential point here is that two housing parts 20, 23 of the housing 13 are displaced relative to each other and thereby the cannula insertion mechanism 5 is transferred from its actuation state 9 to a state in which the cannula insertion mechanism 5 relieves the infusion cannula 4, here radially, at least partially, in particular completely.
[0146] The exemplary embodiments show possible embodiment variants, whereby it should be noted at this point that the invention is not limited to the specifically illustrated embodiment variants, but rather various combinations of the individual embodiment variants are also possible and this possibility of variation lies within the skill of the person skilled in this technical field due to the teaching on technical action by the present invention.
[0147] The scope of protection is defined by the claims. However, the description and drawings must be consulted for the interpretation of the claims. Individual features or combinations of features from the different embodiments shown and described can, in themselves, represent independent inventive solutions. The problem underlying these independent inventive solutions can be found in the description.
[0148] All references to value ranges in this description are to be understood as encompassing any and all sub-ranges thereof, e.g., the reference 1 to 10 is to be understood as including all sub-ranges, starting from the lower limit 1 and the upper limit 10, i.e., all sub-ranges begin with a lower limit of 1 or greater and end with an upper limit of 10 or less, e.g., 1 to 1.7, or 3.2 to 8.1, or 5.5 to 10.
[0149] Finally, for the sake of clarity, it should be noted that, for better understanding of the structure, some elements have been shown not to scale and / or enlarged and / or reduced in size. Reference symbol list
[0150] Infusion pump 32 Dosing device Reservoir container
[0151] Cannula arrangement
[0152] Infusion cannula
[0153] Cannula insertion mechanism
[0154] Container-side cannula end
[0155] Recipient-side cannula end
[0156] Initial state
[0157] Actuation state
[0158] Initial position
[0159] insertion position
[0160] Infusion recipient
[0161] Housing
[0162] Injection actuator
[0163] firing lever
[0164] Starting position
[0165] Actuation position
[0166] Locking cam
[0167] Return element
[0168] Lower housing part
[0169] Site area
[0170] Housing section
[0171] Upper housing part
[0172] source of power
[0173] Disposable unit
[0174] Reusable unit
[0175] Electrical contact
[0176] Power supply device
[0177] User interface
[0178] Display
[0179] Control unit
Claims
- 35 - Patent claims 1. Dosing device (32), in particular an infusion pump (1), for preferably subcutaneous administration of a fluid, comprising a housing (13), a reservoir container (2) with an interior space for receiving the fluid and a cannula arrangement (3), - wherein the housing (13) is multi-part and comprises a first housing part (20) and a second housing part (23), - wherein the cannula arrangement (3) comprises a cannula insertion mechanism (5) and an infusion cannula (4) with a container-side cannula end (6) and a receiver-side cannula end (7) on which a cannula tip is formed, - wherein the infusion cannula (4) is fluidically coupled to the interior of the container at its container-side cannula end (6), in particular fluidically coupled, - wherein a state of the cannula insertion mechanism (5) can be shifted or changed between an initial state (8) and an actuation state (9), - wherein the cannula insertion mechanism (5) is operatively connected to the infusion cannula (4) when it is moved into the actuated state (9) or in the actuated state (9) such that the recipient-side cannula end (7) can be moved from an initial position (10) to an insertion position (11), in particular by an elastic bending of the infusion cannula (4) and / or a pivoting of the recipient-side cannula end (7), specifically can be moved abruptly, or is moved, so that the fluid can be administered subcutaneously via the cannula tip by means of the metering device (32) and through the recipient-side cannula end (7) of the infusion cannula (4) moved into the insertion position (11), - wherein a first group of components of the dosing device (32) are coupled to the first housing part (20) and a second group of components of the dosing device (32) are coupled to the second housing part (23) in a housing-fixed manner or are each formed as a section of the housing (13), characterized by the fact that Components of the first group are operatively connected to components of the second group when the housing parts (20, 23) are displaced relative to each other, in particular when the housing parts (20, 23) are brought together to produce an assembled state of the dosing device (32) by an assembly movement or when the dosing device (32) is disassembled.- 36 - 2.Metering device (32) according to claim 1, characterized in that the reservoir container (2) is designed in a hollow cylindrical or hollow ovoid shape with a first longitudinal extension along a central axis of the reservoir container (2), wherein the housing (13) has a second longitudinal extension, wherein the second longitudinal extension is aligned along the first longitudinal extension or substantially parallel to the first longitudinal extension, wherein the second longitudinal extension is aligned with a longitudinal axis of a Cartesian coordinate system and the metering device does not have a longer longitudinal extension in the direction of a transverse axis or in the direction of a normal axis of the Cartesian coordinate system than the second longitudinal extension.
3. Dosing device (32) according to claim 2, characterized in that the reservoir container (2) can be inserted or installed into the housing (13) substantially along the second longitudinal extent of the housing (13).
4. Dosing device (32) according to one of claims 2 or 3, characterized in that the assembly movement for producing an assembled state of the dosing device (32) comprises a movement vector for bringing together the housing parts (20, 23) with a substantial portion parallel to the second longitudinal extent of the housing (13).
5. Dosing device (32) according to one of the preceding claims, characterized in that the cannula insertion mechanism (5) is operatively connected with its complementary housing part of the housing (13), wherein the state of the cannula insertion mechanism (5) can be changed when the housing parts (20, 23) are displaced relative to each other.
6. Dosing device (32) according to claim 5, characterized in that the housing (13) interacts with the cannula insertion mechanism (5) in such a way that the cannula insertion mechanism (5) can be brought from its actuated state (9) into a state in which the receiver-side cannula end (7) is not displaced from the cannula insertion mechanism (5) by a displacement of the housing parts (20, 23) relative to each other.
7. Dosing device according to claim 5 or 6, characterized in that the infusion cannula (4) performs a return movement automatically or by force, in particular by spring force, by moving the cannula insertion mechanism (5) from its actuated state (9), by which the recipient-side cannula end (7) can be moved back from the insertion position (11) to the initial position (10), in particular to the initial position (10).
8. Dosing device (32) according to one of the preceding claims, characterized in that the cannula insertion mechanism (5) can be moved to the initial state (8) when the housing parts (20, 23) are moved relative to each other and when the housing (13) of the dosing device (32) is moved to an assembled state, wherein the cannula insertion mechanism (5) is ineffective in the initial state (8) with respect to the infusion cannula (4).
9. Dosing device (32) according to one of the preceding claims, characterized in that the cannula insertion mechanism (5) comprises an insertion device, in particular an insertion actuator (14) or a pivotable insertion lever (15), which is coupled or can be coupled to the infusion cannula (4) in a force-transmitting manner and which is displaceable, in particular pivotable, between a starting position (16) and an actuating position (17), wherein the insertion device can be controlled electrically or mechanically.
10. Dosing device (32) according to claim 9, characterized in that the injection device is designed as an injection actuator (14), wherein the infusion cannula (4) can be displaced from its initial position (16) by means of the injection actuator (14) and during its movement to the insertion position (11), in particular by elastic bending and / or by pivoting the infusion cannula (4) in the direction of the insertion position (11), so that the recipient-side cannula end (7) can be displaced from the initial position (10) to the insertion position (11), in particular abruptly, and / or, that the cannula insertion mechanism (5) can be returned from its actuated state (9) to its initial state (8) by the insertion actuator (14) being able to be moved back from its actuated position (17) to its initial position (16), and / or that the housing (13) is designed to interact with the insertion actuator (14) in such a way that by a displacement of the two housing parts (20, 23) of the housing (13) relative to each other the insertion actuator (14) can be moved from its actuated position (17) to a position in which the infusion cannula (4) is at least partially, in particular completely, relieved of pressure from the insertion actuator (14).
11. Metering device (32) according to one of the preceding claims, characterized in that the displacement of the two housing parts (20, 23) relative to each other is or comprises a, in particular linear, displacement of the two housing parts (20, 23) relative to each other, preferably that the displacement comprises a directional component which runs parallel or orthogonal to the underside of the housing.
12. Dosing device (32) according to one of the preceding claims, characterized in that the cannula insertion mechanism (5) comprises a return element (19) by actuation of which the cannula insertion mechanism (5) can be displaced from its actuated state (9), in particular into its initial state (8), wherein the return element (19) slides along an inclined contact surface (21) of a housing section (22) of the housing (13), in particular a ramp-shaped housing section (22), when the two housing parts (20, 23) are displaced relative to each other, thereby displacing the return element (19), in particular pivoting or shifting it, preferably that the housing section (22) with the inclined contact surface (21) is fixedly arranged on one housing part (20) and the return element (19) on the other housing part (23).
13. Dosing device (32) according to one of the preceding claims, characterized in that the container-side cannula end (6) can be coupled to the container interior or to the reservoir container by the assembly movement, in particular by moving the two housing parts (20, 23) relative to each other.
14. Dosing device (32) according to one of the preceding claims, characterized in that the two housing parts (20, 23) are designed as a disposable housing part (20) and as a reusable housing part (23), preferably that the reservoir container (2) and the infusion cannula (4), in particular also the housing section (22) with the inclined contact surface (21), are mounted on the disposable housing part (20), which preferably together form a pre-assembled disposable unit (25), and / or that the cannula insertion mechanism (5) and / or the insertion device, in particular also the return element (19) and / or a drive source (24), in particular a drive motor, and optionally further drive elements, are mounted on the reusable housing part (23), which preferably together form a pre-assembled reusable unit (26).
15. Dosing device (32) according to one of the preceding claims, characterized in that the reservoir container (2) is permanently connected to the housing (13), in particular the disposable housing part (20), in particular without tools and / or without force, or forms a replaceable cartridge, preferably that the reservoir container (2) can be installed in a pre-filled state together with the disposable housing part (20) as a pre-assembled unit or the replaceable cartridge can be installed in a pre-filled state.
16. Dispensing device (32) according to one of the preceding claims, characterized in that the two housing parts (20, 23) are designed as a disposable housing part (20) and as a reusable housing part (23), wherein the reusable housing part (23) comprises a power supply device (28), in particular a rechargeable power supply device (28), and a display (30), wherein the disposable housing part (20) comprises a further power supply device, in particular a battery, wherein the power supply device (28) can be electrically coupled when moving housing parts (20, 23) into the assembled state of the dispensing device (32) and / or is electrically coupled in the assembled state of the dispensing device (32), so that the power supply device (28) can be recharged by means of the further power supply device.
17. Dosing device (32) according to one of the preceding claims, characterized in that the dosing device (32) comprises a user interface (29) with a display (30) and / or with an operating unit (31) having one or more buttons, preferably that the user interface (29) is part of the reusable unit (26).