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WO2025078373A1 - Dispositif de dosage comprenant un piston doseur et des moyens de poussée ou de traction qui sont fonctionnellement reliés à celui-ci - Google Patents

Dispositif de dosage comprenant un piston doseur et des moyens de poussée ou de traction qui sont fonctionnellement reliés à celui-ci Download PDF

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Publication number
WO2025078373A1
WO2025078373A1 PCT/EP2024/078281 EP2024078281W WO2025078373A1 WO 2025078373 A1 WO2025078373 A1 WO 2025078373A1 EP 2024078281 W EP2024078281 W EP 2024078281W WO 2025078373 A1 WO2025078373 A1 WO 2025078373A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
housing part
drive
infusion
dosing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/078281
Other languages
German (de)
English (en)
Inventor
Thomas Bragagna
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tripenso Ag
Original Assignee
Tripenso Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE102023127532.1A external-priority patent/DE102023127532A1/de
Priority claimed from DE102023127528.3A external-priority patent/DE102023127528A1/de
Application filed by Tripenso Ag filed Critical Tripenso Ag
Publication of WO2025078373A1 publication Critical patent/WO2025078373A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M2005/14573—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for quick connection/disconnection with a driving system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

Definitions

  • the invention relates to a dosing device, in particular an infusion pump for administering a defined amount of a fluid, in particular an infusion solution.
  • Portable infusion pumps also known as patch pumps, which are the subject of the proposed solution presented below, are usually worn attached to the body and deliver a specific amount of an infusion solution into the human body within a specific time, continuously or via a predefined volume-time profile, either subcutaneously or intravenously, in order to achieve a desired concentration and thus a corresponding effect in the human body.
  • the spectrum of such fluids, especially infusion solutions ranges from low- to high-viscosity, from simple low-molecular-weight substances with a molecular size of just a few Daltons to high-molecular-weight substances with a molecular size of up to 1,000,000 Daltons.
  • the cable is led out of the front of the reservoir container, is then deflected, guided outside next to the reservoir container to its rear side, and there, after being deflected again, is led back into the reservoir container, where the cable is attached to the dosing piston at its second end in the rear section of the reservoir container.
  • a spindle nut that can be moved linearly on a spindle is drive-coupled to the cable section that runs outside next to the reservoir container as a further train component. The spindle is in turn driven in rotation by the drive source.
  • infusion cannula is fluidically coupled or can be coupled to the front section of the container interior
  • the drive train comprises a pressure or traction means coupled to the dosing piston
  • the dosing device can be brought into a functional state, in particular exclusively, by an assembly movement of the dosing device by assembling the first housing part with the second housing part.
  • a first surface of the opening with the counter thread and a second surface of the fine-thread spindle with the thread to have a material or material pairing and/or thread shape that seals the container interior against the rear section of the reservoir container.
  • the pressure or tension means is strand-shaped, rope-shaped or thread-shaped, with a longitudinal extent which is a multiple of a transverse extent of the pressure or tension means, wherein the in particular strand-shaped pressure or tension means is designed as a filament and predominantly from a first material, from a first material series comprising PTFE, PEEK, fluoropolymers, Kevlar, aramid, ultra-high molecular weight polyethylene (UHMWPE) such as Dyneema or Spectra, nylon, polypropylene PP, cyclic olefin polymers COP, cyclic olefin copolymers COC, blends thereof and metal.
  • UHMWPE ultra-high molecular weight polyethylene
  • the proposed material selection for the filament advantageously ensures that a surface of the filament wetted by the fluid, particularly insulin, prevents fibrillation or folding of peptide or protein molecules. Hydrophobic materials tend to be less suitable for this purpose. This naturally also affects the material selection for the reservoir container, the dosing piston, any seals, or other fluid-wetted or wettable components of the dosing device.
  • the selected average diameter of the filament in conjunction with the choice of material or, in particular, with the specific design of the filament, for example, as a core-sheath construction requires that the pressure or tension means, i.e. the filament, is stable in tension and pressure within the intended limits to ensure safe, particularly patient-safe, operation of the dosing device.
  • the pressure or tension means prefferably be designed in the form of a fabric band with a longitudinal extent which is a multiple of a height extent and a width extent of the pressure or tension means, wherein the pressure or tension means is predominantly made of a first material from a first material list comprising PTFE, PEEK, fluoropolymers, Kevlar, aramid, ultra-high molecular weight polyethylene (UHMWPE) such as Dyneema or Spectra, nylon, polypropylene PP, cyclic olefin polymers COP, cyclic olefin copolymers COC and blends thereof.
  • a first material list comprising PTFE, PEEK, fluoropolymers, Kevlar, aramid, ultra-high molecular weight polyethylene (UHMWPE) such as Dyneema or Spectra, nylon, polypropylene PP, cyclic olefin polymers COP, cyclic olefin copo
  • UHMWPE which belongs to the polyethylene (PE) group
  • PEs with similar properties can also be used.
  • nylon which belongs to the polyamide (PA) group
  • PAs with similar properties can also be used.
  • a pressure generating device to be arranged in the rear section of the reservoir container, by means of which the dosing piston can be displaced in the feed direction, and for the pressure or tension means to be designed in operative connection with the drive source as a retaining device against the dosing piston striving in the feed direction by means of the pressure generating device, wherein the drive source is designed for the step-by-step release of the pressure or tension means in the feed direction.
  • the pressure generating device is, for example, a hydrogen-producing button cell or a spring-loaded piston, so that the dosing piston strives in the feed direction by means of the pressure generating device.
  • the pressure or tension means is designed as a filament according to previous exemplary embodiments, wherein the filament is designed to retain the dosing piston and is operatively connected to the drive source for the step-by-step release of the filament in the feed direction.
  • the drive source can also be, for example, a mechanical balance anchor with step-by-step release of the feed via a gear. This achieves a controlled feed while simultaneously achieving a space-saving design of the dosing device.
  • the pressure or tension means is fixed in position at a first end on the reservoir container, is guided along a longitudinal extension of the pressure or tension means through the container interior and is sealed by an opening through the dosing piston, wherein the drive element, and in particular also the drive source, is designed as a component of a plunger in the rear section of the container interior and immediately adjacent to the dosing piston, so that the dosing piston can be moved in the feed direction by means of the plunger during operation of the drive source by rotating the drive element along the pressure or tension means.
  • the pressure or tension means is fixed in position at a first end on the dosing piston, is guided along a longitudinal extension of the pressure or tension means through the container interior and sealed by a pressure or tension means passage opening of the reservoir container, and that the drive element is directly coupled or can be directly coupled in terms of drive technology to a section of the pressure or tension means led out of the reservoir container in operative connection with a deflection body, wherein the drive element is coupled or can be coupled to the pressure or tension means in particular as a knurled drive and the deflection body is designed as a counter bearing for the coupling, so that a force in the feed direction can be introduced onto the dosing piston by means of the pressure or tension means during operation of the drive source.
  • the dosing device comprises a cannula propulsion mechanism, wherein a reservoir container-side end of the infusion cannula is Cannula propulsion mechanism can be moved from an initial position, in which the infusion cannula is arranged completely outside the interior of the reservoir container, into a puncture position, in which the reservoir container-side end protrudes into the interior of the container, so that the infusion cannula is fluidically coupled to the interior of the container in the puncture position.
  • the cannula propulsion mechanism prefferably be actuated by the assembly movement, so that the reservoir container-side end of the infusion cannula can be moved into the insertion position by the assembly movement.
  • the reservoir container-side end can be displaced into the puncture position by elastic deformation of the infusion cannula, in particular by elastic deformation of a central cannula section, in particular a bending section.
  • the infusion cannula has a substantially straight insertion section extending towards an infusion receiver-side end, wherein the insertion section remains unchanged in its position during the assembly movement.
  • the cannula propulsion mechanism has a deflection lever, wherein the reservoir container-side end of the infusion cannula can be displaced into the puncture position by means of the deflection lever.
  • the reversing lever is a reversing lever pivotable about a lever axis, preferably that the reversing lever is mounted on the first housing part
  • the deflection lever of the second housing part can be pivoted by the assembly movement, in particular can be pivoted about the lever axis, so that the reservoir container-side end of the infusion cannula can be displaced into the puncture position by means of the deflection lever when the same is pivoted.
  • the reservoir container is non-detachably connected to the housing, in particular the disposable housing part, or forms a replaceable cartridge or at least one that can be inserted into the housing part, 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.
  • the drive element and/or the deflection body are arranged, partially or completely, within a projection of the reservoir container running in the feed direction.
  • the pressure or tension means is guided past the deflecting body during operation, in particular a section of the pressure or tension means passes the deflecting body, or that the pressure or tension means is wound onto the deflecting body during operation.
  • the plurality of drive elements and/or the plurality of deflecting bodies are connected to one another in a rotationally fixed manner via a connecting shaft.
  • a non-circular cross-section in particular, has the advantage of providing optimal guidance for the dosing piston.
  • the infusion pump has a monitoring arrangement for monitoring the axial position of the dosing piston in the container interior of the reservoir container, preferably that the monitoring arrangement has Hall sensors on the reservoir container and a magnet interacting therewith on the dosing piston, and/or that the monitoring arrangement has an angle sensor for detecting an angular position of the drive element and/or deflection body, and/or that the monitoring arrangement has a laser which detects the position of the dosing piston by means of electro-optical distance measurement, in particular laser triangulation or laser interferometry, and/or that the monitoring arrangement has an arrangement for determining the axial position of the dosing piston based on magnetoresistive effects and/or according to the vernier principle, and/or that the monitoring arrangement has a linear potentiometer, and/or that the monitoring arrangement has a capacitive and/or inductive measuring sensor.
  • the infusion pump has a monitoring arrangement for monitoring the axial position of the dosing piston.
  • a monitoring arrangement can be designed in different ways and has the advantage that the defined amount of fluid, in particular infusion solution, to be administered is optimally maintained and, in particular, is independent of any play or slippage that may occur in the drive train.
  • the dosing piston itself is monitored, i.e., its position is directly detected, for example, by means of a laser-based measuring instrument, hereinafter referred to as a laser.
  • the housing is constructed in several parts and has a housing part on which disposable components, i.e. components that cannot be reused after the reservoir container has been emptied, are mounted, as well as a further housing part on which reusable components, i.e. components that can be reused after the reservoir container has been emptied, are arranged.
  • disposable components i.e. components that cannot be reused after the reservoir container has been emptied
  • reusable components i.e. components that can be reused after the reservoir container has been emptied
  • a dosing device or, in particular, an infusion pump for administering a defined amount of a fluid, in particular an infusion solution is conceivable, wherein the infusion pump has a reservoir container with a container interior and, in the container interior, a dosing piston which is movable in a feed direction and can be guided sealingly along the inside of the reservoir container and divides the container interior into a sealed, front section for receiving the fluid and a rear section, wherein the infusion pump has an infusion cannula which is or can be connected fluidically to the front section of the reservoir container, wherein the infusion pump has a drive arrangement for generating a feed movement of the dosing piston along the inside of the reservoir container, wherein the drive arrangement has a drive source and at least or exactly one drive train which couples the drive source to the dosing piston in a drive-related manner and has a plurality of train components, and wherein the infusion pump has a multi-part housing which has at least a first housing part and a second housing part
  • the cannula propulsion mechanism allows the force applied to displace the reservoir-side end of the infusion cannula to be exerted on the infusion cannula or its reservoir-side end in a direction that is independent of the assembly movement.
  • the proposal creates a possibility of redirecting the force introduced into the housing parts during assembly into another direction, namely the propulsion direction of the infusion cannula.
  • the provision of such redirection allows the individual components to be arranged relatively freely within the housing and thus in a particularly space-saving manner, thus enabling optimized space utilization. This, in turn, enables smaller dimensions of the infusion pump and thus improved wearing comfort and handling.
  • the assembly movement which causes the actuation of the cannula propulsion mechanism is directed transversely, in particular orthogonally, to the underside of the first housing part.
  • the infusion cannula is bent to enter the interior of the reservoir container, i.e., only a section of the infusion cannula is moved relative to the reservoir container, not the infusion cannula as a whole.
  • This is a particularly simple method for redirecting a movement introduced into the infusion cannula by the housing.
  • the infusion cannula has a substantially straight puncture section extending towards its reservoir-side end, which extends along the direction of advance when the reservoir-side end of the infusion cannula is in the initial position and/or puncture position, and which, when the reservoir-side end of the infusion cannula is moved from the initial position into the puncture position, is displaced parallel to the direction of advance.
  • the deflection lever is positioned at an angle to the direction of the assembly movement when the reservoir container-side end of the infusion cannula is in the initial position.
  • the deflection lever is deflected by a housing section of the second housing part during the assembly movement.
  • the infusion pump has, as an energy source, a primary or secondary battery, in particular one that can be removed individually, preferably that the energy source is a component of the disposable unit.
  • Fig. 4 is a representation of an alternative construction of the drive arrangement according to section A-A of Fig. 3;
  • FIG. 5 Detailed views of a cannula propulsion mechanism of the proposed first embodiment of the infusion pump with sectional views;
  • Fig. 6 shows a possible second embodiment of the dosing device;
  • Fig. 7 shows a possible third embodiment of the dosing device.
  • the infusion pump 1 has an infusion cannula 8 which is or can be fluidly connected to the front section 6 of the reservoir container 2.
  • the infusion pump 1 also has a drive arrangement 9 for generating a feed movement of the dosing piston 5 along the inside of the reservoir container 2, wherein the drive arrangement 9 has a drive source 10 and at least or exactly one drive train 11 with a plurality of train components, which drive-technically couples the drive source 10 to the dosing piston 5, wherein the drive train 11 has as one of the train components a pressure or tension means 12 which is drive-technically coupled to the dosing piston 5 and exerts a tensile force on the dosing piston 5 during operation.
  • the infusion pump 1 can be worn by the infusion receiver 13 on the body under clothing, in particular when fixed and/or glued to the skin, and is thus "portable" regardless of location.
  • the "administration" of an infusion solution takes place intravenously and/or subcutaneously, and thus corresponds to the delivery of an infusion directly into the tissue of an infusion recipient 13, in particular into the human body.
  • the reservoir container 2 arranged in a housing part 14 in Fig. 2 can be designed as an exchangeable container, also referred to as a cartridge, or as a functional component rigidly connected to the housing part 14 of the infusion pump 1, in particular designed integrally therewith.
  • a dosing piston 5 can be guided sealingly along the inside of the reservoir container 2, which is thus in sealing contact with the reservoir container 2 while being guided along the inside thereof, which is shown here and is therefore preferably carried out by means of one or more sealing elements such as sealing lips, sealing rings or the like, which are either designed as separate components with the dosing piston 5, alternatively are injection-molded onto the latter as a second component or form an integral part of the dosing piston 5 itself.
  • sealing elements such as sealing lips, sealing rings or the like, which are either designed as separate components with the dosing piston 5, alternatively are injection-molded onto the latter as a second component or form an integral part of the dosing piston 5 itself.
  • the sealing engagement of the dosing piston 5 in the reservoir container 2 creates a front section 6 which is liquid-tight and sealed off from the surroundings of the reservoir container 2, so that the infusion solution can only escape from this section via the infusion cannula 8.
  • infusion cannula 8 refers to a tube, here and preferably made of plastic or metal, in particular a stainless steel alloy or a nickel-titanium alloy, which is already fluidically connected to the reservoir container 2 at its first tube end, either directly or via a further interface, or is only fluidically connected to the reservoir container 2 during the preparation of an infusion, for example, by piercing a septum.
  • the second tube end is usually inserted directly into the body of the infusion recipient 13, or pierced into their skin tissue, for subcutaneous infusion. and preferably the infusion cannula 8 has an outer diameter of less than 500 pm, preferably less than 350 pm, more preferably less than 300 pm.
  • connection of the second tube end to the infusion receiver 13 can also take place with an infusion set arranged fluidically therebetween, wherein at the end of the infusion set there can again be an infusion cannula 8 which is either inserted directly into the body of the infusion receiver 13 or is connected to the body via another interface.
  • the infusion cannula 8 in the simplest case establishes the fluidic connection to the body of the infusion recipient 13 on one side (Fig. 1), whereby the fluid/infusion solution is guided through the infusion cannula 8 to the body of the infusion recipient 13 and delivered to it.
  • the infusion cannula 8 is fluidically connectable to the reservoir container 2 ( Figures 2-4), which means that the connection can be established manually before the first administration, or automatically during the insertion of the cartridge, in particular by the insertion movement of the cartridge relative to a housing part of the infusion pump 1.
  • the term drive coupling in the drive arrangement 9 means that a drive force, a drive torque and/or a movement is transmitted, preferably directly - i.e. here and preferably a drive force of the drive source 10 is introduced into the drive train 11 and is discharged from the drive train 11 to the dosing piston 5 in order to move the latter in the feed direction 4.
  • the pressure or tension means 12, as a train component of the drive train 11, is preferably and in this respect shown, fastened to the dosing piston 5, in particular at its first end 15.
  • the drive source 10 shown only systemically in Figures 3 and 4, is preferably a drive motor, in particular an electric one, preferably a stepper motor, and is arranged completely outside the reservoir container 2, as are all train components of the drive train 11 with the exception of the pressure or traction means 12.
  • the exception becomes clear in section AA of Fig. 3 and Fig. 4, since here and preferably the pressure or traction means 12 runs through the container interior 3 before it is sealingly guided through a pressure or traction means passage opening 16 in the reservoir container 2 and exits therefrom.
  • the pressure or traction means 12 is in sealing engagement with the edge of the pressure or traction means passage opening 16, so that during operation of the infusion pump 1, i.e. in the state in which the drive arrangement 9 is actuated, for example to deliver a defined amount of an infusion solution to the infusion receiver 13, the infusion solution can equally exit exclusively via the infusion cannula 8.
  • the aforementioned operation of the infusion pump 1 can be triggered autonomously via a control/operating device not shown in the figures, which is otherwise integrated into the infusion pump 1.
  • the programming of the desired on and off profiles can be carried out directly on the infusion pump 1 by the infusion receiver 13 or trained (specialist) personnel.
  • the operating state can alternatively be triggered using a smart device application installed on a smart device, i.e., a multifunctional wearable device such as a smartphone or smartwatch. Accordingly, control commands are sent from a smart device via radio communication to the infusion pump 1 and/or, conversely, sensor signals or other data are sent via radio communication to the smart device, or the smart device application.
  • a smart device application installed on a smart device, i.e., a multifunctional wearable device such as a smartphone or smartwatch.
  • the drive element 17 is a component that is set into a circular or rotating movement by the drive source 10.
  • the drive source 10 generates a drive torque or a drive force that is transmitted directly to the drive element 17.
  • "Directly" means that the drive source 10 is directly coupled to the drive element 17, i.e., as shown here, the drive element 17 is positively and non-positively mounted on, for example, the output shaft of the drive source 10, for example a motor shaft.
  • an "indirect" transmission of a drive torque or a drive force which is also included, means that a further strand component is interposed for drive purposes, which, however, is not the compression or tension means 12 or is not coupled to it for drive purposes.
  • the deflecting body 18 is here and preferably rotatable, i.e. a body that rotates about a single geometric axis of rotation relative to the reservoir container 2, or alternatively, optionally also pivots, such as a wheel here, for example.
  • the deflecting body 18 can alternatively also be movable in a rotating manner, i.e. be a component that is movable along an orbit relative to the reservoir container 2, such as an endless belt, which then runs about several, for example two, geometric axes of rotation.
  • the drive element 17 and the deflecting body 18 each have a geometric axis of rotation, that the axis of rotation of the drive element 17 and the axis of rotation of the deflecting body 18 run parallel or transversely, in particular orthogonally, to one another, and/or that the axis of rotation of the drive element 17 and/or of the deflecting body 18 runs transversely, in particular orthogonally, or parallel to the geometric longitudinal axis of the pressure or tension means 12.
  • the axis of rotation of the drive element 17 and the axis of rotation of the deflecting body 18 run parallel to one another, and the axis of rotation of the drive element 17 and of the deflecting body 18 each run orthogonally to the geometric longitudinal axis of the pressure or tension means 12.
  • radial refers to the geometric axis of rotation of the drive element 17 and/or the deflection body 18.
  • the pressure or tension means 12 it is additionally or alternatively conceivable for the pressure or tension means 12 to have a first end 15, which is drive-coupled to the dosing piston 5 in the front section 6 of the reservoir container 2 for exerting a tensile force on the dosing piston 5, and a second end 19, which is decoupled from the dosing piston 5 and in particular is spaced apart, wherein preferably no tensile force acts on the second end 19.
  • a slight tensile force to act on the second end 19, as long as this is a lower tensile force than on the first end 15.
  • a spring element to act on the second end 19 of the pressure or tension means 12 in order to facilitate guiding the second end 19 of the pressure or tension means 12 through its spring preload.
  • the infusion pump 1 has a deflecting body 18 for each pressure or traction means 12, which deflects the respective pressure or traction means 12.
  • the plurality of drive elements 17 and/or the plurality of deflecting bodies 18 are connected to one another in a rotationally fixed manner via a connecting shaft 22.
  • This embodiment can be seen in the perspective view in Fig. 3 and serves to synchronize the rotational or circulating movement of the plurality of drive elements 17 and/or the plurality of deflecting bodies 18.
  • the cross section runs orthogonally to the feed direction 4 of the dosing piston 5.
  • a dosing piston 5 with a non-circular cross section can be seen in the perspective view of Fig. 3.
  • the advantage of this embodiment is that it achieves guidance of the dosing piston 5 in the reservoir container 2.
  • the disposable unit 25 is the unit facing the user during use. After its intended use, it is removed from the body, separated from the reusable unit 26, and then disposed of.
  • the drive element 17 and any further strand components preferably also a cannula insertion mechanism, electronic components, in particular control components, a user interface 30 with a display 31 and/or with an operating unit 32, which can have one or more buttons, as well as, if applicable, components of the monitoring arrangement 23 of the reusable unit 26 are to be assigned and mounted on the reusable housing part 24.
  • Fig. 1a shows the arrangement of the portable infusion pump 1 in use, for example, on the upper arm of the infusion recipient 13.
  • the housing 20 can be fixed or adhered to the skin.
  • the reservoir container 2 has, in addition to the pressure or traction means passage opening 16, a further fluid opening 27 for the fluidic connection of the container interior 3 of the reservoir container 2 with the infusion cannula 8.
  • both openings 16, 27 are provided on the reservoir container front associated with the front section 6 of the reservoir container 2.
  • the reservoir container 2 is permanently connected to the housing 20, in particular the disposable housing part 14, wherein in particular a conventional filling port is provided on the reservoir container 2 or forms a replaceable cartridge. It is preferably provided here that the reservoir container 2 can be installed in a pre-filled state together with the disposable housing part 14 as a pre-assembled unit. However, according to another embodiment not shown here, it is also conceivable for a replaceable cartridge to be installed in a pre-filled state. This can then be attached to the disposable housing part 14 or inserted into it.
  • Suitable materials for the reservoir container 2 include, in particular, COC (cycloolefin copolymers) or COP (cycloolefin polymers), as well as glass-coated plastics. These materials are suitable for storage and prevent substances from dissolving into the fluid to be infused or causing changes in the fluid (e.g., the folding of protein chains in contact with certain plastics causes insulin inactivation).
  • the positions "initial position” and “puncture position” mentioned here refer to positions relative to the first housing part 14 and/or to the reservoir container 2.
  • the cannula propulsion mechanism 34 is actuated with the reservoir container 2 arranged as intended on the first housing part 14.
  • the reservoir container 2 is therefore in a position relative to the first housing part 14 that allows it to be assembled with the second housing part 24.
  • this position is the final position intended for administration, i.e., the reservoir container 2 is not moved any further from this position when the first housing part 14 is assembled with the second housing part 24.
  • the assembly of the first housing part 14 and the second housing part 24 will displace the reservoir container 2 into its final position, from which the administration of the fluid is intended.
  • the assembly movement that causes the actuation of the cannula propulsion mechanism 34 is preferably directed transversely, in particular orthogonally, to the underside of the first housing part 14. "Transversely” in this context means that the direction of the assembly movement crosses the plane of the underside of the first housing part 14.
  • the underside of the first housing part 14 is a side with a relatively large surface area. Accordingly, if, as here, the assembly movement is transverse, In particular, orthogonally, to the underside of the first housing part 14, a particularly large opening or a particularly large area can be provided on the opposite side of the first housing part 14, which has the advantage that the components of the infusion pump 1, in particular the reservoir container 2, infusion cannula 8, energy source 29, but also parts of the drive arrangement 9, are optimally accessible. Furthermore, it is generally the case that, for pleasant wearing comfort, the extension of a housing 14 of an infusion pump 1 in the direction orthogonal to the underside is advantageously less than parallel to the underside.
  • the cannula propulsion mechanism 34 when actuated, bends a part of the infusion cannula 8, in particular significantly or exclusively elastically, and thereby drives the reservoir container-side end 35 of the infusion cannula 8 from the initial position into the puncture position.
  • the infusion cannula 8 is bent via the provided cannula propulsion mechanism 34.
  • the proposal to establish a fluidic connection, only a section of the infusion cannula 8 is moved relative to the reservoir container 2, not the infusion cannula 8 as a whole. This allows the infusion cannula 8 and the reservoir container 2 to be pre-assembled and optimally aligned with one another on the first housing part 14, in particular in its interior, before the cannula propulsion mechanism 34 is actuated. Both components are therefore arranged on one and the same housing part from the outset and are not moved towards one another as a whole during the assembly of the two housing parts 14, 24.
  • the infusion cannula 8 has different axial sections, i.e. sections arranged along its longitudinal extent, which each have different functions and are arranged in a special way for the proposed solution, which is described below.
  • the infusion cannula 8 - as such an axial section - has a substantially straight puncture section 44 extending towards its reservoir-side end 35, which, when the reservoir-side end 35 of the Infusion cannula 8 is in the initial position and/or puncture position, extends along the advance direction 42 and which, when the reservoir container-side end 35 of the infusion cannula 8 is moved from the initial position into the puncture position, is displaced parallel to the advance direction 42.
  • the puncture section 44 forms the axial section of the infusion cannula 8, which is intended for insertion into the reservoir container 2 and in particular for piercing the septum 43 in order to establish the fluidic connection.
  • the insertion section 38 forms the axial section of the infusion cannula 8, which is provided for connecting the infusion cannula 8 to the body of the infusion receiver 13, if necessary using a fluidically interposed infusion set.
  • the infusion cannula 8 has, adjacent to the puncture section 44 and/or adjacent to the insertion section 38 - as a further axial section - a bending section 36 which, when the reservoir-side end 35 of the infusion cannula 8 is moved from the initial position into the puncture position, bends and/or executes a twisting movement in a partial section about a geometric axis skewed to the direction of advance 42.
  • the bending section 36 forms the axial section of the infusion cannula 8, which allows bending and ultimately makes it possible to move the puncture section 44 relative to the insertion section 38 towards the reservoir container 2.
  • the cannula propulsion mechanism 34 here and preferably has a deflection element or a deflection lever 39 which, during the assembly movement which causes the actuation of the cannula propulsion mechanism 34, displaces a part of the infusion cannula 8, in particular the puncture section 44, and thereby drives the reservoir container-side end 35 of the infusion cannula 8 from the initial position into the puncture position.
  • This deflection element or deflection lever 39 is preferably lever-shaped, which will be explained in more detail with reference to the exemplary embodiment shown in the figures.
  • deflection lever 39 it can also be provided that during the assembly movement, which causes the actuation of the cannula propulsion mechanism 34, a part of the infusion cannula 8, In particular, the puncture section 44 slides along a contact surface of a ramp-shaped housing section of the second housing part 24, which extends obliquely to the direction of the assembly movement.
  • the reservoir-side end 35 of the infusion cannula 8 can also be driven from the initial position into the puncture position. In principle, both would be conceivable: the provision of a ramp-shaped housing section and a deflection lever 39, which then slides along the ramp-shaped housing section.
  • the deflection lever 39 is deflected by a housing section 48 of the second housing part 24 during the assembly movement. It is preferably the case here that the deflection lever 39 engages with a part of the infusion cannula 8, in particular the puncture section 44 and/or the bending section 36, during the assembly movement and drives the reservoir-side end 35 of the infusion cannula 8 from the initial position into the puncture position.
  • the first housing part 14 is a disposable housing part and the second housing part 24 is a reusable housing part.
  • the reservoir container 2 with the dosing piston 5 as well as the infusion cannula 8 and in particular the deflection lever 39 are preferably mounted on the disposable housing part, in this case the first or lower housing part 14, which together preferably form a pre-assembled disposable unit 25.
  • the drive source 10 and in particular several of the strand components are mounted on the reusable housing part, in this case the second or upper housing part 24, which together preferably form a pre-assembled reusable unit 26.
  • the housing parts can preferably be detached from one another or assembled from one another without tools, preferably using a snap-in connection between the housing parts, for particularly easy separation of the disposable unit 25 from the reusable unit 26.
  • the disposable unit 25 is the unit facing the user during application. After its intended use, it is removed from the body, separated from the reusable unit 26, and then disposed of.
  • the reusable unit 26 shown in Fig. 2 above is, as previously described, separated from the disposable unit 25 after its intended use and can then be reattached to a new, unused disposable unit 25, since the reusable components stored thereon are reusable.
  • reusable components of the infusion pump 1 in addition to the drive source 10, in particular several of the strand components, preferably also a cannula insertion mechanism, electronic components, in particular control components, a user interface 30 with a display 31 and/or with an operating unit 32, which can have one or more buttons, and optionally components of the monitoring arrangement of the reusable unit 26 are to be assigned and mounted on the reusable housing part, in this case the second or upper housing part 24.
  • Fig. 1a shows the arrangement of the portable infusion pump 1 in use, for example, on the upper arm of the infusion recipient 13.
  • the housing 20 can be fixed or adhered to the skin.
  • non-detachable means a connection between the reservoir container 2 and the housing 14, in particular the first or lower housing part 14, 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.
  • Suitable materials for the reservoir container 2 include, in particular, COC (cycloolefin copolymers) or COP (cycloolefin polymers), as well as glass-coated plastics. These materials are suitable for storage and prevent substances from dissolving into the fluid to be infused or causing changes in the fluid (e.g., the folding of protein chains in contact with certain plastics causes insulin inactivation).
  • FIGS. 6 and 7 show further possible embodiments of the dosing device 33 in a highly simplified, schematic representation.
  • a second embodiment of the dosing device 33 can be provided, wherein the pressure or tension means 12 is connected at a first end 15 to the Reservoir container 2 is fixed in position, is guided along a longitudinal extent of the pressure or tension means 12 through the container interior 3 and sealed by an opening through the dosing piston 5, wherein the drive element 17, and in particular also the drive source 10, is designed as a component of a plunger in the rear section 7 of the container interior 3 and immediately adjacent to the dosing piston 5, so that the dosing piston 5 can be moved in the feed direction 4 by means of the plunger during operation of the drive source 10 by rotating the drive element 17 along the pressure or tension means 12.
  • Front section 34 Cannula propulsion mechanism

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif de dosage (33), de préférence pour l'administration sous-cutanée d'un fluide, comprenant un boîtier (20), un récipient de réservoir (2) avec un intérieur de récipient (3), une canule de perfusion (8) et un ensemble d'entraînement (9). Le boîtier (20) est conçu en de multiples parties, comprenant une première partie de boîtier (14) et une seconde partie de boîtier (24), la première partie de boîtier (14) et la seconde partie de boîtier (24) pouvant être assemblées de préférence dans un mouvement d'installation avec précision. Un piston doseur (5) qui est positionné dans l'intérieur de récipient (3) et qui peut être déplacé dans une direction d'avance (4) est reçu dans le récipient de réservoir (2), et la canule de perfusion (8) peut être couplée de manière fluidique à la section avant (6) de l'intérieur de récipient (3). L'ensemble d'entraînement (9) comprend une source d'entraînement (10) et une section d'entraînement (11) qui est accouplée par entraînement au piston de dosage (5), ladite section d'entraînement (11) comprenant un moyen de poussée ou de traction (12) qui est accouplé par entraînement au piston doseur (5), et la section d'entraînement (11) comprend un élément d'entraînement (17) qui peut être accouplé directement par entraînement au moyen de poussée ou de traction (12) et qui entraîne un mouvement de rotation. L'élément d'entraînement (17) est couplé par entraînement à la source d'entraînement (10), et le dispositif de dosage (33) peut être converti en un état prêt à l'emploi par assemblage de la première partie de boîtier (14) et de la seconde partie de boîtier (24), en particulier uniquement au moyen d'un mouvement d'installation du dispositif de dosage (33).
PCT/EP2024/078281 2023-10-09 2024-10-08 Dispositif de dosage comprenant un piston doseur et des moyens de poussée ou de traction qui sont fonctionnellement reliés à celui-ci Pending WO2025078373A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102023127528.3 2023-10-09
DE102023127532.1A DE102023127532A1 (de) 2023-10-09 2023-10-09 Tragbare Infusionspumpe zum Verabreichen einer definierten Menge eines Fluids, insbesondere einer Infusionslösung
DE102023127528.3A DE102023127528A1 (de) 2023-10-09 2023-10-09 Tragbare Infusionspumpe zum Verabreichen einer definierten Menge eines Fluids, insbesondere einer Infusionslösung
DE102023127532.1 2023-10-09

Publications (1)

Publication Number Publication Date
WO2025078373A1 true WO2025078373A1 (fr) 2025-04-17

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Application Number Title Priority Date Filing Date
PCT/EP2024/078281 Pending WO2025078373A1 (fr) 2023-10-09 2024-10-08 Dispositif de dosage comprenant un piston doseur et des moyens de poussée ou de traction qui sont fonctionnellement reliés à celui-ci

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WO (1) WO2025078373A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988005643A1 (fr) 1987-02-02 1988-08-11 Avl Ag Procede et dispositif pour determiner des parametres interessants dans des organismes vivants
EP1624914A1 (fr) 2003-05-08 2006-02-15 Novo Nordisk A/S Module d'insertion d'aiguille interne
US20060200073A1 (en) * 2003-07-08 2006-09-07 Novo Nordisk A/S Portable drug delivery device having an encapsulated needle
US20150209505A1 (en) * 2012-08-29 2015-07-30 Unitract Syringe Pty Ltd Controlled delivery drive mechanisms for drug delivery pumps
US20170056582A1 (en) * 2014-05-14 2017-03-02 Meamedical Ag Metering device for dispensing pharmaceutical fluid from a reservoir having a spindle rod for displacement of the piston
WO2023049361A1 (fr) * 2021-09-24 2023-03-30 Becton, Dickinson And Company Mécanisme de pompe pour administration de médicament et système d'administration de médicament
US20230125644A1 (en) * 2021-10-25 2023-04-27 Tecmed Ag Delivery device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988005643A1 (fr) 1987-02-02 1988-08-11 Avl Ag Procede et dispositif pour determiner des parametres interessants dans des organismes vivants
EP1624914A1 (fr) 2003-05-08 2006-02-15 Novo Nordisk A/S Module d'insertion d'aiguille interne
US20060200073A1 (en) * 2003-07-08 2006-09-07 Novo Nordisk A/S Portable drug delivery device having an encapsulated needle
US20150209505A1 (en) * 2012-08-29 2015-07-30 Unitract Syringe Pty Ltd Controlled delivery drive mechanisms for drug delivery pumps
US20170056582A1 (en) * 2014-05-14 2017-03-02 Meamedical Ag Metering device for dispensing pharmaceutical fluid from a reservoir having a spindle rod for displacement of the piston
WO2023049361A1 (fr) * 2021-09-24 2023-03-30 Becton, Dickinson And Company Mécanisme de pompe pour administration de médicament et système d'administration de médicament
US20230125644A1 (en) * 2021-10-25 2023-04-27 Tecmed Ag Delivery device

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