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CN-121985971-A - Drug delivery device with housing parts operatively connected upon displacement

CN121985971ACN 121985971 ACN121985971 ACN 121985971ACN-121985971-A

Abstract

The invention relates to a drug delivery device (32), in particular an infusion pump (1), preferably for subcutaneous administration of a fluid, comprising a housing (13), a reservoir container (2) having a container interior for containing the fluid, and a cannula assembly (3), wherein the housing (13) is designed in multiple parts, comprising a first housing part (20) and a second housing part (23), wherein in each case a first set of components of the drug delivery device (32) is coupled to the first housing part (20) and a second set of components of the drug delivery device (32) is coupled to the second housing part (23) for fixation to the housing, or each component is designed as a section of the housing (13). The components of the first set are operatively connected with the components of the second set during displacement of the housing parts (20, 23) relative to each other, in particular during an assembled state in which the housing parts (20, 23) are moved closer together by assembly to create the drug delivery device (32) or during disassembly of the drug delivery device (32).

Inventors

  • Thomas. Bragania

Assignees

  • 特里彭索股份公司

Dates

Publication Date
20260505
Application Date
20241008
Priority Date
20231009

Claims (17)

  1. 1. A drug delivery device (32), in particular an infusion pump (1), preferably for subcutaneous administration of a fluid, the drug delivery device (32) comprising a housing (13), a reservoir container (2) having a container interior for containing the fluid, and a cannula assembly (3), Wherein the housing (13) is formed in several parts and comprises a first housing part (20) and a second housing part (23), Wherein the cannula assembly (3) comprises a cannula insertion mechanism (5) and an infusion cannula (4) having 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 fluidly couplable with the container interior, in particular with the container interior, at its container-side cannula end (6), Wherein the state of the cannula insertion mechanism (5) is displaceable or switchable between an initial state (8) and an actuated state (9), Wherein the cannula insertion mechanism (5) is operatively connected with the infusion cannula (4) upon displacement thereof into the actuated state (9) or in the actuated state (9) such that the recipient-side cannula end (7) is displaceable, in particular is displaceable abruptly, or in particular by elastic bending of the infusion cannula (4) and/or pivoting of the recipient-side cannula end (7), from an initial position (10) to a puncturing position (11) such that the fluid can be subcutaneously administered via the cannula tip by means of the drug delivery device (32) and by the recipient-side cannula end (7) of the infusion cannula (4) being displaced into the puncturing position (11), Wherein a first set of components of the drug delivery device (32) is coupled to the first housing part (20) in a housing-fixed manner, respectively, and a second set of components of the drug delivery device (32) is coupled to the second housing part (23) in a housing-fixed manner, respectively, or is formed as a section of the housing (13), respectively, It is characterized in that the method comprises the steps of, The first set of components is operatively connected with the second set of components during displacement of the housing parts (20, 23) relative to each other, in particular during engagement of the housing parts (20, 23) by an assembly movement to create an assembled state of the drug delivery device (32) or during disassembly of the drug delivery device (32).
  2. 2. The drug delivery device (32) according to claim 1, wherein the reservoir container (2) is formed as a hollow cylinder or hollow oval 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 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 wherein the drug delivery device does not have a longitudinal extension longer than the second longitudinal extension in either a lateral or normal axial direction of the cartesian coordinate system.
  3. 3. Drug delivery device (32) according to claim 2, characterized in that the reservoir container (2) is insertable or mountable into the housing (13) substantially along the second longitudinal extension of the housing (13).
  4. 4. A drug delivery device (32) according to claim 2 or 3, wherein the assembly movement for establishing an assembled state of the drug delivery device (32) comprises a movement vector for engaging the housing parts (20, 23), a significant part of which is parallel to the second longitudinal extension of the housing (13).
  5. 5. The drug delivery device (32) according to any of the preceding claims, wherein the cannula insertion mechanism (5) is operatively connected with its complementary housing parts of the housing (13), wherein the state of the cannula insertion mechanism (5) is variable during displacement of the housing parts (20, 23) relative to each other.
  6. 6. The drug delivery device (32) according to claim 5, wherein the housing (13) interacts with the cannula insertion mechanism (5) such that the cannula insertion mechanism (5) can be transferred from an actuated state (9) of the cannula insertion mechanism (5) to a state in which the recipient-side cannula end (7) is not displaced by the cannula insertion mechanism (5) by displacement of the housing parts (20, 23) relative to each other.
  7. 7. The drug delivery device according to claim 5 or 6, characterized in that by transferring the cannula insertion mechanism (5) from its actuated state (9), the infusion cannula (4) automatically or drivingly, in particular spring-driven, performs a return movement by which the recipient-side cannula end (7) can be moved back from the puncture position (11) towards the initial position (10), in particular into the initial position (10).
  8. 8. The drug delivery device (32) according to any of the preceding claims, wherein the cannula insertion mechanism (5) is displaceable to the initial state (8) upon displacement of the housing parts (20, 23) relative to each other and upon displacement into an assembled state of the housing (13) of the drug delivery device (32), wherein in the initial state (8) the cannula insertion mechanism (5) is not working relative to the infusion cannula (4).
  9. 9. Drug delivery device (32) according to any 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 rod (15), which is coupled or coupleable to the infusion cannula (4) in a force-transmitting manner and is displaceable, in particular pivotable, between a starting position (16) and an actuation position (17), wherein the insertion device is electrically or mechanically controllable.
  10. 10. Drug delivery device (32) according to claim 9, characterized in that the insertion device is designed as an insertion actuator (14), wherein the infusion cannula (4) can be displaced from its starting position (16) by means of the insertion actuator (14) and mechanically deflected in the direction of the puncture position (11), in particular by elastic bending and/or pivoting of the infusion cannula (4), during its movement towards the puncture position (11), so that the recipient-side cannula end (7) can be displaced from the starting position (10) into the puncture position (11), in particular suddenly into, and/or, By means of the insertion actuator (14) being able to return from its actuation position (17) to its starting position (16), the cannula insertion mechanism (5) is thereby able to return from its actuation state (9) to its initial state (8), and/or, The housing (13) is designed to interact with the insertion actuator (14) such that the insertion actuator (14) can be moved from its actuation position (17) to a position in which the infusion cannula (4) is at least partially, in particular completely unloaded from the insertion actuator (14) by displacement of the two housing parts (20, 23) of the housing (13) relative to each other.
  11. 11. The drug delivery device (32) according to any of the preceding claims, wherein the displacement of the two housing parts (20, 23) relative to each other is or comprises a sliding, in particular a linear sliding, of the two housing parts (20, 23) relative to each other, preferably the sliding comprises a directional component extending parallel or orthogonal to the bottom side of the housing.
  12. 12. The drug delivery device (32) according to any of the preceding claims, wherein the cannula insertion mechanism (5) comprises a return member (19), the cannula insertion mechanism (5) being displaceable, in particular to its initial state (8), from its actuated state (9) by actuating the return member (19), wherein the return member (19) slides along an inclined contact surface (21) of a housing section (22) of the housing (13), in particular along a ramp-shaped housing section (22), during displacement of the two housing parts (20, 23) relative to each other, whereby the return member (19) is displaced, in particular pivoted or translated, preferably the housing section (22) with the inclined contact surface (21) is arranged on the one housing part (20) in a manner fixed to the housing, and the return member (19) is arranged on the other housing part (23) in a manner fixed to the housing.
  13. 13. The drug delivery device (32) according to any of the preceding claims, wherein the container-side cannula end (6) is coupleable with the container interior space or with the reservoir container by the assembly movement, in particular by sliding the two housing parts (20, 23) relative to each other.
  14. 14. The drug delivery device (32) according to any of the preceding claims, characterized in that the two housing parts (20, 23) are designed as a disposable housing part (20) and a reusable housing part (23), preferably the reservoir container (2) and the infusion cannula (4) are mounted on the disposable housing part (20), in particular also the housing section (22) with the inclined contact surface (21), which preferably together form a pre-assembled disposable unit (25), and/or the cannula insertion mechanism (5) and/or the insertion device, in particular also the return member (19) and/or a drive source (24), in particular a drive motor, and optionally further drive elements, which preferably together form a pre-assembled reusable unit (26), are mounted on the reusable housing part (23).
  15. 15. The drug delivery device (32) according to any of the preceding claims, wherein the reservoir container (2) is non-detachably connected to the housing (13), in particular the disposable housing part (20), in particular without tools and/or without effort, or forms a replaceable cartridge, preferably the reservoir container (2) together with the disposable housing part (20) in a pre-filled state is mountable as a pre-assembled unit or in a pre-filled state.
  16. 16. Drug delivery device (32) according to any of the preceding claims, characterized in that the two housing parts (20, 23) are designed as a disposable housing part (20) and 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 comprises 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) and the further power supply device are electrically coupleable when the housing parts (20, 23) are displaced into an assembled state of the drug delivery device (32) and/or electrically coupleable in an assembled state of the drug delivery device (32), such that the power supply device (28) is chargeable by means of the further power supply device.
  17. 17. Drug delivery device (32) according to any of the preceding claims, characterized in that the drug delivery device (32) comprises a user interface (29) with a display (30) and/or with an operating unit (31) with one or more buttons, preferably the user interface (29) is part of the reusable unit (26).

Description

Drug delivery device with housing parts operatively connected upon displacement The present invention relates to a drug delivery device for subcutaneous and/or intravenous administration of a defined amount of a fluid, in particular an infusion solution, a liquid drug solution or a therapeutic agent, and/or for subcutaneous and/or intravenous sampling and/or measurement through a cannula. In general, a drug delivery device according to the present invention may be understood as an infusion pump as one possible embodiment. Infusion pumps (also known as patch pumps) are the subject of this solution and described below, which can be worn in a fixed position on the human body and deliver a specific amount of fluid (in particular infusion solution) subcutaneously or intravenously into the human body, continuously or through a predetermined quantity-time curve, over a specific time period, to achieve a desired concentration and thus a corresponding effect in the human body. Such fluids (particularly infusion solutions) range from low to high viscosities, from simple low molecular weight materials with molecular dimensions of a few daltons to high molecular weight materials with molecular dimensions up to 1,000,000 daltons. From simple physiological saline to highly complex bioactive components such as peptides, proteins, monoclonal antibodies, various types of vaccines, analgesics, therapeutic agents for cancer treatment or nutritional solutions, the required amounts can be precisely and safely delivered to the appropriate location within the human body by the administration device. However, not only can an immunological, prophylactic or prophylactically effective or therapeutic fluid or infusion solution be administered using such an infusion pump, but also analytically important fluids as well as fluids containing nutrients, even a combination of all of the foregoing, and with the required accuracy and/or within the desired therapeutic and/or beneficial window. Drug delivery devices, in particular infusion pumps, for the treatment of diabetes and the like have been known since 1970 s. These pumps typically deliver a fluid comprising water, auxiliary substances and peptide (hormone) insulin. Sometimes, such infusion pumps also deliver other fluids. Over the years, with continued innovation, the size of such infusion pumps delivering insulin-containing infusion solutions has been reduced from the size of hiking backpacks to the currently most compact 52 x 39 x 14 mm infusion pumps (Omnipod from instret, acton, MA, USA). Pumps worn on a belt (or in a pocket or under clothing) with infusion devices are common in 1990 to 2015 (in short, this is a tube with a connection for the infusion pump at one end and an infusion port at the other end, which usually provides direct access to the body of the infusion recipient), but in recent years patients are increasingly turning to particularly small, skin-mounted, administration devices, so-called patch pumps. Patch pumps are not only extremely compact and therefore generally unobtrusive, but in many cases have the advantage that the infusion device connected to the pump is no longer needed as an interface with the human body. The tube of the infusion set has the disadvantage that it may become tangled and, in the worst case, torn off, especially when the child is playing or playing sports. In addition, the tubing may kink and thus the interior of the tubing and/or the interior of the infusion pump may build up a certain pressure which may suddenly be released when the kink reopens. Furthermore, tubing may lead to errors in accurate infusion, and the difference in height from, for example, an infusion pump worn in the abdomen to an infusion port attached to the upper arm may create a back pressure, for example, up to 1 meter of liquid column for a person of high height, of 10,000 Pa, which back pressure acts on the mechanical structure of the infusion pump. If the infusion recipient now moves to a horizontal position (e.g., sleeps), the pressure created by the fluid column will dissipate. These positional changes in turn lead to variations in the accuracy of the administration. In theoretical tests according to IEC 60601-2-24, such fluctuations in infusion rate accuracy are not considered, as only static systems are tested. Nevertheless, risk analysis for infusion device risk is often critical. In particular for young children, continuous and close monitoring using an infusion pump with an infusion device is essential. Patch pumps are delivered either as a ready-to-use infusion pump (in addition to filling) or as a kit of parts. These infusion pumps are filled after unpacking and, if necessary, assembly. Filling is typically done by a separate filling system, a filling fitment, or by a syringe, which is typically used to transfer a portion of the contents of a bottle containing, for example, 10 milliliters of infusion solution into the reservoir of the infusion pump. After fi