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CN-122003262-A - Administration device having an administration piston and a pressure or traction device operatively connected thereto

CN122003262ACN 122003262 ACN122003262 ACN 122003262ACN-122003262-A

Abstract

The invention relates to a drug delivery device (33) for administering a fluid, preferably subcutaneously, comprising a housing (20), a storage container (2) having a container interior (3), an infusion cannula (8) and a drive device (9), wherein the housing (20) is formed in multiple parts and comprises a first housing part (14) and a second housing part (24), wherein the first housing part (14) and the second housing part (24) can be engaged, preferably in exactly one assembly movement, wherein a drug delivery piston (5) which is positioned in the container interior (3) and is movable in a feed direction (4) is received in the storage container (2), and wherein the infusion cannula (8) is fluidically coupleable with a front section (6) of the container interior (3), wherein the drive device (9) comprises a drive source (10) and a transmission system (11) which is drivingly coupled with the drug delivery piston (5), wherein the transmission system (11) comprises a pressure or traction device (12) which is drivingly coupled with the drug delivery piston (5), and wherein the transmission system (11) comprises a rotary drive element (17) which is directly coupleable with the drive source (17) which is drivingly coupled with the drive element (17), and wherein the drug delivery device (33) can be brought into a functional state by engaging the first housing part (14) with the second housing part (24) by means of an assembly movement of the drug delivery device (33), in particular only.

Inventors

  • Thomas. Bragania

Assignees

  • 特里彭索股份公司

Dates

Publication Date
20260508
Application Date
20241008
Priority Date
20231009

Claims (20)

  1. 1. A drug delivery device (33), in particular an infusion pump (1), for administering a fluid, in particular an infusion solution, preferably subcutaneously, the drug delivery device (33) comprising a housing (20), a storage container (2) with a container interior (3), an infusion cannula (8) and a drive device (9), Wherein the housing (20) is formed in multiple parts and comprises a first housing part (14) and a second housing part (24), Wherein the first housing part (14) and the second housing part (24) can be joined preferably in exactly one fitting movement, Wherein a dosing piston (5) which is positioned in the container interior (3) and is movable in a feed direction (4) is received in the storage container (2), -Wherein the dosing piston (5) is sealed with respect to the inner surface of the container interior (3) and divides the container interior (3) into a rear section (7) and a sealed, in particular liquid-tight, front section (6) for receiving the fluid, -And wherein the infusion cannula (8) is or can be fluidly coupled with the front section (6) of the container interior (3), And wherein the drive means (9) comprises a drive source (10) and a transmission system (11) drivingly coupled to the dosing piston (5), -Wherein said transmission system (11) comprises a pressure or traction device (12) drivingly coupled to said dosing piston (5), -And wherein the transmission system (11) comprises a rotationally driven drive element (17) which is directly drive-coupled or directly drive-coupled with the pressure or traction means (12), wherein the drive element (17) is drive-coupled with the drive source (10), It is characterized in that the method comprises the steps of, The drug delivery device (33) can be brought into a functional state by engaging the first housing part (14) with the second housing part (24), in particular only by an assembly movement of the drug delivery device (33).
  2. 2. The drug delivery device (33) according to claim 1, characterized in that the drive source (10) and in particular the drive element (17) are formed as an integrated part of the second housing part (24), that the storage container (2) is positioned or positionable in the first housing part (14), and that the drive element (17) is coupleable with the pressure or traction means (12) by the assembly movement such that the drive means (9) is active in an assembled state of the second housing part (24) with the first housing part (14), wherein the second housing part (24) is formed as a reusable unit (26).
  3. 3. The dosing device (33) according to one of the preceding claims, characterized in that the pressure or traction device (12) is formed as a fine-threaded spindle, wherein the fine-threaded spindle passes through the dosing piston (5) by means of a perforation having a mating thread complementary to the thread shape of the fine-threaded spindle and protrudes preferably unsupported into the front section (6) of the container interior (3), wherein the fine-threaded spindle can be rotationally driven by the drive element (17) during operation of the drive source (10), in particular in the rear section (7) of the container interior (3), such that the dosing piston (5) is movable in the feed direction (4).
  4. 4. The drug delivery device (33) according to claim 1 or 2, characterized in that the pressure or traction device (12) is formed in strands or threads, the longitudinal extension of which is a multiple of the lateral extension of the pressure or traction device (12), wherein in particular the strands of pressure or traction device (12) are formed as filaments and are mainly formed 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 polymer COP, cyclic olefin copolymer COC, blends thereof and metals.
  5. 5. Drug delivery device (33) according to claim 4, characterized in that the pressure or traction device (12) has a sheath and a core, wherein the core is formed of a second material, in particular fibers of the second material, from a second material list comprising carbon fibers, aramid fibers, kevlar, glass fibers, UHMWPE and metal, and wherein the sheath is formed of a first material, in particular fibers of the first material.
  6. 6. The drug delivery device (33) according to one of the preceding claims, characterized in that the pressure or traction device (12) has an average diameter of 0.5 mm to 3 mm, in particular 0.9 mm to 1.5 mm, measured transversely to the longitudinal extension of the pressure or traction device (12).
  7. 7. The drug delivery device (33) according to claim 1 or 2, characterized in that the pressure or traction device (12) is formed in the form of a textile belt with a longitudinal extension that is a multiple of the height extension and width extension of the pressure or traction device (12), wherein the pressure or traction device (12) is mainly formed of a first material from a first material list comprising PTFE, PEEK, fluoropolymers, kevlar, aramid, ultra High Molecular Weight Polyethylene (UHMWPE) such as dynema or Spectra, nylon, polypropylene PP, cyclic olefin polymer COP, cyclic olefin copolymer COC and blends thereof.
  8. 8. Drug delivery device (33) according to one of claims 1,2 or 4 to 7, characterized in that a pressure generating device is arranged in the rear section (7) of the storage container (2), by means of which pressure generating device the drug delivery piston (5) can be displaced in the feed direction (4), and that the pressure or traction device (12) is formed in operative connection with the drive source (10) as a holding device for the drug delivery piston (5) which is prevented from being advanced in the feed direction (4) by the pressure generating device, wherein the drive source (10) is designed for a gradual release of the pressure or traction device (12) in the feed direction (4).
  9. 9. The dosing device (33) according to one of claims 1,2 or 4 to 6, characterized in that the pressure or traction device (12) is positionally fixed with its first end (15) on the storage container (2), extends through the container interior (3) in the longitudinal extension of the pressure or traction device (12) and extends in a sealing manner through a perforation through the dosing piston (5), wherein the drive element (17) and in particular the drive source (10) are formed in the rear section (7) of the container interior (3) and in close proximity to the dosing piston (5) as a component of a plunger, such that the dosing piston (5) is movable in the feed direction (4) along the pressure or traction device (12) by a rotational movement of the drive element (17) during operation of the drive source (10).
  10. 10. The dosing device (33) according to one of claims 1,2 or 4 to 7, characterized in that the pressure or traction device (12) is positionally fixed with its first end (15) on the dosing piston (5), is guided through the container interior (3) in the longitudinal direction of the pressure or traction device (12) and is guided in a sealing manner through a pressure or traction device passage opening (16) of the storage container (2), and that the drive element (17) operatively connected with a deflection body (18) is directly drive-coupled or directly drive-couplable with a section of the pressure or traction device (12) extending outside the storage container (2), wherein the drive element (17), in particular as a knurled drive, is coupled or couplable with the pressure or traction device (12), and that the deflection body (18) is formed as a counter bearing for coupling, such that a force can be exerted on the dosing piston (5) in the feed direction (4) by the pressure or traction device (12) during operation of the drive source (10).
  11. 11. Drug delivery device (33) according to one of the preceding claims, characterized in that the drug delivery device (33) comprises a cannula advancing mechanism (34), wherein a reservoir-side end (35) of the infusion cannula (8) is displaceable by the cannula advancing mechanism (34) from an initial position, in which the infusion cannula (8) is arranged completely outside the reservoir interior (3) of the reservoir (2), to a puncturing position, in which the reservoir-side end (35) protrudes into the reservoir interior (3), such that in the puncturing position the infusion cannula (8) is fluidly coupled with the reservoir interior (3).
  12. 12. Drug delivery device (33) according to claim 11, characterized in that the cannula advancing mechanism (34) is actuatable by the fitting movement such that the reservoir-side end (35) of the infusion cannula (8) is displaceable by the fitting movement to the piercing position.
  13. 13. Drug delivery device (33) according to claim 11 or 12, characterized in that the reservoir-side end (35) is displaceable to the piercing position by elastic deformation of the infusion cannula (8), in particular by elastic deformation of a central cannula section, in particular a bending section (36).
  14. 14. The drug delivery device (33) according to one of claims 11 to 13, characterized in that the infusion cannula (8) has a substantially straight insertion section (38) extending towards an infusion receiver side end (37), wherein the insertion section (38) maintains its position during the fitting movement.
  15. 15. Drug delivery device (33) according to one of claims 11 to 14, characterized in that the cannula advancing mechanism (34) has a deflection lever (39), wherein a reservoir-side end (35) of the infusion cannula (8) can be displaced by the deflection lever (39) into the piercing position.
  16. 16. Drug delivery device (33) according to claim 15, characterized in that the deflection lever (39) is a deflection lever (39) pivotable about a lever axis (40), preferably that the deflection lever (39) is mounted on the first housing part (14).
  17. 17. Drug delivery device (33) according to claim 15 or 16, characterized in that the deflection lever (39) is pivotable by means of the second housing part (24) by means of the fitting movement, in particular about the lever axis (40), such that the reservoir-side end (35) of the infusion cannula (8) can be displaced by the deflection lever (39) into the piercing position when the deflection lever (39) is pivoted.
  18. 18. The drug delivery device (33) according to one of claims 15 to 17, characterized in that the first housing part (14) has a rigid holder (41) and that the deflection lever (39) is latched or positionally fixed on the rigid holder (41) when the storage container side end (35) of the infusion cannula (8) is in the piercing position and/or that a part of the infusion cannula (8), in particular the bending section (36), can be guided by the rigid holder (41) when the storage container side end (35) of the infusion cannula (8) is moved from the initial position to the piercing position.
  19. 19. The dosing device (33) according to one of the preceding claims, characterized in that the dosing device (33) has a monitoring device (23) for monitoring the axial position of the dosing piston (5) in the container interior (3) of the storage container (2), preferably the monitoring device (23) has a hall sensor on the storage container (2) and a magnet on the dosing piston (5) that interacts with the hall sensor, and/or the monitoring device (23) has an angle sensor for detecting the angular position of the drive element (17), and/or the monitoring device (23) has a laser for detecting the position of the dosing piston (5) by electro-optical distance measurement, in particular laser triangulation or laser interferometry, and/or the monitoring device (23) has a device for determining the axial position of the dosing piston (5) on the basis of the magneto-resistive effect and/or according to the vernier principle, and/or the monitoring device (23) has a linear potentiometer, and/or the capacitive measuring device (23) has an inductive sensor.
  20. 20. Drug delivery device (33) according to one of the preceding claims, characterized in that the first housing part (14) is formed as a disposable housing part (14) and the second housing part (24) is formed as a reusable housing part (24), wherein the reservoir (2) together with the drug delivery piston (5) and pressure or traction device (12) and in particular the infusion cannula (8) and/or the deflection body (18) are mounted on the disposable housing part (14), which preferably together form a pre-assembled disposable unit (25), and/or the drive source (10) and the drive element (17), in particular the entire transmission system (11) except for the pressure or traction device (12), are mounted on the reusable housing part (24), which preferably together form a pre-assembled reusable unit (26).

Description

Administration device having an administration piston and a pressure or traction device operatively connected thereto The present invention relates to a drug delivery 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) are the subject of the solutions proposed and described below, which are generally worn fixedly on the body and deliver a specific amount of infusion solution subcutaneously or intravenously into the human body continuously or over a predetermined amount-time curve over a specific time period to achieve the desired concentration in the human body and thus produce the corresponding effect. Such fluids (particularly infusion solutions) range from low to high viscosities, from simple low molecular weight materials of a few daltons molecular size to high molecular weight materials of up to 1,000,000 daltons molecular size. From simple saline solutions to highly complex bioactive components such as peptides, proteins, monoclonal antibodies, various vaccines and analgesics, the required amounts can be delivered accurately and safely to the appropriate location in the human body by infusion pumps. However, not only can the immunization, prophylaxis or therapeutic fluid or infusion solution be administered with such an infusion pump with the required accuracy and/or within the desired therapeutic and/or useful window, but also fluids of importance in the analysis as well as fluids containing nutrients, even a combination of all of the foregoing fluids, can be administered with such an infusion pump with the required accuracy and/or within the desired therapeutic and/or useful window. Infusion pumps have been known since the 70 s of the 20 th century, in particular for the treatment of diabetes. These pumps typically deliver a fluid consisting of water, excipients and peptide (hormonal) insulin. Sometimes such infusion pumps also deliver one to three other fluids. Over the years, with continued innovation, such infusion pumps delivering insulin-containing infusion solutions have been reduced from the size of hiking backpacks to the current most compact infusion pumps of size 52 x 39 x 14 mm (Omnipod @ of instet, akton, massachusetts, usa). During 1990 to 2015, pumps with infusion sets (simply tubes, with a connection to the infusion pump at one end and an infusion port at the other end, which usually provides a direct passage into the body of the infusion recipient) are common to wear on the belt (or in a pocket or under clothing), while in recent years patients are increasingly turning to particularly compact pumps, so-called patch pumps, which are fixed or glued to the skin. Patch pumps are not only extremely compact and thus often unobtrusive, but in many cases also have the advantage that an infusion set connected to such a pump is no longer needed as an interface with the human body. A disadvantage of the tube of the infusion set is that it may become entangled and in the worst case may be torn apart, especially when used for children during play or play. 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 is reopened. Furthermore, accurate infusion may be subject to errors due to tubing, because the difference in height from an infusion pump worn, for example, in the abdomen to an infusion port attached to the upper arm may create a counter-pressure that when a person of high height creates a liquid column of up to 1 meter, for example, equivalent to 10,000 Pa, and acts on the mechanical structure of the infusion pump. If the infusion recipient now moves to a horizontal position, such as sleeping, the pressure created by the aforementioned fluid column is removed. These positional changes in turn lead to variations in the accuracy of application. In theoretical tests according to IEC 60601-2-24, such fluctuations in the accuracy of the infusion rate are not considered. Nevertheless, risk analysis regarding infusion set hazards is often critical. In particular for young children, continuous and close monitoring is necessary using infusion pumps with infusion sets. Patch pumps are delivered either as infusion pumps ready (except for filling) or as a kit of parts consisting of several parts. After unpacking and assembly (if necessary), these infusion pumps are filled. Filling is typically performed by means of a syringe by means of which a portion of the content of a vial containing e.g. 10ml of infusion solution is usually transferred to a reservoir of an infusion pump. After filling, the patch pump is placed on the body of the infusion recipient and the infusion cannula, which is directly or indirectly connected to the reservoir, is connected to the body at its second end, either subcutaneously or intravenously. During the filling process, the