WO2021249967A1 - Dispositif d'injection doté d'un réservoir de nettoyage - Google Patents

Dispositif d'injection doté d'un réservoir de nettoyage Download PDF

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Publication number
WO2021249967A1
WO2021249967A1 PCT/EP2021/065214 EP2021065214W WO2021249967A1 WO 2021249967 A1 WO2021249967 A1 WO 2021249967A1 EP 2021065214 W EP2021065214 W EP 2021065214W WO 2021249967 A1 WO2021249967 A1 WO 2021249967A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle cannula
injection device
cleaning
needle
radial wall
Prior art date
Application number
PCT/EP2021/065214
Other languages
English (en)
Inventor
Simon Munch Pedersen
Original Assignee
Novo Nordisk A/S
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
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2021249967A1 publication Critical patent/WO2021249967A1/fr

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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
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3293—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle hub
    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/2474—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31521—Pistons with a forward extending skirt at their front end
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body

Definitions

  • the invention relates to an injection device for delivering doses of a liquid drug. More specif ically, the invention relates to an injection device wherein at least the distal tip of the needle cannula is cleaned in a cleaning reservoir between subsequent injections.
  • the invention preferably relates to the inner shape of such cleaning reservoir.
  • the invention further relates to a cleaning reservoir for an injection device wherein at least a part of the cleaning reservoir has an uneven inner surface.
  • US 3,354,881 disclose a traditional injection syringe wherein the distal tip of the needle can nula is maintained in a flexible cleaning reservoir between injections.
  • the cleaning reservoir contains an ethyl alcohol for cleaning the needle cannula between subse quent injections.
  • US 4,416,663 disclose a different solution for cleaning the distal tip of a needle cannula of a traditional syringe.
  • a spring actuated needle shield covers the needle cannula between injections.
  • the needle shield is distally provided with a cleaning reservoir containing a liquid cleaning agent such that the distal tip of the needle cannula is cleaned between injections.
  • Such injec tion devices typically secure a cartridge which is either permanently encapsulate in the injec tion device or exchangeable mounted.
  • the cartridge contains a volume of a liquid drug to be expelled in a plurality of doses. These doses can either be fixed or settable.
  • the liquid drug contains a preservative to prevent the growth of bacteria in the liquid drug should bacte ria flow backwards through the lumen of the needle cannula during injection and hence con taminate the liquid drug inside the cartridge.
  • a spring ac tuated needle shield Surrounding the needle cannula is a spring ac tuated needle shield which distally carries a cleaning reservoir wherein the liquid cleaning agent in the cleaning reservoir comprises the same preservative as present in the liquid drug in the cartridge.
  • the liquid cleaning agent is a volume of the same preservative containing liquid drug as present in the cartridge. This volume is prefera bly but not necessarily filled into the cleaning reservoir by a user operated initiation process performed first time the injection device is taken into use.
  • the clean ing reservoir comprises a first compartment which connects to a funnel part.
  • the cleaning reservoir which is connected to the needle shield is further occupied by a movable plunger such that the cleaning reservoir has a variable volume.
  • Such small amount of air present inside the cleaning reservoir after the reservoir has been filled tends to form air-bubbles which can form around the needle cannula inside the cleaning reservoir.
  • air-bubbles around the needle cannula prevents the liquid cleaning agent from being in contact with the entire surface of the needle cannula. Consequently, bacteria can in such scenario survive on the part of the surface of the needle cannula which is not in contact with the liquid cleaning agent which is highly unwanted.
  • the present invention relates to an injection device for delivering doses of a liquid drug.
  • This injection device comprises:
  • a housing structure securing a dose setting and expelling mechanism and a cartridge containing the liquid drug.
  • the housing structure is structured around a centre axis (X).
  • a needle cannula preferably located co-axial with the centre axis (X) and having a distal tip and a proximal end and a lumen therebetween.
  • the needle cannula is oper ationally attached to the housing structure to form a liquid communication with the in terior of the cartridge.
  • a needle shield which is axially movable along the centre axis and which covers at least the distal tip of the needle cannula between injections, wherein the needle shield distally carries a cleaning reservoir defining an interior containing a liquid cleaning agent for cleaning at least the distal tip of the needle cannula between injec tions.
  • the interior of the cleaning reservoir comprises a first compartment defined by an inner pe ripheral wall, a first radial wall having a first surface and a second radial wall having a second surface wherein the first surface and the second surface which faces each other are substan tially parallel and surrounds the needle cannula , and wherein the first surface and/or the second surface are/is provided with a ring-shaped trench or ridge surrounding the needle cannula for keeping air-bobbles away from the needle cannula.
  • the liquid cleaning agent present in the cleaning reservoir can be any kind of liquid cleaning agent suitable in preventing growth of bacteria on the surface of the needle cannula and thus keep the needle cannula clean.
  • the liquid cleaning agent is a phenol and/or meta-cresol.
  • the cleaning reservoir is filled with the same liquid drug as present in the cartridge in the injection device, such that the preservative in the liquid drug is utilized as the liquid cleaning agent.
  • phenol and/or meta- cresol are used as preservatives.
  • One or both of the surfaces of the radial walls of the cleaning reservoir are thus provided with a ring which surrounds the needle cannula. These rings are formed as a trench surrounding the needle cannula or as a ridge also surrounding the needle cannula.
  • any air trapped in a liquid will seek to take the form and position that requires least energy.
  • the air will position along the outer wall of the cleaning reservoir and on the periphery of the rings due to the energy equilibrium.
  • the air will position itself in the least energy absorbing position which is on the outer periphery of the ring rather than crossing the ring.
  • the air will henceforth automatically position itself in a position away from the needle cannula. This effect is henceforth best if the rings are formed in both radial surfaces, however, the effect can be obtained by only having the ring in one of the radial surfaces.
  • the radial walls forming the cleaning reservoir are preferably formed as tubular walls following the geometry of the injec tion device.
  • the first radial wall has at least a first surface and the second radial wall has at least a second surface. These two surfaces face each other and are substantially parallel.
  • the ring is provided in either only the first surface or only in the second surface or in both surfaces and are shaped as an endless trench engraved into the surface or as an endless ridge extending axially out from the surface.
  • engraved is not meant a specific method of production but merely that the ring is somehow countersunk into in the surface.
  • the en graved ring can be moulded or cut or otherwise shaped into the relevant surface.
  • the rings are a ridge
  • such ridge is preferably shaped on the relevant surface during moulding of the specific element.
  • the rings can be a plurality of dot-shaped protrusion formed into or out from the surface and connected to form an endless belt around the centre axis.
  • the cleaning reservoir preferably has a tubular shape and the length between the two surfaces are preferably smaller than the radius of the cleaning reservoir.
  • first radial wall and the first surface are carried by the needle shield and in a further example the second radial wall and the second surface are carried by a movable piston.
  • the cleaning reservoir has a variable volume as the movable piston can be moved a variable distance in relation to the first wall and the first surface.
  • the cleaning reservoir is connected to the needle shield and is henceforth axially movable in relation to the needle cannula together with the needle shield. Consequently, both the first wall and the first surface and the second wall and the second surface moves axially in relation to the needle cannula during injection.
  • the cleaning reservoir comprises a funnel part which connects to the first compartment.
  • the cleaning reservoir comprises the first compartment and the funnel part.
  • the funnel part preferably extends along the centre axis (X) and connects to the first com partment through the first radial wall.
  • the inner surface of the funnel part preferably has an uneven inner surface.
  • the uneven inner surface is meant to be in a cross-sectional viewing and at least along some of the axial extension of the inner surface of the funnel part.
  • the inner surface cross-sectionally comprises a non circular geometry which in one example comprises trenches, slits or bulges.
  • the injection device comprises:
  • a housing structure securing a dose setting and expelling mechanism and a car tridge containing the liquid drug.
  • the housing structure is structured around a centre axis (X),
  • a needle cannula having a distal tip and a proximal end and a lumen therebetween, the needle cannula being associated with the housing structure such that the lumen forms a liquid communication with the cartridge,
  • a needle shield movable along the centre axis “X” and covering at least the distal tip of the needle cannula between injections, wherein the needle shield distally carries a cleaning reservoir containing a liquid cleaning agent for cleaning at least the distal tip of the needle cannula between injections,
  • the cleaning reservoir comprises a first compartment defined by an inner peripheral wall, a first radial wall having a first surface and a second radial wall having a second surface wherein both surfaces are substantially parallel, faces each other and surrounds the needle cannula.
  • the cleaning reservoir further comprises a funnel part which extend along the centre axis (X) and connects to the first compartment preferably through the first radial wall and which funnel part at least partly comprises an uneven inner surface.
  • the funnel part is provided with an uneven inner surface as in the first example however without the radial surfaces of the cleaning reservoir being provided with trenches and/or ridges.
  • the inner surface cross-sectionally comprises a non-circular geometry such as trenches, slits or bulges.
  • injection pen is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.
  • needle Cannula is used to describe the actual conduit performing the penetra tion of the skin during injection.
  • a needle cannula is usually made from a metallic material such as e.g. stainless steel and preferably connected to a hub made from a suitable material e.g. a polymer.
  • a needle cannula could however also be made from a polymeric material or a glass material.
  • Liquid drug is meant to encompass any drug-containing flowa- ble medicine capable of being passed through a delivery means such as a hollow needle cannula in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • Repre sentative drugs include pharmaceuticals such as peptides, proteins (e.g. insulin, insulin ana logues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene-based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • Cartridg es are usually made from glass but could also be moulded from any suitable polymer.
  • a car tridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the “septum” which can be pierced e.g. by the non-patient end of a needle cannula.
  • Such septum is usually self-sealing which means that the opening created during penetration seals automatically by the inherent resiliency once the needle cannula is removed from the sep tum.
  • the opposite end of the cartridge is typically closed by a plunger or piston made from rubber or a suitable polymer. The plunger or piston can be slidable moved inside the car tridge. The space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger decreased the volume of the space holding the drug.
  • the cartridges used for both pre-filled injection devices and for durable injections devices are typically filled at the factory by the manufacturer with a predetermined volume of a liquid drug.
  • a large number of the cartridges currently available contains either 1 ,5 ml or 3 ml of liquid drug.
  • “Cleaning reservoir” is in the present description broadly meant to be any kind of reservoir containing a cleaning solvent to clean at least the distal tip of the needle cannula between subsequent injections.
  • Such cleaning reservoir is preferably both distally and proximally sealed by a pierceable septum or the like.
  • the proximal septum could be replaced by any kind of sealing which would seal against the outer surface of the needle cannula e.g. a movable plunger with some kind of sealing.
  • the distal septum and the proximal septum or seal of the cleaning reservoir defines a confinement containing the cleaning solvent which cleaning solvent in a preferred embodiment is identical to the preservative contained in the liquid drug used in the specific injection device.
  • the same pre servative containing liquid drug is present both in the cleaning reservoir and in the cartridge of the injection device thereby avoiding contamination of the preservative containing drug inside the cartridge.
  • Pre-filled injection device an injection device in which the filled car tridge containing the liquid drug is permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device.
  • the user normally discards the entire injection device.
  • the cartridge which has been filled by the manufacturer with a specific amount of liquid drug is secured in a cartridge holder part which is then permanently and ir reversible connected in a housing structure such that the cartridge cannot be removed.
  • Pre-filled injection devices are usu ally sold in packages containing more than one injection device whereas durable injection devices are usually sold one at a time.
  • pre-filled injection devices an average user might require as many as 50 to 100 injection devices per year whereas when using du- rable injection devices one single injection device could last for several years, however, the average user would require 50 to 100 new cartridges per year.
  • Scale drum is meant to be a preferably cylinder-shaped element carrying indicia indicating the size of the selected dose to the user of the injection device.
  • the cylinder-shaped element making up the scale drum can either be solid or hollow.
  • “Indicia” is meant to incorporate any kind of printing or otherwise provided symbols e.g. engraved or adhered symbols. These symbols are preferably, but not exclusively, Arabian numbers from “0” to “9”. In a different example, alphabetic letters from any alphabet available can be used. However, the symbols can also be graphical pictures indicating a specific situation or specific use such symbols could e.g. be a key, a lock, a drop or similar symbol which provides the user information re lating to the use of the injection device. In a traditional pen configuration, the indicia are viewable through a window or opening provided in the housing structure.
  • Automatic in conjunction with injection device means that, the injection device is able to perform the injection without the user of the injection device delivering the force needed to expel the drug during dosing.
  • the force is typically delivered - automatically
  • the spring for the spring drive is usually strained by the user during dose setting, however, such springs are usually prestrained in order to avoid problems of delivering very small doses.
  • the spring can be fully preloaded by the manufacturer with a preload sufficient to empty the entire drug cartridge though a number of doses.
  • the user activates a latch mechanism provided either on the sur face of the housing or at the proximal end of the injection device to release - fully or partially
  • protective cap is herein meant to refer to a cover or a sleeve-like structure which is mounted at the distal end of the injection device between injections. Such cover or sleeve-like structure is usually closed at the distal end to fully encapsulate the distal part of the injection device.
  • the protective cap is hence secured to the distal end of the injection de vice and protects the distal end of the injection device between injections. Should a needle cannula be mounted to the distal end of the injection device, either permanently or ex changeable, such needle cannula is henceforth also protected by the protective cap. Since the protective cap is mounted each time an injection has been performed, the word “re mounted” can also be used to describe the mounting of the protective cap. Further, since the housing structure of an injection device often has a window through which the user can visu- ally inspect the liquid drug, the protective cap also serves to protect the liquid drug from long time exposure to light as some liquid drugs are sensitive to light, especially in the UV range.
  • Permanently connected or “permanently embedded” as used in this descrip tion is intended to mean that the parts, which in this application is embodied as a cartridge permanently embedded in the housing, requires the use of tools in order to be separated and should the parts be separated it would permanently damage at least one of the parts.
  • Figure 1 show a perspective view of the injection device with the protective cap re moved.
  • Figure 2 show an exploded view of the injection device.
  • Figure 3 show an exploded view of the cleaning unit and the needle hub.
  • Figure 4 show a cross sectional view of the cleaning unit and the needle hub.
  • Figure 5A show a cross sectional view of the needle cannula inserted into the car tridge, but prior to filling the cleaning reservoir.
  • Figure 5B show a cross sectional view of the needle cannula inserted into the car tridge and wherein the cleaning reservoir is filled.
  • Figure 6 show a side view of the cleaning assembly, (partly cross sectional).
  • Figure 7 A show a cross sectional view of the chamber part and the movable piston in a disassembled state.
  • Figure 7B show a cross sectional view of the chamber part and the movable piston in an assembled state.
  • Figure 8 show a perspective view of the chamber part and movable piston
  • Figure 9 show a cross-sectional view of the chamber part in a further example.
  • Figure 10 show a view through the lines A-A in figure 9.
  • distal end in the appended fig ures is meant to refer to the end of the injection device securing the needle cannula and pointing towards the user during injection
  • proximal end is meant to refer to the opposite end which usually carries the dose dial button as depicted in figure 1.
  • Distal and proximal is meant to be along an axial orientation extending along the longitudinal axis (X) of the injection device as also disclosed in figure 1.
  • Translational movement is meant to be a strictly linear movement preferably in the axial di rection but without any rotation.
  • “Rotational movement” is any movement of rotation around a centre which centre can be a centre point i.e. in one planar or a centre axis i.e. having a longitudinal extension.
  • Axial movement means any movement in an axial direction e.g. along the centre axis. Such movement can be a strictly translational movement or include a rotational movement which thus makes it a “Helically movement” as this is meant to be the combination of a translational movement and a rotational movement.
  • Telescopic is meant to cover the situation in which a movable element moves out from, or into, a base element.
  • the movement can be translational i.e. without any rotation, or the movement can include a rotation thus making the telescopic movement helical.
  • figure 1 disclose the injection device in a perspec tive view with the protective cap 16 removed and figure 2 disclose an exploded view of the injection device.
  • the injection device comprises a housing body 1 having a window 2 through which a dose indication is visible.
  • the dose indication is preferably indicia provided on a scale drum 7.
  • the housing body 1 secures the dose expelling mechanism which can be any kind of mech anism suitable for expelling a plurality of doses of a liquid drug contained in a cartridge 10.
  • the dose expelling mechanism is preferably a spring-operated mechanism such that the dose dial button 5 is not moved axially during dose setting or dose expelling.
  • the injection device could be a so-called multiple fixed dose device which expel a plurality of equally sized doses. In such case a dose dial button 5 is not required.
  • the housing body 1 carries a cartridge holder 14 which holds the cartridge 10 con taining the liquid drug.
  • the cartridge holder 14 is secured to the housing body 1 by an inter mediate part 15 which also forms a helical track for guiding the needle shield 20.
  • the cartridge holder 14 is covered by a protective cap 16.
  • the housing body 1, the cartridge holder 14 and the intermediate part 15 defines the outer parameter of the injec tion device and is herein together with the spring base 19 referred to as the housing struc ture.
  • the housing structure is provided with a telescopically movable needle shield 20 which is able to telescope relative to the housing structure during injection.
  • the needle shield 20 covers the needle cannula 40 between injections and is movable in the proximal direction during injection preferably against the bias of a compression spring encompassed between the housing body 1 and the needle shield 20.
  • the compression spring is combined with a torsion spring 6 by providing the torsion spring 6 with a number of open windings.
  • a separate compression spring could be provided.
  • the user rotates the dose setting button 5 which via a rotational shaft part 18 and a ratchet element 17 strains the torsion spring 6 and rotates the scale drum 7.
  • the tor sion spring 6 is secured between the ratchet element 17 and the spring base 19 which is part of the housing structure.
  • the torque stored in the torsion spring 6 upon rotation of the dose setting button 5 is during dose expelling used to rotate the drive element 8.
  • the drive ele ment 8 is during dose setting locked to the housing body 1 but during dose expelling the drive element 8 is moved in the proximal direction against the compression force of the tor sion spring 6, preferably by the needle shield 20, and out of engagement with the housing body 1 thus allowing the drive element 8 to rotate under influence of the torque stored in the torsion spring 6.
  • the torque from the torsion spring 6 is preferably transferred to the drive element 8 via the ratchet element 17.
  • the rotation of the drive element 8 is transferred to a similar rotation of the piston rod 9 which is thus rotated and moved helically in the distal di rection.
  • the piston rod 9 is preferably coupled to a piston rod foot 3 at its distal end to better distribute the forces onto the plunger 11 inside the cartridge 10 and can, as in the example disclosed in figure 2, be provided with a threaded end-of-content nut .
  • a detailed description of this dose setting and expelling mechanism is provided in WO 2019/002020.
  • the piston rod foot 3 can in one example be replaced by an electronic module which can communicate pis ton rod movement to a remote receiver to thereby provided the user with information regard ing ejected dose sizes.
  • the scale drum 7 which carries the indicia viewable by the user through the window 2 is preferably threaded to an internal thread provided on the inner surface of housing body 1 such that the scale drum 7 moves helically when rotated.
  • a stop for the rotation and helical movement scale drum 7 is preferably moulded in the housing structure. Alternatively, such stop can be created during assembly of the injection device such that a general “one-fits-all” housing body 1 can be used for a range of different injection devices having different scale drums 7. The stop can in one example be created by pressing one of a number of pre moulded segments in the wall structure of the housing body 1 inwards using a press tool.
  • the stop can also be created by means of a special press tool which locally creates a defor mation of the wall of the housing body 1.
  • Local heating e.g. using ultrasound is also a possi bility for forming such inwardly pointing stop.
  • a nail or spike can be pierced through the wall of the housing body 1 e.g. through one of a plurality of pre-shaped holes in the wall to thereby create the stop for the scale drum 7.
  • the stop so formed in the housing body 1 can be hidden by a label which is usually glued to the outer surface of the housing body 1.
  • the needle cannula 40 has a distal tip 41 for penetrating the skin of the user and a proximal end 42 which is able to penetrate into a cartridge 10 as will be explained.
  • the needle cannu la 40 further has a hollow lumen through which the liquid drug can flow during injection and the needle cannula 40 is attached to a needle hub 70 as e.g. disclosed in figure 4.
  • a connector element 4 can be provided to transfer the axial movement of the needle shield 20 to a similar axial movement of the drive element 8.
  • the needle shield 20 carries a cleaning unit 50 with a cleaning reservoir containing a liquid cleaning agent for cleaning the distal tip 41 of the needle cannula 40 between injec tions.
  • the cleaning unit 50 which is disclosed in an exploded view in figure 3 and in a cross- sectional view in figure 4 comprises a front element 52 which is click-fitted to the needle shield 20 via an outer click arm 53 such that the front element 52 is locked to the needle shield 20.
  • the front element 52 has a click opening 54 by which the front element 52 clicks to an outwardly pointing protrusion on chamber part 55.
  • the front element 52 and the chamber part 55 thus moves together with the needle shield 20 both rotational and trans lational.
  • the needle shield 20 is indicated with dotted lines.
  • Both the outer click arms 53 and the click opening 54 can be provided in any suitable number but are preferably provided in pairs.
  • the distal end of the chamber part 55 is sealed by a distal septum 56 which is locked to the chamber part 55 by a metal bend 57 using the technology commonly known from pharma ceutical cartridges.
  • the chamber part 55 defines a cleaning reservoir comprising a first compartment 51 as an inner peripheral wall 58 (figure 6) of the chamber part 55 forms the outer parameter of this first compartment 51.
  • the first compartment 51 is sealed by a movable piston 65 which is able to move axially such that the volume of the first compartment 51 in the pre sent example of the invention is variable.
  • the movable piston 65 comprises a solid part 66 and a softer part 67 e.g. made from a suit able rubber component or TPE material.
  • Figure 3 and 4 further discloses the needle hub 70 which secures the needle cannula 40.
  • the needle cannula 40 is preferably glued or welded to the needle hub 70 but can easily be attached using alternative bonding methods.
  • the proximal end 42 of the needle cannula 40 is preferably placed in a closing element 75 which maintains the proximal end 42 of the needle cannula 40 sterile.
  • the closing element 75 comprises a rigid part 76 and a soft part 77 which in one example can be moulded to gether in a 2K moulding.
  • the proximal part 42 of the needle cannula 40 is inserted into the closing element 75 when the injection device is delivered to the user.
  • the needle shield 20 is moved in the proximal direction in an initiation process which is described in further details in WO 2020/193,100.
  • the front element 52 follows this movement and con sequently the proximal movement of the needle shield 20 and the front element 52 is trans ferred to a similar movement of the needle hub 70 and henceforth the needle cannula 40 in the proximal direction.
  • Figure 5A discloses the state in which the needle shield 20 has been moved in the proximal direction and wherein the needle hub 70 (and the needle cannula 40) has followed this prox imal movement such that the proximal part 42 of the needle cannula 40 has been moved out through the closing element 75 and into the cartridge 10.
  • the cartridge 10 is at its distal end provided with a pierceable septum 12 through which the proximal end 42 of the needle can nula 40 is able to penetrate. In this situation has the distal surface of the closing element 75 obtained physical contact with the needle hub 70.
  • a further movement of the needle hub 70 in the proximal direction as disclosed in figure 5B is transferred to a similar movement of the cartridge 10 in the proximal direction.
  • the closing element 75 distally abut the needle hub 70 and proximally abut the car tridge 10 such that when the needle hub 70 is moved in the proximal direction, this move ment is transferred to the closing element 75 and further onto the cartridge 10 which is thus moved proximally.
  • the cartridge 10 is provided with a plunger 11 which is moved in the distal direction by the dose setting and expelling mechanism during dose expelling. At the same time, the dose ex pelling mechanism prevents the plunger 11 from any movement in the proximal direction.
  • the distal tip of the needle cannula 40 is hereafter maintained inside the cleaning reservoir between injections.
  • the liquid drug contained in the cartridge 10 and after the initiation also inside the cleaning reservoir preferably contains a preservative which will prevent unwanted growth of bacteria and thus keep the distal tip 41 of the needle cannula 40 clean for multiple use.
  • the preservative containing liquid drug in the cartridge 10 as a liq uid cleaning agent by filling a volume of this liquid drug into the cleaning reservoir.
  • the cleaning reservoir can contain any kind of suitable liquid cleaning agent and can in one example be filled by the manufacturer of the injection device.
  • the liquid drug in the cartridge 10 contains meta-cresol and/or phenol as a preservative. If a quantum of this liquid drug is transferred into the cleaning reservoir as described herein, the meta-cresol and/or phenol works as the liquid cleaning agent keeping the distal tip 41 of the needle cannula 40 clean between injections.
  • the cleaning reservoir can be filled directly with meta-cresol and/or phenol dur ing manufacture of the injection device to thereby keep the distal tip 41 of the needle cannula 40 clean between injections.
  • the cleaning unit 50 is moved from the position disclosed in figure 5B and further in the proximal direction such that the distal tip 41 of the needle cannula 40 is moved outside and distal to the cleaning reservoir.
  • the compression part of the torsion spring 6 urges the needle shield 20 and the cleaning unit 50 including the cleaning reservoir in the distal di rection such that the distal tip 41 of the needle cannula 40 is again positioned inside the cleaning reservoir.
  • Figure 6 discloses the chamber part 55 and the movable piston 65 in a disassembled state.
  • the first compartment 51 is primarily defined by the peripheral wall 58.
  • Distally the cleaning reservoir is sealed by the distal septum 56 and proximally sealed by the movable piston 65.
  • first compartment 51 of the cleaning reservoir has a first radial wall 63 which defines a first surface 59 and the movable piston 65 has a second radial wall 64 which de fines a second surface 68.
  • the first radial wall 63 is in the disclosed example connected with a longitudinal funnel part 60 which extend along the centre axis “X” and distally terminates into the distal septum 56.
  • the cleaning reservoir thus comprises the first compartment 51 and the funnel part 60.
  • the air inside the cleaning reservoir is pushed in front of the liquid front during fill ing of the cleaning reservoir.
  • the liquid cleaning agent e.g. the preservative containing liquid drug flows out from the distal tip 41 of the needle can nula 40 and thus flows into the funnel 60 first.
  • the air will thus be pushed in the proximal di rection and into the base of the first compartment 51.
  • the air moves through the funnel 60 and reaches the distal base of the first compartment 51 it will flow to the side of the first compartment 51. Consequently, the air can position itself such that the outer surface of the needle cannula 40 is not fully covered by the preservative liquid drug but partially covered by the air.
  • FIG 5B This air inside the first compartment 51, in the form of an air-bobble, is functionally illustrated in figure 5B and indexed with the reference number “61”.
  • air- bobble 61 could take up a position at the outer surface of the needle cannula 40 which would have the consequence that a part of the outer surface of the needle cannula 40 is not in physical contact with the liquid cleaning agent. Consequently, bacteria could grow on the part of outer surface of the needle cannula 40 which is not in contact with the liquid cleaning agent.
  • the first surface 59 can according to the present invention be provided with a ring 62 and the second surface 68 can be provided with a similar ring 69.
  • These rings 62, 69 enables the air-bobble 61 when pressed against the side of the first com partment 51 to find a more optimal equilibrium, i.e. a more optimal energy state, by following the rings 62, 69 rather than crossing the rings 62, 69 an reaching the outer surface of the needle cannula 40.
  • These two rings 62, 69 can be formed as either a trench-like ring-shaped depressions 62 or as a raised ring-shaped ridge 69 which both has a ring-shaped extension and surrounds the centre axis “X” and thus the needle cannula 40 which extends along the centre axis “X”.
  • the trench-like ring-shaped depression 62 is disclosed as formed in the chamber element 55 and the raised ring-shaped ridge 69 is disclosed as formed in the movable plunger 65.
  • any of the two rings 62, 69 can be randomly shaped as a trench and/or as a ridge.
  • the chamber part 55 as disclosed in the figures 2 to 6 is slightly different from the chamber part 55 disclosed in the figures 7A-B to figure 10, however functionally it is the same compo nent.
  • any air trapped inside the first compartment 51 will hereafter position itself between the end less wall 58 of the first compartment 51 and the periphery of these rings 62, 69 and hence forth the air-bobble 61 will be kept away from the outer surface of the needle cannula 40.
  • Figure 7A also contains and inside end-view of the first surface 59 wherein the distribution of the air-bobble 61 along the trench like ring-shaped depression 62 in one example is seen.
  • the funnel part 60 can have an uneven inner sur- face 45.
  • Such uneven surface 45 can be shaped as a number of longitudinal extra trenches or bulges following the funnel part 60 at least along a part of the funnel part 60.
  • Figure 10 discloses a view through the lines A-A. These extra trenches or bulges allow more volume to pass through the funnel part 60 and thus makes it less likely that air will be caught inside the funnel part 60.

Abstract

L'invention concerne un dispositif d'injection dans lequel la pointe distale de la canule d'aiguille est nettoyée entre des injections ultérieures. Le nettoyage est exécuté dans une chambre de nettoyage portée par un protecteur d'aiguille mobile de manière télescopique. Selon la présente invention, les parois radiales de la chambre de nettoyage sont pourvues d'une ou de plusieurs tranchées ou crêtes en forme d'anneau pour empêcher les bulles d'air dans le médicament liquide d'entrer en contact physique avec la canule d'aiguille.
PCT/EP2021/065214 2020-06-11 2021-06-08 Dispositif d'injection doté d'un réservoir de nettoyage WO2021249967A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20179516 2020-06-11
EP20179516.8 2020-06-11

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Publication Number Publication Date
WO2021249967A1 true WO2021249967A1 (fr) 2021-12-16

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3354881A (en) 1964-11-03 1967-11-28 Universal Oil Prod Co Hypodermic needle protector
US4416663A (en) 1981-10-26 1983-11-22 Steri-Pac, Inc. Self-sterilizing hypodermic syringe
US20050209555A1 (en) * 2004-03-18 2005-09-22 Lance Middleton Systems and methods for mixing fluids
US20130253436A1 (en) 2007-06-04 2013-09-26 Becton, Dickinson And Company Positive Displacement Stopper for a Pre-Filled Syringe
WO2015062845A1 (fr) 2013-10-31 2015-05-07 Novo Nordisk A/S Dispositif d'injection avec canule à aiguille
WO2019002020A1 (fr) 2017-06-27 2019-01-03 Novo Nordisk A/S Dispositif d'injection entrainé par ressort de torsion
WO2019101670A1 (fr) 2017-11-21 2019-05-31 Novo Nordisk A/S Dispositif d'injection avec nettoyage d'aiguille
WO2020193100A1 (fr) 2019-03-26 2020-10-01 Novo Nordisk A/S Dispositif médical protégé d'injection à chambre de nettoyage

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3354881A (en) 1964-11-03 1967-11-28 Universal Oil Prod Co Hypodermic needle protector
US4416663A (en) 1981-10-26 1983-11-22 Steri-Pac, Inc. Self-sterilizing hypodermic syringe
US20050209555A1 (en) * 2004-03-18 2005-09-22 Lance Middleton Systems and methods for mixing fluids
US20130253436A1 (en) 2007-06-04 2013-09-26 Becton, Dickinson And Company Positive Displacement Stopper for a Pre-Filled Syringe
WO2015062845A1 (fr) 2013-10-31 2015-05-07 Novo Nordisk A/S Dispositif d'injection avec canule à aiguille
WO2019002020A1 (fr) 2017-06-27 2019-01-03 Novo Nordisk A/S Dispositif d'injection entrainé par ressort de torsion
WO2019101670A1 (fr) 2017-11-21 2019-05-31 Novo Nordisk A/S Dispositif d'injection avec nettoyage d'aiguille
WO2020193100A1 (fr) 2019-03-26 2020-10-01 Novo Nordisk A/S Dispositif médical protégé d'injection à chambre de nettoyage

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