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EP4577269A1 - Auto-injecteur amélioré - Google Patents

Auto-injecteur amélioré

Info

Publication number
EP4577269A1
EP4577269A1 EP23761131.4A EP23761131A EP4577269A1 EP 4577269 A1 EP4577269 A1 EP 4577269A1 EP 23761131 A EP23761131 A EP 23761131A EP 4577269 A1 EP4577269 A1 EP 4577269A1
Authority
EP
European Patent Office
Prior art keywords
housing parts
locking
housing part
sleeve
housing
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
EP23761131.4A
Other languages
German (de)
English (en)
Inventor
Markus Tschirren
Christian Schrul
Mario Bernhard
Nicolas Gruenig
Marcel ALLENSPACH
Gabriel KALBERMATTER
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.)
Ypsomed AG
Original Assignee
Ypsomed 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
Application filed by Ypsomed AG filed Critical Ypsomed AG
Publication of EP4577269A1 publication Critical patent/EP4577269A1/fr
Pending legal-status Critical Current

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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/3129—Syringe barrels
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
    • 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
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8281—Mechanical spring operated

Definitions

  • Injection devices or injection devices for the simplified administration of a substance include, among other things, so-called autoinjectors, which have an energy storage device with which the release can be carried out automatically, that is to say without external force to be supplied or used by a user.
  • the energy storage advantageously stores the energy required for automatic substance release in mechanical form.
  • Such an energy storage device can be a spring, which is installed in the injection device in a tensioned state and releases energy when relaxed. The energy is delivered to a piston rod or a pressure element, which pushes a piston into a product container.
  • the energy storage can also be provided to automate the process of inserting an injection needle. Alternatively, the piercing process can be carried out manually, i.e. exclusively by a user, without using energy stored in the injection device.
  • the injection device can comprise a product container holder for holding a product container, wherein the product container can be held radially, axially and preferably also in a rotationally fixed manner in the product container holder.
  • the product container holder can be connected to the housing of the injection device in an axial and rotationally fixed manner, or can be movable relative to the housing during a piercing and/or needle retraction process.
  • the product container can be a carpule for repeatedly detachable connection with disposable injection needles or a disposable pre-filled syringe with an injection needle that is permanently connected to it.
  • the product container has a hollow cylindrical shape
  • Product container section which slidably supports a piston or stopper.
  • the piston can form a sealing gap with the inner circumference of the product container section and can be displaced in a distal direction by means of a piston rod in order to dispense product from the product container via the injection needle.
  • the injection device can have a needle protection sleeve which, after the injection has been carried out, stands distally over the distal end of the injection needle or is moved into this position relative to the housing while relaxing a needle protection sleeve spring in order to prevent accidental access to the injection needle and reduce the risk of injury.
  • the needle protection sleeve can also serve as a trigger element for triggering the product release, with the needle protection sleeve being displaced in the proximal direction relative to the housing.
  • the autoinjector can be triggered by pressing a trigger button on the autoinjector, with the needle protection sleeve at least serving as a privacy screen before using the autoinjector.
  • a mainspring as a drive is characterized by high forces and is therefore suitable for a delay-free start of the distribution, even for autoinjectors with a long storage period.
  • a variable thread pitch of the threaded rod can compensate for a variable characteristic of the mainspring in order to ensure the most constant distribution force possible. This means that even large quantities of 5 ml or more can be dispensed evenly and continuously within a maximum of 60 s. If the delivery time is longer than that of standard auto-injectors of more than 10 s The user can ensure at any time that the injection is progressing as intended so that the injection is not interrupted prematurely in an unintentional manner.
  • CH 714527 A2 shows an injection device with a cap for removing a needle protection cap from a product container and a method for assembling an injection device, the cap comprising an engagement element for removing the needle protection cap from the product container when removing the cap from the injection device to effect.
  • EP 3241580 Al shows an improved snap connection between the cartridge holder and the device body.
  • the reduced radial dimensions of the snap elements reduce the deformation of the cartridge holder during final assembly and thus increase the security against glass breakage of the cartridge.
  • the patent application published as WO 2013/153011 A1 shows a cartridge holder which is connected to a device housing by means of a snap connection is connectable.
  • the snap connection has an improved flow of force because the projections in the device housing engage in windows with rounded corners on the cartridge holder.
  • the patent application published as WO 2016/055625 A1 shows an improved coupling of a cartridge holder to the outer housing of an administration device.
  • a first snap connection between the cartridge holder and the outer housing is supplemented by a separate axially offset second connection between the cartridge holder and the outer housing and by a third connection as an anti-rotation device on a distally extending projection of the outer housing.
  • the term “product”, “medication” or “medical substance” includes any flowable medical formulation that is suitable for controlled administration using a cannula or hollow needle into subcutaneous or intramuscular tissue, for example a liquid, a solution, a gel or a fine suspension containing one or more medicinal active ingredients.
  • a drug may therefore be a single active ingredient composition or a premixed or co-formulated multi-active ingredient composition from a single container.
  • the term includes in particular drugs such as peptides (e.g.
  • insulins insulin-containing drugs, GLP-1-containing and derived or analogous preparations
  • proteins and hormones proteins and hormones
  • biologically derived or active active ingredients active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances both in solid (suspended) or liquid form.
  • the term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base, auxiliary and carrier materials.
  • distal refers to a side or direction directed towards the front, puncture-side end of the administration device or towards the tip of the injection needle.
  • proximal refers to a side or direction directed towards the rear end of the administration device opposite the puncture end.
  • the term “injector” is understood to mean a device in which the injection needle is removed from the tissue after a controlled amount of the medical substance has been delivered. This leaves you with an injector In contrast to an infusion system, the injection needle does not remain in the tissue for a long period of several hours.
  • the assembly of the auto-injector or its assemblies and the insertion of a product container during final assembly should be possible more reliably and the operation and handling of the auto-injector should be easier and safer.
  • the pre-assembly of assemblies or storage and transport as well as feeding of the same, which is separated in time and place from the final assembly of the auto-injector, should be ensured in a simpler and safer manner; in particular, the integrity of the assemblies should be maintained during transport and feeding.
  • the display should be designed in such a way that even if the user's hand is in an unfavorable, in particular unintended, grip position on the autoinjector, the user can recognize the ongoing delivery without having to change the grip position.
  • An autoinjector comprises a one-piece or multi-part housing with a longitudinal axis and a prefilled syringe with a product container and an injection needle or cannula permanently attached to it.
  • the pre-filled syringe is accommodated in the housing in an axially non-displaceable manner, with a tip of the injection needle protruding past a distal end of the housing by at least one penetration depth in the distal direction.
  • the auto-injector further comprises a torsion spring pretensioned to dispense a maximum content of the product container once, a drive element, a propulsion element, and a needle protection sleeve.
  • the torsion spring sets the drive element in rotation about the longitudinal axis, and the rotating drive element causes a linear movement of the propulsion element to displace a piston in the product container.
  • the needle protection sleeve is pressed against a needle when the autoinjector is pressed Injection site and the resulting piercing of the injection needle into the injection site moves by an actuation stroke in the proximal direction and starts or thereby enables liquid to be released.
  • the actuation stroke of the needle protection sleeve corresponds at least to the insertion depth of the injection needle.
  • the contrast pattern is at most discreetly rotationally symmetrical about the longitudinal axis, but not continuously rotationally symmetrical, so that rotation of the contrast pattern can also be recognized.
  • the contrast pattern comprises at least one area, zone or a graphic element in a color or gray tone or brightness that is different from a background color, preferably in the form of graphic elements repeating in the direction of rotation, such as parallel lines, in particular parallel lines which extend to the longitudinal axis of the auto-injector inclined and/or curved.
  • the contrast pattern can have at least one to approximately 60, in particular 8 to 16 lines or areas or graphic elements.
  • the contrast pattern contains in particular one of the physiologically easily perceptible colors green or black.
  • the display element can be manufactured or designed as follows.
  • the contrast pattern can be applied to the base body of the display element using the pad printing process.
  • the contrast pattern can be produced in different colors using 2-component injection molding.
  • the two components are preferably divided in such a way that the 1st component, preferably made of PBT, contains the functional elements, such as Snapper included. This means that the functional elements are always created with the same material and preferably in the same color.
  • the visual, aesthetic elements such as the counter pattern can be created with the second component, preferably made of colored ABS or PP, and can vary in color.
  • the contrast pattern can be generated using a laser process, preferably using a UV laser, by locally removing material from the display element on the visible surface, whereby a modified structure, in particular a gray one, is created.
  • the surface of the display element can also be melted using a laser process and a suitable choice of material, whereby pigments become visible or the plastic foams due to its ingredients, thereby changing the optical properties in a contrasting manner.
  • material can be removed locally and in a finely structured manner using laser or erosion on the previously polished visible surface of the injection molding tool, whereby structures, in particular roof or cube structures, can be created, which are later transferred to the plastic part during injection molding.
  • Such structures can have a depth or elevation of 0.01 to 0.5 mm. This is an advantageous design for reasons of sustainability, as no different materials are mixed for the component, no paint is applied to the material, or the material is changed locally using laser marking.
  • the contrast pattern can also be created using openings in the visible surface of the display element.
  • the openings allow a view into the dark interior of the auto-injector, in particular the metallic spiral torsion spring.
  • the display element performs less than one revolution, preferably less than half a revolution or even less than a third of a revolution per second during the distribution. This ensures that the rotational movement of the contrast pattern can be easily followed by the eye and does not blur into an indefinite rotationally symmetrical pattern for the viewer.
  • the display element does not display an initial or final state, nor does it provide any relative information about the progress of the distribution; it serves exclusively to signal the progress or continuation of the distribution.
  • the rotating display element and the housing or the window are designed to generate a pouring noise, which additionally acoustically signals to the user that the pouring process is ongoing.
  • the pouring noise is preferably a continuous clicking noise, which is generated by a grid on the window or on the housing and a radially or axially flexible engagement element on the display element, or vice versa by a rotating grid on the display element and a stationary engagement element.
  • the window has a first, cylindrical region parallel to the longitudinal axis, and a second region, which adjoins the first seamlessly in the proximal direction and has a constantly or continuously decreasing diameter.
  • the first area allows a view of the display element from any lateral viewing direction perpendicular to the longitudinal axis
  • the second area allows a view of the display element in the distal viewing direction from behind, or vertically held autoinjector from above.
  • the second region is rounded or constricted in the proximal direction and can end in a third region perpendicular to the longitudinal axis.
  • the display element can have a convex display surface following the course of the window or a cone-shaped display surface with an average inclination with respect to the longitudinal axis.
  • the window is preferably rotationally symmetrical with respect to the longitudinal axis, i.e. with circular cross sections in section planes perpendicular to the longitudinal axis.
  • the autoinjector comprises a needle protection sleeve, which protrudes distally over the housing in the delivery state of the autoinjector and is biased in the distal direction by a needle protection spring.
  • the needle protection sleeve When the autoinjector is pressed against an injection site, the needle protection sleeve carries out an actuation movement in the proximal direction and when the autoinjector is removed from the injection site, it performs a needle protection movement in the distal direction in order to laterally surround and radially cover the injection needle with a sleeve-shaped, preferably rotationally symmetrical section.
  • the needle protection sleeve has an annular flange or foot at a distal end as an enlarged contact surface for the tissue around the injection site.
  • the flange is permanently connected to the sleeve-shaped section and is preferably formed in one piece with it. A maximum diameter of the flange is larger than a maximum diameter of the sleeve-shaped section.
  • the outer edge or periphery of the flange is adapted to the shape of a distal opening in the housing.
  • the flange forms a closure of the housing.
  • the flange is concavely curved, so that the outer edge is located further distally than the transition between the flange and the sleeve-shaped section.
  • the autoinjector comprises a threaded rod as a drive element and a drive sleeve with an internal thread as a drive element, alternatively a drive sleeve with an internal thread as a drive element and a threaded rod as a drive element, the drive element being a groove or a cam Axial guide element for an exclusively linear propulsion movement in the housing.
  • the autoinjector is preferably dimensioned to accommodate a prefilled pre-filled syringe comprising the product container and the injection needle, and having a filling volume of at least 3 ml, preferably at least 5 ml.
  • an auto-injector according to aspects of the invention can be designed as follows:
  • a display for signaling the continuation of a distribution comprising a rotating display element driven by the drive element with an optical contrast pattern, and comprising a window at the proximal end of the autoinjector through which the rotating contrast pattern is visible, characterized in that the window is around the Longitudinal axis is a completely circumferential window.
  • Autoinjector wherein the display element performs less than one, preferably less than half, revolution per second during a distribution.
  • the drive element is a threaded rod and the propulsion element is a propulsion sleeve with an axial guide element for an exclusively linear propulsion movement in the housing.
  • Autoinjector further comprising a prefilled pre-filled syringe comprising the product container and the injection needle, and having a filling volume of at least 3 ml, preferably at least 5 ml.
  • an autoinjector comprises a drive device having a sleeve-shaped first housing part comprising a drive assembly having a spring coil with a drive spring, a drive element in particular a threaded rod, a driving element in particular a piston rod with an internal thread suitable for automatically driving the stopper, a product container receiving device having a sleeve-shaped second Housing part defining a longitudinal axis which extends from distal to proximal, comprising a syringe holder designed to hold a prefilled syringe with a cylindrical product container which tapers over a shoulder at its distal end with a needle protective cap of a needle and one for dispensing a medication from the product container along the Longitudinal axis through the Drive assembly movable plug, a device cap in which the needle protection cap can be received, the first housing part and the second housing part being coaxially connectable in a joining direction, in that on one of the two housing parts, the connection-side end section is
  • the housing parts can be connected one after the other in defined positions or defined linear movement steps in the joining direction or can be detached against the joining direction, which creates advantages for storage, transport and further processing on an automatic machine.
  • the locking through the at least third or last latching connection cannot be opened non-destructively, which improves the operational and manipulation security of the autoinjector. With the third or last locking connection locked, the autoinjector reaches its configuration and/or dimensions for delivery or use.
  • the auto-injector is preferably further developed in that the first housing part and the second housing part can be mutually connected in the joining direction by a linear movement parallel to the longitudinal axis or can be detached against the joining direction.
  • The, in particular all, insertion movements or the movements for joining the housing parts in and releasing the housing parts against the joining direction are aligned and in particular run exclusively in or parallel to the longitudinal axis.
  • This does not include more complex movements of the housing parts, which are caused, for example, by bayonet, screw or threaded fasteners.
  • This enables cost-effective and precise handling of the parts on automatic assembly machines and, thanks to the ability to be connected and detached, the parts can be stored or transported together in a defined position relative to one another before final assembly, ie before inserting a product container.
  • the interior of the pre-assembled auto-injector is protected.
  • the parts connected in this way can be stored and transported as a unit in a rack to save space and safely.
  • the parts or assemblies connected in this way can easily be taken over by an automatic machine, separated in a defined position for the insertion of the pre-filled syringe and then reconnected and finally assembled.
  • the autoinjector is preferably further developed in that a first, second and third locking position of the first housing part is defined relative to the second housing part along the longitudinal axis by the first locking connection and the second and third locking connections. This allows simplified automation and positioning on the assembly machine.
  • the autoinjector is preferably further developed in that one of the housing parts, with its radial step introducing the tapered end section, can be completely abutted all around the connecting end of the other housing part and so the two housing parts together form a stepless lateral surface, which makes the handling of the autoinjector safer, the radial Step in the circumferential direction can be straight or continuously wavy or discontinuously offset. The latter improves anti-twist protection and can support the rotational positioning of the housing parts.
  • the radial step can rotate at right angles or at an angle to the axis.
  • the step formed on one housing part can be abutted in a circumferentially interrupted manner at the connection-side end of the other housing part.
  • the auto-injector is preferably further developed in that one of the housing parts with its radial step initiating the end section abuts the connection-side end of the other housing part in a circumferential manner when the third or last of the latching connections is locked in a form-fitting manner.
  • the autoinjector is preferably further developed in that the two housing parts have longitudinal guides in the area of the end section and/or form a non-circular cross section of the gap guide.
  • the gap guide is preferably not circularly centrally symmetrical in cross section, in particular 2-fold or 4-fold centrally symmetrical, that is, possible assembly positions arise every 180° or 90°.
  • axially extending structures of the locking connections are mutual on both housing parts with respect to the longitudinal axis of the auto-injector and thus form longitudinal guides.
  • the auto-injector is preferably further developed in that one of the housing parts has at least one assembly opening on its end section, which is accessible from the outside at least in the first locking position and is completely covered by the other of the housing parts in at least the third or last locking position.
  • the assembly tool which extends into the interior of the housing part, can serve to hold a component that is movably mounted inside the housing and/or subjected to force or torque at a defined location during an assembly movement and then to release it again. For example, snapping or anchoring of the component can be ensured in this way.
  • the auto-injector is preferably further developed in that the two housing parts can assume exactly three locking positions along the longitudinal axis.
  • the auto-injector is preferably further developed in that the two housing parts are fastened to one another in the third or last locking position alternatively or in addition to the locking connection by gluing or welding. This increases the stability and precision of the connection and ensures the tightness of the butt joint between the two housing parts.
  • the autoinjector is preferably further developed in that it further has a syringe adapter, which can be abutted with its distal end against the proximal end of the pre-filled syringe, the proximal end of the syringe adapter being formed by an elastic element which is operatively connected to the first housing part.
  • the autoinjector is preferably further developed in that the elastic element of the syringe adapter, to which the support surface is connected, is pretensioned or further tensioned by the second joining step or by the movement into the third or last locking position. Which simplifies the final assembly process.
  • the auto-injector is preferably further developed in that the propulsion element can be screwed onto the drive element into a desired starting position. This is how you can do it When the autoinjector is finally assembled, eliminate the free play between the piston in the pre-filled syringe and the propulsion element and/or adapt the starting position of the propulsion element to a piston position of a partially filled pre-filled syringe.
  • the invention presented includes a method for the final assembly of an auto-injector which defines a longitudinal axis, comprising several of the steps:
  • Fig. 1 shows the components of an autoinjector
  • FIG. 2 shows two longitudinal sections through the auto-injector from FIG. 1 before the injection
  • FIG. 5 shows two views of a second embodiment of an auto-injector rotated by 90° relative to one another
  • FIG. 6 shows the components of the autoinjector or the assemblies from FIG. 5,
  • FIG. 7 shows two longitudinal sections of the auto-injector from FIG. 5, rotated by 90° relative to one another, in the delivery state
  • FIG. 8 shows two longitudinal sections of the auto-injector from FIG. 5 rotated by 90° relative to one another in the trigger lock state
  • 12a shows two longitudinal sections of the auto-injector from FIG. 5, rotated by 90° relative to one another, in the dispensing state,
  • Fig. 12c Cross section from a distal view of the display element with display window of the auto-injector from Fig. 5,
  • FIG. 13 shows two longitudinal sections of the auto-injector from FIG. 5, rotated by 90° relative to one another, in the discharge state
  • FIG. 14 shows two longitudinal sections of the auto-injector from FIG.
  • 15a shows two longitudinal sections of the auto-injector from FIG. 5, rotated by 90° relative to one another, broken off in the dispensing state,
  • FIG. 16 shows a view and a longitudinal section of the auto-injector from FIG. 5 in the pre-snapped state
  • 17 shows two longitudinal sections of the product container receiving device with insert pre-assembled, rotated by 90° relative to one another
  • Fig. 19 two longitudinal sections of the product container receiving device with insert and pre-filled syringe finally assembled, rotated by 90° relative to each other,
  • the locking member 18a engages behind a proximally directed edge of the auto-injector or snaps into an axially fixed recess of the auto-injector and thus locks the locking sleeve 18 against distal movement.
  • the switching sleeve 17 is pushed in the distal direction over the locking member 18a by the needle protection spring 15, whereupon the locking member engages behind a proximally directed edge of the switching sleeve 17 in a locking position due to the spring action of the arm and the switching sleeve and the needle protection sleeve locked or blocked against renewed movement in the proximal direction.
  • an additional injection movement indicator is integrated at the proximal end of the auto-injector.
  • the injection force is transmitted from the propulsion element 22 via the drive element via the interfaces 22a/21a, 21c/20c, 20n/25o, 25h/13v and 13e/10o 21, the spring coil 20b, the display window 25b and the mechanical holder 13 are transferred to the drive housing part 10a.
  • Fig. 13 shows two longitudinal sections of the auto-injector from Fig. 5, rotated by 90 ° relative to one another, in the discharge state.
  • the displacement of the stopper 26 in the distal direction stops automatically as soon as it strikes the corresponding contact surface l li of the pre-filled syringe 11 with its contact surface 1 Ij arranged at the distal end.
  • the automatic injection is now ended.
  • the completed distribution can be seen by a user through the motionless display element 25a and the absence of the clicking noise can be perceived, which is caused by the relative movement of the display element 25a and the display window 25b fixed to the housing.
  • Fig. 14 shows two longitudinal sections of the auto-injector from Fig. 5, rotated by 90 ° relative to one another, in the needle protection lock activated state.
  • the needle protection sleeve 14 is moved back into its original position in the distal direction by the spring force of the needle protection spring 15, together with the switching sleeve 17, and is blocked by the locking sleeve 18 against further puncture.
  • the needle protection sleeve 14 and the switching sleeve 17 are displaced distally again into their original positions until the holding openings 14f of the needle protection sleeve 14 come into contact again with the holding cams 10d of the syringe housing part 10b.
  • the switching sleeve 17 is moved in the distal direction into its original position by the spring force of the needle protection spring 15 together with the needle protection sleeve 14.
  • the locking arms 18a of the locking sleeve 18 are briefly deflected inwards until the switching sleeve 17 has completely moved away from the locking cams 18f of the locking arms 18a, whereby the locking cams 18f of the locking arms 18a are now behind the proximal end the switching sleeve
  • the displacement of the switching sleeve 17 relative to the locking sleeve 18 causes its holding arms 18h, which were previously in contact by their contact surfaces 18i, which were in contact with the correspondingly arranged contact surfaces 17g of the switching sleeve 17 and were thus secured against deflection, to now deflect outwards.
  • the coupling sleeve 23 can now be moved in the proximal direction relative to the locking sleeve 18 and the mechanical holder 13.
  • the coupling sleeve 23 Due to the spring force of the needle protection spring 15, which has its proximal spring end 15b in contact with the corresponding spring support 23b of the coupling sleeve 23, the coupling sleeve 23 is now displaced in the proximal direction relative to the locking sleeve 18 until it is in contact with the corresponding contact surfaces 23h Support surfaces 13z of the mechanical holder 13 designed for this purpose are present.
  • the holding surfaces 23g of the holding arms 23e of the coupling sleeve 23 deflect the holding arms 18h of the locking sleeve 18 outwards.
  • Fig. 15a shows two longitudinal sections of the auto-injector from FIG.
  • An injection termination or a stop of the delivery occurs if a user removes the auto-injector 1 from the injection site before the delivery is completed, which also activates the automatic needle protection lock. At the same time, the automatic distribution is stopped, thus preventing unwanted dripping of the remaining medication from the injection needle 11b.
  • the switching sleeve 17 is moved in the distal direction into its original position by the spring force of the needle protection spring 15 together with the needle protection sleeve 14.
  • the locking arms 18a of the locking sleeve 18 are briefly deflected inwards until the switching sleeve 17 has completely moved away from the locking cams 18f of the locking arms 18a, whereby the locking cams 18f of the locking arms 18a are now behind the proximal end the switching sleeve
  • the displacement of the switching sleeve 17 relative to the locking sleeve 18 causes its holding arms 18h, which were previously in contact by their contact surfaces 18i, which were in contact with the correspondingly arranged contact surfaces 17g of the switching sleeve 17 and were thus secured against deflection, to now deflect outwards.
  • the coupling sleeve 23 can now move in the proximal direction relative to the locking sleeve 18 and the mechanical holder 13.
  • the coupling sleeve 23 Due to the spring force of the needle protection spring 15, which has its proximal spring end 15b in contact with the corresponding spring support 23b of the coupling sleeve 23, the coupling sleeve 23 is now displaced in the proximal direction relative to the locking sleeve 18 until it is in contact with the corresponding contact surfaces 23h Support surfaces 13z of the mechanical holder 13 designed for this purpose are present.
  • the holding surfaces 23g of the holding arms 23e of the coupling sleeve 23 deflect the holding arms 18h of the locking sleeve 18 outwards.
  • the displacement of the coupling sleeve 23 in the proximal direction relative to the spring coil 20b causes its contact surfaces 23f of the coupling cams 23a to engage with the corresponding contact surfaces 20o of the proximal arranged clutch cams 20p of the spring coil 20b come - Fig. 15b. This blocks the rotation of the spring coil 20b and stops the automatic distribution.
  • the axial position of the stopper 26 of the pre-filled syringe 11 can be seen through the viewing window 10c of the syringe housing part, whereby a user can estimate how much injection volume has been delivered or how much residual medication is still left.
  • Fig. 16 shows a view and a longitudinal section of the autoinjector 1 from Fig. 5 in the pre-snapped state.
  • the pre-snapped state is the initial state for the assembly of a pre-filled syringe and the final assembly of the auto-injector 1.
  • the two subassemblies, drive device 80 and product container receiving device 90 are separably connected to one another and can be safely stored and transported in a defined position relative to one another due to the non-positive axial and positive rotary fixation become.
  • the subassemblies of product container receiving device 90 and drive device 80 are pre-snapped by means of the releasable snap connection lOv / lOu between the syringe housing part 10b and the drive housing part 10a.
  • the locking cam lOu on the drive housing part 10a engages behind the proximal edge of the locking groove lOv in the syringe housing part 10b.
  • the distal side of the double holding cams 10g abuts the proximal edge of the double holding groove 1Of and thus positions the housing parts 10a, 10b axially relative to one another at a defined distance as shown in FIG. 16.
  • a circumferential step lOy introduces a distal end section lOw on the drive housing part 10a.
  • the mounting windows 10t in the distal end section lOw of the drive housing part 10a are visible and accessible from the outside.
  • the end section lOw is partially inserted into the proximal end of the syringe housing part 10b, with a circumferential axially acting gap guide lOx being formed between the two housing parts 10a, 10b in the area of the end section lOw.
  • Fig. 17 shows two longitudinal sections of the product container receiving device 90 with insert 30 pre-assembled, rotated by 90° relative to one another.
  • the drive device 80 was removed from the pre-snapped auto-injector in a first step and the product container receiving device 90 is now ready to receive a pre-filled syringe in a joining process through the proximal opening.
  • the insert 30, with its distal holding openings 30b engages with the corresponding holding cams 16b of the device cap 16.
  • the holding slots 3 Qj of the holding arms 30a are positioned in relation to the correspondingly arranged holding ribs 12a of the syringe holder 12 so that the flexible holding arms with the holding cams 30a can deflect outwards, with the holding ribs 12a of the syringe holder 12 in the holding slots 3 Qj of the Retract the holding arms 30a or find space for the holding arms 30a in the axially running recesses next to the holding ribs 12a.
  • Fig. 18 shows two longitudinal sections of the product container receiving device 90 with pre-assembled pre-assembled syringe 11 (PFS with RNS), rotated by 90 ° relative to each other.
  • the pre-filled syringe 11 is inserted axially in the distal direction into the product container receiving device 90 until its support surface 1 Id comes into contact with the corresponding holding arms with holding cams 30a and the support surfaces 30h of the insert 30.
  • the holding cams of the flexible holding arms 30a of the insert 30 slide over the lateral surface of the needle protection cap 11a of the pre-filled syringe 11 until the holding cams snap elastically into place on the holding arm 30a proximal to the shoulder 1 If of the needle protection cap 11a.
  • Fig. 19 shows two longitudinal sections of the product container receiving device 90 with insert 30 and pre-filled syringe 11 (PFS with RNS), rotated by 90° relative to one another, finally assembled.
  • the pre-filled syringe 11 is inserted further axially in the distal direction into the auto-injector until its support surfaces or shoulders 1 Id come into contact with the correspondingly arranged support edges 12c of the syringe holder 12. Due to the contact of the support surface 1 Id of the pre-filled syringe 11 with the corresponding holding cams 30a and the end-side support surfaces 30h of the insert 30, the latter is pushed in the distal direction relative to the device cap 16.
  • the holding cams 16b change from the distal holding openings 30b to the proximal holding openings 30c.
  • the holding snap 14d of the needle protection sleeve 14 changes from the holding opening 30d into the correspondingly designed proximal holding openings 30e of the insert 30.
  • Fig. 20a shows a longitudinal section of the product container receiving device 90 with mounted pre-filled syringe 11 after a first joining step of the drive device 80.
  • an assembly tool (not shown) can be inserted laterally through the assembly window 10t (see Fig. 16) and the switching sleeve 17 through Fix the engagement in the mounting groove 17j (see Fig. 6) axially relative to the housing part 10a, which ensures that the locking catch 17e on the held switching sleeve 17 can deflect into the holding opening 14k of the needle protection sleeve 14 during the first joining step.
  • 20b shows a longitudinal section of the product container receiving device 90 with the pre-filled syringe 11 mounted after a second final joining step of the drive device 80.
  • the assembly tool (not shown) is removed.
  • the drive device 80 is inserted axially into the product container receiving device 90 in a linear movement along the gap guide lOx up to the stop at the step lOy, the double holding cams 10g snapping into their corresponding double snap grooves lOf and the drive device 80 in a form-fitting manner thus permanently connected to the product container receiving device 90.
  • the assembly windows 10t at the distal end section lOw of the drive housing part 10a are covered by the circumferential sleeve-shaped end of the syringe housing part 10b, as a result of which the outer shell of the finally assembled auto-injector 1 is not broken through by disruptive openings and the interior of the auto-injector 1 remains protected.
  • the support surface 13c of the syringe adapter 13a is axially positioned by the support surface I le at the proximal end of the pre-filled syringe 11, the flexible elements 13d of the syringe adapter 13a, to which the support surface 13c is connected, being prestressed by the second joining step.
  • Fig. 21a shows an auto-injector variant for an exemplary piercing depth of 8 mm in the delivery state and Fig. 21b in the pierced state.
  • Fig. 22a shows an auto-injector variant for an exemplary puncture depth of 5 mm in the delivery state and Fig. 22b in the pierced state.
  • These two and other variants only differ in that they have different needle protection sleeves 14, in which the axially extending section 14b is made shorter or longer, whereby the flange 14c to be placed on the skin is positioned differently, which limits the penetration depth of the needle 11b accordingly.
  • different drive springs can be installed.
  • the mainsprings have different spring band widths and therefore deliver different spring torques.
  • filling profiles 25s of different lengths extending axially can be provided distally on the display window 25b so that the installation space for the spring is axially limited. This prevents the spring spiral from breaking out in the axial direction.
  • 24a and 24b each show a longitudinal section through autoinjectors with prefilled syringes, which are prefilled with different volumes of medication.
  • the stroke of the propulsion element 22 is maximum.
  • the stroke of the can be reduced by means of different mounting positions, whereby the same parts can be used.
  • the propulsion element 22 can be screwed onto the drive element 21 into a desired starting position. Gradations of the different starting positions for the propulsion element 22 result from its axially extending anti-rotation rib 22b, which is guided in the correspondingly arranged anti-rotation groove 13h of the mechanical holder 13.
  • the gradation of the different starting positions of the propulsion element 22 is further dependent on the design of the coupling 23 or the spring coil 20b with regard to the number of retaining cams 23c, coupling cams distal 20e, coupling cams proximal 20p as well as on the thread pitch and the number of thread turns on the external thread section 21a Drive element 21.
  • an adapted syringe housing part 10b with shorter viewing windows 10c can be used.
  • a trigger sleeve 30k with claws 301 inclined distally and towards the axis L can be fastened in a form-fitting manner, in particular irreversibly snapped, in the device cap 16 (instead of the insert 30).
  • the claws 301 slide along the lateral surface of the needle protection cap 11a.
  • the claws grab into the lateral surface and take the needle protection cap 11a with them, whereby the clamping area 11g and the injection needle 11b of the pre-filled syringe 11 are exposed.

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 auto-injecteur comprenant : - un dispositif d'entraînement (80) qui présente une première partie de boîtier (10a) ; - un dispositif de réception de récipient de produit (90) qui comprend une seconde partie de boîtier (10b) comprenant un support de seringue (12) conçu pour recevoir une seringue complète pré-remplie (11) et un bouchon mobile (26) pour verser un médicament à partir du récipient de produit (11c) ; la première partie de boîtier (10a) et la seconde partie de boîtier (10b) pouvant être reliées de manière coaxiale dans la direction de jonction par une partie d'extrémité côté liaison (10w) qui est appuyée sur un épaulement de l'une des deux parties de boîtier (10a, 10b) de telle sorte que ladite partie d'extrémité peut être poussée dans l'autre des deux parties de boîtier (10a, 10b) ; une première liaison par clipsage (10u, 10v) ainsi qu'une deuxième et une troisième liaison par clipsage (10f, 10g) étant situées dans la région de la partie d'extrémité (10w) et pouvant être successivement clipsées dans la direction de jonction ; et, à l'inverse de la direction de jonction, la première des liaisons par clipsage (10u, 10v) étant libérable et au moins la troisième ou la troisième ou la dernière liaison par clipsage (10f, 10g) se verrouillant. L'invention concerne également un procédé d'assemblage final d'un auto-injecteur.
EP23761131.4A 2022-08-25 2023-08-24 Auto-injecteur amélioré Pending EP4577269A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22192171.1A EP4327847A1 (fr) 2022-08-25 2022-08-25 Auto-injecteur amélioré
PCT/EP2023/073281 WO2024042188A1 (fr) 2022-08-25 2023-08-24 Auto-injecteur amélioré

Publications (1)

Publication Number Publication Date
EP4577269A1 true EP4577269A1 (fr) 2025-07-02

Family

ID=83080929

Family Applications (2)

Application Number Title Priority Date Filing Date
EP22192171.1A Withdrawn EP4327847A1 (fr) 2022-08-25 2022-08-25 Auto-injecteur amélioré
EP23761131.4A Pending EP4577269A1 (fr) 2022-08-25 2023-08-24 Auto-injecteur amélioré

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP22192171.1A Withdrawn EP4327847A1 (fr) 2022-08-25 2022-08-25 Auto-injecteur amélioré

Country Status (4)

Country Link
US (1) US20250186699A1 (fr)
EP (2) EP4327847A1 (fr)
CN (1) CN119768200A (fr)
WO (1) WO2024042188A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4552673A1 (fr) * 2023-11-07 2025-05-14 Ypsomed AG Dispositif d'injection à quantité réduite de pièces

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE499961T1 (de) * 2000-03-23 2011-03-15 Antares Pharma Inc Einwegdruckstrahlinjektor
AU2012269771B2 (en) 2011-06-17 2015-04-16 Shl Medical Ag Injection device
JP2014526369A (ja) * 2011-09-22 2014-10-06 アッヴィ・インコーポレイテッド 自動注入装置
EP2596822A1 (fr) 2011-11-24 2013-05-29 Sanofi-Aventis Deutschland GmbH Auto-injecteur
CA2856915C (fr) 2011-11-25 2015-12-29 Shl Group Ab Dispositif de distribution de medicament
WO2013153011A1 (fr) 2012-04-11 2013-10-17 Sanofi-Aventis Deutschland Gmbh Support de cartouche et injecteur de type stylo-injecteur
AR102195A1 (es) 2014-10-09 2017-02-08 Sanofi Sa Alojamiento y dispositivo de administración de fármacos con el mismo
CH711240A2 (de) 2015-06-23 2016-12-30 Tecpharma Licensing Ag Autoinjektionsvorrichtung.
EP3241580A1 (fr) 2016-05-03 2017-11-08 Sanofi-Aventis Deutschland GmbH Logement pour un dispositif d'injection
CH714527A2 (de) 2019-03-28 2019-06-28 Tecpharma Licensing Ag Injektionsvorrichtung mit einer Kappe zur Entfernung einer Nadelschutzkappe von einem Produktbehälter und Verfahren zum Montieren einer Injektionsvorrichtung.
EP4228723A1 (fr) * 2020-10-14 2023-08-23 SHL Medical AG Mécanisme de verrouillage pour un dispositif d'administration de médicament

Also Published As

Publication number Publication date
WO2024042188A1 (fr) 2024-02-29
US20250186699A1 (en) 2025-06-12
CN119768200A (zh) 2025-04-04
EP4327847A1 (fr) 2024-02-28

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